Harvard medical school sued over stolen body part scandal

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A Massachusetts-based law firm has filed a class action lawsuit against Harvard Medical School, alleging that it failed to protect the remains of people who donated their bodies to the university for research and education.

Plaintiffs include relatives of people whose remains were allegedly stolen and sold. The lawsuit alleges that as many as 400 cadavers may have been trafficked in a multi-year scheme. Details were revealed in a June 13 indictment by the U.S. attorney for the Middle District of Pennsylvania.

“Medical schools like Harvard have a duty to ensure [donated remains] are handled properly and with decency and to ensure they are used for their intended purpose of scientific study,” attorney Jeff Catalano said in a statement.

“I do think Harvard has that duty,” said Arthur Caplan, PhD, director, Division of Medical Ethics, New York University. But, he added, “I will say there’s not much they can do when employees set out to systematically undermine them.”

The indictment alleges that from 2018 through August 2022, Harvard morgue manager Cedric Lodge stole dissected portions of donated cadavers, including heads, brains, skin, and bones, which were then sold by him and his wife, Denise Lodge, to Katrina Maclean, owner of Kat’s Creepy Creations, Peabody, Mass. Ms. Maclean allegedly sold human remains to Joshua Taylor and Jeremy Pauley, both Pennsylvania residents.

On occasion, Mr. Lodge allowed Ms. Maclean, Mr. Taylor, and others into the morgue to choose which parts they wanted, according to the indictment. Mr. Taylor, Ms. Maclean, and Denise Lodge are all named in the indictment. Mr. Pauley was charged separately.

They each face a maximum of 15 years in prison.

Ms. Maclean allegedly bought two dissected faces for $600 and shipped human skin to Mr. Pauley to be made into leather; Mr. Pauley then eventually shipped the “tanned human skin” back to Ms. Maclean, according to the indictment. Over a 3-year period, Mr. Taylor paid the Lodges some $37,000 for stolen human remains, the indictment charges.

Mr. Pauley also purchased human remains from Candace Chapman Scott, who stole them from her employer, a mortuary in Little Rock, Ark. The mortuary received remains for cremation from an area medical school, according to the indictment.

After being notified of the investigation in March, Harvard cooperated fully, the school said in a statement from George Q. Daley, MD, PhD, dean of the Faculty of Medicine.

“We are appalled to learn that something so disturbing could happen on our campus – a community dedicated to healing and serving others,” the statement said. “The reported incidents are a betrayal of HMS and, most importantly, each of the individuals who altruistically chose to will their bodies to HMS through the Anatomical Gift Program to advance medical education and research.”

The U.S. attorney thanked Harvard for its cooperation, saying that it “is also a victim here.”

Dr. Caplan, who also writes an ethics column for this news organization, agrees. The school was betrayed, he said.

“You expect professionalism, integrity on the part of your doctors, on the part of your technicians, on the part of your workforce,” he said. He noted that those expectations are explained in institutions’ codes of ethics and policies.

Harvard said Mr. Lodge had worked in the morgue since 1995 and that he took several leaves: from September 2021 to February 2022, and again starting February 14. The school terminated his employment on May 6.

His duties included intake of anatomic donors’ bodies. He coordinated embalming and oversaw the storage and movement of cadavers to and from teaching labs. When studies were complete, he prepared remains to be transported to and from the external crematorium and, when appropriate, for burial, according to a Harvard fact sheet for families.

The medical school has convened an outside expert panel to evaluate the Anatomical Gift Program and morgue policies and practices. The panel is expected to make its findings public at the end of the summer.

Dr. Caplan said he hoped the committee recommends unannounced audits of cadaver donation programs and medical tissue and bone suppliers, which could help expose illicit diversions. “You need to keep an eye, which no one seems to do because it’s a state issue and it’s not a priority, on that trade in body parts,” he said.

He believes other medical schools will reexamine their donation programs, especially given Harvard’s status.

“With a prominent place like that having this kind of problem, I can’t imagine there’s not a little bit of a scramble at a lot of the body programs to make sure that they know that things are as they should be,” Dr. Caplan said.

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

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A Massachusetts-based law firm has filed a class action lawsuit against Harvard Medical School, alleging that it failed to protect the remains of people who donated their bodies to the university for research and education.

Plaintiffs include relatives of people whose remains were allegedly stolen and sold. The lawsuit alleges that as many as 400 cadavers may have been trafficked in a multi-year scheme. Details were revealed in a June 13 indictment by the U.S. attorney for the Middle District of Pennsylvania.

“Medical schools like Harvard have a duty to ensure [donated remains] are handled properly and with decency and to ensure they are used for their intended purpose of scientific study,” attorney Jeff Catalano said in a statement.

“I do think Harvard has that duty,” said Arthur Caplan, PhD, director, Division of Medical Ethics, New York University. But, he added, “I will say there’s not much they can do when employees set out to systematically undermine them.”

The indictment alleges that from 2018 through August 2022, Harvard morgue manager Cedric Lodge stole dissected portions of donated cadavers, including heads, brains, skin, and bones, which were then sold by him and his wife, Denise Lodge, to Katrina Maclean, owner of Kat’s Creepy Creations, Peabody, Mass. Ms. Maclean allegedly sold human remains to Joshua Taylor and Jeremy Pauley, both Pennsylvania residents.

On occasion, Mr. Lodge allowed Ms. Maclean, Mr. Taylor, and others into the morgue to choose which parts they wanted, according to the indictment. Mr. Taylor, Ms. Maclean, and Denise Lodge are all named in the indictment. Mr. Pauley was charged separately.

They each face a maximum of 15 years in prison.

Ms. Maclean allegedly bought two dissected faces for $600 and shipped human skin to Mr. Pauley to be made into leather; Mr. Pauley then eventually shipped the “tanned human skin” back to Ms. Maclean, according to the indictment. Over a 3-year period, Mr. Taylor paid the Lodges some $37,000 for stolen human remains, the indictment charges.

Mr. Pauley also purchased human remains from Candace Chapman Scott, who stole them from her employer, a mortuary in Little Rock, Ark. The mortuary received remains for cremation from an area medical school, according to the indictment.

After being notified of the investigation in March, Harvard cooperated fully, the school said in a statement from George Q. Daley, MD, PhD, dean of the Faculty of Medicine.

“We are appalled to learn that something so disturbing could happen on our campus – a community dedicated to healing and serving others,” the statement said. “The reported incidents are a betrayal of HMS and, most importantly, each of the individuals who altruistically chose to will their bodies to HMS through the Anatomical Gift Program to advance medical education and research.”

The U.S. attorney thanked Harvard for its cooperation, saying that it “is also a victim here.”

Dr. Caplan, who also writes an ethics column for this news organization, agrees. The school was betrayed, he said.

“You expect professionalism, integrity on the part of your doctors, on the part of your technicians, on the part of your workforce,” he said. He noted that those expectations are explained in institutions’ codes of ethics and policies.

Harvard said Mr. Lodge had worked in the morgue since 1995 and that he took several leaves: from September 2021 to February 2022, and again starting February 14. The school terminated his employment on May 6.

His duties included intake of anatomic donors’ bodies. He coordinated embalming and oversaw the storage and movement of cadavers to and from teaching labs. When studies were complete, he prepared remains to be transported to and from the external crematorium and, when appropriate, for burial, according to a Harvard fact sheet for families.

The medical school has convened an outside expert panel to evaluate the Anatomical Gift Program and morgue policies and practices. The panel is expected to make its findings public at the end of the summer.

Dr. Caplan said he hoped the committee recommends unannounced audits of cadaver donation programs and medical tissue and bone suppliers, which could help expose illicit diversions. “You need to keep an eye, which no one seems to do because it’s a state issue and it’s not a priority, on that trade in body parts,” he said.

He believes other medical schools will reexamine their donation programs, especially given Harvard’s status.

“With a prominent place like that having this kind of problem, I can’t imagine there’s not a little bit of a scramble at a lot of the body programs to make sure that they know that things are as they should be,” Dr. Caplan said.

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

A Massachusetts-based law firm has filed a class action lawsuit against Harvard Medical School, alleging that it failed to protect the remains of people who donated their bodies to the university for research and education.

Plaintiffs include relatives of people whose remains were allegedly stolen and sold. The lawsuit alleges that as many as 400 cadavers may have been trafficked in a multi-year scheme. Details were revealed in a June 13 indictment by the U.S. attorney for the Middle District of Pennsylvania.

“Medical schools like Harvard have a duty to ensure [donated remains] are handled properly and with decency and to ensure they are used for their intended purpose of scientific study,” attorney Jeff Catalano said in a statement.

“I do think Harvard has that duty,” said Arthur Caplan, PhD, director, Division of Medical Ethics, New York University. But, he added, “I will say there’s not much they can do when employees set out to systematically undermine them.”

The indictment alleges that from 2018 through August 2022, Harvard morgue manager Cedric Lodge stole dissected portions of donated cadavers, including heads, brains, skin, and bones, which were then sold by him and his wife, Denise Lodge, to Katrina Maclean, owner of Kat’s Creepy Creations, Peabody, Mass. Ms. Maclean allegedly sold human remains to Joshua Taylor and Jeremy Pauley, both Pennsylvania residents.

On occasion, Mr. Lodge allowed Ms. Maclean, Mr. Taylor, and others into the morgue to choose which parts they wanted, according to the indictment. Mr. Taylor, Ms. Maclean, and Denise Lodge are all named in the indictment. Mr. Pauley was charged separately.

They each face a maximum of 15 years in prison.

Ms. Maclean allegedly bought two dissected faces for $600 and shipped human skin to Mr. Pauley to be made into leather; Mr. Pauley then eventually shipped the “tanned human skin” back to Ms. Maclean, according to the indictment. Over a 3-year period, Mr. Taylor paid the Lodges some $37,000 for stolen human remains, the indictment charges.

Mr. Pauley also purchased human remains from Candace Chapman Scott, who stole them from her employer, a mortuary in Little Rock, Ark. The mortuary received remains for cremation from an area medical school, according to the indictment.

After being notified of the investigation in March, Harvard cooperated fully, the school said in a statement from George Q. Daley, MD, PhD, dean of the Faculty of Medicine.

“We are appalled to learn that something so disturbing could happen on our campus – a community dedicated to healing and serving others,” the statement said. “The reported incidents are a betrayal of HMS and, most importantly, each of the individuals who altruistically chose to will their bodies to HMS through the Anatomical Gift Program to advance medical education and research.”

The U.S. attorney thanked Harvard for its cooperation, saying that it “is also a victim here.”

Dr. Caplan, who also writes an ethics column for this news organization, agrees. The school was betrayed, he said.

“You expect professionalism, integrity on the part of your doctors, on the part of your technicians, on the part of your workforce,” he said. He noted that those expectations are explained in institutions’ codes of ethics and policies.

Harvard said Mr. Lodge had worked in the morgue since 1995 and that he took several leaves: from September 2021 to February 2022, and again starting February 14. The school terminated his employment on May 6.

His duties included intake of anatomic donors’ bodies. He coordinated embalming and oversaw the storage and movement of cadavers to and from teaching labs. When studies were complete, he prepared remains to be transported to and from the external crematorium and, when appropriate, for burial, according to a Harvard fact sheet for families.

The medical school has convened an outside expert panel to evaluate the Anatomical Gift Program and morgue policies and practices. The panel is expected to make its findings public at the end of the summer.

Dr. Caplan said he hoped the committee recommends unannounced audits of cadaver donation programs and medical tissue and bone suppliers, which could help expose illicit diversions. “You need to keep an eye, which no one seems to do because it’s a state issue and it’s not a priority, on that trade in body parts,” he said.

He believes other medical schools will reexamine their donation programs, especially given Harvard’s status.

“With a prominent place like that having this kind of problem, I can’t imagine there’s not a little bit of a scramble at a lot of the body programs to make sure that they know that things are as they should be,” Dr. Caplan said.

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

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Product updates and reviews

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REVIEW
 

Butterfly iQ+: Offering day-to-day portable ultrasound tech

The Butterfly iQ+ app with an ultrasound probe and cable is available from Butterfly Network, Inc, in Guilford, Connecticut.

Background. It could be reasonably argued that ultrasonography has surpassed the speculum as the single most important tool in ObGyn. From its origins in 1949 with the pioneering work of George Ludwig using A-mode (amplitude-mode) ultrasound and the first publication of its use in pregnancy using B-mode (brightness-mode) ultrasound in Lancet in 1958 by Donald and colleagues, this technology has become so ingrained into ObGyn that it is often frustrating to practice comfortably without it. Thus, today, the biggest question facing most practitioners is not whether or not to have an ultrasound in their practice but which one to have.

Given the wide range of quality, functionality, and price within the ultrasound device space, choosing the right technology can feel as daunting as choosing the perfect restaurant in New York City. That said, when looking for entry-level ultrasound technology to address the day-to-day basic needs of your average ObGyn, the Butterfly iQ+ may be an easy choice.

Design/Functionality. The Butterfly iQ+ app does not come with a screen. Rather, the device is compatible with both iOS and Android systems and readily connects to a vast array of easily purchased devices, with either lightening or USB-C ports. In our office, we use an iPad mini. The probe is lightweight (309 g) and contains a rechargeable 2600 mAh lithium ion battery, so that its power source is independent of the device to which it is attached. The probe is a 2D array with 9000 micro-machined sensors. It allows for imaging using M-mode, B-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler. (I don’t know what the last two are or what they are used for, but they sound important.) It has a scan depth range of 1 cm to 30 cm. The downloadable Butterfly iQ+ app that has the software that makes the probe functional has more tools, controls, and presets than anyone could ever need. But that’s not all. The App has data encrypted HIPAA/HITECH-compliant Cloud-based connectivity that offers unlimited image storage, access to reports, and embedded CPT codes should billing capabilities be needed.

The true beauty of the Butterfly iQ+ is that the image quality is awesome and it is really easy to use. The software is mostly intuitive and takes only a minimal effort to learn. The device holds its charge more than adequately for a day in the office and the recharging process is fast and easy. When it comes to the device’s design and functionality–as a Capricorn–I am still looking for its flaws.

Innovation. The real innovations of the Butterfly iQ+ are its “ultrasound-on-a-chip”™ technology and its incorporation of a rechargeable battery into the probe. This combination allows for crystal clear imaging in a cordless, portable device. While most other similar technologies waste their time, technology, space, and cost on the screen, the Butterfly iQ+ punted on that challenge and put all their efforts into the probe and the software. It was a great choice.

Summary. In our office, the Butterfly iQ+ has changed the way we practice. Our trusty fetal dopplers are mostly gone, having been replaced by the Butterfly iQ+. At almost every prenatal visit, patients can now see their baby rather than just hear the heartbeat (and they can hear it too if they want by using the M-mode functionality on the device). Patients love it, and so do the doctors. Instead of just hearing heart beats, fetal position and quick fluid checks are now routine, so we think our care is actually a little better than it was. The Butterfly iQ+ is also great for confirming IUD locations after placement or when the strings are not visible. All-in-all, I love this product. Who doesn’t love butterflies?!

For more information, visit https://www.butterflynetwork.com

The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

References

  1. Kaproth-Joslin KA, Nicola R, Dogra VS. The History of US: from bats and boats to the bedside and beyond: RSNA centennial article. Radiographics. 2015;35:960-970.
  2. Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188-1195.
 
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The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

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The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

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The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

Article PDF
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REVIEW
 

Butterfly iQ+: Offering day-to-day portable ultrasound tech

The Butterfly iQ+ app with an ultrasound probe and cable is available from Butterfly Network, Inc, in Guilford, Connecticut.

Background. It could be reasonably argued that ultrasonography has surpassed the speculum as the single most important tool in ObGyn. From its origins in 1949 with the pioneering work of George Ludwig using A-mode (amplitude-mode) ultrasound and the first publication of its use in pregnancy using B-mode (brightness-mode) ultrasound in Lancet in 1958 by Donald and colleagues, this technology has become so ingrained into ObGyn that it is often frustrating to practice comfortably without it. Thus, today, the biggest question facing most practitioners is not whether or not to have an ultrasound in their practice but which one to have.

Given the wide range of quality, functionality, and price within the ultrasound device space, choosing the right technology can feel as daunting as choosing the perfect restaurant in New York City. That said, when looking for entry-level ultrasound technology to address the day-to-day basic needs of your average ObGyn, the Butterfly iQ+ may be an easy choice.

Design/Functionality. The Butterfly iQ+ app does not come with a screen. Rather, the device is compatible with both iOS and Android systems and readily connects to a vast array of easily purchased devices, with either lightening or USB-C ports. In our office, we use an iPad mini. The probe is lightweight (309 g) and contains a rechargeable 2600 mAh lithium ion battery, so that its power source is independent of the device to which it is attached. The probe is a 2D array with 9000 micro-machined sensors. It allows for imaging using M-mode, B-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler. (I don’t know what the last two are or what they are used for, but they sound important.) It has a scan depth range of 1 cm to 30 cm. The downloadable Butterfly iQ+ app that has the software that makes the probe functional has more tools, controls, and presets than anyone could ever need. But that’s not all. The App has data encrypted HIPAA/HITECH-compliant Cloud-based connectivity that offers unlimited image storage, access to reports, and embedded CPT codes should billing capabilities be needed.

The true beauty of the Butterfly iQ+ is that the image quality is awesome and it is really easy to use. The software is mostly intuitive and takes only a minimal effort to learn. The device holds its charge more than adequately for a day in the office and the recharging process is fast and easy. When it comes to the device’s design and functionality–as a Capricorn–I am still looking for its flaws.

Innovation. The real innovations of the Butterfly iQ+ are its “ultrasound-on-a-chip”™ technology and its incorporation of a rechargeable battery into the probe. This combination allows for crystal clear imaging in a cordless, portable device. While most other similar technologies waste their time, technology, space, and cost on the screen, the Butterfly iQ+ punted on that challenge and put all their efforts into the probe and the software. It was a great choice.

Summary. In our office, the Butterfly iQ+ has changed the way we practice. Our trusty fetal dopplers are mostly gone, having been replaced by the Butterfly iQ+. At almost every prenatal visit, patients can now see their baby rather than just hear the heartbeat (and they can hear it too if they want by using the M-mode functionality on the device). Patients love it, and so do the doctors. Instead of just hearing heart beats, fetal position and quick fluid checks are now routine, so we think our care is actually a little better than it was. The Butterfly iQ+ is also great for confirming IUD locations after placement or when the strings are not visible. All-in-all, I love this product. Who doesn’t love butterflies?!

For more information, visit https://www.butterflynetwork.com

The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

References

  1. Kaproth-Joslin KA, Nicola R, Dogra VS. The History of US: from bats and boats to the bedside and beyond: RSNA centennial article. Radiographics. 2015;35:960-970.
  2. Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188-1195.
 

 

REVIEW
 

Butterfly iQ+: Offering day-to-day portable ultrasound tech

The Butterfly iQ+ app with an ultrasound probe and cable is available from Butterfly Network, Inc, in Guilford, Connecticut.

Background. It could be reasonably argued that ultrasonography has surpassed the speculum as the single most important tool in ObGyn. From its origins in 1949 with the pioneering work of George Ludwig using A-mode (amplitude-mode) ultrasound and the first publication of its use in pregnancy using B-mode (brightness-mode) ultrasound in Lancet in 1958 by Donald and colleagues, this technology has become so ingrained into ObGyn that it is often frustrating to practice comfortably without it. Thus, today, the biggest question facing most practitioners is not whether or not to have an ultrasound in their practice but which one to have.

Given the wide range of quality, functionality, and price within the ultrasound device space, choosing the right technology can feel as daunting as choosing the perfect restaurant in New York City. That said, when looking for entry-level ultrasound technology to address the day-to-day basic needs of your average ObGyn, the Butterfly iQ+ may be an easy choice.

Design/Functionality. The Butterfly iQ+ app does not come with a screen. Rather, the device is compatible with both iOS and Android systems and readily connects to a vast array of easily purchased devices, with either lightening or USB-C ports. In our office, we use an iPad mini. The probe is lightweight (309 g) and contains a rechargeable 2600 mAh lithium ion battery, so that its power source is independent of the device to which it is attached. The probe is a 2D array with 9000 micro-machined sensors. It allows for imaging using M-mode, B-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler. (I don’t know what the last two are or what they are used for, but they sound important.) It has a scan depth range of 1 cm to 30 cm. The downloadable Butterfly iQ+ app that has the software that makes the probe functional has more tools, controls, and presets than anyone could ever need. But that’s not all. The App has data encrypted HIPAA/HITECH-compliant Cloud-based connectivity that offers unlimited image storage, access to reports, and embedded CPT codes should billing capabilities be needed.

The true beauty of the Butterfly iQ+ is that the image quality is awesome and it is really easy to use. The software is mostly intuitive and takes only a minimal effort to learn. The device holds its charge more than adequately for a day in the office and the recharging process is fast and easy. When it comes to the device’s design and functionality–as a Capricorn–I am still looking for its flaws.

Innovation. The real innovations of the Butterfly iQ+ are its “ultrasound-on-a-chip”™ technology and its incorporation of a rechargeable battery into the probe. This combination allows for crystal clear imaging in a cordless, portable device. While most other similar technologies waste their time, technology, space, and cost on the screen, the Butterfly iQ+ punted on that challenge and put all their efforts into the probe and the software. It was a great choice.

Summary. In our office, the Butterfly iQ+ has changed the way we practice. Our trusty fetal dopplers are mostly gone, having been replaced by the Butterfly iQ+. At almost every prenatal visit, patients can now see their baby rather than just hear the heartbeat (and they can hear it too if they want by using the M-mode functionality on the device). Patients love it, and so do the doctors. Instead of just hearing heart beats, fetal position and quick fluid checks are now routine, so we think our care is actually a little better than it was. The Butterfly iQ+ is also great for confirming IUD locations after placement or when the strings are not visible. All-in-all, I love this product. Who doesn’t love butterflies?!

For more information, visit https://www.butterflynetwork.com

The views of the author are personal opinions and do not necessarily represent the views of OBG Management. Dr. Greenberg personally trials all the products he reviews. Dr. Greenberg has no conflicts of interest with this product or the company that produces it.

References

  1. Kaproth-Joslin KA, Nicola R, Dogra VS. The History of US: from bats and boats to the bedside and beyond: RSNA centennial article. Radiographics. 2015;35:960-970.
  2. Donald I, MacVicar J, Brown TG. Investigation of abdominal masses by pulsed ultrasound. Lancet. 1958;1:1188-1195.
 
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New cannabis laws, higher binge drinking rates linked

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TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

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TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

 

TOPLINE:

After passage of state laws that allow recreational cannabis use, binge drinking declined among those younger than 21 but increased among those aged 31 and older.

METHODOLOGY:

Among adolescents, binge drinking, defined as having five or more drinks for men and four or more drinks for women at one time, is associated with poor academic performance, sexual risk, and injury in the short term, as well as the development of alcohol use disorder and academic disengagement in the long term.

Current evidence regarding the association between recreational cannabis laws (RCLs) and binge drinking is limited.

States in which RCLs have been implemented include Colorado, Washington, Alaska, Oregon, Nevada, California, Massachusetts, and Vermont, as well as the District of Columbia.

The study included 817,359 people aged 12 and older who participated in the 2008-2019 National Survey on Drug Use and Health (NSDUH), a nationally representative survey of the U.S. population.
 

TAKEAWAY:

Overall, states that have not enacted cannabis laws showed consistently lower rates of binge drinking over time among all age groups.

In all states, there were substantial declines in reporting of past-month binge drinking in some age groups – from 17.5% (95% confidence interval, 16.9-18.2) in 2008 to 11.1% (10.4-11.8) in 2019 among those aged 12-20 and a drop from 43.7% (42.4-44.9) to 40.2% (39.1-41.1) among those aged 21-30.

There were overall increases in binge drinking in all states regardless of cannabis laws among individuals aged 31 and older. The most extensive increases were among people aged 31-40 (from 28.1% [95% CI, 26.6-29.6] to 33.3% [32.1-34.6]), followed by participants aged 51 and over (from 13.3% [95% CI, 12.2-14.4] to 16.8% [15.8-17.7]).
 

IN PRACTICE:

“Our findings support calls to reinforce health care providers’ discussions about alcohol use with older adults,” particularly in RCL states, the researchers write.

STUDY DETAILS:

The study was conducted out by Priscila Dib Gonçalves, PhD, department of epidemiology, Columbia University School of Public Health, New York, and colleagues. It was published in the International Journal of Drug Policy.

LIMITATIONS:

Alcohol-related measures, including binge drinking, were self-reported, which may introduce recall bias and underreporting. NSDUH binge drinking measures were not adjusted for sex differences from 2008 to 2014, which may result in underreporting of binge drinking in females before 2015. The researchers did not examine cannabis policy provisions, such as cultivation restrictions, pricing control, the tax imposed, and consumption restrictions.

DISCLOSURES:

The study received support from the National Institutes of Health, the National Institute on Drug Abuse, the National Center for Injury Prevention and Control, and the Centers for Disease Control and Prevention. The authors report no relevant conflicts of interest.

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

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Ruptured aneurysm turns MD couple into doctor-patient

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Dr. Taylor Delgado: It was Saturday night, and we had just gone to bed. Suddenly, Ali sat up, and screamed, “My head!” She then became nonresponsive and had a seizure. I was in disbelief, but I also knew exactly what was happening. I called 911: “My wife is having a head bleed. I need an ambulance.” It was a bad connection, and they could barely understand me.

As I tried to carry Ali downstairs, she vomited. She still had rubber bands in her mouth from the jaw fracture that was a result of her accident just a month ago. I knew she needed an airway. 

I grabbed a tracheostomy tube, but the opening over her trachea put in for the accident had since closed. I tried to push the tube through her neck, but it hurt her; her eyes opened.

I thought to myself: Maybe she doesn’t need it. This can wait until she gets to the hospital. I can’t do this to her. But she vomited again, and I knew what I had to do.

We were at the top of our stairs. I didn’t have a blade or any other equipment, just the tracheostomy tube with the dilator. I pushed hard, and she started fighting me. I had to hold her hands away with one arm. The tube popped in and she stared back at me in pain and fear.

I finally got her downstairs and called medical control at University Hospital of Cincinnati. I was able to speak with one of the attendings: “Ali’s aneurysm ruptured, and she just had a seizure. She has a GCS of 11 or 12. I replaced her tracheostomy tube. We’ll be there shortly.”

When I heard sirens come down our street, I carried Ali outside, but the sirens were from a firetruck. They likely assumed someone had fallen and had a head laceration. It was beyond deflating. I yelled incredulously: “We need an ambulance here now!”

When the ambulance finally arrived, they tried to tell me that I could not ride with them. Or if I did, I would have to sit up front. After arguing back and forth for a few seconds, I finally demanded: “This is medical control. This is MD-88, and this is my patient. I’m sitting in back with you. She needs four Zofran and two midazolam IV now.”
 

One month earlier ...

Dr. Alison Delgado: Taylor and I were both 4 months into our second year of residency, and we had been married for 5 months. I was a pediatric resident at Cincinnati Children’s Hospital. She was an emergency medicine resident at the University Hospital. I was having my first day off in a couple weeks, and she was working a shift in the emergency department. She was also a part of the flight crew that day. Second-year residents would go out to the scenes of accidents or to other hospitals to transport the patient back to their Level I trauma center via helicopter. The resident was the physician and considered the leader on these flights.

That afternoon, I went for a bicycle ride. About three-quarters of the way through my ride, I was struck by a car.

The EMS crew got to me fairly quickly. They intubated me at the scene and got me to the closest hospital. Immediately, the hospital realized my case was outside the scope of their care. They contacted University Hospital requesting that their flight crew come to transport me.

Dr. Taylor Delgado: At around 5:30 p.m. the day of my shift, the tones went out on the radio: “AirCare 1 and Pod Doc, you are requested for interhospital transfer, 27-year-old Jane Doe, GCS 5.” That was the only information given.

When we landed at the hospital, I walked in with my nurse. I was listening to the doctor’s report and doing my once over. The patient was a little bit bradycardic, heart rate in the 40s or 50s. Blood pressure was normal if not a little bit elevated. There was obvious facial trauma. The endotracheal tube in place.

She was covered with a blanket, but some of her clothing was visible. Suddenly, I recognized it. It was our cycling team’s kit. I thought, please don’t let it be Ali. I looked at her face and realized that this was Alison.

I said: “That’s my wife.” Everyone stopped and looked at me. The room went silent.


My flight nurse went out and called back to dispatch. “This is my doc’s wife. Dispatch the second helicopter!” She had to repeat herself a few times before they understood what was happening.

As Ali’s spouse, I couldn’t be the flight doctor. I didn’t care. I called medical control myself and told them: “This is Ali. We have to fly her. She has a head injury.” They said: “You can’t fly her.” I said: “We can’t delay her care. I have to fly her.” They said: “No, you can’t fly her.” I broke down. Devastated.

I went back into the room and looked at Ali. Her heart rate was dropping. My flight nurse was in the trauma bay with the emergency physician. We realized definitive care was being delayed because of my presence, which was an awful feeling to have. I think at that point we realized, you do nothing, or you act. So, we acted.

I told my flight nurse: “Let’s give her atropine to increase her heart rate.” I asked about sedation, and she hadn’t had anything. I spurted off some doses: “a hundred of fentanyl and five of midazolam.” My flight nurse actually administered smaller doses. She thought it was a bit aggressive, and she was correct. I was trying to maintain composure, but it was hard.

The emergency medicine physician volunteered to fly with her, so I called back medical control in desperation: “This doctor’s willing to fly. Let him take her.”

They told me apologetically, knowing my agony, that he was not trained to fly and therefore could not do so. I sat down in the ambulance bay crying, waiting for the second helicopter to arrive.

When we got Ali onto AirCare 2, my nurse then told me I couldn’t fly with her. I said, “I’m flying with her.” She said, “no, it’s not safe.” I said, “I’m not leaving her. I’ll sit in the front. What do you think I’m going to do? Jump out of the helicopter?” I think they realized there was no other option that I would agree to. I rode up front.

It was the fastest flight to the trauma center that I had ever experienced. They did a hot offload, meaning they didn’t even shut down the blades. We got her to the trauma center. And then it was a whole other layer of chaos.

 

 

Dr. Alison Delgado: Taylor’s presence may have delayed my transfer, but the University emergency department was prepped and waiting for me. Radiology was on hold, surgery and neurosurgery were there waiting. Everyone was in the trauma bay.

Dr. Taylor Delgado: My younger sister was a social worker in that emergency department, and she was on shift. She and my residency director went to CT with Ali. As the images from Ali’s CT scan showed up on the screens, everyone in the room gasped. She had a nonsurvivable head injury.

The AirCare 2 doctor collapsed into our director’s arms and cried: “She’s going to die tonight.” He responded: “I know. But we’ve got work to do.” Then he asked my sister how close she was with me. She told him we were extremely close. “Good, because we have to break the news that she’s going to die tonight.”

But the doctor never told me. I was in the consultation room. He came in and told me that she had a lot of bleeding around the brain, but he couldn’t find the words to tell me the true severity. He didn’t have to.

Dr. Alison Delgado: I was in a coma for 5 days. Shift by shift, they were amazed that I was still there. I had a broken jaw, broken vertebrae in my spine, a broken clavicle and sternum and contusions to my heart and lungs. I was later found to have a dissection of my carotid artery as well as an aneurysm to the carotid artery. These were both caused by the accident.

My jaw was wired shut and a tracheostomy was placed. They coiled the aneurysm and put a stent in the dissection. I was placed on dual antiplatelet therapy to prevent stent thrombosis.

When I initially woke from the coma during my hospital stay, I could not speak, but I remember being told why I was there. My first two thoughts were: Was it my fault? and I need to get back to work.

Two and a half weeks later, I was stable enough to go to an in-patient rehab facility.

I was very motivated. I made a lot of good progress, because Taylor was there with me. We looked through pictures, trying to jog my memory and help with my vocabulary. I’d look at a bird and know this is a flying animal but couldn’t think of the word bird. I couldn’t remember my mom’s name.

Dr. Taylor Delgado: She was becoming more fluent with her speech each day. Her right arm was working more normally. We started going on walks outside. Within 14 days she was discharged home.

When we left the rehab facility, I took a couple extra tracheostomy tubes and supplies, because I didn’t know how long Ali would have her trach. The emergency medicine person in me just thought, always have these things on hand.

A few days later, her ENT doctor decannulated her tracheostomy tube. In our minds, we were done.

The next night, she had the intracranial hemorrhage.
 

 

 

Return to the hospital ...

Dr. Taylor Delgado: The aneurysm they had coiled had ruptured. Ali had a recurrent subarachnoid hemorrhage and an intracranial hemorrhage, and she was still bleeding. So, they took her to IR to try to embolize it and accomplished as much as they possibly could.

She had hydrocephalus, the ventricles in her brain were enlarged. Normally, they would put in a drain, but they couldn’t because she was on aspirin and Plavix (clopidogrel). That would risk her having a bleed around that insertion site, which would cause a brain hemorrhage.

Dr. Alison Delgado: I was like a ticking time bomb. We knew I would have to have surgery as soon as possible to open my skull and clip the aneurysm. But I had to be on the Plavix and aspirin for at least 6 weeks before it would be considered safe to discontinue them. It was another 3 weeks before they could proceed with the surgery.

The second hospitalization was scarier than the first, because I was much more aware. I knew that I might not be able to return to my residency and do the thing I had dreamed of doing. There were risks of me becoming blind or paralyzed during the surgery. I might not even leave the hospital.

Dr. Taylor Delgado: It was mid-December by then, and my dad asked her, “Ali, what do you want for Christmas?” She looked at him deadpan and said, “normal brain.”

Dr. Alison Delgado: The surgery was successful. I went home a few days later. But I’d lost everything I had gained in rehabilitation. My speech was back to square one.

None of the doctors really expected me to go back to work. But from my standpoint, I thought, I could have died the day I was hit. I could have died when the aneurysm ruptured, or at any point along the way. But I’m here and I’m going back to work.

Dr. Taylor Delgado: In January, I went back to work and I had to fly on the helicopter. They were worried about how I would react. My flight director flew with me on my first shift. Our first flight was an inter-facility STEMI transfer. No big deal. The second one was a car accident outside of Batesville, Ind. We were in the back of the ambulance, and I looked at this woman. She was 27 years old, thin, with long hair. She looked exactly like Ali.

Ali flashed into my mind, and I was like, nope. Ali’s at home. She’s fine. This person is right here, right now. Do what you do. I intubated her in the helicopter. We gave her hypertonic saline. I started a blood transfusion. Afterward, my flight director came up to me and said: “You’re released back to full duty. That was the hardest test you could possibly have on your first day back flying, and you nailed it.”

Dr. Alison Delgado: I finished my residency in December of 2012 and passed my pediatric board exam on the first try, almost exactly 3 years after my accident.

The spring before I started medical school in 2005, I had won the Cincinnati Flying Pig marathon. In 2011, a few months after my accident, they invited us to be the starters of the race. When we stood at the starting line, I decided right then I was going to run this marathon again the next year. In spring 2012, I returned and finished in fourth place, beating my previous winning time by two minutes.

I have a different level of empathy for my patients now. I know what it’s like to be scared. I know what it’s like to not know if you’re going to leave the hospital. I’ve lived that. The process of writing my book was also cathartic for me. I told my story to try to give people hope.

Dr. Taylor Delgado: I have a tattoo on my wrist showing the date of Ali’s accident. The idea was to remind myself of what we’ve come through and everyone who went above and beyond. To show gratitude to them and remember everything that they did for us. It’s also to remember that every patient I see is somebody else’s Alison.

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

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Dr. Taylor Delgado: It was Saturday night, and we had just gone to bed. Suddenly, Ali sat up, and screamed, “My head!” She then became nonresponsive and had a seizure. I was in disbelief, but I also knew exactly what was happening. I called 911: “My wife is having a head bleed. I need an ambulance.” It was a bad connection, and they could barely understand me.

As I tried to carry Ali downstairs, she vomited. She still had rubber bands in her mouth from the jaw fracture that was a result of her accident just a month ago. I knew she needed an airway. 

I grabbed a tracheostomy tube, but the opening over her trachea put in for the accident had since closed. I tried to push the tube through her neck, but it hurt her; her eyes opened.

I thought to myself: Maybe she doesn’t need it. This can wait until she gets to the hospital. I can’t do this to her. But she vomited again, and I knew what I had to do.

We were at the top of our stairs. I didn’t have a blade or any other equipment, just the tracheostomy tube with the dilator. I pushed hard, and she started fighting me. I had to hold her hands away with one arm. The tube popped in and she stared back at me in pain and fear.

I finally got her downstairs and called medical control at University Hospital of Cincinnati. I was able to speak with one of the attendings: “Ali’s aneurysm ruptured, and she just had a seizure. She has a GCS of 11 or 12. I replaced her tracheostomy tube. We’ll be there shortly.”

When I heard sirens come down our street, I carried Ali outside, but the sirens were from a firetruck. They likely assumed someone had fallen and had a head laceration. It was beyond deflating. I yelled incredulously: “We need an ambulance here now!”

When the ambulance finally arrived, they tried to tell me that I could not ride with them. Or if I did, I would have to sit up front. After arguing back and forth for a few seconds, I finally demanded: “This is medical control. This is MD-88, and this is my patient. I’m sitting in back with you. She needs four Zofran and two midazolam IV now.”
 

One month earlier ...

Dr. Alison Delgado: Taylor and I were both 4 months into our second year of residency, and we had been married for 5 months. I was a pediatric resident at Cincinnati Children’s Hospital. She was an emergency medicine resident at the University Hospital. I was having my first day off in a couple weeks, and she was working a shift in the emergency department. She was also a part of the flight crew that day. Second-year residents would go out to the scenes of accidents or to other hospitals to transport the patient back to their Level I trauma center via helicopter. The resident was the physician and considered the leader on these flights.

That afternoon, I went for a bicycle ride. About three-quarters of the way through my ride, I was struck by a car.

The EMS crew got to me fairly quickly. They intubated me at the scene and got me to the closest hospital. Immediately, the hospital realized my case was outside the scope of their care. They contacted University Hospital requesting that their flight crew come to transport me.

Dr. Taylor Delgado: At around 5:30 p.m. the day of my shift, the tones went out on the radio: “AirCare 1 and Pod Doc, you are requested for interhospital transfer, 27-year-old Jane Doe, GCS 5.” That was the only information given.

When we landed at the hospital, I walked in with my nurse. I was listening to the doctor’s report and doing my once over. The patient was a little bit bradycardic, heart rate in the 40s or 50s. Blood pressure was normal if not a little bit elevated. There was obvious facial trauma. The endotracheal tube in place.

She was covered with a blanket, but some of her clothing was visible. Suddenly, I recognized it. It was our cycling team’s kit. I thought, please don’t let it be Ali. I looked at her face and realized that this was Alison.

I said: “That’s my wife.” Everyone stopped and looked at me. The room went silent.


My flight nurse went out and called back to dispatch. “This is my doc’s wife. Dispatch the second helicopter!” She had to repeat herself a few times before they understood what was happening.

As Ali’s spouse, I couldn’t be the flight doctor. I didn’t care. I called medical control myself and told them: “This is Ali. We have to fly her. She has a head injury.” They said: “You can’t fly her.” I said: “We can’t delay her care. I have to fly her.” They said: “No, you can’t fly her.” I broke down. Devastated.

I went back into the room and looked at Ali. Her heart rate was dropping. My flight nurse was in the trauma bay with the emergency physician. We realized definitive care was being delayed because of my presence, which was an awful feeling to have. I think at that point we realized, you do nothing, or you act. So, we acted.

I told my flight nurse: “Let’s give her atropine to increase her heart rate.” I asked about sedation, and she hadn’t had anything. I spurted off some doses: “a hundred of fentanyl and five of midazolam.” My flight nurse actually administered smaller doses. She thought it was a bit aggressive, and she was correct. I was trying to maintain composure, but it was hard.

The emergency medicine physician volunteered to fly with her, so I called back medical control in desperation: “This doctor’s willing to fly. Let him take her.”

They told me apologetically, knowing my agony, that he was not trained to fly and therefore could not do so. I sat down in the ambulance bay crying, waiting for the second helicopter to arrive.

When we got Ali onto AirCare 2, my nurse then told me I couldn’t fly with her. I said, “I’m flying with her.” She said, “no, it’s not safe.” I said, “I’m not leaving her. I’ll sit in the front. What do you think I’m going to do? Jump out of the helicopter?” I think they realized there was no other option that I would agree to. I rode up front.

It was the fastest flight to the trauma center that I had ever experienced. They did a hot offload, meaning they didn’t even shut down the blades. We got her to the trauma center. And then it was a whole other layer of chaos.

 

 

Dr. Alison Delgado: Taylor’s presence may have delayed my transfer, but the University emergency department was prepped and waiting for me. Radiology was on hold, surgery and neurosurgery were there waiting. Everyone was in the trauma bay.

Dr. Taylor Delgado: My younger sister was a social worker in that emergency department, and she was on shift. She and my residency director went to CT with Ali. As the images from Ali’s CT scan showed up on the screens, everyone in the room gasped. She had a nonsurvivable head injury.

The AirCare 2 doctor collapsed into our director’s arms and cried: “She’s going to die tonight.” He responded: “I know. But we’ve got work to do.” Then he asked my sister how close she was with me. She told him we were extremely close. “Good, because we have to break the news that she’s going to die tonight.”

But the doctor never told me. I was in the consultation room. He came in and told me that she had a lot of bleeding around the brain, but he couldn’t find the words to tell me the true severity. He didn’t have to.

Dr. Alison Delgado: I was in a coma for 5 days. Shift by shift, they were amazed that I was still there. I had a broken jaw, broken vertebrae in my spine, a broken clavicle and sternum and contusions to my heart and lungs. I was later found to have a dissection of my carotid artery as well as an aneurysm to the carotid artery. These were both caused by the accident.

My jaw was wired shut and a tracheostomy was placed. They coiled the aneurysm and put a stent in the dissection. I was placed on dual antiplatelet therapy to prevent stent thrombosis.

When I initially woke from the coma during my hospital stay, I could not speak, but I remember being told why I was there. My first two thoughts were: Was it my fault? and I need to get back to work.

Two and a half weeks later, I was stable enough to go to an in-patient rehab facility.

I was very motivated. I made a lot of good progress, because Taylor was there with me. We looked through pictures, trying to jog my memory and help with my vocabulary. I’d look at a bird and know this is a flying animal but couldn’t think of the word bird. I couldn’t remember my mom’s name.

Dr. Taylor Delgado: She was becoming more fluent with her speech each day. Her right arm was working more normally. We started going on walks outside. Within 14 days she was discharged home.

When we left the rehab facility, I took a couple extra tracheostomy tubes and supplies, because I didn’t know how long Ali would have her trach. The emergency medicine person in me just thought, always have these things on hand.

A few days later, her ENT doctor decannulated her tracheostomy tube. In our minds, we were done.

The next night, she had the intracranial hemorrhage.
 

 

 

Return to the hospital ...

Dr. Taylor Delgado: The aneurysm they had coiled had ruptured. Ali had a recurrent subarachnoid hemorrhage and an intracranial hemorrhage, and she was still bleeding. So, they took her to IR to try to embolize it and accomplished as much as they possibly could.

She had hydrocephalus, the ventricles in her brain were enlarged. Normally, they would put in a drain, but they couldn’t because she was on aspirin and Plavix (clopidogrel). That would risk her having a bleed around that insertion site, which would cause a brain hemorrhage.

Dr. Alison Delgado: I was like a ticking time bomb. We knew I would have to have surgery as soon as possible to open my skull and clip the aneurysm. But I had to be on the Plavix and aspirin for at least 6 weeks before it would be considered safe to discontinue them. It was another 3 weeks before they could proceed with the surgery.

The second hospitalization was scarier than the first, because I was much more aware. I knew that I might not be able to return to my residency and do the thing I had dreamed of doing. There were risks of me becoming blind or paralyzed during the surgery. I might not even leave the hospital.

Dr. Taylor Delgado: It was mid-December by then, and my dad asked her, “Ali, what do you want for Christmas?” She looked at him deadpan and said, “normal brain.”

Dr. Alison Delgado: The surgery was successful. I went home a few days later. But I’d lost everything I had gained in rehabilitation. My speech was back to square one.

None of the doctors really expected me to go back to work. But from my standpoint, I thought, I could have died the day I was hit. I could have died when the aneurysm ruptured, or at any point along the way. But I’m here and I’m going back to work.

Dr. Taylor Delgado: In January, I went back to work and I had to fly on the helicopter. They were worried about how I would react. My flight director flew with me on my first shift. Our first flight was an inter-facility STEMI transfer. No big deal. The second one was a car accident outside of Batesville, Ind. We were in the back of the ambulance, and I looked at this woman. She was 27 years old, thin, with long hair. She looked exactly like Ali.

Ali flashed into my mind, and I was like, nope. Ali’s at home. She’s fine. This person is right here, right now. Do what you do. I intubated her in the helicopter. We gave her hypertonic saline. I started a blood transfusion. Afterward, my flight director came up to me and said: “You’re released back to full duty. That was the hardest test you could possibly have on your first day back flying, and you nailed it.”

Dr. Alison Delgado: I finished my residency in December of 2012 and passed my pediatric board exam on the first try, almost exactly 3 years after my accident.

The spring before I started medical school in 2005, I had won the Cincinnati Flying Pig marathon. In 2011, a few months after my accident, they invited us to be the starters of the race. When we stood at the starting line, I decided right then I was going to run this marathon again the next year. In spring 2012, I returned and finished in fourth place, beating my previous winning time by two minutes.

I have a different level of empathy for my patients now. I know what it’s like to be scared. I know what it’s like to not know if you’re going to leave the hospital. I’ve lived that. The process of writing my book was also cathartic for me. I told my story to try to give people hope.

Dr. Taylor Delgado: I have a tattoo on my wrist showing the date of Ali’s accident. The idea was to remind myself of what we’ve come through and everyone who went above and beyond. To show gratitude to them and remember everything that they did for us. It’s also to remember that every patient I see is somebody else’s Alison.

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

Dr. Taylor Delgado: It was Saturday night, and we had just gone to bed. Suddenly, Ali sat up, and screamed, “My head!” She then became nonresponsive and had a seizure. I was in disbelief, but I also knew exactly what was happening. I called 911: “My wife is having a head bleed. I need an ambulance.” It was a bad connection, and they could barely understand me.

As I tried to carry Ali downstairs, she vomited. She still had rubber bands in her mouth from the jaw fracture that was a result of her accident just a month ago. I knew she needed an airway. 

I grabbed a tracheostomy tube, but the opening over her trachea put in for the accident had since closed. I tried to push the tube through her neck, but it hurt her; her eyes opened.

I thought to myself: Maybe she doesn’t need it. This can wait until she gets to the hospital. I can’t do this to her. But she vomited again, and I knew what I had to do.

We were at the top of our stairs. I didn’t have a blade or any other equipment, just the tracheostomy tube with the dilator. I pushed hard, and she started fighting me. I had to hold her hands away with one arm. The tube popped in and she stared back at me in pain and fear.

I finally got her downstairs and called medical control at University Hospital of Cincinnati. I was able to speak with one of the attendings: “Ali’s aneurysm ruptured, and she just had a seizure. She has a GCS of 11 or 12. I replaced her tracheostomy tube. We’ll be there shortly.”

When I heard sirens come down our street, I carried Ali outside, but the sirens were from a firetruck. They likely assumed someone had fallen and had a head laceration. It was beyond deflating. I yelled incredulously: “We need an ambulance here now!”

When the ambulance finally arrived, they tried to tell me that I could not ride with them. Or if I did, I would have to sit up front. After arguing back and forth for a few seconds, I finally demanded: “This is medical control. This is MD-88, and this is my patient. I’m sitting in back with you. She needs four Zofran and two midazolam IV now.”
 

One month earlier ...

Dr. Alison Delgado: Taylor and I were both 4 months into our second year of residency, and we had been married for 5 months. I was a pediatric resident at Cincinnati Children’s Hospital. She was an emergency medicine resident at the University Hospital. I was having my first day off in a couple weeks, and she was working a shift in the emergency department. She was also a part of the flight crew that day. Second-year residents would go out to the scenes of accidents or to other hospitals to transport the patient back to their Level I trauma center via helicopter. The resident was the physician and considered the leader on these flights.

That afternoon, I went for a bicycle ride. About three-quarters of the way through my ride, I was struck by a car.

The EMS crew got to me fairly quickly. They intubated me at the scene and got me to the closest hospital. Immediately, the hospital realized my case was outside the scope of their care. They contacted University Hospital requesting that their flight crew come to transport me.

Dr. Taylor Delgado: At around 5:30 p.m. the day of my shift, the tones went out on the radio: “AirCare 1 and Pod Doc, you are requested for interhospital transfer, 27-year-old Jane Doe, GCS 5.” That was the only information given.

When we landed at the hospital, I walked in with my nurse. I was listening to the doctor’s report and doing my once over. The patient was a little bit bradycardic, heart rate in the 40s or 50s. Blood pressure was normal if not a little bit elevated. There was obvious facial trauma. The endotracheal tube in place.

She was covered with a blanket, but some of her clothing was visible. Suddenly, I recognized it. It was our cycling team’s kit. I thought, please don’t let it be Ali. I looked at her face and realized that this was Alison.

I said: “That’s my wife.” Everyone stopped and looked at me. The room went silent.


My flight nurse went out and called back to dispatch. “This is my doc’s wife. Dispatch the second helicopter!” She had to repeat herself a few times before they understood what was happening.

As Ali’s spouse, I couldn’t be the flight doctor. I didn’t care. I called medical control myself and told them: “This is Ali. We have to fly her. She has a head injury.” They said: “You can’t fly her.” I said: “We can’t delay her care. I have to fly her.” They said: “No, you can’t fly her.” I broke down. Devastated.

I went back into the room and looked at Ali. Her heart rate was dropping. My flight nurse was in the trauma bay with the emergency physician. We realized definitive care was being delayed because of my presence, which was an awful feeling to have. I think at that point we realized, you do nothing, or you act. So, we acted.

I told my flight nurse: “Let’s give her atropine to increase her heart rate.” I asked about sedation, and she hadn’t had anything. I spurted off some doses: “a hundred of fentanyl and five of midazolam.” My flight nurse actually administered smaller doses. She thought it was a bit aggressive, and she was correct. I was trying to maintain composure, but it was hard.

The emergency medicine physician volunteered to fly with her, so I called back medical control in desperation: “This doctor’s willing to fly. Let him take her.”

They told me apologetically, knowing my agony, that he was not trained to fly and therefore could not do so. I sat down in the ambulance bay crying, waiting for the second helicopter to arrive.

When we got Ali onto AirCare 2, my nurse then told me I couldn’t fly with her. I said, “I’m flying with her.” She said, “no, it’s not safe.” I said, “I’m not leaving her. I’ll sit in the front. What do you think I’m going to do? Jump out of the helicopter?” I think they realized there was no other option that I would agree to. I rode up front.

It was the fastest flight to the trauma center that I had ever experienced. They did a hot offload, meaning they didn’t even shut down the blades. We got her to the trauma center. And then it was a whole other layer of chaos.

 

 

Dr. Alison Delgado: Taylor’s presence may have delayed my transfer, but the University emergency department was prepped and waiting for me. Radiology was on hold, surgery and neurosurgery were there waiting. Everyone was in the trauma bay.

Dr. Taylor Delgado: My younger sister was a social worker in that emergency department, and she was on shift. She and my residency director went to CT with Ali. As the images from Ali’s CT scan showed up on the screens, everyone in the room gasped. She had a nonsurvivable head injury.

The AirCare 2 doctor collapsed into our director’s arms and cried: “She’s going to die tonight.” He responded: “I know. But we’ve got work to do.” Then he asked my sister how close she was with me. She told him we were extremely close. “Good, because we have to break the news that she’s going to die tonight.”

But the doctor never told me. I was in the consultation room. He came in and told me that she had a lot of bleeding around the brain, but he couldn’t find the words to tell me the true severity. He didn’t have to.

Dr. Alison Delgado: I was in a coma for 5 days. Shift by shift, they were amazed that I was still there. I had a broken jaw, broken vertebrae in my spine, a broken clavicle and sternum and contusions to my heart and lungs. I was later found to have a dissection of my carotid artery as well as an aneurysm to the carotid artery. These were both caused by the accident.

My jaw was wired shut and a tracheostomy was placed. They coiled the aneurysm and put a stent in the dissection. I was placed on dual antiplatelet therapy to prevent stent thrombosis.

When I initially woke from the coma during my hospital stay, I could not speak, but I remember being told why I was there. My first two thoughts were: Was it my fault? and I need to get back to work.

Two and a half weeks later, I was stable enough to go to an in-patient rehab facility.

I was very motivated. I made a lot of good progress, because Taylor was there with me. We looked through pictures, trying to jog my memory and help with my vocabulary. I’d look at a bird and know this is a flying animal but couldn’t think of the word bird. I couldn’t remember my mom’s name.

Dr. Taylor Delgado: She was becoming more fluent with her speech each day. Her right arm was working more normally. We started going on walks outside. Within 14 days she was discharged home.

When we left the rehab facility, I took a couple extra tracheostomy tubes and supplies, because I didn’t know how long Ali would have her trach. The emergency medicine person in me just thought, always have these things on hand.

A few days later, her ENT doctor decannulated her tracheostomy tube. In our minds, we were done.

The next night, she had the intracranial hemorrhage.
 

 

 

Return to the hospital ...

Dr. Taylor Delgado: The aneurysm they had coiled had ruptured. Ali had a recurrent subarachnoid hemorrhage and an intracranial hemorrhage, and she was still bleeding. So, they took her to IR to try to embolize it and accomplished as much as they possibly could.

She had hydrocephalus, the ventricles in her brain were enlarged. Normally, they would put in a drain, but they couldn’t because she was on aspirin and Plavix (clopidogrel). That would risk her having a bleed around that insertion site, which would cause a brain hemorrhage.

Dr. Alison Delgado: I was like a ticking time bomb. We knew I would have to have surgery as soon as possible to open my skull and clip the aneurysm. But I had to be on the Plavix and aspirin for at least 6 weeks before it would be considered safe to discontinue them. It was another 3 weeks before they could proceed with the surgery.

The second hospitalization was scarier than the first, because I was much more aware. I knew that I might not be able to return to my residency and do the thing I had dreamed of doing. There were risks of me becoming blind or paralyzed during the surgery. I might not even leave the hospital.

Dr. Taylor Delgado: It was mid-December by then, and my dad asked her, “Ali, what do you want for Christmas?” She looked at him deadpan and said, “normal brain.”

Dr. Alison Delgado: The surgery was successful. I went home a few days later. But I’d lost everything I had gained in rehabilitation. My speech was back to square one.

None of the doctors really expected me to go back to work. But from my standpoint, I thought, I could have died the day I was hit. I could have died when the aneurysm ruptured, or at any point along the way. But I’m here and I’m going back to work.

Dr. Taylor Delgado: In January, I went back to work and I had to fly on the helicopter. They were worried about how I would react. My flight director flew with me on my first shift. Our first flight was an inter-facility STEMI transfer. No big deal. The second one was a car accident outside of Batesville, Ind. We were in the back of the ambulance, and I looked at this woman. She was 27 years old, thin, with long hair. She looked exactly like Ali.

Ali flashed into my mind, and I was like, nope. Ali’s at home. She’s fine. This person is right here, right now. Do what you do. I intubated her in the helicopter. We gave her hypertonic saline. I started a blood transfusion. Afterward, my flight director came up to me and said: “You’re released back to full duty. That was the hardest test you could possibly have on your first day back flying, and you nailed it.”

Dr. Alison Delgado: I finished my residency in December of 2012 and passed my pediatric board exam on the first try, almost exactly 3 years after my accident.

The spring before I started medical school in 2005, I had won the Cincinnati Flying Pig marathon. In 2011, a few months after my accident, they invited us to be the starters of the race. When we stood at the starting line, I decided right then I was going to run this marathon again the next year. In spring 2012, I returned and finished in fourth place, beating my previous winning time by two minutes.

I have a different level of empathy for my patients now. I know what it’s like to be scared. I know what it’s like to not know if you’re going to leave the hospital. I’ve lived that. The process of writing my book was also cathartic for me. I told my story to try to give people hope.

Dr. Taylor Delgado: I have a tattoo on my wrist showing the date of Ali’s accident. The idea was to remind myself of what we’ve come through and everyone who went above and beyond. To show gratitude to them and remember everything that they did for us. It’s also to remember that every patient I see is somebody else’s Alison.

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

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Severe strep infections rebound after pandemic lull

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Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

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

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Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

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

Severe infections caused by group A streptococcus bacteria are on the rise in countries around the world, including the United States, according to new data from the Centers for Disease Control and Prevention.
 

Group A strep bacteria usually cause mild illnesses like strep throat and scarlet fever. But they can also cause more severe diseases, like the flesh-eating disease necrotizing fasciitis and streptococcal toxic shock syndrome, known as invasive group A strep infections. 

These infections fell by 25% during the COVID-19 pandemic and were especially low in children. The number of milder infections also dropped. But in 2022, severe infections came roaring back, particularly in children.

Infections increased earlier in the winter/spring season – from September to November – than in a typical year and rose to higher than prepandemic levels in many parts of the country, such as Colorado and Minnesota.

Now in 2023, invasive infections are high in children in some parts of the country, even after respiratory viruses like the flu and respiratory syncytial virus (RSV) decreased in those areas. Some parts of the country also saw high rates of invasive infections in older adults. 

Less severe strep A infections in children have returned to levels similar to or higher than those seen in prepandemic years.

A similar postpandemic resurgence in invasive infections has also been seen in other countries, including Canada, the United Kingdom, France, and Denmark.

Strep A is a very common bacteria that causes only mild or no symptoms in most people, and severe infections are usually quite rare. They tend to affect the most vulnerable people: those who have another virus, multiple chronic conditions, or an open wound.

People should watch for fever, headaches, or confusion during a strep infection, which all might signal a more severe illness.

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

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Low-calorie tastes sweeter with a little salt

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Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

Jason Tuinstra/Unsplash

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

Benoit-Joseph Laventie, Biozentrum, University of Basel

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Bildflut/Wikimedia Commons

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

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Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

Jason Tuinstra/Unsplash

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

Benoit-Joseph Laventie, Biozentrum, University of Basel

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Bildflut/Wikimedia Commons

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

Low-calorie tastes sweeter with a little salt

Diet and sugar-free foods and drinks seem like a good idea, but it’s hard to get past that strange aftertaste, right? It’s the calling card for the noncaloric aspartame- and stevia-containing sweeteners that we consume to make us feel like we can have the best of both worlds.

That weird lingering taste can be a total turn-off for some (raises hand), but researchers have found an almost facepalm solution to the not-so-sweet problem, and it’s salt.

Jason Tuinstra/Unsplash

Now, the concept of sweet and salty is not a far-fetched partnership when it comes to snack consumption (try M&Ms in your popcorn). The researchers at Almendra, a manufacturer of stevia sweeteners, put that iconic flavor pair to the test by adding mineral salts that have some nutritional value to lessen the effect of a stevia compound, rebaudioside A, found in noncaloric sweeteners.

The researchers added in magnesium chloride, calcium chloride, and potassium chloride separately to lessen rebaudioside A’s intensity, but they needed so much salt that it killed the sweet taste completely. A blend of the three mineral salts, however, reduced the lingering taste by 79% and improved the real sugar-like taste. The researchers tried this blend in reduced-calorie orange juice and a citrus-flavored soft drink, improving the taste in both.

The salty and sweet match comes in for the win once again. This time helping against the fight of obesity instead of making it worse.

Pseudomonas’ Achilles’ heel is more of an Achilles’ genetic switch

Today, on the long-awaited return of “Bacteria vs. the World,” we meet one of the rock stars of infectious disease.

LOTME: Through the use of imaginary technology, we’re talking to Pseudomonas aeruginosa. Thanks for joining us on such short notice, after Neisseria gonorrhoeae canceled at the last minute.

P. aeruginosa: No problem. I think we can all guess what that little devil is up to.

Benoit-Joseph Laventie, Biozentrum, University of Basel

LOTME: Bacterial resistance to antibiotics is a huge problem for our species. What makes you so hard to fight?

P. aeruginosa: We’ve been trying to keep that a secret, actually, but now that researchers in Switzerland and Denmark seem to have figured it out, I guess it’s okay for me to spill the beans.

LOTME: Beans? What do beans have to do with it?

P. aeruginosa: Nothing, it’s just a colloquial expression that means I’m sharing previously private information.

LOTME: Sure, we knew that. Please, continue your spilling.

P. aeruginosa: The secret is … Well, let’s just say we were a little worried when the Clash released “Should I Stay or Should I Go” back in the 1980s.

LOTME: The Clash? Now we’re really confused.

P. aeruginosa: The answer to their question, “Should I stay or should I go? is yes. Successful invasion of a human is all about division of labor. “While one fraction of the bacterial population adheres to the mucosal surface and forms a biofilm, the other subpopulation spreads to distant tissue sites,” is how the investigators described it. We can increase surface colonization by using a “job-sharing” process, they said, and even resist antibiotics because most of us remain in the protective biofilm.

LOTME: And they say you guys don’t have brains.

P. aeruginosa: But wait, there’s more. We don’t just divide the labor randomly. After the initial colonization we form two functionally distinct subpopulations. One has high levels of the bacterial signaling molecule c-di-GMP and stays put to work on the biofilm. The other group, with low levels of c-di-GMP, heads out to the surrounding tissue to continue the colonization. As project leader Urs Jenal put it, “By identifying the genetic switch, we have tracked down the Achilles heel of the pathogen.”

LOTME: Pretty clever stuff, for humans, anyway.

P. aeruginosa: We agree, but now that you know our secret, we can’t let you share it.

LOTME: Wait! The journal article’s already been published. Your secret is out. You can’t stop that by infecting me.

P. aeruginosa: True enough, but are you familiar with the fable of the scorpion and the frog? It’s our nature.

LOTME: Nooooo! N. gonorrhoeae wouldn’t have done this!
 

What a pain in the Butt

Businesses rise and businesses fall. We all know that one cursed location, that spot in town where we see businesses move in and close up in a matter of months. At the same time, though, there are also businesses that have been around as long as anyone can remember, pillars of the community.

Corydon, IN., likely has a few such long-lived shops, but it is officially down one 70-year-old family business as of late April, with the unfortunate passing of beloved local pharmacy Butt Drugs. Prescription pick-up in rear.

Bildflut/Wikimedia Commons

The business dates back to 1952, when it was founded as William H. Butt Drugs. We’re sure William Butt was never teased about his last name. Nope. No one would ever do that. After he passed the store to his children, it underwent a stint as Butt Rexall Drugs. When the shop was passed down to its third-generation and ultimately final owner, Katie Butt Beckort, she decided to simplify the name. Get right down to the bottom of things, as it were.

Butt Drugs was a popular spot, featuring an old-school soda fountain and themed souvenirs. According to Ms. Butt Beckort, people would come from miles away to buy “I love Butt Drugs” T-shirts, magnets, and so on. Yes, they knew perfectly well what they were sitting on.

So, if was such a hit, why did it close? Butt Drugs may have a hilarious name and merchandise to match, but the pharmacy portion of the pharmacy had been losing money for years. You know, the actual point of the business. As with so many things, we can blame it on the insurance companies. More than half the drugs that passed through Butt Drugs’ doors were sold at a loss, because the insurance companies refused to reimburse the store more than the wholesale price of the drug. Not even a good butt drug could clear up that financial diarrhea.

And so, we’ve lost Butt Drugs forever. Spicy food enthusiasts, coffee drinkers, and all patrons of Taco Bell, take a moment to reflect and mourn on what you’ve lost. No more Butt Drugs to relieve your suffering. A true kick in the butt indeed.

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Should you have a chaperone in the exam room? Many say yes

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This transcript has been edited for clarity.

I’m Art Caplan, PhD. I’m at the division of medical ethics at NYU’s Grossman School of Medicine.

An interesting situation has arisen that many doctors who do physical examinations and primary care are facing, which is whether a chaperone has to be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area.

In some institutions, there has been a movement toward saying a chaperone must be present, that it’s mandatory. I know that is true at Yale’s health care centers and clinics. Others do so when the patient requests it. An interesting situation sometimes occurs when the hospital or the clinic requires a chaperone but the patient says, “I don’t want a chaperone. I want my privacy. I want the gynecologist or the urologist only. I don’t want anyone else to be seeing me. I’m not comfortable with anyone other than the doctor in the room.”

Complicating this issue of when is a chaperone appropriate and when can it be refused, if ever, is the fact that the role of chaperone is ill defined. For example, there isn’t really agreement on who can be a chaperone. Could it be a medical student? Could it be a nurse? Could it be another doctor? Should it be someone who at least has finished nursing school or medical school? Can it be a patient representative? There are no standards about who can play the role.

Should the chaperone be available to be seen when they’re in the room? Should they stay behind a curtain or somewhere where they’re not, so to speak, intrusive into what’s going on in the exam room? Do they sit in a chair? Do they stand? How do they behave, if you will? There’s no agreement.

There’s still no agreement on the training that a chaperone should have. Do we charge them with trying to represent what’s going on with the patient or trying to protect the doctor against any accusations that are ill founded about inappropriate conduct? Are they supposed to do both? How do they obtain consent, if they do, from the patient undergoing an examination in a sensitive part of their body or one that they’re sensitive about?

This area really requires some hard thinking if you’re considering having chaperones present. I think there are some online courses that offer some training. I haven’t looked at them, but they might be worth a look to see if they make you more comfortable about getting a chaperone oriented. I think it’s probably important to set a policy saying a chaperone must always be present for these kinds of examinations and list them, or one can be requested no matter what is going on in terms of the kind of exam being conducted.

There needs to be some statement saying that you have permission to either accept them or refuse them – or you don’t. Should they always be present, for example, with patients who are minors, adolescents or children? Does that extend that far out where a guardian, parent, or someone has to give permission?

In this area, I think we can all understand why chaperones have come to the fore, including allegations of misconduct and inappropriate touching, and considering comfort levels of patients to just put them more at ease. It’s obvious that we haven’t, as a nation or a medical profession, thought it through to the degree to which we have to.

I’m certainly not anti-chaperone, and I believe that if patients are more comfortable having one present, or a doctor is more comfortable having one present, or if we all agree that there are certain patients – kids – where certain types of examinations require or ought to expect the chaperone to be present, that’s wonderful.

We’ve got to lay out the rights of the doctors. We’ve got to lay out the rights of the institutions. We’ve got to lay out the rights of the patients. We should agree on who these people are. We should agree on how they’re trained.

We’ve got some work ahead of us if we’re going to have chaperones become a standard part of the medical examination.

Dr. Kaplan reported conflicts of interest with the Franklin Institute, Tengion, Biogen Idec, Johnson & Johnson, and PriCara.

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

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This transcript has been edited for clarity.

I’m Art Caplan, PhD. I’m at the division of medical ethics at NYU’s Grossman School of Medicine.

An interesting situation has arisen that many doctors who do physical examinations and primary care are facing, which is whether a chaperone has to be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area.

In some institutions, there has been a movement toward saying a chaperone must be present, that it’s mandatory. I know that is true at Yale’s health care centers and clinics. Others do so when the patient requests it. An interesting situation sometimes occurs when the hospital or the clinic requires a chaperone but the patient says, “I don’t want a chaperone. I want my privacy. I want the gynecologist or the urologist only. I don’t want anyone else to be seeing me. I’m not comfortable with anyone other than the doctor in the room.”

Complicating this issue of when is a chaperone appropriate and when can it be refused, if ever, is the fact that the role of chaperone is ill defined. For example, there isn’t really agreement on who can be a chaperone. Could it be a medical student? Could it be a nurse? Could it be another doctor? Should it be someone who at least has finished nursing school or medical school? Can it be a patient representative? There are no standards about who can play the role.

Should the chaperone be available to be seen when they’re in the room? Should they stay behind a curtain or somewhere where they’re not, so to speak, intrusive into what’s going on in the exam room? Do they sit in a chair? Do they stand? How do they behave, if you will? There’s no agreement.

There’s still no agreement on the training that a chaperone should have. Do we charge them with trying to represent what’s going on with the patient or trying to protect the doctor against any accusations that are ill founded about inappropriate conduct? Are they supposed to do both? How do they obtain consent, if they do, from the patient undergoing an examination in a sensitive part of their body or one that they’re sensitive about?

This area really requires some hard thinking if you’re considering having chaperones present. I think there are some online courses that offer some training. I haven’t looked at them, but they might be worth a look to see if they make you more comfortable about getting a chaperone oriented. I think it’s probably important to set a policy saying a chaperone must always be present for these kinds of examinations and list them, or one can be requested no matter what is going on in terms of the kind of exam being conducted.

There needs to be some statement saying that you have permission to either accept them or refuse them – or you don’t. Should they always be present, for example, with patients who are minors, adolescents or children? Does that extend that far out where a guardian, parent, or someone has to give permission?

In this area, I think we can all understand why chaperones have come to the fore, including allegations of misconduct and inappropriate touching, and considering comfort levels of patients to just put them more at ease. It’s obvious that we haven’t, as a nation or a medical profession, thought it through to the degree to which we have to.

I’m certainly not anti-chaperone, and I believe that if patients are more comfortable having one present, or a doctor is more comfortable having one present, or if we all agree that there are certain patients – kids – where certain types of examinations require or ought to expect the chaperone to be present, that’s wonderful.

We’ve got to lay out the rights of the doctors. We’ve got to lay out the rights of the institutions. We’ve got to lay out the rights of the patients. We should agree on who these people are. We should agree on how they’re trained.

We’ve got some work ahead of us if we’re going to have chaperones become a standard part of the medical examination.

Dr. Kaplan reported conflicts of interest with the Franklin Institute, Tengion, Biogen Idec, Johnson & Johnson, and PriCara.

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

This transcript has been edited for clarity.

I’m Art Caplan, PhD. I’m at the division of medical ethics at NYU’s Grossman School of Medicine.

An interesting situation has arisen that many doctors who do physical examinations and primary care are facing, which is whether a chaperone has to be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area.

In some institutions, there has been a movement toward saying a chaperone must be present, that it’s mandatory. I know that is true at Yale’s health care centers and clinics. Others do so when the patient requests it. An interesting situation sometimes occurs when the hospital or the clinic requires a chaperone but the patient says, “I don’t want a chaperone. I want my privacy. I want the gynecologist or the urologist only. I don’t want anyone else to be seeing me. I’m not comfortable with anyone other than the doctor in the room.”

Complicating this issue of when is a chaperone appropriate and when can it be refused, if ever, is the fact that the role of chaperone is ill defined. For example, there isn’t really agreement on who can be a chaperone. Could it be a medical student? Could it be a nurse? Could it be another doctor? Should it be someone who at least has finished nursing school or medical school? Can it be a patient representative? There are no standards about who can play the role.

Should the chaperone be available to be seen when they’re in the room? Should they stay behind a curtain or somewhere where they’re not, so to speak, intrusive into what’s going on in the exam room? Do they sit in a chair? Do they stand? How do they behave, if you will? There’s no agreement.

There’s still no agreement on the training that a chaperone should have. Do we charge them with trying to represent what’s going on with the patient or trying to protect the doctor against any accusations that are ill founded about inappropriate conduct? Are they supposed to do both? How do they obtain consent, if they do, from the patient undergoing an examination in a sensitive part of their body or one that they’re sensitive about?

This area really requires some hard thinking if you’re considering having chaperones present. I think there are some online courses that offer some training. I haven’t looked at them, but they might be worth a look to see if they make you more comfortable about getting a chaperone oriented. I think it’s probably important to set a policy saying a chaperone must always be present for these kinds of examinations and list them, or one can be requested no matter what is going on in terms of the kind of exam being conducted.

There needs to be some statement saying that you have permission to either accept them or refuse them – or you don’t. Should they always be present, for example, with patients who are minors, adolescents or children? Does that extend that far out where a guardian, parent, or someone has to give permission?

In this area, I think we can all understand why chaperones have come to the fore, including allegations of misconduct and inappropriate touching, and considering comfort levels of patients to just put them more at ease. It’s obvious that we haven’t, as a nation or a medical profession, thought it through to the degree to which we have to.

I’m certainly not anti-chaperone, and I believe that if patients are more comfortable having one present, or a doctor is more comfortable having one present, or if we all agree that there are certain patients – kids – where certain types of examinations require or ought to expect the chaperone to be present, that’s wonderful.

We’ve got to lay out the rights of the doctors. We’ve got to lay out the rights of the institutions. We’ve got to lay out the rights of the patients. We should agree on who these people are. We should agree on how they’re trained.

We’ve got some work ahead of us if we’re going to have chaperones become a standard part of the medical examination.

Dr. Kaplan reported conflicts of interest with the Franklin Institute, Tengion, Biogen Idec, Johnson & Johnson, and PriCara.

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

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New tool uses nanotechnology to speed up diagnostic testing of infectious disease

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A new tool promises to expedite detection of infectious disease, according to researchers from McGill University, Montreal.

The diagnostic platform, called QolorEX, was developed by investigators at the university by combining existing technologies to build a new tool for accurate pathogen detection in less than 15 minutes. The device was tested for several respiratory viruses and bacteria, including the H1N1 influenza virus and SARS-CoV-2. It achieved 95% accuracy at identifying COVID-19 and its variants in 48 human saliva samples.

“COVID was something that opened our eyes, and now we have to think more seriously about point-of-care diagnostics,” Sara Mahshid, PhD, assistant professor of biomedical engineering and Canada Research Chair in Nano-Biosensing Devices at McGill University, said in an interview. The technology could become important for a range of medical applications, especially in low-resource areas.

The development was detailed in an article in Nature Nanotechnology.
 

Nonclinical setting

The COVID-19 pandemic has demonstrated the need for fast and accurate testing that can be used outside of a clinical setting. The gold-standard diagnostic method is PCR testing, but its accuracy comes with a trade-off. PCR testing involves a lengthy protocol and requires a centralized testing facility.

With QolorEX, the investigators aimed to develop a new test that achieves the accuracy of PCR in an automated tool that can be used outside of a testing facility or hospital setting. Dr. Mahshid noted a particular need for a tool that could be used in congregate settings, such as airports, schools, or restaurants.

The device is compact enough to sit on a tabletop or bench and can be used easily in group settings, according to Dr. Mahshid. In the future, she hopes to further miniaturize the device to make it more scalable for widespread use.

Requiring only a saliva sample, the tool is easy to use. Unlike current COVID-19 rapid tests, which involve several steps, the system is automated and does not require manually mixing reagents. After collecting a sample, a user taps a button in a smartphone or computer application. The device handles the rest.

“We’re not chemists who understand how to mix these solutions,” Dr. Mahshid said. Avoiding those extra steps may reduce the false positives and false negatives caused by user error.
 

Fast results

QolorEX can return results in 13 minutes, like a rapid antigen test does. Like a PCR test, the device uses nucleic acid amplification. But PCR tests typically take much longer. The sample analysis alone takes 1.5-2 hours.

The new test accelerates the reaction by injecting light-excited “hot” electrons from the surface of a nanoplasmonic sensor. The device then uses imaging and a machine learning algorithm to quantify a color transformation that occurs when a pathogen is present.

The fast, reliable results make the system potentially appropriate for use in places such as airports. Previously, passengers had to wait 24 hours for a negative COVID test before boarding a plane. A device such as QolorEX would allow screening on site.

The ability of the tool to distinguish between bacterial and viral infections so quickly is “an application that is both important and extremely difficult to achieve,” according to Nikhil Bhalla, PhD, in a research briefing. Dr. Bhalla is a lecturer in electronic engineering at Ulster University, Belfast, Ireland.

The researchers hope that by delivering results quickly, the device will help reduce the spread of respiratory diseases and possibly save lives.
 

 

 

‘Sensitive and specific’

The primary benefit of the tool is its ability to return results quickly while having low false positive and false negative rates, according to Leyla Soleymani, PhD, of McMaster University, Hamilton, Ont. “It is hard to come by rapid tests that are both sensitive and specific, compared to PCR,” Dr. Soleymani told this news organization.

Although QolorEX was developed to detect COVID-19 and other infectious diseases, the uses of the device are not limited to the pathogens tested. The tool can be applied to a range of tests that currently use PCR technology. Dr. Mahshid and her team are considering several other applications of the technology, such as analyzing therapeutics for antimicrobial-resistant pathogens prioritized by the World Health Organization. The technology may also have potential for detecting cancer and bacterial infections, Dr. Mahshid said in an interview.

But to Dr. Soleymani, the most exciting application remains its use in diagnosing infectious diseases. She noted, however, that it’s unclear whether the price of the device will be too high for widespread home use. It may be more practical for family physician clinics and other facilities.

Before the device becomes commercially available, more testing is needed to validate the results, which are based on a limited number of samples that were available in a research setting.

The study was supported by the MI4 Emergency COVID-19 Research Funding, Natural Sciences and Engineering Research Council of Canada, Canadian Institutes of Health Research, Canada Foundation for Innovation, and McGill University. Dr. Mahshid and Dr. Soleymani reported no relevant financial relationships.

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

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A new tool promises to expedite detection of infectious disease, according to researchers from McGill University, Montreal.

The diagnostic platform, called QolorEX, was developed by investigators at the university by combining existing technologies to build a new tool for accurate pathogen detection in less than 15 minutes. The device was tested for several respiratory viruses and bacteria, including the H1N1 influenza virus and SARS-CoV-2. It achieved 95% accuracy at identifying COVID-19 and its variants in 48 human saliva samples.

“COVID was something that opened our eyes, and now we have to think more seriously about point-of-care diagnostics,” Sara Mahshid, PhD, assistant professor of biomedical engineering and Canada Research Chair in Nano-Biosensing Devices at McGill University, said in an interview. The technology could become important for a range of medical applications, especially in low-resource areas.

The development was detailed in an article in Nature Nanotechnology.
 

Nonclinical setting

The COVID-19 pandemic has demonstrated the need for fast and accurate testing that can be used outside of a clinical setting. The gold-standard diagnostic method is PCR testing, but its accuracy comes with a trade-off. PCR testing involves a lengthy protocol and requires a centralized testing facility.

With QolorEX, the investigators aimed to develop a new test that achieves the accuracy of PCR in an automated tool that can be used outside of a testing facility or hospital setting. Dr. Mahshid noted a particular need for a tool that could be used in congregate settings, such as airports, schools, or restaurants.

The device is compact enough to sit on a tabletop or bench and can be used easily in group settings, according to Dr. Mahshid. In the future, she hopes to further miniaturize the device to make it more scalable for widespread use.

Requiring only a saliva sample, the tool is easy to use. Unlike current COVID-19 rapid tests, which involve several steps, the system is automated and does not require manually mixing reagents. After collecting a sample, a user taps a button in a smartphone or computer application. The device handles the rest.

“We’re not chemists who understand how to mix these solutions,” Dr. Mahshid said. Avoiding those extra steps may reduce the false positives and false negatives caused by user error.
 

Fast results

QolorEX can return results in 13 minutes, like a rapid antigen test does. Like a PCR test, the device uses nucleic acid amplification. But PCR tests typically take much longer. The sample analysis alone takes 1.5-2 hours.

The new test accelerates the reaction by injecting light-excited “hot” electrons from the surface of a nanoplasmonic sensor. The device then uses imaging and a machine learning algorithm to quantify a color transformation that occurs when a pathogen is present.

The fast, reliable results make the system potentially appropriate for use in places such as airports. Previously, passengers had to wait 24 hours for a negative COVID test before boarding a plane. A device such as QolorEX would allow screening on site.

The ability of the tool to distinguish between bacterial and viral infections so quickly is “an application that is both important and extremely difficult to achieve,” according to Nikhil Bhalla, PhD, in a research briefing. Dr. Bhalla is a lecturer in electronic engineering at Ulster University, Belfast, Ireland.

The researchers hope that by delivering results quickly, the device will help reduce the spread of respiratory diseases and possibly save lives.
 

 

 

‘Sensitive and specific’

The primary benefit of the tool is its ability to return results quickly while having low false positive and false negative rates, according to Leyla Soleymani, PhD, of McMaster University, Hamilton, Ont. “It is hard to come by rapid tests that are both sensitive and specific, compared to PCR,” Dr. Soleymani told this news organization.

Although QolorEX was developed to detect COVID-19 and other infectious diseases, the uses of the device are not limited to the pathogens tested. The tool can be applied to a range of tests that currently use PCR technology. Dr. Mahshid and her team are considering several other applications of the technology, such as analyzing therapeutics for antimicrobial-resistant pathogens prioritized by the World Health Organization. The technology may also have potential for detecting cancer and bacterial infections, Dr. Mahshid said in an interview.

But to Dr. Soleymani, the most exciting application remains its use in diagnosing infectious diseases. She noted, however, that it’s unclear whether the price of the device will be too high for widespread home use. It may be more practical for family physician clinics and other facilities.

Before the device becomes commercially available, more testing is needed to validate the results, which are based on a limited number of samples that were available in a research setting.

The study was supported by the MI4 Emergency COVID-19 Research Funding, Natural Sciences and Engineering Research Council of Canada, Canadian Institutes of Health Research, Canada Foundation for Innovation, and McGill University. Dr. Mahshid and Dr. Soleymani reported no relevant financial relationships.

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

A new tool promises to expedite detection of infectious disease, according to researchers from McGill University, Montreal.

The diagnostic platform, called QolorEX, was developed by investigators at the university by combining existing technologies to build a new tool for accurate pathogen detection in less than 15 minutes. The device was tested for several respiratory viruses and bacteria, including the H1N1 influenza virus and SARS-CoV-2. It achieved 95% accuracy at identifying COVID-19 and its variants in 48 human saliva samples.

“COVID was something that opened our eyes, and now we have to think more seriously about point-of-care diagnostics,” Sara Mahshid, PhD, assistant professor of biomedical engineering and Canada Research Chair in Nano-Biosensing Devices at McGill University, said in an interview. The technology could become important for a range of medical applications, especially in low-resource areas.

The development was detailed in an article in Nature Nanotechnology.
 

Nonclinical setting

The COVID-19 pandemic has demonstrated the need for fast and accurate testing that can be used outside of a clinical setting. The gold-standard diagnostic method is PCR testing, but its accuracy comes with a trade-off. PCR testing involves a lengthy protocol and requires a centralized testing facility.

With QolorEX, the investigators aimed to develop a new test that achieves the accuracy of PCR in an automated tool that can be used outside of a testing facility or hospital setting. Dr. Mahshid noted a particular need for a tool that could be used in congregate settings, such as airports, schools, or restaurants.

The device is compact enough to sit on a tabletop or bench and can be used easily in group settings, according to Dr. Mahshid. In the future, she hopes to further miniaturize the device to make it more scalable for widespread use.

Requiring only a saliva sample, the tool is easy to use. Unlike current COVID-19 rapid tests, which involve several steps, the system is automated and does not require manually mixing reagents. After collecting a sample, a user taps a button in a smartphone or computer application. The device handles the rest.

“We’re not chemists who understand how to mix these solutions,” Dr. Mahshid said. Avoiding those extra steps may reduce the false positives and false negatives caused by user error.
 

Fast results

QolorEX can return results in 13 minutes, like a rapid antigen test does. Like a PCR test, the device uses nucleic acid amplification. But PCR tests typically take much longer. The sample analysis alone takes 1.5-2 hours.

The new test accelerates the reaction by injecting light-excited “hot” electrons from the surface of a nanoplasmonic sensor. The device then uses imaging and a machine learning algorithm to quantify a color transformation that occurs when a pathogen is present.

The fast, reliable results make the system potentially appropriate for use in places such as airports. Previously, passengers had to wait 24 hours for a negative COVID test before boarding a plane. A device such as QolorEX would allow screening on site.

The ability of the tool to distinguish between bacterial and viral infections so quickly is “an application that is both important and extremely difficult to achieve,” according to Nikhil Bhalla, PhD, in a research briefing. Dr. Bhalla is a lecturer in electronic engineering at Ulster University, Belfast, Ireland.

The researchers hope that by delivering results quickly, the device will help reduce the spread of respiratory diseases and possibly save lives.
 

 

 

‘Sensitive and specific’

The primary benefit of the tool is its ability to return results quickly while having low false positive and false negative rates, according to Leyla Soleymani, PhD, of McMaster University, Hamilton, Ont. “It is hard to come by rapid tests that are both sensitive and specific, compared to PCR,” Dr. Soleymani told this news organization.

Although QolorEX was developed to detect COVID-19 and other infectious diseases, the uses of the device are not limited to the pathogens tested. The tool can be applied to a range of tests that currently use PCR technology. Dr. Mahshid and her team are considering several other applications of the technology, such as analyzing therapeutics for antimicrobial-resistant pathogens prioritized by the World Health Organization. The technology may also have potential for detecting cancer and bacterial infections, Dr. Mahshid said in an interview.

But to Dr. Soleymani, the most exciting application remains its use in diagnosing infectious diseases. She noted, however, that it’s unclear whether the price of the device will be too high for widespread home use. It may be more practical for family physician clinics and other facilities.

Before the device becomes commercially available, more testing is needed to validate the results, which are based on a limited number of samples that were available in a research setting.

The study was supported by the MI4 Emergency COVID-19 Research Funding, Natural Sciences and Engineering Research Council of Canada, Canadian Institutes of Health Research, Canada Foundation for Innovation, and McGill University. Dr. Mahshid and Dr. Soleymani reported no relevant financial relationships.

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

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How physician-inventors create new, life-saving products

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WakeMed emergency department physician and medical director, Graham Snyder, MD, has seen his fair share of deaths: an average of one or two per day. That’s part of the job. Some of the deaths were the result of risky behavior, ongoing health problems, and other natural causes.

But what he didn’t find acceptable was losing a 6-year-old girl in a backyard pool drowning at what was meant to be a celebratory birthday party and family reunion.

“There were aunts and uncles and brothers and sisters and cousins, and the pool was packed, and they’re having a great time. One of the parents looked over and saw that she was swimming around underneath but acting weird. A relative pulled her up by the arm, and she was dead,” he said. “What nobody could tell me, and what they’ll live with the rest of their life, is how long was she under water?”

So Dr. Snyder invented a solution. The catch: He’s among an interesting set of doctors whose side gigs are solving critical problems affecting patients where they live. These are not medical devices for clinical use. They’re innovative products that everyday folks can use to make their lives safer and healthier. The goal: Improving systemic and “unsolvable” issues that harm society.

The cool part: Any MD with an idea can get in on the game.
 

Keeping little heads above water

Drowning is the leading cause of death in young children ages 1-4 years, and the second leading cause for children ages 5-14 years. The issue, Dr. Snyder explained, is not that rescuers couldn’t get to these children in time. “It’s that nobody knew to start looking.”

Dr. Snyder created a collar that alerts those around the swimmer that they are in trouble. The SEAL SwimSafe drowning prevention technology sets off an alarm system if a child is under water for too long. The necklace has been used to protect more than 10,000 children, including at larger swim facilities, such as the YMCA. 

When Dr. Snyder first started pursuing his invention, he asked himself two key questions: “Has someone already tried this? And if they did, why did they not succeed?” These questions help counteract the potential arrogance, he says, with imagining that you are the first person to have a certain idea. And using whatever reason others didn’t succeed as your “secret sauce” helps lead to more success. He also had to consider obstacles. People might resist wearing a collar or necklace while swimming or putting one on their child, like the reluctance around wearing bicycle helmets when they gained popularity in the 1980s. He concluded that the collars would work best at larger facilities, where they were mandated.

Another obstacle was false alarms. “It was possible to trigger a false alarm, and that could really scare people,” Dr. Snyder said. He is still considering systems to prevent the collars from being stolen or from “13-year-old boys hiding them in the water drain and making everyone really scared when an alarm is going off.”

The demand is real, however, and is based on alarming data. Safe Kids has reported that 66% of natural water drownings and around half of pool drownings happened with an adult supervising. They added, however, that supervision is often lacking or insufficient, such as a parent not being within arm’s reach of a young kid. As Dr. Snyder told reporters in a 2018 story, even the most well-intentioned parents still “miss something” sometimes, and this technology is for that moment.

“This is a completely solvable problem, but not a flip-a-switch, one and done,” he said, pointing to his product as a part of a more comprehensive approach, such as in Europe, where mandated public school swimming lessons are helping to decrease drowning deaths.

The pandemic slowed progress for the SEAL SwimSafe collar, which is currently waiting on a new funder or investor to take the reins. But the concept is alive and well with competitors pursuing related ideas. Dr. Snyder is holding out hope that entrepreneurs, scientists, public health workers, researchers, and others will be interested in continuing this work.
 

 

 

Eliminating the stigma of incontinence

Ever had an accident before making it to the bathroom? So have two-thirds of adult women, and almost one-third of older men. Incontinence is linked to a wide variety of conditions, from pelvic-floor trauma to neurological issues to diabetes, and others. Urologist Jessica Lubahn, MD, in Portland, Ore., saw one too many patients feeling this type of shame, unaware that the condition was so common. In addition, she personally experienced childbirth-related incontinence, and helped a relative who was having incontinence after prostate cancer surgery.

“He had a great result, but he had confided in me ... it was one of the only times in his life that he’s been truly depressed,” Dr. Lubahn said. “It’s not even the amount of leakage, but the smell, the stigma is so embarrassing, that not only is it an inconvenience, but [it affects] your entire psyche.” She thought there had to be a better solution than the “demeaning” act of wearing adult diapers.

Noting the explosion of the period panty industry in the past decade, Dr. Lubahn wanted to “destigmatize” incontinence in the same way menstruation education and products have been. She created ONDR incontinence underwear, specifically meant for urine, to ease the mental and physical burden on her patients and many others.

Dr. Lubahn said a process happens when you decide to start talking about the product you want to make rather than trying to find answers on your own. “A lot of people are so afraid to talk about their ideas because they’re afraid it’s going to get stolen or scooped, or it might fail,” she said. “I just openly discussed it, kind of like cocktail party conversation – ‘Wouldn’t it be funny if you just pee into your underwear?’ ” She noticed each connection led to finding more people to help her along her journey.

Dr. Lubahn studied the apparel industry, learning that overseas manufacturers were more helpful and cost-effective. She navigated issues such as a special stitch that prevented leakage and other details. She was also intent on using eco-friendly products that offset the environmental impact of pads, liners, and diapers. She said there’s a strong entrepreneurship community that can help other physician-inventors get grants, be part of accelerator programs, and receive support.

Six years after the original idea, Dr. Lubahn’s product was released in 2020. She now sells eight types of underwear for women and men’s boxer briefs. She wears them herself daily.
 

Deterring carjackers, saving lives

In 2022, carjackings tripled in Chicago and Memphis. The areas have the highest rates in 30 cities that the Council on Criminal Justice analyzed in a report on pandemic crime rates. According to the report, nearly 40% of offenders used a firearm, more than a quarter of victims were injured, and only around half of the vehicles taken were recovered. In addition, vehicles are sometimes used in secondary crimes, such as drive-by shootings. William Yates, MD, former trauma surgeon, now turned hair restoration surgeon in Chicago, saw the evidence of those crimes daily.

“I was perplexed by carjacking because there wasn’t any answer, and it just kept getting worse and worse. A lot of innocent people were being affected,” he said. “I was seeing deaths – needless. If you give them any push back at all, they will shoot you.”

As a deterrent to counter this “easy crime,” he invented the Yates Device, an alarm system designed to prevent or interrupt carjacking. The driver can activate a switch located beneath the foot pedal or an app on the phone to trigger a programmed high-decibel alarm. Critically, it allows the carjacker to drive a safe distance away from the victim before it starts going off.

The alarm “turns your car into a very noisy Christmas tree on a time delay,” Dr. Yates explained. An external siren blares “stolen vehicle” repeatedly. A camera records everything in the car. Lights flash. Only the original driver can turn off the system. Later, once the car is abandoned, the police can help recover the vehicle.

In Dr. Yates’ experience, the invention process takes longer than you think. He worked through earlier iterations with strobe lights, but these could lead to bystanders getting hurt if the carjacker couldn’t see, for example. Developing the final product and applying for patents was a two-part process.

“The first is part is a pending patent phase, which secures your place in line,” he said. “After 1 year, we filed the utility patent as the final documentation that the invention is truly unique. That has been in process for a year now and the attorneys say we should receive approval soon.”

The product has initially been tested in seven cars for about 1 year. Dr. Yates is measuring how the system performs in all types of weather, including Chicago’s below-zero temperatures. The product is not available to the public for purchase yet because Dr. Yates is still seeking funding to have it mass produced, but it is currently being evaluated by Korean automakers for their car manufacturers.

“Everybody was saying ‘Let’s do something about this,’ but I didn’t see anybody doing anything yet,” Dr. Yates recalled. In the surgeon’s lounge, everybody has ideas. “You go around the room, and every doctor would have five ideas that would make them the richest doctor, but nobody takes it beyond that stage – talk. You have to synthesize that into a plan, to take action.”

Dr. Yates said that many doctors have the intellect to invent, but they aren’t in a network like entrepreneurs to bring their ideas to life.

For Dr. Yates, it takes a curious mindset to solve these daunting problems. “I’m always curious, always looking for how to improve something, to get better outcomes you have to be asking questions and just never let it go.”
 

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

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WakeMed emergency department physician and medical director, Graham Snyder, MD, has seen his fair share of deaths: an average of one or two per day. That’s part of the job. Some of the deaths were the result of risky behavior, ongoing health problems, and other natural causes.

But what he didn’t find acceptable was losing a 6-year-old girl in a backyard pool drowning at what was meant to be a celebratory birthday party and family reunion.

“There were aunts and uncles and brothers and sisters and cousins, and the pool was packed, and they’re having a great time. One of the parents looked over and saw that she was swimming around underneath but acting weird. A relative pulled her up by the arm, and she was dead,” he said. “What nobody could tell me, and what they’ll live with the rest of their life, is how long was she under water?”

So Dr. Snyder invented a solution. The catch: He’s among an interesting set of doctors whose side gigs are solving critical problems affecting patients where they live. These are not medical devices for clinical use. They’re innovative products that everyday folks can use to make their lives safer and healthier. The goal: Improving systemic and “unsolvable” issues that harm society.

The cool part: Any MD with an idea can get in on the game.
 

Keeping little heads above water

Drowning is the leading cause of death in young children ages 1-4 years, and the second leading cause for children ages 5-14 years. The issue, Dr. Snyder explained, is not that rescuers couldn’t get to these children in time. “It’s that nobody knew to start looking.”

Dr. Snyder created a collar that alerts those around the swimmer that they are in trouble. The SEAL SwimSafe drowning prevention technology sets off an alarm system if a child is under water for too long. The necklace has been used to protect more than 10,000 children, including at larger swim facilities, such as the YMCA. 

When Dr. Snyder first started pursuing his invention, he asked himself two key questions: “Has someone already tried this? And if they did, why did they not succeed?” These questions help counteract the potential arrogance, he says, with imagining that you are the first person to have a certain idea. And using whatever reason others didn’t succeed as your “secret sauce” helps lead to more success. He also had to consider obstacles. People might resist wearing a collar or necklace while swimming or putting one on their child, like the reluctance around wearing bicycle helmets when they gained popularity in the 1980s. He concluded that the collars would work best at larger facilities, where they were mandated.

Another obstacle was false alarms. “It was possible to trigger a false alarm, and that could really scare people,” Dr. Snyder said. He is still considering systems to prevent the collars from being stolen or from “13-year-old boys hiding them in the water drain and making everyone really scared when an alarm is going off.”

The demand is real, however, and is based on alarming data. Safe Kids has reported that 66% of natural water drownings and around half of pool drownings happened with an adult supervising. They added, however, that supervision is often lacking or insufficient, such as a parent not being within arm’s reach of a young kid. As Dr. Snyder told reporters in a 2018 story, even the most well-intentioned parents still “miss something” sometimes, and this technology is for that moment.

“This is a completely solvable problem, but not a flip-a-switch, one and done,” he said, pointing to his product as a part of a more comprehensive approach, such as in Europe, where mandated public school swimming lessons are helping to decrease drowning deaths.

The pandemic slowed progress for the SEAL SwimSafe collar, which is currently waiting on a new funder or investor to take the reins. But the concept is alive and well with competitors pursuing related ideas. Dr. Snyder is holding out hope that entrepreneurs, scientists, public health workers, researchers, and others will be interested in continuing this work.
 

 

 

Eliminating the stigma of incontinence

Ever had an accident before making it to the bathroom? So have two-thirds of adult women, and almost one-third of older men. Incontinence is linked to a wide variety of conditions, from pelvic-floor trauma to neurological issues to diabetes, and others. Urologist Jessica Lubahn, MD, in Portland, Ore., saw one too many patients feeling this type of shame, unaware that the condition was so common. In addition, she personally experienced childbirth-related incontinence, and helped a relative who was having incontinence after prostate cancer surgery.

“He had a great result, but he had confided in me ... it was one of the only times in his life that he’s been truly depressed,” Dr. Lubahn said. “It’s not even the amount of leakage, but the smell, the stigma is so embarrassing, that not only is it an inconvenience, but [it affects] your entire psyche.” She thought there had to be a better solution than the “demeaning” act of wearing adult diapers.

Noting the explosion of the period panty industry in the past decade, Dr. Lubahn wanted to “destigmatize” incontinence in the same way menstruation education and products have been. She created ONDR incontinence underwear, specifically meant for urine, to ease the mental and physical burden on her patients and many others.

Dr. Lubahn said a process happens when you decide to start talking about the product you want to make rather than trying to find answers on your own. “A lot of people are so afraid to talk about their ideas because they’re afraid it’s going to get stolen or scooped, or it might fail,” she said. “I just openly discussed it, kind of like cocktail party conversation – ‘Wouldn’t it be funny if you just pee into your underwear?’ ” She noticed each connection led to finding more people to help her along her journey.

Dr. Lubahn studied the apparel industry, learning that overseas manufacturers were more helpful and cost-effective. She navigated issues such as a special stitch that prevented leakage and other details. She was also intent on using eco-friendly products that offset the environmental impact of pads, liners, and diapers. She said there’s a strong entrepreneurship community that can help other physician-inventors get grants, be part of accelerator programs, and receive support.

Six years after the original idea, Dr. Lubahn’s product was released in 2020. She now sells eight types of underwear for women and men’s boxer briefs. She wears them herself daily.
 

Deterring carjackers, saving lives

In 2022, carjackings tripled in Chicago and Memphis. The areas have the highest rates in 30 cities that the Council on Criminal Justice analyzed in a report on pandemic crime rates. According to the report, nearly 40% of offenders used a firearm, more than a quarter of victims were injured, and only around half of the vehicles taken were recovered. In addition, vehicles are sometimes used in secondary crimes, such as drive-by shootings. William Yates, MD, former trauma surgeon, now turned hair restoration surgeon in Chicago, saw the evidence of those crimes daily.

“I was perplexed by carjacking because there wasn’t any answer, and it just kept getting worse and worse. A lot of innocent people were being affected,” he said. “I was seeing deaths – needless. If you give them any push back at all, they will shoot you.”

As a deterrent to counter this “easy crime,” he invented the Yates Device, an alarm system designed to prevent or interrupt carjacking. The driver can activate a switch located beneath the foot pedal or an app on the phone to trigger a programmed high-decibel alarm. Critically, it allows the carjacker to drive a safe distance away from the victim before it starts going off.

The alarm “turns your car into a very noisy Christmas tree on a time delay,” Dr. Yates explained. An external siren blares “stolen vehicle” repeatedly. A camera records everything in the car. Lights flash. Only the original driver can turn off the system. Later, once the car is abandoned, the police can help recover the vehicle.

In Dr. Yates’ experience, the invention process takes longer than you think. He worked through earlier iterations with strobe lights, but these could lead to bystanders getting hurt if the carjacker couldn’t see, for example. Developing the final product and applying for patents was a two-part process.

“The first is part is a pending patent phase, which secures your place in line,” he said. “After 1 year, we filed the utility patent as the final documentation that the invention is truly unique. That has been in process for a year now and the attorneys say we should receive approval soon.”

The product has initially been tested in seven cars for about 1 year. Dr. Yates is measuring how the system performs in all types of weather, including Chicago’s below-zero temperatures. The product is not available to the public for purchase yet because Dr. Yates is still seeking funding to have it mass produced, but it is currently being evaluated by Korean automakers for their car manufacturers.

“Everybody was saying ‘Let’s do something about this,’ but I didn’t see anybody doing anything yet,” Dr. Yates recalled. In the surgeon’s lounge, everybody has ideas. “You go around the room, and every doctor would have five ideas that would make them the richest doctor, but nobody takes it beyond that stage – talk. You have to synthesize that into a plan, to take action.”

Dr. Yates said that many doctors have the intellect to invent, but they aren’t in a network like entrepreneurs to bring their ideas to life.

For Dr. Yates, it takes a curious mindset to solve these daunting problems. “I’m always curious, always looking for how to improve something, to get better outcomes you have to be asking questions and just never let it go.”
 

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

WakeMed emergency department physician and medical director, Graham Snyder, MD, has seen his fair share of deaths: an average of one or two per day. That’s part of the job. Some of the deaths were the result of risky behavior, ongoing health problems, and other natural causes.

But what he didn’t find acceptable was losing a 6-year-old girl in a backyard pool drowning at what was meant to be a celebratory birthday party and family reunion.

“There were aunts and uncles and brothers and sisters and cousins, and the pool was packed, and they’re having a great time. One of the parents looked over and saw that she was swimming around underneath but acting weird. A relative pulled her up by the arm, and she was dead,” he said. “What nobody could tell me, and what they’ll live with the rest of their life, is how long was she under water?”

So Dr. Snyder invented a solution. The catch: He’s among an interesting set of doctors whose side gigs are solving critical problems affecting patients where they live. These are not medical devices for clinical use. They’re innovative products that everyday folks can use to make their lives safer and healthier. The goal: Improving systemic and “unsolvable” issues that harm society.

The cool part: Any MD with an idea can get in on the game.
 

Keeping little heads above water

Drowning is the leading cause of death in young children ages 1-4 years, and the second leading cause for children ages 5-14 years. The issue, Dr. Snyder explained, is not that rescuers couldn’t get to these children in time. “It’s that nobody knew to start looking.”

Dr. Snyder created a collar that alerts those around the swimmer that they are in trouble. The SEAL SwimSafe drowning prevention technology sets off an alarm system if a child is under water for too long. The necklace has been used to protect more than 10,000 children, including at larger swim facilities, such as the YMCA. 

When Dr. Snyder first started pursuing his invention, he asked himself two key questions: “Has someone already tried this? And if they did, why did they not succeed?” These questions help counteract the potential arrogance, he says, with imagining that you are the first person to have a certain idea. And using whatever reason others didn’t succeed as your “secret sauce” helps lead to more success. He also had to consider obstacles. People might resist wearing a collar or necklace while swimming or putting one on their child, like the reluctance around wearing bicycle helmets when they gained popularity in the 1980s. He concluded that the collars would work best at larger facilities, where they were mandated.

Another obstacle was false alarms. “It was possible to trigger a false alarm, and that could really scare people,” Dr. Snyder said. He is still considering systems to prevent the collars from being stolen or from “13-year-old boys hiding them in the water drain and making everyone really scared when an alarm is going off.”

The demand is real, however, and is based on alarming data. Safe Kids has reported that 66% of natural water drownings and around half of pool drownings happened with an adult supervising. They added, however, that supervision is often lacking or insufficient, such as a parent not being within arm’s reach of a young kid. As Dr. Snyder told reporters in a 2018 story, even the most well-intentioned parents still “miss something” sometimes, and this technology is for that moment.

“This is a completely solvable problem, but not a flip-a-switch, one and done,” he said, pointing to his product as a part of a more comprehensive approach, such as in Europe, where mandated public school swimming lessons are helping to decrease drowning deaths.

The pandemic slowed progress for the SEAL SwimSafe collar, which is currently waiting on a new funder or investor to take the reins. But the concept is alive and well with competitors pursuing related ideas. Dr. Snyder is holding out hope that entrepreneurs, scientists, public health workers, researchers, and others will be interested in continuing this work.
 

 

 

Eliminating the stigma of incontinence

Ever had an accident before making it to the bathroom? So have two-thirds of adult women, and almost one-third of older men. Incontinence is linked to a wide variety of conditions, from pelvic-floor trauma to neurological issues to diabetes, and others. Urologist Jessica Lubahn, MD, in Portland, Ore., saw one too many patients feeling this type of shame, unaware that the condition was so common. In addition, she personally experienced childbirth-related incontinence, and helped a relative who was having incontinence after prostate cancer surgery.

“He had a great result, but he had confided in me ... it was one of the only times in his life that he’s been truly depressed,” Dr. Lubahn said. “It’s not even the amount of leakage, but the smell, the stigma is so embarrassing, that not only is it an inconvenience, but [it affects] your entire psyche.” She thought there had to be a better solution than the “demeaning” act of wearing adult diapers.

Noting the explosion of the period panty industry in the past decade, Dr. Lubahn wanted to “destigmatize” incontinence in the same way menstruation education and products have been. She created ONDR incontinence underwear, specifically meant for urine, to ease the mental and physical burden on her patients and many others.

Dr. Lubahn said a process happens when you decide to start talking about the product you want to make rather than trying to find answers on your own. “A lot of people are so afraid to talk about their ideas because they’re afraid it’s going to get stolen or scooped, or it might fail,” she said. “I just openly discussed it, kind of like cocktail party conversation – ‘Wouldn’t it be funny if you just pee into your underwear?’ ” She noticed each connection led to finding more people to help her along her journey.

Dr. Lubahn studied the apparel industry, learning that overseas manufacturers were more helpful and cost-effective. She navigated issues such as a special stitch that prevented leakage and other details. She was also intent on using eco-friendly products that offset the environmental impact of pads, liners, and diapers. She said there’s a strong entrepreneurship community that can help other physician-inventors get grants, be part of accelerator programs, and receive support.

Six years after the original idea, Dr. Lubahn’s product was released in 2020. She now sells eight types of underwear for women and men’s boxer briefs. She wears them herself daily.
 

Deterring carjackers, saving lives

In 2022, carjackings tripled in Chicago and Memphis. The areas have the highest rates in 30 cities that the Council on Criminal Justice analyzed in a report on pandemic crime rates. According to the report, nearly 40% of offenders used a firearm, more than a quarter of victims were injured, and only around half of the vehicles taken were recovered. In addition, vehicles are sometimes used in secondary crimes, such as drive-by shootings. William Yates, MD, former trauma surgeon, now turned hair restoration surgeon in Chicago, saw the evidence of those crimes daily.

“I was perplexed by carjacking because there wasn’t any answer, and it just kept getting worse and worse. A lot of innocent people were being affected,” he said. “I was seeing deaths – needless. If you give them any push back at all, they will shoot you.”

As a deterrent to counter this “easy crime,” he invented the Yates Device, an alarm system designed to prevent or interrupt carjacking. The driver can activate a switch located beneath the foot pedal or an app on the phone to trigger a programmed high-decibel alarm. Critically, it allows the carjacker to drive a safe distance away from the victim before it starts going off.

The alarm “turns your car into a very noisy Christmas tree on a time delay,” Dr. Yates explained. An external siren blares “stolen vehicle” repeatedly. A camera records everything in the car. Lights flash. Only the original driver can turn off the system. Later, once the car is abandoned, the police can help recover the vehicle.

In Dr. Yates’ experience, the invention process takes longer than you think. He worked through earlier iterations with strobe lights, but these could lead to bystanders getting hurt if the carjacker couldn’t see, for example. Developing the final product and applying for patents was a two-part process.

“The first is part is a pending patent phase, which secures your place in line,” he said. “After 1 year, we filed the utility patent as the final documentation that the invention is truly unique. That has been in process for a year now and the attorneys say we should receive approval soon.”

The product has initially been tested in seven cars for about 1 year. Dr. Yates is measuring how the system performs in all types of weather, including Chicago’s below-zero temperatures. The product is not available to the public for purchase yet because Dr. Yates is still seeking funding to have it mass produced, but it is currently being evaluated by Korean automakers for their car manufacturers.

“Everybody was saying ‘Let’s do something about this,’ but I didn’t see anybody doing anything yet,” Dr. Yates recalled. In the surgeon’s lounge, everybody has ideas. “You go around the room, and every doctor would have five ideas that would make them the richest doctor, but nobody takes it beyond that stage – talk. You have to synthesize that into a plan, to take action.”

Dr. Yates said that many doctors have the intellect to invent, but they aren’t in a network like entrepreneurs to bring their ideas to life.

For Dr. Yates, it takes a curious mindset to solve these daunting problems. “I’m always curious, always looking for how to improve something, to get better outcomes you have to be asking questions and just never let it go.”
 

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

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Cutting-edge nasal tech could usher in a new era of medicine

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Noses are like caverns – twisting, turning, no two exactly the same. But if you nose past anyone’s nostrils, you’ll discover a surprisingly sprawling space. 

“The size of the nasal cavity is about the same as a large handkerchief,” said Hugh Smyth, PhD, a professor of molecular pharmaceutics and drug delivery at the University of Texas at Austin. 

Thoroughly coating that cavity with medication can result in rapid, efficient absorption, making the nose’s inner chamber an attractive target for drug delivery.

“It’s very accessible tissue, and it has a lot of blood flow,” said Dr. Smyth. “The speed of onset can often be as fast as injections, sometimes even faster.” 

It’s nothing new to get medicines via your nose. For decades, we’ve squirted various sprays into our nostrils to treat local maladies like allergies or infections. Even the ancients saw wisdom in the nasal route. 

But recently, the nose has gained scientific attention as a gateway to the rest of the body – even the brain, a notoriously difficult target.

The upshot: Someday, inhaling therapies could be as routine as swallowing pills. 

The nasal route is quick, needle free, and user friendly, and it often requires a smaller dose than other methods, since the drug doesn’t have to pass through the digestive tract, losing potency during digestion. 

But there are challenges. 
 

How hard can it be?

Old-school nasal sprayers, mostly unchanged since the 1800s, aren’t cut out for deep-nose delivery. “The technology is relatively limited because you’ve just got a single spray nozzle,” said Michael Hindle, PhD, a professor of pharmaceutics at Virginia Commonwealth University, Richmond. 

These traditional devices (similar to perfume sprayers) don’t consistently push meds past the lower to middle sections inside the nose, called the nasal valve – if they do so at all: In a 2020  Rhinology study (doi: 10.4193/Rhin18.304) conventional nasal sprays only reached this first segment of the nose, a less-than-ideal spot to land. 

Inside the nasal valve, the surface is skin-like and doesn’t absorb very well. Its narrow design slows airflow, preventing particles from moving to deeper regions, where tissue is vascular and porous like the lungs. And even if this structural roadblock is surpassed, other hurdles remain.

The nose is designed to keep stuff out. Nose hair, cilia, mucus, sneezing, coughing – all make “distributing drugs evenly across the nasal cavity difficult,” said Dr. Smyth. “The spray gets filtered out before it reaches those deeper zones,” potentially dripping out of the nostrils instead of being absorbed.

Complicating matters is how every person’s nose is different. In a 2018 study, Dr. Smyth and a research team created three dimensional–printed models of people’s nasal cavities. They varied widely. “Nasal cavities are very different in size, length, and internal geometry,” he said. “This makes it challenging to target specific areas.”

Although carefully positioning the spray nozzle can help, even something as minor as sniffing too hard (constricting the nostrils) can keep sprays from reaching the absorptive deeper regions. 

Still, the benefits are enough to compel researchers to find a way in.

“This really is a drug delivery challenge we’ve been wrestling with,” said Dr. Hindle. “It’s not new formulations we hear about. It’s new devices and delivery methods trying to target the different nasal regions.”


 

 

 

Delivering the goods

In the late aughts, John Hoekman was a graduate student in the University of Washington’s pharmaceutics program, studying nasal drug delivery. In his experiments, he noticed that drugs distributed differently, depending on the region targeted – aiming for the upper nasal cavity led to a spike in absorption.

The results convinced Mr. Hoekman to stake his future on nasal drug delivery.

In 2008, while still in graduate school, he started his own company, now known as Impel Pharmaceuticals. In 2021, Impel released its first product: Trudhesa, a nasal spray for migraines. Although the drug itself – dihydroergotamine mesylate – was hardly novel, used for migraine relief since 1946 (Headache. 2020 Jan;60[1]:40-57), it was usually delivered through an intravenous line, often in the ED. 

But with Mr. Hoekman’s POD device – short for precision olfactory delivery – the drug can be given by the patient, via the nose. This generally means faster, more reliable relief, with fewer side effects. “We were able to lower the dose and improve the overall absorption,” said Mr. Hoekman.

The POD’s nozzle is engineered to spray a soft, narrow plume. It’s gas propelled, so patients don’t have to breathe in any special way to ensure delivery. The drug can zip right through the nasal valve into the upper nasal cavity.

Another company – OptiNose – has a “bidirectional” delivery method that propels drugs, either liquid or dry powder, deep into the nose.

“You insert the nozzle into your nose, and as you blow through the mouthpiece, your soft palate closes,” said Dr. Hindle. With the throat sealed off, “the only place for the drug to go is into one nostril and out the other, coating both sides of the nasal passageways.”

The device is only available for Onzetra Xsail, a powder for migraines. But another application is on its way.

In May, OptiNose announced that the FDA is reviewing Xhance, which uses the system to direct a steroid to the sinuses. In a clinical trial, patients with chronic sinusitis who tried the drug-device combo saw a decline in congestion, facial pain, and inflammation. 
 

Targeting the brain

Both of those migraine drugs – Trudhesa and Onzetra Xsail – are thought to penetrate the upper nasal cavity. That’s where you’ll find the olfactory zone, a sheet of neurons that connects to the olfactory bulb. Located behind the eyes, these two nerve bundles detect odors. 

“The olfactory region is almost like a back door to the brain,” said Mr. Hoekman. 

By bypassing the blood-brain barrier, it offers a direct pathway – the only direct pathway, actually – between an exposed area of the body and the brain. Meaning it can ferry drugs straight from the nasal cavity to the central nervous system. 

Nose-to-brain treatments could be game-changing for central nervous system disorders, such as Parkinson’s disease, Alzheimer’s, or anxiety.

But reaching the olfactory zone is notoriously hard. “The vasculature in your nose is like a big freeway, and the olfactory tract is like a side alley,” explained Mr. Hoekman. “It’s very limiting in what it will allow through.” The region is also small, occupying only 3%-10% of the nasal cavity’s surface area. 

Again, POD means “precision olfactory delivery.” But the device isn’t quite as laser focused on the region as its name implies. “We’re not at the stage where we’re able to exclusively deliver to one target site in the nose,” said Dr. Hindle. 

While wending its way toward the olfactory zone, some of the drug will be absorbed by other regions, then circulate throughout the body. 

“About 59% of the drug that we put into the upper nasal space gets absorbed into the bloodstream,” said Mr. Hoekman. 

Janssen Pharmaceuticals’ Spravato – a nasal spray for drug-resistant depression – is thought to work similarly: Some goes straight to the brain via the olfactory nerves, while the rest takes a more roundabout route, passing through the blood vessels to circulate in your system.
 

 

 

A needle-free option 

Sometimes, the bloodstream is the main target. Because the nose’s middle and upper stretches are so vascular, drugs can be rapidly absorbed. 

This is especially valuable for time-sensitive conditions. “If you give something nasally, you can have peak uptake in 15-30 minutes,” said Mr. Hoekman.

Take Narcan nasal spray, which delivers a burst of naloxone to quickly reverse the effects of opioid an overdose. Or Noctiva nasal spray. Taken just half an hour before bed, it can prevent frequent nighttime urination. 

There’s also a group of seizure-stopping sprays, known as “rescue treatments.” One works by temporarily loosening the space between nasal cells, allowing the seizure drug to be quickly absorbed through the vessels. 

This systemic access also has potential for drugs that would otherwise have to be injected, such as biologics. 

The same goes for vaccines. Mucosal tissue inside the nasal cavity offers direct access to the infection-fighting lymphatic system, making the nose a prime target for inoculation against certain viruses.
 

Inhaling protection against viruses

Despite the recent surge of interest, nasal vaccines faced a rocky start. After the first nasal flu vaccine hit the market in 2001, it was pulled due to potential toxicity and reports of Bell’s palsy, a type of facial paralysis

FluMist came in 2003 and has been plagued by problems ever since. Because it contains a weakened live virus, flu-like side effects can occur. And it doesn’t always work. During the 2016-2017 flu season, FluMist protected only 3% of kids, prompting the Centers for Disease Control and Prevention to advise against the nasal route that year. 

Why FluMist can be so hit-or-miss is poorly understood. But generally, the nose can pose an effectiveness challenge. “The nose is highly cycling,” said Dr. Hindle. “Anything we deposit usually gets transported out within 15-20 minutes.” 

For kids – big fans of not using needles – chronically runny noses can be an issue. “You squirt it in the nose, and it will probably just come back out in their snot,” said Jay Kolls, MD, a professor of medicine and pediatrics at Tulane University, New Orleans, who is developing an intranasal pneumonia vaccine. 

Even so, nasal vaccines became a hot topic among researchers after the world was shut down by a virus that invades through the nose.

“We realized that intramuscular vaccines were effective at preventing severe disease, but they weren’t that effective at preventing transmission,” said Michael Diamond, MD, PhD, an immunologist at Washington University in St. Louis.

Nasal vaccines could solve that problem by putting an immune barrier at the point of entry, denying access to the rest of the body. “You squash the infection early enough that it not only prevents disease,” said Dr. Kolls, “but potentially prevents transmission.”

 

And yes, a nasal COVID vaccine is on the way

In March 2020, Dr. Diamond’s team began exploring a nasal COVID vaccine. Promising results in animals prompted a vaccine development company to license the technology. The resulting nasal vaccine – the first for COVID – has been approved in India, both as a primary vaccine and a booster.

It works by stimulating an influx of IgA, a type of antibody found in the nasal passages, and production of resident memory T cells, immune cells on standby just beneath the surface tissue in the nose. 

By contrast, injected vaccines generate mostly IgG antibodies, which struggle to enter the respiratory tract. Only a tiny fraction – an estimated 1% – typically reach the nose. 

Nasal vaccines could also be used along with shots. The latter could prime the whole body to fight back, while a nasal spritz could pull that immune protection to the mucosal surfaces. 

Nasal technology could yield more effective vaccines for infections like tuberculosis or malaria, or even safeguard against new – sometimes surprising – conditions. 

In a 2021 Nature study, an intranasal vaccine derived from fentanyl was better at preventing overdose than an injected vaccine. “Through some clever chemistry, the drug [in the vaccine] isn’t fentanyl anymore,” said study author Elizabeth Norton, PhD, an assistant professor of microbiology and immunology at Tulane University. “But the immune system still has an antibody response to it.”

Novel applications like this represent the future of nasal drug delivery. 

“We’re not going to innovate in asthma or COPD. We’re not going to innovate in local delivery to the nose,” said Dr. Hindle. “Innovation will only come if we look to treat new conditions.”

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

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Noses are like caverns – twisting, turning, no two exactly the same. But if you nose past anyone’s nostrils, you’ll discover a surprisingly sprawling space. 

“The size of the nasal cavity is about the same as a large handkerchief,” said Hugh Smyth, PhD, a professor of molecular pharmaceutics and drug delivery at the University of Texas at Austin. 

Thoroughly coating that cavity with medication can result in rapid, efficient absorption, making the nose’s inner chamber an attractive target for drug delivery.

“It’s very accessible tissue, and it has a lot of blood flow,” said Dr. Smyth. “The speed of onset can often be as fast as injections, sometimes even faster.” 

It’s nothing new to get medicines via your nose. For decades, we’ve squirted various sprays into our nostrils to treat local maladies like allergies or infections. Even the ancients saw wisdom in the nasal route. 

But recently, the nose has gained scientific attention as a gateway to the rest of the body – even the brain, a notoriously difficult target.

The upshot: Someday, inhaling therapies could be as routine as swallowing pills. 

The nasal route is quick, needle free, and user friendly, and it often requires a smaller dose than other methods, since the drug doesn’t have to pass through the digestive tract, losing potency during digestion. 

But there are challenges. 
 

How hard can it be?

Old-school nasal sprayers, mostly unchanged since the 1800s, aren’t cut out for deep-nose delivery. “The technology is relatively limited because you’ve just got a single spray nozzle,” said Michael Hindle, PhD, a professor of pharmaceutics at Virginia Commonwealth University, Richmond. 

These traditional devices (similar to perfume sprayers) don’t consistently push meds past the lower to middle sections inside the nose, called the nasal valve – if they do so at all: In a 2020  Rhinology study (doi: 10.4193/Rhin18.304) conventional nasal sprays only reached this first segment of the nose, a less-than-ideal spot to land. 

Inside the nasal valve, the surface is skin-like and doesn’t absorb very well. Its narrow design slows airflow, preventing particles from moving to deeper regions, where tissue is vascular and porous like the lungs. And even if this structural roadblock is surpassed, other hurdles remain.

The nose is designed to keep stuff out. Nose hair, cilia, mucus, sneezing, coughing – all make “distributing drugs evenly across the nasal cavity difficult,” said Dr. Smyth. “The spray gets filtered out before it reaches those deeper zones,” potentially dripping out of the nostrils instead of being absorbed.

Complicating matters is how every person’s nose is different. In a 2018 study, Dr. Smyth and a research team created three dimensional–printed models of people’s nasal cavities. They varied widely. “Nasal cavities are very different in size, length, and internal geometry,” he said. “This makes it challenging to target specific areas.”

Although carefully positioning the spray nozzle can help, even something as minor as sniffing too hard (constricting the nostrils) can keep sprays from reaching the absorptive deeper regions. 

Still, the benefits are enough to compel researchers to find a way in.

“This really is a drug delivery challenge we’ve been wrestling with,” said Dr. Hindle. “It’s not new formulations we hear about. It’s new devices and delivery methods trying to target the different nasal regions.”


 

 

 

Delivering the goods

In the late aughts, John Hoekman was a graduate student in the University of Washington’s pharmaceutics program, studying nasal drug delivery. In his experiments, he noticed that drugs distributed differently, depending on the region targeted – aiming for the upper nasal cavity led to a spike in absorption.

The results convinced Mr. Hoekman to stake his future on nasal drug delivery.

In 2008, while still in graduate school, he started his own company, now known as Impel Pharmaceuticals. In 2021, Impel released its first product: Trudhesa, a nasal spray for migraines. Although the drug itself – dihydroergotamine mesylate – was hardly novel, used for migraine relief since 1946 (Headache. 2020 Jan;60[1]:40-57), it was usually delivered through an intravenous line, often in the ED. 

But with Mr. Hoekman’s POD device – short for precision olfactory delivery – the drug can be given by the patient, via the nose. This generally means faster, more reliable relief, with fewer side effects. “We were able to lower the dose and improve the overall absorption,” said Mr. Hoekman.

The POD’s nozzle is engineered to spray a soft, narrow plume. It’s gas propelled, so patients don’t have to breathe in any special way to ensure delivery. The drug can zip right through the nasal valve into the upper nasal cavity.

Another company – OptiNose – has a “bidirectional” delivery method that propels drugs, either liquid or dry powder, deep into the nose.

“You insert the nozzle into your nose, and as you blow through the mouthpiece, your soft palate closes,” said Dr. Hindle. With the throat sealed off, “the only place for the drug to go is into one nostril and out the other, coating both sides of the nasal passageways.”

The device is only available for Onzetra Xsail, a powder for migraines. But another application is on its way.

In May, OptiNose announced that the FDA is reviewing Xhance, which uses the system to direct a steroid to the sinuses. In a clinical trial, patients with chronic sinusitis who tried the drug-device combo saw a decline in congestion, facial pain, and inflammation. 
 

Targeting the brain

Both of those migraine drugs – Trudhesa and Onzetra Xsail – are thought to penetrate the upper nasal cavity. That’s where you’ll find the olfactory zone, a sheet of neurons that connects to the olfactory bulb. Located behind the eyes, these two nerve bundles detect odors. 

“The olfactory region is almost like a back door to the brain,” said Mr. Hoekman. 

By bypassing the blood-brain barrier, it offers a direct pathway – the only direct pathway, actually – between an exposed area of the body and the brain. Meaning it can ferry drugs straight from the nasal cavity to the central nervous system. 

Nose-to-brain treatments could be game-changing for central nervous system disorders, such as Parkinson’s disease, Alzheimer’s, or anxiety.

But reaching the olfactory zone is notoriously hard. “The vasculature in your nose is like a big freeway, and the olfactory tract is like a side alley,” explained Mr. Hoekman. “It’s very limiting in what it will allow through.” The region is also small, occupying only 3%-10% of the nasal cavity’s surface area. 

Again, POD means “precision olfactory delivery.” But the device isn’t quite as laser focused on the region as its name implies. “We’re not at the stage where we’re able to exclusively deliver to one target site in the nose,” said Dr. Hindle. 

While wending its way toward the olfactory zone, some of the drug will be absorbed by other regions, then circulate throughout the body. 

“About 59% of the drug that we put into the upper nasal space gets absorbed into the bloodstream,” said Mr. Hoekman. 

Janssen Pharmaceuticals’ Spravato – a nasal spray for drug-resistant depression – is thought to work similarly: Some goes straight to the brain via the olfactory nerves, while the rest takes a more roundabout route, passing through the blood vessels to circulate in your system.
 

 

 

A needle-free option 

Sometimes, the bloodstream is the main target. Because the nose’s middle and upper stretches are so vascular, drugs can be rapidly absorbed. 

This is especially valuable for time-sensitive conditions. “If you give something nasally, you can have peak uptake in 15-30 minutes,” said Mr. Hoekman.

Take Narcan nasal spray, which delivers a burst of naloxone to quickly reverse the effects of opioid an overdose. Or Noctiva nasal spray. Taken just half an hour before bed, it can prevent frequent nighttime urination. 

There’s also a group of seizure-stopping sprays, known as “rescue treatments.” One works by temporarily loosening the space between nasal cells, allowing the seizure drug to be quickly absorbed through the vessels. 

This systemic access also has potential for drugs that would otherwise have to be injected, such as biologics. 

The same goes for vaccines. Mucosal tissue inside the nasal cavity offers direct access to the infection-fighting lymphatic system, making the nose a prime target for inoculation against certain viruses.
 

Inhaling protection against viruses

Despite the recent surge of interest, nasal vaccines faced a rocky start. After the first nasal flu vaccine hit the market in 2001, it was pulled due to potential toxicity and reports of Bell’s palsy, a type of facial paralysis

FluMist came in 2003 and has been plagued by problems ever since. Because it contains a weakened live virus, flu-like side effects can occur. And it doesn’t always work. During the 2016-2017 flu season, FluMist protected only 3% of kids, prompting the Centers for Disease Control and Prevention to advise against the nasal route that year. 

Why FluMist can be so hit-or-miss is poorly understood. But generally, the nose can pose an effectiveness challenge. “The nose is highly cycling,” said Dr. Hindle. “Anything we deposit usually gets transported out within 15-20 minutes.” 

For kids – big fans of not using needles – chronically runny noses can be an issue. “You squirt it in the nose, and it will probably just come back out in their snot,” said Jay Kolls, MD, a professor of medicine and pediatrics at Tulane University, New Orleans, who is developing an intranasal pneumonia vaccine. 

Even so, nasal vaccines became a hot topic among researchers after the world was shut down by a virus that invades through the nose.

“We realized that intramuscular vaccines were effective at preventing severe disease, but they weren’t that effective at preventing transmission,” said Michael Diamond, MD, PhD, an immunologist at Washington University in St. Louis.

Nasal vaccines could solve that problem by putting an immune barrier at the point of entry, denying access to the rest of the body. “You squash the infection early enough that it not only prevents disease,” said Dr. Kolls, “but potentially prevents transmission.”

 

And yes, a nasal COVID vaccine is on the way

In March 2020, Dr. Diamond’s team began exploring a nasal COVID vaccine. Promising results in animals prompted a vaccine development company to license the technology. The resulting nasal vaccine – the first for COVID – has been approved in India, both as a primary vaccine and a booster.

It works by stimulating an influx of IgA, a type of antibody found in the nasal passages, and production of resident memory T cells, immune cells on standby just beneath the surface tissue in the nose. 

By contrast, injected vaccines generate mostly IgG antibodies, which struggle to enter the respiratory tract. Only a tiny fraction – an estimated 1% – typically reach the nose. 

Nasal vaccines could also be used along with shots. The latter could prime the whole body to fight back, while a nasal spritz could pull that immune protection to the mucosal surfaces. 

Nasal technology could yield more effective vaccines for infections like tuberculosis or malaria, or even safeguard against new – sometimes surprising – conditions. 

In a 2021 Nature study, an intranasal vaccine derived from fentanyl was better at preventing overdose than an injected vaccine. “Through some clever chemistry, the drug [in the vaccine] isn’t fentanyl anymore,” said study author Elizabeth Norton, PhD, an assistant professor of microbiology and immunology at Tulane University. “But the immune system still has an antibody response to it.”

Novel applications like this represent the future of nasal drug delivery. 

“We’re not going to innovate in asthma or COPD. We’re not going to innovate in local delivery to the nose,” said Dr. Hindle. “Innovation will only come if we look to treat new conditions.”

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

Noses are like caverns – twisting, turning, no two exactly the same. But if you nose past anyone’s nostrils, you’ll discover a surprisingly sprawling space. 

“The size of the nasal cavity is about the same as a large handkerchief,” said Hugh Smyth, PhD, a professor of molecular pharmaceutics and drug delivery at the University of Texas at Austin. 

Thoroughly coating that cavity with medication can result in rapid, efficient absorption, making the nose’s inner chamber an attractive target for drug delivery.

“It’s very accessible tissue, and it has a lot of blood flow,” said Dr. Smyth. “The speed of onset can often be as fast as injections, sometimes even faster.” 

It’s nothing new to get medicines via your nose. For decades, we’ve squirted various sprays into our nostrils to treat local maladies like allergies or infections. Even the ancients saw wisdom in the nasal route. 

But recently, the nose has gained scientific attention as a gateway to the rest of the body – even the brain, a notoriously difficult target.

The upshot: Someday, inhaling therapies could be as routine as swallowing pills. 

The nasal route is quick, needle free, and user friendly, and it often requires a smaller dose than other methods, since the drug doesn’t have to pass through the digestive tract, losing potency during digestion. 

But there are challenges. 
 

How hard can it be?

Old-school nasal sprayers, mostly unchanged since the 1800s, aren’t cut out for deep-nose delivery. “The technology is relatively limited because you’ve just got a single spray nozzle,” said Michael Hindle, PhD, a professor of pharmaceutics at Virginia Commonwealth University, Richmond. 

These traditional devices (similar to perfume sprayers) don’t consistently push meds past the lower to middle sections inside the nose, called the nasal valve – if they do so at all: In a 2020  Rhinology study (doi: 10.4193/Rhin18.304) conventional nasal sprays only reached this first segment of the nose, a less-than-ideal spot to land. 

Inside the nasal valve, the surface is skin-like and doesn’t absorb very well. Its narrow design slows airflow, preventing particles from moving to deeper regions, where tissue is vascular and porous like the lungs. And even if this structural roadblock is surpassed, other hurdles remain.

The nose is designed to keep stuff out. Nose hair, cilia, mucus, sneezing, coughing – all make “distributing drugs evenly across the nasal cavity difficult,” said Dr. Smyth. “The spray gets filtered out before it reaches those deeper zones,” potentially dripping out of the nostrils instead of being absorbed.

Complicating matters is how every person’s nose is different. In a 2018 study, Dr. Smyth and a research team created three dimensional–printed models of people’s nasal cavities. They varied widely. “Nasal cavities are very different in size, length, and internal geometry,” he said. “This makes it challenging to target specific areas.”

Although carefully positioning the spray nozzle can help, even something as minor as sniffing too hard (constricting the nostrils) can keep sprays from reaching the absorptive deeper regions. 

Still, the benefits are enough to compel researchers to find a way in.

“This really is a drug delivery challenge we’ve been wrestling with,” said Dr. Hindle. “It’s not new formulations we hear about. It’s new devices and delivery methods trying to target the different nasal regions.”


 

 

 

Delivering the goods

In the late aughts, John Hoekman was a graduate student in the University of Washington’s pharmaceutics program, studying nasal drug delivery. In his experiments, he noticed that drugs distributed differently, depending on the region targeted – aiming for the upper nasal cavity led to a spike in absorption.

The results convinced Mr. Hoekman to stake his future on nasal drug delivery.

In 2008, while still in graduate school, he started his own company, now known as Impel Pharmaceuticals. In 2021, Impel released its first product: Trudhesa, a nasal spray for migraines. Although the drug itself – dihydroergotamine mesylate – was hardly novel, used for migraine relief since 1946 (Headache. 2020 Jan;60[1]:40-57), it was usually delivered through an intravenous line, often in the ED. 

But with Mr. Hoekman’s POD device – short for precision olfactory delivery – the drug can be given by the patient, via the nose. This generally means faster, more reliable relief, with fewer side effects. “We were able to lower the dose and improve the overall absorption,” said Mr. Hoekman.

The POD’s nozzle is engineered to spray a soft, narrow plume. It’s gas propelled, so patients don’t have to breathe in any special way to ensure delivery. The drug can zip right through the nasal valve into the upper nasal cavity.

Another company – OptiNose – has a “bidirectional” delivery method that propels drugs, either liquid or dry powder, deep into the nose.

“You insert the nozzle into your nose, and as you blow through the mouthpiece, your soft palate closes,” said Dr. Hindle. With the throat sealed off, “the only place for the drug to go is into one nostril and out the other, coating both sides of the nasal passageways.”

The device is only available for Onzetra Xsail, a powder for migraines. But another application is on its way.

In May, OptiNose announced that the FDA is reviewing Xhance, which uses the system to direct a steroid to the sinuses. In a clinical trial, patients with chronic sinusitis who tried the drug-device combo saw a decline in congestion, facial pain, and inflammation. 
 

Targeting the brain

Both of those migraine drugs – Trudhesa and Onzetra Xsail – are thought to penetrate the upper nasal cavity. That’s where you’ll find the olfactory zone, a sheet of neurons that connects to the olfactory bulb. Located behind the eyes, these two nerve bundles detect odors. 

“The olfactory region is almost like a back door to the brain,” said Mr. Hoekman. 

By bypassing the blood-brain barrier, it offers a direct pathway – the only direct pathway, actually – between an exposed area of the body and the brain. Meaning it can ferry drugs straight from the nasal cavity to the central nervous system. 

Nose-to-brain treatments could be game-changing for central nervous system disorders, such as Parkinson’s disease, Alzheimer’s, or anxiety.

But reaching the olfactory zone is notoriously hard. “The vasculature in your nose is like a big freeway, and the olfactory tract is like a side alley,” explained Mr. Hoekman. “It’s very limiting in what it will allow through.” The region is also small, occupying only 3%-10% of the nasal cavity’s surface area. 

Again, POD means “precision olfactory delivery.” But the device isn’t quite as laser focused on the region as its name implies. “We’re not at the stage where we’re able to exclusively deliver to one target site in the nose,” said Dr. Hindle. 

While wending its way toward the olfactory zone, some of the drug will be absorbed by other regions, then circulate throughout the body. 

“About 59% of the drug that we put into the upper nasal space gets absorbed into the bloodstream,” said Mr. Hoekman. 

Janssen Pharmaceuticals’ Spravato – a nasal spray for drug-resistant depression – is thought to work similarly: Some goes straight to the brain via the olfactory nerves, while the rest takes a more roundabout route, passing through the blood vessels to circulate in your system.
 

 

 

A needle-free option 

Sometimes, the bloodstream is the main target. Because the nose’s middle and upper stretches are so vascular, drugs can be rapidly absorbed. 

This is especially valuable for time-sensitive conditions. “If you give something nasally, you can have peak uptake in 15-30 minutes,” said Mr. Hoekman.

Take Narcan nasal spray, which delivers a burst of naloxone to quickly reverse the effects of opioid an overdose. Or Noctiva nasal spray. Taken just half an hour before bed, it can prevent frequent nighttime urination. 

There’s also a group of seizure-stopping sprays, known as “rescue treatments.” One works by temporarily loosening the space between nasal cells, allowing the seizure drug to be quickly absorbed through the vessels. 

This systemic access also has potential for drugs that would otherwise have to be injected, such as biologics. 

The same goes for vaccines. Mucosal tissue inside the nasal cavity offers direct access to the infection-fighting lymphatic system, making the nose a prime target for inoculation against certain viruses.
 

Inhaling protection against viruses

Despite the recent surge of interest, nasal vaccines faced a rocky start. After the first nasal flu vaccine hit the market in 2001, it was pulled due to potential toxicity and reports of Bell’s palsy, a type of facial paralysis

FluMist came in 2003 and has been plagued by problems ever since. Because it contains a weakened live virus, flu-like side effects can occur. And it doesn’t always work. During the 2016-2017 flu season, FluMist protected only 3% of kids, prompting the Centers for Disease Control and Prevention to advise against the nasal route that year. 

Why FluMist can be so hit-or-miss is poorly understood. But generally, the nose can pose an effectiveness challenge. “The nose is highly cycling,” said Dr. Hindle. “Anything we deposit usually gets transported out within 15-20 minutes.” 

For kids – big fans of not using needles – chronically runny noses can be an issue. “You squirt it in the nose, and it will probably just come back out in their snot,” said Jay Kolls, MD, a professor of medicine and pediatrics at Tulane University, New Orleans, who is developing an intranasal pneumonia vaccine. 

Even so, nasal vaccines became a hot topic among researchers after the world was shut down by a virus that invades through the nose.

“We realized that intramuscular vaccines were effective at preventing severe disease, but they weren’t that effective at preventing transmission,” said Michael Diamond, MD, PhD, an immunologist at Washington University in St. Louis.

Nasal vaccines could solve that problem by putting an immune barrier at the point of entry, denying access to the rest of the body. “You squash the infection early enough that it not only prevents disease,” said Dr. Kolls, “but potentially prevents transmission.”

 

And yes, a nasal COVID vaccine is on the way

In March 2020, Dr. Diamond’s team began exploring a nasal COVID vaccine. Promising results in animals prompted a vaccine development company to license the technology. The resulting nasal vaccine – the first for COVID – has been approved in India, both as a primary vaccine and a booster.

It works by stimulating an influx of IgA, a type of antibody found in the nasal passages, and production of resident memory T cells, immune cells on standby just beneath the surface tissue in the nose. 

By contrast, injected vaccines generate mostly IgG antibodies, which struggle to enter the respiratory tract. Only a tiny fraction – an estimated 1% – typically reach the nose. 

Nasal vaccines could also be used along with shots. The latter could prime the whole body to fight back, while a nasal spritz could pull that immune protection to the mucosal surfaces. 

Nasal technology could yield more effective vaccines for infections like tuberculosis or malaria, or even safeguard against new – sometimes surprising – conditions. 

In a 2021 Nature study, an intranasal vaccine derived from fentanyl was better at preventing overdose than an injected vaccine. “Through some clever chemistry, the drug [in the vaccine] isn’t fentanyl anymore,” said study author Elizabeth Norton, PhD, an assistant professor of microbiology and immunology at Tulane University. “But the immune system still has an antibody response to it.”

Novel applications like this represent the future of nasal drug delivery. 

“We’re not going to innovate in asthma or COPD. We’re not going to innovate in local delivery to the nose,” said Dr. Hindle. “Innovation will only come if we look to treat new conditions.”

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

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