Federal Practitioner

SILVER SPRING, MD – The FDA issued approval for long-acting, injectable cabotegravir (CAB-LA) on Dec. 21, providing an alternative to daily oral tenofovir disoproxil fumarate-emtricitabine (TDC-FTC) for pre-exposure prophylaxis (PrEP) against HIV acquisition.

The priority review approval was based on phase 2b-3 clinical trial data submitted to the agency this past August, after the study was stopped early due to encouraging efficacy results of the first pre-planned interim end-point analysis.

“Although TDF-FTC PrEP could be almost astoundingly effective in preventing HIV acquisition across populations and risk exposures, the adherence to the daily protocols was really challenging and difficult to attain initially and to maintain for some of our most vulnerable populations,” Raphael Landovitz, MD, MDC, lead study investigator and co-director of The Center for HIV Identification, Prevention, and Treatment Services at UCLA, Los Angeles, told this news organization.

Dr. Landovitz noted that population level benefits observed with PrEP were limited to people who were highly engaged in health care and well resourced, but the same benefits were not observed in the most vulnerable, highest-risk populations. 

“The idea was, is there anything that we can do to improve ... choices for different options, some of which – like long-acting agents – would remove the obligation to adhere to daily prescribing or a post-coital and be more discreet,” he said.
 

Data demonstrated superiority versus TDF-FTC

Details of the prospective, phase 2b-3 randomized, double-blind, double-dummy, active-controlled trial among 4,566 cisgender MSM (men who have sex with men) and transgender women highlighted the superiority of CAB 600 mg intramuscularly versus placebo or active TDF-FTC (300 mg/200 mg), with CAB-LA reducing HIV infection risk by 66%. These results were published August 11 in the New England Journal of Medicine and previously reported by this news organization.

Investigators identified HIV infections in 57 participants (including 52 who acquired HIV infections after enrollment). The hazard ratio for incident HIV infection versus TDG-FTC was 0.34, P < .001. Notably, effects were consistent across prespecified subgroups and populations. 

Additionally, integrase strand-transfer inhibitor (INSTI) resistance mutations were detected in 1 of 4 of baseline HIV infection cases among CAB participants, while 2 of 39 incident infections in TDF-FTC participants occurred despite drug concentrations indicating good PrEP adherence. 
 

Adverse events, breakthrough infections, and other important considerations

Because the trial was halted early, long-term safety data were lacking, thereby prompting investigators to launch an ongoing, open-label extension. In the initial trial, injection site reactions were reported in 81.4% (1,724) of CAB participants, most beginning a median of 1 day (IQR 0-2 days) post-injection, mild to moderate in severity (60.8% pain, 23.7% tenderness), and lasting a median of 3 days (IQR 2-6 days). In comparison, injection site reactions were reported in 31.3% of TDF-FTC participants (who, incidentally, received at least one placebo injection).

Severe adverse events (grade 3 or higher) were similar between CAB and TDF-FTC groups, They consisted mostly of an increase in creatine kinase level (14.2% with CAB vs. 13.5% with TDF-FTC) and a decrease in creatinine clearance (7.0% with CAB vs. 8.3% with TDF-FTC).

Although weight gain was higher among CAB participants (1.23 kg/year vs. 0.37 kg/year, TDF-FTC participants), most of the differences were observed during the first 40 weeks and were driven by weight loss in the TDF-FDC group. Weight changes were similar (~1 kg/year) thereafter.

Importantly, study participants assigned CAB underwent an oral-tablet, 5-week lead-in phase, which might have contributed to eventual treatment failure.

In a companion piece published Nov. 1 in the Journal of Infectious Diseases, investigators noted that adherence to the oral lead-in was poor in roughly one-third of participants with incident, breakthrough infections. They wrote that the barriers to adherence with daily oral PrEP regimens coupled with the favorable CAB-LA safety profile suggested that “the oral phase before CAB-LA initiation might not be necessary or desirable.”

The question remains as to whether or not strategies entailing viral load or other RNA screening tests at follow-up clinic visits might be warranted. 

“It’s one of the biggest sort of ‘what’s next’ questions that’s come out of this study,” Dr. Landovitz said. “We’re now testing the strategy of using viral load or RNA screening at every visit to see if, in fact, we can catch these breakthrough infections earlier and potentially avoid resistance,” he added.

Until more data are available, Dr. Landovitz said that “the guidance for the clinician would be that until you have resistance testing back on someone who breaks through cabotegravir PrEP to use a protease inhibitor-based treatment regimen, at least initially.”

Institutional changes to ensure delivery of injections, tracking, and follow-up to ensure optimal use of long-acting PrEP agents are likely to challenge already overburdened health care systems and may require additional strategies for implementation (for example, pharmacy or at-home administration). Despite these factors, CAB-LA approval is welcome news to clinicians and patients alike.

“We’re constantly searching for new drugs to expand our repertoire of what we can provide patients,” Lina Rosengren-Hovee, MD, MPH, assistant professor of medicine and infectious disease specialist at UNC Health, Chapel Hill, N.C., said in an interview. Dr. Rosengren-Hovee was not involved in the study.

“For folks under 30, the sexual and gender minority, Black, and Latino, they are the ones with the highest need for PrEP, that are in a position that places them at higher risk for HIV. Being able to offer an injectable option is ... a game changer,” she said.

Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.

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

SILVER SPRING, MD – The FDA issued approval for long-acting, injectable cabotegravir (CAB-LA) on Dec. 21, providing an alternative to daily oral tenofovir disoproxil fumarate-emtricitabine (TDC-FTC) for pre-exposure prophylaxis (PrEP) against HIV acquisition.

The priority review approval was based on phase 2b-3 clinical trial data submitted to the agency this past August, after the study was stopped early due to encouraging efficacy results of the first pre-planned interim end-point analysis.

“Although TDF-FTC PrEP could be almost astoundingly effective in preventing HIV acquisition across populations and risk exposures, the adherence to the daily protocols was really challenging and difficult to attain initially and to maintain for some of our most vulnerable populations,” Raphael Landovitz, MD, MDC, lead study investigator and co-director of The Center for HIV Identification, Prevention, and Treatment Services at UCLA, Los Angeles, told this news organization.

Dr. Landovitz noted that population level benefits observed with PrEP were limited to people who were highly engaged in health care and well resourced, but the same benefits were not observed in the most vulnerable, highest-risk populations. 

“The idea was, is there anything that we can do to improve ... choices for different options, some of which – like long-acting agents – would remove the obligation to adhere to daily prescribing or a post-coital and be more discreet,” he said.
 

Data demonstrated superiority versus TDF-FTC

Details of the prospective, phase 2b-3 randomized, double-blind, double-dummy, active-controlled trial among 4,566 cisgender MSM (men who have sex with men) and transgender women highlighted the superiority of CAB 600 mg intramuscularly versus placebo or active TDF-FTC (300 mg/200 mg), with CAB-LA reducing HIV infection risk by 66%. These results were published August 11 in the New England Journal of Medicine and previously reported by this news organization.

Investigators identified HIV infections in 57 participants (including 52 who acquired HIV infections after enrollment). The hazard ratio for incident HIV infection versus TDG-FTC was 0.34, P < .001. Notably, effects were consistent across prespecified subgroups and populations. 

Additionally, integrase strand-transfer inhibitor (INSTI) resistance mutations were detected in 1 of 4 of baseline HIV infection cases among CAB participants, while 2 of 39 incident infections in TDF-FTC participants occurred despite drug concentrations indicating good PrEP adherence. 
 

Adverse events, breakthrough infections, and other important considerations

Because the trial was halted early, long-term safety data were lacking, thereby prompting investigators to launch an ongoing, open-label extension. In the initial trial, injection site reactions were reported in 81.4% (1,724) of CAB participants, most beginning a median of 1 day (IQR 0-2 days) post-injection, mild to moderate in severity (60.8% pain, 23.7% tenderness), and lasting a median of 3 days (IQR 2-6 days). In comparison, injection site reactions were reported in 31.3% of TDF-FTC participants (who, incidentally, received at least one placebo injection).

Severe adverse events (grade 3 or higher) were similar between CAB and TDF-FTC groups, They consisted mostly of an increase in creatine kinase level (14.2% with CAB vs. 13.5% with TDF-FTC) and a decrease in creatinine clearance (7.0% with CAB vs. 8.3% with TDF-FTC).

Although weight gain was higher among CAB participants (1.23 kg/year vs. 0.37 kg/year, TDF-FTC participants), most of the differences were observed during the first 40 weeks and were driven by weight loss in the TDF-FDC group. Weight changes were similar (~1 kg/year) thereafter.

Importantly, study participants assigned CAB underwent an oral-tablet, 5-week lead-in phase, which might have contributed to eventual treatment failure.

In a companion piece published Nov. 1 in the Journal of Infectious Diseases, investigators noted that adherence to the oral lead-in was poor in roughly one-third of participants with incident, breakthrough infections. They wrote that the barriers to adherence with daily oral PrEP regimens coupled with the favorable CAB-LA safety profile suggested that “the oral phase before CAB-LA initiation might not be necessary or desirable.”

The question remains as to whether or not strategies entailing viral load or other RNA screening tests at follow-up clinic visits might be warranted. 

“It’s one of the biggest sort of ‘what’s next’ questions that’s come out of this study,” Dr. Landovitz said. “We’re now testing the strategy of using viral load or RNA screening at every visit to see if, in fact, we can catch these breakthrough infections earlier and potentially avoid resistance,” he added.

Until more data are available, Dr. Landovitz said that “the guidance for the clinician would be that until you have resistance testing back on someone who breaks through cabotegravir PrEP to use a protease inhibitor-based treatment regimen, at least initially.”

Institutional changes to ensure delivery of injections, tracking, and follow-up to ensure optimal use of long-acting PrEP agents are likely to challenge already overburdened health care systems and may require additional strategies for implementation (for example, pharmacy or at-home administration). Despite these factors, CAB-LA approval is welcome news to clinicians and patients alike.

“We’re constantly searching for new drugs to expand our repertoire of what we can provide patients,” Lina Rosengren-Hovee, MD, MPH, assistant professor of medicine and infectious disease specialist at UNC Health, Chapel Hill, N.C., said in an interview. Dr. Rosengren-Hovee was not involved in the study.

“For folks under 30, the sexual and gender minority, Black, and Latino, they are the ones with the highest need for PrEP, that are in a position that places them at higher risk for HIV. Being able to offer an injectable option is ... a game changer,” she said.

Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.

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

SILVER SPRING, MD – The FDA issued approval for long-acting, injectable cabotegravir (CAB-LA) on Dec. 21, providing an alternative to daily oral tenofovir disoproxil fumarate-emtricitabine (TDC-FTC) for pre-exposure prophylaxis (PrEP) against HIV acquisition.

The priority review approval was based on phase 2b-3 clinical trial data submitted to the agency this past August, after the study was stopped early due to encouraging efficacy results of the first pre-planned interim end-point analysis.

“Although TDF-FTC PrEP could be almost astoundingly effective in preventing HIV acquisition across populations and risk exposures, the adherence to the daily protocols was really challenging and difficult to attain initially and to maintain for some of our most vulnerable populations,” Raphael Landovitz, MD, MDC, lead study investigator and co-director of The Center for HIV Identification, Prevention, and Treatment Services at UCLA, Los Angeles, told this news organization.

Dr. Landovitz noted that population level benefits observed with PrEP were limited to people who were highly engaged in health care and well resourced, but the same benefits were not observed in the most vulnerable, highest-risk populations. 

“The idea was, is there anything that we can do to improve ... choices for different options, some of which – like long-acting agents – would remove the obligation to adhere to daily prescribing or a post-coital and be more discreet,” he said.
 

Data demonstrated superiority versus TDF-FTC

Details of the prospective, phase 2b-3 randomized, double-blind, double-dummy, active-controlled trial among 4,566 cisgender MSM (men who have sex with men) and transgender women highlighted the superiority of CAB 600 mg intramuscularly versus placebo or active TDF-FTC (300 mg/200 mg), with CAB-LA reducing HIV infection risk by 66%. These results were published August 11 in the New England Journal of Medicine and previously reported by this news organization.

Investigators identified HIV infections in 57 participants (including 52 who acquired HIV infections after enrollment). The hazard ratio for incident HIV infection versus TDG-FTC was 0.34, P < .001. Notably, effects were consistent across prespecified subgroups and populations. 

Additionally, integrase strand-transfer inhibitor (INSTI) resistance mutations were detected in 1 of 4 of baseline HIV infection cases among CAB participants, while 2 of 39 incident infections in TDF-FTC participants occurred despite drug concentrations indicating good PrEP adherence. 
 

Adverse events, breakthrough infections, and other important considerations

Because the trial was halted early, long-term safety data were lacking, thereby prompting investigators to launch an ongoing, open-label extension. In the initial trial, injection site reactions were reported in 81.4% (1,724) of CAB participants, most beginning a median of 1 day (IQR 0-2 days) post-injection, mild to moderate in severity (60.8% pain, 23.7% tenderness), and lasting a median of 3 days (IQR 2-6 days). In comparison, injection site reactions were reported in 31.3% of TDF-FTC participants (who, incidentally, received at least one placebo injection).

Severe adverse events (grade 3 or higher) were similar between CAB and TDF-FTC groups, They consisted mostly of an increase in creatine kinase level (14.2% with CAB vs. 13.5% with TDF-FTC) and a decrease in creatinine clearance (7.0% with CAB vs. 8.3% with TDF-FTC).

Although weight gain was higher among CAB participants (1.23 kg/year vs. 0.37 kg/year, TDF-FTC participants), most of the differences were observed during the first 40 weeks and were driven by weight loss in the TDF-FDC group. Weight changes were similar (~1 kg/year) thereafter.

Importantly, study participants assigned CAB underwent an oral-tablet, 5-week lead-in phase, which might have contributed to eventual treatment failure.

In a companion piece published Nov. 1 in the Journal of Infectious Diseases, investigators noted that adherence to the oral lead-in was poor in roughly one-third of participants with incident, breakthrough infections. They wrote that the barriers to adherence with daily oral PrEP regimens coupled with the favorable CAB-LA safety profile suggested that “the oral phase before CAB-LA initiation might not be necessary or desirable.”

The question remains as to whether or not strategies entailing viral load or other RNA screening tests at follow-up clinic visits might be warranted. 

“It’s one of the biggest sort of ‘what’s next’ questions that’s come out of this study,” Dr. Landovitz said. “We’re now testing the strategy of using viral load or RNA screening at every visit to see if, in fact, we can catch these breakthrough infections earlier and potentially avoid resistance,” he added.

Until more data are available, Dr. Landovitz said that “the guidance for the clinician would be that until you have resistance testing back on someone who breaks through cabotegravir PrEP to use a protease inhibitor-based treatment regimen, at least initially.”

Institutional changes to ensure delivery of injections, tracking, and follow-up to ensure optimal use of long-acting PrEP agents are likely to challenge already overburdened health care systems and may require additional strategies for implementation (for example, pharmacy or at-home administration). Despite these factors, CAB-LA approval is welcome news to clinicians and patients alike.

“We’re constantly searching for new drugs to expand our repertoire of what we can provide patients,” Lina Rosengren-Hovee, MD, MPH, assistant professor of medicine and infectious disease specialist at UNC Health, Chapel Hill, N.C., said in an interview. Dr. Rosengren-Hovee was not involved in the study.

“For folks under 30, the sexual and gender minority, Black, and Latino, they are the ones with the highest need for PrEP, that are in a position that places them at higher risk for HIV. Being able to offer an injectable option is ... a game changer,” she said.

Dr. Rosengren-Hovee reports no relevant financial relationships. Dr. Landovitz has consulting relationships with Gilead, Janssen, Roche, and Cepheus.

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

Editors at the BMJ have released an urgent request to Facebook’s Mark Zuckerberg and parent company Meta regarding a recent “fact-check” on the medical trade journal’s article about questionable Pfizer vaccine trial practices.

According to an open letter written by outgoing BMJ editor-in-chief Fiona Godlee, MD, and incoming editor-in-chief Kamran Abbasi, MD, Facebook hired a third-party contractor to evaluate the article’s findings. This resulted in “inaccurate, incompetent, and irresponsible” conclusions that “should be of concern to anyone who values and relies on sources such as the BMJ for reliable medical information.”

The article in question investigated data integrity concerns at Pfizer vaccine clinical trial sites. In September 2020, the letter states, a former employee of the research group involved in Pfizer’s main vaccine trials, Ventavia, reached out to the BMJ and “began providing ... dozens of internal company documents, photos, audio recordings, and emails.” According to the company’s website, Ventavia “played a significant part in [COVID-19 clinical trial] recruitment” and “has received recognition by Pfizer for their contribution to vaccine trials.”

It was previously reported that the whistle-blower is a former regional director who was involved in Pfizer’s vaccine trials in Texas during the fall of 2020. She alleges “the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase 3 trial.”

The images provided to the BMJ “showed needles discarded in a plastic biohazard bag instead of a sharps container box” and another displayed “vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”

Despite informing Ventavia, the director’s concerns went unaddressed. She then filed a complaint with the Food and Drug Administration and was subsequently fired the same day. The FDA did not investigate the director’s allegations, said Dr. Godlee and Dr. Abbasi, even though the evidence “revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety.”
 

Article labeled as ‘hoax,’ without pointing out errors

The BMJ hired an investigative reporter to follow up on the clinical trial claims. The findings were published in an article on Nov. 2, 2021, after the article “went through ... the usual high-level legal and editorial oversight and peer review,” according to the journal.

However, by Nov. 10, the journal began receiving complaints from readers unable to share the article on social media. Others had their posts flagged with warnings, such as “missing context ... independent fact-checkers say this information could mislead people.” Administrators of various Facebook groups were notified that posts containing the article were “partly false.”

Readers were informed that Facebook contractor Lead Stories performed the article’s “fact check.” Lead Stories is “an award-winning innovative fact checking and debunking website” and “an active part of Facebook’s partnership with third-party fact checkers” – with the latter granting them “access to listings of content that has been flagged as potentially false by Facebook’s systems or its users.” The company said they “decide independently if we want to fact check it or not.”

Lead Stories stated that they “can enter our fact checks into a tool provided by Facebook and Facebook then uses our data to help slow down the spread of false information on its platform.” Although the contractor is compensated, Lead Stories claims they have “no say or influence over what we fact check or what our conclusions are.”

Both editors question the validity of the fact check performed by Lead Stories, as it failed to provide any “assertions of fact” as to what the BMJ got wrong. Moreover, the editors take issue with Lead Stories referring to the journal as a “news blog” and using the phrase “hoax-alert” in the URL when publishing the story on its site.

The BMJ has reached out to Lead Stories and Facebook, said the letter, but Lead Stories refuses to “change anything about their article or actions that have led to Facebook flagging our article.” Requests for Facebook to remove the “fact-checking” label and allow “readers to freely share the article on [Facebook’s] platform” have been unfruitful.

Dr. Godlee and Dr. Abbasi expressed concern that other “high quality information provider[s] have been affected by the incompetence of Meta’s fact checking regime.” In November, Instagram censored Cochrane, an international provider of independent systematic medical reviews. Instagram, also owned by Meta, prohibited users from tagging Cochrane because the organization “repeatedly posted ... false content about COVID-19 or vaccines.” Cochrane refuted the allegations.

While “fact checking has been a staple of good journalism for decades,” said the editors, Meta has “apparently delegated responsibility to people incompetent in carrying out this crucial task.” They urged the company to reconsider its fact-checking strategy and review the issues that contributed to the error.

This news organization reached out to Meta for comment but did not receive a response at press time.

Lead Stories has posted a reply (Lead Stories’ Response To BMJ Open Letter Objecting To A Lead Stories Fact Check) to the BMJ’s complaint on its website.

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

Editors at the BMJ have released an urgent request to Facebook’s Mark Zuckerberg and parent company Meta regarding a recent “fact-check” on the medical trade journal’s article about questionable Pfizer vaccine trial practices.

According to an open letter written by outgoing BMJ editor-in-chief Fiona Godlee, MD, and incoming editor-in-chief Kamran Abbasi, MD, Facebook hired a third-party contractor to evaluate the article’s findings. This resulted in “inaccurate, incompetent, and irresponsible” conclusions that “should be of concern to anyone who values and relies on sources such as the BMJ for reliable medical information.”

The article in question investigated data integrity concerns at Pfizer vaccine clinical trial sites. In September 2020, the letter states, a former employee of the research group involved in Pfizer’s main vaccine trials, Ventavia, reached out to the BMJ and “began providing ... dozens of internal company documents, photos, audio recordings, and emails.” According to the company’s website, Ventavia “played a significant part in [COVID-19 clinical trial] recruitment” and “has received recognition by Pfizer for their contribution to vaccine trials.”

It was previously reported that the whistle-blower is a former regional director who was involved in Pfizer’s vaccine trials in Texas during the fall of 2020. She alleges “the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase 3 trial.”

The images provided to the BMJ “showed needles discarded in a plastic biohazard bag instead of a sharps container box” and another displayed “vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”

Despite informing Ventavia, the director’s concerns went unaddressed. She then filed a complaint with the Food and Drug Administration and was subsequently fired the same day. The FDA did not investigate the director’s allegations, said Dr. Godlee and Dr. Abbasi, even though the evidence “revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety.”
 

Article labeled as ‘hoax,’ without pointing out errors

The BMJ hired an investigative reporter to follow up on the clinical trial claims. The findings were published in an article on Nov. 2, 2021, after the article “went through ... the usual high-level legal and editorial oversight and peer review,” according to the journal.

However, by Nov. 10, the journal began receiving complaints from readers unable to share the article on social media. Others had their posts flagged with warnings, such as “missing context ... independent fact-checkers say this information could mislead people.” Administrators of various Facebook groups were notified that posts containing the article were “partly false.”

Readers were informed that Facebook contractor Lead Stories performed the article’s “fact check.” Lead Stories is “an award-winning innovative fact checking and debunking website” and “an active part of Facebook’s partnership with third-party fact checkers” – with the latter granting them “access to listings of content that has been flagged as potentially false by Facebook’s systems or its users.” The company said they “decide independently if we want to fact check it or not.”

Lead Stories stated that they “can enter our fact checks into a tool provided by Facebook and Facebook then uses our data to help slow down the spread of false information on its platform.” Although the contractor is compensated, Lead Stories claims they have “no say or influence over what we fact check or what our conclusions are.”

Both editors question the validity of the fact check performed by Lead Stories, as it failed to provide any “assertions of fact” as to what the BMJ got wrong. Moreover, the editors take issue with Lead Stories referring to the journal as a “news blog” and using the phrase “hoax-alert” in the URL when publishing the story on its site.

The BMJ has reached out to Lead Stories and Facebook, said the letter, but Lead Stories refuses to “change anything about their article or actions that have led to Facebook flagging our article.” Requests for Facebook to remove the “fact-checking” label and allow “readers to freely share the article on [Facebook’s] platform” have been unfruitful.

Dr. Godlee and Dr. Abbasi expressed concern that other “high quality information provider[s] have been affected by the incompetence of Meta’s fact checking regime.” In November, Instagram censored Cochrane, an international provider of independent systematic medical reviews. Instagram, also owned by Meta, prohibited users from tagging Cochrane because the organization “repeatedly posted ... false content about COVID-19 or vaccines.” Cochrane refuted the allegations.

While “fact checking has been a staple of good journalism for decades,” said the editors, Meta has “apparently delegated responsibility to people incompetent in carrying out this crucial task.” They urged the company to reconsider its fact-checking strategy and review the issues that contributed to the error.

This news organization reached out to Meta for comment but did not receive a response at press time.

Lead Stories has posted a reply (Lead Stories’ Response To BMJ Open Letter Objecting To A Lead Stories Fact Check) to the BMJ’s complaint on its website.

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

Editors at the BMJ have released an urgent request to Facebook’s Mark Zuckerberg and parent company Meta regarding a recent “fact-check” on the medical trade journal’s article about questionable Pfizer vaccine trial practices.

According to an open letter written by outgoing BMJ editor-in-chief Fiona Godlee, MD, and incoming editor-in-chief Kamran Abbasi, MD, Facebook hired a third-party contractor to evaluate the article’s findings. This resulted in “inaccurate, incompetent, and irresponsible” conclusions that “should be of concern to anyone who values and relies on sources such as the BMJ for reliable medical information.”

The article in question investigated data integrity concerns at Pfizer vaccine clinical trial sites. In September 2020, the letter states, a former employee of the research group involved in Pfizer’s main vaccine trials, Ventavia, reached out to the BMJ and “began providing ... dozens of internal company documents, photos, audio recordings, and emails.” According to the company’s website, Ventavia “played a significant part in [COVID-19 clinical trial] recruitment” and “has received recognition by Pfizer for their contribution to vaccine trials.”

It was previously reported that the whistle-blower is a former regional director who was involved in Pfizer’s vaccine trials in Texas during the fall of 2020. She alleges “the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase 3 trial.”

The images provided to the BMJ “showed needles discarded in a plastic biohazard bag instead of a sharps container box” and another displayed “vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”

Despite informing Ventavia, the director’s concerns went unaddressed. She then filed a complaint with the Food and Drug Administration and was subsequently fired the same day. The FDA did not investigate the director’s allegations, said Dr. Godlee and Dr. Abbasi, even though the evidence “revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety.”
 

Article labeled as ‘hoax,’ without pointing out errors

The BMJ hired an investigative reporter to follow up on the clinical trial claims. The findings were published in an article on Nov. 2, 2021, after the article “went through ... the usual high-level legal and editorial oversight and peer review,” according to the journal.

However, by Nov. 10, the journal began receiving complaints from readers unable to share the article on social media. Others had their posts flagged with warnings, such as “missing context ... independent fact-checkers say this information could mislead people.” Administrators of various Facebook groups were notified that posts containing the article were “partly false.”

Readers were informed that Facebook contractor Lead Stories performed the article’s “fact check.” Lead Stories is “an award-winning innovative fact checking and debunking website” and “an active part of Facebook’s partnership with third-party fact checkers” – with the latter granting them “access to listings of content that has been flagged as potentially false by Facebook’s systems or its users.” The company said they “decide independently if we want to fact check it or not.”

Lead Stories stated that they “can enter our fact checks into a tool provided by Facebook and Facebook then uses our data to help slow down the spread of false information on its platform.” Although the contractor is compensated, Lead Stories claims they have “no say or influence over what we fact check or what our conclusions are.”

Both editors question the validity of the fact check performed by Lead Stories, as it failed to provide any “assertions of fact” as to what the BMJ got wrong. Moreover, the editors take issue with Lead Stories referring to the journal as a “news blog” and using the phrase “hoax-alert” in the URL when publishing the story on its site.

The BMJ has reached out to Lead Stories and Facebook, said the letter, but Lead Stories refuses to “change anything about their article or actions that have led to Facebook flagging our article.” Requests for Facebook to remove the “fact-checking” label and allow “readers to freely share the article on [Facebook’s] platform” have been unfruitful.

Dr. Godlee and Dr. Abbasi expressed concern that other “high quality information provider[s] have been affected by the incompetence of Meta’s fact checking regime.” In November, Instagram censored Cochrane, an international provider of independent systematic medical reviews. Instagram, also owned by Meta, prohibited users from tagging Cochrane because the organization “repeatedly posted ... false content about COVID-19 or vaccines.” Cochrane refuted the allegations.

While “fact checking has been a staple of good journalism for decades,” said the editors, Meta has “apparently delegated responsibility to people incompetent in carrying out this crucial task.” They urged the company to reconsider its fact-checking strategy and review the issues that contributed to the error.

This news organization reached out to Meta for comment but did not receive a response at press time.

Lead Stories has posted a reply (Lead Stories’ Response To BMJ Open Letter Objecting To A Lead Stories Fact Check) to the BMJ’s complaint on its website.

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

While 2022 is lurking around the corner, many of us still have 2020 on our minds. Social media posts are already emerging: “No new years resolutions. It is the circumstances turn to improve [sic],” one post declares. Others proclaim that it is difficult coming to terms with the idea that 2022 is actually pronounced “2020 too.” A critical difference exists between then and now – we have experienced months of living in limbo and rolling with the punches of pandemic life.

In some ways, it has become easy to think of the early pandemic days as a distant memory, yet respect that the impact of 2020 has been indelible for virtually all of us and feels palpable as if it were yesterday.

The year 2020 was marked by the beginning of the COVID-19 pandemic, which was accompanied by extreme uncertainty, loss of all kinds, and emotional turmoil. The early pandemic had a profound economic and social impact, with added stress tethered to political and race-related division in America that created divides among families and friends, and yielded ceaseless discourse related to divergent perspectives. This only exacerbated the stress that came with the pandemic, given that providing support and leaning on one another was more important than ever. All of this was compounded by natural disasters that have plagued the country.

So much was unprecedented. There was a collective sense of feeling “worn down,” and the burnout that was felt was quite profound. Enormous amounts of mental and physical effort were allocated to simply surviving, getting basic needs met, having enough food and supplies, and completing basic tasks. Ordinary relating felt taxing. At this stage of the pandemic, the COVID-19 experience can be conceived of as a traumatic stressor capable of eliciting a traumatic response and exacerbating other mental health symptoms. Our capacity to cope has been diminished. Anxiety rates have soared, as have rates of clinical depression. Those most affected have had lower household incomes, are unmarried, and have experienced pandemic-related stressors. The links between the impact of the pandemic on mental health have been clear.

The pandemic has forced the landscape of social support to dramatically change. Initially, we felt pulled to connect and we leaned into the use of virtual platforms to connect for all matters (simple social gatherings, big birthday events, family reunions, celebration of holidays, work duties, and academic work). However, “Zoom fatigue” began to set in, and our screen time was maxed out. There has been the added dynamic of frontline workers who did not have the option to work virtually or from home. This group largely has felt disconnected from others who didn’t understand the depth of their anxiety and loneliness of their experience. Health care workers have had to make challenging, life-and-death, patient-related decisions that called into question personal morals and ethics all while their own lives were at risk.

Fast-forward to the present, and support systems have either strengthened or worn down – which has yielded a unique dichotomy. Maintaining friendships has either felt of utmost importance given the impact of the disconnect and physical distance or has felt challenging given the mental energy expended from working and connecting virtually. Empathy burnout is also a real and important facet in the equation. We begin to ask the question: Are we checking in with others in the spirit of authentic relating, to cultivate real connection, or to check a box?
 

Impact of layered traumas

It is interesting to think about the pandemic’s traumatic impact being “superimposed” on top of the “ordinary traumas” experienced outside of the pandemic. We are essentially at the 2-year mark, in some ways have cultivated a sense of resilience and found ways to adapt, and in other ways at times feel right back where we were in early 2020. There were moments that felt hopeful, glimmers of normalcy, and setbacks that all ebbed and flowed – but even so, there have not been many “mental breaks,” only temporary and transient reprieves. Some got sick and died; some recovered; and others are still experiencing long-hauler syndrome and have lingering sequelae. Despite adaptation and resilience, one can’t help but wonder the impact of superimposed traumas on top of this collective trauma. Many of us have not even rebounded from the pandemic, and then are faced with loss, grief, challenges, illness, hard and big life decisions. We are challenged to answer the question: How do we endure in the face of this trauma inception?

It has been a challenging time for all, including those who are ordinarily happy-go-lucky, resilient, and see the glass half-full and are struggling with the idea of struggling. I am no “resilience expert” but gleaned much wisdom from responding to the Surfside, Fla., building collapse. This was a collective trauma that took place in the summer of 2021, and the wisdom of this event highlighted the value of collective healing and unification even in spite of the times. What happened in Surfside was a shock, and the loss was felt by those directly affected, the surrounding community, and those who were part of the disaster response efforts. All of those parties had been processing losses prior to this – loss of normalcy because of the pandemic, loss of people we loved as a result, other personal losses – and this community tragedy was yet another loss to disentangle on top of a period in U.S. history demarcated by a great lack of unity, divisiveness, anger, and hatred. The collapse highlighted the small size yet interconnectedness of the community and the power of connection and authentic relating. It was overwhelming in the moment but extremely heartening and beautiful to see the amount of willingness to drop everything and help. Despite feeling worn down from the pandemic, people drew upon their internal resources, natural goodness, and kindness “reserves” to provide support.

Responding to the collapse highlighted that resilience in the context of collective trauma requires flexibility, embracing uncertainty, cultivating unity, and paying attention to meeting basic needs/self-care. The role of kindness cannot be overemphasized. In the realm of reflecting on the notion of kindness, it is worth noting how much power there is to bearing witness to someone’s experience, especially when they are in pain. Sometimes there are no words, nothing “to do,” no solution to offer other than just “being,” which can be enough. People often diminish the role or at the very least do not recognize the power of showing up for someone and just listening. Pandemic resilience, and coping with coalescing traumas, is likely composed of these same facets that were essential in the context of coping with the collapse.

It is not only the immediate impact of a trauma as much as the aftermath that needs to processed and worked through. In one sense, people feel that they should be adjusted to and accustomed to this new reality, and at the same time, one has to remember and reflect on how unnatural this experience has been. There is an impact of a cumulative onslaught of negative events, and it is hard to imagine not being phased, remaining unchanged, or not feeling affected. We may feel hardened and that there are limits to the compassion we have to offer others. We may be feel empathic. There can be desensitization and an apathy to others’ suffering when our patience is worn down and we have limited bandwidth. There are data to support the idea that a level of habituation occurs to individuals who experience multiple traumas, which yields a level of “sensitization” to the negative impact of subsequent events. It becomes easy to make comparisons of suffering. The challenge will be to rise above these and make a conscious effort to connect with who and how we were before we were worn down.

I am still in awe about how much I learned from the victims’ families, survivors, and my colleagues at Surfside – about pain, suffering, loss, resilience, coping, fortitude, and meaning making. We were all forced to think beyond ourselves, show up for others, and unify in a way that remedied this period of fragmentation. With respect to the pandemic and “where we are at now,” some elements of our lives are stabilizing; other aspects feel volatile from the fatigue of what we have been experiencing. This pandemic has not fully abated, but we can find some clarity in the value of setting boundaries and knowing our limits – but not overlooking the power of unity and kindness and the value of the reciprocating those qualities.

Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the college of psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She also serves on the board of directors of the Southeast Florida Association for Psychoanalytic Psychology. Dr. Feldman has no disclosures.

While 2022 is lurking around the corner, many of us still have 2020 on our minds. Social media posts are already emerging: “No new years resolutions. It is the circumstances turn to improve [sic],” one post declares. Others proclaim that it is difficult coming to terms with the idea that 2022 is actually pronounced “2020 too.” A critical difference exists between then and now – we have experienced months of living in limbo and rolling with the punches of pandemic life.

In some ways, it has become easy to think of the early pandemic days as a distant memory, yet respect that the impact of 2020 has been indelible for virtually all of us and feels palpable as if it were yesterday.

The year 2020 was marked by the beginning of the COVID-19 pandemic, which was accompanied by extreme uncertainty, loss of all kinds, and emotional turmoil. The early pandemic had a profound economic and social impact, with added stress tethered to political and race-related division in America that created divides among families and friends, and yielded ceaseless discourse related to divergent perspectives. This only exacerbated the stress that came with the pandemic, given that providing support and leaning on one another was more important than ever. All of this was compounded by natural disasters that have plagued the country.

So much was unprecedented. There was a collective sense of feeling “worn down,” and the burnout that was felt was quite profound. Enormous amounts of mental and physical effort were allocated to simply surviving, getting basic needs met, having enough food and supplies, and completing basic tasks. Ordinary relating felt taxing. At this stage of the pandemic, the COVID-19 experience can be conceived of as a traumatic stressor capable of eliciting a traumatic response and exacerbating other mental health symptoms. Our capacity to cope has been diminished. Anxiety rates have soared, as have rates of clinical depression. Those most affected have had lower household incomes, are unmarried, and have experienced pandemic-related stressors. The links between the impact of the pandemic on mental health have been clear.

The pandemic has forced the landscape of social support to dramatically change. Initially, we felt pulled to connect and we leaned into the use of virtual platforms to connect for all matters (simple social gatherings, big birthday events, family reunions, celebration of holidays, work duties, and academic work). However, “Zoom fatigue” began to set in, and our screen time was maxed out. There has been the added dynamic of frontline workers who did not have the option to work virtually or from home. This group largely has felt disconnected from others who didn’t understand the depth of their anxiety and loneliness of their experience. Health care workers have had to make challenging, life-and-death, patient-related decisions that called into question personal morals and ethics all while their own lives were at risk.

Fast-forward to the present, and support systems have either strengthened or worn down – which has yielded a unique dichotomy. Maintaining friendships has either felt of utmost importance given the impact of the disconnect and physical distance or has felt challenging given the mental energy expended from working and connecting virtually. Empathy burnout is also a real and important facet in the equation. We begin to ask the question: Are we checking in with others in the spirit of authentic relating, to cultivate real connection, or to check a box?
 

Impact of layered traumas

It is interesting to think about the pandemic’s traumatic impact being “superimposed” on top of the “ordinary traumas” experienced outside of the pandemic. We are essentially at the 2-year mark, in some ways have cultivated a sense of resilience and found ways to adapt, and in other ways at times feel right back where we were in early 2020. There were moments that felt hopeful, glimmers of normalcy, and setbacks that all ebbed and flowed – but even so, there have not been many “mental breaks,” only temporary and transient reprieves. Some got sick and died; some recovered; and others are still experiencing long-hauler syndrome and have lingering sequelae. Despite adaptation and resilience, one can’t help but wonder the impact of superimposed traumas on top of this collective trauma. Many of us have not even rebounded from the pandemic, and then are faced with loss, grief, challenges, illness, hard and big life decisions. We are challenged to answer the question: How do we endure in the face of this trauma inception?

It has been a challenging time for all, including those who are ordinarily happy-go-lucky, resilient, and see the glass half-full and are struggling with the idea of struggling. I am no “resilience expert” but gleaned much wisdom from responding to the Surfside, Fla., building collapse. This was a collective trauma that took place in the summer of 2021, and the wisdom of this event highlighted the value of collective healing and unification even in spite of the times. What happened in Surfside was a shock, and the loss was felt by those directly affected, the surrounding community, and those who were part of the disaster response efforts. All of those parties had been processing losses prior to this – loss of normalcy because of the pandemic, loss of people we loved as a result, other personal losses – and this community tragedy was yet another loss to disentangle on top of a period in U.S. history demarcated by a great lack of unity, divisiveness, anger, and hatred. The collapse highlighted the small size yet interconnectedness of the community and the power of connection and authentic relating. It was overwhelming in the moment but extremely heartening and beautiful to see the amount of willingness to drop everything and help. Despite feeling worn down from the pandemic, people drew upon their internal resources, natural goodness, and kindness “reserves” to provide support.

Responding to the collapse highlighted that resilience in the context of collective trauma requires flexibility, embracing uncertainty, cultivating unity, and paying attention to meeting basic needs/self-care. The role of kindness cannot be overemphasized. In the realm of reflecting on the notion of kindness, it is worth noting how much power there is to bearing witness to someone’s experience, especially when they are in pain. Sometimes there are no words, nothing “to do,” no solution to offer other than just “being,” which can be enough. People often diminish the role or at the very least do not recognize the power of showing up for someone and just listening. Pandemic resilience, and coping with coalescing traumas, is likely composed of these same facets that were essential in the context of coping with the collapse.

It is not only the immediate impact of a trauma as much as the aftermath that needs to processed and worked through. In one sense, people feel that they should be adjusted to and accustomed to this new reality, and at the same time, one has to remember and reflect on how unnatural this experience has been. There is an impact of a cumulative onslaught of negative events, and it is hard to imagine not being phased, remaining unchanged, or not feeling affected. We may feel hardened and that there are limits to the compassion we have to offer others. We may be feel empathic. There can be desensitization and an apathy to others’ suffering when our patience is worn down and we have limited bandwidth. There are data to support the idea that a level of habituation occurs to individuals who experience multiple traumas, which yields a level of “sensitization” to the negative impact of subsequent events. It becomes easy to make comparisons of suffering. The challenge will be to rise above these and make a conscious effort to connect with who and how we were before we were worn down.

I am still in awe about how much I learned from the victims’ families, survivors, and my colleagues at Surfside – about pain, suffering, loss, resilience, coping, fortitude, and meaning making. We were all forced to think beyond ourselves, show up for others, and unify in a way that remedied this period of fragmentation. With respect to the pandemic and “where we are at now,” some elements of our lives are stabilizing; other aspects feel volatile from the fatigue of what we have been experiencing. This pandemic has not fully abated, but we can find some clarity in the value of setting boundaries and knowing our limits – but not overlooking the power of unity and kindness and the value of the reciprocating those qualities.

Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the college of psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She also serves on the board of directors of the Southeast Florida Association for Psychoanalytic Psychology. Dr. Feldman has no disclosures.

While 2022 is lurking around the corner, many of us still have 2020 on our minds. Social media posts are already emerging: “No new years resolutions. It is the circumstances turn to improve [sic],” one post declares. Others proclaim that it is difficult coming to terms with the idea that 2022 is actually pronounced “2020 too.” A critical difference exists between then and now – we have experienced months of living in limbo and rolling with the punches of pandemic life.

In some ways, it has become easy to think of the early pandemic days as a distant memory, yet respect that the impact of 2020 has been indelible for virtually all of us and feels palpable as if it were yesterday.

The year 2020 was marked by the beginning of the COVID-19 pandemic, which was accompanied by extreme uncertainty, loss of all kinds, and emotional turmoil. The early pandemic had a profound economic and social impact, with added stress tethered to political and race-related division in America that created divides among families and friends, and yielded ceaseless discourse related to divergent perspectives. This only exacerbated the stress that came with the pandemic, given that providing support and leaning on one another was more important than ever. All of this was compounded by natural disasters that have plagued the country.

So much was unprecedented. There was a collective sense of feeling “worn down,” and the burnout that was felt was quite profound. Enormous amounts of mental and physical effort were allocated to simply surviving, getting basic needs met, having enough food and supplies, and completing basic tasks. Ordinary relating felt taxing. At this stage of the pandemic, the COVID-19 experience can be conceived of as a traumatic stressor capable of eliciting a traumatic response and exacerbating other mental health symptoms. Our capacity to cope has been diminished. Anxiety rates have soared, as have rates of clinical depression. Those most affected have had lower household incomes, are unmarried, and have experienced pandemic-related stressors. The links between the impact of the pandemic on mental health have been clear.

The pandemic has forced the landscape of social support to dramatically change. Initially, we felt pulled to connect and we leaned into the use of virtual platforms to connect for all matters (simple social gatherings, big birthday events, family reunions, celebration of holidays, work duties, and academic work). However, “Zoom fatigue” began to set in, and our screen time was maxed out. There has been the added dynamic of frontline workers who did not have the option to work virtually or from home. This group largely has felt disconnected from others who didn’t understand the depth of their anxiety and loneliness of their experience. Health care workers have had to make challenging, life-and-death, patient-related decisions that called into question personal morals and ethics all while their own lives were at risk.

Fast-forward to the present, and support systems have either strengthened or worn down – which has yielded a unique dichotomy. Maintaining friendships has either felt of utmost importance given the impact of the disconnect and physical distance or has felt challenging given the mental energy expended from working and connecting virtually. Empathy burnout is also a real and important facet in the equation. We begin to ask the question: Are we checking in with others in the spirit of authentic relating, to cultivate real connection, or to check a box?
 

Impact of layered traumas

It is interesting to think about the pandemic’s traumatic impact being “superimposed” on top of the “ordinary traumas” experienced outside of the pandemic. We are essentially at the 2-year mark, in some ways have cultivated a sense of resilience and found ways to adapt, and in other ways at times feel right back where we were in early 2020. There were moments that felt hopeful, glimmers of normalcy, and setbacks that all ebbed and flowed – but even so, there have not been many “mental breaks,” only temporary and transient reprieves. Some got sick and died; some recovered; and others are still experiencing long-hauler syndrome and have lingering sequelae. Despite adaptation and resilience, one can’t help but wonder the impact of superimposed traumas on top of this collective trauma. Many of us have not even rebounded from the pandemic, and then are faced with loss, grief, challenges, illness, hard and big life decisions. We are challenged to answer the question: How do we endure in the face of this trauma inception?

It has been a challenging time for all, including those who are ordinarily happy-go-lucky, resilient, and see the glass half-full and are struggling with the idea of struggling. I am no “resilience expert” but gleaned much wisdom from responding to the Surfside, Fla., building collapse. This was a collective trauma that took place in the summer of 2021, and the wisdom of this event highlighted the value of collective healing and unification even in spite of the times. What happened in Surfside was a shock, and the loss was felt by those directly affected, the surrounding community, and those who were part of the disaster response efforts. All of those parties had been processing losses prior to this – loss of normalcy because of the pandemic, loss of people we loved as a result, other personal losses – and this community tragedy was yet another loss to disentangle on top of a period in U.S. history demarcated by a great lack of unity, divisiveness, anger, and hatred. The collapse highlighted the small size yet interconnectedness of the community and the power of connection and authentic relating. It was overwhelming in the moment but extremely heartening and beautiful to see the amount of willingness to drop everything and help. Despite feeling worn down from the pandemic, people drew upon their internal resources, natural goodness, and kindness “reserves” to provide support.

Responding to the collapse highlighted that resilience in the context of collective trauma requires flexibility, embracing uncertainty, cultivating unity, and paying attention to meeting basic needs/self-care. The role of kindness cannot be overemphasized. In the realm of reflecting on the notion of kindness, it is worth noting how much power there is to bearing witness to someone’s experience, especially when they are in pain. Sometimes there are no words, nothing “to do,” no solution to offer other than just “being,” which can be enough. People often diminish the role or at the very least do not recognize the power of showing up for someone and just listening. Pandemic resilience, and coping with coalescing traumas, is likely composed of these same facets that were essential in the context of coping with the collapse.

It is not only the immediate impact of a trauma as much as the aftermath that needs to processed and worked through. In one sense, people feel that they should be adjusted to and accustomed to this new reality, and at the same time, one has to remember and reflect on how unnatural this experience has been. There is an impact of a cumulative onslaught of negative events, and it is hard to imagine not being phased, remaining unchanged, or not feeling affected. We may feel hardened and that there are limits to the compassion we have to offer others. We may be feel empathic. There can be desensitization and an apathy to others’ suffering when our patience is worn down and we have limited bandwidth. There are data to support the idea that a level of habituation occurs to individuals who experience multiple traumas, which yields a level of “sensitization” to the negative impact of subsequent events. It becomes easy to make comparisons of suffering. The challenge will be to rise above these and make a conscious effort to connect with who and how we were before we were worn down.

I am still in awe about how much I learned from the victims’ families, survivors, and my colleagues at Surfside – about pain, suffering, loss, resilience, coping, fortitude, and meaning making. We were all forced to think beyond ourselves, show up for others, and unify in a way that remedied this period of fragmentation. With respect to the pandemic and “where we are at now,” some elements of our lives are stabilizing; other aspects feel volatile from the fatigue of what we have been experiencing. This pandemic has not fully abated, but we can find some clarity in the value of setting boundaries and knowing our limits – but not overlooking the power of unity and kindness and the value of the reciprocating those qualities.

Dr. Feldman is a licensed clinical psychologist in private practice in Miami. She is an adjunct professor in the college of psychology at Nova Southeastern University, Fort Lauderdale, Fla., where she teaches clinical psychology doctoral students. She also serves on the board of directors of the Southeast Florida Association for Psychoanalytic Psychology. Dr. Feldman has no disclosures.

Patients with obesity and type 2 diabetes who underwent bariatric surgery and had 10-year durable diabetes remission had a 60% lower risk of incident cancer than patients who had usual obesity care.

And women who had bariatric surgery had a 42% lower risk of having cancer during a median 21-year follow-up, compared with women who had usual obesity care.

These findings from 701 patients in the Swedish Obese Subjects (SOS) study who had type 2 diabetes were recently published in Diabetes Care.

The results illustrate the “connection between glucose control and cancer prevention” and suggest that “among patients with type 2 diabetes, many cancer cases are preventable,” lead author Kajsa Sjöholm, PhD, associate professor of molecular medicine at Sahlgrenska Academy, University of Gothenburg (Sweden), said in a press release from the university.

“The global epidemic of both obesity and diabetes leads to an increased risk of cancer, as well as an increased risk of premature death,” added senior author Magdalena Taube, PhD, associate professor of molecular medicine in the same academy.

“It has been estimated that, over the next 10-15 years, obesity may cause more cancer cases than smoking in several countries,” she noted. Therefore, “strategies are needed to prevent this development, and our results can provide vital guidance for prevention of cancer in patients with obesity and type 2 diabetes.”
 

Durable diabetes remission seems key

Two-thirds of the patients in the bariatric surgery group had vertical banded gastroplasty (65%), and the rest had adjustable or nonadjustable gastric banding (18%) or gastric bypass (17%).

Each type of bariatric surgery was associated with higher diabetes remission rates, compared with usual care, in a previous study by these researchers, Dr. Taube said in an interview.

“In our present study,” she added, “we observed a nonsignificant trend, where patients with obesity and type 2 diabetes in the highest weight loss tertile (average weight loss, –44.8 kg) had somewhat lower risk of cancer compared to the lowest tertile [average weight loss, –14.9 kg].”

This might suggest, Dr. Taube continued, that with respect to cancer risk, surgery techniques resulting in greater weight loss (for example, Roux-en-Y gastric bypass and sleeve gastrectomy) should be recommended in patients with obesity and diabetes.

“However, it should also be noted that long-term diabetes remission seems imperative for cancer risk reduction,” she said, “and in a recent meta-analysis by McTigue et al., published in JAMA Surgery, it was shown that patients who had Roux-en-Y gastric bypass had greater weight loss, a slightly higher type 2 diabetes remission rate, less type 2 diabetes relapse, and better long-term glycemic control, compared with those who had sleeve gastrectomy.

“The observed cancer reduction in women with obesity and type 2 diabetes is in line with previous findings showing that cancer risk reduction following bariatric surgery in patients with obesity is more marked among women than men,” Dr. Taube noted. This may be because cancer rates are higher in women with diabetes than in men with diabetes, and common cancer types associated with obesity are female specific.

The main cancers in women were breast cancer, followed by endometrial and colorectal cancer. In men, the main cancers were colorectal, prostate, and urothelial/malignant skin cancer.
 

Study design and findings

It is well established that obesity is a risk factor for 13 types of cancer, and some of these cancers (liver, pancreatic, endometrial, colon and rectal, breast, and bladder) may be related to type 2 diabetes. And bariatric surgery has been shown to reduce cancer risk in patients with obesity.

However, it is not clear how bariatric surgery may affect cancer risk in patients with obesity and type 2 diabetes.

To study this, the researchers examined data from 393 patients who underwent bariatric surgery and 308 patients who received usual obesity treatment, who were part of the SOS study.

The SOS study enrolled men with a body mass index of at least 34 kg/m², and women with a BMI of at least 38 kg/m² who were aged 37-60 years between 1987 and 2001.

The current study outcome – cancer incidence in patients with obesity and type 2 diabetes – was not a prespecified outcome

The intervention groups were matched on 18 variables, including age, sex, serum insulin, alcohol, education, and smoking.

At baseline, the patients had a mean age of about 49 and 60% were women. They had a mean BMI of about 42 and a mean hemoglobin A1c of 7.8%.

On average, patients in the surgery group had lost 27.5 kg and 22.7 kg, and patients in the usual care group had lost 3.2 kg and 4.8 kg, at 2 years and 10 years, respectively.

During a median follow-up of 21 years, there were 74 incident cancers in the control group and 68 cancers in the bariatric surgery group.

The risk of cancer during follow-up was 37% lower in the surgery group than in the usual care group, after multivariable adjustment (adjusted hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P = .008).

A deeper dive showed that there were 86 incident cancers in women and 56 cancers in men. The risk of cancer was significantly lower in women who had bariatric surgery, compared with those who had usual care (aHR, 0.58; 95% CI 0.38-0.90, P = .016). However, the risk of cancer was not significantly lower in men who had bariatric surgery versus those who had usual care (aHR 0.79, 95% CI, 0.46-1.38; P = .413).

Diabetes remission at 10 years was associated with a 60% reduced cancer incidence (aHR, 0.40; 95% CI, 0.22-0.74, P = .003).

The study was funded by the Swedish state (under an agreement between the Swedish government and the county councils), the Swedish Research Council, the Novo Nordisk Foundation, the Swedish Heart-Lung Foundation, and the Swedish Diabetes Foundation. One author received consulting fees from Johnson & Johnson. The other authors had no relevant financial disclosures.

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

Patients with obesity and type 2 diabetes who underwent bariatric surgery and had 10-year durable diabetes remission had a 60% lower risk of incident cancer than patients who had usual obesity care.

And women who had bariatric surgery had a 42% lower risk of having cancer during a median 21-year follow-up, compared with women who had usual obesity care.

These findings from 701 patients in the Swedish Obese Subjects (SOS) study who had type 2 diabetes were recently published in Diabetes Care.

The results illustrate the “connection between glucose control and cancer prevention” and suggest that “among patients with type 2 diabetes, many cancer cases are preventable,” lead author Kajsa Sjöholm, PhD, associate professor of molecular medicine at Sahlgrenska Academy, University of Gothenburg (Sweden), said in a press release from the university.

“The global epidemic of both obesity and diabetes leads to an increased risk of cancer, as well as an increased risk of premature death,” added senior author Magdalena Taube, PhD, associate professor of molecular medicine in the same academy.

“It has been estimated that, over the next 10-15 years, obesity may cause more cancer cases than smoking in several countries,” she noted. Therefore, “strategies are needed to prevent this development, and our results can provide vital guidance for prevention of cancer in patients with obesity and type 2 diabetes.”
 

Durable diabetes remission seems key

Two-thirds of the patients in the bariatric surgery group had vertical banded gastroplasty (65%), and the rest had adjustable or nonadjustable gastric banding (18%) or gastric bypass (17%).

Each type of bariatric surgery was associated with higher diabetes remission rates, compared with usual care, in a previous study by these researchers, Dr. Taube said in an interview.

“In our present study,” she added, “we observed a nonsignificant trend, where patients with obesity and type 2 diabetes in the highest weight loss tertile (average weight loss, –44.8 kg) had somewhat lower risk of cancer compared to the lowest tertile [average weight loss, –14.9 kg].”

This might suggest, Dr. Taube continued, that with respect to cancer risk, surgery techniques resulting in greater weight loss (for example, Roux-en-Y gastric bypass and sleeve gastrectomy) should be recommended in patients with obesity and diabetes.

“However, it should also be noted that long-term diabetes remission seems imperative for cancer risk reduction,” she said, “and in a recent meta-analysis by McTigue et al., published in JAMA Surgery, it was shown that patients who had Roux-en-Y gastric bypass had greater weight loss, a slightly higher type 2 diabetes remission rate, less type 2 diabetes relapse, and better long-term glycemic control, compared with those who had sleeve gastrectomy.

“The observed cancer reduction in women with obesity and type 2 diabetes is in line with previous findings showing that cancer risk reduction following bariatric surgery in patients with obesity is more marked among women than men,” Dr. Taube noted. This may be because cancer rates are higher in women with diabetes than in men with diabetes, and common cancer types associated with obesity are female specific.

The main cancers in women were breast cancer, followed by endometrial and colorectal cancer. In men, the main cancers were colorectal, prostate, and urothelial/malignant skin cancer.
 

Study design and findings

It is well established that obesity is a risk factor for 13 types of cancer, and some of these cancers (liver, pancreatic, endometrial, colon and rectal, breast, and bladder) may be related to type 2 diabetes. And bariatric surgery has been shown to reduce cancer risk in patients with obesity.

However, it is not clear how bariatric surgery may affect cancer risk in patients with obesity and type 2 diabetes.

To study this, the researchers examined data from 393 patients who underwent bariatric surgery and 308 patients who received usual obesity treatment, who were part of the SOS study.

The SOS study enrolled men with a body mass index of at least 34 kg/m², and women with a BMI of at least 38 kg/m² who were aged 37-60 years between 1987 and 2001.

The current study outcome – cancer incidence in patients with obesity and type 2 diabetes – was not a prespecified outcome

The intervention groups were matched on 18 variables, including age, sex, serum insulin, alcohol, education, and smoking.

At baseline, the patients had a mean age of about 49 and 60% were women. They had a mean BMI of about 42 and a mean hemoglobin A1c of 7.8%.

On average, patients in the surgery group had lost 27.5 kg and 22.7 kg, and patients in the usual care group had lost 3.2 kg and 4.8 kg, at 2 years and 10 years, respectively.

During a median follow-up of 21 years, there were 74 incident cancers in the control group and 68 cancers in the bariatric surgery group.

The risk of cancer during follow-up was 37% lower in the surgery group than in the usual care group, after multivariable adjustment (adjusted hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P = .008).

A deeper dive showed that there were 86 incident cancers in women and 56 cancers in men. The risk of cancer was significantly lower in women who had bariatric surgery, compared with those who had usual care (aHR, 0.58; 95% CI 0.38-0.90, P = .016). However, the risk of cancer was not significantly lower in men who had bariatric surgery versus those who had usual care (aHR 0.79, 95% CI, 0.46-1.38; P = .413).

Diabetes remission at 10 years was associated with a 60% reduced cancer incidence (aHR, 0.40; 95% CI, 0.22-0.74, P = .003).

The study was funded by the Swedish state (under an agreement between the Swedish government and the county councils), the Swedish Research Council, the Novo Nordisk Foundation, the Swedish Heart-Lung Foundation, and the Swedish Diabetes Foundation. One author received consulting fees from Johnson & Johnson. The other authors had no relevant financial disclosures.

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

Patients with obesity and type 2 diabetes who underwent bariatric surgery and had 10-year durable diabetes remission had a 60% lower risk of incident cancer than patients who had usual obesity care.

And women who had bariatric surgery had a 42% lower risk of having cancer during a median 21-year follow-up, compared with women who had usual obesity care.

These findings from 701 patients in the Swedish Obese Subjects (SOS) study who had type 2 diabetes were recently published in Diabetes Care.

The results illustrate the “connection between glucose control and cancer prevention” and suggest that “among patients with type 2 diabetes, many cancer cases are preventable,” lead author Kajsa Sjöholm, PhD, associate professor of molecular medicine at Sahlgrenska Academy, University of Gothenburg (Sweden), said in a press release from the university.

“The global epidemic of both obesity and diabetes leads to an increased risk of cancer, as well as an increased risk of premature death,” added senior author Magdalena Taube, PhD, associate professor of molecular medicine in the same academy.

“It has been estimated that, over the next 10-15 years, obesity may cause more cancer cases than smoking in several countries,” she noted. Therefore, “strategies are needed to prevent this development, and our results can provide vital guidance for prevention of cancer in patients with obesity and type 2 diabetes.”
 

Durable diabetes remission seems key

Two-thirds of the patients in the bariatric surgery group had vertical banded gastroplasty (65%), and the rest had adjustable or nonadjustable gastric banding (18%) or gastric bypass (17%).

Each type of bariatric surgery was associated with higher diabetes remission rates, compared with usual care, in a previous study by these researchers, Dr. Taube said in an interview.

“In our present study,” she added, “we observed a nonsignificant trend, where patients with obesity and type 2 diabetes in the highest weight loss tertile (average weight loss, –44.8 kg) had somewhat lower risk of cancer compared to the lowest tertile [average weight loss, –14.9 kg].”

This might suggest, Dr. Taube continued, that with respect to cancer risk, surgery techniques resulting in greater weight loss (for example, Roux-en-Y gastric bypass and sleeve gastrectomy) should be recommended in patients with obesity and diabetes.

“However, it should also be noted that long-term diabetes remission seems imperative for cancer risk reduction,” she said, “and in a recent meta-analysis by McTigue et al., published in JAMA Surgery, it was shown that patients who had Roux-en-Y gastric bypass had greater weight loss, a slightly higher type 2 diabetes remission rate, less type 2 diabetes relapse, and better long-term glycemic control, compared with those who had sleeve gastrectomy.

“The observed cancer reduction in women with obesity and type 2 diabetes is in line with previous findings showing that cancer risk reduction following bariatric surgery in patients with obesity is more marked among women than men,” Dr. Taube noted. This may be because cancer rates are higher in women with diabetes than in men with diabetes, and common cancer types associated with obesity are female specific.

The main cancers in women were breast cancer, followed by endometrial and colorectal cancer. In men, the main cancers were colorectal, prostate, and urothelial/malignant skin cancer.
 

Study design and findings

It is well established that obesity is a risk factor for 13 types of cancer, and some of these cancers (liver, pancreatic, endometrial, colon and rectal, breast, and bladder) may be related to type 2 diabetes. And bariatric surgery has been shown to reduce cancer risk in patients with obesity.

However, it is not clear how bariatric surgery may affect cancer risk in patients with obesity and type 2 diabetes.

To study this, the researchers examined data from 393 patients who underwent bariatric surgery and 308 patients who received usual obesity treatment, who were part of the SOS study.

The SOS study enrolled men with a body mass index of at least 34 kg/m², and women with a BMI of at least 38 kg/m² who were aged 37-60 years between 1987 and 2001.

The current study outcome – cancer incidence in patients with obesity and type 2 diabetes – was not a prespecified outcome

The intervention groups were matched on 18 variables, including age, sex, serum insulin, alcohol, education, and smoking.

At baseline, the patients had a mean age of about 49 and 60% were women. They had a mean BMI of about 42 and a mean hemoglobin A1c of 7.8%.

On average, patients in the surgery group had lost 27.5 kg and 22.7 kg, and patients in the usual care group had lost 3.2 kg and 4.8 kg, at 2 years and 10 years, respectively.

During a median follow-up of 21 years, there were 74 incident cancers in the control group and 68 cancers in the bariatric surgery group.

The risk of cancer during follow-up was 37% lower in the surgery group than in the usual care group, after multivariable adjustment (adjusted hazard ratio, 0.63; 95% confidence interval, 0.44-0.89; P = .008).

A deeper dive showed that there were 86 incident cancers in women and 56 cancers in men. The risk of cancer was significantly lower in women who had bariatric surgery, compared with those who had usual care (aHR, 0.58; 95% CI 0.38-0.90, P = .016). However, the risk of cancer was not significantly lower in men who had bariatric surgery versus those who had usual care (aHR 0.79, 95% CI, 0.46-1.38; P = .413).

Diabetes remission at 10 years was associated with a 60% reduced cancer incidence (aHR, 0.40; 95% CI, 0.22-0.74, P = .003).

The study was funded by the Swedish state (under an agreement between the Swedish government and the county councils), the Swedish Research Council, the Novo Nordisk Foundation, the Swedish Heart-Lung Foundation, and the Swedish Diabetes Foundation. One author received consulting fees from Johnson & Johnson. The other authors had no relevant financial disclosures.

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

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has announced that women no longer will have to pick up the abortion pill mifepristone (Mifeprex) in person at certain certified sites and can get a prescription via an online consultation and delivery through the mail.

In April 2021, the FDA lifted the in-person dispensing requirement for mifepristone for the duration of the COVID-19 pandemic and in December the agency made that decision permanent.

As this news organization reported on April 12, 2021, acting commissioner of food and drugs, Janet Woodcock, MD, stated that the FDA would “permit the dispensing of mifepristone through the mail when done by or under the supervision of a certified prescriber; or through a mail-order pharmacy under the supervision of a certified prescriber.”

That decision came after suspension of the in-person dispensing requirement in response to COVID-19 safety concerns for patients as well as providers associated with in-person clinic visits.
 

Decision comes amid Supreme Court debate

The FDA decision comes as the Supreme Court nears a decision on whether to overturn its 1973 ruling on Roe v. Wade.

Additionally, the Supreme Court on returned a lawsuit over Texas’ ban on abortions after 6 weeks to a federal appeals court that has twice allowed the law to stay in effect, rather than to a district judge who wanted it blocked.

Alexis McGill Johnson, president and CEO, of the Planned Parenthood Federation of America, said in a statement, “Abortion is time sensitive, essential health care, and this decision will remove a sometimes insurmountable barrier for patients seeking an abortion. With abortion rights at risk like never before, the FDA’s decision is a long overdue step toward expanding people’s access to safe medication abortion.”

Georgeanne Usova, senior legislative counsel at the American Civil Liberties Union told CNBC News: “The FDA’s decision will come as a tremendous relief for countless abortion and miscarriage patients.”

Catherine D. Cansino, MD, MPH, associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis, and member of the editorial advisory board for ObGyn News said in an interview: “I think that this change is a long time coming and speaks to the fact that science matters and medicine prevails over politics. We need to protect health rights first!”

Others expressed doubt or outrage.

Fidelma Rigby, MD, a professor in the department of obstetrics and gynecology, division of maternal fetal medicine, Virginia Commonwealth University Medical Center, Richmond, said in an interview: “My concern is that what if there is an ectopic pregnancy? I’m not as enthusiastic as some of my partners would be about this announcement.”

“The FDA’s decision today places women at risk,” said Carol Tobias, president of the National Right to Life Committee. “These changes do not make this abortion process safer for women. What these changes do is make the process easier for the abortion industry.”

The antiabortion groups Charlotte Lozier Institute and the Susan B. Anthony List were among other organizations issuing statements against Dec. 16’s FDA ruling.

The FDA stated that mifepristone prescribers will still need to earn certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.

The FDA said in updated guidance on its website that after conducting a review of the Risk Evaluation and Mitigation Strategy for mifepristone, it “determined that the data support modification of the REMS to reduce burden on patient access and the health care delivery system and to ensure the benefits of the product outweigh the risks.”

The modifications include:

• “Removing the requirement that mifepristone be dispensed only in certain health care settings, specifically clinics, medical offices, and hospitals (referred to as the ‘in-person dispensing requirement’).”
• Adding a requirement that pharmacies must be certified to dispense the drug.

The FDA said removing the in-person dispensing rule will allow delivery of mifepristone by mail via certified prescribers or pharmacies, in addition to in-person dispensing in clinics, medical offices, and hospitals.

In 2018, an expert National Academies of Science, Engineering, and Medicine panel concluded that requiring that medication abortion be provided at only certain facilities, solely by a physician or in the physical presence of certain providers, did not improve safety or quality of care.

Mifepristone is used, together with misoprostol, to end an early pregnancy. The FDA first approved Mifeprex in 2000 for use through 10 weeks’ gestation. According to the FDA, mifepristone is approved in more than 60 other countries.
 

Many states bar mailing of abortion pills

However, according to the Guttmacher Institute, 19 U.S. states have laws that bar telehealth consultations or mailing of abortion pills.

Reuters reported that women in those states would not be able to make use of the rule change get the drug delivered to their home but could potentially travel to other states to obtain medication abortion.

“States such as California and New York that have sought to strengthen access to abortion may make the drug available to women from other states,” Reuters reported.

Jessica Arons, senior advocacy and policy counsel for reproductive freedom at the ACLU, told CBS News, “Medication abortion is one more lens through which we see that we are witnessing a tale of two countries. Half the states are protecting access to abortion and half are trying every single way they can to eliminate access to abortion care.”
 

Positive results when Canada lifted restrictions

As this news organization has reported, a study found positive results when Canada lifted restrictions on access to the abortion pills and a good safety profile for mifepristone.

A study in the New England Journal of Medicine found abortion rates remained stable and adverse events were rare after mifepristone prescribing restrictions were lifted in Canada.

Senior author Wendy V. Norman, MD, professor in the department of family practice at the University of British Columbia, Vancouver, said in a statement, “Our study is a signal to other countries that restrictions are not necessary to ensure patient safety.”

Another recent study in JAMA Network Open (2021 Aug 24. doi: 10.1001/jamanetworkopen.2021.22320) found that abortion via telehealth prescriptions may be just as safe and effective as in-person care.

The study investigators said that, “of the 110 women from whom researchers collected remote abortion outcome data, 95% had a complete abortion without additional medical interventions, such as aspiration or surgery, and none experienced adverse events. Researchers said this efficacy rate is similar to in-person visits.”

The Food and Drug Administration has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Olivier Le Moal/Getty Images

This makes lumateperone the only FDA-approved drug for this indication.

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said in a company news release.

Lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.
 

‘Positioned to launch immediately’

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42-mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale score versus placebo.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is “positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

Full prescribing information is available online.

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

The Food and Drug Administration has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Olivier Le Moal/Getty Images

This makes lumateperone the only FDA-approved drug for this indication.

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said in a company news release.

Lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.
 

‘Positioned to launch immediately’

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42-mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale score versus placebo.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is “positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

Full prescribing information is available online.

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

The Food and Drug Administration has expanded approval of lumateperone (Caplyta) to include treatment of adults with depressive episodes associated with bipolar I and II disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Olivier Le Moal/Getty Images

This makes lumateperone the only FDA-approved drug for this indication.

“The efficacy, and favorable safety and tolerability profile, make Caplyta an important treatment option for the millions of patients living with bipolar I or II depression and represents a major development for these patients,” Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, and head of the mood disorders psychopharmacology unit, said in a company news release.

Lumateperone was first approved by the FDA in 2019 for the treatment of adults with schizophrenia.
 

‘Positioned to launch immediately’

The new indication stems from results of two phase 3 studies that showed treatment with lumateperone, alone or with lithium or valproate, significantly improved depressive symptoms for patients with major depressive episodes associated with bipolar I and bipolar II disorders.

In these studies, treatment with a 42-mg once-daily dose was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale score versus placebo.

Lumateperone also showed a statistically significant improvement in the key secondary endpoint relating to clinical global impression of bipolar disorder.

Somnolence/sedation, dizziness, nausea, and dry mouth were the most commonly reported adverse events associated with the medication. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. Incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, noted in the same press release that the company is “positioned to launch immediately and are excited to offer Caplyta to the millions of patients living with bipolar depression.”

Full prescribing information is available online.

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

Key clinical point: A higher preoperative multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System (PI‐RADS) score is associated with upstaging on surgical pathology in patients with prostate cancer.

Major finding: PI-RADS score was greater than 3 in 87% of patients. Upstaging was reported in 47% of patients. PI-RADS was an independent risk predictor for upstaging (adjusted odds ratio, 2.034; P < .001).

Study details: A retrospective study of 294 patients with prostate cancer who underwent a prostate mpMRI and radical prostatectomy between 2016 and 2020.

Disclosures: No funding source was identified for this work. The authors declared no conflict of interests.

Source: Pockros B et al. Prostate. 2021 Dec 8. doi: 10.1002/pros.24280.

Key clinical point: A higher preoperative multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System (PI‐RADS) score is associated with upstaging on surgical pathology in patients with prostate cancer.

Major finding: PI-RADS score was greater than 3 in 87% of patients. Upstaging was reported in 47% of patients. PI-RADS was an independent risk predictor for upstaging (adjusted odds ratio, 2.034; P < .001).

Study details: A retrospective study of 294 patients with prostate cancer who underwent a prostate mpMRI and radical prostatectomy between 2016 and 2020.

Disclosures: No funding source was identified for this work. The authors declared no conflict of interests.

Source: Pockros B et al. Prostate. 2021 Dec 8. doi: 10.1002/pros.24280.

Key clinical point: A higher preoperative multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System (PI‐RADS) score is associated with upstaging on surgical pathology in patients with prostate cancer.

Major finding: PI-RADS score was greater than 3 in 87% of patients. Upstaging was reported in 47% of patients. PI-RADS was an independent risk predictor for upstaging (adjusted odds ratio, 2.034; P < .001).

Study details: A retrospective study of 294 patients with prostate cancer who underwent a prostate mpMRI and radical prostatectomy between 2016 and 2020.

Disclosures: No funding source was identified for this work. The authors declared no conflict of interests.

Source: Pockros B et al. Prostate. 2021 Dec 8. doi: 10.1002/pros.24280.

Key clinical point: Cumulative androgen deprivation therapy (ADT) is associated with a significant risk for dementia in older men with prostate cancer.

Major finding: At a median follow-up of 7 years, 2.3% of patients were diagnosed with dementia. Cumulative ADT use showed a significant association with dementia (hazard ratio [HR], 2.02; P < .01). No significant association was seen between primary treatment type and onset of dementia in the patients who did not receive ADT (HR, 1.4; P = .14).

Study details: A retrospective study of 13,570 patients aged ≥50 years from the CaPSURE registry diagnosed with prostate cancer between 1995 and 2017.

Disclosures: This study was supported by the UCSF Goldberg-Benioff Program in Translational Cancer Biology. The authors reported no competing interests.

Source: Lonergan PE et al. J Urol. 2021 Dec 2. doi: 10.1097/JU.0000000000002335.

Key clinical point: Cumulative androgen deprivation therapy (ADT) is associated with a significant risk for dementia in older men with prostate cancer.

Major finding: At a median follow-up of 7 years, 2.3% of patients were diagnosed with dementia. Cumulative ADT use showed a significant association with dementia (hazard ratio [HR], 2.02; P < .01). No significant association was seen between primary treatment type and onset of dementia in the patients who did not receive ADT (HR, 1.4; P = .14).

Study details: A retrospective study of 13,570 patients aged ≥50 years from the CaPSURE registry diagnosed with prostate cancer between 1995 and 2017.

Disclosures: This study was supported by the UCSF Goldberg-Benioff Program in Translational Cancer Biology. The authors reported no competing interests.

Source: Lonergan PE et al. J Urol. 2021 Dec 2. doi: 10.1097/JU.0000000000002335.

Key clinical point: Cumulative androgen deprivation therapy (ADT) is associated with a significant risk for dementia in older men with prostate cancer.

Major finding: At a median follow-up of 7 years, 2.3% of patients were diagnosed with dementia. Cumulative ADT use showed a significant association with dementia (hazard ratio [HR], 2.02; P < .01). No significant association was seen between primary treatment type and onset of dementia in the patients who did not receive ADT (HR, 1.4; P = .14).

Study details: A retrospective study of 13,570 patients aged ≥50 years from the CaPSURE registry diagnosed with prostate cancer between 1995 and 2017.

Disclosures: This study was supported by the UCSF Goldberg-Benioff Program in Translational Cancer Biology. The authors reported no competing interests.

Source: Lonergan PE et al. J Urol. 2021 Dec 2. doi: 10.1097/JU.0000000000002335.

Key clinical point: More than 9% of men with prostate cancer undergoing radical prostatectomy report a bad urinary incontinence score. Only approximately 9% of these men receive subsequent incontinence surgery.

Major finding: About 5,165 men completed a posttreatment survey after a median time of 18.6 months. A “bad” urinary incontinence score was reported by 9.3% of patients, and 4% also reported having had a big problem with their urinary function. Only 9.1% of patients with "bad" urinary incontinence scores underwent incontinence surgery within 6 months.

Study details: A retrospective study of 11,290 patients with prostate cancer who underwent radical prostatectomy between April 2014 and January 2016.

Disclosures: This work was supported by National Institute of Health Research, Medical Research Council, University College London Hospitals/University College London Comprehensive Biomedical Research Centre, and others. The authors received honoraria, advisory fees, travel expenses, and/or being employed outside this work.

Source: Parry MG et al. BJU Int. 2021 Nov 30. doi: 10.1111/bju.15663.

Key clinical point: More than 9% of men with prostate cancer undergoing radical prostatectomy report a bad urinary incontinence score. Only approximately 9% of these men receive subsequent incontinence surgery.

Major finding: About 5,165 men completed a posttreatment survey after a median time of 18.6 months. A “bad” urinary incontinence score was reported by 9.3% of patients, and 4% also reported having had a big problem with their urinary function. Only 9.1% of patients with "bad" urinary incontinence scores underwent incontinence surgery within 6 months.

Study details: A retrospective study of 11,290 patients with prostate cancer who underwent radical prostatectomy between April 2014 and January 2016.

Disclosures: This work was supported by National Institute of Health Research, Medical Research Council, University College London Hospitals/University College London Comprehensive Biomedical Research Centre, and others. The authors received honoraria, advisory fees, travel expenses, and/or being employed outside this work.

Source: Parry MG et al. BJU Int. 2021 Nov 30. doi: 10.1111/bju.15663.

Key clinical point: More than 9% of men with prostate cancer undergoing radical prostatectomy report a bad urinary incontinence score. Only approximately 9% of these men receive subsequent incontinence surgery.

Major finding: About 5,165 men completed a posttreatment survey after a median time of 18.6 months. A “bad” urinary incontinence score was reported by 9.3% of patients, and 4% also reported having had a big problem with their urinary function. Only 9.1% of patients with "bad" urinary incontinence scores underwent incontinence surgery within 6 months.

Study details: A retrospective study of 11,290 patients with prostate cancer who underwent radical prostatectomy between April 2014 and January 2016.

Disclosures: This work was supported by National Institute of Health Research, Medical Research Council, University College London Hospitals/University College London Comprehensive Biomedical Research Centre, and others. The authors received honoraria, advisory fees, travel expenses, and/or being employed outside this work.

Source: Parry MG et al. BJU Int. 2021 Nov 30. doi: 10.1111/bju.15663.