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Florida-based doctor arrested in Haiti president’s assassination
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.
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.
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.
Contentious Alzheimer’s drug likely to get national coverage plan, CMS says
On July 12, 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, 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, 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.
Medicare proposes direct payments to PAs, telehealth expansion
It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.
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.
It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.
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.
It also intends to change the approach to payments for office visits and for coaching programs for diabetes prevention.
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.
Gender pay gap most pronounced in procedural specialties
Salary disparities persist in academic internal medicine specialties and are most obvious in procedural specialties, such as cardiology, in which there are fewer women, research suggests.
“Substantial salary inequities persist at the highest faculty levels and specifically in procedural-based specialties,” Teresa Wang, MD, and colleagues reported in a research letter published online July 12, 2021, in JAMA Internal Medicine.
To examine the demographics and salaries of academic internal medicine physician specialists, Dr. Wang, who is with the division of cardiovascular medicine at the University of Pennsylvania, Philadelphia, and coauthors analyzed survey results from faculty at 154 U.S. medical schools.
They used data from the Association of American Medical Colleges Faculty Salary Report of 2018-2019 to assess the median annual salary, faculty rank, and gender for 21,905 faculty in 13 internal medicine specialties.
Overall, women made up less than 40% of full-time faculty across ranks. Female representation was approximately equal at the instructor and assistant ranks – 47% and 46%, respectively – but decreased to 24% at the professor level.
The authors found that women made up the majority in three specialties – general internal medicine, endocrinology, and geriatrics. In contrast, women were least represented in the procedural specialties of pulmonology, critical/intensive care, gastroenterology, and cardiology.
The greatest imbalance was in cardiology, in which only 21% were women, the researchers noted.
Across faculty ranks, the median annual salary was less for women than for men. The median salary for women was within $25,000 of that for men at all ranks except chief and was at least 90% of that for men in 10 of 13 internal medicine specialties.
Cardiology, gastroenterology, and critical/intensive care were the three specialties in which women’s median salary did not reach 90% of men’s. These specialties tended to be better paid overall, “but also demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology,” the researchers said.
The reasons for gender disparities are unclear, though internal medicine procedural specialties “have long been male dominated in composition and leadership,” the authors noted. The findings indicate that workforce gender parity may be associated with salary equity.
“Despite the growing awareness of workforce disparities in medicine, our findings suggest that women internal medicine specialists remain underpaid and are not promoted to senior level academic ranks when compared with career trajectories of their male counterparts,” study author Nosheen Reza, MD, of the division of cardiovascular medicine at the University of Pennsylvania, told this news organization.
The researchers noted that they were unable to adjust at the individual level for various factors that may influence salary, such as professional service, academic productivity, clinical volume, and supplementary funding sources, and that the results might not apply to all U.S. medical schools, in which departmental structures vary.
Procedures versus evaluation and management
Still, the research “provides an interesting snapshot of current salary disparities in academic internal medicine,” comment Rita F. Redberg, MD, and colleagues in a related editorial. Dr. Redberg, the editor of JAMA Internal Medicine, is affiliated with the department of medicine at the University of California, San Francisco.
Internal medicine has 13 specialties and dozens of subspecialties, and “procedural subspecialties are more male dominated and better paid than nonprocedural subspecialties – both topics deserving of further exploration,” the editorialists wrote.
The field needs to address various issues that drive some women to “shun male-dominated procedural-based fields – including lack of role models, macho ‘cowboy’ culture, unpredictable schedules, longer training periods, or cultural factors,” Dr. Redberg and coauthors suggested. “Concurrently, the medical profession overall, as well as specialties, should thoughtfully and frequently reassess how to distribute pay more equitably and to remove the premium currently paid for procedures over evaluation and management services.”
“Unfortunately, it is not a surprise that there continues to be a gender gap for salary in academic medicine,” Dr. Redberg said in an interview. “It was interesting to see that gender pay disparities were greatest in the procedure-intensive specialties, and we do know that procedures are much more highly reimbursed than evaluation and management time, even in the IM specialties. From a patient perspective, I think what they value most highly is having their doctor talk with them and explain treatment options and risks and benefits. Sadly, our fee-for-service–based reimbursement system values procedures more highly than talking with patients. And part of the gender gap in salary is attributed to less women being proceduralists.”
The Medicare Payment Advisory Commission “has made some excellent recommendations to Congress on helping to correct this imbalance,” Dr. Redberg added.
In a separate viewpoint article, Leah M. Marcotte, MD, of the department of medicine at the University of Washington, Seattle, and colleagues describe reasons why women physicians may have “slower promotional time lines,” compared with men, such as receiving fewer and smaller grants, being underrepresented as speakers at national conferences, and receiving fewer invitations to author editorials.
“To narrow this gap, institutions should proactively nominate women, with a greater focus on those underrepresented in medicine, for internal and external awards and speaking opportunities,” Dr. Marcotte and coauthors wrote. “Institutions should adopt policies to cover child care, breastfeeding/pumping accommodations, and dependent travel. Academic departments should continue to offer virtual speaking opportunities even after COVID-19 pandemic travel restrictions become unnecessary.”
Institutions can also assist women faculty in preparing promotion dossiers.
“Gender disparities in promotion in academic medicine have been described for decades, and yet progress to close the gap has been untenably slow,” they said. “Rather than expecting faculty to adapt to existing systems, we need to change the promotion process to work better for all.”
The authors disclosed no relevant financial relationships. Dr. Redberg has received grants from Arnold Ventures, the Greenwall Foundation, and the National Heart, Lung, and Blood Institute outside the submitted work. One viewpoint coauthor has received honoraria from the American Board of Internal Medicine, and another has received personal fees from F-Prime Capital, both outside the submitted work.
A version of this article first appeared on Medscape.com.
Salary disparities persist in academic internal medicine specialties and are most obvious in procedural specialties, such as cardiology, in which there are fewer women, research suggests.
“Substantial salary inequities persist at the highest faculty levels and specifically in procedural-based specialties,” Teresa Wang, MD, and colleagues reported in a research letter published online July 12, 2021, in JAMA Internal Medicine.
To examine the demographics and salaries of academic internal medicine physician specialists, Dr. Wang, who is with the division of cardiovascular medicine at the University of Pennsylvania, Philadelphia, and coauthors analyzed survey results from faculty at 154 U.S. medical schools.
They used data from the Association of American Medical Colleges Faculty Salary Report of 2018-2019 to assess the median annual salary, faculty rank, and gender for 21,905 faculty in 13 internal medicine specialties.
Overall, women made up less than 40% of full-time faculty across ranks. Female representation was approximately equal at the instructor and assistant ranks – 47% and 46%, respectively – but decreased to 24% at the professor level.
The authors found that women made up the majority in three specialties – general internal medicine, endocrinology, and geriatrics. In contrast, women were least represented in the procedural specialties of pulmonology, critical/intensive care, gastroenterology, and cardiology.
The greatest imbalance was in cardiology, in which only 21% were women, the researchers noted.
Across faculty ranks, the median annual salary was less for women than for men. The median salary for women was within $25,000 of that for men at all ranks except chief and was at least 90% of that for men in 10 of 13 internal medicine specialties.
Cardiology, gastroenterology, and critical/intensive care were the three specialties in which women’s median salary did not reach 90% of men’s. These specialties tended to be better paid overall, “but also demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology,” the researchers said.
The reasons for gender disparities are unclear, though internal medicine procedural specialties “have long been male dominated in composition and leadership,” the authors noted. The findings indicate that workforce gender parity may be associated with salary equity.
“Despite the growing awareness of workforce disparities in medicine, our findings suggest that women internal medicine specialists remain underpaid and are not promoted to senior level academic ranks when compared with career trajectories of their male counterparts,” study author Nosheen Reza, MD, of the division of cardiovascular medicine at the University of Pennsylvania, told this news organization.
The researchers noted that they were unable to adjust at the individual level for various factors that may influence salary, such as professional service, academic productivity, clinical volume, and supplementary funding sources, and that the results might not apply to all U.S. medical schools, in which departmental structures vary.
Procedures versus evaluation and management
Still, the research “provides an interesting snapshot of current salary disparities in academic internal medicine,” comment Rita F. Redberg, MD, and colleagues in a related editorial. Dr. Redberg, the editor of JAMA Internal Medicine, is affiliated with the department of medicine at the University of California, San Francisco.
Internal medicine has 13 specialties and dozens of subspecialties, and “procedural subspecialties are more male dominated and better paid than nonprocedural subspecialties – both topics deserving of further exploration,” the editorialists wrote.
The field needs to address various issues that drive some women to “shun male-dominated procedural-based fields – including lack of role models, macho ‘cowboy’ culture, unpredictable schedules, longer training periods, or cultural factors,” Dr. Redberg and coauthors suggested. “Concurrently, the medical profession overall, as well as specialties, should thoughtfully and frequently reassess how to distribute pay more equitably and to remove the premium currently paid for procedures over evaluation and management services.”
“Unfortunately, it is not a surprise that there continues to be a gender gap for salary in academic medicine,” Dr. Redberg said in an interview. “It was interesting to see that gender pay disparities were greatest in the procedure-intensive specialties, and we do know that procedures are much more highly reimbursed than evaluation and management time, even in the IM specialties. From a patient perspective, I think what they value most highly is having their doctor talk with them and explain treatment options and risks and benefits. Sadly, our fee-for-service–based reimbursement system values procedures more highly than talking with patients. And part of the gender gap in salary is attributed to less women being proceduralists.”
The Medicare Payment Advisory Commission “has made some excellent recommendations to Congress on helping to correct this imbalance,” Dr. Redberg added.
In a separate viewpoint article, Leah M. Marcotte, MD, of the department of medicine at the University of Washington, Seattle, and colleagues describe reasons why women physicians may have “slower promotional time lines,” compared with men, such as receiving fewer and smaller grants, being underrepresented as speakers at national conferences, and receiving fewer invitations to author editorials.
“To narrow this gap, institutions should proactively nominate women, with a greater focus on those underrepresented in medicine, for internal and external awards and speaking opportunities,” Dr. Marcotte and coauthors wrote. “Institutions should adopt policies to cover child care, breastfeeding/pumping accommodations, and dependent travel. Academic departments should continue to offer virtual speaking opportunities even after COVID-19 pandemic travel restrictions become unnecessary.”
Institutions can also assist women faculty in preparing promotion dossiers.
“Gender disparities in promotion in academic medicine have been described for decades, and yet progress to close the gap has been untenably slow,” they said. “Rather than expecting faculty to adapt to existing systems, we need to change the promotion process to work better for all.”
The authors disclosed no relevant financial relationships. Dr. Redberg has received grants from Arnold Ventures, the Greenwall Foundation, and the National Heart, Lung, and Blood Institute outside the submitted work. One viewpoint coauthor has received honoraria from the American Board of Internal Medicine, and another has received personal fees from F-Prime Capital, both outside the submitted work.
A version of this article first appeared on Medscape.com.
Salary disparities persist in academic internal medicine specialties and are most obvious in procedural specialties, such as cardiology, in which there are fewer women, research suggests.
“Substantial salary inequities persist at the highest faculty levels and specifically in procedural-based specialties,” Teresa Wang, MD, and colleagues reported in a research letter published online July 12, 2021, in JAMA Internal Medicine.
To examine the demographics and salaries of academic internal medicine physician specialists, Dr. Wang, who is with the division of cardiovascular medicine at the University of Pennsylvania, Philadelphia, and coauthors analyzed survey results from faculty at 154 U.S. medical schools.
They used data from the Association of American Medical Colleges Faculty Salary Report of 2018-2019 to assess the median annual salary, faculty rank, and gender for 21,905 faculty in 13 internal medicine specialties.
Overall, women made up less than 40% of full-time faculty across ranks. Female representation was approximately equal at the instructor and assistant ranks – 47% and 46%, respectively – but decreased to 24% at the professor level.
The authors found that women made up the majority in three specialties – general internal medicine, endocrinology, and geriatrics. In contrast, women were least represented in the procedural specialties of pulmonology, critical/intensive care, gastroenterology, and cardiology.
The greatest imbalance was in cardiology, in which only 21% were women, the researchers noted.
Across faculty ranks, the median annual salary was less for women than for men. The median salary for women was within $25,000 of that for men at all ranks except chief and was at least 90% of that for men in 10 of 13 internal medicine specialties.
Cardiology, gastroenterology, and critical/intensive care were the three specialties in which women’s median salary did not reach 90% of men’s. These specialties tended to be better paid overall, “but also demonstrated the largest gender disparities in both representation and salary, particularly within the higher ranks of cardiology and gastroenterology,” the researchers said.
The reasons for gender disparities are unclear, though internal medicine procedural specialties “have long been male dominated in composition and leadership,” the authors noted. The findings indicate that workforce gender parity may be associated with salary equity.
“Despite the growing awareness of workforce disparities in medicine, our findings suggest that women internal medicine specialists remain underpaid and are not promoted to senior level academic ranks when compared with career trajectories of their male counterparts,” study author Nosheen Reza, MD, of the division of cardiovascular medicine at the University of Pennsylvania, told this news organization.
The researchers noted that they were unable to adjust at the individual level for various factors that may influence salary, such as professional service, academic productivity, clinical volume, and supplementary funding sources, and that the results might not apply to all U.S. medical schools, in which departmental structures vary.
Procedures versus evaluation and management
Still, the research “provides an interesting snapshot of current salary disparities in academic internal medicine,” comment Rita F. Redberg, MD, and colleagues in a related editorial. Dr. Redberg, the editor of JAMA Internal Medicine, is affiliated with the department of medicine at the University of California, San Francisco.
Internal medicine has 13 specialties and dozens of subspecialties, and “procedural subspecialties are more male dominated and better paid than nonprocedural subspecialties – both topics deserving of further exploration,” the editorialists wrote.
The field needs to address various issues that drive some women to “shun male-dominated procedural-based fields – including lack of role models, macho ‘cowboy’ culture, unpredictable schedules, longer training periods, or cultural factors,” Dr. Redberg and coauthors suggested. “Concurrently, the medical profession overall, as well as specialties, should thoughtfully and frequently reassess how to distribute pay more equitably and to remove the premium currently paid for procedures over evaluation and management services.”
“Unfortunately, it is not a surprise that there continues to be a gender gap for salary in academic medicine,” Dr. Redberg said in an interview. “It was interesting to see that gender pay disparities were greatest in the procedure-intensive specialties, and we do know that procedures are much more highly reimbursed than evaluation and management time, even in the IM specialties. From a patient perspective, I think what they value most highly is having their doctor talk with them and explain treatment options and risks and benefits. Sadly, our fee-for-service–based reimbursement system values procedures more highly than talking with patients. And part of the gender gap in salary is attributed to less women being proceduralists.”
The Medicare Payment Advisory Commission “has made some excellent recommendations to Congress on helping to correct this imbalance,” Dr. Redberg added.
In a separate viewpoint article, Leah M. Marcotte, MD, of the department of medicine at the University of Washington, Seattle, and colleagues describe reasons why women physicians may have “slower promotional time lines,” compared with men, such as receiving fewer and smaller grants, being underrepresented as speakers at national conferences, and receiving fewer invitations to author editorials.
“To narrow this gap, institutions should proactively nominate women, with a greater focus on those underrepresented in medicine, for internal and external awards and speaking opportunities,” Dr. Marcotte and coauthors wrote. “Institutions should adopt policies to cover child care, breastfeeding/pumping accommodations, and dependent travel. Academic departments should continue to offer virtual speaking opportunities even after COVID-19 pandemic travel restrictions become unnecessary.”
Institutions can also assist women faculty in preparing promotion dossiers.
“Gender disparities in promotion in academic medicine have been described for decades, and yet progress to close the gap has been untenably slow,” they said. “Rather than expecting faculty to adapt to existing systems, we need to change the promotion process to work better for all.”
The authors disclosed no relevant financial relationships. Dr. Redberg has received grants from Arnold Ventures, the Greenwall Foundation, and the National Heart, Lung, and Blood Institute outside the submitted work. One viewpoint coauthor has received honoraria from the American Board of Internal Medicine, and another has received personal fees from F-Prime Capital, both outside the submitted work.
A version of this article first appeared on Medscape.com.
Most U.S. adults age 50+ report good health: Survey
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.
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.
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.
St. Jude to pay $27 million to end DOJ suit over faulty ICDs
St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.
Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.
“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
Premature battery depletion
The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.
The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.
And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.
However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.
Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.
In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.
After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.
In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.
“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.
“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.
The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.
The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.
A version of this article first appeared on Medscape.com.
St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.
Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.
“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
Premature battery depletion
The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.
The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.
And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.
However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.
Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.
In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.
After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.
In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.
“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.
“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.
The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.
The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.
A version of this article first appeared on Medscape.com.
St. Jude Medical, now part of Abbott Laboratories, will pay the American government $27 million to settle allegations that it knowingly sold defective implantable cardiac defibrillators to health care facilities, which were implanted into patients, causing injuries and two deaths, the U.S. Department of Justice (DOJ) has announced.
“Medical device manufacturers have an obligation to be truthful with the Food and Drug Administration, and the U.S. government will not pay for devices that are unsafe and risk injury or death,” Jonathan F. Lenzner, Acting U.S. Attorney for the District of Maryland, said in a July 8 statement.
“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall,” Mr. Lenzner added.
Those claims were submitted to the Medicare, TRICARE, and Federal Employees Health Benefits programs, according to the settlement agreement.
“The U.S. Attorney’s Office is committed to protecting Medicare and other federal health care programs from fraud, and in doing so, strengthen[ing] patient safety,” Mr. Lenzner said.
Premature battery depletion
The government alleges that St. Jude failed to disclose “serious adverse health events” related to premature battery depletion of certain models of its Fortify, Fortify Assura, Quadra, and Unify implantable defibrillators.
The government further alleges that, by 2013, St. Jude knew that lithium clusters could form on the batteries, causing them to short and run out of power. But it took until late 2014 for St. Jude to ask the FDA to approve a change to prevent lithium clusters from draining the battery.
And at this point, St. Jude told the FDA that “no serious injury, permanent harm, or deaths have been reported associated with this” issue, the government alleges.
However, according to the government’s allegations, St. Jude was aware at that time of two reported serious injuries and one death associated with the faulty batteries and continued to distribute devices that had been manufactured without the new design.
Not until August 2016 did St. Jude inform the FDA that the number of premature battery depletion events had increased to 729, including two deaths and 29 events associated with loss of pacing, the government alleges.
In October 2016, St. Jude issued a medical advisory regarding the battery problem, which the FDA classified as a Class I recall, the most serious type.
After the recall, St. Jude no longer sold the older devices, but thousands of them had been implanted into patients between November 2014 and October 2016.
In September 2017, as reported by this news organization, a nationwide class-action lawsuit was filed against St. Jude Medical and parent company Abbott Laboratories alleging that, despite knowing about a battery-depletion defect in some of its cardiac defibrillators as early as 2011, St. Jude failed to adequately report the risk and waited nearly 5 years before issuing a recall.
“To ensure the health and safety of patients, manufacturers of implantable cardiac devices must be transparent when communicating with the government about safety issues and incidents,” Acting Assistant Attorney General Brian Boynton, from the DOJ’s Civil Division, said in the DOJ statement announcing the settlement.
“We will hold accountable those companies whose conduct violates the law and puts patients’ health at risk,” Mr. Boynton said.
The civil settlement includes the resolution of claims brought under the qui tam, or whistleblower, provisions of the False Claims Act by Debbie Burke, a patient who received one of the devices that was subject to recall.
The claims resolved by the settlement are allegations only; there has been no determination of liability, the DOJ noted. St. Jude denies the allegations raised in the lawsuit.
A version of this article first appeared on Medscape.com.
South Asian ancestry associated with twice the risk of heart disease
according to the results of a new study.
These findings confirm previous reports and practice guidelines that identify South Asian ancestry as a risk enhancer for atherosclerotic cardiovascular disease (ASCVD), suggesting that earlier heart disease screening and prevention is warranted in this patient population, lead author Aniruddh P. Patel, MD, research fellow at the Center for Genomic Medicine, Massachusetts General Hospital, Boston, and colleagues said.
“Previous studies in multiple countries have estimated a 1.7- to 4-fold higher risk of ASCVD among South Asian individuals, compared with other ancestries, but have important potential limitations,” Dr. Patel and colleagues wrote in the paper on their prospective cohort study, published in Circulation.
The INTERHEART case-control study, for example, which assessed risk factors for acute myocardial infarction among more than 15,000 cases from 52 countries, is now 2 decades old, and “may not reflect recent advances in cardiovascular disease prevention,” the investigators wrote.
Most studies in the area have been small and retrospective, they added, and have not adequately assessed emerging risk factors, such as prediabetes, which appear to play a relatively greater role in the development of heart disease among South Asians.
Methods and results
To address this knowledge gap, Dr. Patel and colleagues analyzed data from the UK Biobank prospective cohort study, including 449,349 middle-aged participants of European ancestry and 8,124 similarly aged participants of South Asian descent who did not have heart disease upon enrollment. Respective rates of incident ASCVD (i.e., MI, ischemic stroke, or coronary revascularization) were analyzed in the context of a variety of lifestyle, anthropometric, and clinical factors.
After a median follow-up of 11.1 years, individuals of South Asian descent had an incident ASCVD rate of 6.8%, compared with 4.4% for individuals of European descent, representing twice the relative risk (adjusted hazard ratio, 2.03; 95% CI, 1.86-2.22; P < .001). Even after accounting for all covariates, risk of ASCVD remained 45% higher for South Asian individuals (aHR, 1.45; 95% CI, 1.28-1.65; P < .001). This elevation in risk was not captured by existing risk calculators, including the American College of Cardiology/American Heart Association Pooled Cohort Equations, or the QRISK3 equations.
The findings were “largely consistent across a range of age, sex, and clinical subgroups,” and “confirm and extend previous reports that hypertension, diabetes, and central adiposity are the leading associations in this observed disparity,” the investigators wrote.
Two diabetes subtypes are more prevalent in South Asians
Hypertension, diabetes, and central adiposity do not fully explain South Asians’ higher risk for ASCVD, wrote Namratha R. Kandula, MD, of Northwestern University Medical Center, Chicago, and Alka M. Kanaya, MD, of the University of California, San Francisco, in an accompanying editorial published in Circulation.
Some of the undetected risk may stem from unique diabetes disease factors, Dr. Kandula and Dr. Kanaya added.
“Newer data have demonstrated distinct subtypes of type 2 diabetes, with South Asians having a higher prevalence of both a severe insulin resistant with obesity subtype and a less recognized severe insulin deficient subtype,” they wrote. “Importantly, both of these more prevalent diabetes subtypes in South Asians were associated with a higher incidence of coronary artery calcium, a marker of subclinical atherosclerosis and strong predictor of future ASCVD, compared to other diabetes subtypes.”
Diabetes rate is higher for South Asians in the U.S.
Although the present study was conducted in the United Kingdom, the findings likely apply to individuals of South Asian ancestry living in the United States, according to principal author Amit V. Khera, MD, associate director of the precision medicine unit at the Center for Genomic Medicine, Massachusetts General Hospital.
“There are already more than 5 million individuals of South Asian ancestry in the U.S. and this represents one of the fastest-growing ethnic subgroups,” Dr. Khera said in an interview. “As in our study of individuals in the U.K., South Asians in the U.S. suffer from diabetes at much higher rates – 23% versus 12% – and this often occurs even in the absence of obesity.”
Dr. Khera noted that the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease identify South Asian ancestry as a risk-enhancing factor, calling this a “stopgap measure.” More work is needed, he said, in the research arena and in the clinic.
Zero South Asians included in studies used to develop risk estimator
“I think the first step is to simply acknowledge that the risk estimators we use in clinical practice have important limitations when it comes to diverse patient populations,” Dr. Khera said in an interview. “We saw this in our study, where – despite a more than doubling of risk – the predicted risk based on the equations used in primary care showed no difference. This risk estimator was developed based on legacy cohort studies, in [which] zero South Asians were included. Despite important differences across race/ethnicity, the current state-of-the-art in the U.S. is to use one equation for Black individuals and another for all other ethnicities.”
Experts suggest steps for reducing heart disease risk
While risk modeling remains suboptimal, Dr. Khera suggested that clinicians can take immediate steps to reduce the risk of heart disease among individuals with South Asian ancestry.
“Despite all of the uncertainty – we still don’t have a complete understanding of why the risk is so high – there are still several things primary care doctors can do for their patients,” Dr. Khera said.
Foremost, he recommended lifestyle and dietary counseling.
“Dietary counseling is particularly effective if put in the context of cultural norms,” Dr. Khera said. “Many South Asians consider fruit juices or white rice to be healthy, when they lead to rapid spikes in blood sugar.”
Dr. Khera also advised earlier heart disease screening, such as coronary calcium scanning “sometime between age 40-50 years,” noting that positive test results may motivate patients to start or adhere to medications, such as cholesterol-lowering therapies. If necessary, clinicians can also refer to heart centers for South Asian patients, which are becoming increasingly common.
According to Cheryl A.M. Anderson, PhD, chair of the AHA’s Council on Epidemiology and Prevention, and professor and dean of the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, the current study suggests that heart disease management strategies for South Asian patients may be lacking.
“We have had a tradition of preventing or trying to treat heart disease in a fashion that doesn’t yet account for the increased risk that might be prevalent in those of South Asian ancestry,” Dr. Anderson said in an interview.
She suggested that improving associated risk-analysis tools could be beneficial, although the tools themselves, in the context of race or ethnicity, may present their own risks.
“We want to be mindful of potential adverse implications from having everything linked to one’s ancestry, which I think this tool doesn’t do,” Dr. Anderson said, referring to the AHA/ACC Pooled Cohort Equations. “But in sort of the bigger picture of things, we always want to expand and refine our toolkit.”
According to Rajesh Dash, MD, PhD, associate professor, cardiologist, and director of the South Asian Translational Heart Initiative (SSATHI) Prevention Clinic and CardioClick Telemedicine Clinic at Stanford (Calif.) HealthCare, the science supports more active risk mitigation strategies for South Asian patients, and the AHA and the ACC “are the two entities that need to lead the way.”
“Certainly the American Heart Association and the American College of Cardiology should be taking a more active leadership role in this,” Dr. Dash said in an interview.
In 2018, the AHA issued a scientific statement about the elevated risk of ASCVD among South Asian individuals, “but it did not rise to the level of specific recommendations, and did not necessarily go as far as to incorporate new screening parameters for that population,” Dr. Dash said. He also noted that the most recent AHA/ACC guideline identifies South Asian ancestry as a risk-enhancing feature, a statement similarly lacking in actionable value.
“That does not definitively lead someone like a primary care physician to a decision to start a statin, or to be more aggressive with a diagnostic workup, like a stress test, for instance, for a patient who they otherwise would not have done one in had they not been South Asian,” Dr. Dash said.
The steps taken by the AHA and the ACC are “a healthy step forward,” he noted, “but not nearly the degree of attention or vigilance that is required, as well as the level of action that is required to change the narrative for the population.”
At the SSATHI Prevention Clinic, Dr. Dash and colleagues aren’t waiting for the narrative to change, and are already taking a more aggressive approach.
The clinic has an average patient age of 41 years, “easily 15 years younger than the average age in most cardiology clinics,” Dr. Dash said, based on the fact that approximately two-thirds of heart attacks in South Asian individuals occur under the age of 55. “We have to look earlier.”
The SSATHI Prevention Clinic screens for both traditional and emerging risk factors, and Dr. Dash suggested that primary care doctors should do the same.
“If you have a South Asian patient as a primary care physician, you should be aggressively looking for risk factors, traditional ones to start, like elevated cholesterol, hypertension, diabetes, or – and I would argue strongly – prediabetes or insulin resistance.”
Dr. Dash also recommended looking into family history, and considering screening for inflammatory biomarkers, the latter of which are commonly elevated at an earlier age among South Asian individuals, and may have a relatively greater prognostic impact.
To encourage broader implementation of this kind of approach, Dr. Dash called for more large-scale studies. Ideally, these would be randomized clinical trials, but, realistically, real-world datasets may be the answer.
The study was supported by the National Heart, Lung, and Blood Institute; the Broad Institute at MIT and Harvard; the National Human Genome Research Institute; and others. The investigators disclosed relationships with IBM Research, Sanofi, Amgen, and others. Dr. Dash disclosed relationships with HealthPals and AstraZeneca. Dr. Anderson reported no relevant conflicts of interest.
according to the results of a new study.
These findings confirm previous reports and practice guidelines that identify South Asian ancestry as a risk enhancer for atherosclerotic cardiovascular disease (ASCVD), suggesting that earlier heart disease screening and prevention is warranted in this patient population, lead author Aniruddh P. Patel, MD, research fellow at the Center for Genomic Medicine, Massachusetts General Hospital, Boston, and colleagues said.
“Previous studies in multiple countries have estimated a 1.7- to 4-fold higher risk of ASCVD among South Asian individuals, compared with other ancestries, but have important potential limitations,” Dr. Patel and colleagues wrote in the paper on their prospective cohort study, published in Circulation.
The INTERHEART case-control study, for example, which assessed risk factors for acute myocardial infarction among more than 15,000 cases from 52 countries, is now 2 decades old, and “may not reflect recent advances in cardiovascular disease prevention,” the investigators wrote.
Most studies in the area have been small and retrospective, they added, and have not adequately assessed emerging risk factors, such as prediabetes, which appear to play a relatively greater role in the development of heart disease among South Asians.
Methods and results
To address this knowledge gap, Dr. Patel and colleagues analyzed data from the UK Biobank prospective cohort study, including 449,349 middle-aged participants of European ancestry and 8,124 similarly aged participants of South Asian descent who did not have heart disease upon enrollment. Respective rates of incident ASCVD (i.e., MI, ischemic stroke, or coronary revascularization) were analyzed in the context of a variety of lifestyle, anthropometric, and clinical factors.
After a median follow-up of 11.1 years, individuals of South Asian descent had an incident ASCVD rate of 6.8%, compared with 4.4% for individuals of European descent, representing twice the relative risk (adjusted hazard ratio, 2.03; 95% CI, 1.86-2.22; P < .001). Even after accounting for all covariates, risk of ASCVD remained 45% higher for South Asian individuals (aHR, 1.45; 95% CI, 1.28-1.65; P < .001). This elevation in risk was not captured by existing risk calculators, including the American College of Cardiology/American Heart Association Pooled Cohort Equations, or the QRISK3 equations.
The findings were “largely consistent across a range of age, sex, and clinical subgroups,” and “confirm and extend previous reports that hypertension, diabetes, and central adiposity are the leading associations in this observed disparity,” the investigators wrote.
Two diabetes subtypes are more prevalent in South Asians
Hypertension, diabetes, and central adiposity do not fully explain South Asians’ higher risk for ASCVD, wrote Namratha R. Kandula, MD, of Northwestern University Medical Center, Chicago, and Alka M. Kanaya, MD, of the University of California, San Francisco, in an accompanying editorial published in Circulation.
Some of the undetected risk may stem from unique diabetes disease factors, Dr. Kandula and Dr. Kanaya added.
“Newer data have demonstrated distinct subtypes of type 2 diabetes, with South Asians having a higher prevalence of both a severe insulin resistant with obesity subtype and a less recognized severe insulin deficient subtype,” they wrote. “Importantly, both of these more prevalent diabetes subtypes in South Asians were associated with a higher incidence of coronary artery calcium, a marker of subclinical atherosclerosis and strong predictor of future ASCVD, compared to other diabetes subtypes.”
Diabetes rate is higher for South Asians in the U.S.
Although the present study was conducted in the United Kingdom, the findings likely apply to individuals of South Asian ancestry living in the United States, according to principal author Amit V. Khera, MD, associate director of the precision medicine unit at the Center for Genomic Medicine, Massachusetts General Hospital.
“There are already more than 5 million individuals of South Asian ancestry in the U.S. and this represents one of the fastest-growing ethnic subgroups,” Dr. Khera said in an interview. “As in our study of individuals in the U.K., South Asians in the U.S. suffer from diabetes at much higher rates – 23% versus 12% – and this often occurs even in the absence of obesity.”
Dr. Khera noted that the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease identify South Asian ancestry as a risk-enhancing factor, calling this a “stopgap measure.” More work is needed, he said, in the research arena and in the clinic.
Zero South Asians included in studies used to develop risk estimator
“I think the first step is to simply acknowledge that the risk estimators we use in clinical practice have important limitations when it comes to diverse patient populations,” Dr. Khera said in an interview. “We saw this in our study, where – despite a more than doubling of risk – the predicted risk based on the equations used in primary care showed no difference. This risk estimator was developed based on legacy cohort studies, in [which] zero South Asians were included. Despite important differences across race/ethnicity, the current state-of-the-art in the U.S. is to use one equation for Black individuals and another for all other ethnicities.”
Experts suggest steps for reducing heart disease risk
While risk modeling remains suboptimal, Dr. Khera suggested that clinicians can take immediate steps to reduce the risk of heart disease among individuals with South Asian ancestry.
“Despite all of the uncertainty – we still don’t have a complete understanding of why the risk is so high – there are still several things primary care doctors can do for their patients,” Dr. Khera said.
Foremost, he recommended lifestyle and dietary counseling.
“Dietary counseling is particularly effective if put in the context of cultural norms,” Dr. Khera said. “Many South Asians consider fruit juices or white rice to be healthy, when they lead to rapid spikes in blood sugar.”
Dr. Khera also advised earlier heart disease screening, such as coronary calcium scanning “sometime between age 40-50 years,” noting that positive test results may motivate patients to start or adhere to medications, such as cholesterol-lowering therapies. If necessary, clinicians can also refer to heart centers for South Asian patients, which are becoming increasingly common.
According to Cheryl A.M. Anderson, PhD, chair of the AHA’s Council on Epidemiology and Prevention, and professor and dean of the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, the current study suggests that heart disease management strategies for South Asian patients may be lacking.
“We have had a tradition of preventing or trying to treat heart disease in a fashion that doesn’t yet account for the increased risk that might be prevalent in those of South Asian ancestry,” Dr. Anderson said in an interview.
She suggested that improving associated risk-analysis tools could be beneficial, although the tools themselves, in the context of race or ethnicity, may present their own risks.
“We want to be mindful of potential adverse implications from having everything linked to one’s ancestry, which I think this tool doesn’t do,” Dr. Anderson said, referring to the AHA/ACC Pooled Cohort Equations. “But in sort of the bigger picture of things, we always want to expand and refine our toolkit.”
According to Rajesh Dash, MD, PhD, associate professor, cardiologist, and director of the South Asian Translational Heart Initiative (SSATHI) Prevention Clinic and CardioClick Telemedicine Clinic at Stanford (Calif.) HealthCare, the science supports more active risk mitigation strategies for South Asian patients, and the AHA and the ACC “are the two entities that need to lead the way.”
“Certainly the American Heart Association and the American College of Cardiology should be taking a more active leadership role in this,” Dr. Dash said in an interview.
In 2018, the AHA issued a scientific statement about the elevated risk of ASCVD among South Asian individuals, “but it did not rise to the level of specific recommendations, and did not necessarily go as far as to incorporate new screening parameters for that population,” Dr. Dash said. He also noted that the most recent AHA/ACC guideline identifies South Asian ancestry as a risk-enhancing feature, a statement similarly lacking in actionable value.
“That does not definitively lead someone like a primary care physician to a decision to start a statin, or to be more aggressive with a diagnostic workup, like a stress test, for instance, for a patient who they otherwise would not have done one in had they not been South Asian,” Dr. Dash said.
The steps taken by the AHA and the ACC are “a healthy step forward,” he noted, “but not nearly the degree of attention or vigilance that is required, as well as the level of action that is required to change the narrative for the population.”
At the SSATHI Prevention Clinic, Dr. Dash and colleagues aren’t waiting for the narrative to change, and are already taking a more aggressive approach.
The clinic has an average patient age of 41 years, “easily 15 years younger than the average age in most cardiology clinics,” Dr. Dash said, based on the fact that approximately two-thirds of heart attacks in South Asian individuals occur under the age of 55. “We have to look earlier.”
The SSATHI Prevention Clinic screens for both traditional and emerging risk factors, and Dr. Dash suggested that primary care doctors should do the same.
“If you have a South Asian patient as a primary care physician, you should be aggressively looking for risk factors, traditional ones to start, like elevated cholesterol, hypertension, diabetes, or – and I would argue strongly – prediabetes or insulin resistance.”
Dr. Dash also recommended looking into family history, and considering screening for inflammatory biomarkers, the latter of which are commonly elevated at an earlier age among South Asian individuals, and may have a relatively greater prognostic impact.
To encourage broader implementation of this kind of approach, Dr. Dash called for more large-scale studies. Ideally, these would be randomized clinical trials, but, realistically, real-world datasets may be the answer.
The study was supported by the National Heart, Lung, and Blood Institute; the Broad Institute at MIT and Harvard; the National Human Genome Research Institute; and others. The investigators disclosed relationships with IBM Research, Sanofi, Amgen, and others. Dr. Dash disclosed relationships with HealthPals and AstraZeneca. Dr. Anderson reported no relevant conflicts of interest.
according to the results of a new study.
These findings confirm previous reports and practice guidelines that identify South Asian ancestry as a risk enhancer for atherosclerotic cardiovascular disease (ASCVD), suggesting that earlier heart disease screening and prevention is warranted in this patient population, lead author Aniruddh P. Patel, MD, research fellow at the Center for Genomic Medicine, Massachusetts General Hospital, Boston, and colleagues said.
“Previous studies in multiple countries have estimated a 1.7- to 4-fold higher risk of ASCVD among South Asian individuals, compared with other ancestries, but have important potential limitations,” Dr. Patel and colleagues wrote in the paper on their prospective cohort study, published in Circulation.
The INTERHEART case-control study, for example, which assessed risk factors for acute myocardial infarction among more than 15,000 cases from 52 countries, is now 2 decades old, and “may not reflect recent advances in cardiovascular disease prevention,” the investigators wrote.
Most studies in the area have been small and retrospective, they added, and have not adequately assessed emerging risk factors, such as prediabetes, which appear to play a relatively greater role in the development of heart disease among South Asians.
Methods and results
To address this knowledge gap, Dr. Patel and colleagues analyzed data from the UK Biobank prospective cohort study, including 449,349 middle-aged participants of European ancestry and 8,124 similarly aged participants of South Asian descent who did not have heart disease upon enrollment. Respective rates of incident ASCVD (i.e., MI, ischemic stroke, or coronary revascularization) were analyzed in the context of a variety of lifestyle, anthropometric, and clinical factors.
After a median follow-up of 11.1 years, individuals of South Asian descent had an incident ASCVD rate of 6.8%, compared with 4.4% for individuals of European descent, representing twice the relative risk (adjusted hazard ratio, 2.03; 95% CI, 1.86-2.22; P < .001). Even after accounting for all covariates, risk of ASCVD remained 45% higher for South Asian individuals (aHR, 1.45; 95% CI, 1.28-1.65; P < .001). This elevation in risk was not captured by existing risk calculators, including the American College of Cardiology/American Heart Association Pooled Cohort Equations, or the QRISK3 equations.
The findings were “largely consistent across a range of age, sex, and clinical subgroups,” and “confirm and extend previous reports that hypertension, diabetes, and central adiposity are the leading associations in this observed disparity,” the investigators wrote.
Two diabetes subtypes are more prevalent in South Asians
Hypertension, diabetes, and central adiposity do not fully explain South Asians’ higher risk for ASCVD, wrote Namratha R. Kandula, MD, of Northwestern University Medical Center, Chicago, and Alka M. Kanaya, MD, of the University of California, San Francisco, in an accompanying editorial published in Circulation.
Some of the undetected risk may stem from unique diabetes disease factors, Dr. Kandula and Dr. Kanaya added.
“Newer data have demonstrated distinct subtypes of type 2 diabetes, with South Asians having a higher prevalence of both a severe insulin resistant with obesity subtype and a less recognized severe insulin deficient subtype,” they wrote. “Importantly, both of these more prevalent diabetes subtypes in South Asians were associated with a higher incidence of coronary artery calcium, a marker of subclinical atherosclerosis and strong predictor of future ASCVD, compared to other diabetes subtypes.”
Diabetes rate is higher for South Asians in the U.S.
Although the present study was conducted in the United Kingdom, the findings likely apply to individuals of South Asian ancestry living in the United States, according to principal author Amit V. Khera, MD, associate director of the precision medicine unit at the Center for Genomic Medicine, Massachusetts General Hospital.
“There are already more than 5 million individuals of South Asian ancestry in the U.S. and this represents one of the fastest-growing ethnic subgroups,” Dr. Khera said in an interview. “As in our study of individuals in the U.K., South Asians in the U.S. suffer from diabetes at much higher rates – 23% versus 12% – and this often occurs even in the absence of obesity.”
Dr. Khera noted that the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease identify South Asian ancestry as a risk-enhancing factor, calling this a “stopgap measure.” More work is needed, he said, in the research arena and in the clinic.
Zero South Asians included in studies used to develop risk estimator
“I think the first step is to simply acknowledge that the risk estimators we use in clinical practice have important limitations when it comes to diverse patient populations,” Dr. Khera said in an interview. “We saw this in our study, where – despite a more than doubling of risk – the predicted risk based on the equations used in primary care showed no difference. This risk estimator was developed based on legacy cohort studies, in [which] zero South Asians were included. Despite important differences across race/ethnicity, the current state-of-the-art in the U.S. is to use one equation for Black individuals and another for all other ethnicities.”
Experts suggest steps for reducing heart disease risk
While risk modeling remains suboptimal, Dr. Khera suggested that clinicians can take immediate steps to reduce the risk of heart disease among individuals with South Asian ancestry.
“Despite all of the uncertainty – we still don’t have a complete understanding of why the risk is so high – there are still several things primary care doctors can do for their patients,” Dr. Khera said.
Foremost, he recommended lifestyle and dietary counseling.
“Dietary counseling is particularly effective if put in the context of cultural norms,” Dr. Khera said. “Many South Asians consider fruit juices or white rice to be healthy, when they lead to rapid spikes in blood sugar.”
Dr. Khera also advised earlier heart disease screening, such as coronary calcium scanning “sometime between age 40-50 years,” noting that positive test results may motivate patients to start or adhere to medications, such as cholesterol-lowering therapies. If necessary, clinicians can also refer to heart centers for South Asian patients, which are becoming increasingly common.
According to Cheryl A.M. Anderson, PhD, chair of the AHA’s Council on Epidemiology and Prevention, and professor and dean of the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego, the current study suggests that heart disease management strategies for South Asian patients may be lacking.
“We have had a tradition of preventing or trying to treat heart disease in a fashion that doesn’t yet account for the increased risk that might be prevalent in those of South Asian ancestry,” Dr. Anderson said in an interview.
She suggested that improving associated risk-analysis tools could be beneficial, although the tools themselves, in the context of race or ethnicity, may present their own risks.
“We want to be mindful of potential adverse implications from having everything linked to one’s ancestry, which I think this tool doesn’t do,” Dr. Anderson said, referring to the AHA/ACC Pooled Cohort Equations. “But in sort of the bigger picture of things, we always want to expand and refine our toolkit.”
According to Rajesh Dash, MD, PhD, associate professor, cardiologist, and director of the South Asian Translational Heart Initiative (SSATHI) Prevention Clinic and CardioClick Telemedicine Clinic at Stanford (Calif.) HealthCare, the science supports more active risk mitigation strategies for South Asian patients, and the AHA and the ACC “are the two entities that need to lead the way.”
“Certainly the American Heart Association and the American College of Cardiology should be taking a more active leadership role in this,” Dr. Dash said in an interview.
In 2018, the AHA issued a scientific statement about the elevated risk of ASCVD among South Asian individuals, “but it did not rise to the level of specific recommendations, and did not necessarily go as far as to incorporate new screening parameters for that population,” Dr. Dash said. He also noted that the most recent AHA/ACC guideline identifies South Asian ancestry as a risk-enhancing feature, a statement similarly lacking in actionable value.
“That does not definitively lead someone like a primary care physician to a decision to start a statin, or to be more aggressive with a diagnostic workup, like a stress test, for instance, for a patient who they otherwise would not have done one in had they not been South Asian,” Dr. Dash said.
The steps taken by the AHA and the ACC are “a healthy step forward,” he noted, “but not nearly the degree of attention or vigilance that is required, as well as the level of action that is required to change the narrative for the population.”
At the SSATHI Prevention Clinic, Dr. Dash and colleagues aren’t waiting for the narrative to change, and are already taking a more aggressive approach.
The clinic has an average patient age of 41 years, “easily 15 years younger than the average age in most cardiology clinics,” Dr. Dash said, based on the fact that approximately two-thirds of heart attacks in South Asian individuals occur under the age of 55. “We have to look earlier.”
The SSATHI Prevention Clinic screens for both traditional and emerging risk factors, and Dr. Dash suggested that primary care doctors should do the same.
“If you have a South Asian patient as a primary care physician, you should be aggressively looking for risk factors, traditional ones to start, like elevated cholesterol, hypertension, diabetes, or – and I would argue strongly – prediabetes or insulin resistance.”
Dr. Dash also recommended looking into family history, and considering screening for inflammatory biomarkers, the latter of which are commonly elevated at an earlier age among South Asian individuals, and may have a relatively greater prognostic impact.
To encourage broader implementation of this kind of approach, Dr. Dash called for more large-scale studies. Ideally, these would be randomized clinical trials, but, realistically, real-world datasets may be the answer.
The study was supported by the National Heart, Lung, and Blood Institute; the Broad Institute at MIT and Harvard; the National Human Genome Research Institute; and others. The investigators disclosed relationships with IBM Research, Sanofi, Amgen, and others. Dr. Dash disclosed relationships with HealthPals and AstraZeneca. Dr. Anderson reported no relevant conflicts of interest.
FROM CIRCULATION
Are oncologists liable for pandemic-related treatment delays?
Albuquerque oncologist Barbara McAneny, MD, has a patient in his 30s who experienced rectal bleeding for 6 months in 2020 but didn’t see a physician because he was afraid of catching COVID-19. He hoped it was just hemorrhoids.
When he finally came in to see her recently, Dr. McAneny diagnosed a large colon cancer. She fears the delay could prove fatal. “We’ll do our best to cure him, but I don’t know if he’ll be treatable,” she said. “Six months absolutely can make a difference.”
She and other oncologists around the country are seeing many patients in the past few months with advanced breast, colon, lung, and other cancers who were not diagnosed and treated during the COVID-19 pandemic because the patients didn’t want to come in, or because medical facilities weren’t taking nonemergency or non-COVID patients.
Given that failure to diagnose cancer is among the most common medical malpractice allegations, should oncologists be worried that they are at legal risk?
Pandemic provides ‘safe harbor’
In a March survey done by medical malpractice insurer The Doctors Company, one-third of physicians said they were very concerned or somewhat concerned that malpractice claims related to care during the pandemic will rise.
But in most of these cases, physicians and hospitals have little to worry about in terms of medical malpractice liability, according to veteran plaintiff and defense attorneys and the head of a large medical liability insurer.
“You had people with diseases like cancer not getting care because health care systems were overwhelmed,” said Sean Domnick, JD, a malpractice plaintiff attorney in Boca Raton, Fla. “Will those lead to successful malpractice lawsuits? Most likely not.”
“The risks will be low because it’s hard to pin it on the doctor if the patient didn’t want to come in or facilities weren’t scheduling appointments because of the public health emergency,” said Richard Roberts, MD, JD, a professor of family medicine at the University of Wisconsin–Madison who is also a malpractice defense attorney.
In addition, liability protections enacted in more than 30 states because of the COVID-19 pandemic will help shield clinicians from lawsuits. Those laws generally require allegations of gross negligence or reckless conduct far beyond ordinary negligence, which are hard to prove. But the immunity provisions remain largely untested in the courts, and it’s unclear how they will affect cases involving care for conditions other than COVID-19.
Another helpful factor is the widespread public appreciation of the valiant work by health care professionals throughout the pandemic, though that halo effect could fade over the next several years as malpractice claims from the pandemic period are filed and tried.
“In many circumstances, the pandemic will prove to be a safe harbor for providers,” said Steven Wigrizer, JD, a malpractice plaintiff attorney in Philadelphia. “Jurors will be reluctant to impose liability on providers who were doing their best in a global pandemic the world hadn’t seen in 100 years.”
Risky situations
These predictions from liability experts should reassure physicians who are anxious over reports that many cancer diagnoses were missed as a result of the COVID-19 pandemic.
Still, there are situations where physicians and hospitals could be vulnerable to malpractice claims despite the pandemic conditions. The highest-risk cases are those where patients recognized a potential cancer symptom like a breast lump or rectal bleeding, and tried to visit a doctor’s office or hospital, but were told they couldn’t be seen.
“Those kinds of cases lend themselves to delayed diagnosis claims,” said Richard Anderson, MD, an oncologist who is chairman and CEO of The Doctors Company. “My guess is we will see claims,” though he expects a reduced number arising from 2020 care scenarios, compared with previous years.
So far, his company has seen 20% fewer claims in 2020, which he said isn’t surprising given that the volume of physician and hospital visits plummeted.
Another risky situation is where physicians – particularly primary care physicians but also specialists like gynecologists and urologists – did not inform patients about concerning test results and order a follow-up test or visit. That is dangerous even if the physician did try to schedule a visit but the patient canceled the appointment.
“The jury will ask, ‘What did you do to get the patient back?’ ” said Sean Byrne, JD, a malpractice defense attorney in Richmond, Va. “The provider will say: ‘I’m sure we called.’ But it’s a difficult defense to say the patient didn’t return the call. I need written proof.”
Mr. Domnick said failures to follow up on suspicious test results could produce viable malpractice claims, pandemic or not. “The question becomes to what extent doctors will try to hide behind COVID to explain otherwise run-of-the-mill negligence,” he said. “We’ll have to see how that plays out.”
There are also worries about missed cancer diagnoses during telemedicine visits. “On telemedicine, I can’t feel a lymph node, I can’t palpate a breast mass, and I can’t see if someone’s liver is enlarged,” Dr. McAneny fretted. “I think you’ll get suits because you’ll miss stuff.”
One other area of exposure cited by the experts: Radiologists and pathologists could be sued for missing tumors in reading imaging tests. “The COVID-19 demand on resources has been immense,” Mr. Byrne said. “If that production pressure resulted in any quality loss in testing services, we could see claims.”
Patient protocols provide protection
There’s no question that cancer screenings dropped sharply during the pandemic. In June 2020, the National Cancer Institute estimated there was a 75% decrease in mammograms and colonoscopies during the first few months of the pandemic. It projected that delays in screenings, diagnoses, and treatment likely would result in 10,000 more breast and colorectal cancer deaths than otherwise expected over the next decade.
Delays of even 1 month in treatment for seven common forms of cancer can increase mortality risk by 6%-13%, according to a BMJ study.
While many medical facilities stopped doing preventive screening tests during the height of the pandemic last year, health care professionals still found ways to bring in patients with diagnosed cancers or who were at heightened cancer risk for tests and treatment.
Most facilities convened multidisciplinary tumor boards to decide which patients could wait for treatment, which patients could be maintained on drug therapy, and which ones needed immediate surgery, said Carla Fisher, MD, director of breast surgery at Indiana University, Indianapolis. For breast cancer, they used guidelines from her professional group, the American Society of Breast Surgeons.
Following such protocols for prioritizing patients for treatment during the pandemic should help protect against liability, experts said.
Even if it can be shown that a clinician’s negligence led to delayed diagnosis or treatment of a patient’s cancer, plaintiff attorneys will be wary about filing such claims. That is because it is difficult in most cases to prove that the delay significantly worsened the course of the patient’s disease or the odds of survival. Showing harm may be more possible with certain cancers known to be particularly aggressive.
“The plaintiff attorney will have to get an expert to say that the 3-month delay in getting the patient a mammogram caused her great harm,” said Dr. Roberts. “But it’s hard to calculate that scientifically, and it’s really hard to lay that all on the doctor or health system, because they were supposed to lock down during the pandemic.”
Playing catch-up
With patients now feeling more comfortable about coming in for physician visits, Mr. Byrne urges clinicians to make a special effort to mitigate potential liability arising from the past year. Physicians should carefully review patients’ charts and make sure to catch them up on preventive screenings. Some health systems, like Kaiser Permanente, have been doing proactive patient outreach for cancer screening throughout the pandemic.
“Providers may need to be extra diligent, and consider expanding the exam into a wellness visit and remind patients about cancer surveillance,” he said.
Overall, however, the expert consensus is that physicians should focus on providing the best quality care going forward, and not worry excessively about the care they wish they could have delivered over the past year during the extraordinary pandemic conditions.
“Liability risks will be decreased, because state laws have changed and doctors will be cut some slack, not just by judges and juries but by patients themselves,” Dr. Roberts said. “As you are running down the hall to take care of the next person, don’t be looking over your shoulder or you’ll run into the wall.”
A version of this article first appeared on Medscape.com.
Albuquerque oncologist Barbara McAneny, MD, has a patient in his 30s who experienced rectal bleeding for 6 months in 2020 but didn’t see a physician because he was afraid of catching COVID-19. He hoped it was just hemorrhoids.
When he finally came in to see her recently, Dr. McAneny diagnosed a large colon cancer. She fears the delay could prove fatal. “We’ll do our best to cure him, but I don’t know if he’ll be treatable,” she said. “Six months absolutely can make a difference.”
She and other oncologists around the country are seeing many patients in the past few months with advanced breast, colon, lung, and other cancers who were not diagnosed and treated during the COVID-19 pandemic because the patients didn’t want to come in, or because medical facilities weren’t taking nonemergency or non-COVID patients.
Given that failure to diagnose cancer is among the most common medical malpractice allegations, should oncologists be worried that they are at legal risk?
Pandemic provides ‘safe harbor’
In a March survey done by medical malpractice insurer The Doctors Company, one-third of physicians said they were very concerned or somewhat concerned that malpractice claims related to care during the pandemic will rise.
But in most of these cases, physicians and hospitals have little to worry about in terms of medical malpractice liability, according to veteran plaintiff and defense attorneys and the head of a large medical liability insurer.
“You had people with diseases like cancer not getting care because health care systems were overwhelmed,” said Sean Domnick, JD, a malpractice plaintiff attorney in Boca Raton, Fla. “Will those lead to successful malpractice lawsuits? Most likely not.”
“The risks will be low because it’s hard to pin it on the doctor if the patient didn’t want to come in or facilities weren’t scheduling appointments because of the public health emergency,” said Richard Roberts, MD, JD, a professor of family medicine at the University of Wisconsin–Madison who is also a malpractice defense attorney.
In addition, liability protections enacted in more than 30 states because of the COVID-19 pandemic will help shield clinicians from lawsuits. Those laws generally require allegations of gross negligence or reckless conduct far beyond ordinary negligence, which are hard to prove. But the immunity provisions remain largely untested in the courts, and it’s unclear how they will affect cases involving care for conditions other than COVID-19.
Another helpful factor is the widespread public appreciation of the valiant work by health care professionals throughout the pandemic, though that halo effect could fade over the next several years as malpractice claims from the pandemic period are filed and tried.
“In many circumstances, the pandemic will prove to be a safe harbor for providers,” said Steven Wigrizer, JD, a malpractice plaintiff attorney in Philadelphia. “Jurors will be reluctant to impose liability on providers who were doing their best in a global pandemic the world hadn’t seen in 100 years.”
Risky situations
These predictions from liability experts should reassure physicians who are anxious over reports that many cancer diagnoses were missed as a result of the COVID-19 pandemic.
Still, there are situations where physicians and hospitals could be vulnerable to malpractice claims despite the pandemic conditions. The highest-risk cases are those where patients recognized a potential cancer symptom like a breast lump or rectal bleeding, and tried to visit a doctor’s office or hospital, but were told they couldn’t be seen.
“Those kinds of cases lend themselves to delayed diagnosis claims,” said Richard Anderson, MD, an oncologist who is chairman and CEO of The Doctors Company. “My guess is we will see claims,” though he expects a reduced number arising from 2020 care scenarios, compared with previous years.
So far, his company has seen 20% fewer claims in 2020, which he said isn’t surprising given that the volume of physician and hospital visits plummeted.
Another risky situation is where physicians – particularly primary care physicians but also specialists like gynecologists and urologists – did not inform patients about concerning test results and order a follow-up test or visit. That is dangerous even if the physician did try to schedule a visit but the patient canceled the appointment.
“The jury will ask, ‘What did you do to get the patient back?’ ” said Sean Byrne, JD, a malpractice defense attorney in Richmond, Va. “The provider will say: ‘I’m sure we called.’ But it’s a difficult defense to say the patient didn’t return the call. I need written proof.”
Mr. Domnick said failures to follow up on suspicious test results could produce viable malpractice claims, pandemic or not. “The question becomes to what extent doctors will try to hide behind COVID to explain otherwise run-of-the-mill negligence,” he said. “We’ll have to see how that plays out.”
There are also worries about missed cancer diagnoses during telemedicine visits. “On telemedicine, I can’t feel a lymph node, I can’t palpate a breast mass, and I can’t see if someone’s liver is enlarged,” Dr. McAneny fretted. “I think you’ll get suits because you’ll miss stuff.”
One other area of exposure cited by the experts: Radiologists and pathologists could be sued for missing tumors in reading imaging tests. “The COVID-19 demand on resources has been immense,” Mr. Byrne said. “If that production pressure resulted in any quality loss in testing services, we could see claims.”
Patient protocols provide protection
There’s no question that cancer screenings dropped sharply during the pandemic. In June 2020, the National Cancer Institute estimated there was a 75% decrease in mammograms and colonoscopies during the first few months of the pandemic. It projected that delays in screenings, diagnoses, and treatment likely would result in 10,000 more breast and colorectal cancer deaths than otherwise expected over the next decade.
Delays of even 1 month in treatment for seven common forms of cancer can increase mortality risk by 6%-13%, according to a BMJ study.
While many medical facilities stopped doing preventive screening tests during the height of the pandemic last year, health care professionals still found ways to bring in patients with diagnosed cancers or who were at heightened cancer risk for tests and treatment.
Most facilities convened multidisciplinary tumor boards to decide which patients could wait for treatment, which patients could be maintained on drug therapy, and which ones needed immediate surgery, said Carla Fisher, MD, director of breast surgery at Indiana University, Indianapolis. For breast cancer, they used guidelines from her professional group, the American Society of Breast Surgeons.
Following such protocols for prioritizing patients for treatment during the pandemic should help protect against liability, experts said.
Even if it can be shown that a clinician’s negligence led to delayed diagnosis or treatment of a patient’s cancer, plaintiff attorneys will be wary about filing such claims. That is because it is difficult in most cases to prove that the delay significantly worsened the course of the patient’s disease or the odds of survival. Showing harm may be more possible with certain cancers known to be particularly aggressive.
“The plaintiff attorney will have to get an expert to say that the 3-month delay in getting the patient a mammogram caused her great harm,” said Dr. Roberts. “But it’s hard to calculate that scientifically, and it’s really hard to lay that all on the doctor or health system, because they were supposed to lock down during the pandemic.”
Playing catch-up
With patients now feeling more comfortable about coming in for physician visits, Mr. Byrne urges clinicians to make a special effort to mitigate potential liability arising from the past year. Physicians should carefully review patients’ charts and make sure to catch them up on preventive screenings. Some health systems, like Kaiser Permanente, have been doing proactive patient outreach for cancer screening throughout the pandemic.
“Providers may need to be extra diligent, and consider expanding the exam into a wellness visit and remind patients about cancer surveillance,” he said.
Overall, however, the expert consensus is that physicians should focus on providing the best quality care going forward, and not worry excessively about the care they wish they could have delivered over the past year during the extraordinary pandemic conditions.
“Liability risks will be decreased, because state laws have changed and doctors will be cut some slack, not just by judges and juries but by patients themselves,” Dr. Roberts said. “As you are running down the hall to take care of the next person, don’t be looking over your shoulder or you’ll run into the wall.”
A version of this article first appeared on Medscape.com.
Albuquerque oncologist Barbara McAneny, MD, has a patient in his 30s who experienced rectal bleeding for 6 months in 2020 but didn’t see a physician because he was afraid of catching COVID-19. He hoped it was just hemorrhoids.
When he finally came in to see her recently, Dr. McAneny diagnosed a large colon cancer. She fears the delay could prove fatal. “We’ll do our best to cure him, but I don’t know if he’ll be treatable,” she said. “Six months absolutely can make a difference.”
She and other oncologists around the country are seeing many patients in the past few months with advanced breast, colon, lung, and other cancers who were not diagnosed and treated during the COVID-19 pandemic because the patients didn’t want to come in, or because medical facilities weren’t taking nonemergency or non-COVID patients.
Given that failure to diagnose cancer is among the most common medical malpractice allegations, should oncologists be worried that they are at legal risk?
Pandemic provides ‘safe harbor’
In a March survey done by medical malpractice insurer The Doctors Company, one-third of physicians said they were very concerned or somewhat concerned that malpractice claims related to care during the pandemic will rise.
But in most of these cases, physicians and hospitals have little to worry about in terms of medical malpractice liability, according to veteran plaintiff and defense attorneys and the head of a large medical liability insurer.
“You had people with diseases like cancer not getting care because health care systems were overwhelmed,” said Sean Domnick, JD, a malpractice plaintiff attorney in Boca Raton, Fla. “Will those lead to successful malpractice lawsuits? Most likely not.”
“The risks will be low because it’s hard to pin it on the doctor if the patient didn’t want to come in or facilities weren’t scheduling appointments because of the public health emergency,” said Richard Roberts, MD, JD, a professor of family medicine at the University of Wisconsin–Madison who is also a malpractice defense attorney.
In addition, liability protections enacted in more than 30 states because of the COVID-19 pandemic will help shield clinicians from lawsuits. Those laws generally require allegations of gross negligence or reckless conduct far beyond ordinary negligence, which are hard to prove. But the immunity provisions remain largely untested in the courts, and it’s unclear how they will affect cases involving care for conditions other than COVID-19.
Another helpful factor is the widespread public appreciation of the valiant work by health care professionals throughout the pandemic, though that halo effect could fade over the next several years as malpractice claims from the pandemic period are filed and tried.
“In many circumstances, the pandemic will prove to be a safe harbor for providers,” said Steven Wigrizer, JD, a malpractice plaintiff attorney in Philadelphia. “Jurors will be reluctant to impose liability on providers who were doing their best in a global pandemic the world hadn’t seen in 100 years.”
Risky situations
These predictions from liability experts should reassure physicians who are anxious over reports that many cancer diagnoses were missed as a result of the COVID-19 pandemic.
Still, there are situations where physicians and hospitals could be vulnerable to malpractice claims despite the pandemic conditions. The highest-risk cases are those where patients recognized a potential cancer symptom like a breast lump or rectal bleeding, and tried to visit a doctor’s office or hospital, but were told they couldn’t be seen.
“Those kinds of cases lend themselves to delayed diagnosis claims,” said Richard Anderson, MD, an oncologist who is chairman and CEO of The Doctors Company. “My guess is we will see claims,” though he expects a reduced number arising from 2020 care scenarios, compared with previous years.
So far, his company has seen 20% fewer claims in 2020, which he said isn’t surprising given that the volume of physician and hospital visits plummeted.
Another risky situation is where physicians – particularly primary care physicians but also specialists like gynecologists and urologists – did not inform patients about concerning test results and order a follow-up test or visit. That is dangerous even if the physician did try to schedule a visit but the patient canceled the appointment.
“The jury will ask, ‘What did you do to get the patient back?’ ” said Sean Byrne, JD, a malpractice defense attorney in Richmond, Va. “The provider will say: ‘I’m sure we called.’ But it’s a difficult defense to say the patient didn’t return the call. I need written proof.”
Mr. Domnick said failures to follow up on suspicious test results could produce viable malpractice claims, pandemic or not. “The question becomes to what extent doctors will try to hide behind COVID to explain otherwise run-of-the-mill negligence,” he said. “We’ll have to see how that plays out.”
There are also worries about missed cancer diagnoses during telemedicine visits. “On telemedicine, I can’t feel a lymph node, I can’t palpate a breast mass, and I can’t see if someone’s liver is enlarged,” Dr. McAneny fretted. “I think you’ll get suits because you’ll miss stuff.”
One other area of exposure cited by the experts: Radiologists and pathologists could be sued for missing tumors in reading imaging tests. “The COVID-19 demand on resources has been immense,” Mr. Byrne said. “If that production pressure resulted in any quality loss in testing services, we could see claims.”
Patient protocols provide protection
There’s no question that cancer screenings dropped sharply during the pandemic. In June 2020, the National Cancer Institute estimated there was a 75% decrease in mammograms and colonoscopies during the first few months of the pandemic. It projected that delays in screenings, diagnoses, and treatment likely would result in 10,000 more breast and colorectal cancer deaths than otherwise expected over the next decade.
Delays of even 1 month in treatment for seven common forms of cancer can increase mortality risk by 6%-13%, according to a BMJ study.
While many medical facilities stopped doing preventive screening tests during the height of the pandemic last year, health care professionals still found ways to bring in patients with diagnosed cancers or who were at heightened cancer risk for tests and treatment.
Most facilities convened multidisciplinary tumor boards to decide which patients could wait for treatment, which patients could be maintained on drug therapy, and which ones needed immediate surgery, said Carla Fisher, MD, director of breast surgery at Indiana University, Indianapolis. For breast cancer, they used guidelines from her professional group, the American Society of Breast Surgeons.
Following such protocols for prioritizing patients for treatment during the pandemic should help protect against liability, experts said.
Even if it can be shown that a clinician’s negligence led to delayed diagnosis or treatment of a patient’s cancer, plaintiff attorneys will be wary about filing such claims. That is because it is difficult in most cases to prove that the delay significantly worsened the course of the patient’s disease or the odds of survival. Showing harm may be more possible with certain cancers known to be particularly aggressive.
“The plaintiff attorney will have to get an expert to say that the 3-month delay in getting the patient a mammogram caused her great harm,” said Dr. Roberts. “But it’s hard to calculate that scientifically, and it’s really hard to lay that all on the doctor or health system, because they were supposed to lock down during the pandemic.”
Playing catch-up
With patients now feeling more comfortable about coming in for physician visits, Mr. Byrne urges clinicians to make a special effort to mitigate potential liability arising from the past year. Physicians should carefully review patients’ charts and make sure to catch them up on preventive screenings. Some health systems, like Kaiser Permanente, have been doing proactive patient outreach for cancer screening throughout the pandemic.
“Providers may need to be extra diligent, and consider expanding the exam into a wellness visit and remind patients about cancer surveillance,” he said.
Overall, however, the expert consensus is that physicians should focus on providing the best quality care going forward, and not worry excessively about the care they wish they could have delivered over the past year during the extraordinary pandemic conditions.
“Liability risks will be decreased, because state laws have changed and doctors will be cut some slack, not just by judges and juries but by patients themselves,” Dr. Roberts said. “As you are running down the hall to take care of the next person, don’t be looking over your shoulder or you’ll run into the wall.”
A version of this article first appeared on Medscape.com.
Limited English proficiency linked with less health care in U.S.
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.
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.
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.
FROM HEALTH AFFAIRS
Garlic cloves in the nose and beer dreams and pareidolia faces
Insert clove A into nostril B
Just when you start wondering what crazy and potentially dangerous thing people can do to themselves next, comes a crazy and potentially dangerous new trend. The good folks at TikTok have provided patients a new treatment for stuffed up sinuses.
Dangerous? Well, that’s what doctors say, anyway.
“We typically do not recommend putting anything into the nostril for the obvious fact that it could get dislodged or lodged up into the nasal cavity,” Anthony Del Signore, MD, of Mount Sinai Union Square, New York, told TODAY.
“Not only does it have the potential to rot or cause a nasal obstruction, it can induce an episode of sinusitis,” Omid Mehdizadeh, MD, of Providence Saint John’s Health Center, Santa Monica, Calif., explained to Shape.
But who doesn't want to breathe easier and keep blood-sucking vampires at bay?
TikTokers are posting videos of themselves sticking garlic cloves in their nostrils for several minutes. They, “then, pull the garlic out, followed, typically, by long strands of mucus,” according to The Hill.
That can’t be real, you’re probably saying. Or maybe you think that no one is actually watching this stuff. Well, wake up! This isn’t network television we’re talking about. It’s freakin’ TikTok! One video has been favorited over half a million times. Another is up to 2.2 million.
It’s all true. Really. We couldn’t make this stuff up if we tried.
Seeing faces in random places?
Ever look up at the clouds, at a fast-moving train, or into your morning bowl of cereal and see two eyes, a nose, and a mouth looking back at you? You may shake it off and think you’re imagining something, but it's actually your brain doing what it’s built to do and researchers know why.
The phenomenon is called face pareidolia, and it’s technically an error function of the human brain. Evolution has molded our brains to rapidly identify faces, according to David Alais, PhD, of the University of Sydney, Australia, lead author of the study.
“But the system plays ‘fast and loose’ by applying a crude template of two eyes over a nose and mouth. Lots of things can satisfy that template and thus trigger a face detection response,” he said in a separate statement. But not only are we seeing faces, our brains go one step further and seemingly give those faces feelings.
In the study, Dr. Alais and his team looked for two things about each pareidolia face: Was it analyzed for facial expression or just rejected as a face altogether? The participants were shown a series of faces and then asked to rate the expression on a scale from angry to happy. What the researchers found was that once a face was detected, the brain analyzed the pareidolia face in the same way as a human face. Have you ever seen an angry trash can? Or a smile on an over-easy egg?
The other question faced: Was there a bias on emotion? Yup, and excuse the dad joke.
The researchers showed a mixed series of human faces and pareidolia faces to participants and found that responses were influenced by the previous face seen, no matter if the face was human or not.
So if someone smiled at you on the way to the grocery store and you see a grinning tomato in the produce section, your mind is playing tricks on you, and it’s totally normal.
Corporate dream manipulation
Advertisements are quite literally everywhere. On billboards, in commercials, in videos, in movies; the list goes on and on. Still, at least you can shut your eyes and be mercifully free of corporate interference inside your own head, right? Right?
Early in 2021, Coors launched an ad campaign that seemed to be a b bit of a gimmick, if not a joke. Coors claimed that if people watched an ad before bed, and played an 8-hour soundscape while sleeping, their dreams would be filled with crisp mountains and cold, thirst-quenching beverages. While, the Coors campaign didn’t go viral, someone was paying attention. A group of 35 leading researchers published an open letter on the subject of corporate dream manipulation, in the journal Dream Engineering.
"Multiple marketing studies are openly testing new ways to alter and motivate purchasing behavior through dream and sleep hacking. The commercial, for-profit use of dream incubation is rapidly becoming a reality," wrote the investigators. "As sleep and dream researchers, we are deeply concerned about marketing plans aimed at generating profits at the cost of interfering with our natural nocturnal memory processing."
People have tried to manipulate their dreams for countless years, but only in recent years have scientists attempted to target or manipulate behavior through dreams. In a 2014 study, smokers exposed to tobacco smoke and rotten egg smell while sleeping reduced their cigarette consumption by 30%.
Most research into dream manipulation has been aimed at positive results, but the experts warn that there’s no reason corporations couldn’t use it for their own purposes, especially given the widespread usage of devices such as Alexa. A company could play a certain sound during a commercial, they suggested, and then replay that sound through a device while people are sleeping to trigger a dream about that product.
And just when our COVID-19–driven anxiety dreams were starting to subside.
The experts said that the Federal Trade Commission could intervene to prevent companies from attempting dream manipulation, and have done so in the past to stop subliminal advertising, but as of right now, there’s nothing stopping big business from messing with your dreams. But hey, at least they’re not directly beaming commercials into our heads with gamma radiation. Yet.
Got breast milk?
As we know, breast milk has endless benefits for newbords and babies, but many things can stand in the way of a mother’s ability to breastfeed. Baby formula has served as a good enough substitute. But now, there might be something that’s even better.
A start-up company called BIOMILQ created a product that could be groundbreaking. Using “breakthrough mammary biotechnology,” BIOMILQ created cell-cultured breast milk.
Leila Strickland, a biologist who is the company’s cofounder and chief science officer, said she’s had her own personal experience with breastfeeding and believes the product could benefit many if just given a chance. "Some of the cells we’ve looked at can produce milk for months and months," according to a company statement
Baby formula has done its job feeding and nourishing babies since 1865, but could BIOMILQ do better?
Time – and babies – will tell.
Insert clove A into nostril B
Just when you start wondering what crazy and potentially dangerous thing people can do to themselves next, comes a crazy and potentially dangerous new trend. The good folks at TikTok have provided patients a new treatment for stuffed up sinuses.
Dangerous? Well, that’s what doctors say, anyway.
“We typically do not recommend putting anything into the nostril for the obvious fact that it could get dislodged or lodged up into the nasal cavity,” Anthony Del Signore, MD, of Mount Sinai Union Square, New York, told TODAY.
“Not only does it have the potential to rot or cause a nasal obstruction, it can induce an episode of sinusitis,” Omid Mehdizadeh, MD, of Providence Saint John’s Health Center, Santa Monica, Calif., explained to Shape.
But who doesn't want to breathe easier and keep blood-sucking vampires at bay?
TikTokers are posting videos of themselves sticking garlic cloves in their nostrils for several minutes. They, “then, pull the garlic out, followed, typically, by long strands of mucus,” according to The Hill.
That can’t be real, you’re probably saying. Or maybe you think that no one is actually watching this stuff. Well, wake up! This isn’t network television we’re talking about. It’s freakin’ TikTok! One video has been favorited over half a million times. Another is up to 2.2 million.
It’s all true. Really. We couldn’t make this stuff up if we tried.
Seeing faces in random places?
Ever look up at the clouds, at a fast-moving train, or into your morning bowl of cereal and see two eyes, a nose, and a mouth looking back at you? You may shake it off and think you’re imagining something, but it's actually your brain doing what it’s built to do and researchers know why.
The phenomenon is called face pareidolia, and it’s technically an error function of the human brain. Evolution has molded our brains to rapidly identify faces, according to David Alais, PhD, of the University of Sydney, Australia, lead author of the study.
“But the system plays ‘fast and loose’ by applying a crude template of two eyes over a nose and mouth. Lots of things can satisfy that template and thus trigger a face detection response,” he said in a separate statement. But not only are we seeing faces, our brains go one step further and seemingly give those faces feelings.
In the study, Dr. Alais and his team looked for two things about each pareidolia face: Was it analyzed for facial expression or just rejected as a face altogether? The participants were shown a series of faces and then asked to rate the expression on a scale from angry to happy. What the researchers found was that once a face was detected, the brain analyzed the pareidolia face in the same way as a human face. Have you ever seen an angry trash can? Or a smile on an over-easy egg?
The other question faced: Was there a bias on emotion? Yup, and excuse the dad joke.
The researchers showed a mixed series of human faces and pareidolia faces to participants and found that responses were influenced by the previous face seen, no matter if the face was human or not.
So if someone smiled at you on the way to the grocery store and you see a grinning tomato in the produce section, your mind is playing tricks on you, and it’s totally normal.
Corporate dream manipulation
Advertisements are quite literally everywhere. On billboards, in commercials, in videos, in movies; the list goes on and on. Still, at least you can shut your eyes and be mercifully free of corporate interference inside your own head, right? Right?
Early in 2021, Coors launched an ad campaign that seemed to be a b bit of a gimmick, if not a joke. Coors claimed that if people watched an ad before bed, and played an 8-hour soundscape while sleeping, their dreams would be filled with crisp mountains and cold, thirst-quenching beverages. While, the Coors campaign didn’t go viral, someone was paying attention. A group of 35 leading researchers published an open letter on the subject of corporate dream manipulation, in the journal Dream Engineering.
"Multiple marketing studies are openly testing new ways to alter and motivate purchasing behavior through dream and sleep hacking. The commercial, for-profit use of dream incubation is rapidly becoming a reality," wrote the investigators. "As sleep and dream researchers, we are deeply concerned about marketing plans aimed at generating profits at the cost of interfering with our natural nocturnal memory processing."
People have tried to manipulate their dreams for countless years, but only in recent years have scientists attempted to target or manipulate behavior through dreams. In a 2014 study, smokers exposed to tobacco smoke and rotten egg smell while sleeping reduced their cigarette consumption by 30%.
Most research into dream manipulation has been aimed at positive results, but the experts warn that there’s no reason corporations couldn’t use it for their own purposes, especially given the widespread usage of devices such as Alexa. A company could play a certain sound during a commercial, they suggested, and then replay that sound through a device while people are sleeping to trigger a dream about that product.
And just when our COVID-19–driven anxiety dreams were starting to subside.
The experts said that the Federal Trade Commission could intervene to prevent companies from attempting dream manipulation, and have done so in the past to stop subliminal advertising, but as of right now, there’s nothing stopping big business from messing with your dreams. But hey, at least they’re not directly beaming commercials into our heads with gamma radiation. Yet.
Got breast milk?
As we know, breast milk has endless benefits for newbords and babies, but many things can stand in the way of a mother’s ability to breastfeed. Baby formula has served as a good enough substitute. But now, there might be something that’s even better.
A start-up company called BIOMILQ created a product that could be groundbreaking. Using “breakthrough mammary biotechnology,” BIOMILQ created cell-cultured breast milk.
Leila Strickland, a biologist who is the company’s cofounder and chief science officer, said she’s had her own personal experience with breastfeeding and believes the product could benefit many if just given a chance. "Some of the cells we’ve looked at can produce milk for months and months," according to a company statement
Baby formula has done its job feeding and nourishing babies since 1865, but could BIOMILQ do better?
Time – and babies – will tell.
Insert clove A into nostril B
Just when you start wondering what crazy and potentially dangerous thing people can do to themselves next, comes a crazy and potentially dangerous new trend. The good folks at TikTok have provided patients a new treatment for stuffed up sinuses.
Dangerous? Well, that’s what doctors say, anyway.
“We typically do not recommend putting anything into the nostril for the obvious fact that it could get dislodged or lodged up into the nasal cavity,” Anthony Del Signore, MD, of Mount Sinai Union Square, New York, told TODAY.
“Not only does it have the potential to rot or cause a nasal obstruction, it can induce an episode of sinusitis,” Omid Mehdizadeh, MD, of Providence Saint John’s Health Center, Santa Monica, Calif., explained to Shape.
But who doesn't want to breathe easier and keep blood-sucking vampires at bay?
TikTokers are posting videos of themselves sticking garlic cloves in their nostrils for several minutes. They, “then, pull the garlic out, followed, typically, by long strands of mucus,” according to The Hill.
That can’t be real, you’re probably saying. Or maybe you think that no one is actually watching this stuff. Well, wake up! This isn’t network television we’re talking about. It’s freakin’ TikTok! One video has been favorited over half a million times. Another is up to 2.2 million.
It’s all true. Really. We couldn’t make this stuff up if we tried.
Seeing faces in random places?
Ever look up at the clouds, at a fast-moving train, or into your morning bowl of cereal and see two eyes, a nose, and a mouth looking back at you? You may shake it off and think you’re imagining something, but it's actually your brain doing what it’s built to do and researchers know why.
The phenomenon is called face pareidolia, and it’s technically an error function of the human brain. Evolution has molded our brains to rapidly identify faces, according to David Alais, PhD, of the University of Sydney, Australia, lead author of the study.
“But the system plays ‘fast and loose’ by applying a crude template of two eyes over a nose and mouth. Lots of things can satisfy that template and thus trigger a face detection response,” he said in a separate statement. But not only are we seeing faces, our brains go one step further and seemingly give those faces feelings.
In the study, Dr. Alais and his team looked for two things about each pareidolia face: Was it analyzed for facial expression or just rejected as a face altogether? The participants were shown a series of faces and then asked to rate the expression on a scale from angry to happy. What the researchers found was that once a face was detected, the brain analyzed the pareidolia face in the same way as a human face. Have you ever seen an angry trash can? Or a smile on an over-easy egg?
The other question faced: Was there a bias on emotion? Yup, and excuse the dad joke.
The researchers showed a mixed series of human faces and pareidolia faces to participants and found that responses were influenced by the previous face seen, no matter if the face was human or not.
So if someone smiled at you on the way to the grocery store and you see a grinning tomato in the produce section, your mind is playing tricks on you, and it’s totally normal.
Corporate dream manipulation
Advertisements are quite literally everywhere. On billboards, in commercials, in videos, in movies; the list goes on and on. Still, at least you can shut your eyes and be mercifully free of corporate interference inside your own head, right? Right?
Early in 2021, Coors launched an ad campaign that seemed to be a b bit of a gimmick, if not a joke. Coors claimed that if people watched an ad before bed, and played an 8-hour soundscape while sleeping, their dreams would be filled with crisp mountains and cold, thirst-quenching beverages. While, the Coors campaign didn’t go viral, someone was paying attention. A group of 35 leading researchers published an open letter on the subject of corporate dream manipulation, in the journal Dream Engineering.
"Multiple marketing studies are openly testing new ways to alter and motivate purchasing behavior through dream and sleep hacking. The commercial, for-profit use of dream incubation is rapidly becoming a reality," wrote the investigators. "As sleep and dream researchers, we are deeply concerned about marketing plans aimed at generating profits at the cost of interfering with our natural nocturnal memory processing."
People have tried to manipulate their dreams for countless years, but only in recent years have scientists attempted to target or manipulate behavior through dreams. In a 2014 study, smokers exposed to tobacco smoke and rotten egg smell while sleeping reduced their cigarette consumption by 30%.
Most research into dream manipulation has been aimed at positive results, but the experts warn that there’s no reason corporations couldn’t use it for their own purposes, especially given the widespread usage of devices such as Alexa. A company could play a certain sound during a commercial, they suggested, and then replay that sound through a device while people are sleeping to trigger a dream about that product.
And just when our COVID-19–driven anxiety dreams were starting to subside.
The experts said that the Federal Trade Commission could intervene to prevent companies from attempting dream manipulation, and have done so in the past to stop subliminal advertising, but as of right now, there’s nothing stopping big business from messing with your dreams. But hey, at least they’re not directly beaming commercials into our heads with gamma radiation. Yet.
Got breast milk?
As we know, breast milk has endless benefits for newbords and babies, but many things can stand in the way of a mother’s ability to breastfeed. Baby formula has served as a good enough substitute. But now, there might be something that’s even better.
A start-up company called BIOMILQ created a product that could be groundbreaking. Using “breakthrough mammary biotechnology,” BIOMILQ created cell-cultured breast milk.
Leila Strickland, a biologist who is the company’s cofounder and chief science officer, said she’s had her own personal experience with breastfeeding and believes the product could benefit many if just given a chance. "Some of the cells we’ve looked at can produce milk for months and months," according to a company statement
Baby formula has done its job feeding and nourishing babies since 1865, but could BIOMILQ do better?
Time – and babies – will tell.
