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CDC supports ‘test-to-stay’ for COVID- exposed students
The Centers for Disease Control and Prevention has announced that in the following days.
The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.
“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.
When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.
In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.
“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”
In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.
The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.
Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.
In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.
The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.
In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.
The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.
Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.
“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.
“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention has announced that in the following days.
The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.
“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.
When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.
In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.
“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”
In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.
The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.
Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.
In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.
The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.
In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.
The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.
Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.
“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.
“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention has announced that in the following days.
The new guidance, known as the “test-to-stay” protocol, would reduce the number of children who are expected to stay home as a close contact to someone who tested positive for the virus.
“Test-to-stay is an encouraging public health practice to keep our children in schools,” Rochelle Walensky, MD, director of the CDC, said during a White House press briefing.
When a COVID-19 case is identified in a school, the test-to-stay strategy allows schools to implement regular testing rather than quarantine close contacts. If the contacts don’t experience symptoms and test negative at least twice in a seven-day period, they can continue in-person learning. If they test positive, then they are required to isolate.
In recent months, the CDC has collaborated with several school districts across the United States to evaluate test-to-stay programs. On Dec. 17, the CDC published two studies in its Morbidity and Mortality Weekly Report that demonstrated the effectiveness of these programs in limiting the spread of the virus while also keeping students in class.
“CDC is updating our materials to help schools and parents know how to best implement this promising and now-proven practice, along with our multi-layer prevention strategies that will help keep our children in the classroom safely,” Dr. Walensky said. “These studies demonstrated that test-to-stay works to keep unvaccinated children in school safely.”
In one study, researchers analyzed data for public schools in Los Angeles County between Aug. 16 and Oct. 31, where 432 schools implemented test-to-stay and 1,635 did not.
The Los Angeles County Department of Public Health found that COVID-19 cases did not increase among the schools that used the protocol, as compared with schools that didn’t.
Before test-to-stay was implemented, the average daily number of cases was 10 cases per 100,000 students in districts that later adopted the protocol and 20 cases per 100,000 students in districts that didn’t. After the program was implemented, average daily case rates declined in all school districts but remained lower in test-to-stay districts, with 6 cases per 100,000 students as compared with 11 cases per 100,000 students in districts that didn’t do the protocol.
In addition, schools that didn’t use the test-to-stay program “lost substantial in-person school days,” researchers wrote. At the same time, implementing the program “requires resources that might be currently unavailable for some schools,” they added, noting that “a higher percentage of disadvantaged schools” didn’t do the protocol.
The program requires personnel who can track which students need to be tested, their results and when they can come off the list of close contacts, officials told CNN. This can be a challenge for overstretched school nursing staff.
In another study published last week, researchers analyzed data between Aug. 9 and Oct. 29 for 90 schools across 31 districts in Lake County, Ill., that implemented test-to-stay programs. During that time, the schools reported 258 COVID-19 cases and 1,664 close contacts.
The Lake County Health Department examined the number of close contacts that later tested positive and whether the virus further spread from the close contacts to other people. They found that 16 of the close contacts tested positive and that these were all students. No one appeared to transmit the virus to others at school, but nine cases were identified among household contacts.
Overall, study authors wrote, the test-to-stay protocol preserved in-person learning days for students. In addition, regular testing, masking, and physical distancing led to lower virus transmission in school.
“The test-to-stay-programs are really good at balancing the costs and benefits,” Zoe McLaren, a health policy expert at the University of Maryland at Baltimore, told The New York Times.
“What the test-to-stay program does is help us keep COVID cases down, while also trying to make sure we keep kids in school as much as possible, which I think is really important,” she said.
A version of this article first appeared on WebMD.com.
FDA grants new indication to lumateperone (Caplyta) for bipolar depression
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.
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’
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.
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’
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.
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’
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.
Class I recall of percutaneous thrombolytic device
Arrow International, a subsidiary of Teleflex, has recalled a total of 3,241 Arrow-Trerotola over-the-wire 7FR percutaneous thrombolytic device (PTD) kits because of the risk of the orange inner lumen of the catheter’s tip component separating from the basket.
The U.S. Food and Drug Administration has identified this as a Class I recall, the most serious type, because of the potential for serious injury or death.
The recalled kits include a rotatable catheter with an outer sheath and an inner cable with a self-expanding basket. The Arrow-Trerotola PTD catheter is used with the Arrow rotator drive unit to remove clots in patients with arteriovenous fistulas and synthetic dialysis grafts.
“If the orange inner lumen separates from the basket, it may fracture and detach and block the blood vessel(s),” the FDA says in the recall notice posted on the FDA website.
“If the orange inner lumen detaches from the basket, health consequences depend upon where the fractured tip component embolizes. If the embolization is local to the treatment target site, retrieval may be attempted, requiring an additional intervention and consequent delay of therapy,” the agency notes.
“In some cases, the embolization could be central or possibly even to the heart or pulmonary arteries. This may lead to serious adverse events such as vessel damage, need for additional medical procedures, or possibly death,” the agency says.
To date, there have been seven complaints and no injuries or deaths reported for this device.
The recalled devices were distributed in the United States between Nov. 1, 2019, and July 31, 2021. Product codes and lot numbers pertaining to the devices are listed on the FDA website.
Teleflex has sent an urgent field safety notice to customers requesting that they check inventory for affected product and remove and quarantine all recalled product.
Customers are also asked to complete the enclosed acknowledgement form and fax it to 1-855-419-8507 (attention: customer service) or e-mail the form to [email protected].
Customers with recalled product service will be contacted by a company representative with instructions for returning any recalled products.
Customers who have questions about this recall should contact Teleflex customer service by phone at 1-866-396-2111, by fax at 1-855-419-8507, or by email at [email protected].
Health care providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Arrow International, a subsidiary of Teleflex, has recalled a total of 3,241 Arrow-Trerotola over-the-wire 7FR percutaneous thrombolytic device (PTD) kits because of the risk of the orange inner lumen of the catheter’s tip component separating from the basket.
The U.S. Food and Drug Administration has identified this as a Class I recall, the most serious type, because of the potential for serious injury or death.
The recalled kits include a rotatable catheter with an outer sheath and an inner cable with a self-expanding basket. The Arrow-Trerotola PTD catheter is used with the Arrow rotator drive unit to remove clots in patients with arteriovenous fistulas and synthetic dialysis grafts.
“If the orange inner lumen separates from the basket, it may fracture and detach and block the blood vessel(s),” the FDA says in the recall notice posted on the FDA website.
“If the orange inner lumen detaches from the basket, health consequences depend upon where the fractured tip component embolizes. If the embolization is local to the treatment target site, retrieval may be attempted, requiring an additional intervention and consequent delay of therapy,” the agency notes.
“In some cases, the embolization could be central or possibly even to the heart or pulmonary arteries. This may lead to serious adverse events such as vessel damage, need for additional medical procedures, or possibly death,” the agency says.
To date, there have been seven complaints and no injuries or deaths reported for this device.
The recalled devices were distributed in the United States between Nov. 1, 2019, and July 31, 2021. Product codes and lot numbers pertaining to the devices are listed on the FDA website.
Teleflex has sent an urgent field safety notice to customers requesting that they check inventory for affected product and remove and quarantine all recalled product.
Customers are also asked to complete the enclosed acknowledgement form and fax it to 1-855-419-8507 (attention: customer service) or e-mail the form to [email protected].
Customers with recalled product service will be contacted by a company representative with instructions for returning any recalled products.
Customers who have questions about this recall should contact Teleflex customer service by phone at 1-866-396-2111, by fax at 1-855-419-8507, or by email at [email protected].
Health care providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
Arrow International, a subsidiary of Teleflex, has recalled a total of 3,241 Arrow-Trerotola over-the-wire 7FR percutaneous thrombolytic device (PTD) kits because of the risk of the orange inner lumen of the catheter’s tip component separating from the basket.
The U.S. Food and Drug Administration has identified this as a Class I recall, the most serious type, because of the potential for serious injury or death.
The recalled kits include a rotatable catheter with an outer sheath and an inner cable with a self-expanding basket. The Arrow-Trerotola PTD catheter is used with the Arrow rotator drive unit to remove clots in patients with arteriovenous fistulas and synthetic dialysis grafts.
“If the orange inner lumen separates from the basket, it may fracture and detach and block the blood vessel(s),” the FDA says in the recall notice posted on the FDA website.
“If the orange inner lumen detaches from the basket, health consequences depend upon where the fractured tip component embolizes. If the embolization is local to the treatment target site, retrieval may be attempted, requiring an additional intervention and consequent delay of therapy,” the agency notes.
“In some cases, the embolization could be central or possibly even to the heart or pulmonary arteries. This may lead to serious adverse events such as vessel damage, need for additional medical procedures, or possibly death,” the agency says.
To date, there have been seven complaints and no injuries or deaths reported for this device.
The recalled devices were distributed in the United States between Nov. 1, 2019, and July 31, 2021. Product codes and lot numbers pertaining to the devices are listed on the FDA website.
Teleflex has sent an urgent field safety notice to customers requesting that they check inventory for affected product and remove and quarantine all recalled product.
Customers are also asked to complete the enclosed acknowledgement form and fax it to 1-855-419-8507 (attention: customer service) or e-mail the form to [email protected].
Customers with recalled product service will be contacted by a company representative with instructions for returning any recalled products.
Customers who have questions about this recall should contact Teleflex customer service by phone at 1-866-396-2111, by fax at 1-855-419-8507, or by email at [email protected].
Health care providers can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.
A version of this article first appeared on Medscape.com.
COVID cases spike as questions remain about Omicron’s threat
The best way to stay protected is by getting vaccinated and boosted, they said.
“For the unvaccinated, you’re looking at a winter of severe illness and death – for yourselves, families, and the hospitals who may soon overwhelm,” White House COVID-19 Response Coordinator Jeff Zients said at a news briefing Dec. 17. “We need the American people to do their part.”
The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.
The strain is more transmissible than the already highly infectious Delta variant, and although there was early evidence that it caused more mild disease, she said that is likely because many of those infected have been vaccinated and boosted.
“Although Delta continues to circulate widely in the United States, Omicron is increasing rapidly and we expect it to become the dominant strain in the United States, as it has in other countries, in the coming weeks,” Dr. Walensky said.
The United States is averaging close to 1,300 deaths from COVID-19 each day. New cases, deaths, and hospitalizations are higher now than in the previous winter – before vaccines were so widely available. The New York Times reported on Dec. 17 that new infections in Connecticut and Maine have grown 150% in the past 2 weeks, and Ohio and Indiana are seeing hospitalization rates nearing the worst of 2020-2021’s winter surge.
Dueling reports released recently gave cause for relief and concern about Omicron.
A study from South Africa released on Dec. 14 shows lower hospitalizations during the first 3 weeks of the Omicron wave than during earlier waves from other variants. That’s the good news.
The concerning news is out of the United Kingdom, where Imperial College London reported Dec. 17 that the risk of reinfection with COVID-19 from Omicron is more than 5 times as high and that cases of Omicron-based COVID-19 are doubling every 2 days.
What’s more, the study “finds no evidence of Omicron having lower severity than Delta, judged by either the proportion of people testing positive who report symptoms, or by the proportion of cases seeking hospital care after infection. However, hospitalization data remains very limited at this time,” the researchers said.
“We have no evidence that the virus itself is more mild,” Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape, told PBS NewsHour. “Until we have that, we have to assume that people who don’t have any protection are highly vulnerable to getting very ill.”
The White House COVID-19 team continues to urge parents and guardians to get their children vaccinated, especially in anticipation of a post-holiday spike. Dr. Walensky said the CDC’s vaccine advisory board met on Dec. 16 to continue the safety discussion about COVID-19 vaccinations in children.
So far, 20 million children under 17 and 5 million under 11 have received their shots.
“Looking specifically at vaccine safety data from over 50,000 children 5-11 years old, we found no evidence of serious safety concerns,” Dr. Walensky said.
Top infectious disease expert Anthony S. Fauci, MD, highlighted the importance of getting vaccinated and boosted to avoid serious disease from Delta and Omicron.
“We’re in a situation where we are now facing a very important Delta surge and we are looking over our shoulder at an oncoming Omicron surge,” he said. “The optimum protection is fully vaccinated plus a boost.”
A version of this article first appeared on WebMD.com.
The best way to stay protected is by getting vaccinated and boosted, they said.
“For the unvaccinated, you’re looking at a winter of severe illness and death – for yourselves, families, and the hospitals who may soon overwhelm,” White House COVID-19 Response Coordinator Jeff Zients said at a news briefing Dec. 17. “We need the American people to do their part.”
The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.
The strain is more transmissible than the already highly infectious Delta variant, and although there was early evidence that it caused more mild disease, she said that is likely because many of those infected have been vaccinated and boosted.
“Although Delta continues to circulate widely in the United States, Omicron is increasing rapidly and we expect it to become the dominant strain in the United States, as it has in other countries, in the coming weeks,” Dr. Walensky said.
The United States is averaging close to 1,300 deaths from COVID-19 each day. New cases, deaths, and hospitalizations are higher now than in the previous winter – before vaccines were so widely available. The New York Times reported on Dec. 17 that new infections in Connecticut and Maine have grown 150% in the past 2 weeks, and Ohio and Indiana are seeing hospitalization rates nearing the worst of 2020-2021’s winter surge.
Dueling reports released recently gave cause for relief and concern about Omicron.
A study from South Africa released on Dec. 14 shows lower hospitalizations during the first 3 weeks of the Omicron wave than during earlier waves from other variants. That’s the good news.
The concerning news is out of the United Kingdom, where Imperial College London reported Dec. 17 that the risk of reinfection with COVID-19 from Omicron is more than 5 times as high and that cases of Omicron-based COVID-19 are doubling every 2 days.
What’s more, the study “finds no evidence of Omicron having lower severity than Delta, judged by either the proportion of people testing positive who report symptoms, or by the proportion of cases seeking hospital care after infection. However, hospitalization data remains very limited at this time,” the researchers said.
“We have no evidence that the virus itself is more mild,” Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape, told PBS NewsHour. “Until we have that, we have to assume that people who don’t have any protection are highly vulnerable to getting very ill.”
The White House COVID-19 team continues to urge parents and guardians to get their children vaccinated, especially in anticipation of a post-holiday spike. Dr. Walensky said the CDC’s vaccine advisory board met on Dec. 16 to continue the safety discussion about COVID-19 vaccinations in children.
So far, 20 million children under 17 and 5 million under 11 have received their shots.
“Looking specifically at vaccine safety data from over 50,000 children 5-11 years old, we found no evidence of serious safety concerns,” Dr. Walensky said.
Top infectious disease expert Anthony S. Fauci, MD, highlighted the importance of getting vaccinated and boosted to avoid serious disease from Delta and Omicron.
“We’re in a situation where we are now facing a very important Delta surge and we are looking over our shoulder at an oncoming Omicron surge,” he said. “The optimum protection is fully vaccinated plus a boost.”
A version of this article first appeared on WebMD.com.
The best way to stay protected is by getting vaccinated and boosted, they said.
“For the unvaccinated, you’re looking at a winter of severe illness and death – for yourselves, families, and the hospitals who may soon overwhelm,” White House COVID-19 Response Coordinator Jeff Zients said at a news briefing Dec. 17. “We need the American people to do their part.”
The Omicron variant has been detected in at least 39 states and 75 countries, according to CDC director Rochelle Walensky, MD.
The strain is more transmissible than the already highly infectious Delta variant, and although there was early evidence that it caused more mild disease, she said that is likely because many of those infected have been vaccinated and boosted.
“Although Delta continues to circulate widely in the United States, Omicron is increasing rapidly and we expect it to become the dominant strain in the United States, as it has in other countries, in the coming weeks,” Dr. Walensky said.
The United States is averaging close to 1,300 deaths from COVID-19 each day. New cases, deaths, and hospitalizations are higher now than in the previous winter – before vaccines were so widely available. The New York Times reported on Dec. 17 that new infections in Connecticut and Maine have grown 150% in the past 2 weeks, and Ohio and Indiana are seeing hospitalization rates nearing the worst of 2020-2021’s winter surge.
Dueling reports released recently gave cause for relief and concern about Omicron.
A study from South Africa released on Dec. 14 shows lower hospitalizations during the first 3 weeks of the Omicron wave than during earlier waves from other variants. That’s the good news.
The concerning news is out of the United Kingdom, where Imperial College London reported Dec. 17 that the risk of reinfection with COVID-19 from Omicron is more than 5 times as high and that cases of Omicron-based COVID-19 are doubling every 2 days.
What’s more, the study “finds no evidence of Omicron having lower severity than Delta, judged by either the proportion of people testing positive who report symptoms, or by the proportion of cases seeking hospital care after infection. However, hospitalization data remains very limited at this time,” the researchers said.
“We have no evidence that the virus itself is more mild,” Eric Topol, MD, executive vice president of Scripps Research and editor-in-chief of Medscape, told PBS NewsHour. “Until we have that, we have to assume that people who don’t have any protection are highly vulnerable to getting very ill.”
The White House COVID-19 team continues to urge parents and guardians to get their children vaccinated, especially in anticipation of a post-holiday spike. Dr. Walensky said the CDC’s vaccine advisory board met on Dec. 16 to continue the safety discussion about COVID-19 vaccinations in children.
So far, 20 million children under 17 and 5 million under 11 have received their shots.
“Looking specifically at vaccine safety data from over 50,000 children 5-11 years old, we found no evidence of serious safety concerns,” Dr. Walensky said.
Top infectious disease expert Anthony S. Fauci, MD, highlighted the importance of getting vaccinated and boosted to avoid serious disease from Delta and Omicron.
“We’re in a situation where we are now facing a very important Delta surge and we are looking over our shoulder at an oncoming Omicron surge,” he said. “The optimum protection is fully vaccinated plus a boost.”
A version of this article first appeared on WebMD.com.
FDA approves new myasthenia gravis drug
“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director, office of neuroscience, FDA Center for Drug Evaluation and Research, said in a news release.
This approval represents “an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases,” Dr. Dunn added.
Effective, well tolerated
The rare and chronic autoimmune neuromuscular disorder of gMG causes debilitating and potentially life-threatening muscle weakness and significantly impaired independence and quality of life. Most patients with gMG have IgG antibodies, which are most often directed against skeletal muscle nicotinic acetylcholine receptors.
Efgartigimod is an antibody fragment designed to reduce pathogenic IgG antibodies and block the IgG recycling process in patients with gMG.
The novel agent binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels.
As previously reported, efgartigimod was effective and well tolerated in the phase 3, randomized, placebo-controlled ADAPT trial, which enrolled 187 adults with gMG regardless of acetylcholine receptor antibody status. All had a Myasthenia Gravis–Activities of Daily Living score of at least 5 (>50% nonocular) on a background of a stable dose of at least one MG drug.
For 26 weeks, 84 patients were randomly assigned to receive efgartigimod 10 mg/kg and 83 to receive matching placebo. Both treatments were administered as four infusions per cycle at one infusion per week. The process was repeated as needed, depending on clinical response no sooner than 8 weeks after initiation of the previous cycle.
Treatment with efgartigimod reduced disease burden and improved strength and quality of life in patients with gMG across four MG-specific scales. In addition, these benefits were observed early and were reproducible and durable.
The results were published in Lancet Neurology.
‘Important new advance’
Efgartigimod is a “very rapidly acting drug relative to other treatments that may take 4, 6, sometimes 10 months before they start to work; and the side-effect profile is much like placebo,” said principal investigator James Howard Jr., MD, department of neurology, University of North Carolina at Chapel Hill.
The FDA granted efgartigimod fast track and orphan drug designation.
“People living with gMG have been in need of new treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” Dr. Howard said in a company news release issued upon approval.
This approval “represents an important new advance for gMG patients and families affected by this debilitating disease. This therapy has the potential to reduce the disease burden of gMG and transform the way we treat this disease,” Dr. Howard added.
A version of this article first appeared on Medscape.com.
“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director, office of neuroscience, FDA Center for Drug Evaluation and Research, said in a news release.
This approval represents “an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases,” Dr. Dunn added.
Effective, well tolerated
The rare and chronic autoimmune neuromuscular disorder of gMG causes debilitating and potentially life-threatening muscle weakness and significantly impaired independence and quality of life. Most patients with gMG have IgG antibodies, which are most often directed against skeletal muscle nicotinic acetylcholine receptors.
Efgartigimod is an antibody fragment designed to reduce pathogenic IgG antibodies and block the IgG recycling process in patients with gMG.
The novel agent binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels.
As previously reported, efgartigimod was effective and well tolerated in the phase 3, randomized, placebo-controlled ADAPT trial, which enrolled 187 adults with gMG regardless of acetylcholine receptor antibody status. All had a Myasthenia Gravis–Activities of Daily Living score of at least 5 (>50% nonocular) on a background of a stable dose of at least one MG drug.
For 26 weeks, 84 patients were randomly assigned to receive efgartigimod 10 mg/kg and 83 to receive matching placebo. Both treatments were administered as four infusions per cycle at one infusion per week. The process was repeated as needed, depending on clinical response no sooner than 8 weeks after initiation of the previous cycle.
Treatment with efgartigimod reduced disease burden and improved strength and quality of life in patients with gMG across four MG-specific scales. In addition, these benefits were observed early and were reproducible and durable.
The results were published in Lancet Neurology.
‘Important new advance’
Efgartigimod is a “very rapidly acting drug relative to other treatments that may take 4, 6, sometimes 10 months before they start to work; and the side-effect profile is much like placebo,” said principal investigator James Howard Jr., MD, department of neurology, University of North Carolina at Chapel Hill.
The FDA granted efgartigimod fast track and orphan drug designation.
“People living with gMG have been in need of new treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” Dr. Howard said in a company news release issued upon approval.
This approval “represents an important new advance for gMG patients and families affected by this debilitating disease. This therapy has the potential to reduce the disease burden of gMG and transform the way we treat this disease,” Dr. Howard added.
A version of this article first appeared on Medscape.com.
“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director, office of neuroscience, FDA Center for Drug Evaluation and Research, said in a news release.
This approval represents “an important step in providing a novel therapy option for patients and underscores the agency’s commitment to help make new treatment options available for people living with rare diseases,” Dr. Dunn added.
Effective, well tolerated
The rare and chronic autoimmune neuromuscular disorder of gMG causes debilitating and potentially life-threatening muscle weakness and significantly impaired independence and quality of life. Most patients with gMG have IgG antibodies, which are most often directed against skeletal muscle nicotinic acetylcholine receptors.
Efgartigimod is an antibody fragment designed to reduce pathogenic IgG antibodies and block the IgG recycling process in patients with gMG.
The novel agent binds to the neonatal Fc receptor (FcRn), which is widely expressed throughout the body and plays a central role in rescuing IgG antibodies from degradation. Blocking FcRn reduces IgG antibody levels.
As previously reported, efgartigimod was effective and well tolerated in the phase 3, randomized, placebo-controlled ADAPT trial, which enrolled 187 adults with gMG regardless of acetylcholine receptor antibody status. All had a Myasthenia Gravis–Activities of Daily Living score of at least 5 (>50% nonocular) on a background of a stable dose of at least one MG drug.
For 26 weeks, 84 patients were randomly assigned to receive efgartigimod 10 mg/kg and 83 to receive matching placebo. Both treatments were administered as four infusions per cycle at one infusion per week. The process was repeated as needed, depending on clinical response no sooner than 8 weeks after initiation of the previous cycle.
Treatment with efgartigimod reduced disease burden and improved strength and quality of life in patients with gMG across four MG-specific scales. In addition, these benefits were observed early and were reproducible and durable.
The results were published in Lancet Neurology.
‘Important new advance’
Efgartigimod is a “very rapidly acting drug relative to other treatments that may take 4, 6, sometimes 10 months before they start to work; and the side-effect profile is much like placebo,” said principal investigator James Howard Jr., MD, department of neurology, University of North Carolina at Chapel Hill.
The FDA granted efgartigimod fast track and orphan drug designation.
“People living with gMG have been in need of new treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” Dr. Howard said in a company news release issued upon approval.
This approval “represents an important new advance for gMG patients and families affected by this debilitating disease. This therapy has the potential to reduce the disease burden of gMG and transform the way we treat this disease,” Dr. Howard added.
A version of this article first appeared on Medscape.com.
COVID-19 interrupted global poliovirus surveillance and immunization
Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.
The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.
The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”
Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”
The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.
The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”
The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.
Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”
Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.
Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”
“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.
For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.
Dr. Wenger and Dr. Wassilak report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.
The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.
The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”
Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”
The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.
The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”
The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.
Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”
Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.
Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”
“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.
For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.
Dr. Wenger and Dr. Wassilak report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Most (86%) of these outbreaks were caused by cVDPV2 (circulating VDPV type 2 poliovirus, which originated with the vaccine), and most occurred in Africa, according to a new study of vaccine-derived poliovirus outbreaks between Jan. 2020 and June 2021 published in the CDC’s Morbidity and Mortality Weekly Report.
The Global Polio Eradication Initiative (GPEI) was launched in 1988 and used live attenuated oral poliovirus vaccine (OPV). Since then, cases of wild poliovirus have declined more than 99.99%.
The cVDPV2 likely originated among children born in areas with poor vaccine coverage. Jay Wenger, MD, director, Polio, at the Bill and Melinda Gates Foundation, told this news organization that “the inactivated vaccines that we give in most developed countries now are good in that they provide humoral immunity, the antibodies in the bloodstream. They don’t necessarily provide mucosal immunity. They don’t make the kid’s gut immune to getting reinfected or actually immune to reproducing the virus if they get it in their gut. So we could still have a situation where everybody was vaccinated with IPV [inactivated poliovirus], but the virus could still be transmitting around because kids’ guts would still be producing the virus and there will still be transmission in your population, probably without much or any paralysis because of the IPV. As soon as that virus hit a population that was not vaccinated, they would get paralyzed.”
Dr. Wenger added, “The ideal vaccine would be an oral vaccine that didn’t mutate back and couldn’t cause these VDPVs.” Scientists developed such a vaccine, approved by the World Health Organization last year under an Emergency Use Authorization. This nOPV2 (novel oral poliovirus type 2) vaccine has been given since March 2021 in areas with the VDPD2 outbreaks. The nOPV2 should allow them to “basically stamp out the outbreaks.”
The world had almost eradicated the disease, with the last cases of polio from wild virus occurring in Nigeria, Afghanistan, and Pakistan as of 2014. Africa was declared free of wild polio in 2020 after it had been eradicated from Nigeria, which accounted for more than half of the world’s cases only a decade earlier. Now cVDPV outbreaks affect 28 African countries, plus Iran, Yemen, Afghanistan, Pakistan, Tajikistan, Malaysia, the Philippines, and Indonesia. And there was also one case in China. Globally, there were 1,335 cases of cVDPV causing paralysis during the reporting period.
The COVID-19 pandemic has had a significant impact on polio, accounting for much of this year’s increase in cases. Dr. Wenger said, “We couldn’t do any campaigns. We pretty much stopped doing outbreak response campaigns in the middle of the year because of COVID.”
The CDC report notes that many of the supplementary immunizations in response to cVDPV2 outbreaks were of “poor quality,” and prolonged delays enabled geographically expanding cVDPV2 transmission.
Steve Wassilak, MD, chief coauthor of the CDC study, told this news organization that, because of COVID, “what we’ve been lacking is a rapid response for the most part. Some of that is due to laboratory delays and shipment because of COVID’s effect on international travel.” He noted, however, that there has been good recovery in surveillance and immunization activities despite COVID. And, he added, eradication “can be done, and many outbreaks have closed even during the [COVID] outbreak.”
Dr. Wassilak said that in Nigeria, “the face of the campaign became national.” In Pakistan, much of the work is done by national and international partners.
Dr. Wenger said that in Nigeria and other challenging areas, “the approach was essentially to make direct contact with the traditional leaders and the religious leaders and the local actors in each of these populations. So, it’s really getting down to the grassroots level.” Infectious disease officials send teams to speak with individuals in the “local, traditional leader system.”
“Just talking to them actually got us a long way and giving them the information that they need. In most cases, I mean, people want to do things to help their kids,” said Dr. Wenger.
For now, the initial plan, per the CDC, is to “initiate prompt and high coverage outbreak responses with available type 2 OPV to interrupt transmission” until a better supply of nOPV2 is available, then switch to IPVs.
Dr. Wenger and Dr. Wassilak report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Tofacitinib approved for new ankylosing spondylitis indication
The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.
The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.
Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.
The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.
Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.
The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.
Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.
The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.
Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration approved a supplemental new drug application for tofacitinib (Xeljanz, Xeljanz XR) that adds active ankylosing spondylitis in adults to its list of indications, according to a Dec. 14 announcement from manufacturer Pfizer.
The approval makes the drug the first Janus kinase (JAK) inhibitor to be approved for ankylosing spondylitis, joining tofacitinib’s other indications of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular-course juvenile idiopathic arthritis.
Like other JAK inhibitors that are indicated for immune-mediated inflammatory diseases, tofacitinib’s use for all indications is limited to patients who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.
The agency based its decision on the results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial in 269 adults with active ankylosing spondylitis that tested tofacitinib 5 mg twice daily.
The study met its primary endpoint showing that at week 16 the percentage of tofacitinib-treated patients who achieved 20% improvement in Assessment in SpondyloArthritis International Society response criteria (ASAS20) was significantly greater than with placebo (56.4% vs. 29.4%; P < .0001). The percentage of responders for ASAS40 criteria was likewise significantly greater with tofacitinib vs. placebo (40.6% vs. 12.5%; P < .0001). Pfizer said that the safety profile of tofacitinib observed in patients with ankylosing spondylitis was consistent with the safety profile observed in patients with either rheumatoid arthritis or psoriatic arthritis.
Pfizer noted in its announcement that the FDA updated the prescribing information this month for tofacitinib (and other JAK inhibitors approved for immune-mediated inflammatory conditions, upadacitinib [Rinvoq] and baricitinib [Olumiant]). This update included a new boxed warning for major adverse cardiovascular events and updated boxed warnings regarding mortality, malignancies, and thrombosis. These changes were made in light of results from the ORAL Surveillance postmarketing study of patients with rheumatoid arthritis aged 50 years and older with at least one cardiovascular risk factor. That study found an association between tofacitinib and increased risk of heart attack or stroke, cancer, blood clots, and death in comparison with patients who took the TNF blockers adalimumab or etanercept.
A version of this article first appeared on Medscape.com.
Califf plans work on opioids, accelerated approvals on return to FDA
Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.
Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.
Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.
Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.
Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.
Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.
In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”
The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.
People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.
“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.
“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.
Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.
Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.
“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
‘Work to do’ on opioids
Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.
There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.
Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.
“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.
Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Dr. Califf said.
Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.
At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.
Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.
While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.
The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.
Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.
Question on accelerated approvals
The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.
The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.
The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.
“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.
Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.
But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.
“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
Worries about the medical supply chain
Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.
Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.
This committee will soon release a report with specific recommendations, Dr. Califf said.
“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”
A version of this article first appeared on Medscape.com.
Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.
Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.
Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.
Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.
Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.
Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.
In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”
The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.
People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.
“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.
“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.
Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.
Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.
“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
‘Work to do’ on opioids
Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.
There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.
Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.
“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.
Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Dr. Califf said.
Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.
At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.
Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.
While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.
The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.
Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.
Question on accelerated approvals
The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.
The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.
The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.
“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.
Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.
But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.
“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
Worries about the medical supply chain
Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.
Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.
This committee will soon release a report with specific recommendations, Dr. Califf said.
“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”
A version of this article first appeared on Medscape.com.
Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.
Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.
Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.
Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.
Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.
Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.
In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”
The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.
People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.
“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.
“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.
Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.
Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.
“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
‘Work to do’ on opioids
Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.
There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.
Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.
“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.
Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.
“So I know we have work to do,” Dr. Califf said.
Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.
At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.
Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.
While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.
The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.
Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.
Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.
Question on accelerated approvals
The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.
The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.
The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.
At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.
“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.
Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”
Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.
But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.
“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
Worries about the medical supply chain
Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.
Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.
This committee will soon release a report with specific recommendations, Dr. Califf said.
“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”
A version of this article first appeared on Medscape.com.
FDA authorizes Pfizer boosters for 16- and 17-year-olds
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
New HIV PrEP guidelines call for clinicians to talk to patients about HIV prevention meds
Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.
“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.
There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.
The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.
But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.
Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
Normalizing PrEP in primary care
When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”
Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.
“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”
That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.
“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”
The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.
It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.
“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
‘Don’t grill them’
The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.
That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”
There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.
“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
A mandate and a guideline
Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it.
The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”
But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.
“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”
Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.
“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.
There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.
The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.
But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.
Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
Normalizing PrEP in primary care
When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”
Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.
“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”
That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.
“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”
The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.
It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.
“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
‘Don’t grill them’
The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.
That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”
There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.
“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
A mandate and a guideline
Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it.
The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”
But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.
“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”
Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.
“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.
There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.
The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.
But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.
Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
Normalizing PrEP in primary care
When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”
Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.
“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”
That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.
“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”
The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.
It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.
“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
‘Don’t grill them’
The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.
That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”
There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.
“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
A mandate and a guideline
Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it.
The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”
But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.
“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”
Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.