MDedge Psychiatry

A Haitian-born doctor, who was based in Florida for more than 2 decades, has been arrested as a central suspect in the assassination of Haiti’s President Jovenel Moïse, according to The New York Times.

About two dozen people have been arrested as suspects, the newspaper reported, though police believe Christian Emmanuel Sanon, 63, was plotting to become president.

“He arrived by private plane in June with political objectives and contacted a private security firm to recruit the people who committed this act,” Léon Charles, Haiti’s national police chief, said during a news conference on July 11.

The firm, called CTU Security, is a Venezuelan company based in Miami, Mr. Charles said. During a raid at Mr. Sanon’s home in Port-au-Prince, police found six rifles, 20 boxes of bullets, 24 unused shooting targets, pistol holsters, and a hat with a U.S. Drug Enforcement Agency logo.

“This initial mission that was given to these assailants was to protect the individual named Emmanuel Sanon, but afterwards, the mission changed,” Mr. Charles said.

The new “mission” was to arrest President Moïse and install Mr. Sanon as president, The New York Times reported, though Mr. Charles didn’t explain when the mission changed to assassination or how Mr. Sanon could have taken control of the government.

President Moïse was shot to death on July 7 at his home in Port-au-Prince by a “team of commandos,” according to The Washington Post. On July 9, Haiti asked the U.S. to send troops to the country to protect its airport and key infrastructure.

The announcement of Mr. Sanon’s arrest came hours after FBI and Department of Homeland Security officials arrived in Haiti on July 11 to discuss how the U.S. can offer assistance, the newspaper reported.

Mr. Sanon has a YouTube channel with three political campaign videos from 2011, which include discussions about Haitian politics, according to Forbes. In one of the videos, titled “Dr. Christian Sanon – Leadership for Haiti,” Mr. Sanon talks about corruption in the country and presents himself as a potential leader.

Mr. Sanon lived in Florida for more than 20 years, ranging from the Tampa Bay area to South Florida, according to the Miami Herald. Public records show that he had more than a dozen businesses registered in the state, including medical services and real estate, though most are inactive.

Mr. Sanon is the third person with links to the U.S. who has been arrested in connection with the assassination, the Miami Herald reported. Two Haitian-Americans from southern Florida – James Solages, 35, and Joseph G. Vincent, 55 – were arrested by local police. They claimed they were working as translators for the assassins.

The first lady, Martine Moïse, was wounded in the attack and is now receiving treatment at a hospital in Miami, the newspaper reported.

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

A Haitian-born doctor, who was based in Florida for more than 2 decades, has been arrested as a central suspect in the assassination of Haiti’s President Jovenel Moïse, according to The New York Times.

About two dozen people have been arrested as suspects, the newspaper reported, though police believe Christian Emmanuel Sanon, 63, was plotting to become president.

“He arrived by private plane in June with political objectives and contacted a private security firm to recruit the people who committed this act,” Léon Charles, Haiti’s national police chief, said during a news conference on July 11.

The firm, called CTU Security, is a Venezuelan company based in Miami, Mr. Charles said. During a raid at Mr. Sanon’s home in Port-au-Prince, police found six rifles, 20 boxes of bullets, 24 unused shooting targets, pistol holsters, and a hat with a U.S. Drug Enforcement Agency logo.

“This initial mission that was given to these assailants was to protect the individual named Emmanuel Sanon, but afterwards, the mission changed,” Mr. Charles said.

The new “mission” was to arrest President Moïse and install Mr. Sanon as president, The New York Times reported, though Mr. Charles didn’t explain when the mission changed to assassination or how Mr. Sanon could have taken control of the government.

President Moïse was shot to death on July 7 at his home in Port-au-Prince by a “team of commandos,” according to The Washington Post. On July 9, Haiti asked the U.S. to send troops to the country to protect its airport and key infrastructure.

The announcement of Mr. Sanon’s arrest came hours after FBI and Department of Homeland Security officials arrived in Haiti on July 11 to discuss how the U.S. can offer assistance, the newspaper reported.

Mr. Sanon has a YouTube channel with three political campaign videos from 2011, which include discussions about Haitian politics, according to Forbes. In one of the videos, titled “Dr. Christian Sanon – Leadership for Haiti,” Mr. Sanon talks about corruption in the country and presents himself as a potential leader.

Mr. Sanon lived in Florida for more than 20 years, ranging from the Tampa Bay area to South Florida, according to the Miami Herald. Public records show that he had more than a dozen businesses registered in the state, including medical services and real estate, though most are inactive.

Mr. Sanon is the third person with links to the U.S. who has been arrested in connection with the assassination, the Miami Herald reported. Two Haitian-Americans from southern Florida – James Solages, 35, and Joseph G. Vincent, 55 – were arrested by local police. They claimed they were working as translators for the assassins.

The first lady, Martine Moïse, was wounded in the attack and is now receiving treatment at a hospital in Miami, the newspaper reported.

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

A Haitian-born doctor, who was based in Florida for more than 2 decades, has been arrested as a central suspect in the assassination of Haiti’s President Jovenel Moïse, according to The New York Times.

About two dozen people have been arrested as suspects, the newspaper reported, though police believe Christian Emmanuel Sanon, 63, was plotting to become president.

“He arrived by private plane in June with political objectives and contacted a private security firm to recruit the people who committed this act,” Léon Charles, Haiti’s national police chief, said during a news conference on July 11.

The firm, called CTU Security, is a Venezuelan company based in Miami, Mr. Charles said. During a raid at Mr. Sanon’s home in Port-au-Prince, police found six rifles, 20 boxes of bullets, 24 unused shooting targets, pistol holsters, and a hat with a U.S. Drug Enforcement Agency logo.

“This initial mission that was given to these assailants was to protect the individual named Emmanuel Sanon, but afterwards, the mission changed,” Mr. Charles said.

The new “mission” was to arrest President Moïse and install Mr. Sanon as president, The New York Times reported, though Mr. Charles didn’t explain when the mission changed to assassination or how Mr. Sanon could have taken control of the government.

President Moïse was shot to death on July 7 at his home in Port-au-Prince by a “team of commandos,” according to The Washington Post. On July 9, Haiti asked the U.S. to send troops to the country to protect its airport and key infrastructure.

The announcement of Mr. Sanon’s arrest came hours after FBI and Department of Homeland Security officials arrived in Haiti on July 11 to discuss how the U.S. can offer assistance, the newspaper reported.

Mr. Sanon has a YouTube channel with three political campaign videos from 2011, which include discussions about Haitian politics, according to Forbes. In one of the videos, titled “Dr. Christian Sanon – Leadership for Haiti,” Mr. Sanon talks about corruption in the country and presents himself as a potential leader.

Mr. Sanon lived in Florida for more than 20 years, ranging from the Tampa Bay area to South Florida, according to the Miami Herald. Public records show that he had more than a dozen businesses registered in the state, including medical services and real estate, though most are inactive.

Mr. Sanon is the third person with links to the U.S. who has been arrested in connection with the assassination, the Miami Herald reported. Two Haitian-Americans from southern Florida – James Solages, 35, and Joseph G. Vincent, 55 – were arrested by local police. They claimed they were working as translators for the assassins.

The first lady, Martine Moïse, was wounded in the attack and is now receiving treatment at a hospital in Miami, the newspaper reported.

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

More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.

Fatal overdoses rose by nearly 30% last year to a total of more than 93,000 deaths, according to the provisional data the National Center for Health Statistics reported.

The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.

The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.

Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.

Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.

“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”

Healthday contributed to this report. A version of this article first appeared on WebMD.com.

More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.

Fatal overdoses rose by nearly 30% last year to a total of more than 93,000 deaths, according to the provisional data the National Center for Health Statistics reported.

The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.

The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.

Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.

Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.

“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”

Healthday contributed to this report. A version of this article first appeared on WebMD.com.

More Americans died from drug overdoses in 2020 than in any other year, the CDC said July 14.

Fatal overdoses rose by nearly 30% last year to a total of more than 93,000 deaths, according to the provisional data the National Center for Health Statistics reported.

The spikes are largely attributed to the rise in use of fentanyl and other synthetic opioids.

The Washington Post reported that more than 69,000 overdose deaths involved opioids, up from 50,963 in 2019.

Amid the crush of overdoses, the White House announced that President Joe Biden has nominated Rahul Gupta, MD, to lead the White House Office of National Drug Control Policy.

Dr. Gupta is a former health commissioner of West Virginia, and is chief medical and health officer for the March of Dimes.

“Dr. Gupta led efforts in West Virginia to address the opioid crisis, gaining national prominence as a leader in tackling this issue,” March of Dimes President and CEO Stacey Stewart said in a statement. “At March of Dimes, he has advocated for policies and programs to prevent and treat substance use, with a focus on the safety and care of pregnant women and infants.”

Healthday contributed to this report. A version of this article first appeared on WebMD.com.

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

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

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

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

On July 12, federal officials announced they are seeking to establish a national coverage policy for aducanumab (Aduhelm) for Alzheimer’s disease (AD), a process that will take until next year to complete.

The Centers for Medicare & Medicaid Services said it will accept public comments about how Medicare should cover aducanumab through Aug. 11. The agency intends to post a draft decision memo on its coverage approach by Jan. 12, 2022, and then finalize this policy by April 12. Coverage decisions about aducanumab now are being made at the local level by Medicare’s administrative contractors, CMS said in a press release.

The announcement followed separate public calls for such a review by America’s Health Insurance Plans (AHIP) and the Alzheimer’s Association.

On June 30, AHIP submitted a formal request to the CMS. In it, AHIP requests that CMS take “swift action” on a national coverage determination for aducanumab. In the request, the organization specifically urged CMS to use a policy known as coverage with evidence development (CED) for Aduhelm.

This CED approach would allow access for patients considered most likely to benefit from the drug while Biogen continues research needed to definitively show its clinical benefit, said AHIP chief executive Matt Eyles.

In June, the Food and Drug Administration approved aducanumab based on data suggesting the drug might slow AD progression using the surrogate marker of a reduction in amyloid plaque.

The FDA’s accelerated approval letter set a 2030 deadline for Biogen to produce evidence from a phase 3 clinical trial definitively proving the drug’s efficacy.
 

Hefty price tag

Even if Biogen meets the FDA’s deadline, patients with AD, their families, clinicians, and insurers likely will wrestle for years with questions about whether to use this costly drug without clear evidence of benefit. The drug is estimated to cost $56,000 per year.

In addition, patients taking the drug will be required to undergo MRI scans to monitor for brain swelling or bleeding, complications that were experienced by those participating in previous studies of the drug, Mr. Eyles noted in his letter to CMS, which AHIP provided to this news organization.

About 80% of those eligible for aducanumab in the United States are enrolled in Medicare, write James D. Chambers, PhD, MPharm, Tufts University, Boston, and coauthors in a June article in the journal Health Affairs. Like AHIP, these authors also recommended CMS consider the CED path for the drug.

CMS has used the CED approach since 2003 to evaluate interventions such as amyloid PET for clinical evaluation of AD to implantable cardioverter defibrillators.

Applying CED to aducanumab “would provide the medical community, patients, caregivers, and payers with additional information long before the FDA’s required postapproval studies are completed,” Dr. Chambers and coauthors wrote. “It would also ensure that data on every patient treated would add to the knowledge base about how aducanumab impacts patient outcomes such as cognition, function, and quality of life.”

In the AHIP request to CMS, Mr. Eyles also noted that an independent review organization, the Institute for Clinical and Economic Review, said the evidence from studies done to date on aducanumab is “insufficient” to show a net health benefit for patients with mild cognitive impairment because of AD or mild AD.

At the ICER meeting, which will take place July 15, one of ICER’s expert panels, the California Technology Assessment Forum, said it will further consider all of the available scientific data on aducanumab and vote on a series of questions about its efficacy and value.

ICER’s reports have clout because insurers use its recommendations to help determine how to cover drugs and medical treatments. Among the questions ICER has posted online ahead of the meeting is one about the relative effects of aducanumab plus supportive care versus supportive care alone.
 

‘Dark irony’

Even as the medical community waits for Biogen to present clear evidence of a benefit for aducanumab, clinics specializing in AD may get a financial boost, said Jason Karlawish, MD, professor of medicine, medical ethics, health policy, and neurology at the University of Pennsylvania, Philadelphia, and codirector of Penn’s Memory Center.

Some clinicians see the arrival of the drug as a “win” for the field despite lingering concerns about its approval, said Dr. Karlawish at a panel discussion held July 12 by the nonprofit Hastings Center, a bioethics research institute. Dr. Karlawish is a fellow at Hastings.

In May, Dr. Karlawish published an article in STAT titled “If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it.” Dr. Karlawish told this news organization that he was a site investigator for Biogen studies of aducanumab and has worked on studies sponsored by Lilly and Eisai.

During the discussion July 12, Dr. Karlawish said he had altered his view and now might be a “reluctant prescriber.” This shift is because of his commitment “to preserve, protect and defend their autonomy” of patients with AD.

He also noted the drug could draw more money into the field to help care for patients with AD by providing increased access to diagnostics. Additionally, funds provided to clinics for administering aducanumab will aid specialty memory centers, “which have been basically impoverished since their creation,” Dr. Karlawish said.

“There is a dark irony that it takes a questionably beneficial drug to bring in the revenue to finally get memory centers up and functioning,” Dr. Karlawish said, adding that there needs to be “a larger conversation about how a big, vast, and problematic disease is being treated.”

Aducanumab’s approval shows that diseases in the U.S. are not fully considered as diseases until they have “a business model, and much of that business model relies on the pharmaceutical industry,” he noted.
 

Dr. Woodcock’s ‘personal commitment’

In early July, the FDA took two highly publicized steps to address criticism of its handling of the aducanumab approval. It revised the drug’s label to limit its use to patients with mild cognitive impairment likely related to AD or those in the mild stages of the disease.

In addition, Janet Woodcock, MD, the FDA’s acting commissioner, took to Twitter and posted a letter she sent to the Office of the Inspector General that called for a federal investigation into the drug’s approval that would examine agency staff interactions with Biogen.

AHIP spokesperson Kristine Grow said July 12 that her organization is still seeking a national Medicare coverage decision, but that the label revision was a “step in the right direction.”

“Patients with Alzheimer’s disease, and their families and caregivers, deserve safe, effective treatments. We applaud the FDA for this label adjustment, which brings indicated patients a bit closer to those included in clinical trials,” Ms. Grow said in an interview.

“At the same time, we remain concerned about the limited clinical evidence demonstrating efficacy and the serious safety risks that aducanumab poses for patients. We look forward to additional information from the FDA and other regulators, including CMS’ coverage guidance for patients who are Medicare eligible,” she added.

The controversy surrounding the approval of aducanumab is drawing more attention to the lack of a confirmed FDA commissioner. But in her letter to OIG, Dr. Woodcock wrote as if she intends to remain at the helm of the agency for at least a while longer. She wrote in her letter that OIG has her “personal commitment” that the FDA will fully cooperate if the investigative unit decides to undertake a review.

Dr. Woodcock also urged that a review be conducted as soon as possible, noting “should such a review result in actionable items, you also have my commitment to addressing these issues.”

A former FDA adviser who resigned over the agency’s handling of aducanumab said July 12 there needs to be a broader investigation of the FDA’s actions.

Attending the Hastings Center event was Aaron S. Kesselheim, MD, JD, MPH, of Harvard Medical School, Boston, one of three former members of an FDA advisory committee who resigned over the agency’s handling of aducanumab. Dr. Kesselheim said in an interview that he has no financial relationships to disclose in connection with this discussion.

“I would suggest that instead all aspects of this approval process should be investigated,” Dr. Kesselheim said, including the relationship between FDA and Biogen.

Dr. Karlawish said he was also concerned that Dr. Woodcock’s request for an investigation was “very narrow,” and noted members of Congress have said they are examining the FDA’s handling of this drug.

In a July 9 joint statement, House Committee on Energy and Commerce Chairman Frank Pallone Jr (D-N.J.), and House Committee on Oversight and Reform Chairwoman Carolyn B. Maloney (D-N.Y.) said they were “pleased” by Dr. Woodcock’s announcement, but they will keep digging into ongoing questions about the drug. In their view, the OIG review of FDA staff interactions with Biogen officials would complement their committees’ “robust investigation of this matter.”

“We continue to have concerns about the approval process for Aduhelm, how Biogen set its price, and the implications for seniors, providers, and taxpayers,” Mr. Pallone and Ms. Maloney added.
 

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

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

The reintroduction of congressional bills that aim to end seasonal time change and move permanently to daylight saving time (DST) – and action on the issue by 19 states in the last 4 years – signal political momentum and up the ante on sleep medicine to educate others and to more uniformly weigh in on the health consequences of such a change.

This was the message of several sleep scientists and physicians who participated in moderated discussions of DST at the virtual annual meeting of the Associated Professional Sleep Societies.

A position paper issued about a year ago by the American Academy of Sleep Medicine objected to the proposed switch and instead called for elimination of DST in favor of permanent standard time (ST). While there are detrimental health effects with time changes in either direction, there is “abundant” evidence that the transition from standard time to daylight saving time is worse, the AASM statement says.

Some experts have questioned, however, whether the evidence is weighty and comprehensive enough to drive a change in national policy. Others, such as SLEEP 2021 discussant Karin Johnson, MD, say there is unawareness outside of sleep medicine – and even within – of a growing body of literature on circadian misalignment and its associated health risks.

“There’s an educational gap for what’s out there [in the literature],” Dr. Johnson, medical director of the Baystate Health regional sleep program and Baystate Medical Center sleep laboratory in Springfield, Mass., said in an interview after the meeting.

Calls for more research, particularly on the chronic effects of DST and ST, are concerning because discussions of abolishing seasonal time change are “moving forward with or without us,” Kenneth Wright Jr., PhD, director of the chronobiology laboratory at the University of Colorado in Boulder and professor in the university’s department of integrative biology, said at the meeting.

“We don’t have time ... to have the studies we’d need to prove unequivocally that permanent standard time [is best]. We need to consider the scientific evidence before us – what’s known about human biology and health with respect to light and circadian timing,” Dr. Wright said. “The argument that pushing our clocks later is going to be healthier is not tenable. We cannot support that given the vast amount of scientific evidence we have from circadian and sleep science.”

Underscoring the sense of urgency to be engaged in the issue were the messages of Rep. Raymond Ward, MD, PhD, a Utah legislator in the state’s House of Representatives who introduced a bill to permanently observe DST, pending the amendment of federal law to permit such a change, and provided that five other Western states enact the same legislation.

“I chose to support DST because I became convinced this is the only thing that’s politically possible,” said Rep. Ward, a family practice physician at the Ogden Clinic in Bountiful. National polls have shown a “strong preference” to end seasonal time change, he said, and a poll conducted in his district showed that nearly 80% “wanted to stop changing the clocks, and 65% wanted the summer time schedule.”

“To me, the train seems to be moving in one direction,” said Rep. Ward. “The bills open in Congress in both the House and the Senate don’t have enough support yet, but every time another state legislature passes [legislation to establish permanent DST], they pick up a few more supporters.”

The Sunshine Protection Act of 2021 introduced in the House in January by Rep. Vern Buchanan (R-Fla.) has 23 cosponsors, and a bill of the same name introduced in the Senate in March by Marco Rubio (R-Fla.) has 14 cosponsors. Both bills have bipartisan support and are reintroductions of legislation initially put forth in 2019. A press release issued by Sen. Rubio’s office says that “extending DST can benefit the economy and our overall health.”

According to the National Conference of State Legislatures, 19 states have enacted legislation or passed resolutions in the last several years to provide for year-round DST, if Congress were to allow such a change. And according to a Congressional Research Service (CRS) report on DST updated in September 2020, at least 45 states have, since 2015, proposed legislation to change their observance of DST.

These efforts include proposals to exempt a state from DST observance, which is allowable under existing law, and proposals that would establish permanent DST, which would require Congress to amend the Uniform Time Act of 1966, the CRS report says.
 

The state of the science

Shifting from ST to DST has been associated with an increase in cardiovascular morbidity (heart attacks and atrial fibrillation), increased missed medical appointments, increased ED visits, increased mood disturbances and suicide risk, increased risk of fatal car crashes and medical errors – and sleep loss, said Elizabeth Klerman, MD, PhD, professor of neurology in the division of sleep medicine at Harvard Medical School, Boston.

These associations are covered in AASM statement, along with acknowledgment that most studies on the chronic effects of DST have “either been retrospective or addressed the issue indirectly.”

For Dr. Johnson, who refers to DST as “sleep deprivation time,” the most convincing data regarding the dangers of permanent DST come from studies comparing locations within time zones. “The farther you’re off from the meridian, the more you have that ‘social jet lag’ or circadian misalignment [between the innate circadian rhythm, which is synchronized with solar time, and school or work schedules],” she said at the meeting.

Researchers reported in 2017, for instance, that the risk for all cancers and many specific cancers increased from east to west within a time zone, as solar time is progressively delayed. “They documented changes in risk for every 5 degrees west from the meridian,” she said.

Dr. Johnson is a case in point of the “educational gap” that she believes needs attention. Two years ago, as chair of the sleep section of the American Academy of Neurology, she delved into the literature after the AAN asked the section whether it should endorse the AASM’s position paper on DST. “I didn’t know the literature even as a sleep scientist until I got into this,” she said.

“If you’re asked me 2 years ago,” she added in the later interview, “I would have said that permanent DST is fine.”

The sleep section recommended that the AAN endorse permanent ST, but the AAN ultimately decided it “didn’t feel strongly enough to say that standard time is unequivocally the better option,” Dr. Johnson said in an interview. “They agreed that there’s science [in favor of it], but ... it’s a big public policy decision.”

Jamie Zeitzer, PhD, associate professor of psychiatry and behavioral sciences at Stanford (Calif.) University’s Center for Sleep Sciences and Medicine, voiced similar concerns at the meeting about currently advocating a shift in either direction. It’s “absolutely clear that switching clocks, especially since it’s occurring at a population level, is deleterious and we need to get rid of it,” he said. “But before we put forth dictates on public health [with a shift to permanent ST], I think we better be sure we’re correct.”

“I think we’re getting close. I think the data thus far [are indicating] that permanent standard time is better for health,” Dr. Zeitzer said. “But I don’t think there’s a cumulative amount of evidence to really say that we have to subvert all other interests because this is so important for public health. We need at least a few more studies.”

There is not enough evidence, for instance, to conclude that the body clock does not eventually adjust to DST, he said, and it is not yet clear what roles electric light and sunlight each play in the body’s circadian time.

“And we need to think about north-south. What may be important for the upper Midwest, and for Maine, and for Washington, may not be ... good for Florida and Texas and southern California,” Dr. Zeitzer said. “You have very different patterns of light exposure, especially when it deals with seasons.”
 

Historical considerations

In his comments at the meeting, Muhammad Rishi, MBBS, the lead author of the AASM’s position statement, added that circadian misalignment – that “asynchrony between the internal and external clocks” – is associated in studies with an increased risk of obesity, metabolic syndrome, and depression.

But he also emphasized that the “historical evidence” against permanent DST is at least as strong as the medical evidence.

“The U.S. has gone on permanent daylight savings time several times in the past, most recently in the 1970s during the OPEC [oil embargo], and it was so unpopular,” said Dr. Rishi, of the department of pulmonology, critical care and sleep medicine at the Mayo Clinic Health System in Eau Claire, Wis. “England also did it in the 1960s and then abolished it, and most recently Russia did it ... it became so unpopular with increased depression and mood disorders that they abolished it.”

Rep. Ward said that China has offered a large natural experiment with its move decades ago from five time zones to one time zone – Beijing time. “I don’t think we’ve seen any sweeping changes in their health because they have one large time zone,” he said.

Dr. Klerman took issue, saying she “knows someone in China who is trying to get that data about health outcomes and is unable to get it.”

Arguments that DST saves energy hold little to no weight upon scrutiny of the data, Dr. Johnson said. Moreover, research other than oft-cited, older Department of Transportation studies suggests that “permanent DST is bad for energy and bad for the climate,” she said. “This really needs to be more fully evaluated by the government and others.”

Dr. Johnson said after the meeting that it’s important for experts from the energy and climate sectors, education, and medicine – including pediatrics, oncology, and other specialties with “a stake in this” – to come together and share information so “we won’t all be in our silos.” She and other sleep experts in the neurology field are planning to host a summit in 2022 to do just this.

Dr. Johnson and Kin Yuen, MD, of the Sleep Disorders Center at the University of California, San Francisco, both expressed concern at the meeting that adoption of permanent DST would negate the benefits of delayed school start times in middle and high school students.

There is some evidence that delayed start times have led to decreased tardiness and absences, Dr. Yuen said. To have the same impact with permanent DST, “instead of starting at 8:30 a.m., you’d have to start at 9:30,” Dr. Johnson added after the meeting.

The first discussion of DST at the SLEEP 2021 meeting was led by Erin E. Flynn-Evans, PhD, MPH, director of the Fatigue Countermeasures Laboratory at the National Aeronautics and Space Administration Ames Research Center. Dr. Yuen led a later second question-and-answer session. They and each of the eight participants reported that they had no relevant conflicts of interest.

Dr. Yuen and Dr. Flynn-Evans are both coauthors of the AASM’s position statement on DST. Dr. Klerman is a coauthor of the Society for Research on Biological Rhythms 2019 position paper on DST.

The AASM’s statement has been endorsed by 19 organizations, including the American College of Chest Physicians, the SRBR, the American Academy of Cardiovascular Sleep Medicine, the Society of Behavioral Sleep Medicine, the National PTA, and the American College of Occupational and Environmental Medicine.

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Medicare intends next year to allow physician assistants (PAs) to begin directly billing for their work and to expand coverage of telehealth services. It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.

adventtr/iStock/Getty Images Plus

The Centers for Medicare & Medicaid Services recently posted its proposed 2022 physician fee schedule. Running to more than 1,700 pages, the draft rule contains myriad other changes in how the giant federal health program pays for medical care, including revisions to its approach to evaluation and management (E/M) services, which represent many office visits. In addition, Medicare is seeking to increase participation in a program intended to prevent people from developing diabetes.

Physician groups posted quick complaints about a proposed 3.75% reduction to the conversion factor because of budget neutrality requirements. The cut reinstates a reduction Congress prevented in late 2020.

In a statement, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, called the draft rule a “mixed bag for physician practices.” Mr. Gilberg said the MGMA will seek congressional intervention to avert the cut for services in 2022.

In keeping with a provision Congress included in a massive spending bill enacted in December, Medicare will let PAs directly bill, as nurse practitioners already can. In a press release, CMS on July 13 described this as a move likely to expand access to care and reduce administrative burden. In 2020, the American Academy of PAs praised the inclusion in the spending bill of the provision allowing its members to directly bill Medicare.

In the draft rule, CMS also intends to remove certain geographic restrictions regarding use of telehealth services for diagnosis, evaluation, and treatment of mental health disorders. CMS also is proposing to allow payment to eligible clinicians for certain mental health and behavioral health services to patients via audio-only telephone calls. These services would include counseling and therapy services provided through opioid treatment programs.

“These changes would be particularly helpful for those in areas with poor broadband infrastructure and among people with Medicare who are not capable of, or do not consent to the use of, devices that permit a two-way, audio/video interaction for their health care visits,” CMS said in a statement.
 

Slimmer Medicare enrollees, bigger payments for coaches?

CMS is seeking to draw more participants to the Medicare Diabetes Prevention Program (MDPP). This program includes organizations that provide structured, coach-led sessions in community and health care settings to help people lose weight and exercise more. During the COVID-19 public health emergency, CMS waived an enrollment fee for new suppliers of services in MDPP. CMS now is proposing to waive this fee for all organizations that submit an application to enroll in Medicare as an MDPP supplier on or after Jan. 1, 2022.

Another proposed change in MDPP services is a restructuring of payments so that organizations involved in coaching would receive larger payments when their participants reach milestones for attendance and for becoming slimmer.

“We propose to increase performance payments for MDPP beneficiary achievement of the 5% weight-loss goal, as well as continued attendance during each core maintenance interval,” CMS said in a statement.

Medicare remains engaged in a review of its payments for E/M services. In the draft rule, CMS is proposing a number of refinements to current policies for split, or shared, E/M visits, critical care services, and services furnished by teaching physicians involving residents. The intention of these changes is to “better reflect the current practice of medicine, the evolving role of nonphysician practitioners as members of the medical team, and to clarify conditions of payment that must be met to bill Medicare for these services,” CMS said.

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

People receiving the Johnson and Johnson COVID-19 vaccine could be at increased risk for developing Guillain-Barré syndrome, the Food and Drug Administration is expected to announce as early as July 13, according to multiple media reports.

Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.

More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.

Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.

Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.

Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.

The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.

The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.

The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.

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

Most U.S. adults (77%) ages 50 and older in the United States rated their overall health as good, very good, or excellent in an online survey conducted by WebMD and Capital Caring Health (CCH), a nonprofit hospice/advanced illness care organization based in Virginia.

Among the respondents, 41% said their health was very good or excellent.

However, the ratings differed largely by race, employment status, and income.

Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.

The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).

Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).

Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).

WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020.  WebMD.com readers were randomly invited to take a 10-minute online survey.
 

Aging at home a priority

The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.

“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.

Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.

The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.

When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
 

Use of telemedicine

Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.

However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%).  They were also more likely to already have used telemedicine.

Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.

Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.

Close to one-quarter of respondents would not allow any type of monitoring.

Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.

People see monitoring of some movements as “Orwellian,” Mr. Cone says.
 

Knowledge of hospice

The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.

When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.

He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.

“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”

Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.

In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”

He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.

However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.

The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
 

Most using hospice are White

More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”

However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.

Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
 

Health costs top concern

The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.

More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).

Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.

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

Most U.S. adults (77%) ages 50 and older in the United States rated their overall health as good, very good, or excellent in an online survey conducted by WebMD and Capital Caring Health (CCH), a nonprofit hospice/advanced illness care organization based in Virginia.

Among the respondents, 41% said their health was very good or excellent.

However, the ratings differed largely by race, employment status, and income.

Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.

The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).

Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).

Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).

WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020.  WebMD.com readers were randomly invited to take a 10-minute online survey.
 

Aging at home a priority

The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.

“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.

Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.

The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.

When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
 

Use of telemedicine

Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.

However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%).  They were also more likely to already have used telemedicine.

Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.

Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.

Close to one-quarter of respondents would not allow any type of monitoring.

Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.

People see monitoring of some movements as “Orwellian,” Mr. Cone says.
 

Knowledge of hospice

The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.

When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.

He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.

“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”

Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.

In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”

He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.

However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.

The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
 

Most using hospice are White

More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”

However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.

Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
 

Health costs top concern

The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.

More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).

Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.

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

Most U.S. adults (77%) ages 50 and older in the United States rated their overall health as good, very good, or excellent in an online survey conducted by WebMD and Capital Caring Health (CCH), a nonprofit hospice/advanced illness care organization based in Virginia.

Among the respondents, 41% said their health was very good or excellent.

However, the ratings differed largely by race, employment status, and income.

Employment status was also associated with a significant difference in the way people viewed their health at the top tier and bottom tier.

The middle tier (“good” health) was reported similarly (from 33% to 37%) whether a person was employed, retired, or not employed. However, employed respondents were much more likely to report they had “excellent” or “very good” health (51% vs. 44% for retirees and 21% for the not employed).

Conversely, those who were not employed were far more likely to report “fair” or “poor” health (45%) than those who were employed (13%) or retired (20%).

Similarly, respondents with incomes of less than $50,000 were three times more likely to report their health as “fair” or “poor” than were those with incomes of more than $100,000 (36% vs. 12%).

WebMD/CCH surveyed 3,464 U.S. residents ages 50 and older between Aug. 13 and Nov. 9, 2020.  WebMD.com readers were randomly invited to take a 10-minute online survey.
 

Aging at home a priority

The survey also highlighted a strong preference for aging in place, says Steve Cone, chief of communications and philanthropy at CCH.

“More now than ever before, thanks to the COVID experience, baby boomers and their children really believe that’s the holy grail,” he says.

Mr. Cone notes that the quick spread of COVID-19 through some nursing homes early in the pandemic likely has strengthened people’s resolve to live out their lives in their own homes.

The survey indicated that 85% of people aged 50+ who are living in their own home, a family member’s home, or a loved one’s home responded that it is “very important” or “important” to stay in their home as they age.

When asked what services they would need to continue their living situation, the most common responses were housekeeping, home repair services, and transportation (listed as needs by 35% to 45% of respondents). Regarding changes they would have to make to feel safe in their home as they age, installing grab bars and/or safety rails in the bath/shower was the most popular answer (50%).
 

Use of telemedicine

Respondents were also asked about their acceptance of telemedicine, and 62% said they would be likely or very likely to engage in virtual visits with a doctor it in the future.

However, the likelihood varied by income level. Specifically, respondents with incomes over $100,000 were significantly more likely to say they would use telemedicine in the future than were those with incomes below $50,000 (74% vs. 60%).  They were also more likely to already have used telemedicine.

Although respondents generally embraced telemedicine, they are less confident about some types of monitoring, according to Mr. Cone.

Emergency response (64%) was the leading type of remote monitoring respondents ages 50 and older would allow. Only a minority of respondents would allow the other types of monitoring asked about in the survey.

Close to one-quarter of respondents would not allow any type of monitoring.

Fewer than one-third would allow tracking of medication compliance, refrigerator use, sleep habits, or bathroom use.

People see monitoring of some movements as “Orwellian,” Mr. Cone says.
 

Knowledge of hospice

The survey findings support the need for more widespread use of hospice so people can stay in their homes as they age, Mr. Cone says.

When illness gets severe, “There’s no reason you have to get rushed to the emergency room or wind up in a hospital,” Mr. Cone says.

He notes that hospice and palliative care can come to patients wherever they reside – in their home, an assisted living center, a nursing home, or even a hospital room.

“That doesn’t mean the physician isn’t involved,” he says. “But working as a team, we can keep them in their homes and their lifestyle intact.”

Patients whose doctors attest that they are likely to live a maximum 6 months are eligible for hospice. But most families wait too long to long to start hospice or palliative care for a patient, Mr. Cone says, and may not be aware of what these services typically cover, including meal preparation and pet care.

In the survey, nearly one-third of respondents said they did not know that palliative care is something that “can be given at any stage of a serious illness” or “provides non-medical services (e.g., patient/family communication, help with insurance issues, scheduling appointments, arranging transportation).”

He notes palliative care and hospice are covered by Medicare and Medicaid and also by most private insurance plans or by individual companies providing the service.

However, health care providers may have to overcome a general reluctance to discuss hospice when sharing options for those severely ill.

The survey showed that while 51% of those 50 and older are at least “slightly interested” in learning more about hospice, a nearly equal number say they are “not at all interested” (49%).
 

Most using hospice are White

More than 90% of those surveyed reported that aspects of hospice care, including “comfort and relief from pain at the end of patients’ lives,” providing a dedicated care team, and an alternative to other care settings, are “very important” or “important.”

However, national hospice use rates are extremely low for minorities and the LGBTQ community, according to Mr. Cone. Among Medicare hospice recipients, 82% were white, 8.2% Black, 6.7% Hispanic, and 1.8% Asian or Pacific Islander, according to the National Hospice and Palliative Care Organization.

Those numbers signal a need for outreach to those communities with information on what services are available and how to access them, he says.
 

Health costs top concern

The survey also asked about level of concern regarding matters including family, health, financials, and end-of-life directives and found adults aged 50 and older expressed the greatest amount of concern for health care costs that are not covered by insurance.

More than half (56%) said they were concerned or very concerned about those costs, which was higher than the percentage concerned about losing a spouse (49%).

Respondents were less concerned (“slightly concerned” or “not at all concerned”) about their children living far away, planning end-of life-directives, and falling or having reduced mobility.

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

After several weeks of outcry and heated debate over the Food and Drug Administration’s controversial approval of the Alzheimer’s drug aducanumab (Aduhelm), the head of the agency is now calling for a federal investigation into its own approval proceedings.

Janet Woodcock, MD, the FDA’s acting commissioner, sent a letter to the Office of the Inspector General on July 9, she announced in a tweet.

Dr. Woodcock is asking for an investigation into questionable meetings and other interactions between Biogen and FDA staff members prior to the drug’s approval that “may have occurred outside of the formal correspondence process.”

The letter explains that concerns around these issues “could undermine the public’s confidence in the FDA’s decision.” Therefore, an independent investigation is needed to determine whether anything occurred that was “inconsistent with FDA policies and procedures.”

Dr. Woodcock noted that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research” involved in the review process.

However, “FDA is dedicated to scientific integrity, to reviewing data without bias, and to basing its regulatory decisions on data,” she wrote. “You have my personal commitment that the Agency will fully cooperate should your office undertake a review.”

Dr. Woodcock concluded by urging that a review be conducted as soon as possible, noting that “should such a review result in actionable items, you also have my commitment to addressing these issues.”

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

After several weeks of outcry and heated debate over the Food and Drug Administration’s controversial approval of the Alzheimer’s drug aducanumab (Aduhelm), the head of the agency is now calling for a federal investigation into its own approval proceedings.

Janet Woodcock, MD, the FDA’s acting commissioner, sent a letter to the Office of the Inspector General on July 9, she announced in a tweet.

Dr. Woodcock is asking for an investigation into questionable meetings and other interactions between Biogen and FDA staff members prior to the drug’s approval that “may have occurred outside of the formal correspondence process.”

The letter explains that concerns around these issues “could undermine the public’s confidence in the FDA’s decision.” Therefore, an independent investigation is needed to determine whether anything occurred that was “inconsistent with FDA policies and procedures.”

Dr. Woodcock noted that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research” involved in the review process.

However, “FDA is dedicated to scientific integrity, to reviewing data without bias, and to basing its regulatory decisions on data,” she wrote. “You have my personal commitment that the Agency will fully cooperate should your office undertake a review.”

Dr. Woodcock concluded by urging that a review be conducted as soon as possible, noting that “should such a review result in actionable items, you also have my commitment to addressing these issues.”

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

After several weeks of outcry and heated debate over the Food and Drug Administration’s controversial approval of the Alzheimer’s drug aducanumab (Aduhelm), the head of the agency is now calling for a federal investigation into its own approval proceedings.

Janet Woodcock, MD, the FDA’s acting commissioner, sent a letter to the Office of the Inspector General on July 9, she announced in a tweet.

Dr. Woodcock is asking for an investigation into questionable meetings and other interactions between Biogen and FDA staff members prior to the drug’s approval that “may have occurred outside of the formal correspondence process.”

The letter explains that concerns around these issues “could undermine the public’s confidence in the FDA’s decision.” Therefore, an independent investigation is needed to determine whether anything occurred that was “inconsistent with FDA policies and procedures.”

Dr. Woodcock noted that she has “tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research” involved in the review process.

However, “FDA is dedicated to scientific integrity, to reviewing data without bias, and to basing its regulatory decisions on data,” she wrote. “You have my personal commitment that the Agency will fully cooperate should your office undertake a review.”

Dr. Woodcock concluded by urging that a review be conducted as soon as possible, noting that “should such a review result in actionable items, you also have my commitment to addressing these issues.”

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

Adults with limited English skills receive far less health care than do those proficient in English, according to a new study in Health Affairs.

Jessica Himmelstein, MD, a Harvard research fellow and primary care physician at Cambridge Health Alliance in Cambridge, Mass., led a study of more than 120,000 adults published July 6, 2021. The study population included 17,776 Hispanic adults with limited English proficiency, 14,936 Hispanic adults proficient in English and 87,834 non-Hispanic, English-proficient adults.

Researchers compared several measures of care usage from information in the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey from 1998 to 2018.

They found that, in adjusted analyses, total use of care per capita from 2014-2018, measured by health care expenditures, was $1,463 lower (98% confidence interval, $1,030-$1,897), or 35% lower for primary-Spanish speakers than for Hispanic adults who were English proficient and $2,802 lower (98% CI, $2,356-$3,247), or 42% lower versus non-Hispanic adults who were English proficient.

Spanish speakers also had 36% fewer outpatient visits and 48% fewer prescription medications than non-Hispanic adults, and 35% fewer outpatient visits and 37% fewer prescription medications than English-proficient Hispanic adults.

Even when accounting for differences in health, age, sex, income and insurance, adults with language barriers fared worse.
 

Gaps span all types of care

The services that those with limited English skills are missing are “the types of care people need to lead a healthy life,” from routine visits and medications to urgent or emergency care, Dr. Himmelstein said in an interview.

She said the gaps were greater in outpatient care and in medication use, compared with emergency department visits and inpatient care, but the inequities were present in all the categories she and her coinvestigators studied.

Underlying causes for having less care may include that people who struggle with English may not feel comfortable accessing the health system or may feel unwelcome or discriminated against.

“An undercurrent of biases, including racism, could also be contributing,” she said.

The data show that, despite several federal policy changes aimed at promoting language services in hospitals and clinics, several language-based disparities have not improved over 2 decades.

Some of the changes have included an executive order in 2000 requiring interpreters to be available in federally funded health facilities. In 2010, the Affordable Care Act enhanced the definition of meaningful access to language services and setting standards for qualified interpreters.
 

Gap widened over 2 decades

The adjusted gap in annual health care expenditures per capita between adults with limited English skills and non-Hispanic, English-proficient adults widened by $1,596 (98% CI, $837-$2,356) between 1999-2000 and 2017-2018, after accounting for inflation.

Dr. Himmelstein said that though this study period predated COVID-19, its findings may help explain the disproportionate burden the pandemic placed on the Hispanic population.

“This is a community that traditionally wasn’t getting access to care and then suddenly something like COVID-19 comes and they were even more devastated,” she noted.

Telehealth, which proved an important way to access care during the pandemic, also added a degree of communication difficulty for those with fewer English skills, she said.

Many of the telehealth changes are here to stay, and it will be important to ask: “Are we ensuring equity in telehealth use for individuals who face language barriers?” Dr. Himmelstein said.

Olga Garcia-Bedoya, MD, an associate professor at University of Illinois at Chicago’s department of medicine and medical director of UIC’s Institute for Minority Health Research, said having access to interpreters with high accuracy is key to narrowing the gaps.

“The literature is very clear that access to professional medical interpreters is associated with decreased health disparities for patients with limited English proficiency,” she said.

More cultural training for clinicians is needed surrounding beliefs about illness and that some care may be declined not because of a person’s limited English proficiency, but because their beliefs may keep them from getting care, Dr. Garcia-Bedoya added. When it comes to getting a flu shot, for example, sometimes belief systems, rather than English proficiency, keep people from accessing care.
 

What can be done?

Addressing barriers caused by lack of English proficiency will likely take change in policies, including one related reimbursement for medical interpreters, Dr. Himmelstein said.

Currently, only 15 states’ Medicaid programs or Children’s Health Insurance Programs reimburse providers for language services, the paper notes, and neither Medicare nor private insurers routinely pay for those services.

Recruiting bilingual providers and staff at health care facilities and in medical and nursing schools will also be important to narrow the gaps, Dr. Himmelstein said.

Strengthening standards for interpreters also will help. “Currently such standards vary by state or by institution and are not necessarily enforced,” she explained.

It will also be important to make sure patients know that they are entitled by law to care, free of discriminatory practices and to have certain language services including qualified interpreters, Dr. Himmelstein said.

Dr. Garcia-Bedoya said changes need to come from health systems working in combination with clinicians, providing resources so that quality interpreters can be accessed and making sure that equipment supports clear communication in telehealth. Patients’ language preferences should also be noted as soon as they make the appointment.

The findings of the study may have large significance as one in seven people in the United States speak Spanish at home, and 25 million people in the United States have limited English proficiency, the authors noted.

Dr. Himmelstein receives funding support from an Institutional National Research Service Award. Dr. Garcia-Bedoya reports no relevant financial relationships.

Adults with limited English skills receive far less health care than do those proficient in English, according to a new study in Health Affairs.

Jessica Himmelstein, MD, a Harvard research fellow and primary care physician at Cambridge Health Alliance in Cambridge, Mass., led a study of more than 120,000 adults published July 6, 2021. The study population included 17,776 Hispanic adults with limited English proficiency, 14,936 Hispanic adults proficient in English and 87,834 non-Hispanic, English-proficient adults.

Researchers compared several measures of care usage from information in the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey from 1998 to 2018.

They found that, in adjusted analyses, total use of care per capita from 2014-2018, measured by health care expenditures, was $1,463 lower (98% confidence interval, $1,030-$1,897), or 35% lower for primary-Spanish speakers than for Hispanic adults who were English proficient and $2,802 lower (98% CI, $2,356-$3,247), or 42% lower versus non-Hispanic adults who were English proficient.

Spanish speakers also had 36% fewer outpatient visits and 48% fewer prescription medications than non-Hispanic adults, and 35% fewer outpatient visits and 37% fewer prescription medications than English-proficient Hispanic adults.

Even when accounting for differences in health, age, sex, income and insurance, adults with language barriers fared worse.
 

Gaps span all types of care

The services that those with limited English skills are missing are “the types of care people need to lead a healthy life,” from routine visits and medications to urgent or emergency care, Dr. Himmelstein said in an interview.

She said the gaps were greater in outpatient care and in medication use, compared with emergency department visits and inpatient care, but the inequities were present in all the categories she and her coinvestigators studied.

Underlying causes for having less care may include that people who struggle with English may not feel comfortable accessing the health system or may feel unwelcome or discriminated against.

“An undercurrent of biases, including racism, could also be contributing,” she said.

The data show that, despite several federal policy changes aimed at promoting language services in hospitals and clinics, several language-based disparities have not improved over 2 decades.

Some of the changes have included an executive order in 2000 requiring interpreters to be available in federally funded health facilities. In 2010, the Affordable Care Act enhanced the definition of meaningful access to language services and setting standards for qualified interpreters.
 

Gap widened over 2 decades

The adjusted gap in annual health care expenditures per capita between adults with limited English skills and non-Hispanic, English-proficient adults widened by $1,596 (98% CI, $837-$2,356) between 1999-2000 and 2017-2018, after accounting for inflation.

Dr. Himmelstein said that though this study period predated COVID-19, its findings may help explain the disproportionate burden the pandemic placed on the Hispanic population.

“This is a community that traditionally wasn’t getting access to care and then suddenly something like COVID-19 comes and they were even more devastated,” she noted.

Telehealth, which proved an important way to access care during the pandemic, also added a degree of communication difficulty for those with fewer English skills, she said.

Many of the telehealth changes are here to stay, and it will be important to ask: “Are we ensuring equity in telehealth use for individuals who face language barriers?” Dr. Himmelstein said.

Olga Garcia-Bedoya, MD, an associate professor at University of Illinois at Chicago’s department of medicine and medical director of UIC’s Institute for Minority Health Research, said having access to interpreters with high accuracy is key to narrowing the gaps.

“The literature is very clear that access to professional medical interpreters is associated with decreased health disparities for patients with limited English proficiency,” she said.

More cultural training for clinicians is needed surrounding beliefs about illness and that some care may be declined not because of a person’s limited English proficiency, but because their beliefs may keep them from getting care, Dr. Garcia-Bedoya added. When it comes to getting a flu shot, for example, sometimes belief systems, rather than English proficiency, keep people from accessing care.
 

What can be done?

Addressing barriers caused by lack of English proficiency will likely take change in policies, including one related reimbursement for medical interpreters, Dr. Himmelstein said.

Currently, only 15 states’ Medicaid programs or Children’s Health Insurance Programs reimburse providers for language services, the paper notes, and neither Medicare nor private insurers routinely pay for those services.

Recruiting bilingual providers and staff at health care facilities and in medical and nursing schools will also be important to narrow the gaps, Dr. Himmelstein said.

Strengthening standards for interpreters also will help. “Currently such standards vary by state or by institution and are not necessarily enforced,” she explained.

It will also be important to make sure patients know that they are entitled by law to care, free of discriminatory practices and to have certain language services including qualified interpreters, Dr. Himmelstein said.

Dr. Garcia-Bedoya said changes need to come from health systems working in combination with clinicians, providing resources so that quality interpreters can be accessed and making sure that equipment supports clear communication in telehealth. Patients’ language preferences should also be noted as soon as they make the appointment.

The findings of the study may have large significance as one in seven people in the United States speak Spanish at home, and 25 million people in the United States have limited English proficiency, the authors noted.

Dr. Himmelstein receives funding support from an Institutional National Research Service Award. Dr. Garcia-Bedoya reports no relevant financial relationships.

Adults with limited English skills receive far less health care than do those proficient in English, according to a new study in Health Affairs.

Jessica Himmelstein, MD, a Harvard research fellow and primary care physician at Cambridge Health Alliance in Cambridge, Mass., led a study of more than 120,000 adults published July 6, 2021. The study population included 17,776 Hispanic adults with limited English proficiency, 14,936 Hispanic adults proficient in English and 87,834 non-Hispanic, English-proficient adults.

Researchers compared several measures of care usage from information in the Agency for Healthcare Research and Quality’s Medical Expenditure Panel Survey from 1998 to 2018.

They found that, in adjusted analyses, total use of care per capita from 2014-2018, measured by health care expenditures, was $1,463 lower (98% confidence interval, $1,030-$1,897), or 35% lower for primary-Spanish speakers than for Hispanic adults who were English proficient and $2,802 lower (98% CI, $2,356-$3,247), or 42% lower versus non-Hispanic adults who were English proficient.

Spanish speakers also had 36% fewer outpatient visits and 48% fewer prescription medications than non-Hispanic adults, and 35% fewer outpatient visits and 37% fewer prescription medications than English-proficient Hispanic adults.

Even when accounting for differences in health, age, sex, income and insurance, adults with language barriers fared worse.
 

Gaps span all types of care

The services that those with limited English skills are missing are “the types of care people need to lead a healthy life,” from routine visits and medications to urgent or emergency care, Dr. Himmelstein said in an interview.

She said the gaps were greater in outpatient care and in medication use, compared with emergency department visits and inpatient care, but the inequities were present in all the categories she and her coinvestigators studied.

Underlying causes for having less care may include that people who struggle with English may not feel comfortable accessing the health system or may feel unwelcome or discriminated against.

“An undercurrent of biases, including racism, could also be contributing,” she said.

The data show that, despite several federal policy changes aimed at promoting language services in hospitals and clinics, several language-based disparities have not improved over 2 decades.

Some of the changes have included an executive order in 2000 requiring interpreters to be available in federally funded health facilities. In 2010, the Affordable Care Act enhanced the definition of meaningful access to language services and setting standards for qualified interpreters.
 

Gap widened over 2 decades

The adjusted gap in annual health care expenditures per capita between adults with limited English skills and non-Hispanic, English-proficient adults widened by $1,596 (98% CI, $837-$2,356) between 1999-2000 and 2017-2018, after accounting for inflation.

Dr. Himmelstein said that though this study period predated COVID-19, its findings may help explain the disproportionate burden the pandemic placed on the Hispanic population.

“This is a community that traditionally wasn’t getting access to care and then suddenly something like COVID-19 comes and they were even more devastated,” she noted.

Telehealth, which proved an important way to access care during the pandemic, also added a degree of communication difficulty for those with fewer English skills, she said.

Many of the telehealth changes are here to stay, and it will be important to ask: “Are we ensuring equity in telehealth use for individuals who face language barriers?” Dr. Himmelstein said.

Olga Garcia-Bedoya, MD, an associate professor at University of Illinois at Chicago’s department of medicine and medical director of UIC’s Institute for Minority Health Research, said having access to interpreters with high accuracy is key to narrowing the gaps.

“The literature is very clear that access to professional medical interpreters is associated with decreased health disparities for patients with limited English proficiency,” she said.

More cultural training for clinicians is needed surrounding beliefs about illness and that some care may be declined not because of a person’s limited English proficiency, but because their beliefs may keep them from getting care, Dr. Garcia-Bedoya added. When it comes to getting a flu shot, for example, sometimes belief systems, rather than English proficiency, keep people from accessing care.
 

What can be done?

Addressing barriers caused by lack of English proficiency will likely take change in policies, including one related reimbursement for medical interpreters, Dr. Himmelstein said.

Currently, only 15 states’ Medicaid programs or Children’s Health Insurance Programs reimburse providers for language services, the paper notes, and neither Medicare nor private insurers routinely pay for those services.

Recruiting bilingual providers and staff at health care facilities and in medical and nursing schools will also be important to narrow the gaps, Dr. Himmelstein said.

Strengthening standards for interpreters also will help. “Currently such standards vary by state or by institution and are not necessarily enforced,” she explained.

It will also be important to make sure patients know that they are entitled by law to care, free of discriminatory practices and to have certain language services including qualified interpreters, Dr. Himmelstein said.

Dr. Garcia-Bedoya said changes need to come from health systems working in combination with clinicians, providing resources so that quality interpreters can be accessed and making sure that equipment supports clear communication in telehealth. Patients’ language preferences should also be noted as soon as they make the appointment.

The findings of the study may have large significance as one in seven people in the United States speak Spanish at home, and 25 million people in the United States have limited English proficiency, the authors noted.

Dr. Himmelstein receives funding support from an Institutional National Research Service Award. Dr. Garcia-Bedoya reports no relevant financial relationships.