MDedge Infectious Disease

An Ohio physician pled guilty to charges that he prescribed opioids for nonmedical purposes and continued to prescribe to patients he knew had psychiatric and substance use disorders, admitting that he also engaged in sex with at least three patients in exchange for opioids.

Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.

Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.

Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.

The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.

In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.

Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.

Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.

The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.

Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.

The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.

Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.

The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.

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

An Ohio physician pled guilty to charges that he prescribed opioids for nonmedical purposes and continued to prescribe to patients he knew had psychiatric and substance use disorders, admitting that he also engaged in sex with at least three patients in exchange for opioids.

Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.

Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.

Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.

The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.

In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.

Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.

Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.

The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.

Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.

The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.

Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.

The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.

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

An Ohio physician pled guilty to charges that he prescribed opioids for nonmedical purposes and continued to prescribe to patients he knew had psychiatric and substance use disorders, admitting that he also engaged in sex with at least three patients in exchange for opioids.

Jeffrey B. Sutton, DO, a neuromuscular medicine specialist, pled guilty on January 30 in federal court to 31 counts of illegally prescribing opioids and other controlled substances, 1 count of illegally distributing controlled substances, and 20 counts of health care fraud.

Prosecutors said Dr. Sutton admitted that he ignored warnings from prescription drug management organizations, insurers, and state authorities that he was prescribing excessively high dosages of opioids.

Dr. Sutton also admitted to ignoring patient requests to lower dosages and that he also ignored signs that patients were selling prescribed medications or otherwise engaging in illicit activity, including violations of a “pain management agreement” that he required them to sign.

The fraud counts pertained to Dr. Sutton billing Medicare, Medicaid, and other insurers for medically unnecessary visits that he required of patients so that he could prescribe inappropriate or unnecessary opioids.

In the charging document shared with this news organization, prosecutors said Dr. Sutton had sex with at least three patients, including during office visits and outside of the office. Occasionally, the physician would give opioids or other controlled substances – often benzodiazepines – to these patients, without a prescription or valid medical need.

Dr. Sutton escalated the dosage for one of those patients, even as the subjective pain score did not improve and when the patient’s urine tests showed the presence of THC and buprenorphine, but not any of the prescribed medications.

Another patient came to Dr. Sutton in 2007 with a warning that she had a history of “narcotic-seeking” behavior and diagnoses of depression, anxiety, paranoid schizophrenia, and obsessive-compulsive disorder.

The patient was hospitalized in 2018 for complications from benzodiazepine use (prescribed by Dr. Sutton). She weighed 80 pounds at the time. Dr. Sutton continued to prescribe benzodiazepines and extreme doses of opioids – in excess of 2,000 morphine equivalent dose – “despite recognizing and documenting repeated instances of noncompliance with treatment for psychiatric conditions, and despite the known contraindications of long-term opioid use for patients with these mental illnesses,” according to the charging document.

Dr. Sutton continued to prescribe opioids despite two hospitalizations for overdoses, more than 20 failed urine drug screens that showed presence of illicit drugs such as cocaine, and documented excessive use of alprazolam (Xanax) and methadone.

The physician surrendered his Drug Enforcement Administration Certificate of Registration of Controlled Substances Privileges in February 2022 “as an indication of your good faith in desiring to remedy any incorrect or unlawful practices on your part,” according to a letter to Dr. Sutton from the State Medical Board of Ohio. In that September 2022 letter, the Board notified Dr. Sutton of its intention to possibly suspend or revoke his license.

Dr. Sutton did not request a hearing, and the Board permanently revoked his medical license on January 16.

The court will sentence Dr. Sutton on May 23, according to a report by WFMJ.

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

Long-acting antiretroviral therapy (ART) for HIV involving injections every 1 or 2 months not only shows noninferiority to a standard daily oral treatment regimen, it also suppresses HIV even in patients who do not already have virologic suppression, as is typically required before initiation, results from two new studies suggest.

Meanwhile, a third study shows early promise of a long-acting ART regimen that could require injections only twice yearly.

“Instead of having the burden of taking a pill every day, patients with HIV can now have these choices of being able to forget about their treatment for up to 2 months at a time,” Moti N. Ramgopal, MD, first author of one of the three studies, said in a press conference at the Conference on Retroviruses and Opportunistic Infections. “My patients tell me that it’s game-changing for them.”
 

First head-to-head comparison

The injectable intramuscular combination of cabotegravir and rilpivirine, administered once every 1 or 2 months, is the first and only long-acting ART to be approved by the Food and Drug Administration for people with HIV. At the meeting, Dr. Ramgopal, from the Midway Immunology and Research Center in Fort Pierce, Fla., reported the results from the first head-to-head study comparing the regimen with the standard daily oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF).

For the phase 3b SOLAR trial, adults with HIV who were already virologically suppressed and treated with daily B/FTC/TAF were randomly assigned to remain on the oral regimen (n = 223) or switch to the long-acting injections every 2 months, either with an oral lead-in (n = 173) or without a lead-in (n = 274).

The results after 12 months showed noninferiority between the groups, with 90% of the long-acting ART group and 93% in the oral daily pill group maintaining viral suppression, defined as plasma HIV-1 RNA less than 50 copies/mL.

Two patients (0.4%) receiving the long-acting ART in a modified-intention to treat and 3 (0.6%) in the intention-to-treat populations had confirmed virologic failure, and rates of adverse events leading to withdrawal were 6% with the long-acting ART group versus 1% with the oral treatment group.

As many as 90% of subjects reported preferring the long-acting ART over their previous oral therapy at the end of the study, and those in the long-acting group also reported significantly greater improvements in quality of life on the HIV Treatment Satisfaction Questionnaire status version compared with the oral therapy group at the end of the study (P < .001).

Prior to the randomization, as many as 47% of patients on the oral regimen reported “always” or “often” having psychosocial challenges with the daily therapy, including worries of having their HIV status revealed and forgetting to take the medication.

“These data demonstrate that [the long-acting regimen] addresses important unmet needs for people with HIV who are virally suppressed on oral daily HIV therapy, while improving the quality of life,” said Dr. Ramgopal.
 

Suppression at onset not necessarily required

For all of its benefits, a key caveat of the cabotegravir and rilpivirine long-acting regimen is that it is approved only for patients who have already achieved viral suppression and are currently on oral ART, meaning some of the people most in need, including those with unstable housing, mental illness, or substance abuse disorders, may be excluded.

To evaluate the therapy’s efficacy among those patient types, Monica Gandhi, MD, MPH, professor of medicine and associate division chief at the University of California, San Francisco, enrolled 133 participants between June 2021 and November 2022 at the Ward 86 HIV Clinic, a safety-net clinic in San Francisco, to initiate long-acting ART. Participants included 57 patients (43%) with untreated or unsuppressed HIV, and 76 who were virally suppressed on oral ART.

Of the whole study group, 66% reported unstable housing, 8% reported experiencing homelessness, 38% reported having a mental illness, and 33% reported substance use.

Although all of the subjects (100%) who started with viral suppression remained suppressed over the study’s 26-week follow-up, the rate of viral suppression at the study’s end was nearly as high – 55 of 57 subjects (96.5%) – among those who started long-acting ART without having viral suppression.

Of note, the overall rate of study participants who did not achieve or maintain viral suppression (1.5%) was consistent with rates reported in clinical trials of long-acting ART in people with HIV who had previously achieved viral suppression on daily oral ART.

“Our patient population does not look like the patient population that got enrolled in the clinical trials to determine the approval criteria for long-acting ART,” Dr. Gandhi said in presenting the findings.

“If 10% of the population carries 90% of the HIV virus – which we see in modeling – then we need innovations for this population if we want to end the HIV epidemic,” she added.

“We tried long-acting ART in our diverse, urban, low-income population and we saw very high virologic suppression rates equal to those that were seen in the clinical trials,” Dr. Ghandi reported. “This shows that long-acting ART, used creatively and used boldly, could really make a dent in the [efforts] to end the HIV epidemic movement.”

Commenting on the study in a press statement, Nora Volkow, MD, director of the National Institute on Drug Abuse, said “Dr. Gandhi and her team have made state-of-the-art HIV treatment finally available to people with unique challenges, like those who use drugs, and have found success.”

“This is the sweet spot for addressing HIV – thinking outside the box to deliver care in a way that meets people’s needs, even when that means it happens outside the clinic walls, by phone, or on neighborhood streets,” she said. “This can be done, but it requires creativity and resolve.”
 

Twice-yearly dosing option?

Looking ahead, an even more intriguing scenario of a long-acting ART requiring injections only once every 6 months may be getting closer to fruition. Researchers at CROI 2023 reported early but promising safety and efficacy results of an innovative combination of the first-in-class HIV-1 capsid inhibitor lenacapavir with teropavimab and zinlirvimab, two broadly neutralizing antibodies (bNAbs).

To achieve the goal of the longer-acting therapy, Joseph J. Eron, MD, of the University of North Carolina at Chapel Hill, and colleagues modified both antibodies to extend their half-lives and allow less-frequent dosing.

For the phase 1b trial, 20 adult patients with virologically suppressed HIV for at least 18 months were randomly assigned to one of two doses of the ART, both groups receiving lenacapavir at 927 mg subcutaneous after oral loading, plus teropavimab (30 mg/kg IV) and zinlirvimab at either 10 mg/kg or 30 mg/kg.

Patients had to have a CD4 count greater than 500 and CD4 nadir greater than 350, and importantly, patients had to demonstrate sensitivity on DNA phenotyping to both bNAbs at baseline.

After 26 weeks, 18 of the 20 participants (90%) maintained a viral suppression of HIV-1 RNA less than 50 copies/mL.

Of the remaining two patients, one in the 10–mg/kg zinlirvimab group had a confirmed HIV RNA of 50 c/mL (155 copies/mL, confirmed 524 copies/mL) at week 16 and was able to be resuppressed with reinitiation of baseline ART, and one participant in the zinlirvimab 30 mg/kg group withdrew consent at week 12, with viral suppression, and chose to go back on oral therapy

The safety profile looked favorable, with no serious adverse events and two patients with grade 3 AEs, including one experiencing an injection site cellulitis and one with injection site erythema.

Dr. Eron noted that “bNAb sensitivity is an important issue and a limitation for broad use, [because] only about 50% of people with HIV in the U.S. would be sensitive to both antibodies.”

However, “we are doing a pilot of only 10 participants looking to see if it works with sensitivity to a single antibody, which would increase [applicability] to about 90% of people with HIV,” he said in an interview.

At a press conference, Dr. Eron commented on how far HIV treatment has come, from the early days of patients having to wake up every 4 hours to take their medication, then to having to take 15-20 pills a day, to the current option of long-acting ART every other month, and now the potential of just a twice-yearly treatment.

“This is a very preliminary proof-of-concept study and not a very large study, but I think it’s incredibly important,” he said.

The SOLAR study was funded by ViiV Healthcare. Dr. Ramgopal has received speaking and/or consulting fees from AbbVie, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. Dr. Eron’s study was funded by Gilead Sciences.

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

Long-acting antiretroviral therapy (ART) for HIV involving injections every 1 or 2 months not only shows noninferiority to a standard daily oral treatment regimen, it also suppresses HIV even in patients who do not already have virologic suppression, as is typically required before initiation, results from two new studies suggest.

Meanwhile, a third study shows early promise of a long-acting ART regimen that could require injections only twice yearly.

“Instead of having the burden of taking a pill every day, patients with HIV can now have these choices of being able to forget about their treatment for up to 2 months at a time,” Moti N. Ramgopal, MD, first author of one of the three studies, said in a press conference at the Conference on Retroviruses and Opportunistic Infections. “My patients tell me that it’s game-changing for them.”
 

First head-to-head comparison

The injectable intramuscular combination of cabotegravir and rilpivirine, administered once every 1 or 2 months, is the first and only long-acting ART to be approved by the Food and Drug Administration for people with HIV. At the meeting, Dr. Ramgopal, from the Midway Immunology and Research Center in Fort Pierce, Fla., reported the results from the first head-to-head study comparing the regimen with the standard daily oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF).

For the phase 3b SOLAR trial, adults with HIV who were already virologically suppressed and treated with daily B/FTC/TAF were randomly assigned to remain on the oral regimen (n = 223) or switch to the long-acting injections every 2 months, either with an oral lead-in (n = 173) or without a lead-in (n = 274).

The results after 12 months showed noninferiority between the groups, with 90% of the long-acting ART group and 93% in the oral daily pill group maintaining viral suppression, defined as plasma HIV-1 RNA less than 50 copies/mL.

Two patients (0.4%) receiving the long-acting ART in a modified-intention to treat and 3 (0.6%) in the intention-to-treat populations had confirmed virologic failure, and rates of adverse events leading to withdrawal were 6% with the long-acting ART group versus 1% with the oral treatment group.

As many as 90% of subjects reported preferring the long-acting ART over their previous oral therapy at the end of the study, and those in the long-acting group also reported significantly greater improvements in quality of life on the HIV Treatment Satisfaction Questionnaire status version compared with the oral therapy group at the end of the study (P < .001).

Prior to the randomization, as many as 47% of patients on the oral regimen reported “always” or “often” having psychosocial challenges with the daily therapy, including worries of having their HIV status revealed and forgetting to take the medication.

“These data demonstrate that [the long-acting regimen] addresses important unmet needs for people with HIV who are virally suppressed on oral daily HIV therapy, while improving the quality of life,” said Dr. Ramgopal.
 

Suppression at onset not necessarily required

For all of its benefits, a key caveat of the cabotegravir and rilpivirine long-acting regimen is that it is approved only for patients who have already achieved viral suppression and are currently on oral ART, meaning some of the people most in need, including those with unstable housing, mental illness, or substance abuse disorders, may be excluded.

To evaluate the therapy’s efficacy among those patient types, Monica Gandhi, MD, MPH, professor of medicine and associate division chief at the University of California, San Francisco, enrolled 133 participants between June 2021 and November 2022 at the Ward 86 HIV Clinic, a safety-net clinic in San Francisco, to initiate long-acting ART. Participants included 57 patients (43%) with untreated or unsuppressed HIV, and 76 who were virally suppressed on oral ART.

Of the whole study group, 66% reported unstable housing, 8% reported experiencing homelessness, 38% reported having a mental illness, and 33% reported substance use.

Although all of the subjects (100%) who started with viral suppression remained suppressed over the study’s 26-week follow-up, the rate of viral suppression at the study’s end was nearly as high – 55 of 57 subjects (96.5%) – among those who started long-acting ART without having viral suppression.

Of note, the overall rate of study participants who did not achieve or maintain viral suppression (1.5%) was consistent with rates reported in clinical trials of long-acting ART in people with HIV who had previously achieved viral suppression on daily oral ART.

“Our patient population does not look like the patient population that got enrolled in the clinical trials to determine the approval criteria for long-acting ART,” Dr. Gandhi said in presenting the findings.

“If 10% of the population carries 90% of the HIV virus – which we see in modeling – then we need innovations for this population if we want to end the HIV epidemic,” she added.

“We tried long-acting ART in our diverse, urban, low-income population and we saw very high virologic suppression rates equal to those that were seen in the clinical trials,” Dr. Ghandi reported. “This shows that long-acting ART, used creatively and used boldly, could really make a dent in the [efforts] to end the HIV epidemic movement.”

Commenting on the study in a press statement, Nora Volkow, MD, director of the National Institute on Drug Abuse, said “Dr. Gandhi and her team have made state-of-the-art HIV treatment finally available to people with unique challenges, like those who use drugs, and have found success.”

“This is the sweet spot for addressing HIV – thinking outside the box to deliver care in a way that meets people’s needs, even when that means it happens outside the clinic walls, by phone, or on neighborhood streets,” she said. “This can be done, but it requires creativity and resolve.”
 

Twice-yearly dosing option?

Looking ahead, an even more intriguing scenario of a long-acting ART requiring injections only once every 6 months may be getting closer to fruition. Researchers at CROI 2023 reported early but promising safety and efficacy results of an innovative combination of the first-in-class HIV-1 capsid inhibitor lenacapavir with teropavimab and zinlirvimab, two broadly neutralizing antibodies (bNAbs).

To achieve the goal of the longer-acting therapy, Joseph J. Eron, MD, of the University of North Carolina at Chapel Hill, and colleagues modified both antibodies to extend their half-lives and allow less-frequent dosing.

For the phase 1b trial, 20 adult patients with virologically suppressed HIV for at least 18 months were randomly assigned to one of two doses of the ART, both groups receiving lenacapavir at 927 mg subcutaneous after oral loading, plus teropavimab (30 mg/kg IV) and zinlirvimab at either 10 mg/kg or 30 mg/kg.

Patients had to have a CD4 count greater than 500 and CD4 nadir greater than 350, and importantly, patients had to demonstrate sensitivity on DNA phenotyping to both bNAbs at baseline.

After 26 weeks, 18 of the 20 participants (90%) maintained a viral suppression of HIV-1 RNA less than 50 copies/mL.

Of the remaining two patients, one in the 10–mg/kg zinlirvimab group had a confirmed HIV RNA of 50 c/mL (155 copies/mL, confirmed 524 copies/mL) at week 16 and was able to be resuppressed with reinitiation of baseline ART, and one participant in the zinlirvimab 30 mg/kg group withdrew consent at week 12, with viral suppression, and chose to go back on oral therapy

The safety profile looked favorable, with no serious adverse events and two patients with grade 3 AEs, including one experiencing an injection site cellulitis and one with injection site erythema.

Dr. Eron noted that “bNAb sensitivity is an important issue and a limitation for broad use, [because] only about 50% of people with HIV in the U.S. would be sensitive to both antibodies.”

However, “we are doing a pilot of only 10 participants looking to see if it works with sensitivity to a single antibody, which would increase [applicability] to about 90% of people with HIV,” he said in an interview.

At a press conference, Dr. Eron commented on how far HIV treatment has come, from the early days of patients having to wake up every 4 hours to take their medication, then to having to take 15-20 pills a day, to the current option of long-acting ART every other month, and now the potential of just a twice-yearly treatment.

“This is a very preliminary proof-of-concept study and not a very large study, but I think it’s incredibly important,” he said.

The SOLAR study was funded by ViiV Healthcare. Dr. Ramgopal has received speaking and/or consulting fees from AbbVie, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. Dr. Eron’s study was funded by Gilead Sciences.

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

Long-acting antiretroviral therapy (ART) for HIV involving injections every 1 or 2 months not only shows noninferiority to a standard daily oral treatment regimen, it also suppresses HIV even in patients who do not already have virologic suppression, as is typically required before initiation, results from two new studies suggest.

Meanwhile, a third study shows early promise of a long-acting ART regimen that could require injections only twice yearly.

“Instead of having the burden of taking a pill every day, patients with HIV can now have these choices of being able to forget about their treatment for up to 2 months at a time,” Moti N. Ramgopal, MD, first author of one of the three studies, said in a press conference at the Conference on Retroviruses and Opportunistic Infections. “My patients tell me that it’s game-changing for them.”
 

First head-to-head comparison

The injectable intramuscular combination of cabotegravir and rilpivirine, administered once every 1 or 2 months, is the first and only long-acting ART to be approved by the Food and Drug Administration for people with HIV. At the meeting, Dr. Ramgopal, from the Midway Immunology and Research Center in Fort Pierce, Fla., reported the results from the first head-to-head study comparing the regimen with the standard daily oral regimen of bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF).

For the phase 3b SOLAR trial, adults with HIV who were already virologically suppressed and treated with daily B/FTC/TAF were randomly assigned to remain on the oral regimen (n = 223) or switch to the long-acting injections every 2 months, either with an oral lead-in (n = 173) or without a lead-in (n = 274).

The results after 12 months showed noninferiority between the groups, with 90% of the long-acting ART group and 93% in the oral daily pill group maintaining viral suppression, defined as plasma HIV-1 RNA less than 50 copies/mL.

Two patients (0.4%) receiving the long-acting ART in a modified-intention to treat and 3 (0.6%) in the intention-to-treat populations had confirmed virologic failure, and rates of adverse events leading to withdrawal were 6% with the long-acting ART group versus 1% with the oral treatment group.

As many as 90% of subjects reported preferring the long-acting ART over their previous oral therapy at the end of the study, and those in the long-acting group also reported significantly greater improvements in quality of life on the HIV Treatment Satisfaction Questionnaire status version compared with the oral therapy group at the end of the study (P < .001).

Prior to the randomization, as many as 47% of patients on the oral regimen reported “always” or “often” having psychosocial challenges with the daily therapy, including worries of having their HIV status revealed and forgetting to take the medication.

“These data demonstrate that [the long-acting regimen] addresses important unmet needs for people with HIV who are virally suppressed on oral daily HIV therapy, while improving the quality of life,” said Dr. Ramgopal.
 

Suppression at onset not necessarily required

For all of its benefits, a key caveat of the cabotegravir and rilpivirine long-acting regimen is that it is approved only for patients who have already achieved viral suppression and are currently on oral ART, meaning some of the people most in need, including those with unstable housing, mental illness, or substance abuse disorders, may be excluded.

To evaluate the therapy’s efficacy among those patient types, Monica Gandhi, MD, MPH, professor of medicine and associate division chief at the University of California, San Francisco, enrolled 133 participants between June 2021 and November 2022 at the Ward 86 HIV Clinic, a safety-net clinic in San Francisco, to initiate long-acting ART. Participants included 57 patients (43%) with untreated or unsuppressed HIV, and 76 who were virally suppressed on oral ART.

Of the whole study group, 66% reported unstable housing, 8% reported experiencing homelessness, 38% reported having a mental illness, and 33% reported substance use.

Although all of the subjects (100%) who started with viral suppression remained suppressed over the study’s 26-week follow-up, the rate of viral suppression at the study’s end was nearly as high – 55 of 57 subjects (96.5%) – among those who started long-acting ART without having viral suppression.

Of note, the overall rate of study participants who did not achieve or maintain viral suppression (1.5%) was consistent with rates reported in clinical trials of long-acting ART in people with HIV who had previously achieved viral suppression on daily oral ART.

“Our patient population does not look like the patient population that got enrolled in the clinical trials to determine the approval criteria for long-acting ART,” Dr. Gandhi said in presenting the findings.

“If 10% of the population carries 90% of the HIV virus – which we see in modeling – then we need innovations for this population if we want to end the HIV epidemic,” she added.

“We tried long-acting ART in our diverse, urban, low-income population and we saw very high virologic suppression rates equal to those that were seen in the clinical trials,” Dr. Ghandi reported. “This shows that long-acting ART, used creatively and used boldly, could really make a dent in the [efforts] to end the HIV epidemic movement.”

Commenting on the study in a press statement, Nora Volkow, MD, director of the National Institute on Drug Abuse, said “Dr. Gandhi and her team have made state-of-the-art HIV treatment finally available to people with unique challenges, like those who use drugs, and have found success.”

“This is the sweet spot for addressing HIV – thinking outside the box to deliver care in a way that meets people’s needs, even when that means it happens outside the clinic walls, by phone, or on neighborhood streets,” she said. “This can be done, but it requires creativity and resolve.”
 

Twice-yearly dosing option?

Looking ahead, an even more intriguing scenario of a long-acting ART requiring injections only once every 6 months may be getting closer to fruition. Researchers at CROI 2023 reported early but promising safety and efficacy results of an innovative combination of the first-in-class HIV-1 capsid inhibitor lenacapavir with teropavimab and zinlirvimab, two broadly neutralizing antibodies (bNAbs).

To achieve the goal of the longer-acting therapy, Joseph J. Eron, MD, of the University of North Carolina at Chapel Hill, and colleagues modified both antibodies to extend their half-lives and allow less-frequent dosing.

For the phase 1b trial, 20 adult patients with virologically suppressed HIV for at least 18 months were randomly assigned to one of two doses of the ART, both groups receiving lenacapavir at 927 mg subcutaneous after oral loading, plus teropavimab (30 mg/kg IV) and zinlirvimab at either 10 mg/kg or 30 mg/kg.

Patients had to have a CD4 count greater than 500 and CD4 nadir greater than 350, and importantly, patients had to demonstrate sensitivity on DNA phenotyping to both bNAbs at baseline.

After 26 weeks, 18 of the 20 participants (90%) maintained a viral suppression of HIV-1 RNA less than 50 copies/mL.

Of the remaining two patients, one in the 10–mg/kg zinlirvimab group had a confirmed HIV RNA of 50 c/mL (155 copies/mL, confirmed 524 copies/mL) at week 16 and was able to be resuppressed with reinitiation of baseline ART, and one participant in the zinlirvimab 30 mg/kg group withdrew consent at week 12, with viral suppression, and chose to go back on oral therapy

The safety profile looked favorable, with no serious adverse events and two patients with grade 3 AEs, including one experiencing an injection site cellulitis and one with injection site erythema.

Dr. Eron noted that “bNAb sensitivity is an important issue and a limitation for broad use, [because] only about 50% of people with HIV in the U.S. would be sensitive to both antibodies.”

However, “we are doing a pilot of only 10 participants looking to see if it works with sensitivity to a single antibody, which would increase [applicability] to about 90% of people with HIV,” he said in an interview.

At a press conference, Dr. Eron commented on how far HIV treatment has come, from the early days of patients having to wake up every 4 hours to take their medication, then to having to take 15-20 pills a day, to the current option of long-acting ART every other month, and now the potential of just a twice-yearly treatment.

“This is a very preliminary proof-of-concept study and not a very large study, but I think it’s incredibly important,” he said.

The SOLAR study was funded by ViiV Healthcare. Dr. Ramgopal has received speaking and/or consulting fees from AbbVie, Gilead Sciences, Janssen, Merck, and ViiV Healthcare. Dr. Eron’s study was funded by Gilead Sciences.

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

If the pandemic served as a window into our health, what it revealed was a U.S. population that is not only sick but also seemingly only getting sicker. Life expectancy is falling precipitously. Three-fourths of Americans are overweight or obese, half have diabetes or prediabetes, and a majority are metabolically unhealthy. Furthermore, the rates of allergic, inflammatory, and autoimmune diseases are rising at rates of 3%-9% per year in the West, far faster than the speed of genetic change in this population.

Of course, diet and lifestyle are major factors behind such trends, but a grossly underappreciated driver in what ails us is the role of environmental toxins and endocrine-disrupting chemicals. In years past, these factors have largely evaded the traditional Western medical establishment; however, mounting evidence now supports their significance in fertility, metabolic health, and cancer.

Although several industrial chemicals and toxins have been identified as carcinogens and have subsequently been regulated, many more remain persistent in the environment and continue to be freely used. It is therefore incumbent upon both the general public and clinicians to be knowledgeable about these exposures. Here, we review some of the most common exposures and the substantial health risks associated with them, along with some general guidance around best practices for how to minimize exposure.
 

Microplastics

“Microplastics” is a term used to describe small fragments or particles of plastic breakdown or microbeads from household or personal care products, measuring less than 5 mm in length.

Plastic waste is accumulating at alarming and devastating proportions – by 2050, it is estimated that by weight, there will be more plastic than fish in the oceans. That translates into hundreds of thousands of tons of microplastics and trillions of these particles in the seas. A recent study demonstrated that microplastics were present in the bloodstream in the majority of 22 otherwise healthy participants.

Since the 1950s, plastic exposure has been shown to promote tumorigenesis in animal studies, and in vitro studies have demonstrated the toxicity of microplastics at the cellular level. However, it is not well known whether the plastic itself is toxic or if it simply serves as a carrier for other environmental toxins to bioaccumulate.

According to Tasha Stoiber, a senior scientist at the Environmental Working Group, “Microplastics have been widely detected in fish and seafood, as well as other products like bottled water, beer, honey, and tap water.” The EWG states there are no formal advisories on fish consumption to avoid exposure to microplastics at the moment.

Pressure also is mounting for a ban on microbeads in personal care products.

Until such bans are put in place, it is advised to avoid single-use plastics, favor reusable tote bags for grocery shopping rather than plastic bags, and opt for loose leaf tea or paper tea bags rather than mesh-based alternatives.
 

Phthalates

Phthalates are chemicals used to make plastics soft and durable, as well as to bind fragrances. They are commonly found in household items such as vinyl (for example, flooring, shower curtains) and fragrances, air fresheners, and perfumes.

Phthalates are known hormone-disrupting chemicals, exposure to which has been associated with abnormal sexual and brain development in children, as well as lower levels of testosterone in men. Exposures are thought to occur via inhalation, ingestion, and skin contact; however, fasting studies demonstrate that a majority of exposure is probably food related.

To avoid phthalate exposures, recommendations include avoiding polyvinyl chloride plastics (particularly food containers, plastic wrap, and children’s toys), which are identifiable by the recycle code number 3, as well as air fresheners and fragranced products.

The EWG’s Skin Deep database provides an important resource on phthalate-free personal care products.

Despite pressure from consumer advocacy groups, the U.S. Food and Drug Administration has not yet banned phthalates in food packaging.
 

Bisphenol A (BPA)

BPA is a chemical additive used to make clear and hard polycarbonate plastics, as well as epoxy and thermal papers. BPA is one of the highest-volume chemicals, with roughly 6 billion pounds produced each year. BPA is traditionally found in many clear plastic bottles and sippy cups, as well as in the lining of canned foods.

Structurally, BPA acts as an estrogen mimetic and has been associated with cardiovascular disease, obesity, and male sexual dysfunction. Since 2012, BPA has been banned in sippy cups and baby bottles, but there is some debate as to whether its replacements (bisphenol S and bisphenol F) are any safer; they appear to have similar hormonal effects as BPA.

As with phthalates, the majority of ingestion is thought to be food related. BPA has been found in more than 90% of a representative study population in the United States.

Guidance advises avoiding polycarbonate plastics (identifiable with the recycling code number 7), as well as avoiding handling thermal papers such as tickets and receipts, if possible. Food and beverages should be stored in glass or stainless steel. If plastic must be used, opt for polycarbonate- and polyvinyl chloride–free plastics, and food and beverages should never be reheated in plastic containers or wrapping. Canned foods should ideally be avoided, particularly canned tunas and condensed soups. If canned products are bought, they should ideally be BPA free.
 

Dioxins and polychlorinated biphenyls (PCBs)

Dioxins are mainly the byproducts of industrial practices; they are released after incineration, trash burning, and fires. PCBs, which are somewhat structurally related to dioxins, were previously found in products such as flame retardants and coolants. Dioxins and PCBs are often grouped in the same category under the umbrella term “persistent organic pollutants” because they break down slowly and remain in the environment even after emissions have been curbed.

Tetrachlorodibenzodioxin, perhaps the best-known dioxin, is a known carcinogen. Dioxins also have been associated with a host of health implications in development, immunity, and reproductive and endocrine systems. Higher levels of PCB exposure have also been associated with an increased risk for mortality from cardiovascular disease.

Notably, dioxin emissions have been reduced by 90% since the 1980s, and the U.S. Environmental Protection Agency has banned the use of PCBs in industrial manufacturing since 1979. However, environmental dioxins and PCBs still enter the food chain and accumulate in fat.

The best ways to avoid exposures are through limiting meat, fish, and dairy consumption and trimming the skin and fat from meats. The level of dioxins and PCBs found in meat, eggs, fish, and dairy are approximately 5-10 times higher than they are in plant-based foods. Research has shown that farmed salmon is likely to be the most PCB-contaminated protein source in the U.S. diet; however, newer forms of land-based and sustainable aquaculture probably avoid this exposure.
 

Pesticides

The growth of modern monoculture agriculture in the United States over the past century has coincided with a dramatic surge in the use of industrial pesticides. In fact, over 90% of the U.S. population have pesticides in their urine and blood, regardless of where they live. Exposures are thought to be food related.

Approximately 1 billion pounds of pesticides are used annually in the United States, including nearly 300 million pounds of glyphosate, which has been identified as a probable carcinogen by European agencies. The EPA has not yet reached this conclusion, although the matter is currently being litigated.

A large European prospective cohort trial demonstrated a lower risk for cancer in those with a greater frequency of self-reported organic food consumption. In addition to cancer risk, relatively elevated blood levels of a pesticide known as beta-hexachlorocyclohexane (B-HCH) are associated with higher all-cause mortality. Also, exposure to DDE – a metabolite of DDT, a chlorinated pesticide heavily used in the 1940s-1960s that still persists in the environment today – has been shown to increase the risk for Alzheimer’s-type dementia as well as overall cognitive decline.

Because these chlorinated pesticides are often fat soluble, they seem to accumulate in animal products. Therefore, people consuming a vegetarian diet have been found to have lower levels of B-HCH. This has led to the recommendation that consumers of produce should favor organic over conventional, if possible. Here too, the EWG provides an important resource to consumers in the form of shopper guides regarding pesticides in produce.
 

Per- and polyfluoroalkyl substances (PFAS)

PFAS are a group of fluorinated compounds discovered in the 1930s. Their chemical composition includes a durable carbon-fluoride bond, giving them a persistence within the environment that has led to their being referred to as “forever chemicals.”

PFAS have been detected in the blood of 98% of Americans, and in the rainwater of locations as far afield as Tibet and Antarctica. Even low levels of exposure have been associated with an increased risk for cancer, liver disease, low birth weight, and hormonal disruption.

The properties of PFAS also make them both durable at very high heat and water repellent. Notoriously, the chemical was used by 3M to make Scotchgard for carpets and fabrics and by Dupont to make Teflon for nonstick coating of pots and pans. Although perfluorooctanoic acid (PFOA) was removed from nonstick cookware in 2013, PFAS – a family of thousands of synthetic compounds – remain common in fast-food packaging, water- and stain-repellent clothing, firefighting foam, and personal care products. PFAS are released into the environment during the breakdown of these consumer and industrial products, as well as from dumping from waste facilities.

Alarmingly, the EWG notes that up to 200 million Americans may be exposed to PFAS in their drinking water. In March 2021, the EPA announced that they will be regulating PFAS in drinking water; however, the regulations have not been finalized. Currently, it is up to individual states to test for its presence in the water. The EWG has compiled a map of all known PFAS contamination sites.

To avoid or prevent exposures from PFAS, recommendations include filtering tap water with either reverse osmosis or activated carbon filters, as well as avoiding fast food and carry-out food, if possible, and consumer products labeled as “water resistant,” “stain-resistant,” and “nonstick.”

In a testament to how harmful these chemicals are, the EPA recently revised their lifetime health advisories for PFAS, such as PFOA, to 0.004 parts per trillion, which is more than 10,000 times smaller than the previous limit of 70 parts per trillion. The EPA also has proposed formally designating certain PFAS chemicals as “hazardous substances.”

Dr. Goel, clinical assistant professor of medicine at Weill Cornell Medicine, New York, has disclosed no relevant financial relationships. A version of this article originally appeared on Medscape.com.

If the pandemic served as a window into our health, what it revealed was a U.S. population that is not only sick but also seemingly only getting sicker. Life expectancy is falling precipitously. Three-fourths of Americans are overweight or obese, half have diabetes or prediabetes, and a majority are metabolically unhealthy. Furthermore, the rates of allergic, inflammatory, and autoimmune diseases are rising at rates of 3%-9% per year in the West, far faster than the speed of genetic change in this population.

Of course, diet and lifestyle are major factors behind such trends, but a grossly underappreciated driver in what ails us is the role of environmental toxins and endocrine-disrupting chemicals. In years past, these factors have largely evaded the traditional Western medical establishment; however, mounting evidence now supports their significance in fertility, metabolic health, and cancer.

Although several industrial chemicals and toxins have been identified as carcinogens and have subsequently been regulated, many more remain persistent in the environment and continue to be freely used. It is therefore incumbent upon both the general public and clinicians to be knowledgeable about these exposures. Here, we review some of the most common exposures and the substantial health risks associated with them, along with some general guidance around best practices for how to minimize exposure.
 

Microplastics

“Microplastics” is a term used to describe small fragments or particles of plastic breakdown or microbeads from household or personal care products, measuring less than 5 mm in length.

Plastic waste is accumulating at alarming and devastating proportions – by 2050, it is estimated that by weight, there will be more plastic than fish in the oceans. That translates into hundreds of thousands of tons of microplastics and trillions of these particles in the seas. A recent study demonstrated that microplastics were present in the bloodstream in the majority of 22 otherwise healthy participants.

Since the 1950s, plastic exposure has been shown to promote tumorigenesis in animal studies, and in vitro studies have demonstrated the toxicity of microplastics at the cellular level. However, it is not well known whether the plastic itself is toxic or if it simply serves as a carrier for other environmental toxins to bioaccumulate.

According to Tasha Stoiber, a senior scientist at the Environmental Working Group, “Microplastics have been widely detected in fish and seafood, as well as other products like bottled water, beer, honey, and tap water.” The EWG states there are no formal advisories on fish consumption to avoid exposure to microplastics at the moment.

Pressure also is mounting for a ban on microbeads in personal care products.

Until such bans are put in place, it is advised to avoid single-use plastics, favor reusable tote bags for grocery shopping rather than plastic bags, and opt for loose leaf tea or paper tea bags rather than mesh-based alternatives.
 

Phthalates

Phthalates are chemicals used to make plastics soft and durable, as well as to bind fragrances. They are commonly found in household items such as vinyl (for example, flooring, shower curtains) and fragrances, air fresheners, and perfumes.

Phthalates are known hormone-disrupting chemicals, exposure to which has been associated with abnormal sexual and brain development in children, as well as lower levels of testosterone in men. Exposures are thought to occur via inhalation, ingestion, and skin contact; however, fasting studies demonstrate that a majority of exposure is probably food related.

To avoid phthalate exposures, recommendations include avoiding polyvinyl chloride plastics (particularly food containers, plastic wrap, and children’s toys), which are identifiable by the recycle code number 3, as well as air fresheners and fragranced products.

The EWG’s Skin Deep database provides an important resource on phthalate-free personal care products.

Despite pressure from consumer advocacy groups, the U.S. Food and Drug Administration has not yet banned phthalates in food packaging.
 

Bisphenol A (BPA)

BPA is a chemical additive used to make clear and hard polycarbonate plastics, as well as epoxy and thermal papers. BPA is one of the highest-volume chemicals, with roughly 6 billion pounds produced each year. BPA is traditionally found in many clear plastic bottles and sippy cups, as well as in the lining of canned foods.

Structurally, BPA acts as an estrogen mimetic and has been associated with cardiovascular disease, obesity, and male sexual dysfunction. Since 2012, BPA has been banned in sippy cups and baby bottles, but there is some debate as to whether its replacements (bisphenol S and bisphenol F) are any safer; they appear to have similar hormonal effects as BPA.

As with phthalates, the majority of ingestion is thought to be food related. BPA has been found in more than 90% of a representative study population in the United States.

Guidance advises avoiding polycarbonate plastics (identifiable with the recycling code number 7), as well as avoiding handling thermal papers such as tickets and receipts, if possible. Food and beverages should be stored in glass or stainless steel. If plastic must be used, opt for polycarbonate- and polyvinyl chloride–free plastics, and food and beverages should never be reheated in plastic containers or wrapping. Canned foods should ideally be avoided, particularly canned tunas and condensed soups. If canned products are bought, they should ideally be BPA free.
 

Dioxins and polychlorinated biphenyls (PCBs)

Dioxins are mainly the byproducts of industrial practices; they are released after incineration, trash burning, and fires. PCBs, which are somewhat structurally related to dioxins, were previously found in products such as flame retardants and coolants. Dioxins and PCBs are often grouped in the same category under the umbrella term “persistent organic pollutants” because they break down slowly and remain in the environment even after emissions have been curbed.

Tetrachlorodibenzodioxin, perhaps the best-known dioxin, is a known carcinogen. Dioxins also have been associated with a host of health implications in development, immunity, and reproductive and endocrine systems. Higher levels of PCB exposure have also been associated with an increased risk for mortality from cardiovascular disease.

Notably, dioxin emissions have been reduced by 90% since the 1980s, and the U.S. Environmental Protection Agency has banned the use of PCBs in industrial manufacturing since 1979. However, environmental dioxins and PCBs still enter the food chain and accumulate in fat.

The best ways to avoid exposures are through limiting meat, fish, and dairy consumption and trimming the skin and fat from meats. The level of dioxins and PCBs found in meat, eggs, fish, and dairy are approximately 5-10 times higher than they are in plant-based foods. Research has shown that farmed salmon is likely to be the most PCB-contaminated protein source in the U.S. diet; however, newer forms of land-based and sustainable aquaculture probably avoid this exposure.
 

Pesticides

The growth of modern monoculture agriculture in the United States over the past century has coincided with a dramatic surge in the use of industrial pesticides. In fact, over 90% of the U.S. population have pesticides in their urine and blood, regardless of where they live. Exposures are thought to be food related.

Approximately 1 billion pounds of pesticides are used annually in the United States, including nearly 300 million pounds of glyphosate, which has been identified as a probable carcinogen by European agencies. The EPA has not yet reached this conclusion, although the matter is currently being litigated.

A large European prospective cohort trial demonstrated a lower risk for cancer in those with a greater frequency of self-reported organic food consumption. In addition to cancer risk, relatively elevated blood levels of a pesticide known as beta-hexachlorocyclohexane (B-HCH) are associated with higher all-cause mortality. Also, exposure to DDE – a metabolite of DDT, a chlorinated pesticide heavily used in the 1940s-1960s that still persists in the environment today – has been shown to increase the risk for Alzheimer’s-type dementia as well as overall cognitive decline.

Because these chlorinated pesticides are often fat soluble, they seem to accumulate in animal products. Therefore, people consuming a vegetarian diet have been found to have lower levels of B-HCH. This has led to the recommendation that consumers of produce should favor organic over conventional, if possible. Here too, the EWG provides an important resource to consumers in the form of shopper guides regarding pesticides in produce.
 

Per- and polyfluoroalkyl substances (PFAS)

PFAS are a group of fluorinated compounds discovered in the 1930s. Their chemical composition includes a durable carbon-fluoride bond, giving them a persistence within the environment that has led to their being referred to as “forever chemicals.”

PFAS have been detected in the blood of 98% of Americans, and in the rainwater of locations as far afield as Tibet and Antarctica. Even low levels of exposure have been associated with an increased risk for cancer, liver disease, low birth weight, and hormonal disruption.

The properties of PFAS also make them both durable at very high heat and water repellent. Notoriously, the chemical was used by 3M to make Scotchgard for carpets and fabrics and by Dupont to make Teflon for nonstick coating of pots and pans. Although perfluorooctanoic acid (PFOA) was removed from nonstick cookware in 2013, PFAS – a family of thousands of synthetic compounds – remain common in fast-food packaging, water- and stain-repellent clothing, firefighting foam, and personal care products. PFAS are released into the environment during the breakdown of these consumer and industrial products, as well as from dumping from waste facilities.

Alarmingly, the EWG notes that up to 200 million Americans may be exposed to PFAS in their drinking water. In March 2021, the EPA announced that they will be regulating PFAS in drinking water; however, the regulations have not been finalized. Currently, it is up to individual states to test for its presence in the water. The EWG has compiled a map of all known PFAS contamination sites.

To avoid or prevent exposures from PFAS, recommendations include filtering tap water with either reverse osmosis or activated carbon filters, as well as avoiding fast food and carry-out food, if possible, and consumer products labeled as “water resistant,” “stain-resistant,” and “nonstick.”

In a testament to how harmful these chemicals are, the EPA recently revised their lifetime health advisories for PFAS, such as PFOA, to 0.004 parts per trillion, which is more than 10,000 times smaller than the previous limit of 70 parts per trillion. The EPA also has proposed formally designating certain PFAS chemicals as “hazardous substances.”

Dr. Goel, clinical assistant professor of medicine at Weill Cornell Medicine, New York, has disclosed no relevant financial relationships. A version of this article originally appeared on Medscape.com.

If the pandemic served as a window into our health, what it revealed was a U.S. population that is not only sick but also seemingly only getting sicker. Life expectancy is falling precipitously. Three-fourths of Americans are overweight or obese, half have diabetes or prediabetes, and a majority are metabolically unhealthy. Furthermore, the rates of allergic, inflammatory, and autoimmune diseases are rising at rates of 3%-9% per year in the West, far faster than the speed of genetic change in this population.

Of course, diet and lifestyle are major factors behind such trends, but a grossly underappreciated driver in what ails us is the role of environmental toxins and endocrine-disrupting chemicals. In years past, these factors have largely evaded the traditional Western medical establishment; however, mounting evidence now supports their significance in fertility, metabolic health, and cancer.

Although several industrial chemicals and toxins have been identified as carcinogens and have subsequently been regulated, many more remain persistent in the environment and continue to be freely used. It is therefore incumbent upon both the general public and clinicians to be knowledgeable about these exposures. Here, we review some of the most common exposures and the substantial health risks associated with them, along with some general guidance around best practices for how to minimize exposure.
 

Microplastics

“Microplastics” is a term used to describe small fragments or particles of plastic breakdown or microbeads from household or personal care products, measuring less than 5 mm in length.

Plastic waste is accumulating at alarming and devastating proportions – by 2050, it is estimated that by weight, there will be more plastic than fish in the oceans. That translates into hundreds of thousands of tons of microplastics and trillions of these particles in the seas. A recent study demonstrated that microplastics were present in the bloodstream in the majority of 22 otherwise healthy participants.

Since the 1950s, plastic exposure has been shown to promote tumorigenesis in animal studies, and in vitro studies have demonstrated the toxicity of microplastics at the cellular level. However, it is not well known whether the plastic itself is toxic or if it simply serves as a carrier for other environmental toxins to bioaccumulate.

According to Tasha Stoiber, a senior scientist at the Environmental Working Group, “Microplastics have been widely detected in fish and seafood, as well as other products like bottled water, beer, honey, and tap water.” The EWG states there are no formal advisories on fish consumption to avoid exposure to microplastics at the moment.

Pressure also is mounting for a ban on microbeads in personal care products.

Until such bans are put in place, it is advised to avoid single-use plastics, favor reusable tote bags for grocery shopping rather than plastic bags, and opt for loose leaf tea or paper tea bags rather than mesh-based alternatives.
 

Phthalates

Phthalates are chemicals used to make plastics soft and durable, as well as to bind fragrances. They are commonly found in household items such as vinyl (for example, flooring, shower curtains) and fragrances, air fresheners, and perfumes.

Phthalates are known hormone-disrupting chemicals, exposure to which has been associated with abnormal sexual and brain development in children, as well as lower levels of testosterone in men. Exposures are thought to occur via inhalation, ingestion, and skin contact; however, fasting studies demonstrate that a majority of exposure is probably food related.

To avoid phthalate exposures, recommendations include avoiding polyvinyl chloride plastics (particularly food containers, plastic wrap, and children’s toys), which are identifiable by the recycle code number 3, as well as air fresheners and fragranced products.

The EWG’s Skin Deep database provides an important resource on phthalate-free personal care products.

Despite pressure from consumer advocacy groups, the U.S. Food and Drug Administration has not yet banned phthalates in food packaging.
 

Bisphenol A (BPA)

BPA is a chemical additive used to make clear and hard polycarbonate plastics, as well as epoxy and thermal papers. BPA is one of the highest-volume chemicals, with roughly 6 billion pounds produced each year. BPA is traditionally found in many clear plastic bottles and sippy cups, as well as in the lining of canned foods.

Structurally, BPA acts as an estrogen mimetic and has been associated with cardiovascular disease, obesity, and male sexual dysfunction. Since 2012, BPA has been banned in sippy cups and baby bottles, but there is some debate as to whether its replacements (bisphenol S and bisphenol F) are any safer; they appear to have similar hormonal effects as BPA.

As with phthalates, the majority of ingestion is thought to be food related. BPA has been found in more than 90% of a representative study population in the United States.

Guidance advises avoiding polycarbonate plastics (identifiable with the recycling code number 7), as well as avoiding handling thermal papers such as tickets and receipts, if possible. Food and beverages should be stored in glass or stainless steel. If plastic must be used, opt for polycarbonate- and polyvinyl chloride–free plastics, and food and beverages should never be reheated in plastic containers or wrapping. Canned foods should ideally be avoided, particularly canned tunas and condensed soups. If canned products are bought, they should ideally be BPA free.
 

Dioxins and polychlorinated biphenyls (PCBs)

Dioxins are mainly the byproducts of industrial practices; they are released after incineration, trash burning, and fires. PCBs, which are somewhat structurally related to dioxins, were previously found in products such as flame retardants and coolants. Dioxins and PCBs are often grouped in the same category under the umbrella term “persistent organic pollutants” because they break down slowly and remain in the environment even after emissions have been curbed.

Tetrachlorodibenzodioxin, perhaps the best-known dioxin, is a known carcinogen. Dioxins also have been associated with a host of health implications in development, immunity, and reproductive and endocrine systems. Higher levels of PCB exposure have also been associated with an increased risk for mortality from cardiovascular disease.

Notably, dioxin emissions have been reduced by 90% since the 1980s, and the U.S. Environmental Protection Agency has banned the use of PCBs in industrial manufacturing since 1979. However, environmental dioxins and PCBs still enter the food chain and accumulate in fat.

The best ways to avoid exposures are through limiting meat, fish, and dairy consumption and trimming the skin and fat from meats. The level of dioxins and PCBs found in meat, eggs, fish, and dairy are approximately 5-10 times higher than they are in plant-based foods. Research has shown that farmed salmon is likely to be the most PCB-contaminated protein source in the U.S. diet; however, newer forms of land-based and sustainable aquaculture probably avoid this exposure.
 

Pesticides

The growth of modern monoculture agriculture in the United States over the past century has coincided with a dramatic surge in the use of industrial pesticides. In fact, over 90% of the U.S. population have pesticides in their urine and blood, regardless of where they live. Exposures are thought to be food related.

Approximately 1 billion pounds of pesticides are used annually in the United States, including nearly 300 million pounds of glyphosate, which has been identified as a probable carcinogen by European agencies. The EPA has not yet reached this conclusion, although the matter is currently being litigated.

A large European prospective cohort trial demonstrated a lower risk for cancer in those with a greater frequency of self-reported organic food consumption. In addition to cancer risk, relatively elevated blood levels of a pesticide known as beta-hexachlorocyclohexane (B-HCH) are associated with higher all-cause mortality. Also, exposure to DDE – a metabolite of DDT, a chlorinated pesticide heavily used in the 1940s-1960s that still persists in the environment today – has been shown to increase the risk for Alzheimer’s-type dementia as well as overall cognitive decline.

Because these chlorinated pesticides are often fat soluble, they seem to accumulate in animal products. Therefore, people consuming a vegetarian diet have been found to have lower levels of B-HCH. This has led to the recommendation that consumers of produce should favor organic over conventional, if possible. Here too, the EWG provides an important resource to consumers in the form of shopper guides regarding pesticides in produce.
 

Per- and polyfluoroalkyl substances (PFAS)

PFAS are a group of fluorinated compounds discovered in the 1930s. Their chemical composition includes a durable carbon-fluoride bond, giving them a persistence within the environment that has led to their being referred to as “forever chemicals.”

PFAS have been detected in the blood of 98% of Americans, and in the rainwater of locations as far afield as Tibet and Antarctica. Even low levels of exposure have been associated with an increased risk for cancer, liver disease, low birth weight, and hormonal disruption.

The properties of PFAS also make them both durable at very high heat and water repellent. Notoriously, the chemical was used by 3M to make Scotchgard for carpets and fabrics and by Dupont to make Teflon for nonstick coating of pots and pans. Although perfluorooctanoic acid (PFOA) was removed from nonstick cookware in 2013, PFAS – a family of thousands of synthetic compounds – remain common in fast-food packaging, water- and stain-repellent clothing, firefighting foam, and personal care products. PFAS are released into the environment during the breakdown of these consumer and industrial products, as well as from dumping from waste facilities.

Alarmingly, the EWG notes that up to 200 million Americans may be exposed to PFAS in their drinking water. In March 2021, the EPA announced that they will be regulating PFAS in drinking water; however, the regulations have not been finalized. Currently, it is up to individual states to test for its presence in the water. The EWG has compiled a map of all known PFAS contamination sites.

To avoid or prevent exposures from PFAS, recommendations include filtering tap water with either reverse osmosis or activated carbon filters, as well as avoiding fast food and carry-out food, if possible, and consumer products labeled as “water resistant,” “stain-resistant,” and “nonstick.”

In a testament to how harmful these chemicals are, the EPA recently revised their lifetime health advisories for PFAS, such as PFOA, to 0.004 parts per trillion, which is more than 10,000 times smaller than the previous limit of 70 parts per trillion. The EPA also has proposed formally designating certain PFAS chemicals as “hazardous substances.”

Dr. Goel, clinical assistant professor of medicine at Weill Cornell Medicine, New York, has disclosed no relevant financial relationships. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University’s Grossman School of Medicine, where I’m the director.

It’s flu season, yet again. For many parts of the country, we’re already in the thick of it, and for other places, we’re going to have flu outbreaks continuing and intensifying. I’ve long believed that every health care institution – nursing homes, hospitals, clinics, home care, hospice – should require flu shots for all doctors and all nurses because it is the easiest, cheapest, and most ethical way to protect the workforce, who you need to be in there when flu outbreaks take place, and to protect patients against getting the flu when they come into hospital settings and get exposed to health care workers who may have the flu already but don’t know it.

In a recent poll, I was happy to see that the majority of physicians surveyed agreed with me: 65% said they supported mandatory flu vaccination in hospitals and only 23% said they did not. I think flu vaccination is something that has already been shown to be useful and important, not only in stopping people from getting the flu but also in making sure that they don’t get as sick when they get the flu.

Just like COVID-19 vaccination, it doesn’t always prevent somebody from getting infected, but if you get it, it keeps you from winding up sick at home, or worse – from dying and winding up in the morgue. Flu kills many, many people every year. We don’t want that to happen. A flu vaccine will really help prevent deaths, help prevent the number of symptoms that somebody gets, and will get people back to work. The benefits are pretty clear.

Does the flu vaccine work equally well every year? It does not. Some years, the strains that are picked for the vaccine don’t match the ones that circulate, and we don’t get as much protection as we hoped for. I think the safety side is so strong that it’s worth making the investment and the effort to promote mandatory flu vaccination.

Can you opt out on religious grounds? Well, some hospitals permit that at New York University. You have to go before a committee and make a case that your exemption on religious grounds is based on an authentic set of beliefs that are deeply held, and not just something you thought up the day before flu vaccine requirements went into effect.

There may be room for some exemptions – obviously, for health reasons. If people think that the flu vaccine is dangerous to them and can get a physician to agree and sign off that they are not appropriate to vaccinate, okay.

On the other hand, if you’re working with an especially vulnerable population – newborns, people who are immunosuppressed – then I think you’ve got to be vaccinated and you shouldn’t be working around people who are at huge risk of getting the flu if you refuse to be vaccinated or, for that matter, can’t be vaccinated.

Would I extend these mandates? Yes, I would. I’d extend them to COVID-19 vaccination and to measles vaccination. I think physicians and nurses should be good role models. They should get vaccinated. We know that the best available evidence says that vaccination for infectious disease is safe. It is really the best thing we can do to combat a variety of diseases such as the flu and COVID-19.

It seems to me that, in addition, the data that are out there in terms of risks from flu and COVID-19 – deaths in places like nursing homes – are overwhelming about the importance of trying to get staff vaccinated so they don’t bring flu into an institutionalized population. This is similar for prison health and many other settings where people are kept close together and staff may move from place to place, rotating from institution to institution, spreading infectious disease.

I’m going to go with the poll. Let’s keep pushing for health care workers to do the right thing and to be good role models. Let’s get everybody a flu vaccination. Let’s extend it to a COVID-19 vaccination and its boosters.

Let’s try to show the nation that health care is going to be guided by good science, a duty to one’s own health, and a duty to one’s patients. It shouldn’t be political. It should be based on what works best for the interests of health care providers and those they care for.

I’m Art Caplan at the New York University Grossman School of Medicine. Thanks for watching.
 

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University’s Grossman School of Medicine, where I’m the director.

It’s flu season, yet again. For many parts of the country, we’re already in the thick of it, and for other places, we’re going to have flu outbreaks continuing and intensifying. I’ve long believed that every health care institution – nursing homes, hospitals, clinics, home care, hospice – should require flu shots for all doctors and all nurses because it is the easiest, cheapest, and most ethical way to protect the workforce, who you need to be in there when flu outbreaks take place, and to protect patients against getting the flu when they come into hospital settings and get exposed to health care workers who may have the flu already but don’t know it.

In a recent poll, I was happy to see that the majority of physicians surveyed agreed with me: 65% said they supported mandatory flu vaccination in hospitals and only 23% said they did not. I think flu vaccination is something that has already been shown to be useful and important, not only in stopping people from getting the flu but also in making sure that they don’t get as sick when they get the flu.

Just like COVID-19 vaccination, it doesn’t always prevent somebody from getting infected, but if you get it, it keeps you from winding up sick at home, or worse – from dying and winding up in the morgue. Flu kills many, many people every year. We don’t want that to happen. A flu vaccine will really help prevent deaths, help prevent the number of symptoms that somebody gets, and will get people back to work. The benefits are pretty clear.

Does the flu vaccine work equally well every year? It does not. Some years, the strains that are picked for the vaccine don’t match the ones that circulate, and we don’t get as much protection as we hoped for. I think the safety side is so strong that it’s worth making the investment and the effort to promote mandatory flu vaccination.

Can you opt out on religious grounds? Well, some hospitals permit that at New York University. You have to go before a committee and make a case that your exemption on religious grounds is based on an authentic set of beliefs that are deeply held, and not just something you thought up the day before flu vaccine requirements went into effect.

There may be room for some exemptions – obviously, for health reasons. If people think that the flu vaccine is dangerous to them and can get a physician to agree and sign off that they are not appropriate to vaccinate, okay.

On the other hand, if you’re working with an especially vulnerable population – newborns, people who are immunosuppressed – then I think you’ve got to be vaccinated and you shouldn’t be working around people who are at huge risk of getting the flu if you refuse to be vaccinated or, for that matter, can’t be vaccinated.

Would I extend these mandates? Yes, I would. I’d extend them to COVID-19 vaccination and to measles vaccination. I think physicians and nurses should be good role models. They should get vaccinated. We know that the best available evidence says that vaccination for infectious disease is safe. It is really the best thing we can do to combat a variety of diseases such as the flu and COVID-19.

It seems to me that, in addition, the data that are out there in terms of risks from flu and COVID-19 – deaths in places like nursing homes – are overwhelming about the importance of trying to get staff vaccinated so they don’t bring flu into an institutionalized population. This is similar for prison health and many other settings where people are kept close together and staff may move from place to place, rotating from institution to institution, spreading infectious disease.

I’m going to go with the poll. Let’s keep pushing for health care workers to do the right thing and to be good role models. Let’s get everybody a flu vaccination. Let’s extend it to a COVID-19 vaccination and its boosters.

Let’s try to show the nation that health care is going to be guided by good science, a duty to one’s own health, and a duty to one’s patients. It shouldn’t be political. It should be based on what works best for the interests of health care providers and those they care for.

I’m Art Caplan at the New York University Grossman School of Medicine. Thanks for watching.
 

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape. A version of this article originally appeared on Medscape.com.

This transcript has been edited for clarity.

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University’s Grossman School of Medicine, where I’m the director.

It’s flu season, yet again. For many parts of the country, we’re already in the thick of it, and for other places, we’re going to have flu outbreaks continuing and intensifying. I’ve long believed that every health care institution – nursing homes, hospitals, clinics, home care, hospice – should require flu shots for all doctors and all nurses because it is the easiest, cheapest, and most ethical way to protect the workforce, who you need to be in there when flu outbreaks take place, and to protect patients against getting the flu when they come into hospital settings and get exposed to health care workers who may have the flu already but don’t know it.

In a recent poll, I was happy to see that the majority of physicians surveyed agreed with me: 65% said they supported mandatory flu vaccination in hospitals and only 23% said they did not. I think flu vaccination is something that has already been shown to be useful and important, not only in stopping people from getting the flu but also in making sure that they don’t get as sick when they get the flu.

Just like COVID-19 vaccination, it doesn’t always prevent somebody from getting infected, but if you get it, it keeps you from winding up sick at home, or worse – from dying and winding up in the morgue. Flu kills many, many people every year. We don’t want that to happen. A flu vaccine will really help prevent deaths, help prevent the number of symptoms that somebody gets, and will get people back to work. The benefits are pretty clear.

Does the flu vaccine work equally well every year? It does not. Some years, the strains that are picked for the vaccine don’t match the ones that circulate, and we don’t get as much protection as we hoped for. I think the safety side is so strong that it’s worth making the investment and the effort to promote mandatory flu vaccination.

Can you opt out on religious grounds? Well, some hospitals permit that at New York University. You have to go before a committee and make a case that your exemption on religious grounds is based on an authentic set of beliefs that are deeply held, and not just something you thought up the day before flu vaccine requirements went into effect.

There may be room for some exemptions – obviously, for health reasons. If people think that the flu vaccine is dangerous to them and can get a physician to agree and sign off that they are not appropriate to vaccinate, okay.

On the other hand, if you’re working with an especially vulnerable population – newborns, people who are immunosuppressed – then I think you’ve got to be vaccinated and you shouldn’t be working around people who are at huge risk of getting the flu if you refuse to be vaccinated or, for that matter, can’t be vaccinated.

Would I extend these mandates? Yes, I would. I’d extend them to COVID-19 vaccination and to measles vaccination. I think physicians and nurses should be good role models. They should get vaccinated. We know that the best available evidence says that vaccination for infectious disease is safe. It is really the best thing we can do to combat a variety of diseases such as the flu and COVID-19.

It seems to me that, in addition, the data that are out there in terms of risks from flu and COVID-19 – deaths in places like nursing homes – are overwhelming about the importance of trying to get staff vaccinated so they don’t bring flu into an institutionalized population. This is similar for prison health and many other settings where people are kept close together and staff may move from place to place, rotating from institution to institution, spreading infectious disease.

I’m going to go with the poll. Let’s keep pushing for health care workers to do the right thing and to be good role models. Let’s get everybody a flu vaccination. Let’s extend it to a COVID-19 vaccination and its boosters.

Let’s try to show the nation that health care is going to be guided by good science, a duty to one’s own health, and a duty to one’s patients. It shouldn’t be political. It should be based on what works best for the interests of health care providers and those they care for.

I’m Art Caplan at the New York University Grossman School of Medicine. Thanks for watching.
 

Dr. Caplan has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape. A version of this article originally appeared on Medscape.com.

The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.

“This was the first trial to evaluate doxycycline PEP for cisgender women,” said first author Jenell Stewart, DO, of the University of Minnesota, Minneapolis, in discussing the findings at a press conference at the Conference on Retroviruses & Opportunistic Infections.

“Unfortunately, our primary outcome was not statistically significant – we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women,” she said.

The findings are from a study of 449 nonpregnant cisgender women (mean age, 24 years) in Kenya who had been taking daily oral HIV preexposure prophylaxis (PrEP) for a median of about 7 months.

The women were randomly assigned to receive either Doxy PEP 200 mg, to be taken within 72 hours of sex (n = 224), or standard care, which included quarterly screening and treatment of STIs (n = 225).

Of the women, 36.7% reported transactional sex at enrollment; their baseline prevalence of STIs was 17.9%, including 14.1% with chlamydia, 3.8% gonorrhea, and 0.4% syphilis. There were no differences between the study groups.

In surveys, 78% of the women reported adherence to the use of Doxy PEP; they took the prophylaxis at least as many days as they had sex.

Nevertheless, there was no significant difference in the incidence of STIs, reported over 1 year, at quarterly visits that included genital STI testing, between groups, with 50 patients in the Doxy PEP group and 59 in the standard screening group developing STIs (relative risk, 0.88; P = .51).

Of the infections, 85 were chlamydia, including 35 in the Doxy PEP group and 50 with standard of care, while 31 were gonorrhea, including 19 in the Doxy PEP group and 12 with standard of care; 8 had both infections, and there was 1 syphilis infection.

The results were consistent across subanalyses of patients grouped according to STI, who became pregnant (n = 80), or sorted by other factors including age, contraceptive use, transactional sex, and STI at baseline.

None of the women developed HIV, and there were no serious events associated with the Doxy PEP treatment.
 

Cisgender women bear ‘highest burden’ of STIs

The findings are disappointing in light of the higher rates of STIs among cisgender women, with the Centers for Disease Control and Prevention reporting that women also disproportionately bear the long-term consequences of STIs.

“For example, each year, untreated sexually transmitted diseases cause infertility in at least 20,000 women in the United States, and a pregnant woman is highly likely to pass syphilis unto her unborn baby if left untested or untreated,” the CDC reports.

The STI rates are particularly high for women taking HIV PrEP in regions like East Africa, where rates of STIs among cisgender women in many cases are higher than rates for men taking PrEP in high income countries, Dr. Stewart said.

Previous studies of Doxy PEP in men and transgender women taking HIV PrEP, including new research presented at CROI, have shown highly encouraging reductions in STIs, at rates of up to approximately 80% for chlamydia and syphilis.
 

Adherence, anatomy, resistance

The key theories for the lack of a prevention of infections in cisgender women surround the issues of resistances, as well as anatomy and adherence, said Dr. Stewart.

In terms of bacterial resistances, while initial testing in a limited number of samples the study found no evidence of markers of resistance for chlamydia, all of the gonorrhea samples did show tetracycline-resistant N gonorrhea at baseline and follow-up in both groups.

Regarding anatomic differences, doxycycline may not prevent STIs in endocervical tissue among cisgender women, Dr. Stewart noted. Women are known to be at higher risk of infection because the lining of the vagina is thinner than the skin of the penis, allowing for easier penetration of bacteria and viruses.

The study was designed to optimize adherence to Doxy PEP. Measures included monitoring with weekly text message surveys, in which the women reported a high rate of adherence.

The overall retention rate in the study was high; as many as 97% of the quarterly follow-up visits were completed, including 95% in the Doxy PEP group and 98% of the standard care group. The response rate for the weekly surveys was 81%.

Of note, women reported the use of the treatment to be “imperfect,” suggesting social problems, such as biases toward the use of the prophylaxis.

The results underscore the need for ongoing efforts to make sure no groups of patients are left behind as interventions advance, Dr. Stewart said.

“The burden of STIs on cisgender women is large and growing,” she concluded. “STI prevention interventions are needed.”

Commenting on the study, Renee A. Heffron, PhD, MPH, said the findings “are somewhat surprising because results from trials in other populations have been positive.

“But cisgender women are exposed through the cervix, and this tissue is different from rectal or urethral tissue,” Dr. Heffron, a professor at the department of medicine and director of the Center for AIDS Research at the University of Alabama, Birmingham, told this news organization.

Further findings from the research should help shed light on key issues of adherence and drug concentration levels in cervical tissue, she added.

“For cisgender women, these data are the first and the beginning of understanding whether this is a viable strategy,” Dr. Heffron said.

“We have more to learn to better understand the results from the trial main outcomes, and if there are tweaks to this strategy that would improve efficacy.”

The authors and Dr. Heffron have disclosed no relevant financial relationships.

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

The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.

“This was the first trial to evaluate doxycycline PEP for cisgender women,” said first author Jenell Stewart, DO, of the University of Minnesota, Minneapolis, in discussing the findings at a press conference at the Conference on Retroviruses & Opportunistic Infections.

“Unfortunately, our primary outcome was not statistically significant – we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women,” she said.

The findings are from a study of 449 nonpregnant cisgender women (mean age, 24 years) in Kenya who had been taking daily oral HIV preexposure prophylaxis (PrEP) for a median of about 7 months.

The women were randomly assigned to receive either Doxy PEP 200 mg, to be taken within 72 hours of sex (n = 224), or standard care, which included quarterly screening and treatment of STIs (n = 225).

Of the women, 36.7% reported transactional sex at enrollment; their baseline prevalence of STIs was 17.9%, including 14.1% with chlamydia, 3.8% gonorrhea, and 0.4% syphilis. There were no differences between the study groups.

In surveys, 78% of the women reported adherence to the use of Doxy PEP; they took the prophylaxis at least as many days as they had sex.

Nevertheless, there was no significant difference in the incidence of STIs, reported over 1 year, at quarterly visits that included genital STI testing, between groups, with 50 patients in the Doxy PEP group and 59 in the standard screening group developing STIs (relative risk, 0.88; P = .51).

Of the infections, 85 were chlamydia, including 35 in the Doxy PEP group and 50 with standard of care, while 31 were gonorrhea, including 19 in the Doxy PEP group and 12 with standard of care; 8 had both infections, and there was 1 syphilis infection.

The results were consistent across subanalyses of patients grouped according to STI, who became pregnant (n = 80), or sorted by other factors including age, contraceptive use, transactional sex, and STI at baseline.

None of the women developed HIV, and there were no serious events associated with the Doxy PEP treatment.
 

Cisgender women bear ‘highest burden’ of STIs

The findings are disappointing in light of the higher rates of STIs among cisgender women, with the Centers for Disease Control and Prevention reporting that women also disproportionately bear the long-term consequences of STIs.

“For example, each year, untreated sexually transmitted diseases cause infertility in at least 20,000 women in the United States, and a pregnant woman is highly likely to pass syphilis unto her unborn baby if left untested or untreated,” the CDC reports.

The STI rates are particularly high for women taking HIV PrEP in regions like East Africa, where rates of STIs among cisgender women in many cases are higher than rates for men taking PrEP in high income countries, Dr. Stewart said.

Previous studies of Doxy PEP in men and transgender women taking HIV PrEP, including new research presented at CROI, have shown highly encouraging reductions in STIs, at rates of up to approximately 80% for chlamydia and syphilis.
 

Adherence, anatomy, resistance

The key theories for the lack of a prevention of infections in cisgender women surround the issues of resistances, as well as anatomy and adherence, said Dr. Stewart.

In terms of bacterial resistances, while initial testing in a limited number of samples the study found no evidence of markers of resistance for chlamydia, all of the gonorrhea samples did show tetracycline-resistant N gonorrhea at baseline and follow-up in both groups.

Regarding anatomic differences, doxycycline may not prevent STIs in endocervical tissue among cisgender women, Dr. Stewart noted. Women are known to be at higher risk of infection because the lining of the vagina is thinner than the skin of the penis, allowing for easier penetration of bacteria and viruses.

The study was designed to optimize adherence to Doxy PEP. Measures included monitoring with weekly text message surveys, in which the women reported a high rate of adherence.

The overall retention rate in the study was high; as many as 97% of the quarterly follow-up visits were completed, including 95% in the Doxy PEP group and 98% of the standard care group. The response rate for the weekly surveys was 81%.

Of note, women reported the use of the treatment to be “imperfect,” suggesting social problems, such as biases toward the use of the prophylaxis.

The results underscore the need for ongoing efforts to make sure no groups of patients are left behind as interventions advance, Dr. Stewart said.

“The burden of STIs on cisgender women is large and growing,” she concluded. “STI prevention interventions are needed.”

Commenting on the study, Renee A. Heffron, PhD, MPH, said the findings “are somewhat surprising because results from trials in other populations have been positive.

“But cisgender women are exposed through the cervix, and this tissue is different from rectal or urethral tissue,” Dr. Heffron, a professor at the department of medicine and director of the Center for AIDS Research at the University of Alabama, Birmingham, told this news organization.

Further findings from the research should help shed light on key issues of adherence and drug concentration levels in cervical tissue, she added.

“For cisgender women, these data are the first and the beginning of understanding whether this is a viable strategy,” Dr. Heffron said.

“We have more to learn to better understand the results from the trial main outcomes, and if there are tweaks to this strategy that would improve efficacy.”

The authors and Dr. Heffron have disclosed no relevant financial relationships.

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

The benefits of doxycycline postexposure prophylaxis (Doxy PEP) in preventing the transmission of sexually transmitted infections (STIs) in men and transgender women do not appear to extend to cisgender women, who have disproportionately high rates of infection in many regions.

“This was the first trial to evaluate doxycycline PEP for cisgender women,” said first author Jenell Stewart, DO, of the University of Minnesota, Minneapolis, in discussing the findings at a press conference at the Conference on Retroviruses & Opportunistic Infections.

“Unfortunately, our primary outcome was not statistically significant – we did not see a reduction in STIs among cisgender women, which is in stark contrast to [reported effects] among cisgender men and transgender women,” she said.

The findings are from a study of 449 nonpregnant cisgender women (mean age, 24 years) in Kenya who had been taking daily oral HIV preexposure prophylaxis (PrEP) for a median of about 7 months.

The women were randomly assigned to receive either Doxy PEP 200 mg, to be taken within 72 hours of sex (n = 224), or standard care, which included quarterly screening and treatment of STIs (n = 225).

Of the women, 36.7% reported transactional sex at enrollment; their baseline prevalence of STIs was 17.9%, including 14.1% with chlamydia, 3.8% gonorrhea, and 0.4% syphilis. There were no differences between the study groups.

In surveys, 78% of the women reported adherence to the use of Doxy PEP; they took the prophylaxis at least as many days as they had sex.

Nevertheless, there was no significant difference in the incidence of STIs, reported over 1 year, at quarterly visits that included genital STI testing, between groups, with 50 patients in the Doxy PEP group and 59 in the standard screening group developing STIs (relative risk, 0.88; P = .51).

Of the infections, 85 were chlamydia, including 35 in the Doxy PEP group and 50 with standard of care, while 31 were gonorrhea, including 19 in the Doxy PEP group and 12 with standard of care; 8 had both infections, and there was 1 syphilis infection.

The results were consistent across subanalyses of patients grouped according to STI, who became pregnant (n = 80), or sorted by other factors including age, contraceptive use, transactional sex, and STI at baseline.

None of the women developed HIV, and there were no serious events associated with the Doxy PEP treatment.
 

Cisgender women bear ‘highest burden’ of STIs

The findings are disappointing in light of the higher rates of STIs among cisgender women, with the Centers for Disease Control and Prevention reporting that women also disproportionately bear the long-term consequences of STIs.

“For example, each year, untreated sexually transmitted diseases cause infertility in at least 20,000 women in the United States, and a pregnant woman is highly likely to pass syphilis unto her unborn baby if left untested or untreated,” the CDC reports.

The STI rates are particularly high for women taking HIV PrEP in regions like East Africa, where rates of STIs among cisgender women in many cases are higher than rates for men taking PrEP in high income countries, Dr. Stewart said.

Previous studies of Doxy PEP in men and transgender women taking HIV PrEP, including new research presented at CROI, have shown highly encouraging reductions in STIs, at rates of up to approximately 80% for chlamydia and syphilis.
 

Adherence, anatomy, resistance

The key theories for the lack of a prevention of infections in cisgender women surround the issues of resistances, as well as anatomy and adherence, said Dr. Stewart.

In terms of bacterial resistances, while initial testing in a limited number of samples the study found no evidence of markers of resistance for chlamydia, all of the gonorrhea samples did show tetracycline-resistant N gonorrhea at baseline and follow-up in both groups.

Regarding anatomic differences, doxycycline may not prevent STIs in endocervical tissue among cisgender women, Dr. Stewart noted. Women are known to be at higher risk of infection because the lining of the vagina is thinner than the skin of the penis, allowing for easier penetration of bacteria and viruses.

The study was designed to optimize adherence to Doxy PEP. Measures included monitoring with weekly text message surveys, in which the women reported a high rate of adherence.

The overall retention rate in the study was high; as many as 97% of the quarterly follow-up visits were completed, including 95% in the Doxy PEP group and 98% of the standard care group. The response rate for the weekly surveys was 81%.

Of note, women reported the use of the treatment to be “imperfect,” suggesting social problems, such as biases toward the use of the prophylaxis.

The results underscore the need for ongoing efforts to make sure no groups of patients are left behind as interventions advance, Dr. Stewart said.

“The burden of STIs on cisgender women is large and growing,” she concluded. “STI prevention interventions are needed.”

Commenting on the study, Renee A. Heffron, PhD, MPH, said the findings “are somewhat surprising because results from trials in other populations have been positive.

“But cisgender women are exposed through the cervix, and this tissue is different from rectal or urethral tissue,” Dr. Heffron, a professor at the department of medicine and director of the Center for AIDS Research at the University of Alabama, Birmingham, told this news organization.

Further findings from the research should help shed light on key issues of adherence and drug concentration levels in cervical tissue, she added.

“For cisgender women, these data are the first and the beginning of understanding whether this is a viable strategy,” Dr. Heffron said.

“We have more to learn to better understand the results from the trial main outcomes, and if there are tweaks to this strategy that would improve efficacy.”

The authors and Dr. Heffron have disclosed no relevant financial relationships.

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

Prone positioning significantly reduced the need for intubation among nonintubated adults with COVID-19, as indicated by data from a new meta-analysis of more than 2,000 individuals.

The use of prone positioning for nonintubated patients (so-called “awake prone positioning”) has been common since the early days of the COVID-19 pandemic. Prone positioning is more comfortable for patients, and it entails no additional cost. Also, awake prone positioning is less labor intensive than prone positioning for intubated patients, said Jie Li, PhD, in a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

However, data on the specific benefits of prone positioning are lacking and contradictory, said Dr. Li, a respiratory care specialist at Rush University, Chicago.

Dr. Li and colleagues from a multinational research group found that outcomes were improved for patients who were treated with awake prone positioning – notably, fewer treatment failures at day 28 – but a pair of subsequent studies by other researchers showed contradictory outcomes.

For more definitive evidence, Dr. Li and colleagues conducted a systematic review and meta-analysis of 11 randomized, controlled trials and one unpublished study of awake prone positioning for patients with COVID-19. The studies were published between Jan. 1, 2020, and July 1, 2022, and included a total of 2,886 adult patients.

The primary outcome was the reported cumulative risk of intubation among nonintubated COVID-19 patients. Secondary outcomes included mortality, the need for escalating respiratory support, length of hospital length of stay, ICU admission, and adverse events.

Overall, awake prone positioning significantly reduced the intubation risk among nonintubated patients compared to standard care (risk ratio, 0.85).

A further subgroup analysis showed a significant reduction in risk for intubation among patients supported by high-flow nasal cannula or noninvasive ventilation (RR, 0.83).

However, no additional reduction in intubation risk occurred among patients who received conventional oxygen therapy (RR, 1.02).

Mortality rates were similar for patients who underwent awake prone positioning and those who underwent supine positioning (RR, 0.96), as was the need for additional respiratory support (RR, 1.03). The length of hospital stay, ICU admission, and adverse events were similar between the patients who underwent prone positioning and those who underwent supine positioning.

The findings were limited by several factors. There was a potential for confounding by disease severity, which may have increased the use of respiratory support devices, Li said in her presentation.

“Another factor we should not ignore is the daily duration of prone positioning,” said Dr. Li. More research is needed to identify which factors play the greatest roles in treatment success.

The current study was important in that it evaluated the current evidence of awake prone positioning, “particularly to identify the patients who benefit most from this treatment, in order to guide clinical practice,” Dr. Li said in an interview.

“Since early in the pandemic, awake prone positioning has been broadly utilized to treat patients with COVID-19,” she said. “In 2021, we published a multinational randomized controlled trial with over 1,100 patients enrolled and reported lower treatment failure. However, no significant differences of treatment failure were reported in several subsequent multicenter randomized, controlled trials published after our study.”

Dr. Li said she was not surprised by the findings, which reflect those of her team’s previously published meta-analysis. “The increased number of patients helps confirm our previous finding, even with the inclusion of several recently published randomized controlled trials,” she said.

For clinicians, “the current evidence supports the use of awake prone positioning for patients with COVID-19, particularly those who require advanced respiratory support from high-flow nasal cannula or noninvasive ventilation,” Dr. Li said.

The study received no outside funding. Dr. Li has relationships with AARC, Heyer, Aeorgen, the Rice Foundation, and Fisher & Paykel Healthcare.

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

Prone positioning significantly reduced the need for intubation among nonintubated adults with COVID-19, as indicated by data from a new meta-analysis of more than 2,000 individuals.

The use of prone positioning for nonintubated patients (so-called “awake prone positioning”) has been common since the early days of the COVID-19 pandemic. Prone positioning is more comfortable for patients, and it entails no additional cost. Also, awake prone positioning is less labor intensive than prone positioning for intubated patients, said Jie Li, PhD, in a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

However, data on the specific benefits of prone positioning are lacking and contradictory, said Dr. Li, a respiratory care specialist at Rush University, Chicago.

Dr. Li and colleagues from a multinational research group found that outcomes were improved for patients who were treated with awake prone positioning – notably, fewer treatment failures at day 28 – but a pair of subsequent studies by other researchers showed contradictory outcomes.

For more definitive evidence, Dr. Li and colleagues conducted a systematic review and meta-analysis of 11 randomized, controlled trials and one unpublished study of awake prone positioning for patients with COVID-19. The studies were published between Jan. 1, 2020, and July 1, 2022, and included a total of 2,886 adult patients.

The primary outcome was the reported cumulative risk of intubation among nonintubated COVID-19 patients. Secondary outcomes included mortality, the need for escalating respiratory support, length of hospital length of stay, ICU admission, and adverse events.

Overall, awake prone positioning significantly reduced the intubation risk among nonintubated patients compared to standard care (risk ratio, 0.85).

A further subgroup analysis showed a significant reduction in risk for intubation among patients supported by high-flow nasal cannula or noninvasive ventilation (RR, 0.83).

However, no additional reduction in intubation risk occurred among patients who received conventional oxygen therapy (RR, 1.02).

Mortality rates were similar for patients who underwent awake prone positioning and those who underwent supine positioning (RR, 0.96), as was the need for additional respiratory support (RR, 1.03). The length of hospital stay, ICU admission, and adverse events were similar between the patients who underwent prone positioning and those who underwent supine positioning.

The findings were limited by several factors. There was a potential for confounding by disease severity, which may have increased the use of respiratory support devices, Li said in her presentation.

“Another factor we should not ignore is the daily duration of prone positioning,” said Dr. Li. More research is needed to identify which factors play the greatest roles in treatment success.

The current study was important in that it evaluated the current evidence of awake prone positioning, “particularly to identify the patients who benefit most from this treatment, in order to guide clinical practice,” Dr. Li said in an interview.

“Since early in the pandemic, awake prone positioning has been broadly utilized to treat patients with COVID-19,” she said. “In 2021, we published a multinational randomized controlled trial with over 1,100 patients enrolled and reported lower treatment failure. However, no significant differences of treatment failure were reported in several subsequent multicenter randomized, controlled trials published after our study.”

Dr. Li said she was not surprised by the findings, which reflect those of her team’s previously published meta-analysis. “The increased number of patients helps confirm our previous finding, even with the inclusion of several recently published randomized controlled trials,” she said.

For clinicians, “the current evidence supports the use of awake prone positioning for patients with COVID-19, particularly those who require advanced respiratory support from high-flow nasal cannula or noninvasive ventilation,” Dr. Li said.

The study received no outside funding. Dr. Li has relationships with AARC, Heyer, Aeorgen, the Rice Foundation, and Fisher & Paykel Healthcare.

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

Prone positioning significantly reduced the need for intubation among nonintubated adults with COVID-19, as indicated by data from a new meta-analysis of more than 2,000 individuals.

The use of prone positioning for nonintubated patients (so-called “awake prone positioning”) has been common since the early days of the COVID-19 pandemic. Prone positioning is more comfortable for patients, and it entails no additional cost. Also, awake prone positioning is less labor intensive than prone positioning for intubated patients, said Jie Li, PhD, in a presentation at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

However, data on the specific benefits of prone positioning are lacking and contradictory, said Dr. Li, a respiratory care specialist at Rush University, Chicago.

Dr. Li and colleagues from a multinational research group found that outcomes were improved for patients who were treated with awake prone positioning – notably, fewer treatment failures at day 28 – but a pair of subsequent studies by other researchers showed contradictory outcomes.

For more definitive evidence, Dr. Li and colleagues conducted a systematic review and meta-analysis of 11 randomized, controlled trials and one unpublished study of awake prone positioning for patients with COVID-19. The studies were published between Jan. 1, 2020, and July 1, 2022, and included a total of 2,886 adult patients.

The primary outcome was the reported cumulative risk of intubation among nonintubated COVID-19 patients. Secondary outcomes included mortality, the need for escalating respiratory support, length of hospital length of stay, ICU admission, and adverse events.

Overall, awake prone positioning significantly reduced the intubation risk among nonintubated patients compared to standard care (risk ratio, 0.85).

A further subgroup analysis showed a significant reduction in risk for intubation among patients supported by high-flow nasal cannula or noninvasive ventilation (RR, 0.83).

However, no additional reduction in intubation risk occurred among patients who received conventional oxygen therapy (RR, 1.02).

Mortality rates were similar for patients who underwent awake prone positioning and those who underwent supine positioning (RR, 0.96), as was the need for additional respiratory support (RR, 1.03). The length of hospital stay, ICU admission, and adverse events were similar between the patients who underwent prone positioning and those who underwent supine positioning.

The findings were limited by several factors. There was a potential for confounding by disease severity, which may have increased the use of respiratory support devices, Li said in her presentation.

“Another factor we should not ignore is the daily duration of prone positioning,” said Dr. Li. More research is needed to identify which factors play the greatest roles in treatment success.

The current study was important in that it evaluated the current evidence of awake prone positioning, “particularly to identify the patients who benefit most from this treatment, in order to guide clinical practice,” Dr. Li said in an interview.

“Since early in the pandemic, awake prone positioning has been broadly utilized to treat patients with COVID-19,” she said. “In 2021, we published a multinational randomized controlled trial with over 1,100 patients enrolled and reported lower treatment failure. However, no significant differences of treatment failure were reported in several subsequent multicenter randomized, controlled trials published after our study.”

Dr. Li said she was not surprised by the findings, which reflect those of her team’s previously published meta-analysis. “The increased number of patients helps confirm our previous finding, even with the inclusion of several recently published randomized controlled trials,” she said.

For clinicians, “the current evidence supports the use of awake prone positioning for patients with COVID-19, particularly those who require advanced respiratory support from high-flow nasal cannula or noninvasive ventilation,” Dr. Li said.

The study received no outside funding. Dr. Li has relationships with AARC, Heyer, Aeorgen, the Rice Foundation, and Fisher & Paykel Healthcare.

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

Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the Food and Drug Administration warns.

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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

Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the Food and Drug Administration warns.

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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

Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the Food and Drug Administration warns.

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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

There are times when, as health care providers dealing with the stress of the profession, many doctors feel that tapping into a higher purpose – or even praying – might be a helpful way to cope.

Whether you’re spiritual, religious – or neither – the Medscape Physician Lifestyle & Happiness Report 2023 asked if you have a religious or spiritual belief. Turns out 69% of physicians shared that they have a spiritual or religious practice.
 

Tapping into the universe

Nick Shamie, MD, an orthopedic surgeon specializing in spine surgery at University of California, Los Angeles, says the constant challenges of making life-and-death decisions offer an opportunity to check in with a higher power.

“Sometimes when I’m going into a tough surgery or have a tough situation, I pause and think about how this isn’t about me and the situation I’m in,” says Dr. Shamie, whose family is Muslim. “It’s about the whole universe. I feel like someone, or some being, is looking over my shoulders, and if my intentions are good, I’ll be fine. The person I’m going to take care of will be fine. That’s how I use my faith.”

Having a belief in something greater than herself also fuels Jill Carnahan, MD, a family medicine physician and functional medicine expert in Boulder, Colo.

“This is key for me as a physician,” says Dr. Carnahan, author of “Unexpected: Finding Resilience Through Functional Medicine, Science, and Faith.” “I urge physicians to think about their source of strength. That’s not necessarily even religious. It could be meditation or being in nature.”

Dr. Carnahan likes to share with patients that there are lessons that can come from being ill – whether treating ill patients or struggling with one’s own illness.

“I like to teach this idea of illness as a teacher,” says Dr. Carnahan, who has Crohn’s disease and is a cancer survivor. “This is tough, but what you’re saying here is that there is meaning or purpose to this experience. It brings awareness to your life that may not have been there before.”

Often illness is our body’s way of getting our attention that our life, relationships, or work needs adjustment. Illness can be a reminder to make changes. “For example, a diagnosis of autoimmunity may be a reminder to take better care of ourselves, or a diagnosis of cancer may cause us to get out of an unhealthy relationship or change jobs to do something more fulfilling, as we have increased awareness of the brevity of life.”

When patients are affected by illness, pain, reduced functionality, and even imminent death, understanding the experience is difficult, and finding any purpose in it may seem impossible. Still, studies show that those who find meaning in the experience cope better with their illness.

Finding that meaning may be a strong driver of survival and may be positively related to hope, belief, and happiness.
 

Spirituality supports patients

Even if you’re not religious yourself, it can be helpful to support a patient who opts to pray before an arduous procedure, says Sharyar Baradaran, DDS, a periodontist specializing in gum surgery in Beverly Hills, Calif.

“I’ve had patients who go into meditation mode, or they say a prayer before I start surgery,” he says. “I take that opportunity to connect. In that instance, we hold hands. I want them to know that I understand what they’re going through and how they’re trying to find the courage to undergo surgery.”

When Dr. Shamie was a child, his father described religion as embodying the basic tenet of being good to others. “I’ve taken that to heart,” he says. “All religions, all faiths have that as a central premise.”

These doctors agree that when you take the time to stop and hold a patient’s hand, bow your head during their prayer, or acknowledge or speak for a few moments about their faith, especially during a health crisis, surgery, or challenging diagnosis, patients appreciate it and develop an even deeper connection with you.

Dr. Baradaran believes spirituality can play an important role in how health care providers care for patients. Though it may not be widely discussed or reported, and physicians may find little time and space to address patients’ spiritual needs, there is growing sensitivity regarding spirituality in health care. One study found that while physicians understand its importance, nurses are more apt to integrate spirituality into practice.

“No matter the religion, if you’re spiritual, it means you’re listening and being respectful,” says Dr. Baradaran, who is Jewish. “There are times that I’m not familiar with the prayers my patients are saying, but I always take them in, absorb them, and respect them. This allows me to have a deeper connection with them, which is wonderful.”

Dr. Shamie says that he turns to his faith in good times as well as tough ones.

“I see a lot of people who are dealing with very difficult situations, and it’s not their choice to be in this position,” he says. “At those moments, I think to myself how fortunate I am that I’m not experiencing what this individual or family is going through. I do thank God at that time. I appreciate the life I have, and when I witness hardships, it resets my appreciation.”

For Dr. Carnahan, faith is about becoming comfortable with the inevitable uncertainty of life. It’s also about finding ways to tap into the day’s stresses.

“As physicians, we’re workaholics, and one in four of us are burnt out,” she says. “One solution that really works is to step back from the day-to-day grind and find time to pray or meditate or be in nature.”

There are times when a tragedy occurs, and despite your most intense efforts, a patient may die. Those experiences can be crushing to a physician. However, to guide you through the loss of a patient or the daily juggles of managing your practice, Dr. Carnahan suggests finding time every morning to focus on the day ahead and how you connect with the universe.

“I take 15 minutes in the morning and think about how I will bring love to the world,” she says. “If you look for the miracles and the good and the unexpected, that gratitude shift allows your mind to be transformed by what’s happening. It’s often in those moments that you’ll realize again why you went into medicine in the first place.”
 

Doctors without faith

So, what does this mean if you’re among the 25% of physicians in the Medscape report who do not have a religious or spiritual leaning and aren’t apt to be spiritually minded when it comes to your patients? An article on KevinMD.com points out that atheist physicians are often in the closet about their atheism because they usually bow their heads or keep a respectful silence when a patient or their family offers a prayer request before surgery or a prayer of thanks after a procedure.

The retired atheist physician who wrote the piece reminds us that nonreligious doctors are good people with a high moral compass who may not believe in an afterlife. However, that means they try to make their patients’ quality of life the best they can.

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

There are times when, as health care providers dealing with the stress of the profession, many doctors feel that tapping into a higher purpose – or even praying – might be a helpful way to cope.

Whether you’re spiritual, religious – or neither – the Medscape Physician Lifestyle & Happiness Report 2023 asked if you have a religious or spiritual belief. Turns out 69% of physicians shared that they have a spiritual or religious practice.
 

Tapping into the universe

Nick Shamie, MD, an orthopedic surgeon specializing in spine surgery at University of California, Los Angeles, says the constant challenges of making life-and-death decisions offer an opportunity to check in with a higher power.

“Sometimes when I’m going into a tough surgery or have a tough situation, I pause and think about how this isn’t about me and the situation I’m in,” says Dr. Shamie, whose family is Muslim. “It’s about the whole universe. I feel like someone, or some being, is looking over my shoulders, and if my intentions are good, I’ll be fine. The person I’m going to take care of will be fine. That’s how I use my faith.”

Having a belief in something greater than herself also fuels Jill Carnahan, MD, a family medicine physician and functional medicine expert in Boulder, Colo.

“This is key for me as a physician,” says Dr. Carnahan, author of “Unexpected: Finding Resilience Through Functional Medicine, Science, and Faith.” “I urge physicians to think about their source of strength. That’s not necessarily even religious. It could be meditation or being in nature.”

Dr. Carnahan likes to share with patients that there are lessons that can come from being ill – whether treating ill patients or struggling with one’s own illness.

“I like to teach this idea of illness as a teacher,” says Dr. Carnahan, who has Crohn’s disease and is a cancer survivor. “This is tough, but what you’re saying here is that there is meaning or purpose to this experience. It brings awareness to your life that may not have been there before.”

Often illness is our body’s way of getting our attention that our life, relationships, or work needs adjustment. Illness can be a reminder to make changes. “For example, a diagnosis of autoimmunity may be a reminder to take better care of ourselves, or a diagnosis of cancer may cause us to get out of an unhealthy relationship or change jobs to do something more fulfilling, as we have increased awareness of the brevity of life.”

When patients are affected by illness, pain, reduced functionality, and even imminent death, understanding the experience is difficult, and finding any purpose in it may seem impossible. Still, studies show that those who find meaning in the experience cope better with their illness.

Finding that meaning may be a strong driver of survival and may be positively related to hope, belief, and happiness.
 

Spirituality supports patients

Even if you’re not religious yourself, it can be helpful to support a patient who opts to pray before an arduous procedure, says Sharyar Baradaran, DDS, a periodontist specializing in gum surgery in Beverly Hills, Calif.

“I’ve had patients who go into meditation mode, or they say a prayer before I start surgery,” he says. “I take that opportunity to connect. In that instance, we hold hands. I want them to know that I understand what they’re going through and how they’re trying to find the courage to undergo surgery.”

When Dr. Shamie was a child, his father described religion as embodying the basic tenet of being good to others. “I’ve taken that to heart,” he says. “All religions, all faiths have that as a central premise.”

These doctors agree that when you take the time to stop and hold a patient’s hand, bow your head during their prayer, or acknowledge or speak for a few moments about their faith, especially during a health crisis, surgery, or challenging diagnosis, patients appreciate it and develop an even deeper connection with you.

Dr. Baradaran believes spirituality can play an important role in how health care providers care for patients. Though it may not be widely discussed or reported, and physicians may find little time and space to address patients’ spiritual needs, there is growing sensitivity regarding spirituality in health care. One study found that while physicians understand its importance, nurses are more apt to integrate spirituality into practice.

“No matter the religion, if you’re spiritual, it means you’re listening and being respectful,” says Dr. Baradaran, who is Jewish. “There are times that I’m not familiar with the prayers my patients are saying, but I always take them in, absorb them, and respect them. This allows me to have a deeper connection with them, which is wonderful.”

Dr. Shamie says that he turns to his faith in good times as well as tough ones.

“I see a lot of people who are dealing with very difficult situations, and it’s not their choice to be in this position,” he says. “At those moments, I think to myself how fortunate I am that I’m not experiencing what this individual or family is going through. I do thank God at that time. I appreciate the life I have, and when I witness hardships, it resets my appreciation.”

For Dr. Carnahan, faith is about becoming comfortable with the inevitable uncertainty of life. It’s also about finding ways to tap into the day’s stresses.

“As physicians, we’re workaholics, and one in four of us are burnt out,” she says. “One solution that really works is to step back from the day-to-day grind and find time to pray or meditate or be in nature.”

There are times when a tragedy occurs, and despite your most intense efforts, a patient may die. Those experiences can be crushing to a physician. However, to guide you through the loss of a patient or the daily juggles of managing your practice, Dr. Carnahan suggests finding time every morning to focus on the day ahead and how you connect with the universe.

“I take 15 minutes in the morning and think about how I will bring love to the world,” she says. “If you look for the miracles and the good and the unexpected, that gratitude shift allows your mind to be transformed by what’s happening. It’s often in those moments that you’ll realize again why you went into medicine in the first place.”
 

Doctors without faith

So, what does this mean if you’re among the 25% of physicians in the Medscape report who do not have a religious or spiritual leaning and aren’t apt to be spiritually minded when it comes to your patients? An article on KevinMD.com points out that atheist physicians are often in the closet about their atheism because they usually bow their heads or keep a respectful silence when a patient or their family offers a prayer request before surgery or a prayer of thanks after a procedure.

The retired atheist physician who wrote the piece reminds us that nonreligious doctors are good people with a high moral compass who may not believe in an afterlife. However, that means they try to make their patients’ quality of life the best they can.

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

There are times when, as health care providers dealing with the stress of the profession, many doctors feel that tapping into a higher purpose – or even praying – might be a helpful way to cope.

Whether you’re spiritual, religious – or neither – the Medscape Physician Lifestyle & Happiness Report 2023 asked if you have a religious or spiritual belief. Turns out 69% of physicians shared that they have a spiritual or religious practice.
 

Tapping into the universe

Nick Shamie, MD, an orthopedic surgeon specializing in spine surgery at University of California, Los Angeles, says the constant challenges of making life-and-death decisions offer an opportunity to check in with a higher power.

“Sometimes when I’m going into a tough surgery or have a tough situation, I pause and think about how this isn’t about me and the situation I’m in,” says Dr. Shamie, whose family is Muslim. “It’s about the whole universe. I feel like someone, or some being, is looking over my shoulders, and if my intentions are good, I’ll be fine. The person I’m going to take care of will be fine. That’s how I use my faith.”

Having a belief in something greater than herself also fuels Jill Carnahan, MD, a family medicine physician and functional medicine expert in Boulder, Colo.

“This is key for me as a physician,” says Dr. Carnahan, author of “Unexpected: Finding Resilience Through Functional Medicine, Science, and Faith.” “I urge physicians to think about their source of strength. That’s not necessarily even religious. It could be meditation or being in nature.”

Dr. Carnahan likes to share with patients that there are lessons that can come from being ill – whether treating ill patients or struggling with one’s own illness.

“I like to teach this idea of illness as a teacher,” says Dr. Carnahan, who has Crohn’s disease and is a cancer survivor. “This is tough, but what you’re saying here is that there is meaning or purpose to this experience. It brings awareness to your life that may not have been there before.”

Often illness is our body’s way of getting our attention that our life, relationships, or work needs adjustment. Illness can be a reminder to make changes. “For example, a diagnosis of autoimmunity may be a reminder to take better care of ourselves, or a diagnosis of cancer may cause us to get out of an unhealthy relationship or change jobs to do something more fulfilling, as we have increased awareness of the brevity of life.”

When patients are affected by illness, pain, reduced functionality, and even imminent death, understanding the experience is difficult, and finding any purpose in it may seem impossible. Still, studies show that those who find meaning in the experience cope better with their illness.

Finding that meaning may be a strong driver of survival and may be positively related to hope, belief, and happiness.
 

Spirituality supports patients

Even if you’re not religious yourself, it can be helpful to support a patient who opts to pray before an arduous procedure, says Sharyar Baradaran, DDS, a periodontist specializing in gum surgery in Beverly Hills, Calif.

“I’ve had patients who go into meditation mode, or they say a prayer before I start surgery,” he says. “I take that opportunity to connect. In that instance, we hold hands. I want them to know that I understand what they’re going through and how they’re trying to find the courage to undergo surgery.”

When Dr. Shamie was a child, his father described religion as embodying the basic tenet of being good to others. “I’ve taken that to heart,” he says. “All religions, all faiths have that as a central premise.”

These doctors agree that when you take the time to stop and hold a patient’s hand, bow your head during their prayer, or acknowledge or speak for a few moments about their faith, especially during a health crisis, surgery, or challenging diagnosis, patients appreciate it and develop an even deeper connection with you.

Dr. Baradaran believes spirituality can play an important role in how health care providers care for patients. Though it may not be widely discussed or reported, and physicians may find little time and space to address patients’ spiritual needs, there is growing sensitivity regarding spirituality in health care. One study found that while physicians understand its importance, nurses are more apt to integrate spirituality into practice.

“No matter the religion, if you’re spiritual, it means you’re listening and being respectful,” says Dr. Baradaran, who is Jewish. “There are times that I’m not familiar with the prayers my patients are saying, but I always take them in, absorb them, and respect them. This allows me to have a deeper connection with them, which is wonderful.”

Dr. Shamie says that he turns to his faith in good times as well as tough ones.

“I see a lot of people who are dealing with very difficult situations, and it’s not their choice to be in this position,” he says. “At those moments, I think to myself how fortunate I am that I’m not experiencing what this individual or family is going through. I do thank God at that time. I appreciate the life I have, and when I witness hardships, it resets my appreciation.”

For Dr. Carnahan, faith is about becoming comfortable with the inevitable uncertainty of life. It’s also about finding ways to tap into the day’s stresses.

“As physicians, we’re workaholics, and one in four of us are burnt out,” she says. “One solution that really works is to step back from the day-to-day grind and find time to pray or meditate or be in nature.”

There are times when a tragedy occurs, and despite your most intense efforts, a patient may die. Those experiences can be crushing to a physician. However, to guide you through the loss of a patient or the daily juggles of managing your practice, Dr. Carnahan suggests finding time every morning to focus on the day ahead and how you connect with the universe.

“I take 15 minutes in the morning and think about how I will bring love to the world,” she says. “If you look for the miracles and the good and the unexpected, that gratitude shift allows your mind to be transformed by what’s happening. It’s often in those moments that you’ll realize again why you went into medicine in the first place.”
 

Doctors without faith

So, what does this mean if you’re among the 25% of physicians in the Medscape report who do not have a religious or spiritual leaning and aren’t apt to be spiritually minded when it comes to your patients? An article on KevinMD.com points out that atheist physicians are often in the closet about their atheism because they usually bow their heads or keep a respectful silence when a patient or their family offers a prayer request before surgery or a prayer of thanks after a procedure.

The retired atheist physician who wrote the piece reminds us that nonreligious doctors are good people with a high moral compass who may not believe in an afterlife. However, that means they try to make their patients’ quality of life the best they can.

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

One-eyed, one-horned, flying purple veggie eater

Big Fruits and Vegetables is at it again. You notice how they’re always like “Oh, vegetables are good for your health,” and “Eating fruits every day makes you live longer,” but come on. It’s a marketing ploy, leading us astray from our personal savior, McDonald’s.

PxHere

Just look at this latest bit of research: According to researchers from Finland, eating purple vegetables can protect against diabetes. Considering nearly 40 million Americans have diabetes (and nearly 100 million have prediabetes), anything to reduce the incidence of diabetes (people with diabetes account for one-fourth of every dollar spent in U.S. health care) would be beneficial. So, let’s humor the fruits and veggies people this time and hear them out.

It all comes down to a chemical called anthocyanin, which is a pigment that gives fruits and vegetables such as blueberries, radishes, and red cabbages their purplish color. Anthocyanin also has probiotic and anti-inflammatory effects, meaning it can help improve intestinal lining health and regulate glucose and lipid metabolic pathways. Obviously, good things if you want to avoid diabetes.

The investigators also found that, while standard anthocyanin was beneficial, acylated anthocyanin (which has an acyl group added to the sugar molecules of anthocyanin) is really what you want to go for. The acylated version, found in abundance in purple potatoes, purple carrots, radishes, and red cabbages, is tougher to digest, but the positive effects it has in the body are enhanced over the standard version.

Now, this all a compelling bit of research, but at the end of the day, you’re still eating fruits and vegetables, and we are red-blooded Americans here. We don’t do healthy foods. Although, if you were to dye our burgers with anthocyanin and make them purple, you’d have our attention. Purple is our favorite color.
 

Manuka honey better as building material than antibiotic

Milk, according to the old saying, builds strong bones, but when it comes to patients with bone loss caused by various medical reasons, researchers found that manuka honey, produced only in New Zealand and some parts of Australia, may also do the job. They soaked collagen scaffolds used for bone implants in various concentrations of the honey and found that 5% led to higher mineral formation and osteoprotegerin production, which suggests increased bone production.

Marley Dewey

But, and this is a pretty big one, the other half of the study – testing manuka honey’s ability to ward off bacteria – wasn’t so successful. Bone implants, apparently, count for almost half of all hospital-acquired infections, which obviously can put a damper on the healing process. The hope was that a biomaterial would be more effective than something like metal in lessening bacteria formation. Nope.

When the researchers soaked paper disks in honey and added them to cultures of Pseudomonas aeruginosa and Staphylococcus aureus, none of the various concentrations stopped bacterial growth in the scaffolding, even when they added antibiotics.

The sticky conclusion, you could say, is more bitter than sweet.
 

It may sound like Korn, but can it play ‘Freak on a Leash’?

Like all right-thinking Americans, we love corn, corn-based products, and almost corn. Corn on the cob grilled in the husk? Mmm. Plus, we’re big fans of the band Korn. Also, we once had a reporter here named Tim Kirn. And don’t even get us started with Karn. Best Family Feud host ever.

Quorn

But what about Quorn? Oh sure, the fungi-based meat alternative is full of yummy mycoprotein, but can it prevent colorectal cancer? Can we add Quorn to our favorites list? Let’s see what Science has to say.

Researchers at Northumbria University in Newcastle upon Tyne, England, fed a group of 20 men some meat (240 g/day) for 2 weeks – hopefully, they were allowed to eat some other food as well – and then gave them the same amount of Quorn, excuse us, fungi-derived mycoprotein equivalents, for 2 more weeks, with a 4-week washout period in between.

Levels of cancer-causing chemicals known as genotoxins fell significantly in the mycoprotein phase but rose during the meat phase. The mycoprotein diet also improved gut health “by increasing the abundance of protective bacteria such as Lactobacilli, Roseburia, and Akkermansia, which are associated with offering protection against chemically induced tumours, inflammation and bowel cancer,” they said in a statement from the university.

The meat phase, on the other hand, resulted in an increase in “gut bacteria linked with issues such as cancer, cardiovascular diseases, weight gain and other negative health outcomes,” they noted.

Science, then, seems to approve of Quorn, and that’s good enough for us. We’re adding Quorn to our diet, starting with a fungi-derived mycoproteinburger tonight while we’re watching the Cornell Big Red take the court against their archrivals, the Big Green of Dartmouth College. GO RED!

One-eyed, one-horned, flying purple veggie eater

Big Fruits and Vegetables is at it again. You notice how they’re always like “Oh, vegetables are good for your health,” and “Eating fruits every day makes you live longer,” but come on. It’s a marketing ploy, leading us astray from our personal savior, McDonald’s.

PxHere

Just look at this latest bit of research: According to researchers from Finland, eating purple vegetables can protect against diabetes. Considering nearly 40 million Americans have diabetes (and nearly 100 million have prediabetes), anything to reduce the incidence of diabetes (people with diabetes account for one-fourth of every dollar spent in U.S. health care) would be beneficial. So, let’s humor the fruits and veggies people this time and hear them out.

It all comes down to a chemical called anthocyanin, which is a pigment that gives fruits and vegetables such as blueberries, radishes, and red cabbages their purplish color. Anthocyanin also has probiotic and anti-inflammatory effects, meaning it can help improve intestinal lining health and regulate glucose and lipid metabolic pathways. Obviously, good things if you want to avoid diabetes.

The investigators also found that, while standard anthocyanin was beneficial, acylated anthocyanin (which has an acyl group added to the sugar molecules of anthocyanin) is really what you want to go for. The acylated version, found in abundance in purple potatoes, purple carrots, radishes, and red cabbages, is tougher to digest, but the positive effects it has in the body are enhanced over the standard version.

Now, this all a compelling bit of research, but at the end of the day, you’re still eating fruits and vegetables, and we are red-blooded Americans here. We don’t do healthy foods. Although, if you were to dye our burgers with anthocyanin and make them purple, you’d have our attention. Purple is our favorite color.
 

Manuka honey better as building material than antibiotic

Milk, according to the old saying, builds strong bones, but when it comes to patients with bone loss caused by various medical reasons, researchers found that manuka honey, produced only in New Zealand and some parts of Australia, may also do the job. They soaked collagen scaffolds used for bone implants in various concentrations of the honey and found that 5% led to higher mineral formation and osteoprotegerin production, which suggests increased bone production.

Marley Dewey

But, and this is a pretty big one, the other half of the study – testing manuka honey’s ability to ward off bacteria – wasn’t so successful. Bone implants, apparently, count for almost half of all hospital-acquired infections, which obviously can put a damper on the healing process. The hope was that a biomaterial would be more effective than something like metal in lessening bacteria formation. Nope.

When the researchers soaked paper disks in honey and added them to cultures of Pseudomonas aeruginosa and Staphylococcus aureus, none of the various concentrations stopped bacterial growth in the scaffolding, even when they added antibiotics.

The sticky conclusion, you could say, is more bitter than sweet.
 

It may sound like Korn, but can it play ‘Freak on a Leash’?

Like all right-thinking Americans, we love corn, corn-based products, and almost corn. Corn on the cob grilled in the husk? Mmm. Plus, we’re big fans of the band Korn. Also, we once had a reporter here named Tim Kirn. And don’t even get us started with Karn. Best Family Feud host ever.

Quorn

But what about Quorn? Oh sure, the fungi-based meat alternative is full of yummy mycoprotein, but can it prevent colorectal cancer? Can we add Quorn to our favorites list? Let’s see what Science has to say.

Researchers at Northumbria University in Newcastle upon Tyne, England, fed a group of 20 men some meat (240 g/day) for 2 weeks – hopefully, they were allowed to eat some other food as well – and then gave them the same amount of Quorn, excuse us, fungi-derived mycoprotein equivalents, for 2 more weeks, with a 4-week washout period in between.

Levels of cancer-causing chemicals known as genotoxins fell significantly in the mycoprotein phase but rose during the meat phase. The mycoprotein diet also improved gut health “by increasing the abundance of protective bacteria such as Lactobacilli, Roseburia, and Akkermansia, which are associated with offering protection against chemically induced tumours, inflammation and bowel cancer,” they said in a statement from the university.

The meat phase, on the other hand, resulted in an increase in “gut bacteria linked with issues such as cancer, cardiovascular diseases, weight gain and other negative health outcomes,” they noted.

Science, then, seems to approve of Quorn, and that’s good enough for us. We’re adding Quorn to our diet, starting with a fungi-derived mycoproteinburger tonight while we’re watching the Cornell Big Red take the court against their archrivals, the Big Green of Dartmouth College. GO RED!

One-eyed, one-horned, flying purple veggie eater

Big Fruits and Vegetables is at it again. You notice how they’re always like “Oh, vegetables are good for your health,” and “Eating fruits every day makes you live longer,” but come on. It’s a marketing ploy, leading us astray from our personal savior, McDonald’s.

PxHere

Just look at this latest bit of research: According to researchers from Finland, eating purple vegetables can protect against diabetes. Considering nearly 40 million Americans have diabetes (and nearly 100 million have prediabetes), anything to reduce the incidence of diabetes (people with diabetes account for one-fourth of every dollar spent in U.S. health care) would be beneficial. So, let’s humor the fruits and veggies people this time and hear them out.

It all comes down to a chemical called anthocyanin, which is a pigment that gives fruits and vegetables such as blueberries, radishes, and red cabbages their purplish color. Anthocyanin also has probiotic and anti-inflammatory effects, meaning it can help improve intestinal lining health and regulate glucose and lipid metabolic pathways. Obviously, good things if you want to avoid diabetes.

The investigators also found that, while standard anthocyanin was beneficial, acylated anthocyanin (which has an acyl group added to the sugar molecules of anthocyanin) is really what you want to go for. The acylated version, found in abundance in purple potatoes, purple carrots, radishes, and red cabbages, is tougher to digest, but the positive effects it has in the body are enhanced over the standard version.

Now, this all a compelling bit of research, but at the end of the day, you’re still eating fruits and vegetables, and we are red-blooded Americans here. We don’t do healthy foods. Although, if you were to dye our burgers with anthocyanin and make them purple, you’d have our attention. Purple is our favorite color.
 

Manuka honey better as building material than antibiotic

Milk, according to the old saying, builds strong bones, but when it comes to patients with bone loss caused by various medical reasons, researchers found that manuka honey, produced only in New Zealand and some parts of Australia, may also do the job. They soaked collagen scaffolds used for bone implants in various concentrations of the honey and found that 5% led to higher mineral formation and osteoprotegerin production, which suggests increased bone production.

Marley Dewey

But, and this is a pretty big one, the other half of the study – testing manuka honey’s ability to ward off bacteria – wasn’t so successful. Bone implants, apparently, count for almost half of all hospital-acquired infections, which obviously can put a damper on the healing process. The hope was that a biomaterial would be more effective than something like metal in lessening bacteria formation. Nope.

When the researchers soaked paper disks in honey and added them to cultures of Pseudomonas aeruginosa and Staphylococcus aureus, none of the various concentrations stopped bacterial growth in the scaffolding, even when they added antibiotics.

The sticky conclusion, you could say, is more bitter than sweet.
 

It may sound like Korn, but can it play ‘Freak on a Leash’?

Like all right-thinking Americans, we love corn, corn-based products, and almost corn. Corn on the cob grilled in the husk? Mmm. Plus, we’re big fans of the band Korn. Also, we once had a reporter here named Tim Kirn. And don’t even get us started with Karn. Best Family Feud host ever.

Quorn

But what about Quorn? Oh sure, the fungi-based meat alternative is full of yummy mycoprotein, but can it prevent colorectal cancer? Can we add Quorn to our favorites list? Let’s see what Science has to say.

Researchers at Northumbria University in Newcastle upon Tyne, England, fed a group of 20 men some meat (240 g/day) for 2 weeks – hopefully, they were allowed to eat some other food as well – and then gave them the same amount of Quorn, excuse us, fungi-derived mycoprotein equivalents, for 2 more weeks, with a 4-week washout period in between.

Levels of cancer-causing chemicals known as genotoxins fell significantly in the mycoprotein phase but rose during the meat phase. The mycoprotein diet also improved gut health “by increasing the abundance of protective bacteria such as Lactobacilli, Roseburia, and Akkermansia, which are associated with offering protection against chemically induced tumours, inflammation and bowel cancer,” they said in a statement from the university.

The meat phase, on the other hand, resulted in an increase in “gut bacteria linked with issues such as cancer, cardiovascular diseases, weight gain and other negative health outcomes,” they noted.

Science, then, seems to approve of Quorn, and that’s good enough for us. We’re adding Quorn to our diet, starting with a fungi-derived mycoproteinburger tonight while we’re watching the Cornell Big Red take the court against their archrivals, the Big Green of Dartmouth College. GO RED!

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

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

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

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

The latest study to show high efficacy of doxycycline post-exposure prophylaxis (Doxy PEP) in preventing sexually transmitted infections among men who have sex with men (MSM) adds a new twist, showing – for the first time – reductions in gonorrhea among those receiving the meningococcal B vaccine.

“Among men who have sex with men on HIV PrEP, doxycycline PEP significantly reduced the incidence of chlamydia and syphilis and also had a significant impact on the incidence of gonorrhea,” said first author Jean-Michel Molina, MD, PhD, in presenting the findings at the Conference on Retroviruses and Opportunistic Infections.

In addition, “two doses of the meningococcal B vaccine reduced the incidence of a first episode of gonorrhea by roughly 50% among men who have sex with men,” said Dr. Molina, a professor of infectious diseases at the University of Paris, and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, Paris.

Whereas the advent of PrEP has been associated with significant reductions in HIV transmission, rates of STIs have conversely been on the rise among MSM, specifically among those receiving PrEP.

Post-exposure prophylaxis with Doxy PEP has been shown to reduce the incidence of chlamydia and syphilis by approximately 70%; however, effects on prevention of gonorrhea have been less clear.

Meningococcal B vaccination has, meanwhile, shown intriguing reductions of gonorrhea incidence of as much as 26%-46% in some observational studies.

Therefore, Dr. Molina and colleagues decided to further investigate Doxy PEP as well as the meningococcal B vaccine in prevention of STIs.

For the ANRS 174 DOXYVAC trial, they enrolled 546 MSM in the open-label, multicenter study between January 2021 and July 2022.

The men were randomly assigned to one of 4 groups: doxycycline postexposure prophylaxis (Doxy PEP: 200 mg; n = 332), no Doxy PEP (n = 170), two shots of meningococcal B vaccine (4CMenB vaccine; n = 257), or no 4CMenB vaccine (n = 245).

All participants were assigned to their groups within 72 hours of condomless sex.

The men, who had a median age of 39, had a median time of PrEP use of 42 months, a history of an STI in the past year, and their median number of sexual partners in the past 3 months was 10.

Their characteristics were well-balanced across the treatment groups. After discontinuations of 54 patients across the groups, the final analysis included 502 participants.

With a median follow-up of 9 months, the intent-to-treat analysis showed 13 subjects had a first episode of chlamydia or syphilis in the Doxy PEP group, versus 49 subjects infected in the no Doxy PEP arm, for an incidence of 5.6 versus 35.4 per 100 person-years, respectively (adjusted hazard ratio, 0.16; P < .0001).

Infection specifically with chlamydia occurred among 21 men with no Doxy PEP versus 5 receiving Dox PEP (19.3 vs. 2.1 per 100 person-years, respectively; HR, 0.11; P < .0001).

And infection with syphilis occurred in 18 men receiving no Doxy PEP versus 8 receiving the treatment (16.3 vs. 3.4 per 100 person-years, respectively; HR, 0.21; P < .001).

The corresponding rates for gonorrhea infection were an incidence 41.3 versus 20.5 per 100 person-years, in the no Doxy PEP versus Doxy PEP arms, respectively (adjusted HR, 0.49; P = .001), and 29.4 versus 16.8 per 100 person-years for Mycoplasma genitalium infection (aHR, 0.55; P = .015).

Throughout the study, about 80% of patients in the Doxy PEP group reported using the prophylaxis treatment after their most recent sexual intercourse, with subjects reporting taking a median of seven pills per month.

In the vaccine/no vaccine comparisons, 32 subjects in the no meningococcal vaccine group were infected with a first gonorrhea infection, compared with 17 in the vaccine group, representing an incidence of 19.7 versus 9.8 per 100 person-years, respectively (adjusted HR, 0.49; P = .016), which Dr. Molina called “highly significant.”

An analysis of the cumulative incidence of gonorrhea infection with the meningococcal vaccine showed rates in the no vaccine versus vaccine groups of 30.4 versus 20.1 per 100 person-years, respectively; however, statistical significance was not reached (aHR, 0.66; P = .052).

Importantly, there were no significant interactions in the results between those receiving Doxy PEP or the 4CMenB vaccine group, and there were no significant differences in drug-related serious adverse events between the groups.

Dr. Molina noted that the meningococcal B vaccine is known to contain key antigens that are shared between meningitis and gonorrhea, which could explain the benefits.

Although chlamydia and syphilis thus far appear to remain susceptible to Doxy PEP, resistances with gonorrhea remain a concern, hence the ability of the vaccine to provide some protection could be an added bonus.

“We know that [gonorrhea] is able to very quickly develop resistances to any antibiotics, so that was why we wanted to look beyond the antibiotic prophylaxis,” said Dr. Molina.

Among questions to explore looking ahead is the potential longevity of protection with the vaccine.

“We don’t know at this point how long the protection with the vaccine could last, or if [people] may need booster injections, for instance, but the literature suggests benefits for at least a year,” Dr. Molina said. “We are still monitoring the patients in the study to see what happens.”

He added that combination of the interventions may be of benefit.

“In the future, we think we may need to combine these approaches if we want to meet the WHO/UNAIDS targets to reduce the incidence of HIV and STIs by 90% by 2030.”

Commenting on the study, CROI vice-chair Landon Myer, MD, PhD, noted that “gonorrhea develops resistance quickly and can be hard to treat or prophylaxis, so the vaccine finding, which was hinted at by previous observational data, is really important.”

He agrees that “the duration of protective efficacy – a big thing in vaccines – is unknown.”

“Still, this is really significant,” Dr. Myer stressed. “An efficacious vaccine against a stubborn sexually transmitted infection.”

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