Ex-Army chief Dannatt refused Lariam drug used by troops

Ex-Army chief Dannatt refused Lariam drug used by troops

By Joanna Gosling & Sarah Hatchard
Victoria Derbyshire programme
  • 31 August 2016
  • From the section UK

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Media captionLord Dannatt: My son became “extremely depressed” after taking Lariam

A former Army chief has admitted he has refused to take a controversial anti-malaria drug despite it being offered to his troops.

Lord Dannatt told the BBC’s Victoria Derbyshire programme he personally believes the drug can have “catastrophic” mental health effects.

He said his own son took Lariam and became “extremely depressed”.

The Ministry of Defence said: “The vast majority of deployed personnel already receive alternatives to Lariam.”

Lord Dannatt said he was “quite content to say sorry” to troops who had taken the drug while he was head of the Army, between 2006 and 2009.

‘Very withdrawn’

Lord Dannatt said his son Bertie had suffered mental health problems after taking two doses of Lariam – the brand name for mefloquine – before visiting Africa as a civilian in the late 1990s.

He was not in the armed forces at the time, but had been prescribed the drug by his father’s Army doctor.

“He became extremely depressed,” Lord Dannatt said, “not the person that he would normally be – a very bubbly, personable sort of individual.

“He got very withdrawn, and we got very worried about him.

“If that had been untreated, who knows where it would have gone.”

Image copyright
Lord Dannatt

Image caption

Lord Dannatt with his son Bertie

The MoD’s doctors prescribed Lariam to more than 17,000 troops between April 2007 and March 2015, although it is not the main anti-malaria drug used by the armed forces.

Lord Dannatt said the drug’s side-effects – which can include depression and suicidal thoughts – could be “pretty catastrophic”.

He said: “Because Bertie had that effect, whenever I’ve needed anti-malarial drugs, I’ve said, ‘I’ll take anything, but I’m not taking Lariam.'”

Image copyright
PA

Image caption

Lord Dannatt said his time as Army boss had been dominated by Iraq and Afghanistan (pictured), which did not have problems with malaria

Lord Dannatt said he was “quite content to say sorry” to troops who had taken Lariam while he was head of the Army, admitting the issue had not been treated as a priority.

Asked why soldiers had continued to be prescribed Lariam during his years in charge, he said the MoD at the time “hadn’t reached a settled view on whether Lariam was more beneficial or harmful”.

Lord Dannatt said: “I suppose, in that period from 2003 right through to 2014 – when we were focused on Iraq and Afghanistan, which were not malarial areas, and we weren’t giving a large number of people Lariam – it probably slightly slipped off our mainstream radar.

“I think we put it on the backburner.”


Lariam ‘turned me into an ogre’

Image copyright
PA

“Andy” – not his real name – took Lariam on the Army’s tour of Sierra Leone in 2000, and says he still feels its side effects.

“The effects were almost immediate… I can be a nasty, violent person and I attribute it to this drug.

“Anything could be misconstrued – a look, a phrase, a word, something completely innocent in someone else’s eyes – but it would be enough to trigger a reaction. A reaction you knew you were doing but you couldn’t stop it.

“It was as if the wiring in your brain had completely gone.

“Had I known what the side effects were, I would have taken my chances with malaria. It turned me into an ogre.”

Andy says he also gets “depressed to the point of suicidal thoughts”. He explained the only reason he has come through such periods is that he has “a little girl now, and she needs a daddy. That’s the only saving grace.”


The MoD says that, since 2013, its doctors have prescribed Lariam to soldiers only following individual risk assessments.

Lawyers acting for ex-soldiers seeking compensation take this to mean that before then there was no systematic requirement for this to happen.

Lord Dannatt said the MoD was afraid of opening “the floodgates” to “very expensive” claims if it admitted Lariam had harmed troops, adding that “frankly, the MoD doesn’t have much money”.

He said: “The right response by the MoD would be to take a generous approach, as far as Lariam is concerned, and invite those who think they have lost a loved one, or indeed an individual who believes he or she is still suffering as a result of Lariam, to put their case forward and have their case examined.”

Critics of the use of Lariam by the MoD have described its effects as similar to “friendly fire”, a mistaken attack by a military force on its own personnel.

Lord Dannatt called this a “very fair description”.

The Ministry of Defence said it had “a duty to protect our personnel from malaria, and, as the last Defence Committee report concluded, in some cases, Lariam will be the most effective way of doing that.”

It added: “[Lariam] continues to be recommended as safe by Public Health England and the World Health Organisation.”

The drug’s manufacturers, Roche, said it “will continue to work with the Ministry of Defence to ensure that they have all the relevant information to ensure Lariam is prescribed appropriately”.

The Victoria Derbyshire programme is broadcast on weekdays between 09:00 and 11:00 on BBC Two and the BBC News channel.

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Ex-Army chief Dannatt refused Lariam drug used by troops

Ex-Army chief Dannatt refused Lariam drug used by troops

By Joanna Gosling & Sarah Hatchard
Victoria Derbyshire programme
  • 31 August 2016
  • From the section UK

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Media captionLord Dannatt: My son became “extremely depressed” after taking Lariam

A former Army chief has admitted he has refused to take a controversial anti-malaria drug despite it being offered to his troops.

Lord Dannatt told the BBC’s Victoria Derbyshire programme he personally believes the drug can have “catastrophic” mental health effects.

He said his own son took Lariam and became “extremely depressed”.

The Ministry of Defence said: “The vast majority of deployed personnel already receive alternatives to Lariam.”

Lord Dannatt said he was “quite content to say sorry” to troops who had taken the drug while he was head of the Army, between 2006 and 2009.

‘Very withdrawn’

Lord Dannatt said his son Bertie had suffered mental health problems after taking two doses of Lariam – the brand name for mefloquine – before visiting Africa as a civilian in the late 1990s.

He was not in the armed forces at the time, but had been prescribed the drug by his father’s Army doctor.

“He became extremely depressed,” Lord Dannatt said, “not the person that he would normally be – a very bubbly, personable sort of individual.

“He got very withdrawn, and we got very worried about him.

“If that had been untreated, who knows where it would have gone.”

Image copyright
Lord Dannatt

Image caption

Lord Dannatt with his son Bertie

The MoD’s doctors prescribed Lariam to more than 17,000 troops between April 2007 and March 2015, although it is not the main anti-malaria drug used by the armed forces.

Lord Dannatt said the drug’s side-effects – which can include depression and suicidal thoughts – could be “pretty catastrophic”.

He said: “Because Bertie had that effect, whenever I’ve needed anti-malarial drugs, I’ve said, ‘I’ll take anything, but I’m not taking Lariam.'”

Image copyright
PA

Image caption

Lord Dannatt said his time as Army boss had been dominated by Iraq and Afghanistan (pictured), which did not have problems with malaria

Lord Dannatt said he was “quite content to say sorry” to troops who had taken Lariam while he was head of the Army, admitting the issue had not been treated as a priority.

Asked why soldiers had continued to be prescribed Lariam during his years in charge, he said the MoD at the time “hadn’t reached a settled view on whether Lariam was more beneficial or harmful”.

Lord Dannatt said: “I suppose, in that period from 2003 right through to 2014 – when we were focused on Iraq and Afghanistan, which were not malarial areas, and we weren’t giving a large number of people Lariam – it probably slightly slipped off our mainstream radar.

“I think we put it on the backburner.”


Lariam ‘turned me into an ogre’

Image copyright
PA

“Andy” – not his real name – took Lariam on the Army’s tour of Sierra Leone in 2000, and says he still feels its side effects.

“The effects were almost immediate… I can be a nasty, violent person and I attribute it to this drug.

“Anything could be misconstrued – a look, a phrase, a word, something completely innocent in someone else’s eyes – but it would be enough to trigger a reaction. A reaction you knew you were doing but you couldn’t stop it.

“It was as if the wiring in your brain had completely gone.

“Had I known what the side effects were, I would have taken my chances with malaria. It turned me into an ogre.”

Andy says he also gets “depressed to the point of suicidal thoughts”. He explained the only reason he has come through such periods is that he has “a little girl now, and she needs a daddy. That’s the only saving grace.”


The MoD says that, since 2013, its doctors have prescribed Lariam to soldiers only following individual risk assessments.

Lawyers acting for ex-soldiers seeking compensation take this to mean that before then there was no systematic requirement for this to happen.

Lord Dannatt said the MoD was afraid of opening “the floodgates” to “very expensive” claims if it admitted Lariam had harmed troops, adding that “frankly, the MoD doesn’t have much money”.

He said: “The right response by the MoD would be to take a generous approach, as far as Lariam is concerned, and invite those who think they have lost a loved one, or indeed an individual who believes he or she is still suffering as a result of Lariam, to put their case forward and have their case examined.”

Critics of the use of Lariam by the MoD have described its effects as similar to “friendly fire”, a mistaken attack by a military force on its own personnel.

Lord Dannatt called this a “very fair description”.

The Ministry of Defence said it had “a duty to protect our personnel from malaria, and, as the last Defence Committee report concluded, in some cases, Lariam will be the most effective way of doing that.”

It added: “[Lariam] continues to be recommended as safe by Public Health England and the World Health Organisation.”

The drug’s manufacturers, Roche, said it “will continue to work with the Ministry of Defence to ensure that they have all the relevant information to ensure Lariam is prescribed appropriately”.

The Victoria Derbyshire programme is broadcast on weekdays between 09:00 and 11:00 on BBC Two and the BBC News channel.

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Google DeepMind targets NHS head and neck cancer treatment

Google DeepMind targets NHS head and neck cancer treatment

By Chris Baraniuk
Technology reporter
  • 31 August 2016
  • From the section Technology

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Brain scansImage copyright
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DeepMind will analyse anonymised scans from 700 former cancer patients

Anonymised CT and MRI scans from 700 former University College London Hospital radiotherapy patients will be analysed by Google’s artificial intelligence division, DeepMind.

The aim is to develop an algorithm that can automatically differentiate between healthy and cancerous tissues.

This “segmentation” is necessary in patients with head and neck cancers.

And it is hoped the time it takes to design targeted radiotherapy treatments could be cut from four hours to one.

“Clinicians will remain responsible for deciding radiotherapy treatment plans,” UCLH said.

Complex tumours

“From my perspective, one of the challenges that we have in the treatment of all tumours, but particularly brain and neck [tumours], is their complexity,” said Dr Kieran Breen, of Brain Tumour Research, who is not involved in the work.

“One way we can really improve this is by using the knowledge we already have,” he told the BBC.

“This is essentially what this project is doing.”

More precise radiotherapy helps reduce side effects of such treatment, according to Dr Justine Alford, senior science information officer at Cancer Research UK.

“Using computers to help plan radiotherapy could help deliver better treatment for patients by speeding up the process and improving accuracy,” she said.

“But we won’t know until results from this innovative new project are produced.”

The former patients have consented to their anonymised scans being used for medical research.

Ownership of the data will be retained by the hospital.

And, at the end of the partnership, DeepMind will “securely destroy” any information provided to it.

One in 75 men and one in 150 women will be diagnosed with oral cancer during their lifetime, according to Google.

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Google DeepMind targets NHS head and neck cancer treatment

Google DeepMind targets NHS head and neck cancer treatment

By Chris Baraniuk
Technology reporter
  • 31 August 2016
  • From the section Technology

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Brain scansImage copyright
Thinkstock

Image caption

DeepMind will analyse anonymised scans from 700 former cancer patients

Anonymised CT and MRI scans from 700 former University College London Hospital radiotherapy patients will be analysed by Google’s artificial intelligence division, DeepMind.

The aim is to develop an algorithm that can automatically differentiate between healthy and cancerous tissues.

This “segmentation” is necessary in patients with head and neck cancers.

And it is hoped the time it takes to design targeted radiotherapy treatments could be cut from four hours to one.

“Clinicians will remain responsible for deciding radiotherapy treatment plans,” UCLH said.

Complex tumours

“From my perspective, one of the challenges that we have in the treatment of all tumours, but particularly brain and neck [tumours], is their complexity,” said Dr Kieran Breen, of Brain Tumour Research, who is not involved in the work.

“One way we can really improve this is by using the knowledge we already have,” he told the BBC.

“This is essentially what this project is doing.”

More precise radiotherapy helps reduce side effects of such treatment, according to Dr Justine Alford, senior science information officer at Cancer Research UK.

“Using computers to help plan radiotherapy could help deliver better treatment for patients by speeding up the process and improving accuracy,” she said.

“But we won’t know until results from this innovative new project are produced.”

The former patients have consented to their anonymised scans being used for medical research.

Ownership of the data will be retained by the hospital.

And, at the end of the partnership, DeepMind will “securely destroy” any information provided to it.

One in 75 men and one in 150 women will be diagnosed with oral cancer during their lifetime, according to Google.

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Thirteen Indians among Zika infected people in Singapore: source

By Raju Gopalakrishnan and Marius Zaharia
| SINGAPORE

Thirteen Indian citizens are among those infected in an outbreak of the Zika virus in Singapore, according to a person at the Indian High Commission in the city-state.

Foreign construction workers have been hit hardest in the first days of the mosquito-borne disease’s outbreak. Singapore announced the first locally contracted case of Zika late on Saturday.

Of the first 56 cases of Zika identified by late Monday, three dozen were foreign workers on a property development site where they worked and lived with more than 450 others.

Total Zika infections had increased to 82 by late Tuesday, but the Singapore government has not disclosed whether any of the more recent cases involved foreign workers. It did not respond to Reuters questions about the nationality of those infected.

The person at the Indian High Commission did not know if the Indian citizens affected were in the construction industry.

India’s Ministry of External Affairs said it had asked the Singapore government if any of its nationals were among those diagnosed with the Zika virus, but had yet to hear back. Many of the 360,000 or so foreign workers in Singapore’s building industry are from the Indian sub-continent, including India, Bangladesh and Sri Lanka.

While many are paid as little as S$2 an hour ($1.47), work 12-14 hour days and rarely take days off, they can still potentially earn significantly more in Singapore than at home.

“MOST SUSCEPTIBLE”

Some dormitory rooms where workers live can house more than a dozen people and have no working fans, increasing their potential exposure to mosquitoes as windows are often left open, rights groups and some foreign workers told Reuters.

Government regulations already require employers and dormitory operators to take efforts to avoid mosquito breeding habitats as part of a long-standing battle with dengue, another mosquito-borne virus, but rights groups say they are concerned that these rules are not always followed.

Heena Kanwar, executive director of the Humanitarian Organisation for Migration Economics, says foreign workers are “the most susceptible group” for infections “because of their living conditions.”

Reuters was unable to gain access to workers at the construction site which was the focal point of the initial Zika infections. A spokesperson for Woh Hup, the main contractor at the site – which is under a “stop work” order – directed queries to the authorities “as the case is still under investigation.”

A spokeswoman for the site’s owner, Guocoland, said the company was unable to comment “beyond what has been released by the authorities.”

Only local media were invited to a site visit by Minister of State for Manpower Teo Ser Luck on Tuesday, reporting that those diagnosed with the Zika virus were still living on site, but were separated from other workers, in rooms with internet access and delivered meals.

Debbie Fordyce, member of the executive committee of the group Transient Workers Count Too, noted that Singapore doesn’t release a nationality breakdown of foreign workers in its construction industry, so it’s not surprising it has not disclosed where workers with the Zika virus are from.

“It could either be for the protection of the foreign workers, so that certain groups are not ostracized and identified as carriers of the virus, or to avoid drawing further attention to the poor living conditions,” she said.

Dormitory operators, who spoke to Reuters on condition of anonymity, said government agencies carry out regular site inspections, and this week sprayed insecticide and looked for potential mosquito breeding habitats.

They say the government acts quickly if conditions are sub-standard, and operators are required to have at least one sick bay available or contingency plans for infectious diseases.

One dorm operator said it was hard to monitor the spread of infectious diseases, noting there were as many as 240 workers on just one level of his premises.

Manpower Minister Teo told local media on Tuesday that action would be taken against operators who don’t take preventive measures “because this is a very serious issue.”

It’s still not known where the other foreign workers with Zika are from.

The High Commission of Bangladesh and the Thai embassy said they did not have any workers among those who tested positive. A Sri Lankan foreign ministry official said it had not been informed of any infections, and the Chinese foreign ministry said in Beijing it had no information about any of its nationals in Singapore having Zika.

(Reporting by Marius Zaharia, Fathin Ungku, Nicole Nee, Imogen Braddick, Masayuki Kitano and Aradhana Aravindan in SINGAPORE, Douglas Busvine in NEW DELHI and Ryan Woo in Beijing; Editing by Martin Howell and Ian Geoghegan)


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Thirteen Indians among Zika infected people in Singapore: source

By Raju Gopalakrishnan and Marius Zaharia
| SINGAPORE

Thirteen Indian citizens are among those infected in an outbreak of the Zika virus in Singapore, according to a person at the Indian High Commission in the city-state.

Foreign construction workers have been hit hardest in the first days of the mosquito-borne disease’s outbreak. Singapore announced the first locally contracted case of Zika late on Saturday.

Of the first 56 cases of Zika identified by late Monday, three dozen were foreign workers on a property development site where they worked and lived with more than 450 others.

Total Zika infections had increased to 82 by late Tuesday, but the Singapore government has not disclosed whether any of the more recent cases involved foreign workers. It did not respond to Reuters questions about the nationality of those infected.

The person at the Indian High Commission did not know if the Indian citizens affected were in the construction industry.

India’s Ministry of External Affairs said it had asked the Singapore government if any of its nationals were among those diagnosed with the Zika virus, but had yet to hear back. Many of the 360,000 or so foreign workers in Singapore’s building industry are from the Indian sub-continent, including India, Bangladesh and Sri Lanka.

While many are paid as little as S$2 an hour ($1.47), work 12-14 hour days and rarely take days off, they can still potentially earn significantly more in Singapore than at home.

“MOST SUSCEPTIBLE”

Some dormitory rooms where workers live can house more than a dozen people and have no working fans, increasing their potential exposure to mosquitoes as windows are often left open, rights groups and some foreign workers told Reuters.

Government regulations already require employers and dormitory operators to take efforts to avoid mosquito breeding habitats as part of a long-standing battle with dengue, another mosquito-borne virus, but rights groups say they are concerned that these rules are not always followed.

Heena Kanwar, executive director of the Humanitarian Organisation for Migration Economics, says foreign workers are “the most susceptible group” for infections “because of their living conditions.”

Reuters was unable to gain access to workers at the construction site which was the focal point of the initial Zika infections. A spokesperson for Woh Hup, the main contractor at the site – which is under a “stop work” order – directed queries to the authorities “as the case is still under investigation.”

A spokeswoman for the site’s owner, Guocoland, said the company was unable to comment “beyond what has been released by the authorities.”

Only local media were invited to a site visit by Minister of State for Manpower Teo Ser Luck on Tuesday, reporting that those diagnosed with the Zika virus were still living on site, but were separated from other workers, in rooms with internet access and delivered meals.

Debbie Fordyce, member of the executive committee of the group Transient Workers Count Too, noted that Singapore doesn’t release a nationality breakdown of foreign workers in its construction industry, so it’s not surprising it has not disclosed where workers with the Zika virus are from.

“It could either be for the protection of the foreign workers, so that certain groups are not ostracized and identified as carriers of the virus, or to avoid drawing further attention to the poor living conditions,” she said.

Dormitory operators, who spoke to Reuters on condition of anonymity, said government agencies carry out regular site inspections, and this week sprayed insecticide and looked for potential mosquito breeding habitats.

They say the government acts quickly if conditions are sub-standard, and operators are required to have at least one sick bay available or contingency plans for infectious diseases.

One dorm operator said it was hard to monitor the spread of infectious diseases, noting there were as many as 240 workers on just one level of his premises.

Manpower Minister Teo told local media on Tuesday that action would be taken against operators who don’t take preventive measures “because this is a very serious issue.”

It’s still not known where the other foreign workers with Zika are from.

The High Commission of Bangladesh and the Thai embassy said they did not have any workers among those who tested positive. A Sri Lankan foreign ministry official said it had not been informed of any infections, and the Chinese foreign ministry said in Beijing it had no information about any of its nationals in Singapore having Zika.

(Reporting by Marius Zaharia, Fathin Ungku, Nicole Nee, Imogen Braddick, Masayuki Kitano and Aradhana Aravindan in SINGAPORE, Douglas Busvine in NEW DELHI and Ryan Woo in Beijing; Editing by Martin Howell and Ian Geoghegan)


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Few people of color in 'artificial pancreas' tests

By Lisa Rapaport

(Reuters Health) – For years, doctors and patients have been waiting for the arrival of an “artificial pancreas” to take the guesswork out of life with diabetes by measuring blood sugar levels and automatically delivering the amount of insulin needed to keep the disease in check.

But now that this experimental device is close to becoming reality, a new study suggests that tests to date have largely ignored a big segment of the patient population that might use it – people of color.

This oversight is leading to “a minority digital diabetes divide,” said senior study author Dr. David Kerr of the William Sansun Diabetes Center in Santa Barbara, California.

“Minorities already have worse control and more complications of diabetes in general,” Kerr said by email. “Failure to understand the potential social and cultural determinants of health and disease could lead to their exclusion from accessing and affording this potential life-changing technology.”

To see how many non-white patients have been included in tests of the artificial pancreas, Kerr and colleagues reviewed 99 previously published studies on the device.

Only six of these studies mentioned race or ethnicity at all, and just four reported the number of participants belonging to different racial or ethnic groups, researchers report in The Lancet Diabetes and Endocrinology.

In one of those four studies, 43 of the 46 participants were white. Similarly, in a second study 24 of 25 people were white, as were 11 of 15 and 11 of 12 in the two other tests that included racial and ethnic data.

These patients had what’s known as type 1 diabetes, a chronic condition typically diagnosed in children and young adults. With this type of diabetes, the pancreas produces little or no insulin, a hormone needed to allow blood sugar, or glucose, to enter cells and produce energy.

People with type 1 diabetes typically have to test their own blood sugar levels throughout the day and inject insulin to manage it. Nights are often a problem because dangerous blood sugar changes can happen while the person is sleeping, and automatic blood sugar monitoring and delivery of insulin is one solution.

Poorly controlled, diabetes can lead to cardiovascular disease, kidney complications and death.

While the artificial pancreas remains an experimental device, research to date suggests it may be a safe and effective way for patients to manage diabetes and minimize the risk of complications.

Because white patients appear to make up the majority of trial participants, they’re getting access to the device much sooner than patients of color who might benefit from the chance to join the trials, the study authors argue.

This would put white patients at the front of the line to get the device, also known as a closed loop insulin-delivery system, when it becomes commercially available as early as next year, the authors note.

At the same time, it’s possible patients of color might have different outcomes with the device that won’t be discovered because the trials included mostly white people.

It isn’t unusual for smaller initial tests of new devices to exclude data on the race or ethnicity of participants, said Dr. Roman Hovorka, of the University of Cambridge Metabolic Research Laboratories in the UK.

But when these tests include mostly white people, it can limit how much the results will apply to the general population, Hovorka, who wasn’t involved in the current study, added by email.

“The research should be inclusive to allow generalizability of the results,” Hovorka said.

SOURCE: bit.ly/2bT5Pei The Lancet Diabetes and Endocrinology, online August 1, 2016.


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Few people of color in 'artificial pancreas' tests

By Lisa Rapaport

(Reuters Health) – For years, doctors and patients have been waiting for the arrival of an “artificial pancreas” to take the guesswork out of life with diabetes by measuring blood sugar levels and automatically delivering the amount of insulin needed to keep the disease in check.

But now that this experimental device is close to becoming reality, a new study suggests that tests to date have largely ignored a big segment of the patient population that might use it – people of color.

This oversight is leading to “a minority digital diabetes divide,” said senior study author Dr. David Kerr of the William Sansun Diabetes Center in Santa Barbara, California.

“Minorities already have worse control and more complications of diabetes in general,” Kerr said by email. “Failure to understand the potential social and cultural determinants of health and disease could lead to their exclusion from accessing and affording this potential life-changing technology.”

To see how many non-white patients have been included in tests of the artificial pancreas, Kerr and colleagues reviewed 99 previously published studies on the device.

Only six of these studies mentioned race or ethnicity at all, and just four reported the number of participants belonging to different racial or ethnic groups, researchers report in The Lancet Diabetes and Endocrinology.

In one of those four studies, 43 of the 46 participants were white. Similarly, in a second study 24 of 25 people were white, as were 11 of 15 and 11 of 12 in the two other tests that included racial and ethnic data.

These patients had what’s known as type 1 diabetes, a chronic condition typically diagnosed in children and young adults. With this type of diabetes, the pancreas produces little or no insulin, a hormone needed to allow blood sugar, or glucose, to enter cells and produce energy.

People with type 1 diabetes typically have to test their own blood sugar levels throughout the day and inject insulin to manage it. Nights are often a problem because dangerous blood sugar changes can happen while the person is sleeping, and automatic blood sugar monitoring and delivery of insulin is one solution.

Poorly controlled, diabetes can lead to cardiovascular disease, kidney complications and death.

While the artificial pancreas remains an experimental device, research to date suggests it may be a safe and effective way for patients to manage diabetes and minimize the risk of complications.

Because white patients appear to make up the majority of trial participants, they’re getting access to the device much sooner than patients of color who might benefit from the chance to join the trials, the study authors argue.

This would put white patients at the front of the line to get the device, also known as a closed loop insulin-delivery system, when it becomes commercially available as early as next year, the authors note.

At the same time, it’s possible patients of color might have different outcomes with the device that won’t be discovered because the trials included mostly white people.

It isn’t unusual for smaller initial tests of new devices to exclude data on the race or ethnicity of participants, said Dr. Roman Hovorka, of the University of Cambridge Metabolic Research Laboratories in the UK.

But when these tests include mostly white people, it can limit how much the results will apply to the general population, Hovorka, who wasn’t involved in the current study, added by email.

“The research should be inclusive to allow generalizability of the results,” Hovorka said.

SOURCE: bit.ly/2bT5Pei The Lancet Diabetes and Endocrinology, online August 1, 2016.


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ESC: Apixaban the Better Option in AFib Patients Who've Fallen?

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • Patients diagnosed with atrial fibrillation who also have a previous history of falls should receive anticoagulation therapy with apixaban to prevent strokes.
  • Note that the group with a history of falls had similar adjusted rates of stroke or systemic embolism and hemorrhagic stroke, but higher rates of major bleeding and mortality.

ROME — Patients diagnosed with atrial fibrillation who also have a previous history of falls should receive anticoagulation therapy with apixaban (Eliquis) to prevent strokes, researchers said here.

In a subset analysis of the 753 patients with a history of falls in the ARISTOTLE trial, no patients taking apixaban experienced intracranial bleeding versus five (0.85%) on warfarin, reported Christopher Granger, MD, of Duke University Medical Center in Durham, N.C., and colleagues at the European Society of Cardiology annual meeting.

ARISTOTLE demonstrated that apixaban was superior to warfarin in preventing stroke and bleeding episodes.

“These are small numbers, but it is consistent with the idea that the safety profile of apixaban is something that could be very important in the high-risk population that has fallen,” Granger said. “I would extend this to all the non-vitamin K anticoagulants — they all have this characteristic of less intracranial bleeding.”

“A prior history of falls is a commonly cited reason for concern for risk of bleeding with anticoagulation,” the authors explained, even though little is known about the relative increased risk of bleeding and of stroke among patients on anticoagulants with history of falls, and whether the relative benefits of apixaban versus warfarin are consistent in this population.

“This is an extremely important and underappreciated clinical issue,” Granger told MedPage Today. “Patients with atrial fibrillation are at substantial risk of stroke, which are preventable with anticoagulants. But at least half the time anticoagulants are not being used, and a substantial part of the reason is because of concern of frailty, bleeding, and falls – and particularly falls.”

Granger’s group evaluated the ARISTOTLE data and determined that about 5% of the 18,000 people in the study had a history of falls. They found that 753 (4.6%) of patients had a history of falls in the past year at baseline. They were compared with 15,738 patients recruited in ARISTOTLE without a history of falls.

Compared with patients without a history of falls, those with a prior history of falls were:

  • Older: median age 75 versus 70
  • More likely to be female
  • Have dementia, depression, osteoporosis, and fractures
  • Have more prior bleeding of most types
  • Have higher CHADS score (mean 2.53 versus 2.14)
  • Have higher HAS-BLED score (mean 2.40 versus 1.77)
  • Higher rates of study drug discontinuation

The group with a history of falls had similar adjusted rates of stroke or systemic embolism and hemorrhagic stroke, but higher rates of major bleeding (HR 1.39, 95% CI 1.05 to 1.85) and mortality (HR 1.70, 95% CI 1.36 to 2.14).

“The benefits of apixaban, compared with warfarin, on stroke/systemic embolism, bleeding, myocardial infarction, and death were preserved, irrespective of history of falls,” the authors noted.

“These patients were at higher risk of adverse outcomes, such as mortality, a 30% higher risk of stroke, and a two-fold higher risk of intracranial bleeding, including subdural bleeding, and a greater likelihood of fracture,” Granger explained. “There is about a 1% risk of intracranial bleeding among patients who have a history of falls and about a 0.55% risk in people who did not have a history of falls. The rate of stroke or symptomatic embolism was about 2% in patients with a history of falls compared to about 0.9% of those without a history of falls. Because anticoagulation therapy reduced the risk of stroke by two-thirds, you can extrapolate that anticoagulant therapy far outweighs the risk of intracranial bleeding.”

He said that the substudy indicated that patients with a history of falls “seem to do reasonably well with anticoagulation in respect to the risk-benefit; secondly, apixaban seemed to be particularly good treatment for this high-risk population.”

The overall take-home message is that these patients with a history of falls should be treated with anticoagulants.

“All too often these people are not being treated, and they are having preventable strokes,” he said, adding that “it is most important to get patients on some anticoagulation, even warfarin. It is much better than nothing or just aspirin.”

Granger said that uptake of that message has been slow in the medical community. “The change in the proportion of people being treated has been very modest and we are trying to sort through the reasons for this,” he noted. A concern among healthcare providers about bleeding risks is one reason why, he added.

In commenting on the trial, Richard Becker, MD, chief of cardiology at the University of Cincinnati College of Medicine, agreed, telling MedPage Today that “the medical community … has appreciated the role of falls in patients who are anticoagulated. We may have overestimated the risk, and therefore have not offered anticoagulation for patients who may have benefited from its use in terms of reducing the risk of strokes, in particular.”

“If a physician believes that a patient can be safely treated with anticoagulation, then apixaban would be a better choice than warfarin under those circumstances,” said Becker, who was not involved in the study.

Granger disclosed relevant relationships with Pfizer, BMS, Boehringer Ingelheim, Bayer, Janssen, and Daiichi Sankyo.

Becker disclosed no relevant relationships with industry.


  • Reviewed by
    Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco
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ESC: Apixaban the Better Option in AFib Patients Who've Fallen?

Action Points

  • Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
  • Patients diagnosed with atrial fibrillation who also have a previous history of falls should receive anticoagulation therapy with apixaban to prevent strokes.
  • Note that the group with a history of falls had similar adjusted rates of stroke or systemic embolism and hemorrhagic stroke, but higher rates of major bleeding and mortality.

ROME — Patients diagnosed with atrial fibrillation who also have a previous history of falls should receive anticoagulation therapy with apixaban (Eliquis) to prevent strokes, researchers said here.

In a subset analysis of the 753 patients with a history of falls in the ARISTOTLE trial, no patients taking apixaban experienced intracranial bleeding versus five (0.85%) on warfarin, reported Christopher Granger, MD, of Duke University Medical Center in Durham, N.C., and colleagues at the European Society of Cardiology annual meeting.

ARISTOTLE demonstrated that apixaban was superior to warfarin in preventing stroke and bleeding episodes.

“These are small numbers, but it is consistent with the idea that the safety profile of apixaban is something that could be very important in the high-risk population that has fallen,” Granger said. “I would extend this to all the non-vitamin K anticoagulants — they all have this characteristic of less intracranial bleeding.”

“A prior history of falls is a commonly cited reason for concern for risk of bleeding with anticoagulation,” the authors explained, even though little is known about the relative increased risk of bleeding and of stroke among patients on anticoagulants with history of falls, and whether the relative benefits of apixaban versus warfarin are consistent in this population.

“This is an extremely important and underappreciated clinical issue,” Granger told MedPage Today. “Patients with atrial fibrillation are at substantial risk of stroke, which are preventable with anticoagulants. But at least half the time anticoagulants are not being used, and a substantial part of the reason is because of concern of frailty, bleeding, and falls – and particularly falls.”

Granger’s group evaluated the ARISTOTLE data and determined that about 5% of the 18,000 people in the study had a history of falls. They found that 753 (4.6%) of patients had a history of falls in the past year at baseline. They were compared with 15,738 patients recruited in ARISTOTLE without a history of falls.

Compared with patients without a history of falls, those with a prior history of falls were:

  • Older: median age 75 versus 70
  • More likely to be female
  • Have dementia, depression, osteoporosis, and fractures
  • Have more prior bleeding of most types
  • Have higher CHADS score (mean 2.53 versus 2.14)
  • Have higher HAS-BLED score (mean 2.40 versus 1.77)
  • Higher rates of study drug discontinuation

The group with a history of falls had similar adjusted rates of stroke or systemic embolism and hemorrhagic stroke, but higher rates of major bleeding (HR 1.39, 95% CI 1.05 to 1.85) and mortality (HR 1.70, 95% CI 1.36 to 2.14).

“The benefits of apixaban, compared with warfarin, on stroke/systemic embolism, bleeding, myocardial infarction, and death were preserved, irrespective of history of falls,” the authors noted.

“These patients were at higher risk of adverse outcomes, such as mortality, a 30% higher risk of stroke, and a two-fold higher risk of intracranial bleeding, including subdural bleeding, and a greater likelihood of fracture,” Granger explained. “There is about a 1% risk of intracranial bleeding among patients who have a history of falls and about a 0.55% risk in people who did not have a history of falls. The rate of stroke or symptomatic embolism was about 2% in patients with a history of falls compared to about 0.9% of those without a history of falls. Because anticoagulation therapy reduced the risk of stroke by two-thirds, you can extrapolate that anticoagulant therapy far outweighs the risk of intracranial bleeding.”

He said that the substudy indicated that patients with a history of falls “seem to do reasonably well with anticoagulation in respect to the risk-benefit; secondly, apixaban seemed to be particularly good treatment for this high-risk population.”

The overall take-home message is that these patients with a history of falls should be treated with anticoagulants.

“All too often these people are not being treated, and they are having preventable strokes,” he said, adding that “it is most important to get patients on some anticoagulation, even warfarin. It is much better than nothing or just aspirin.”

Granger said that uptake of that message has been slow in the medical community. “The change in the proportion of people being treated has been very modest and we are trying to sort through the reasons for this,” he noted. A concern among healthcare providers about bleeding risks is one reason why, he added.

In commenting on the trial, Richard Becker, MD, chief of cardiology at the University of Cincinnati College of Medicine, agreed, telling MedPage Today that “the medical community … has appreciated the role of falls in patients who are anticoagulated. We may have overestimated the risk, and therefore have not offered anticoagulation for patients who may have benefited from its use in terms of reducing the risk of strokes, in particular.”

“If a physician believes that a patient can be safely treated with anticoagulation, then apixaban would be a better choice than warfarin under those circumstances,” said Becker, who was not involved in the study.

Granger disclosed relevant relationships with Pfizer, BMS, Boehringer Ingelheim, Bayer, Janssen, and Daiichi Sankyo.

Becker disclosed no relevant relationships with industry.


  • Reviewed by
    Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco
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