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Should you worry about picking up COVID or other infections from public bathrooms?
but some experts disagree with the study’s conclusions. The study was published in Science of the Total Environment.
Sotiris Vardoulakis, PhD, of the Australian National University, Canberra, and colleagues reviewed studies of infections associated with public washrooms.
The researchers used keywords to identify potential articles. After screening study abstracts to ensure that only publicly available washrooms with toilets, sinks, and hand dryers were included, 65 studies remained. The investigators excluded washrooms on public transportation (ships, planes, trains, and buses).
“What most of the studies concluded was that what’s really important is to have good hand hygiene and proper maintenance and ventilation of washrooms,” Dr. Vardoulakis said in an interview. “So if the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”
There has been ongoing debate on whether electric hand dryers or paper towels are better. Some studies focused on hygiene. Others focused on the environmental cost of paper towels. One concern is that air dryers might spread germs further.
One study focused on the idea that the air recirculation from electric dryers may spread infective aerosols. Another study determined that the Airblade filters in some electric dryers clean more than 99% of the bacteria. The first study, published in Mayo Clinic Proceedings by Cunrui Huang, MMed, MSPH, and colleagues, concluded that “drying hands thoroughly with single-use, disposable paper towels is the preferred method of hand drying in terms of hand hygiene.” Many people prefer to use paper towels because they can be used as a barrier when opening the washroom door.
Dr. Vardoulakis dismissed the air-versus-paper debate, saying, “If the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”
Although Dr. Vardoulakis’ review did not find that public washrooms pose a risk for infection, other researchers have shown that some settings do pose problems. For example, toilet plumes are thought to have contributed to the 2003 outbreak of severe acute respiratory syndrome at the Amoy Gardens housing complex in Hong Kong and nearby buildings by aerosolization of fecal waste. Also, norovirus has long been shown to be transmitted by aerosolized particles in vomitus or stool.
Rodney E. Rohde, PhD, professor and chair, clinical lab science program, Texas State University, San Marcos, expressed concern about this systematic review in an interview with this news organization. “I believe one of the major limitations is that studies which involved restrooms on planes, hotels, camping (those camp kids are nasty), and other similar public-access restrooms MUST be included in this type of review. I also believe they excluded restrooms from low-income/rural areas. WHAT? Their ultimate conclusions seem to be in line with the most current understanding about hand hygiene (including drying without devices that create strong air currents, which may create widespread emission of microbes).”
In an interview, Emanuel Goldman, PhD, professor of microbiology, biochemistry, and molecular genetics, New Jersey Medical School, Newark, focused on the COVID-specific aspects of the review. “The chances are less than 1 in 10,000 of getting COVID from a fomite, and that’s very conservative,” he said. “I think it’s a lot lower than that. The virus is fragile. It dies very quickly outside of a human host.” He emphasized, “virtually no infectious virus has been found on fomites over the last 2 years. ... A big mistake in a lot of papers is they confuse viral RNA with the virus. It’s not the same. Viral RNA is the genetic material of the virus, but it also is the ghost of the virus after the virus is dead, and that’s what people are finding. They’re finding the ghost of the virus.”
Because “studies show that the transfer from a surface to fingers is in the neighborhood of 10% efficiency” and one’s fingers also kill the virus, “transmission through your fingers is not easy,” Dr. Goldman said. “You’ve got to really work at it to deliberately infect yourself” with COVID from a fomite.
Dr. Rohde’s conclusion about Dr. Vardoulakis’s review? “So, the question may be, have there been enough studies, in general, of these other areas to include in a review? Otherwise, can we really generalize from this study? I don’t think so.”
Dr. Goldman is not worried about COVID transmission in public bathrooms. His summation: “I think indoor dining is more risky than anything else right now.”
The study was funded by Dyson Technology. Dr. Vardoulakis is a member of the Dyson scientific advisory board.
A version of this article first appeared on Medscape.com.
but some experts disagree with the study’s conclusions. The study was published in Science of the Total Environment.
Sotiris Vardoulakis, PhD, of the Australian National University, Canberra, and colleagues reviewed studies of infections associated with public washrooms.
The researchers used keywords to identify potential articles. After screening study abstracts to ensure that only publicly available washrooms with toilets, sinks, and hand dryers were included, 65 studies remained. The investigators excluded washrooms on public transportation (ships, planes, trains, and buses).
“What most of the studies concluded was that what’s really important is to have good hand hygiene and proper maintenance and ventilation of washrooms,” Dr. Vardoulakis said in an interview. “So if the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”
There has been ongoing debate on whether electric hand dryers or paper towels are better. Some studies focused on hygiene. Others focused on the environmental cost of paper towels. One concern is that air dryers might spread germs further.
One study focused on the idea that the air recirculation from electric dryers may spread infective aerosols. Another study determined that the Airblade filters in some electric dryers clean more than 99% of the bacteria. The first study, published in Mayo Clinic Proceedings by Cunrui Huang, MMed, MSPH, and colleagues, concluded that “drying hands thoroughly with single-use, disposable paper towels is the preferred method of hand drying in terms of hand hygiene.” Many people prefer to use paper towels because they can be used as a barrier when opening the washroom door.
Dr. Vardoulakis dismissed the air-versus-paper debate, saying, “If the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”
Although Dr. Vardoulakis’ review did not find that public washrooms pose a risk for infection, other researchers have shown that some settings do pose problems. For example, toilet plumes are thought to have contributed to the 2003 outbreak of severe acute respiratory syndrome at the Amoy Gardens housing complex in Hong Kong and nearby buildings by aerosolization of fecal waste. Also, norovirus has long been shown to be transmitted by aerosolized particles in vomitus or stool.
Rodney E. Rohde, PhD, professor and chair, clinical lab science program, Texas State University, San Marcos, expressed concern about this systematic review in an interview with this news organization. “I believe one of the major limitations is that studies which involved restrooms on planes, hotels, camping (those camp kids are nasty), and other similar public-access restrooms MUST be included in this type of review. I also believe they excluded restrooms from low-income/rural areas. WHAT? Their ultimate conclusions seem to be in line with the most current understanding about hand hygiene (including drying without devices that create strong air currents, which may create widespread emission of microbes).”
In an interview, Emanuel Goldman, PhD, professor of microbiology, biochemistry, and molecular genetics, New Jersey Medical School, Newark, focused on the COVID-specific aspects of the review. “The chances are less than 1 in 10,000 of getting COVID from a fomite, and that’s very conservative,” he said. “I think it’s a lot lower than that. The virus is fragile. It dies very quickly outside of a human host.” He emphasized, “virtually no infectious virus has been found on fomites over the last 2 years. ... A big mistake in a lot of papers is they confuse viral RNA with the virus. It’s not the same. Viral RNA is the genetic material of the virus, but it also is the ghost of the virus after the virus is dead, and that’s what people are finding. They’re finding the ghost of the virus.”
Because “studies show that the transfer from a surface to fingers is in the neighborhood of 10% efficiency” and one’s fingers also kill the virus, “transmission through your fingers is not easy,” Dr. Goldman said. “You’ve got to really work at it to deliberately infect yourself” with COVID from a fomite.
Dr. Rohde’s conclusion about Dr. Vardoulakis’s review? “So, the question may be, have there been enough studies, in general, of these other areas to include in a review? Otherwise, can we really generalize from this study? I don’t think so.”
Dr. Goldman is not worried about COVID transmission in public bathrooms. His summation: “I think indoor dining is more risky than anything else right now.”
The study was funded by Dyson Technology. Dr. Vardoulakis is a member of the Dyson scientific advisory board.
A version of this article first appeared on Medscape.com.
but some experts disagree with the study’s conclusions. The study was published in Science of the Total Environment.
Sotiris Vardoulakis, PhD, of the Australian National University, Canberra, and colleagues reviewed studies of infections associated with public washrooms.
The researchers used keywords to identify potential articles. After screening study abstracts to ensure that only publicly available washrooms with toilets, sinks, and hand dryers were included, 65 studies remained. The investigators excluded washrooms on public transportation (ships, planes, trains, and buses).
“What most of the studies concluded was that what’s really important is to have good hand hygiene and proper maintenance and ventilation of washrooms,” Dr. Vardoulakis said in an interview. “So if the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”
There has been ongoing debate on whether electric hand dryers or paper towels are better. Some studies focused on hygiene. Others focused on the environmental cost of paper towels. One concern is that air dryers might spread germs further.
One study focused on the idea that the air recirculation from electric dryers may spread infective aerosols. Another study determined that the Airblade filters in some electric dryers clean more than 99% of the bacteria. The first study, published in Mayo Clinic Proceedings by Cunrui Huang, MMed, MSPH, and colleagues, concluded that “drying hands thoroughly with single-use, disposable paper towels is the preferred method of hand drying in terms of hand hygiene.” Many people prefer to use paper towels because they can be used as a barrier when opening the washroom door.
Dr. Vardoulakis dismissed the air-versus-paper debate, saying, “If the hand washing and drying is effective in the first place, it’s unlikely that the bathroom air or surfaces will pose an infectious disease transmission risk.”
Although Dr. Vardoulakis’ review did not find that public washrooms pose a risk for infection, other researchers have shown that some settings do pose problems. For example, toilet plumes are thought to have contributed to the 2003 outbreak of severe acute respiratory syndrome at the Amoy Gardens housing complex in Hong Kong and nearby buildings by aerosolization of fecal waste. Also, norovirus has long been shown to be transmitted by aerosolized particles in vomitus or stool.
Rodney E. Rohde, PhD, professor and chair, clinical lab science program, Texas State University, San Marcos, expressed concern about this systematic review in an interview with this news organization. “I believe one of the major limitations is that studies which involved restrooms on planes, hotels, camping (those camp kids are nasty), and other similar public-access restrooms MUST be included in this type of review. I also believe they excluded restrooms from low-income/rural areas. WHAT? Their ultimate conclusions seem to be in line with the most current understanding about hand hygiene (including drying without devices that create strong air currents, which may create widespread emission of microbes).”
In an interview, Emanuel Goldman, PhD, professor of microbiology, biochemistry, and molecular genetics, New Jersey Medical School, Newark, focused on the COVID-specific aspects of the review. “The chances are less than 1 in 10,000 of getting COVID from a fomite, and that’s very conservative,” he said. “I think it’s a lot lower than that. The virus is fragile. It dies very quickly outside of a human host.” He emphasized, “virtually no infectious virus has been found on fomites over the last 2 years. ... A big mistake in a lot of papers is they confuse viral RNA with the virus. It’s not the same. Viral RNA is the genetic material of the virus, but it also is the ghost of the virus after the virus is dead, and that’s what people are finding. They’re finding the ghost of the virus.”
Because “studies show that the transfer from a surface to fingers is in the neighborhood of 10% efficiency” and one’s fingers also kill the virus, “transmission through your fingers is not easy,” Dr. Goldman said. “You’ve got to really work at it to deliberately infect yourself” with COVID from a fomite.
Dr. Rohde’s conclusion about Dr. Vardoulakis’s review? “So, the question may be, have there been enough studies, in general, of these other areas to include in a review? Otherwise, can we really generalize from this study? I don’t think so.”
Dr. Goldman is not worried about COVID transmission in public bathrooms. His summation: “I think indoor dining is more risky than anything else right now.”
The study was funded by Dyson Technology. Dr. Vardoulakis is a member of the Dyson scientific advisory board.
A version of this article first appeared on Medscape.com.
FROM SCIENCE OF THE TOTAL ENVIRONMENT
U.S. overdose deaths hit an all-time high
a 28.5% increase from the previous year.
Deaths in some states rose even more precipitously. Vermont saw an almost 70% increase, and drug overdose deaths in West Virginia increased by 62%. Many states, including Alabama, California, Kansas, Kentucky, Louisiana, Tennessee, and Washington, had a 45%-50% rise in overdose deaths.
The data released by the CDC was provisional, as there is generally a lag between a reported overdose and confirmation of the death to the National Vital Statistics System. The agency uses statistical models that render the counts almost 100% accurate, the CDC says.
The vast majority (73,757) of overdose deaths involved opioids – with most of those (62,338) involving synthetic opioids such as fentanyl. Federal officials said that one American died every 5 minutes from an overdose, or 265 a day.
“We have to acknowledge what this is – it is a crisis,” Department of Health & Human Services Secretary Xavier Becerra told reporters on a call.
“As much as the numbers speak so vividly, they don’t tell the whole story. We see it in the faces of grieving families and all those overworked caregivers. You hear it every time you get that panicked 911 phone call, you read it in obituaries of sons and daughters who left us way too soon,” Mr. Becerra said.
Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said that “this is unacceptable, and it requires an unprecedented response.”
Dr. Gupta, who noted that he has a waiver to treat substance use disorder patients with buprenorphine, said he’s seen “first-hand the heartbreak of the overdose epidemic,” adding that, with 23 years in practice, “I’ve learned that an overdose is a cry for help and for far too many people that cry goes unanswered.”
Both Mr. Becerra and Dr. Gupta called on Congress to pass President Joe Biden’s fiscal 2022 budget request, noting that it calls for $41 billion – a $669 million increase from fiscal year 2021 – to go to agencies working on drug interdiction and substance use prevention, treatment, and recovery support.
Dr. Gupta also announced that the administration was releasing a model law that could be used by state legislatures to help standardize policies on making the overdose antidote naloxone more accessible. Currently, such policies are a patchwork across the nation.
In addition, the federal government is newly supporting harm reduction, Mr. Becerra said. This means federal money can be used by clinics and outreach programs to buy fentanyl test strips, which they can then distribute to drug users.
“It’s important for Americans to have the ability to make sure that they can test for fentanyl in the substance,” Dr. Gupta said.
Fake pills, fentanyl a huge issue
Federal officials said that both fentanyl and methamphetamine are contributing to rising numbers of fatalities.
“Drug cartels in Mexico are mass-producing fentanyl and methamphetamine largely sourced from chemicals in China and they are distributing these substances throughout the United States,” Anne Milgram, administrator of the Drug Enforcement Administration, said on the call.
Ms. Milgram said the agency had seized 12,000 pounds of fentanyl in 2021, enough to provide every American with a lethal dose. Fentanyl is also mixed in with cocaine, heroin, methamphetamine, and marijuana – often in counterfeit pills, Ms. Milgram said.
The DEA and other law enforcement agencies have seized more than 14 million such pills in 2021. “These types of pills are easily accessible today on social media and e-commerce platforms, Ms. Milgram said.
“Drug dealers are now in our homes,” she said. “Wherever there is a smart phone or a computer, a dealer is one click away,” Ms. Milgram said.
National Institute on Drug Abuse Director Nora D. Volkow, MD, said that dealers will continue to push both fentanyl and methamphetamine because they are among the most addictive substances. They also are more profitable because they don’t require cultivation and harvesting, she said on the call.
Dr. Volkow also noted that naloxone is not as effective in reversing fentanyl overdoses because fentanyl is more potent than heroin and other opioids, and “it gets into the brain extremely rapidly.”
Ongoing research is aimed at developing a faster delivery mechanism and a longer-lasting formulation to counter overdoses, Dr. Volkow said.
A version of this article first appeared on Medscape.com.
a 28.5% increase from the previous year.
Deaths in some states rose even more precipitously. Vermont saw an almost 70% increase, and drug overdose deaths in West Virginia increased by 62%. Many states, including Alabama, California, Kansas, Kentucky, Louisiana, Tennessee, and Washington, had a 45%-50% rise in overdose deaths.
The data released by the CDC was provisional, as there is generally a lag between a reported overdose and confirmation of the death to the National Vital Statistics System. The agency uses statistical models that render the counts almost 100% accurate, the CDC says.
The vast majority (73,757) of overdose deaths involved opioids – with most of those (62,338) involving synthetic opioids such as fentanyl. Federal officials said that one American died every 5 minutes from an overdose, or 265 a day.
“We have to acknowledge what this is – it is a crisis,” Department of Health & Human Services Secretary Xavier Becerra told reporters on a call.
“As much as the numbers speak so vividly, they don’t tell the whole story. We see it in the faces of grieving families and all those overworked caregivers. You hear it every time you get that panicked 911 phone call, you read it in obituaries of sons and daughters who left us way too soon,” Mr. Becerra said.
Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said that “this is unacceptable, and it requires an unprecedented response.”
Dr. Gupta, who noted that he has a waiver to treat substance use disorder patients with buprenorphine, said he’s seen “first-hand the heartbreak of the overdose epidemic,” adding that, with 23 years in practice, “I’ve learned that an overdose is a cry for help and for far too many people that cry goes unanswered.”
Both Mr. Becerra and Dr. Gupta called on Congress to pass President Joe Biden’s fiscal 2022 budget request, noting that it calls for $41 billion – a $669 million increase from fiscal year 2021 – to go to agencies working on drug interdiction and substance use prevention, treatment, and recovery support.
Dr. Gupta also announced that the administration was releasing a model law that could be used by state legislatures to help standardize policies on making the overdose antidote naloxone more accessible. Currently, such policies are a patchwork across the nation.
In addition, the federal government is newly supporting harm reduction, Mr. Becerra said. This means federal money can be used by clinics and outreach programs to buy fentanyl test strips, which they can then distribute to drug users.
“It’s important for Americans to have the ability to make sure that they can test for fentanyl in the substance,” Dr. Gupta said.
Fake pills, fentanyl a huge issue
Federal officials said that both fentanyl and methamphetamine are contributing to rising numbers of fatalities.
“Drug cartels in Mexico are mass-producing fentanyl and methamphetamine largely sourced from chemicals in China and they are distributing these substances throughout the United States,” Anne Milgram, administrator of the Drug Enforcement Administration, said on the call.
Ms. Milgram said the agency had seized 12,000 pounds of fentanyl in 2021, enough to provide every American with a lethal dose. Fentanyl is also mixed in with cocaine, heroin, methamphetamine, and marijuana – often in counterfeit pills, Ms. Milgram said.
The DEA and other law enforcement agencies have seized more than 14 million such pills in 2021. “These types of pills are easily accessible today on social media and e-commerce platforms, Ms. Milgram said.
“Drug dealers are now in our homes,” she said. “Wherever there is a smart phone or a computer, a dealer is one click away,” Ms. Milgram said.
National Institute on Drug Abuse Director Nora D. Volkow, MD, said that dealers will continue to push both fentanyl and methamphetamine because they are among the most addictive substances. They also are more profitable because they don’t require cultivation and harvesting, she said on the call.
Dr. Volkow also noted that naloxone is not as effective in reversing fentanyl overdoses because fentanyl is more potent than heroin and other opioids, and “it gets into the brain extremely rapidly.”
Ongoing research is aimed at developing a faster delivery mechanism and a longer-lasting formulation to counter overdoses, Dr. Volkow said.
A version of this article first appeared on Medscape.com.
a 28.5% increase from the previous year.
Deaths in some states rose even more precipitously. Vermont saw an almost 70% increase, and drug overdose deaths in West Virginia increased by 62%. Many states, including Alabama, California, Kansas, Kentucky, Louisiana, Tennessee, and Washington, had a 45%-50% rise in overdose deaths.
The data released by the CDC was provisional, as there is generally a lag between a reported overdose and confirmation of the death to the National Vital Statistics System. The agency uses statistical models that render the counts almost 100% accurate, the CDC says.
The vast majority (73,757) of overdose deaths involved opioids – with most of those (62,338) involving synthetic opioids such as fentanyl. Federal officials said that one American died every 5 minutes from an overdose, or 265 a day.
“We have to acknowledge what this is – it is a crisis,” Department of Health & Human Services Secretary Xavier Becerra told reporters on a call.
“As much as the numbers speak so vividly, they don’t tell the whole story. We see it in the faces of grieving families and all those overworked caregivers. You hear it every time you get that panicked 911 phone call, you read it in obituaries of sons and daughters who left us way too soon,” Mr. Becerra said.
Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said that “this is unacceptable, and it requires an unprecedented response.”
Dr. Gupta, who noted that he has a waiver to treat substance use disorder patients with buprenorphine, said he’s seen “first-hand the heartbreak of the overdose epidemic,” adding that, with 23 years in practice, “I’ve learned that an overdose is a cry for help and for far too many people that cry goes unanswered.”
Both Mr. Becerra and Dr. Gupta called on Congress to pass President Joe Biden’s fiscal 2022 budget request, noting that it calls for $41 billion – a $669 million increase from fiscal year 2021 – to go to agencies working on drug interdiction and substance use prevention, treatment, and recovery support.
Dr. Gupta also announced that the administration was releasing a model law that could be used by state legislatures to help standardize policies on making the overdose antidote naloxone more accessible. Currently, such policies are a patchwork across the nation.
In addition, the federal government is newly supporting harm reduction, Mr. Becerra said. This means federal money can be used by clinics and outreach programs to buy fentanyl test strips, which they can then distribute to drug users.
“It’s important for Americans to have the ability to make sure that they can test for fentanyl in the substance,” Dr. Gupta said.
Fake pills, fentanyl a huge issue
Federal officials said that both fentanyl and methamphetamine are contributing to rising numbers of fatalities.
“Drug cartels in Mexico are mass-producing fentanyl and methamphetamine largely sourced from chemicals in China and they are distributing these substances throughout the United States,” Anne Milgram, administrator of the Drug Enforcement Administration, said on the call.
Ms. Milgram said the agency had seized 12,000 pounds of fentanyl in 2021, enough to provide every American with a lethal dose. Fentanyl is also mixed in with cocaine, heroin, methamphetamine, and marijuana – often in counterfeit pills, Ms. Milgram said.
The DEA and other law enforcement agencies have seized more than 14 million such pills in 2021. “These types of pills are easily accessible today on social media and e-commerce platforms, Ms. Milgram said.
“Drug dealers are now in our homes,” she said. “Wherever there is a smart phone or a computer, a dealer is one click away,” Ms. Milgram said.
National Institute on Drug Abuse Director Nora D. Volkow, MD, said that dealers will continue to push both fentanyl and methamphetamine because they are among the most addictive substances. They also are more profitable because they don’t require cultivation and harvesting, she said on the call.
Dr. Volkow also noted that naloxone is not as effective in reversing fentanyl overdoses because fentanyl is more potent than heroin and other opioids, and “it gets into the brain extremely rapidly.”
Ongoing research is aimed at developing a faster delivery mechanism and a longer-lasting formulation to counter overdoses, Dr. Volkow said.
A version of this article first appeared on Medscape.com.
Coffee or tea? Drinking both tied to lower stroke, dementia risk
Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.
Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.
“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.
The study was published online Nov. 16 in PLOS Medicine.
Synergistic effect?
Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.
Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.
During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.
After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).
Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).
Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).
Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).
There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.
The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.
Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.
“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.
The study was published online Nov. 16 in PLOS Medicine.
Synergistic effect?
Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.
Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.
During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.
After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).
Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).
Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).
Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).
There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.
The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.
Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.
“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.
The study was published online Nov. 16 in PLOS Medicine.
Synergistic effect?
Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.
Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.
During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.
After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).
Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).
Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).
Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).
There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.
The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Hantavirus 5-Point Screen Tool Identifies Patients With Deadly Infection
In May 2016, Tarrah Oliver had been working as a bench tech in hematology at Tséhootsooí Medical Center (TMC) for 4 years when the hospital launched a 5-point screen for detecting hantavirus cardiopulmonary syndrome (HCPS), a potentially fatal disease that disproportionately affects Native Americans.
Developed at the University of New Mexico, the 5-point screen was particularly useful for facilities like TMC, a 56-bed hospital in Arizona serving Navajo Nation patients. Although the Navajo make up only 1.7% of the population, they account for 18% of all reported HCPS cases in the US.
But Oliver, who was the laboratory Safety and Training supervisor, her department supervisor, and his assistant were the only people who knew how to do the screen. “I was storing completed worksheets in a folder,” Oliver said, “and soon I had to transfer them to a 3-inch binder because we had so many being ordered. I started saving slides that scored high so that I could show my fellow lab mates what certain characteristics looked like under the microscope.” She also created case studies to train staff using analyzer printouts and slides from the patients. “It was my little side project to take care of while I was working and training new employees in the hematology department.”
The screen was to become much more than a side project very quickly.
In 2017, there was a hantavirus outbreak in one of the nearby communities. A team from the Centers for Disease Control and Prevention (CDC) came out to visit the local hospitals to educate the medical staff on what to look for in their patients with suspected hantavirus. Among those: the TMC staff. The visit would prove both serendipitous and synergistic.
Mary Choi, MD, MPH, medical officer with the CDC Viral Special Pathogens Branch, said, “Members of my branch were asked to come to Navajo Nation [Lukachukai chapter, Arizona] because of a cluster of hantaviruses cases that had been occurring in the area over the course of a few years. During a meeting with medical providers at TMC, our team met Tarrah and she told us that TMC had implemented the screen. We were really intrigued and impressed by the initiative of this small community hospital.”
“We were excited that the CDC even knew we existed!” Oliver recalled. “This little lab in the middle of the reservation.”
HCPS is rare but severe. It can quickly progress from nonspecific initial symptoms, such as fever, body aches, and shortness of breath, to severe respiratory distress. Without immediate intervention, patients usually die within 24 to 48 hours of the onset of cardiopulmonary symptoms. “What makes the disease even more challenging,” said Choi, “is that some of the critical lifesaving measures that physicians normally employ to save a critically-ill patient can actually make the situation worse.
“For example, when HCPS patients reach the cardiopulmonary phase of the illness, their blood pressure will drop. The normal response to this is to give IV fluids (IVF). But in hantavirus, giving IVF can actually make the signs and symptoms of the disease worse and only judicious use of IVF is recommended.”
She gave other examples of treatment challenges: “Physicians are taught to intubate critically ill patients. However, intubation of hanta patients during the cardiopulmonary phase can actually be detrimental. Also, in general, extracorporeal membrane oxygenation (ECMO) is an intervention of last resort for most critically-ill patients. As the procedure essentially involves hooking the patient up to a heart-lung machine, which has a lot of complications, doctors do not do this unless they have to. But in hantavirus disease, early initiation of ECMO has been shown to significantly improve survival.”
“Another tricky thing about ECMO is that not all hospitals have an ECMO machine… oftentimes patients have to be transferred from one hospital to another because they need ECMO and it is not available where they are.” The ECMO-equipped facility closest to TMC is 170 miles away, at the University of New Mexico Hospital in Albuquerque.
For all those reasons, Dr. Choi said, it is critically important for physicians to know if the patient they are treating has hantavirus or not. The problem is, there is no rapid test for hantavirus disease. The tests have to be sent out to a laboratory and it can take days before physicians receive a test result. “This is where the 5-point screen is such a valuable tool. Although it is not a diagnostic test, it is a very accurate screening tool. Even better, it is readily and widely available, because to perform the screen, you only need a complete blood count (CBC) and a peripheral blood smear…which can be performed in the vast majority of laboratories and clinics. In addition, the CBC and peripheral blood smear are very commonly ordered tests.”
The screen could be particularly crucial for small community hospitals and clinics. “[TMC] took a screen developed by hematopathologists for hematopathologists,” Choi said, “and adapted it so that it could be performed by clinical laboratorians—because hematopathologists don’t exactly grow on trees! Once we heard about the work that TMC was doing, we knew that this was something we wanted to support and advocate for.”
“We started to throw around the idea of teaching this method to other laboratories on the reservation,” Oliver said. She and Mary Choi teamed up to “knock on everyone’s door to see who was utilizing the screening or if they had their own methods of detecting hantavirus in their patients.”
Two years later, they began holding training sessions at a nearby community college; they also trained an entire laboratory at their hospital in late 2019. Plans were to set up other training sessions towards the border towns before spring of 2020.
Then SARS-CoV-2 showed up.
Hantavirus or coronavirus?
COVID-19 hit the Navajo Nation like a sledgehammer. Native Americans in rural areas, as many Navajo are, may have multigenerational and extended families living in tight quarters, with limited access to running water, miles from the nearest healthcare facility. They were particularly vulnerable to a virus that thrives on close contact, at a time when the most common preventives were distancing, frequent handwashing, and testing. By May 2020, the Navajo Nation had surpassed the epicenters—New York and New Jersey—in cases of infection. Even as late as November 2021, the Navah Nation has reported > 37,000 positive cases, and nearly 1,500 confirmed deaths, despite reaching a 70% vaccination rate.
Making things ever more challenging: How do you know whether the patient has hantavirus or COVID-19? The distinction is critical because the disease courses of the 2 infections differ greatly. “The importance of [TMC’s] work was really brought home by the COVID pandemic,” Mary Choi said. “The signs and symptoms of early COVID and hantavirus are really indistinguishable. But the problem is that most people with COVID will live, while most people with hantavirus will die without critical care.”
The overall US case fatality rates are drastically different: 36% to 38% for hantavirus, 1.6% for COVID-19. In Arizona alone, of 81 patients who developed hantavirus (as of 2019), 27 died. In New Mexico, of 117 patients, 51 died.
“The scary part,” said Tarrah Oliver, “was that when patients were flooding our ER with symptoms exactly like those of hantavirus, I kept thinking that it was now up to us in the lab to scrutinize CBC results for any characteristics of hantavirus because our locum providers and permanent providers would likely not have hanta on their minds right now to suspect it.”
“Once COVID hit Navajo Nation, we really worried about how clinicians were going to distinguish between the two disease entities and worried about possible excess deaths of hanta because they were mistaken for COVID-19,” Choi says. “Unfortunately, in the spring of 2020, 2 fatal cases of hantavirus were reported. Their deaths were initially thought to be due to COVID, but later testing showed that they both died of hantavirus. We knew that we had to study whether the 5-point screen could distinguish between hantavirus disease and COVID.”
They conducted the comparison study at TMC and Emory, in Atlanta. TMC, as a small hospital, might not get many COVID cases while Emory, a large hospital system, had many COVID cases but rarely hantavirus cases (Box).
The researchers found that the screen did indeed work as they had hoped. No matter who performed the screen, the demographics of the population screened, or when in the COVID-19 disease course the sample was taken, individuals positive for COVID-19 received a low score on the screen. None of the participants who were positive for COVID-19 demonstrated all 5 hallmarks of hantavirus infection, and only 3 patients received a score of 4.
The screen was most accurate when the specimen was collected during the cardiopulmonary phase. Before the cardiopulmonary phase [BOX], there is a short febrile prodromal phase in which the platelets are starting to drop but aren’t low enough to be considered thrombocytopenic. Hematocrit and hemoglobin levels are still normal, and immunoblasts or plasma cells haven’t been released into the blood yet. “A patient’s score is likely to be pretty low or intermediate,” Tarrah Oliver said. “In the febrile prodromal phase, the patient will have chills, fever, headache and myalgia lasting 3 to 6 days, which might be written off as the flu or even COVID-19, especially if a provider is not familiar with the endemic regions of the Navajo Nation.”
“When we found that the screen could distinguish between the 2 diseases,” Choi said, “we worked frantically to write up the findings and publish so that healthcare providers would be aware of the value of this tool.”
“I couldn’t be more excited that the word is getting out in the medical community,” Oliver said. They plan to share the information as widely as possible, booking local radio spots, for instance. “We’re trying to disseminate our research across our partners on the reservation.”
The results of the research were recently published in the American Journal of Clinical Pathology. “Our next follow-up research will be an inter-rater reliability between TMC’s 2-year and 4-year-degree medical laboratorians and Emory’s pathologists performing the 5-point hantavirus screen on the same slides. We want to show that rural hospitals without the expertise of pathologists can perform this screen for their patients in a timely manner and still get the same outcomes.”
Lastly, and the most exciting, Oliver said, is putting that training manual she created to wider use. In addition to all the case studies she collected, analyzer printouts, and PowerPoint slides about the epidemiology, the manual includes a procedure, billing codes, and layout of what it looks like on certain medical record software that most Indian Health Service hospitals use. “With the manual, we may be able to expand our reach, so I won’t need to travel,” Oliver said. “We could use Zoom to reach further and I could explain it all while they have the manual right in front them.”
So far, nearly 200 screens have been performed at TMC. Four cases of hantavirus disease have been identified. The screen has proved successful, but for Oliver, there’s a personal reward. “I heard stories as a kid of relatives and friends succumbing to this mystery flu in the 1990s and how our parents protected us from it,” she said. “Now I feel like it’s my turn to take care of my family and friends from both hantavirus and COVID, our current ‘mystery flu.’ … I’ve realized that now I’m doing this for our people, the Diné (Navajo) people.”
This article offers some background and follow-up to Hantavirus Disease and COVID-19: Evaluation of the Hantavirus 5-Point Screen in 139 COVID-19 Patients
In May 2016, Tarrah Oliver had been working as a bench tech in hematology at Tséhootsooí Medical Center (TMC) for 4 years when the hospital launched a 5-point screen for detecting hantavirus cardiopulmonary syndrome (HCPS), a potentially fatal disease that disproportionately affects Native Americans.
Developed at the University of New Mexico, the 5-point screen was particularly useful for facilities like TMC, a 56-bed hospital in Arizona serving Navajo Nation patients. Although the Navajo make up only 1.7% of the population, they account for 18% of all reported HCPS cases in the US.
But Oliver, who was the laboratory Safety and Training supervisor, her department supervisor, and his assistant were the only people who knew how to do the screen. “I was storing completed worksheets in a folder,” Oliver said, “and soon I had to transfer them to a 3-inch binder because we had so many being ordered. I started saving slides that scored high so that I could show my fellow lab mates what certain characteristics looked like under the microscope.” She also created case studies to train staff using analyzer printouts and slides from the patients. “It was my little side project to take care of while I was working and training new employees in the hematology department.”
The screen was to become much more than a side project very quickly.
In 2017, there was a hantavirus outbreak in one of the nearby communities. A team from the Centers for Disease Control and Prevention (CDC) came out to visit the local hospitals to educate the medical staff on what to look for in their patients with suspected hantavirus. Among those: the TMC staff. The visit would prove both serendipitous and synergistic.
Mary Choi, MD, MPH, medical officer with the CDC Viral Special Pathogens Branch, said, “Members of my branch were asked to come to Navajo Nation [Lukachukai chapter, Arizona] because of a cluster of hantaviruses cases that had been occurring in the area over the course of a few years. During a meeting with medical providers at TMC, our team met Tarrah and she told us that TMC had implemented the screen. We were really intrigued and impressed by the initiative of this small community hospital.”
“We were excited that the CDC even knew we existed!” Oliver recalled. “This little lab in the middle of the reservation.”
HCPS is rare but severe. It can quickly progress from nonspecific initial symptoms, such as fever, body aches, and shortness of breath, to severe respiratory distress. Without immediate intervention, patients usually die within 24 to 48 hours of the onset of cardiopulmonary symptoms. “What makes the disease even more challenging,” said Choi, “is that some of the critical lifesaving measures that physicians normally employ to save a critically-ill patient can actually make the situation worse.
“For example, when HCPS patients reach the cardiopulmonary phase of the illness, their blood pressure will drop. The normal response to this is to give IV fluids (IVF). But in hantavirus, giving IVF can actually make the signs and symptoms of the disease worse and only judicious use of IVF is recommended.”
She gave other examples of treatment challenges: “Physicians are taught to intubate critically ill patients. However, intubation of hanta patients during the cardiopulmonary phase can actually be detrimental. Also, in general, extracorporeal membrane oxygenation (ECMO) is an intervention of last resort for most critically-ill patients. As the procedure essentially involves hooking the patient up to a heart-lung machine, which has a lot of complications, doctors do not do this unless they have to. But in hantavirus disease, early initiation of ECMO has been shown to significantly improve survival.”
“Another tricky thing about ECMO is that not all hospitals have an ECMO machine… oftentimes patients have to be transferred from one hospital to another because they need ECMO and it is not available where they are.” The ECMO-equipped facility closest to TMC is 170 miles away, at the University of New Mexico Hospital in Albuquerque.
For all those reasons, Dr. Choi said, it is critically important for physicians to know if the patient they are treating has hantavirus or not. The problem is, there is no rapid test for hantavirus disease. The tests have to be sent out to a laboratory and it can take days before physicians receive a test result. “This is where the 5-point screen is such a valuable tool. Although it is not a diagnostic test, it is a very accurate screening tool. Even better, it is readily and widely available, because to perform the screen, you only need a complete blood count (CBC) and a peripheral blood smear…which can be performed in the vast majority of laboratories and clinics. In addition, the CBC and peripheral blood smear are very commonly ordered tests.”
The screen could be particularly crucial for small community hospitals and clinics. “[TMC] took a screen developed by hematopathologists for hematopathologists,” Choi said, “and adapted it so that it could be performed by clinical laboratorians—because hematopathologists don’t exactly grow on trees! Once we heard about the work that TMC was doing, we knew that this was something we wanted to support and advocate for.”
“We started to throw around the idea of teaching this method to other laboratories on the reservation,” Oliver said. She and Mary Choi teamed up to “knock on everyone’s door to see who was utilizing the screening or if they had their own methods of detecting hantavirus in their patients.”
Two years later, they began holding training sessions at a nearby community college; they also trained an entire laboratory at their hospital in late 2019. Plans were to set up other training sessions towards the border towns before spring of 2020.
Then SARS-CoV-2 showed up.
Hantavirus or coronavirus?
COVID-19 hit the Navajo Nation like a sledgehammer. Native Americans in rural areas, as many Navajo are, may have multigenerational and extended families living in tight quarters, with limited access to running water, miles from the nearest healthcare facility. They were particularly vulnerable to a virus that thrives on close contact, at a time when the most common preventives were distancing, frequent handwashing, and testing. By May 2020, the Navajo Nation had surpassed the epicenters—New York and New Jersey—in cases of infection. Even as late as November 2021, the Navah Nation has reported > 37,000 positive cases, and nearly 1,500 confirmed deaths, despite reaching a 70% vaccination rate.
Making things ever more challenging: How do you know whether the patient has hantavirus or COVID-19? The distinction is critical because the disease courses of the 2 infections differ greatly. “The importance of [TMC’s] work was really brought home by the COVID pandemic,” Mary Choi said. “The signs and symptoms of early COVID and hantavirus are really indistinguishable. But the problem is that most people with COVID will live, while most people with hantavirus will die without critical care.”
The overall US case fatality rates are drastically different: 36% to 38% for hantavirus, 1.6% for COVID-19. In Arizona alone, of 81 patients who developed hantavirus (as of 2019), 27 died. In New Mexico, of 117 patients, 51 died.
“The scary part,” said Tarrah Oliver, “was that when patients were flooding our ER with symptoms exactly like those of hantavirus, I kept thinking that it was now up to us in the lab to scrutinize CBC results for any characteristics of hantavirus because our locum providers and permanent providers would likely not have hanta on their minds right now to suspect it.”
“Once COVID hit Navajo Nation, we really worried about how clinicians were going to distinguish between the two disease entities and worried about possible excess deaths of hanta because they were mistaken for COVID-19,” Choi says. “Unfortunately, in the spring of 2020, 2 fatal cases of hantavirus were reported. Their deaths were initially thought to be due to COVID, but later testing showed that they both died of hantavirus. We knew that we had to study whether the 5-point screen could distinguish between hantavirus disease and COVID.”
They conducted the comparison study at TMC and Emory, in Atlanta. TMC, as a small hospital, might not get many COVID cases while Emory, a large hospital system, had many COVID cases but rarely hantavirus cases (Box).
The researchers found that the screen did indeed work as they had hoped. No matter who performed the screen, the demographics of the population screened, or when in the COVID-19 disease course the sample was taken, individuals positive for COVID-19 received a low score on the screen. None of the participants who were positive for COVID-19 demonstrated all 5 hallmarks of hantavirus infection, and only 3 patients received a score of 4.
The screen was most accurate when the specimen was collected during the cardiopulmonary phase. Before the cardiopulmonary phase [BOX], there is a short febrile prodromal phase in which the platelets are starting to drop but aren’t low enough to be considered thrombocytopenic. Hematocrit and hemoglobin levels are still normal, and immunoblasts or plasma cells haven’t been released into the blood yet. “A patient’s score is likely to be pretty low or intermediate,” Tarrah Oliver said. “In the febrile prodromal phase, the patient will have chills, fever, headache and myalgia lasting 3 to 6 days, which might be written off as the flu or even COVID-19, especially if a provider is not familiar with the endemic regions of the Navajo Nation.”
“When we found that the screen could distinguish between the 2 diseases,” Choi said, “we worked frantically to write up the findings and publish so that healthcare providers would be aware of the value of this tool.”
“I couldn’t be more excited that the word is getting out in the medical community,” Oliver said. They plan to share the information as widely as possible, booking local radio spots, for instance. “We’re trying to disseminate our research across our partners on the reservation.”
The results of the research were recently published in the American Journal of Clinical Pathology. “Our next follow-up research will be an inter-rater reliability between TMC’s 2-year and 4-year-degree medical laboratorians and Emory’s pathologists performing the 5-point hantavirus screen on the same slides. We want to show that rural hospitals without the expertise of pathologists can perform this screen for their patients in a timely manner and still get the same outcomes.”
Lastly, and the most exciting, Oliver said, is putting that training manual she created to wider use. In addition to all the case studies she collected, analyzer printouts, and PowerPoint slides about the epidemiology, the manual includes a procedure, billing codes, and layout of what it looks like on certain medical record software that most Indian Health Service hospitals use. “With the manual, we may be able to expand our reach, so I won’t need to travel,” Oliver said. “We could use Zoom to reach further and I could explain it all while they have the manual right in front them.”
So far, nearly 200 screens have been performed at TMC. Four cases of hantavirus disease have been identified. The screen has proved successful, but for Oliver, there’s a personal reward. “I heard stories as a kid of relatives and friends succumbing to this mystery flu in the 1990s and how our parents protected us from it,” she said. “Now I feel like it’s my turn to take care of my family and friends from both hantavirus and COVID, our current ‘mystery flu.’ … I’ve realized that now I’m doing this for our people, the Diné (Navajo) people.”
This article offers some background and follow-up to Hantavirus Disease and COVID-19: Evaluation of the Hantavirus 5-Point Screen in 139 COVID-19 Patients
In May 2016, Tarrah Oliver had been working as a bench tech in hematology at Tséhootsooí Medical Center (TMC) for 4 years when the hospital launched a 5-point screen for detecting hantavirus cardiopulmonary syndrome (HCPS), a potentially fatal disease that disproportionately affects Native Americans.
Developed at the University of New Mexico, the 5-point screen was particularly useful for facilities like TMC, a 56-bed hospital in Arizona serving Navajo Nation patients. Although the Navajo make up only 1.7% of the population, they account for 18% of all reported HCPS cases in the US.
But Oliver, who was the laboratory Safety and Training supervisor, her department supervisor, and his assistant were the only people who knew how to do the screen. “I was storing completed worksheets in a folder,” Oliver said, “and soon I had to transfer them to a 3-inch binder because we had so many being ordered. I started saving slides that scored high so that I could show my fellow lab mates what certain characteristics looked like under the microscope.” She also created case studies to train staff using analyzer printouts and slides from the patients. “It was my little side project to take care of while I was working and training new employees in the hematology department.”
The screen was to become much more than a side project very quickly.
In 2017, there was a hantavirus outbreak in one of the nearby communities. A team from the Centers for Disease Control and Prevention (CDC) came out to visit the local hospitals to educate the medical staff on what to look for in their patients with suspected hantavirus. Among those: the TMC staff. The visit would prove both serendipitous and synergistic.
Mary Choi, MD, MPH, medical officer with the CDC Viral Special Pathogens Branch, said, “Members of my branch were asked to come to Navajo Nation [Lukachukai chapter, Arizona] because of a cluster of hantaviruses cases that had been occurring in the area over the course of a few years. During a meeting with medical providers at TMC, our team met Tarrah and she told us that TMC had implemented the screen. We were really intrigued and impressed by the initiative of this small community hospital.”
“We were excited that the CDC even knew we existed!” Oliver recalled. “This little lab in the middle of the reservation.”
HCPS is rare but severe. It can quickly progress from nonspecific initial symptoms, such as fever, body aches, and shortness of breath, to severe respiratory distress. Without immediate intervention, patients usually die within 24 to 48 hours of the onset of cardiopulmonary symptoms. “What makes the disease even more challenging,” said Choi, “is that some of the critical lifesaving measures that physicians normally employ to save a critically-ill patient can actually make the situation worse.
“For example, when HCPS patients reach the cardiopulmonary phase of the illness, their blood pressure will drop. The normal response to this is to give IV fluids (IVF). But in hantavirus, giving IVF can actually make the signs and symptoms of the disease worse and only judicious use of IVF is recommended.”
She gave other examples of treatment challenges: “Physicians are taught to intubate critically ill patients. However, intubation of hanta patients during the cardiopulmonary phase can actually be detrimental. Also, in general, extracorporeal membrane oxygenation (ECMO) is an intervention of last resort for most critically-ill patients. As the procedure essentially involves hooking the patient up to a heart-lung machine, which has a lot of complications, doctors do not do this unless they have to. But in hantavirus disease, early initiation of ECMO has been shown to significantly improve survival.”
“Another tricky thing about ECMO is that not all hospitals have an ECMO machine… oftentimes patients have to be transferred from one hospital to another because they need ECMO and it is not available where they are.” The ECMO-equipped facility closest to TMC is 170 miles away, at the University of New Mexico Hospital in Albuquerque.
For all those reasons, Dr. Choi said, it is critically important for physicians to know if the patient they are treating has hantavirus or not. The problem is, there is no rapid test for hantavirus disease. The tests have to be sent out to a laboratory and it can take days before physicians receive a test result. “This is where the 5-point screen is such a valuable tool. Although it is not a diagnostic test, it is a very accurate screening tool. Even better, it is readily and widely available, because to perform the screen, you only need a complete blood count (CBC) and a peripheral blood smear…which can be performed in the vast majority of laboratories and clinics. In addition, the CBC and peripheral blood smear are very commonly ordered tests.”
The screen could be particularly crucial for small community hospitals and clinics. “[TMC] took a screen developed by hematopathologists for hematopathologists,” Choi said, “and adapted it so that it could be performed by clinical laboratorians—because hematopathologists don’t exactly grow on trees! Once we heard about the work that TMC was doing, we knew that this was something we wanted to support and advocate for.”
“We started to throw around the idea of teaching this method to other laboratories on the reservation,” Oliver said. She and Mary Choi teamed up to “knock on everyone’s door to see who was utilizing the screening or if they had their own methods of detecting hantavirus in their patients.”
Two years later, they began holding training sessions at a nearby community college; they also trained an entire laboratory at their hospital in late 2019. Plans were to set up other training sessions towards the border towns before spring of 2020.
Then SARS-CoV-2 showed up.
Hantavirus or coronavirus?
COVID-19 hit the Navajo Nation like a sledgehammer. Native Americans in rural areas, as many Navajo are, may have multigenerational and extended families living in tight quarters, with limited access to running water, miles from the nearest healthcare facility. They were particularly vulnerable to a virus that thrives on close contact, at a time when the most common preventives were distancing, frequent handwashing, and testing. By May 2020, the Navajo Nation had surpassed the epicenters—New York and New Jersey—in cases of infection. Even as late as November 2021, the Navah Nation has reported > 37,000 positive cases, and nearly 1,500 confirmed deaths, despite reaching a 70% vaccination rate.
Making things ever more challenging: How do you know whether the patient has hantavirus or COVID-19? The distinction is critical because the disease courses of the 2 infections differ greatly. “The importance of [TMC’s] work was really brought home by the COVID pandemic,” Mary Choi said. “The signs and symptoms of early COVID and hantavirus are really indistinguishable. But the problem is that most people with COVID will live, while most people with hantavirus will die without critical care.”
The overall US case fatality rates are drastically different: 36% to 38% for hantavirus, 1.6% for COVID-19. In Arizona alone, of 81 patients who developed hantavirus (as of 2019), 27 died. In New Mexico, of 117 patients, 51 died.
“The scary part,” said Tarrah Oliver, “was that when patients were flooding our ER with symptoms exactly like those of hantavirus, I kept thinking that it was now up to us in the lab to scrutinize CBC results for any characteristics of hantavirus because our locum providers and permanent providers would likely not have hanta on their minds right now to suspect it.”
“Once COVID hit Navajo Nation, we really worried about how clinicians were going to distinguish between the two disease entities and worried about possible excess deaths of hanta because they were mistaken for COVID-19,” Choi says. “Unfortunately, in the spring of 2020, 2 fatal cases of hantavirus were reported. Their deaths were initially thought to be due to COVID, but later testing showed that they both died of hantavirus. We knew that we had to study whether the 5-point screen could distinguish between hantavirus disease and COVID.”
They conducted the comparison study at TMC and Emory, in Atlanta. TMC, as a small hospital, might not get many COVID cases while Emory, a large hospital system, had many COVID cases but rarely hantavirus cases (Box).
The researchers found that the screen did indeed work as they had hoped. No matter who performed the screen, the demographics of the population screened, or when in the COVID-19 disease course the sample was taken, individuals positive for COVID-19 received a low score on the screen. None of the participants who were positive for COVID-19 demonstrated all 5 hallmarks of hantavirus infection, and only 3 patients received a score of 4.
The screen was most accurate when the specimen was collected during the cardiopulmonary phase. Before the cardiopulmonary phase [BOX], there is a short febrile prodromal phase in which the platelets are starting to drop but aren’t low enough to be considered thrombocytopenic. Hematocrit and hemoglobin levels are still normal, and immunoblasts or plasma cells haven’t been released into the blood yet. “A patient’s score is likely to be pretty low or intermediate,” Tarrah Oliver said. “In the febrile prodromal phase, the patient will have chills, fever, headache and myalgia lasting 3 to 6 days, which might be written off as the flu or even COVID-19, especially if a provider is not familiar with the endemic regions of the Navajo Nation.”
“When we found that the screen could distinguish between the 2 diseases,” Choi said, “we worked frantically to write up the findings and publish so that healthcare providers would be aware of the value of this tool.”
“I couldn’t be more excited that the word is getting out in the medical community,” Oliver said. They plan to share the information as widely as possible, booking local radio spots, for instance. “We’re trying to disseminate our research across our partners on the reservation.”
The results of the research were recently published in the American Journal of Clinical Pathology. “Our next follow-up research will be an inter-rater reliability between TMC’s 2-year and 4-year-degree medical laboratorians and Emory’s pathologists performing the 5-point hantavirus screen on the same slides. We want to show that rural hospitals without the expertise of pathologists can perform this screen for their patients in a timely manner and still get the same outcomes.”
Lastly, and the most exciting, Oliver said, is putting that training manual she created to wider use. In addition to all the case studies she collected, analyzer printouts, and PowerPoint slides about the epidemiology, the manual includes a procedure, billing codes, and layout of what it looks like on certain medical record software that most Indian Health Service hospitals use. “With the manual, we may be able to expand our reach, so I won’t need to travel,” Oliver said. “We could use Zoom to reach further and I could explain it all while they have the manual right in front them.”
So far, nearly 200 screens have been performed at TMC. Four cases of hantavirus disease have been identified. The screen has proved successful, but for Oliver, there’s a personal reward. “I heard stories as a kid of relatives and friends succumbing to this mystery flu in the 1990s and how our parents protected us from it,” she said. “Now I feel like it’s my turn to take care of my family and friends from both hantavirus and COVID, our current ‘mystery flu.’ … I’ve realized that now I’m doing this for our people, the Diné (Navajo) people.”
This article offers some background and follow-up to Hantavirus Disease and COVID-19: Evaluation of the Hantavirus 5-Point Screen in 139 COVID-19 Patients
Vegetable fats tied to lower stroke risk, animal fats to higher risk
Higher intake of vegetable fats from foods such as olive oil and nuts is associated with a lower risk for stroke, whereas people who eat more animal fats, especially processed red meats, may have a higher stroke risk, observational findings suggest.
In a study of more than 117,000 health professionals who were followed for 27 years, those whose diet was in the highest quintile for intake of vegetable fat had a 12% lower risk for stroke, compared with those who consumed the least amount of vegetable fats.
Conversely, having the highest intake of animal fat from nondairy sources was associated with a 16% increased risk of stroke.
Fenglei Wang, PhD, presented these results at the American Heart Association scientific sessions.
“Our findings support the Dietary Guidelines for Americans and dietary recommendations by AHA,” Dr. Wang, a postdoctoral fellow in the department of nutrition at Harvard University’s T.H. Chan School of Public Health in Boston, told this news organization.
“The main sources of vegetable fat have a large overlap with polyunsaturated fat, such as vegetable oils, nuts, walnuts, and peanut butter,” Dr. Wang noted, adding that fish, especially fatty fish, is a main source of polyunsaturated fat and is recommended for cardiovascular health.
“We would recommend that people reduce consumption of red and processed meat, minimize fatty parts of unprocessed meat if consumed, and replace lard or tallow (beef fat) with nontropical vegetable oils, such as olive oil, corn, or soybean oils in cooking, to lower their stroke risk,” she said.
Moreover, although the results from this study of dietary fat are informative, Dr. Wang continued, “there are other dietary factors (fruits, vegetables, salt, alcohol, et cetera), and lifestyle factors (physical activity, smoking, et cetera), that are associated with stroke risk and worthy of attention as well.”
“Many processed meats are high in salt and saturated fat, and low in vegetable fat,” Alice H. Lichtenstein, DSc, an AHA spokesperson who was not involved with this research, noted in a press release.
“Research shows that replacing processed meat with other protein sources, particularly plant sources, is associated with lower death rates,” added Dr. Lichtenstein, the Stanley N. Gershoff professor of nutrition science and policy at Tufts University in Boston, and lead author of the AHA’s 2021 scientific statement, Dietary Guidance to Improve Cardiovascular Health.
“Key features of a heart-healthy diet pattern,” she summarized, “are to balance calorie intake with calorie needs to achieve and maintain a healthy weight; choose whole grains, lean and plant-based protein, and a variety of fruits and vegetables; limit salt, sugar, animal fat, processed foods, and alcohol; and apply this guidance regardless of where the food is prepared or consumed.”
Replace processed meat with plant proteins
The focus on stroke in this study “is important” because, traditionally, studies of diet and cardiovascular health have focused on coronary heart disease, Andrew Mente, PhD, who also was not involved in this research, said in an email to this news organization.
“Overall, the take-home message from the study is that replacing processed meat with plant sources of protein in the diet is probably beneficial,” Dr. Mente, associate professor, health research methods, evidence, and impact, Faculty of Health Sciences, McMaster University, Hamilton, Ont., said.
The finding that people who ate the most vegetable fat had a modest 12% lower risk of stroke than those who ate the least vegetable fat “points to protective effects of foods like seeds, nuts, vegetables, and olive oil, which has been shown previously,” he continued.
The highest quintile of total red meat intake was associated with an 8% higher risk for stroke, but this was driven mainly by processed red meat (which was associated with a 12% higher risk for stroke). These findings are “generally consistent with cohort studies showing that processed meat, as with most highly processed foods for that matter, are associated with an increased risk of cardiovascular events,” Dr. Mente noted.
“Surprisingly, dairy products (such as cheese, butter, or milk) in the study were not connected with the risk of stroke,” he added. This finding differs from results of meta-analyses of multiple cohort studies of dairy intake and stroke and the recent large international PURE study, which showed that dairy intake was associated with a lower risk for stroke.
“What is needed to move the field forward,” according to Dr. Mente, “is to employ new methods that use cutting-edge technology to study nutritional biomarkers and health outcomes.”
“When dealing with modest associations as usually encountered in nutrition, it is a challenge to make causal connections based on dietary questionnaires, which are fraught with measurement error,” he added. “The use of novel methods is where the field is headed.”
Total dietary fat, different types, and different food sources
Dr. Wang and colleagues investigated how total dietary fat, different types of fat, and fats from different foods were associated with incident stroke in 73,867 women in the 1984-2016 Nurses’ Health Study and 43,269 men who participated in the 1986-2016 Health Professionals Follow-up Study.
The participants had an average age of 50 years, 63% were women, and 97% were White. They replied to food-frequency questionnaires every 4 years.
Total red meat included beef, pork, or lamb (as a main dish or in sandwiches or mixed dishes) as well as processed red meats (such as bacon, sausage, bologna, hot dogs, and salami).
Animal fat sources included meat, beef tallow, lard, and full-fat dairy products, such as full-fat milk and cheese.
The median percentage of total daily calories from different sources of fat ranged from 10% to 20% for vegetable fat, 3% to 10% for dairy fat, and 7% to 17% for nondairy animal fat (for lowest to highest quintiles).
The median percentage of total daily calories from different types of fat ranged from 5% to 8% for polyunsaturated fat, 4% to 7% for n-6 polyunsaturated fat, 9% to 15% for monounsaturated fat, 8% to 14% for saturated fat, and 1% to 2% for trans fat.
During follow-up, there were 6,189 incident strokes, including 2,967 ischemic strokes and 814 hemorrhagic strokes.
The researchers found that intake in the highest quintile of vegetable fat was associated with a lower risk for total stroke, compared with the lowest quintile (hazard ratio, 0.88; 95% confidence interval, 0.81-0.96; P for trend < .001).
Similarly, the highest intake of polyunsaturated fat was also associated with lower total stroke (HR, 0.88; 95% CI, 0.80-0.96; P for trend = .002).
Highest intake of nondairy animal fat, however, was associated with an increased risk for total stroke (HR, 1.16; 95% CI, 1.05-1.29; P for trend < .001). They observed “similar associations” for ischemic stroke, but the only positive association for nondairy animal fat was with hemorrhagic stroke, the abstract notes.
The risk for stroke was lower by 9% per serving per day for vegetable oil but increased by 8% and 12%, respectively, per serving of total red meat or processed red meat.
The association for vegetable oil was attenuated after adjustment for vegetable fat or polyunsaturated fat, whereas adjustment for nondairy animal fat rendered the association for total red meat and processed red meat nonsignificant.
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Wang has no relevant financial disclosures. Dr. Mente has received research funding from the Dairy Farmers of Canada and the National Dairy Council to analyze data on dairy consumption and health outcomes in the PURE study, which is funded by the Population Health Research Institute, Hamilton Health Sciences Research Institute, and more than 70 other sources (government and pharmaceutical).
A version of this article first appeared on Medscape.com.
Higher intake of vegetable fats from foods such as olive oil and nuts is associated with a lower risk for stroke, whereas people who eat more animal fats, especially processed red meats, may have a higher stroke risk, observational findings suggest.
In a study of more than 117,000 health professionals who were followed for 27 years, those whose diet was in the highest quintile for intake of vegetable fat had a 12% lower risk for stroke, compared with those who consumed the least amount of vegetable fats.
Conversely, having the highest intake of animal fat from nondairy sources was associated with a 16% increased risk of stroke.
Fenglei Wang, PhD, presented these results at the American Heart Association scientific sessions.
“Our findings support the Dietary Guidelines for Americans and dietary recommendations by AHA,” Dr. Wang, a postdoctoral fellow in the department of nutrition at Harvard University’s T.H. Chan School of Public Health in Boston, told this news organization.
“The main sources of vegetable fat have a large overlap with polyunsaturated fat, such as vegetable oils, nuts, walnuts, and peanut butter,” Dr. Wang noted, adding that fish, especially fatty fish, is a main source of polyunsaturated fat and is recommended for cardiovascular health.
“We would recommend that people reduce consumption of red and processed meat, minimize fatty parts of unprocessed meat if consumed, and replace lard or tallow (beef fat) with nontropical vegetable oils, such as olive oil, corn, or soybean oils in cooking, to lower their stroke risk,” she said.
Moreover, although the results from this study of dietary fat are informative, Dr. Wang continued, “there are other dietary factors (fruits, vegetables, salt, alcohol, et cetera), and lifestyle factors (physical activity, smoking, et cetera), that are associated with stroke risk and worthy of attention as well.”
“Many processed meats are high in salt and saturated fat, and low in vegetable fat,” Alice H. Lichtenstein, DSc, an AHA spokesperson who was not involved with this research, noted in a press release.
“Research shows that replacing processed meat with other protein sources, particularly plant sources, is associated with lower death rates,” added Dr. Lichtenstein, the Stanley N. Gershoff professor of nutrition science and policy at Tufts University in Boston, and lead author of the AHA’s 2021 scientific statement, Dietary Guidance to Improve Cardiovascular Health.
“Key features of a heart-healthy diet pattern,” she summarized, “are to balance calorie intake with calorie needs to achieve and maintain a healthy weight; choose whole grains, lean and plant-based protein, and a variety of fruits and vegetables; limit salt, sugar, animal fat, processed foods, and alcohol; and apply this guidance regardless of where the food is prepared or consumed.”
Replace processed meat with plant proteins
The focus on stroke in this study “is important” because, traditionally, studies of diet and cardiovascular health have focused on coronary heart disease, Andrew Mente, PhD, who also was not involved in this research, said in an email to this news organization.
“Overall, the take-home message from the study is that replacing processed meat with plant sources of protein in the diet is probably beneficial,” Dr. Mente, associate professor, health research methods, evidence, and impact, Faculty of Health Sciences, McMaster University, Hamilton, Ont., said.
The finding that people who ate the most vegetable fat had a modest 12% lower risk of stroke than those who ate the least vegetable fat “points to protective effects of foods like seeds, nuts, vegetables, and olive oil, which has been shown previously,” he continued.
The highest quintile of total red meat intake was associated with an 8% higher risk for stroke, but this was driven mainly by processed red meat (which was associated with a 12% higher risk for stroke). These findings are “generally consistent with cohort studies showing that processed meat, as with most highly processed foods for that matter, are associated with an increased risk of cardiovascular events,” Dr. Mente noted.
“Surprisingly, dairy products (such as cheese, butter, or milk) in the study were not connected with the risk of stroke,” he added. This finding differs from results of meta-analyses of multiple cohort studies of dairy intake and stroke and the recent large international PURE study, which showed that dairy intake was associated with a lower risk for stroke.
“What is needed to move the field forward,” according to Dr. Mente, “is to employ new methods that use cutting-edge technology to study nutritional biomarkers and health outcomes.”
“When dealing with modest associations as usually encountered in nutrition, it is a challenge to make causal connections based on dietary questionnaires, which are fraught with measurement error,” he added. “The use of novel methods is where the field is headed.”
Total dietary fat, different types, and different food sources
Dr. Wang and colleagues investigated how total dietary fat, different types of fat, and fats from different foods were associated with incident stroke in 73,867 women in the 1984-2016 Nurses’ Health Study and 43,269 men who participated in the 1986-2016 Health Professionals Follow-up Study.
The participants had an average age of 50 years, 63% were women, and 97% were White. They replied to food-frequency questionnaires every 4 years.
Total red meat included beef, pork, or lamb (as a main dish or in sandwiches or mixed dishes) as well as processed red meats (such as bacon, sausage, bologna, hot dogs, and salami).
Animal fat sources included meat, beef tallow, lard, and full-fat dairy products, such as full-fat milk and cheese.
The median percentage of total daily calories from different sources of fat ranged from 10% to 20% for vegetable fat, 3% to 10% for dairy fat, and 7% to 17% for nondairy animal fat (for lowest to highest quintiles).
The median percentage of total daily calories from different types of fat ranged from 5% to 8% for polyunsaturated fat, 4% to 7% for n-6 polyunsaturated fat, 9% to 15% for monounsaturated fat, 8% to 14% for saturated fat, and 1% to 2% for trans fat.
During follow-up, there were 6,189 incident strokes, including 2,967 ischemic strokes and 814 hemorrhagic strokes.
The researchers found that intake in the highest quintile of vegetable fat was associated with a lower risk for total stroke, compared with the lowest quintile (hazard ratio, 0.88; 95% confidence interval, 0.81-0.96; P for trend < .001).
Similarly, the highest intake of polyunsaturated fat was also associated with lower total stroke (HR, 0.88; 95% CI, 0.80-0.96; P for trend = .002).
Highest intake of nondairy animal fat, however, was associated with an increased risk for total stroke (HR, 1.16; 95% CI, 1.05-1.29; P for trend < .001). They observed “similar associations” for ischemic stroke, but the only positive association for nondairy animal fat was with hemorrhagic stroke, the abstract notes.
The risk for stroke was lower by 9% per serving per day for vegetable oil but increased by 8% and 12%, respectively, per serving of total red meat or processed red meat.
The association for vegetable oil was attenuated after adjustment for vegetable fat or polyunsaturated fat, whereas adjustment for nondairy animal fat rendered the association for total red meat and processed red meat nonsignificant.
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Wang has no relevant financial disclosures. Dr. Mente has received research funding from the Dairy Farmers of Canada and the National Dairy Council to analyze data on dairy consumption and health outcomes in the PURE study, which is funded by the Population Health Research Institute, Hamilton Health Sciences Research Institute, and more than 70 other sources (government and pharmaceutical).
A version of this article first appeared on Medscape.com.
Higher intake of vegetable fats from foods such as olive oil and nuts is associated with a lower risk for stroke, whereas people who eat more animal fats, especially processed red meats, may have a higher stroke risk, observational findings suggest.
In a study of more than 117,000 health professionals who were followed for 27 years, those whose diet was in the highest quintile for intake of vegetable fat had a 12% lower risk for stroke, compared with those who consumed the least amount of vegetable fats.
Conversely, having the highest intake of animal fat from nondairy sources was associated with a 16% increased risk of stroke.
Fenglei Wang, PhD, presented these results at the American Heart Association scientific sessions.
“Our findings support the Dietary Guidelines for Americans and dietary recommendations by AHA,” Dr. Wang, a postdoctoral fellow in the department of nutrition at Harvard University’s T.H. Chan School of Public Health in Boston, told this news organization.
“The main sources of vegetable fat have a large overlap with polyunsaturated fat, such as vegetable oils, nuts, walnuts, and peanut butter,” Dr. Wang noted, adding that fish, especially fatty fish, is a main source of polyunsaturated fat and is recommended for cardiovascular health.
“We would recommend that people reduce consumption of red and processed meat, minimize fatty parts of unprocessed meat if consumed, and replace lard or tallow (beef fat) with nontropical vegetable oils, such as olive oil, corn, or soybean oils in cooking, to lower their stroke risk,” she said.
Moreover, although the results from this study of dietary fat are informative, Dr. Wang continued, “there are other dietary factors (fruits, vegetables, salt, alcohol, et cetera), and lifestyle factors (physical activity, smoking, et cetera), that are associated with stroke risk and worthy of attention as well.”
“Many processed meats are high in salt and saturated fat, and low in vegetable fat,” Alice H. Lichtenstein, DSc, an AHA spokesperson who was not involved with this research, noted in a press release.
“Research shows that replacing processed meat with other protein sources, particularly plant sources, is associated with lower death rates,” added Dr. Lichtenstein, the Stanley N. Gershoff professor of nutrition science and policy at Tufts University in Boston, and lead author of the AHA’s 2021 scientific statement, Dietary Guidance to Improve Cardiovascular Health.
“Key features of a heart-healthy diet pattern,” she summarized, “are to balance calorie intake with calorie needs to achieve and maintain a healthy weight; choose whole grains, lean and plant-based protein, and a variety of fruits and vegetables; limit salt, sugar, animal fat, processed foods, and alcohol; and apply this guidance regardless of where the food is prepared or consumed.”
Replace processed meat with plant proteins
The focus on stroke in this study “is important” because, traditionally, studies of diet and cardiovascular health have focused on coronary heart disease, Andrew Mente, PhD, who also was not involved in this research, said in an email to this news organization.
“Overall, the take-home message from the study is that replacing processed meat with plant sources of protein in the diet is probably beneficial,” Dr. Mente, associate professor, health research methods, evidence, and impact, Faculty of Health Sciences, McMaster University, Hamilton, Ont., said.
The finding that people who ate the most vegetable fat had a modest 12% lower risk of stroke than those who ate the least vegetable fat “points to protective effects of foods like seeds, nuts, vegetables, and olive oil, which has been shown previously,” he continued.
The highest quintile of total red meat intake was associated with an 8% higher risk for stroke, but this was driven mainly by processed red meat (which was associated with a 12% higher risk for stroke). These findings are “generally consistent with cohort studies showing that processed meat, as with most highly processed foods for that matter, are associated with an increased risk of cardiovascular events,” Dr. Mente noted.
“Surprisingly, dairy products (such as cheese, butter, or milk) in the study were not connected with the risk of stroke,” he added. This finding differs from results of meta-analyses of multiple cohort studies of dairy intake and stroke and the recent large international PURE study, which showed that dairy intake was associated with a lower risk for stroke.
“What is needed to move the field forward,” according to Dr. Mente, “is to employ new methods that use cutting-edge technology to study nutritional biomarkers and health outcomes.”
“When dealing with modest associations as usually encountered in nutrition, it is a challenge to make causal connections based on dietary questionnaires, which are fraught with measurement error,” he added. “The use of novel methods is where the field is headed.”
Total dietary fat, different types, and different food sources
Dr. Wang and colleagues investigated how total dietary fat, different types of fat, and fats from different foods were associated with incident stroke in 73,867 women in the 1984-2016 Nurses’ Health Study and 43,269 men who participated in the 1986-2016 Health Professionals Follow-up Study.
The participants had an average age of 50 years, 63% were women, and 97% were White. They replied to food-frequency questionnaires every 4 years.
Total red meat included beef, pork, or lamb (as a main dish or in sandwiches or mixed dishes) as well as processed red meats (such as bacon, sausage, bologna, hot dogs, and salami).
Animal fat sources included meat, beef tallow, lard, and full-fat dairy products, such as full-fat milk and cheese.
The median percentage of total daily calories from different sources of fat ranged from 10% to 20% for vegetable fat, 3% to 10% for dairy fat, and 7% to 17% for nondairy animal fat (for lowest to highest quintiles).
The median percentage of total daily calories from different types of fat ranged from 5% to 8% for polyunsaturated fat, 4% to 7% for n-6 polyunsaturated fat, 9% to 15% for monounsaturated fat, 8% to 14% for saturated fat, and 1% to 2% for trans fat.
During follow-up, there were 6,189 incident strokes, including 2,967 ischemic strokes and 814 hemorrhagic strokes.
The researchers found that intake in the highest quintile of vegetable fat was associated with a lower risk for total stroke, compared with the lowest quintile (hazard ratio, 0.88; 95% confidence interval, 0.81-0.96; P for trend < .001).
Similarly, the highest intake of polyunsaturated fat was also associated with lower total stroke (HR, 0.88; 95% CI, 0.80-0.96; P for trend = .002).
Highest intake of nondairy animal fat, however, was associated with an increased risk for total stroke (HR, 1.16; 95% CI, 1.05-1.29; P for trend < .001). They observed “similar associations” for ischemic stroke, but the only positive association for nondairy animal fat was with hemorrhagic stroke, the abstract notes.
The risk for stroke was lower by 9% per serving per day for vegetable oil but increased by 8% and 12%, respectively, per serving of total red meat or processed red meat.
The association for vegetable oil was attenuated after adjustment for vegetable fat or polyunsaturated fat, whereas adjustment for nondairy animal fat rendered the association for total red meat and processed red meat nonsignificant.
The study was funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health. Dr. Wang has no relevant financial disclosures. Dr. Mente has received research funding from the Dairy Farmers of Canada and the National Dairy Council to analyze data on dairy consumption and health outcomes in the PURE study, which is funded by the Population Health Research Institute, Hamilton Health Sciences Research Institute, and more than 70 other sources (government and pharmaceutical).
A version of this article first appeared on Medscape.com.
FROM AHA 2021
Substantial declines in mortality for most cancers
according to a new analysis.
Researchers found that rates for all cancers combined declined by 27% overall between 1971 and 2019 and decreased significantly for 12 of the 15 top cancer sites analyzed.
The data revealed even greater mortality declines for certain cancers in particular years. For example, mortality from lung cancer was 44% lower in 2019, compared with its peak rate in 1993, whereas it was only 13% lower, compared with morality rates in 1971.
“The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment,” lead author Ahmedin Jemal, DVM, PhD, American Cancer Society, Kennesaw, Ga., and colleagues wrote.
Advances in surgery, radiotherapy, chemotherapy, precision medicine, and combinations therapies over the past 5 decades have contributed to these significant declines in mortality, Dr. Jemal and colleagues explained. The researchers also credit the “expanded investment” in the National Cancer Institute’s annual budget following the 1971 National Cancer Act, which increased the budget 25-fold from $227 million in 1971 to $6 billion in 2019.
The report, published online Nov. 11, 2021, in JAMA Oncology, analyzed mortality rates for all cancers as well as the top 15 sites using the National Center for Health Statistics.
The researchers found that, overall, deaths declined significantly for all cancers over the study period. Some of the biggest headway since 1971 occurred for stomach and cervical cancers – with 72% and 69% lower mortality rates, respectively – as well as colorectal cancer (56%), oral cavity and pharynx cancer (43%), and ovarian cancer (41%). Mortality rates of female breast cancer and prostate cancer also dropped considerably – both by 39%.
“The decline in mortality for female breast, cervical, colorectal, and prostate cancer in part reflects increased detection (and removal) of premalignant lesions and early-stage cancers,” Dr. Jemal and colleagues noted.
Data suggest that screening likely explains about half of the observed decline in mortality from colorectal cancer between 1975 and 2002. A 2018 study also found that the use of adjuvant chemotherapy was responsible for 63% of the decline in mortality from female breast cancer between 2000 and 2012.
In addition, the authors noted, “the decline in lung, oral cavity and bladder cancers largely reflects reductions in smoking because of enhanced public awareness of the health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws.”
However, mortality did increase in a few categories. For instance, the mortality rate from pancreatic cancer increased by 3% between 1971 and 2019, and by 8% for both esophageal and brain cancers. Mortality rates from cancer were also greater for 29% of the U.S. counties included in the analysis, mostly those in the South.
The increase in mortality from pancreatic cancer likely reflects the growing rates of obesity in the United States, along with no real advances in pancreatic cancer prevention, early detection, or treatment, the authors suggested. In addition, lack of progress in regions of the south may be related to unequal access to improvements in treatment compared with other parts of the country.
“Improving equity through investment in the social determinants of health and implementation research is critical to furthering the national cancer-control agenda,” the authors concluded.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new analysis.
Researchers found that rates for all cancers combined declined by 27% overall between 1971 and 2019 and decreased significantly for 12 of the 15 top cancer sites analyzed.
The data revealed even greater mortality declines for certain cancers in particular years. For example, mortality from lung cancer was 44% lower in 2019, compared with its peak rate in 1993, whereas it was only 13% lower, compared with morality rates in 1971.
“The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment,” lead author Ahmedin Jemal, DVM, PhD, American Cancer Society, Kennesaw, Ga., and colleagues wrote.
Advances in surgery, radiotherapy, chemotherapy, precision medicine, and combinations therapies over the past 5 decades have contributed to these significant declines in mortality, Dr. Jemal and colleagues explained. The researchers also credit the “expanded investment” in the National Cancer Institute’s annual budget following the 1971 National Cancer Act, which increased the budget 25-fold from $227 million in 1971 to $6 billion in 2019.
The report, published online Nov. 11, 2021, in JAMA Oncology, analyzed mortality rates for all cancers as well as the top 15 sites using the National Center for Health Statistics.
The researchers found that, overall, deaths declined significantly for all cancers over the study period. Some of the biggest headway since 1971 occurred for stomach and cervical cancers – with 72% and 69% lower mortality rates, respectively – as well as colorectal cancer (56%), oral cavity and pharynx cancer (43%), and ovarian cancer (41%). Mortality rates of female breast cancer and prostate cancer also dropped considerably – both by 39%.
“The decline in mortality for female breast, cervical, colorectal, and prostate cancer in part reflects increased detection (and removal) of premalignant lesions and early-stage cancers,” Dr. Jemal and colleagues noted.
Data suggest that screening likely explains about half of the observed decline in mortality from colorectal cancer between 1975 and 2002. A 2018 study also found that the use of adjuvant chemotherapy was responsible for 63% of the decline in mortality from female breast cancer between 2000 and 2012.
In addition, the authors noted, “the decline in lung, oral cavity and bladder cancers largely reflects reductions in smoking because of enhanced public awareness of the health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws.”
However, mortality did increase in a few categories. For instance, the mortality rate from pancreatic cancer increased by 3% between 1971 and 2019, and by 8% for both esophageal and brain cancers. Mortality rates from cancer were also greater for 29% of the U.S. counties included in the analysis, mostly those in the South.
The increase in mortality from pancreatic cancer likely reflects the growing rates of obesity in the United States, along with no real advances in pancreatic cancer prevention, early detection, or treatment, the authors suggested. In addition, lack of progress in regions of the south may be related to unequal access to improvements in treatment compared with other parts of the country.
“Improving equity through investment in the social determinants of health and implementation research is critical to furthering the national cancer-control agenda,” the authors concluded.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to a new analysis.
Researchers found that rates for all cancers combined declined by 27% overall between 1971 and 2019 and decreased significantly for 12 of the 15 top cancer sites analyzed.
The data revealed even greater mortality declines for certain cancers in particular years. For example, mortality from lung cancer was 44% lower in 2019, compared with its peak rate in 1993, whereas it was only 13% lower, compared with morality rates in 1971.
“The cancer mortality rate has reduced considerably since 1971 overall and for most cancer sites because of improvements in prevention, early detection, and treatment,” lead author Ahmedin Jemal, DVM, PhD, American Cancer Society, Kennesaw, Ga., and colleagues wrote.
Advances in surgery, radiotherapy, chemotherapy, precision medicine, and combinations therapies over the past 5 decades have contributed to these significant declines in mortality, Dr. Jemal and colleagues explained. The researchers also credit the “expanded investment” in the National Cancer Institute’s annual budget following the 1971 National Cancer Act, which increased the budget 25-fold from $227 million in 1971 to $6 billion in 2019.
The report, published online Nov. 11, 2021, in JAMA Oncology, analyzed mortality rates for all cancers as well as the top 15 sites using the National Center for Health Statistics.
The researchers found that, overall, deaths declined significantly for all cancers over the study period. Some of the biggest headway since 1971 occurred for stomach and cervical cancers – with 72% and 69% lower mortality rates, respectively – as well as colorectal cancer (56%), oral cavity and pharynx cancer (43%), and ovarian cancer (41%). Mortality rates of female breast cancer and prostate cancer also dropped considerably – both by 39%.
“The decline in mortality for female breast, cervical, colorectal, and prostate cancer in part reflects increased detection (and removal) of premalignant lesions and early-stage cancers,” Dr. Jemal and colleagues noted.
Data suggest that screening likely explains about half of the observed decline in mortality from colorectal cancer between 1975 and 2002. A 2018 study also found that the use of adjuvant chemotherapy was responsible for 63% of the decline in mortality from female breast cancer between 2000 and 2012.
In addition, the authors noted, “the decline in lung, oral cavity and bladder cancers largely reflects reductions in smoking because of enhanced public awareness of the health consequences, implementation of increased cigarette excise taxes, and comprehensive smoke-free laws.”
However, mortality did increase in a few categories. For instance, the mortality rate from pancreatic cancer increased by 3% between 1971 and 2019, and by 8% for both esophageal and brain cancers. Mortality rates from cancer were also greater for 29% of the U.S. counties included in the analysis, mostly those in the South.
The increase in mortality from pancreatic cancer likely reflects the growing rates of obesity in the United States, along with no real advances in pancreatic cancer prevention, early detection, or treatment, the authors suggested. In addition, lack of progress in regions of the south may be related to unequal access to improvements in treatment compared with other parts of the country.
“Improving equity through investment in the social determinants of health and implementation research is critical to furthering the national cancer-control agenda,” the authors concluded.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA ONCOLOGY
New Mexico oncologist faces legal woes once again
A New Mexico oncologist has once again found himself at odds with the law.
Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.
In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.
Mr. Hoag’s attorneys alleged that
“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.
The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.
The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.
Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
Only oncologist in the county
The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.
Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.
Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.
However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.
Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.
However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.
By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
Previous misdemeanor with misbranded drugs
At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.
Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.
A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.
According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.
Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.
At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
Allowed to resume practice
In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.
He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.
Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.
With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”
A version of this article first appeared on Medscape.com.
A New Mexico oncologist has once again found himself at odds with the law.
Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.
In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.
Mr. Hoag’s attorneys alleged that
“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.
The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.
The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.
Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
Only oncologist in the county
The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.
Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.
Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.
However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.
Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.
However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.
By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
Previous misdemeanor with misbranded drugs
At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.
Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.
A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.
According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.
Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.
At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
Allowed to resume practice
In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.
He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.
Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.
With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”
A version of this article first appeared on Medscape.com.
A New Mexico oncologist has once again found himself at odds with the law.
Mohamed Aswad, MD, was still under probation for a past misdemeanor involving misbranded cancer drugs when he allegedly underdosed chemotherapy in a patient with colon cancer. The patient later died.
In a wrongful death case, a jury has awarded $2.3 million in damages to the patient’s wife. The patient, James Hoag, was diagnosed with stage IIIB colon cancer in 2015. He underwent surgery and then went for chemotherapy to Dr. Aswad, who was the only oncologist in the area.
Mr. Hoag’s attorneys alleged that
“It was statistically likely that James would beat his cancer with proper treatment,” said his lawyers during the trial, according to a report in the Albuquerque Journal.
The jury deliberated for only 4 hours, and found that negligence by Dr. Aswad was a proximate cause of the patient’s “lost chance to avoid the loss of his life and resulting damages,” and the jury further described Dr. Aswad’s actions as “wanton,” according to a verdict form filed in the case.
The form also shows that the jury decided Dr. Aswad had obtained Mr. Hoag’s informed consent as to the treatment, but still felt that negligence was a cause of Mr. Hoag’s injury and damages. The original judgment of $2.9 million in damages was subsequently reduced to $2.3 million as the jury found Mr. Hoag was 30% responsible for his injuries.
Dr. Aswad could not be reached for comment. The Albuquerque Journal reports that he plans to appeal the verdict.
Only oncologist in the county
The patient had lived in the rural community of Deming, N.M. following his retirement from a career in law enforcement in Michigan. He was diagnosed with colon cancer in 2015, underwent surgical resection, and then went to Dr. Aswad for follow-up chemotherapy.
Dr. Aswad was the only oncologist in the area. Like many other rural communities throughout the United States, this region has a severe shortage of medical specialists.
Sheila Hoag, the patient’s widow, testified during the trial that following her husband’s surgery in August 2015, which removed the tumor, his “prognosis was very good because they had caught it before it spread.” He had an estimated 5-year survival of about 69%.
However, even though Dr. Aswad followed the National Comprehensive Cancer Network (NCCN) guidelines for adjuvant chemotherapy, he did not use the proper dosing. According to trial testimony, he administered “woefully lower doses” than are recommended, and also exceeded the recommended 6-month duration of chemotherapy by more than double. In addition, Dr. Aswad also failed to adequately monitor the disease during treatment, said Hoag’s lawyers.
Aswad has denied the charges and says that he prescribed a modified regimen spread out over a longer period of time because his patient had requested it. He said that Mr. Hoag did not want to undergo chemotherapy that could cause significant side effects, and this was the reason for the altered treatment plan.
However, the chemotherapy failed to slow the cancer’s progression, and Mr. Hoag never returned to see him after November 2016.
By December 2017, Mr. Hoag had been hospitalized and was being treated by another oncologist, located in Las Cruces, 62 miles away from his home. The new oncologist administered the standard treatment, but by then his cancer had metastasized. Mr. Hoag died in 2020 at age 59.
Previous misdemeanor with misbranded drugs
At the time he was treating Mr. Hoag, Dr. Aswad was on federal probation after pleading guilty in 2014 to one misdemeanor count of the unlawful introduction of misbranded drugs into interstate commerce.
Dr. Aswad had treated cancer patients with a “misbranded” drug imported from abroad and not approved by the U.S. Food and Drug Administration (FDA). Altuzan is a form of bevacizumab that is approved for use in Turkey but not the United States. Between July 2010 and April 2012, Dr. Aswad ordered prescription cancer drugs, including Altuzan, from a Canadian company and then administered the “misbranded” drugs to his patients.
A prescription drug is considered to be “misbranded” if it is manufactured in a facility that has not been registered with the FDA for commercial distribution within the United States.
According to various media reports, Dr. Aswad paid significantly less for these drugs than he would have if had he purchased the U.S.-approved product bearing the same brand or generic name, and then billed federal programs such as Medicare for the full price. He has admitted to making just under $1.3 million in profits.
Under the terms of the plea agreement, he was sentenced to three years of probation, required to pay just under $1.3 million in restitution to Medicare and Tricare, the victims of his criminal conduct, and also to forfeit $750,000, which represented part of his net criminal proceeds, to the United States.
At the trial, Dr. Aswad denied that there was any profit motive in extending Mr. Hoag’s treatment, and in a 2019 deposition, he also denied he was under financial pressure to increase his billings because of the $2 million debt that he owed because of the misbranded drugs fine.
Allowed to resume practice
In late 2015, Dr. Aswad was essentially barred by the federal government from accepting any reimbursement from Medicaid or Medicare for a minimum of 13 years. But because of the urgent need for medical specialists, the New Mexico Human Services Department requested a waiver that would permit him to continuing treating cancer patients since he is the only oncologist in Luna County.
He is currently allowed to treat Medicaid and Medicare patients in four other medically underserved New Mexico counties.
Dr. Aswad, a graduate of the University of Aleppo, in Syria, had an internal medicine residency at Our Lady of Mercy Hospital in New York City, where he also had a fellowship in oncology and hematology. He then settled in Deming and has been licensed in New Mexico since 2003.
With the onset of the COVID-19 pandemic, which caused major disruption to healthcare services, Medicare & Medicaid Services officials requested that Dr. Aswad also be allowed to provide internal medicine services for Medicare patients in Catron and Hildalgo counties for the “duration of the Coronavirus Disease 2019 public health emergency declared by the federal government in January 2020.”
A version of this article first appeared on Medscape.com.
Pulmonary rehabilitation: Similar benefit in both IPF and COPD patients
Patients with idiopathic pulmonary fibrosis (IPF) complete and respond to pulmonary rehabilitation at rates similar to patients with chronic obstructive pulmonary disease (COPD), according to results of a real-world study. The findings reported in an article published in the journal CHEST® reinforce pulmonary rehabilitation’s benefits for this population.
A progressive decline in respiratory and physical function characterizes IPF, with median survival from diagnosis of 3-5 years, according to Claire Nolan, PhD, of Harefield Hospital, Middlesex, England, and colleagues. The effects of pharmacologic therapies on IPF on symptom burden and quality of life are modest, although lung function decline may be slowed. Supporting evidence for pulmonary rehabilitation benefit in IPF is more modest than it is for COPD, for which exercise capacity, dyspnea, and health-related quality of life improvement have been demonstrated.
“We did not design a randomized, controlled trial,” Dr. Nolan said in an interview, “as it was considered unethical by the local ethics committee to withhold pulmonary rehabilitation based on clinical guidance in the United Kingdom.” She pointed out that initial pulmonary rehabilitation trials in COPD included an intervention (pulmonary rehabilitation) and a control (standard medical care) arm.
The study aims were to compare the effects of pulmonary rehabilitation with real-world data between IPF and COPD with respect to magnitude of effect and survival. The authors’ hypothesis was that IPF patients would have a blunted response to pulmonary rehabilitation with reduced completion rates, compared with a matched COPD group, and with increased mortality.
Study details
Investigators use propensity score matching of 163 IPF patients with a control group of 163 patients with COPD referred to pulmonary rehabilitation. Completion rates, responses, and survival status were recorded for 1-year following pulmonary rehabilitation discharge. The 8-week outpatient program was composed of two supervised exercise and education sessions with additional unsupervised home-based exercise each week.
While spirometry data, as expected, showed a higher proportion of IPF patients using supplemental oxygen, pulmonary rehabilitation completion rates were similar for both groups (IPF, 69%; COPD, 63%; P = .24) and there was no between group difference in the number of sessions attended (P = .39). Medical Research Council (muscle strength) (MRC), incremental shuttle walk test (ISW), and Chronic Respiratory Questionnaire total score (CRQ-T) improved significantly in both groups, again with no significant difference between groups.
Over the study course, there was progressive, significant worsening of forced vital capacity percentage, predicted, prescription supplemental oxygen, resting peripheral oxygen saturation, exercise capacity, health-related quality of life and pulmonary rehabilitation adherence across groups of responders (n = 63; 38%), nonresponders (n = 50; 31%) and noncompleters (n = 50; 31%). Among the IPF patients, 6 died before completing pulmonary rehabilitation, with 42 (27%) dying during follow-up.
Benefits of rehabilitation
Multivariable analyses showed that noncompletion and nonresponse were associated with significantly higher risk of all-cause mortality at 1-year. Also, time to all-cause mortality was shorter (P = .001) for noncompleters and nonresponders, compared with completers. A trend toward higher completion rates in the IPF group, compared with the COPD group, may be explained, the researchers explained, by fewer hospitalizations over the prior 12 months in the IPF group.
“Although many programs are designed for people with COPD,” Dr. Nolan and colleagues concluded, “our study demonstrates that people with IPF have similar clinical benefits and completion rates to those with COPD. These data reinforce the importance of referral to and engagement in pulmonary rehabilitation amongst the IPF population.”
These findings, Dr. Nolan emphasized, emerged from a single center, and validation in other settings is needed.
This study was funded by a National Institute for Health Research Doctoral Research Fellowship (2014-07-089) and a Medical Research Council New Investigator Research Grant (98576).
Patients with idiopathic pulmonary fibrosis (IPF) complete and respond to pulmonary rehabilitation at rates similar to patients with chronic obstructive pulmonary disease (COPD), according to results of a real-world study. The findings reported in an article published in the journal CHEST® reinforce pulmonary rehabilitation’s benefits for this population.
A progressive decline in respiratory and physical function characterizes IPF, with median survival from diagnosis of 3-5 years, according to Claire Nolan, PhD, of Harefield Hospital, Middlesex, England, and colleagues. The effects of pharmacologic therapies on IPF on symptom burden and quality of life are modest, although lung function decline may be slowed. Supporting evidence for pulmonary rehabilitation benefit in IPF is more modest than it is for COPD, for which exercise capacity, dyspnea, and health-related quality of life improvement have been demonstrated.
“We did not design a randomized, controlled trial,” Dr. Nolan said in an interview, “as it was considered unethical by the local ethics committee to withhold pulmonary rehabilitation based on clinical guidance in the United Kingdom.” She pointed out that initial pulmonary rehabilitation trials in COPD included an intervention (pulmonary rehabilitation) and a control (standard medical care) arm.
The study aims were to compare the effects of pulmonary rehabilitation with real-world data between IPF and COPD with respect to magnitude of effect and survival. The authors’ hypothesis was that IPF patients would have a blunted response to pulmonary rehabilitation with reduced completion rates, compared with a matched COPD group, and with increased mortality.
Study details
Investigators use propensity score matching of 163 IPF patients with a control group of 163 patients with COPD referred to pulmonary rehabilitation. Completion rates, responses, and survival status were recorded for 1-year following pulmonary rehabilitation discharge. The 8-week outpatient program was composed of two supervised exercise and education sessions with additional unsupervised home-based exercise each week.
While spirometry data, as expected, showed a higher proportion of IPF patients using supplemental oxygen, pulmonary rehabilitation completion rates were similar for both groups (IPF, 69%; COPD, 63%; P = .24) and there was no between group difference in the number of sessions attended (P = .39). Medical Research Council (muscle strength) (MRC), incremental shuttle walk test (ISW), and Chronic Respiratory Questionnaire total score (CRQ-T) improved significantly in both groups, again with no significant difference between groups.
Over the study course, there was progressive, significant worsening of forced vital capacity percentage, predicted, prescription supplemental oxygen, resting peripheral oxygen saturation, exercise capacity, health-related quality of life and pulmonary rehabilitation adherence across groups of responders (n = 63; 38%), nonresponders (n = 50; 31%) and noncompleters (n = 50; 31%). Among the IPF patients, 6 died before completing pulmonary rehabilitation, with 42 (27%) dying during follow-up.
Benefits of rehabilitation
Multivariable analyses showed that noncompletion and nonresponse were associated with significantly higher risk of all-cause mortality at 1-year. Also, time to all-cause mortality was shorter (P = .001) for noncompleters and nonresponders, compared with completers. A trend toward higher completion rates in the IPF group, compared with the COPD group, may be explained, the researchers explained, by fewer hospitalizations over the prior 12 months in the IPF group.
“Although many programs are designed for people with COPD,” Dr. Nolan and colleagues concluded, “our study demonstrates that people with IPF have similar clinical benefits and completion rates to those with COPD. These data reinforce the importance of referral to and engagement in pulmonary rehabilitation amongst the IPF population.”
These findings, Dr. Nolan emphasized, emerged from a single center, and validation in other settings is needed.
This study was funded by a National Institute for Health Research Doctoral Research Fellowship (2014-07-089) and a Medical Research Council New Investigator Research Grant (98576).
Patients with idiopathic pulmonary fibrosis (IPF) complete and respond to pulmonary rehabilitation at rates similar to patients with chronic obstructive pulmonary disease (COPD), according to results of a real-world study. The findings reported in an article published in the journal CHEST® reinforce pulmonary rehabilitation’s benefits for this population.
A progressive decline in respiratory and physical function characterizes IPF, with median survival from diagnosis of 3-5 years, according to Claire Nolan, PhD, of Harefield Hospital, Middlesex, England, and colleagues. The effects of pharmacologic therapies on IPF on symptom burden and quality of life are modest, although lung function decline may be slowed. Supporting evidence for pulmonary rehabilitation benefit in IPF is more modest than it is for COPD, for which exercise capacity, dyspnea, and health-related quality of life improvement have been demonstrated.
“We did not design a randomized, controlled trial,” Dr. Nolan said in an interview, “as it was considered unethical by the local ethics committee to withhold pulmonary rehabilitation based on clinical guidance in the United Kingdom.” She pointed out that initial pulmonary rehabilitation trials in COPD included an intervention (pulmonary rehabilitation) and a control (standard medical care) arm.
The study aims were to compare the effects of pulmonary rehabilitation with real-world data between IPF and COPD with respect to magnitude of effect and survival. The authors’ hypothesis was that IPF patients would have a blunted response to pulmonary rehabilitation with reduced completion rates, compared with a matched COPD group, and with increased mortality.
Study details
Investigators use propensity score matching of 163 IPF patients with a control group of 163 patients with COPD referred to pulmonary rehabilitation. Completion rates, responses, and survival status were recorded for 1-year following pulmonary rehabilitation discharge. The 8-week outpatient program was composed of two supervised exercise and education sessions with additional unsupervised home-based exercise each week.
While spirometry data, as expected, showed a higher proportion of IPF patients using supplemental oxygen, pulmonary rehabilitation completion rates were similar for both groups (IPF, 69%; COPD, 63%; P = .24) and there was no between group difference in the number of sessions attended (P = .39). Medical Research Council (muscle strength) (MRC), incremental shuttle walk test (ISW), and Chronic Respiratory Questionnaire total score (CRQ-T) improved significantly in both groups, again with no significant difference between groups.
Over the study course, there was progressive, significant worsening of forced vital capacity percentage, predicted, prescription supplemental oxygen, resting peripheral oxygen saturation, exercise capacity, health-related quality of life and pulmonary rehabilitation adherence across groups of responders (n = 63; 38%), nonresponders (n = 50; 31%) and noncompleters (n = 50; 31%). Among the IPF patients, 6 died before completing pulmonary rehabilitation, with 42 (27%) dying during follow-up.
Benefits of rehabilitation
Multivariable analyses showed that noncompletion and nonresponse were associated with significantly higher risk of all-cause mortality at 1-year. Also, time to all-cause mortality was shorter (P = .001) for noncompleters and nonresponders, compared with completers. A trend toward higher completion rates in the IPF group, compared with the COPD group, may be explained, the researchers explained, by fewer hospitalizations over the prior 12 months in the IPF group.
“Although many programs are designed for people with COPD,” Dr. Nolan and colleagues concluded, “our study demonstrates that people with IPF have similar clinical benefits and completion rates to those with COPD. These data reinforce the importance of referral to and engagement in pulmonary rehabilitation amongst the IPF population.”
These findings, Dr. Nolan emphasized, emerged from a single center, and validation in other settings is needed.
This study was funded by a National Institute for Health Research Doctoral Research Fellowship (2014-07-089) and a Medical Research Council New Investigator Research Grant (98576).
FROM THE JOURNAL CHEST®
Cancer drug revenue increased 70% over a decade
Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.
By comparison, revenues from other types of medications decreased by 18% during the same period.
“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.
To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.
The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.
Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.
Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.
Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.
“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”
No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.
By comparison, revenues from other types of medications decreased by 18% during the same period.
“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.
To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.
The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.
Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.
Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.
Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.
“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”
No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cumulative annual revenue from cancer drug sales increased by 70% among the world’s largest pharmaceutical companies over the past decade, a retrospective analysis shows.
By comparison, revenues from other types of medications decreased by 18% during the same period.
“Cancer drugs now account for approximately 27% of new drug approvals in the United States, compared to 4% in the 1980s. During this period, there has also been a substantial increase in the price of cancer medicines,” Daniel E. Myers, MD, of the University of Calgary, Canada, and colleagues explain in their report, published online October 6 in Cancer.
To investigate the impact of these trends on pharmaceutical earnings, the investigators performed a retrospective analysis of the revenue generated from oncology drugs in comparison with total drug revenue among 10 large pharmaceutical companies between 2010 and 2019, using itemized product-sales data publicly available through company websites or annual filings.
The data, adjusted for inflation and converted to 2019 U.S. dollars, revealed that annual revenue for the 10 companies increased from $55.8 billion to $95.1 billion during the study period. Most of the growth in revenue occurred in the past 5 years. Over the decade, non-oncology drug revenue decreased by 18% – from $342.2 billion to $281.5 billion.
Overall, revenues from cancer drugs accounted for 25% of the net revenues generated by these companies in 2019, up from 14% in 2010. Roche had both the highest net revenue – $23.9 billion in 2010 and $27.7 billion in 2019 – and the greatest proportion of revenue from cancer drugs – 63.5% in 2016 and 57% in 2019.
Merck saw substantial growth in revenue from cancer drug sales, particularly between 2016 and 2019. In 2016, the company generated $2.4 billion from these medicines, representing 6% of total revenue. By 2019, that amount had grown to $12.3 billion, representing almost 30% of total revenue. This increase was driven largely by their drug pembrolizumab, which alone drew in about $11 billion in 2019, or 12% of total oncology revenue, the investigators note.
Sanofi and GSK had some of the lowest net revenues from cancer drugs during the study period. For instance, in 2019, GSK generated $300 million in revenue from oncology drugs, representing less than 1% of the company’s total revenue, down from 3% of its total revenue in 2010.
“With the cost of cancer drugs rapidly rising, further work is needed to understand how this [overall] increase in sales revenue reflects industry profit, and how this is linked (or not) to improvements in patient and population outcomes,” they conclude. Although data regarding how cancer drug development affects population mortality rates are limited, “there is a notion within biomedicine that rising corporate profitability may not translate into proportional societal gains.”
No funding for the study has been disclosed. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Early trials underway to test mushrooms as COVID treatment
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.
The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.
The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA described the trials.
The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.
“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.
For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.
D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.
“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”
Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.
“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.
Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.
“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”
“Not a crazy concept”
Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.
“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”
Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.
“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.
Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.
“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.
As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.
Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.
He gave the example of St. John’s Wort, which has been problematic in HIV treatment.
“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.
Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”
He, too, pointed out that many traditional medicines were discovered from plants.
“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.
He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»
A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.
FROM JAMA