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Study provides new insight into HSC dormancy
Preclinical research has revealed new insights regarding hematopoietic stem cells’ (HSCs) transition from a dormant state to an active one.
Investigators said they found the transition to be “a continuous developmental path” that is different for each individual cell, rather than a stepwise progression, as researchers previously believed.
The team also found the transition was characterized by low levels of Myc and high expression of retinoic acid.
In fact, the group’s experiments suggested that a diet lacking vitamin A can have a detrimental effect on HSCs.
Nina Cabezas-Wallscheid, PhD, of the German Cancer Research Center (DKFZ) in Heidelberg, Germany, and her colleagues conducted this research and reported their findings in Cell.
The investigators used single-cell RNA sequencing to show that HSCs’ transition from dormant to active cells is “a continuous stream-like progression of steadily increasing metabolic activity and preparation for cell-cycle entry without the apparent presence of accumulating cellular intermediates.”
The team said they observed robust downregulation of biosynthetic processes in dormant HSCs (compared to active HSCs) that was associated with the downregulation of Myc target genes.
The investigators also found that retinoic acid-induced signaling was “highly enriched” in dormant HSCs, and all-trans retinoic acid (ATRA) treatment maintained dormant HSCs in vitro.
In mice, ATRA protected dormant HSCs from activation.
The investigators exposed mice to a few different HSC activation conditions, including bacterial liposaccharide, the double-stranded RNA analog polyI:polyC, and the chemotherapeutic agent 5-fluorouracil. But pre-treatment with ATRA allowed HSCs to maintain a quiescent state in all 3 cases.
Finally, the investigators evaluated the effects of a vitamin A-free diet on HSCs. Adult mice fed a vitamin A-free diet for 14 to 17 weeks lost HSCs, particularly dormant HSCs. And without vitamin A, active HSCs were unable to return to a dormant state.
“Thus, we can prove, for the first time, that vitamin A has a direct impact on blood stem cells,” Dr Cabezas-Wallscheid said. “This shows how vitally important it is to have a sufficient intake of vitamin A from a balanced diet.”
The investigators also believe these findings could be applied in cancer research, as there is evidence to suggest that cancer cells rest in a state of dormancy, which makes them resistant to chemotherapy.
“Once we understand in detail how vitamin A or retinoic acid, respectively, sends normal and malignant stem cells into dormancy, we can try to turn the tables,” said study author Andreas Trumpp, PhD, also of DKFZ.
“If we could make cancer cells temporarily enter an active state, we could thus make them vulnerable to modern therapies.” 
Preclinical research has revealed new insights regarding hematopoietic stem cells’ (HSCs) transition from a dormant state to an active one.
Investigators said they found the transition to be “a continuous developmental path” that is different for each individual cell, rather than a stepwise progression, as researchers previously believed.
The team also found the transition was characterized by low levels of Myc and high expression of retinoic acid.
In fact, the group’s experiments suggested that a diet lacking vitamin A can have a detrimental effect on HSCs.
Nina Cabezas-Wallscheid, PhD, of the German Cancer Research Center (DKFZ) in Heidelberg, Germany, and her colleagues conducted this research and reported their findings in Cell.
The investigators used single-cell RNA sequencing to show that HSCs’ transition from dormant to active cells is “a continuous stream-like progression of steadily increasing metabolic activity and preparation for cell-cycle entry without the apparent presence of accumulating cellular intermediates.”
The team said they observed robust downregulation of biosynthetic processes in dormant HSCs (compared to active HSCs) that was associated with the downregulation of Myc target genes.
The investigators also found that retinoic acid-induced signaling was “highly enriched” in dormant HSCs, and all-trans retinoic acid (ATRA) treatment maintained dormant HSCs in vitro.
In mice, ATRA protected dormant HSCs from activation.
The investigators exposed mice to a few different HSC activation conditions, including bacterial liposaccharide, the double-stranded RNA analog polyI:polyC, and the chemotherapeutic agent 5-fluorouracil. But pre-treatment with ATRA allowed HSCs to maintain a quiescent state in all 3 cases.
Finally, the investigators evaluated the effects of a vitamin A-free diet on HSCs. Adult mice fed a vitamin A-free diet for 14 to 17 weeks lost HSCs, particularly dormant HSCs. And without vitamin A, active HSCs were unable to return to a dormant state.
“Thus, we can prove, for the first time, that vitamin A has a direct impact on blood stem cells,” Dr Cabezas-Wallscheid said. “This shows how vitally important it is to have a sufficient intake of vitamin A from a balanced diet.”
The investigators also believe these findings could be applied in cancer research, as there is evidence to suggest that cancer cells rest in a state of dormancy, which makes them resistant to chemotherapy.
“Once we understand in detail how vitamin A or retinoic acid, respectively, sends normal and malignant stem cells into dormancy, we can try to turn the tables,” said study author Andreas Trumpp, PhD, also of DKFZ.
“If we could make cancer cells temporarily enter an active state, we could thus make them vulnerable to modern therapies.”
Preclinical research has revealed new insights regarding hematopoietic stem cells’ (HSCs) transition from a dormant state to an active one.
Investigators said they found the transition to be “a continuous developmental path” that is different for each individual cell, rather than a stepwise progression, as researchers previously believed.
The team also found the transition was characterized by low levels of Myc and high expression of retinoic acid.
In fact, the group’s experiments suggested that a diet lacking vitamin A can have a detrimental effect on HSCs.
Nina Cabezas-Wallscheid, PhD, of the German Cancer Research Center (DKFZ) in Heidelberg, Germany, and her colleagues conducted this research and reported their findings in Cell.
The investigators used single-cell RNA sequencing to show that HSCs’ transition from dormant to active cells is “a continuous stream-like progression of steadily increasing metabolic activity and preparation for cell-cycle entry without the apparent presence of accumulating cellular intermediates.”
The team said they observed robust downregulation of biosynthetic processes in dormant HSCs (compared to active HSCs) that was associated with the downregulation of Myc target genes.
The investigators also found that retinoic acid-induced signaling was “highly enriched” in dormant HSCs, and all-trans retinoic acid (ATRA) treatment maintained dormant HSCs in vitro.
In mice, ATRA protected dormant HSCs from activation.
The investigators exposed mice to a few different HSC activation conditions, including bacterial liposaccharide, the double-stranded RNA analog polyI:polyC, and the chemotherapeutic agent 5-fluorouracil. But pre-treatment with ATRA allowed HSCs to maintain a quiescent state in all 3 cases.
Finally, the investigators evaluated the effects of a vitamin A-free diet on HSCs. Adult mice fed a vitamin A-free diet for 14 to 17 weeks lost HSCs, particularly dormant HSCs. And without vitamin A, active HSCs were unable to return to a dormant state.
“Thus, we can prove, for the first time, that vitamin A has a direct impact on blood stem cells,” Dr Cabezas-Wallscheid said. “This shows how vitally important it is to have a sufficient intake of vitamin A from a balanced diet.”
The investigators also believe these findings could be applied in cancer research, as there is evidence to suggest that cancer cells rest in a state of dormancy, which makes them resistant to chemotherapy.
“Once we understand in detail how vitamin A or retinoic acid, respectively, sends normal and malignant stem cells into dormancy, we can try to turn the tables,” said study author Andreas Trumpp, PhD, also of DKFZ.
“If we could make cancer cells temporarily enter an active state, we could thus make them vulnerable to modern therapies.”
Tablet-based medical training program improves exam results
Tablet-based, multimedia-enhanced medical training improves examination results among medical students and residents, according to research published in PLOS ONE.
“Ideally, medical training should be taking place at the patient’s bedside rather than in lecture halls,” said study author Daniel C. Baumgart, MD, PhD, of Charité Medical School at Humboldt-University of Berlin in Germany.
“Communication devices, such as tablet computers, digital assistants, and smartphones, make medical data and learning materials available anywhere and anytime. Therefore, our aim was to study the impact of a systematic integration of such devices into medical teaching and training.”
The researchers studied 55 final-year medical students and medical residents doing an inpatient service rotation. The subjects were assigned to receive a tablet personal computer (PC) with a custom multimedia education software package (n=24) or to a control group (n=31).
The multimedia package tested included the Mobile Medical Educator software package (developed in-house) as well as other multimedia learning materials, such as eBooks, eJournals, slide kits, podcasts, videos, animations, image data, and the American College of Physicians’ validated self-assessment software.
The participants had to complete MKSAP® (medical knowledge self-assessment program) exams at the beginning and the end of their training rotations. The final MKSAP score was the study’s primary endpoint.
The mean MKSAP score improved in the tablet PC group but not the control group. The final mean score was significantly higher in the tablet PC group than the control group—59 and 48, respectively (P<0.001).
When the researchers adjusted their analysis for subjects’ baseline score and potential confounders, the tablet PC group had, on average, 11% better MKSAP test results than the control group (P<0.001).
“We were able to show improvements in internal medicine exam results, which were independent of socio-demographic factors,” Dr Baumgart said. “Participant feedback was particularly positive in relation to an integrated, fully digitized workflow for clinical practice and training.”
Tablet-based, multimedia-enhanced medical training improves examination results among medical students and residents, according to research published in PLOS ONE.
“Ideally, medical training should be taking place at the patient’s bedside rather than in lecture halls,” said study author Daniel C. Baumgart, MD, PhD, of Charité Medical School at Humboldt-University of Berlin in Germany.
“Communication devices, such as tablet computers, digital assistants, and smartphones, make medical data and learning materials available anywhere and anytime. Therefore, our aim was to study the impact of a systematic integration of such devices into medical teaching and training.”
The researchers studied 55 final-year medical students and medical residents doing an inpatient service rotation. The subjects were assigned to receive a tablet personal computer (PC) with a custom multimedia education software package (n=24) or to a control group (n=31).
The multimedia package tested included the Mobile Medical Educator software package (developed in-house) as well as other multimedia learning materials, such as eBooks, eJournals, slide kits, podcasts, videos, animations, image data, and the American College of Physicians’ validated self-assessment software.
The participants had to complete MKSAP® (medical knowledge self-assessment program) exams at the beginning and the end of their training rotations. The final MKSAP score was the study’s primary endpoint.
The mean MKSAP score improved in the tablet PC group but not the control group. The final mean score was significantly higher in the tablet PC group than the control group—59 and 48, respectively (P<0.001).
When the researchers adjusted their analysis for subjects’ baseline score and potential confounders, the tablet PC group had, on average, 11% better MKSAP test results than the control group (P<0.001).
“We were able to show improvements in internal medicine exam results, which were independent of socio-demographic factors,” Dr Baumgart said. “Participant feedback was particularly positive in relation to an integrated, fully digitized workflow for clinical practice and training.”
Tablet-based, multimedia-enhanced medical training improves examination results among medical students and residents, according to research published in PLOS ONE.
“Ideally, medical training should be taking place at the patient’s bedside rather than in lecture halls,” said study author Daniel C. Baumgart, MD, PhD, of Charité Medical School at Humboldt-University of Berlin in Germany.
“Communication devices, such as tablet computers, digital assistants, and smartphones, make medical data and learning materials available anywhere and anytime. Therefore, our aim was to study the impact of a systematic integration of such devices into medical teaching and training.”
The researchers studied 55 final-year medical students and medical residents doing an inpatient service rotation. The subjects were assigned to receive a tablet personal computer (PC) with a custom multimedia education software package (n=24) or to a control group (n=31).
The multimedia package tested included the Mobile Medical Educator software package (developed in-house) as well as other multimedia learning materials, such as eBooks, eJournals, slide kits, podcasts, videos, animations, image data, and the American College of Physicians’ validated self-assessment software.
The participants had to complete MKSAP® (medical knowledge self-assessment program) exams at the beginning and the end of their training rotations. The final MKSAP score was the study’s primary endpoint.
The mean MKSAP score improved in the tablet PC group but not the control group. The final mean score was significantly higher in the tablet PC group than the control group—59 and 48, respectively (P<0.001).
When the researchers adjusted their analysis for subjects’ baseline score and potential confounders, the tablet PC group had, on average, 11% better MKSAP test results than the control group (P<0.001).
“We were able to show improvements in internal medicine exam results, which were independent of socio-demographic factors,” Dr Baumgart said. “Participant feedback was particularly positive in relation to an integrated, fully digitized workflow for clinical practice and training.”
Restrictions on pharma reps change docs’ prescribing behavior
New research indicates that limiting how pharmaceutical sales representatives can market their products to physicians changes the physicians’ prescribing behaviors.
Researchers examined the effects of restrictions on pharmaceutical representatives’ visits to doctors’ offices at 19 academic medical centers in 5 US states.
The team found these restrictions were associated with “modest but significant” reductions in prescribing promoted drugs.
“Social science has long demonstrated that professionals, even well-meaning ones, are powerfully influenced by conflicts of interest,” said George Loewenstein, PhD, of Carnegie Mellon University in Pittsburgh, Pennsylvania.
“A large body of research also shows that simply disclosing conflicts of interests is insufficient to reduce their influence and may even exacerbate it. The results from this study underline the effectiveness of, and need for, centralized rules and regulations.”
Dr Loewenstein and his colleagues reported the results of this study in JAMA.
The researchers noted that pharmaceutical sales representatives’ visits to doctors, which are known as “detailing,” are the most common form of interaction between physicians and industry. However, little was known about how practice-level detailing restrictions affect physician prescribing.
To gain some insight, Dr Loewenstein and his colleagues looked at the prescribing behavior of doctors whose practices did and did not have restrictions on detailing.
The team assessed the prescribing behavior of 2126 doctors at 19 academic medical centers in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) before and after the centers introduced policies restricting detailing.
The researchers compared the prescribing behavior of these doctors with the prescribing behavior of a control group of 24,593 physicians practicing in the same geographic regions who were not subject to detailing restrictions.
The data covered 262 drugs in 8 major drug classes—ranging from statins to antidepressants—representing more than $60 billion in aggregate sales in the US.
In all, there were 16,121,483 prescriptions written between January 2006 and June 2012 by both intervention and control physicians.
Overall results
The researchers found the enactment of detailing restrictions was associated with a significant decrease in the prescribing of detailed drugs (1.67 percentage points of market share) and a significant increase in the prescribing of nondetailed drugs (0.84 percentage points, P<0.001 for both).
The mean market share of detailed drugs was 19.3% prior to the enactment of restrictions, so the 1.67 percentage-point reduction represented an 8.7% relative decrease in market share.
The mean market share of nondetailed drugs was 14.2% prior to the enactment of restrictions, so the 0.84 percentage-point increase represented a 5.6% relative increase in market share.
“The study cannot definitively prove a causal link between policies that regulated detailing and changes in physician prescribing, but, absent a randomized control, this evidence is as definitive as possible,” said study author Ian Larkin, PhD, of the University of California, Los Angeles.
“We investigated 19 different policy implementations that happened over a 6-year period, included a control group of highly similar physicians not subject to detailing restrictions, and looked at effects in 8 large drug classes. The results were remarkably robust. After the introduction of policies, about 5% to 10% of physician prescribing behavior changed.”
Results by drug class, medical center
The researchers said detailing restrictions were associated with significant changes in market share for 6 of the 8 drug classes studied (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressants).
Looking at the medical centers individually, the researchers found that detailing restrictions were associated with significant changes in market share for detailed drugs at 9 centers and for nondetailed drugs at 8 centers.
The team noted that detailing restrictions differed among the centers.
Eleven of the centers regulated gifts to physicians, restricted sales representatives’ access to facilities, and had explicit enforcement policies. For 8 of these 11 centers, there was a significant change in prescribing practices.
The remaining 8 centers had less stringent restrictions in that they did not cover all 3 areas of restriction (regulating gifts, restricting access, and having enforcement policies). There was a significant change in prescribing practices for only 1 of these centers.
“No medical center completely barred salesperson visits,” Dr Larkin noted. “Salespeople could and did continue to visit physicians at all medical centers in the study. The most common restriction put in place was a ban on meals and other small gifts.”
“The fact that regulating gifts while still allowing sales calls still led to a switch to cheaper, generic drugs may suggest that gifts such as meals play an important role in influencing physicians. The correlation between meals and prescribing has been well established in the literature, but our study suggests this relationship may be causal in nature.”
New research indicates that limiting how pharmaceutical sales representatives can market their products to physicians changes the physicians’ prescribing behaviors.
Researchers examined the effects of restrictions on pharmaceutical representatives’ visits to doctors’ offices at 19 academic medical centers in 5 US states.
The team found these restrictions were associated with “modest but significant” reductions in prescribing promoted drugs.
“Social science has long demonstrated that professionals, even well-meaning ones, are powerfully influenced by conflicts of interest,” said George Loewenstein, PhD, of Carnegie Mellon University in Pittsburgh, Pennsylvania.
“A large body of research also shows that simply disclosing conflicts of interests is insufficient to reduce their influence and may even exacerbate it. The results from this study underline the effectiveness of, and need for, centralized rules and regulations.”
Dr Loewenstein and his colleagues reported the results of this study in JAMA.
The researchers noted that pharmaceutical sales representatives’ visits to doctors, which are known as “detailing,” are the most common form of interaction between physicians and industry. However, little was known about how practice-level detailing restrictions affect physician prescribing.
To gain some insight, Dr Loewenstein and his colleagues looked at the prescribing behavior of doctors whose practices did and did not have restrictions on detailing.
The team assessed the prescribing behavior of 2126 doctors at 19 academic medical centers in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) before and after the centers introduced policies restricting detailing.
The researchers compared the prescribing behavior of these doctors with the prescribing behavior of a control group of 24,593 physicians practicing in the same geographic regions who were not subject to detailing restrictions.
The data covered 262 drugs in 8 major drug classes—ranging from statins to antidepressants—representing more than $60 billion in aggregate sales in the US.
In all, there were 16,121,483 prescriptions written between January 2006 and June 2012 by both intervention and control physicians.
Overall results
The researchers found the enactment of detailing restrictions was associated with a significant decrease in the prescribing of detailed drugs (1.67 percentage points of market share) and a significant increase in the prescribing of nondetailed drugs (0.84 percentage points, P<0.001 for both).
The mean market share of detailed drugs was 19.3% prior to the enactment of restrictions, so the 1.67 percentage-point reduction represented an 8.7% relative decrease in market share.
The mean market share of nondetailed drugs was 14.2% prior to the enactment of restrictions, so the 0.84 percentage-point increase represented a 5.6% relative increase in market share.
“The study cannot definitively prove a causal link between policies that regulated detailing and changes in physician prescribing, but, absent a randomized control, this evidence is as definitive as possible,” said study author Ian Larkin, PhD, of the University of California, Los Angeles.
“We investigated 19 different policy implementations that happened over a 6-year period, included a control group of highly similar physicians not subject to detailing restrictions, and looked at effects in 8 large drug classes. The results were remarkably robust. After the introduction of policies, about 5% to 10% of physician prescribing behavior changed.”
Results by drug class, medical center
The researchers said detailing restrictions were associated with significant changes in market share for 6 of the 8 drug classes studied (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressants).
Looking at the medical centers individually, the researchers found that detailing restrictions were associated with significant changes in market share for detailed drugs at 9 centers and for nondetailed drugs at 8 centers.
The team noted that detailing restrictions differed among the centers.
Eleven of the centers regulated gifts to physicians, restricted sales representatives’ access to facilities, and had explicit enforcement policies. For 8 of these 11 centers, there was a significant change in prescribing practices.
The remaining 8 centers had less stringent restrictions in that they did not cover all 3 areas of restriction (regulating gifts, restricting access, and having enforcement policies). There was a significant change in prescribing practices for only 1 of these centers.
“No medical center completely barred salesperson visits,” Dr Larkin noted. “Salespeople could and did continue to visit physicians at all medical centers in the study. The most common restriction put in place was a ban on meals and other small gifts.”
“The fact that regulating gifts while still allowing sales calls still led to a switch to cheaper, generic drugs may suggest that gifts such as meals play an important role in influencing physicians. The correlation between meals and prescribing has been well established in the literature, but our study suggests this relationship may be causal in nature.”
New research indicates that limiting how pharmaceutical sales representatives can market their products to physicians changes the physicians’ prescribing behaviors.
Researchers examined the effects of restrictions on pharmaceutical representatives’ visits to doctors’ offices at 19 academic medical centers in 5 US states.
The team found these restrictions were associated with “modest but significant” reductions in prescribing promoted drugs.
“Social science has long demonstrated that professionals, even well-meaning ones, are powerfully influenced by conflicts of interest,” said George Loewenstein, PhD, of Carnegie Mellon University in Pittsburgh, Pennsylvania.
“A large body of research also shows that simply disclosing conflicts of interests is insufficient to reduce their influence and may even exacerbate it. The results from this study underline the effectiveness of, and need for, centralized rules and regulations.”
Dr Loewenstein and his colleagues reported the results of this study in JAMA.
The researchers noted that pharmaceutical sales representatives’ visits to doctors, which are known as “detailing,” are the most common form of interaction between physicians and industry. However, little was known about how practice-level detailing restrictions affect physician prescribing.
To gain some insight, Dr Loewenstein and his colleagues looked at the prescribing behavior of doctors whose practices did and did not have restrictions on detailing.
The team assessed the prescribing behavior of 2126 doctors at 19 academic medical centers in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) before and after the centers introduced policies restricting detailing.
The researchers compared the prescribing behavior of these doctors with the prescribing behavior of a control group of 24,593 physicians practicing in the same geographic regions who were not subject to detailing restrictions.
The data covered 262 drugs in 8 major drug classes—ranging from statins to antidepressants—representing more than $60 billion in aggregate sales in the US.
In all, there were 16,121,483 prescriptions written between January 2006 and June 2012 by both intervention and control physicians.
Overall results
The researchers found the enactment of detailing restrictions was associated with a significant decrease in the prescribing of detailed drugs (1.67 percentage points of market share) and a significant increase in the prescribing of nondetailed drugs (0.84 percentage points, P<0.001 for both).
The mean market share of detailed drugs was 19.3% prior to the enactment of restrictions, so the 1.67 percentage-point reduction represented an 8.7% relative decrease in market share.
The mean market share of nondetailed drugs was 14.2% prior to the enactment of restrictions, so the 0.84 percentage-point increase represented a 5.6% relative increase in market share.
“The study cannot definitively prove a causal link between policies that regulated detailing and changes in physician prescribing, but, absent a randomized control, this evidence is as definitive as possible,” said study author Ian Larkin, PhD, of the University of California, Los Angeles.
“We investigated 19 different policy implementations that happened over a 6-year period, included a control group of highly similar physicians not subject to detailing restrictions, and looked at effects in 8 large drug classes. The results were remarkably robust. After the introduction of policies, about 5% to 10% of physician prescribing behavior changed.”
Results by drug class, medical center
The researchers said detailing restrictions were associated with significant changes in market share for 6 of the 8 drug classes studied (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressants).
Looking at the medical centers individually, the researchers found that detailing restrictions were associated with significant changes in market share for detailed drugs at 9 centers and for nondetailed drugs at 8 centers.
The team noted that detailing restrictions differed among the centers.
Eleven of the centers regulated gifts to physicians, restricted sales representatives’ access to facilities, and had explicit enforcement policies. For 8 of these 11 centers, there was a significant change in prescribing practices.
The remaining 8 centers had less stringent restrictions in that they did not cover all 3 areas of restriction (regulating gifts, restricting access, and having enforcement policies). There was a significant change in prescribing practices for only 1 of these centers.
“No medical center completely barred salesperson visits,” Dr Larkin noted. “Salespeople could and did continue to visit physicians at all medical centers in the study. The most common restriction put in place was a ban on meals and other small gifts.”
“The fact that regulating gifts while still allowing sales calls still led to a switch to cheaper, generic drugs may suggest that gifts such as meals play an important role in influencing physicians. The correlation between meals and prescribing has been well established in the literature, but our study suggests this relationship may be causal in nature.”
Lab mice may be ineffective models for immunology research
Laboratory mice may not be effective models for studying immune responses to disease, according to research published in Nature Communications.
Investigators found substantial differences between the immune systems of lab mice and mice taken from the wild.
In fact, the team identified a population of “highly activated” myeloid cells in wild mice that was not present in lab mice.
The results suggest the immune responses observed in lab mice are not necessarily the same as the responses that will occur in the real world, the investigators said.
They therefore advised exercising “considerable caution” in extrapolating results from lab mice to “free-living” animals and human populations.
Mark Viney, PhD, of the University of Bristol in the UK, and his colleagues conducted this research. They studied the immune systems of 460 wild mice taken from 12 sites in the UK and compared them with mice bred in captivity.
The team assessed 62 immunological measures in the mice and found significant differences between the lab mice and the wild mice for 57 of these measures.
The investigators also found that wild mice had “a substantial burden of infection.” They had all been infected with at least 1 pathogen (whereas all lab mice were infection-free).
The wild mice had high concentrations of serum proteins as well. For example, serum concentrations of IgG were 20-fold higher in the wild mice than in lab mice, and serum concentrations of IgE were 200-fold higher in wild mice.
The investigators also found differences in splenocytes between lab mice and wild mice. For instance, wild mice had fewer natural killer (NK) cells and dendritic cells, both in absolute numbers and in proportion to spleen size. (The wild mice had smaller spleens than lab mice, both in direct comparisons and in comparisons with body mass.)
In addition, the wild mice had “highly activated” NK cells. The investigators said this may be a necessary response to the high pathogen load of the wild environment.
The team also identified a novel cell population in the wild mice that was not present in the lab mice. The investigators dubbed the population “hypergranulocytic myeloid cells.” They said more research is needed to understand the role these cells play in immune defense and regulation.
Finally, the investigators found that, compared to lab mice, wild mice had reduced cytokine responses to pathogen-associated molecular patterns, including CpG, peptidoglycan, lipopolysaccharide, and mitogenic stimulation with anti-CD3 and anti-CD28 antibodies.
“It’s remarkable that, despite the enormous number of studies of laboratory mice, ours is the first in-depth study of wild mice immune systems*,” Dr Viney said. “What this shows is that wild mouse immune systems are working at ‘warp-speed’ compared with their lab cousins.”
“These results point to us having to be much more cautious in extrapolating from the lab to the wild, but laboratory mouse models will continue to be hugely important in biological and biomedical research.”
*In a study published in Nature in 2016, researchers compared the immune systems of lab mice and mice from pet stores.
Laboratory mice may not be effective models for studying immune responses to disease, according to research published in Nature Communications.
Investigators found substantial differences between the immune systems of lab mice and mice taken from the wild.
In fact, the team identified a population of “highly activated” myeloid cells in wild mice that was not present in lab mice.
The results suggest the immune responses observed in lab mice are not necessarily the same as the responses that will occur in the real world, the investigators said.
They therefore advised exercising “considerable caution” in extrapolating results from lab mice to “free-living” animals and human populations.
Mark Viney, PhD, of the University of Bristol in the UK, and his colleagues conducted this research. They studied the immune systems of 460 wild mice taken from 12 sites in the UK and compared them with mice bred in captivity.
The team assessed 62 immunological measures in the mice and found significant differences between the lab mice and the wild mice for 57 of these measures.
The investigators also found that wild mice had “a substantial burden of infection.” They had all been infected with at least 1 pathogen (whereas all lab mice were infection-free).
The wild mice had high concentrations of serum proteins as well. For example, serum concentrations of IgG were 20-fold higher in the wild mice than in lab mice, and serum concentrations of IgE were 200-fold higher in wild mice.
The investigators also found differences in splenocytes between lab mice and wild mice. For instance, wild mice had fewer natural killer (NK) cells and dendritic cells, both in absolute numbers and in proportion to spleen size. (The wild mice had smaller spleens than lab mice, both in direct comparisons and in comparisons with body mass.)
In addition, the wild mice had “highly activated” NK cells. The investigators said this may be a necessary response to the high pathogen load of the wild environment.
The team also identified a novel cell population in the wild mice that was not present in the lab mice. The investigators dubbed the population “hypergranulocytic myeloid cells.” They said more research is needed to understand the role these cells play in immune defense and regulation.
Finally, the investigators found that, compared to lab mice, wild mice had reduced cytokine responses to pathogen-associated molecular patterns, including CpG, peptidoglycan, lipopolysaccharide, and mitogenic stimulation with anti-CD3 and anti-CD28 antibodies.
“It’s remarkable that, despite the enormous number of studies of laboratory mice, ours is the first in-depth study of wild mice immune systems*,” Dr Viney said. “What this shows is that wild mouse immune systems are working at ‘warp-speed’ compared with their lab cousins.”
“These results point to us having to be much more cautious in extrapolating from the lab to the wild, but laboratory mouse models will continue to be hugely important in biological and biomedical research.”
*In a study published in Nature in 2016, researchers compared the immune systems of lab mice and mice from pet stores.
Laboratory mice may not be effective models for studying immune responses to disease, according to research published in Nature Communications.
Investigators found substantial differences between the immune systems of lab mice and mice taken from the wild.
In fact, the team identified a population of “highly activated” myeloid cells in wild mice that was not present in lab mice.
The results suggest the immune responses observed in lab mice are not necessarily the same as the responses that will occur in the real world, the investigators said.
They therefore advised exercising “considerable caution” in extrapolating results from lab mice to “free-living” animals and human populations.
Mark Viney, PhD, of the University of Bristol in the UK, and his colleagues conducted this research. They studied the immune systems of 460 wild mice taken from 12 sites in the UK and compared them with mice bred in captivity.
The team assessed 62 immunological measures in the mice and found significant differences between the lab mice and the wild mice for 57 of these measures.
The investigators also found that wild mice had “a substantial burden of infection.” They had all been infected with at least 1 pathogen (whereas all lab mice were infection-free).
The wild mice had high concentrations of serum proteins as well. For example, serum concentrations of IgG were 20-fold higher in the wild mice than in lab mice, and serum concentrations of IgE were 200-fold higher in wild mice.
The investigators also found differences in splenocytes between lab mice and wild mice. For instance, wild mice had fewer natural killer (NK) cells and dendritic cells, both in absolute numbers and in proportion to spleen size. (The wild mice had smaller spleens than lab mice, both in direct comparisons and in comparisons with body mass.)
In addition, the wild mice had “highly activated” NK cells. The investigators said this may be a necessary response to the high pathogen load of the wild environment.
The team also identified a novel cell population in the wild mice that was not present in the lab mice. The investigators dubbed the population “hypergranulocytic myeloid cells.” They said more research is needed to understand the role these cells play in immune defense and regulation.
Finally, the investigators found that, compared to lab mice, wild mice had reduced cytokine responses to pathogen-associated molecular patterns, including CpG, peptidoglycan, lipopolysaccharide, and mitogenic stimulation with anti-CD3 and anti-CD28 antibodies.
“It’s remarkable that, despite the enormous number of studies of laboratory mice, ours is the first in-depth study of wild mice immune systems*,” Dr Viney said. “What this shows is that wild mouse immune systems are working at ‘warp-speed’ compared with their lab cousins.”
“These results point to us having to be much more cautious in extrapolating from the lab to the wild, but laboratory mouse models will continue to be hugely important in biological and biomedical research.”
*In a study published in Nature in 2016, researchers compared the immune systems of lab mice and mice from pet stores.
Heavily promoted drugs provide less ‘health value,’ study suggests
Drugs that are promoted most heavily in the US are less likely than the top-selling drugs and the top-prescribed drugs to provide “health value,” according to researchers.
The top-promoted drugs were less likely than either or both of the other drug types to demonstrate safety and effectiveness, be affordable, represent a genuine advance in treating a disease, be included on the World Health Organization’s (WHO) list of essential medicines, or be recommended as a first-line treatment.
Among the top-promoted drugs were 4 anticoagulants—Eliquis (apixaban), Xarelto (rivaroxaban), Brilinta (ticagrelor), and Pradaxa (dabigatran).
Tyler Greenway and Joseph S. Ross, MD, both of Yale University School of Medicine in New Haven, Connecticut, conducted this research and reported their findings in The BMJ.
The researchers set out to assess the “health value” of the drugs most aggressively promoted to physicians to better understand the implications of pharmaceutical promotion for patient care.
The team identified the 25 medicinal products associated with the largest total payments to physicians and teaching hospitals from August 2013 to December 2014.
This included all direct and indirect payments, such as speaker fees for education lectures, consulting fees, and honoraria, as well as payments in kind, such as the value of food and gifts. However, research payments, royalties, and licensing fees were excluded, as these are typically not promotional.
The researchers also determined the 25 best-selling medicinal products by 2014 US sales and the 25 most-prescribed drugs in the US during 2013.
One of the 25 top-promoted products was excluded because it was used to test for adrenocortical function. And 1 of the 25 top-selling products was a pneumococcal vaccine, which was also excluded.
Four of the 24 top-promoted drugs (17%) were also among the top-selling drugs—adalimumab, glatiramer, aripiprazole, and budesonide-formoterol. But none of the top-promoted drugs were among the top-prescribed drugs.
Among the top-selling drugs were several used in the field of hematology—Rituxan (rituximab), Neulasta (pegfilgrastim), Neupogen (filgrastim), Revlimid (lenalidomide), and Gleevec (imatinib mesylate).
Results
The researchers estimated the drugs’ value to society using 5 proxy measures:
- Innovation—drugs that were first-in-class or provided a “meaningful advance” over existing treatments
- Effectiveness and safety—assessed using the ratings systems of the French drug industry watchdog Prescrire International
- Generic availability—a measure of affordability
- Clinical value—inclusion on the WHO list of essential medicines in 2015
- First-line status—being recommended as a first-line therapy.
The top-promoted drugs were significantly less likely to be considered innovative than the top-selling drugs (33% vs 72%, relative risk [RR]=0.46, P=0.01). However, the difference was not significant for the top-promoted and top-prescribed drugs (33% vs 52%, RR=0.64, P=0.25).
The top-promoted drugs were significantly less likely to be considered possibly helpful or advantageous according to Prescrire ratings than the top-prescribed drugs (19% vs 76%, RR=0.25, P<0.001). But the difference was not significant for the top-promoted and top-selling drugs (19% vs 44%, RR=0.43, P=0.11).
Generic equivalents were available for 62% of the top-promoted drugs, 32% of the top-selling drugs (RR=1.95, P=0.05), and 100% of the top-prescribed drugs (RR=0.63, P<0.001).
The top-promoted drugs were significantly less likely than either of the other drug types to be on the WHO essential medicines list. One of the top-promoted drugs was on the list, compared to 9 top-selling drugs (RR=0.12, P=0.01) and 14 top-prescribed drugs (RR=0.07, P<0.001).
The top-promoted drugs were significantly less likely to be recommended as first-line treatments than the top-prescribed drugs (33% vs 80%, RR=0.42, P=0.001). But the difference was not significant for the top-selling drugs (33% vs 60%, RR=0.56, P=0.09).
The researchers said these results raise concerns about the purpose of pharmaceutical promotion and its influence on patient care. They believe efforts are needed to better evaluate the value of drugs, ensuring this information is readily available at the point of care so it can inform clinical decision-making and promote the use of higher-value medicines.
The researchers also suggested that clinicians consider taking steps to limit their exposure to industry promotion and consider engaging with non-commercial educational outreach programs that provide evidence-based recommendations about medication choices.
Drugs that are promoted most heavily in the US are less likely than the top-selling drugs and the top-prescribed drugs to provide “health value,” according to researchers.
The top-promoted drugs were less likely than either or both of the other drug types to demonstrate safety and effectiveness, be affordable, represent a genuine advance in treating a disease, be included on the World Health Organization’s (WHO) list of essential medicines, or be recommended as a first-line treatment.
Among the top-promoted drugs were 4 anticoagulants—Eliquis (apixaban), Xarelto (rivaroxaban), Brilinta (ticagrelor), and Pradaxa (dabigatran).
Tyler Greenway and Joseph S. Ross, MD, both of Yale University School of Medicine in New Haven, Connecticut, conducted this research and reported their findings in The BMJ.
The researchers set out to assess the “health value” of the drugs most aggressively promoted to physicians to better understand the implications of pharmaceutical promotion for patient care.
The team identified the 25 medicinal products associated with the largest total payments to physicians and teaching hospitals from August 2013 to December 2014.
This included all direct and indirect payments, such as speaker fees for education lectures, consulting fees, and honoraria, as well as payments in kind, such as the value of food and gifts. However, research payments, royalties, and licensing fees were excluded, as these are typically not promotional.
The researchers also determined the 25 best-selling medicinal products by 2014 US sales and the 25 most-prescribed drugs in the US during 2013.
One of the 25 top-promoted products was excluded because it was used to test for adrenocortical function. And 1 of the 25 top-selling products was a pneumococcal vaccine, which was also excluded.
Four of the 24 top-promoted drugs (17%) were also among the top-selling drugs—adalimumab, glatiramer, aripiprazole, and budesonide-formoterol. But none of the top-promoted drugs were among the top-prescribed drugs.
Among the top-selling drugs were several used in the field of hematology—Rituxan (rituximab), Neulasta (pegfilgrastim), Neupogen (filgrastim), Revlimid (lenalidomide), and Gleevec (imatinib mesylate).
Results
The researchers estimated the drugs’ value to society using 5 proxy measures:
- Innovation—drugs that were first-in-class or provided a “meaningful advance” over existing treatments
- Effectiveness and safety—assessed using the ratings systems of the French drug industry watchdog Prescrire International
- Generic availability—a measure of affordability
- Clinical value—inclusion on the WHO list of essential medicines in 2015
- First-line status—being recommended as a first-line therapy.
The top-promoted drugs were significantly less likely to be considered innovative than the top-selling drugs (33% vs 72%, relative risk [RR]=0.46, P=0.01). However, the difference was not significant for the top-promoted and top-prescribed drugs (33% vs 52%, RR=0.64, P=0.25).
The top-promoted drugs were significantly less likely to be considered possibly helpful or advantageous according to Prescrire ratings than the top-prescribed drugs (19% vs 76%, RR=0.25, P<0.001). But the difference was not significant for the top-promoted and top-selling drugs (19% vs 44%, RR=0.43, P=0.11).
Generic equivalents were available for 62% of the top-promoted drugs, 32% of the top-selling drugs (RR=1.95, P=0.05), and 100% of the top-prescribed drugs (RR=0.63, P<0.001).
The top-promoted drugs were significantly less likely than either of the other drug types to be on the WHO essential medicines list. One of the top-promoted drugs was on the list, compared to 9 top-selling drugs (RR=0.12, P=0.01) and 14 top-prescribed drugs (RR=0.07, P<0.001).
The top-promoted drugs were significantly less likely to be recommended as first-line treatments than the top-prescribed drugs (33% vs 80%, RR=0.42, P=0.001). But the difference was not significant for the top-selling drugs (33% vs 60%, RR=0.56, P=0.09).
The researchers said these results raise concerns about the purpose of pharmaceutical promotion and its influence on patient care. They believe efforts are needed to better evaluate the value of drugs, ensuring this information is readily available at the point of care so it can inform clinical decision-making and promote the use of higher-value medicines.
The researchers also suggested that clinicians consider taking steps to limit their exposure to industry promotion and consider engaging with non-commercial educational outreach programs that provide evidence-based recommendations about medication choices.
Drugs that are promoted most heavily in the US are less likely than the top-selling drugs and the top-prescribed drugs to provide “health value,” according to researchers.
The top-promoted drugs were less likely than either or both of the other drug types to demonstrate safety and effectiveness, be affordable, represent a genuine advance in treating a disease, be included on the World Health Organization’s (WHO) list of essential medicines, or be recommended as a first-line treatment.
Among the top-promoted drugs were 4 anticoagulants—Eliquis (apixaban), Xarelto (rivaroxaban), Brilinta (ticagrelor), and Pradaxa (dabigatran).
Tyler Greenway and Joseph S. Ross, MD, both of Yale University School of Medicine in New Haven, Connecticut, conducted this research and reported their findings in The BMJ.
The researchers set out to assess the “health value” of the drugs most aggressively promoted to physicians to better understand the implications of pharmaceutical promotion for patient care.
The team identified the 25 medicinal products associated with the largest total payments to physicians and teaching hospitals from August 2013 to December 2014.
This included all direct and indirect payments, such as speaker fees for education lectures, consulting fees, and honoraria, as well as payments in kind, such as the value of food and gifts. However, research payments, royalties, and licensing fees were excluded, as these are typically not promotional.
The researchers also determined the 25 best-selling medicinal products by 2014 US sales and the 25 most-prescribed drugs in the US during 2013.
One of the 25 top-promoted products was excluded because it was used to test for adrenocortical function. And 1 of the 25 top-selling products was a pneumococcal vaccine, which was also excluded.
Four of the 24 top-promoted drugs (17%) were also among the top-selling drugs—adalimumab, glatiramer, aripiprazole, and budesonide-formoterol. But none of the top-promoted drugs were among the top-prescribed drugs.
Among the top-selling drugs were several used in the field of hematology—Rituxan (rituximab), Neulasta (pegfilgrastim), Neupogen (filgrastim), Revlimid (lenalidomide), and Gleevec (imatinib mesylate).
Results
The researchers estimated the drugs’ value to society using 5 proxy measures:
- Innovation—drugs that were first-in-class or provided a “meaningful advance” over existing treatments
- Effectiveness and safety—assessed using the ratings systems of the French drug industry watchdog Prescrire International
- Generic availability—a measure of affordability
- Clinical value—inclusion on the WHO list of essential medicines in 2015
- First-line status—being recommended as a first-line therapy.
The top-promoted drugs were significantly less likely to be considered innovative than the top-selling drugs (33% vs 72%, relative risk [RR]=0.46, P=0.01). However, the difference was not significant for the top-promoted and top-prescribed drugs (33% vs 52%, RR=0.64, P=0.25).
The top-promoted drugs were significantly less likely to be considered possibly helpful or advantageous according to Prescrire ratings than the top-prescribed drugs (19% vs 76%, RR=0.25, P<0.001). But the difference was not significant for the top-promoted and top-selling drugs (19% vs 44%, RR=0.43, P=0.11).
Generic equivalents were available for 62% of the top-promoted drugs, 32% of the top-selling drugs (RR=1.95, P=0.05), and 100% of the top-prescribed drugs (RR=0.63, P<0.001).
The top-promoted drugs were significantly less likely than either of the other drug types to be on the WHO essential medicines list. One of the top-promoted drugs was on the list, compared to 9 top-selling drugs (RR=0.12, P=0.01) and 14 top-prescribed drugs (RR=0.07, P<0.001).
The top-promoted drugs were significantly less likely to be recommended as first-line treatments than the top-prescribed drugs (33% vs 80%, RR=0.42, P=0.001). But the difference was not significant for the top-selling drugs (33% vs 60%, RR=0.56, P=0.09).
The researchers said these results raise concerns about the purpose of pharmaceutical promotion and its influence on patient care. They believe efforts are needed to better evaluate the value of drugs, ensuring this information is readily available at the point of care so it can inform clinical decision-making and promote the use of higher-value medicines.
The researchers also suggested that clinicians consider taking steps to limit their exposure to industry promotion and consider engaging with non-commercial educational outreach programs that provide evidence-based recommendations about medication choices.
Blood groups associated with risk of heart attack
PARIS—Having a blood type other than O is associated with a higher risk of heart attack, according to a meta-analysis.
“It has been suggested that people with non-O blood groups (A, B, AB) are at higher risk for heart attacks and overall cardiovascular mortality, but this suggestion comes from case-control studies, which have a low level of evidence,” said Tessa Kole, a student at the University Medical Centre Groningen in the Netherlands.
Therefore, Kole and her fellow investigators conducted a meta-analysis of prospective studies reporting on blood groups and incident cardiovascular events.
The team presented their findings at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure (abstract 697).
The study included 1,362,569 subjects from 11 prospective cohorts, described in 9 articles. There were a total of 23,154 cardiovascular events.
The investigators analyzed the association between blood group and all coronary events, combined cardiovascular events, and fatal coronary events.
The analysis of all coronary events included 771,113 subjects with a non-O blood group and 519,743 with an O blood group, of whom 11,437 (1.5%) and 7220 (1.4%), respectively, suffered a coronary event.
The odds ratio (OR) for all coronary events was significantly higher in subjects with a non-O blood group, at 1.09 (95% confidence interval [CI], 1.06-1.13, P<0.00001).
The analysis of combined cardiovascular events included 708,276 subjects with a non-O blood group and 476,868 with an O blood group, of whom 17,449 (2.5%) and 10,916 (2.3%), respectively, had an event.
The OR for combined cardiovascular events was significantly higher in subjects with non-O blood groups, at 1.09 (95% CI, 1.06-1.11, P=0.006).
The analysis of fatal coronary events did not show a significant difference between people with O and non-O blood groups. The OR was 1.00 (95% CI, 0.85-1.18, P=0.98).
“We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction,” Kole said.
“More research is needed to identify the cause of the apparent increased cardiovascular risk in people with a non-O blood group. Obtaining more information about risk in each non-O blood group (A, B, and AB) might provide further explanations of the causes.”
“In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure. It could be that people with an A blood group should have a lower treatment threshold for dyslipidemia or hypertension, for example. We need further studies to validate if the excess cardiovascular risk in non-O blood group carriers may be amenable to treatment.”
PARIS—Having a blood type other than O is associated with a higher risk of heart attack, according to a meta-analysis.
“It has been suggested that people with non-O blood groups (A, B, AB) are at higher risk for heart attacks and overall cardiovascular mortality, but this suggestion comes from case-control studies, which have a low level of evidence,” said Tessa Kole, a student at the University Medical Centre Groningen in the Netherlands.
Therefore, Kole and her fellow investigators conducted a meta-analysis of prospective studies reporting on blood groups and incident cardiovascular events.
The team presented their findings at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure (abstract 697).
The study included 1,362,569 subjects from 11 prospective cohorts, described in 9 articles. There were a total of 23,154 cardiovascular events.
The investigators analyzed the association between blood group and all coronary events, combined cardiovascular events, and fatal coronary events.
The analysis of all coronary events included 771,113 subjects with a non-O blood group and 519,743 with an O blood group, of whom 11,437 (1.5%) and 7220 (1.4%), respectively, suffered a coronary event.
The odds ratio (OR) for all coronary events was significantly higher in subjects with a non-O blood group, at 1.09 (95% confidence interval [CI], 1.06-1.13, P<0.00001).
The analysis of combined cardiovascular events included 708,276 subjects with a non-O blood group and 476,868 with an O blood group, of whom 17,449 (2.5%) and 10,916 (2.3%), respectively, had an event.
The OR for combined cardiovascular events was significantly higher in subjects with non-O blood groups, at 1.09 (95% CI, 1.06-1.11, P=0.006).
The analysis of fatal coronary events did not show a significant difference between people with O and non-O blood groups. The OR was 1.00 (95% CI, 0.85-1.18, P=0.98).
“We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction,” Kole said.
“More research is needed to identify the cause of the apparent increased cardiovascular risk in people with a non-O blood group. Obtaining more information about risk in each non-O blood group (A, B, and AB) might provide further explanations of the causes.”
“In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure. It could be that people with an A blood group should have a lower treatment threshold for dyslipidemia or hypertension, for example. We need further studies to validate if the excess cardiovascular risk in non-O blood group carriers may be amenable to treatment.”
PARIS—Having a blood type other than O is associated with a higher risk of heart attack, according to a meta-analysis.
“It has been suggested that people with non-O blood groups (A, B, AB) are at higher risk for heart attacks and overall cardiovascular mortality, but this suggestion comes from case-control studies, which have a low level of evidence,” said Tessa Kole, a student at the University Medical Centre Groningen in the Netherlands.
Therefore, Kole and her fellow investigators conducted a meta-analysis of prospective studies reporting on blood groups and incident cardiovascular events.
The team presented their findings at Heart Failure 2017 and the 4th World Congress on Acute Heart Failure (abstract 697).
The study included 1,362,569 subjects from 11 prospective cohorts, described in 9 articles. There were a total of 23,154 cardiovascular events.
The investigators analyzed the association between blood group and all coronary events, combined cardiovascular events, and fatal coronary events.
The analysis of all coronary events included 771,113 subjects with a non-O blood group and 519,743 with an O blood group, of whom 11,437 (1.5%) and 7220 (1.4%), respectively, suffered a coronary event.
The odds ratio (OR) for all coronary events was significantly higher in subjects with a non-O blood group, at 1.09 (95% confidence interval [CI], 1.06-1.13, P<0.00001).
The analysis of combined cardiovascular events included 708,276 subjects with a non-O blood group and 476,868 with an O blood group, of whom 17,449 (2.5%) and 10,916 (2.3%), respectively, had an event.
The OR for combined cardiovascular events was significantly higher in subjects with non-O blood groups, at 1.09 (95% CI, 1.06-1.11, P=0.006).
The analysis of fatal coronary events did not show a significant difference between people with O and non-O blood groups. The OR was 1.00 (95% CI, 0.85-1.18, P=0.98).
“We demonstrate that having a non-O blood group is associated with a 9% increased risk of coronary events and a 9% increased risk of cardiovascular events, especially myocardial infarction,” Kole said.
“More research is needed to identify the cause of the apparent increased cardiovascular risk in people with a non-O blood group. Obtaining more information about risk in each non-O blood group (A, B, and AB) might provide further explanations of the causes.”
“In future, blood group should be considered in risk assessment for cardiovascular prevention, together with cholesterol, age, sex, and systolic blood pressure. It could be that people with an A blood group should have a lower treatment threshold for dyslipidemia or hypertension, for example. We need further studies to validate if the excess cardiovascular risk in non-O blood group carriers may be amenable to treatment.”
Simplifying consent forms doesn’t affect patient comprehension
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
Simplifying consent documents does not affect how well potential participants understand a clinical trial, according to new research.
The study showed no significant difference in comprehension between patients who read a concise consent document and those who read a longer document written at a more advanced reading level.
However, researchers did find that mailing consent forms to patients in advance and explaining the study to patients in person did improve their comprehension.
Christine Grady, PhD, of the NIH Clinical Center in Bethesda, Maryland, and her colleagues reported these findings in PLOS ONE.
The team noted that informed consent is a central tenet of ethical clinical research. However, over time, the documents used to obtain informed consent have grown longer, more complex, and harder to read.
So the researchers developed a concise alternative to consent documents used in the multinational START trial.
The new document was shorter than the old document by almost 70%, at 1821 words. The new document also contained bullet points and tables and had a simpler reading level.
Dr Grady and her colleagues tested the old and new documents with 4229 HIV-positive patients treated at 77 sites seeking enrollment in the START trial between 2009 and 2013.
The sites were randomly allocated to either the concise or the standard consent documents for participants to review.
There was no significant difference in comprehension scores between patients who received the concise form and those who received the standard form (P>0.1). Likewise, there was no significant difference in patient satisfaction or willingness to volunteer (P>0.1).
However, patients who received the concise form were significantly less likely to say the form was too long or too detailed (P<0.001).
The researchers did find several factors that were associated with significantly better comprehension.
Patients had significantly (P<0.05) better comprehension scores if they had a higher education level, were white, were treated at sites with more previous HIV studies, and were treated at sites where staff explained the study and thought patients understood the study very well.
Patients had significantly lower comprehension scores if they were treated at sites that rarely or never mailed the consent form ahead of the clinic visit (P=0.009).
England did not benefit from CDF, analysis suggests
The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.
The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.
The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.
The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.
In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.
The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.
In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.
“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.
“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”
The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.
However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.
The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.
The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.
“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.
“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”
The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.
The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.
The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.
The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.
In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.
The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.
In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.
“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.
“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”
The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.
However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.
The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.
The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.
“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.
“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”
The National Health Service’s (NHS) Cancer Drugs Fund (CDF) has not benefitted the people of England and may have been detrimental for English cancer patients, according to researchers.
The group analyzed 29 drugs that were approved for use through the CDF and found the fund did not “deliver meaningful value for patients or society” and may have resulted in patients suffering unnecessarily from adverse effects.
The CDF is money the English government sets aside to pay for cancer drugs that haven’t been approved by the National Institute for Health and Care Excellence (NICE), the health technology assessment body in the UK, and aren’t available within the NHS, the publicly funded national healthcare system for England.
The original CDF was closed in March 2016, but a new CDF was opened at the end of July 2016.
In a study published in Annals of Oncology, researchers looked at 29 drugs that had been approved for use through the CDF for 47 specific indications and were available in January 2015.
The team said only 18 of the indications (38%) were based on clinical trials that reported a statistically significant benefit in terms of patients’ overall survival. The median overall survival benefit was 3.2 months, ranging from 1.4 months to 15.7 months.
The researchers also considered other factors, such as quality of life and adverse effects, to measure the drugs’ value to patients. And the team found that most of the drugs failed to show any evidence of meaningful clinical benefit.
In fact, the researchers said the benefit to patients in real-world situations was probably less than the benefit observed in the clinical trials, since trial participants are carefully selected, have fewer comorbidities, and tend to be younger than patients not included in trials.
“From 2010 when it started to 2016 when it closed, the Cancer Drugs Fund cost the UK taxpayer a total of £1.27 billion, the equivalent of 1 year’s total spending on all cancer drugs in the NHS,” said study author Ajay Aggarwal, of the London School of Hygiene & Tropical Medicine in England.
“The majority of cancer medicines funded through the CDF were found wanting with respect to what patients, clinicians, and NICE would count as clinically meaningful benefit. In addition, no data on the outcome of patients who used drugs accessed through the fund were collected.”
The researchers said basic information on patients who accessed the fund—including date of treatment cessation, side effects, deaths after 30 days of treatment, and date of death or relapse—was supposed to have been collected by April 2012.
However, even after it became mandatory to collect these data in 2014, 93% of outcome data were incomplete for 2014-2015.
“We also lost a major opportunity to understand how these medicines work in the real world,” said study author Richard Sullivan, MD, PhD, of King’s College London in England.
The original CDF was closed in March 2016 because it had become financially unsustainable, but a new CDF was opened at the end of July 2016.
The new CDF provides managed access to new cancer drugs for a limited period in circumstances where the clinical and cost-effectiveness of the drug is deemed uncertain by NICE. The new CDF works in close collaboration with NICE, to which all newly licensed drugs will be referred for appraisal first.
“This addresses some of the problems with the old CDF; namely, the fund would no longer support the provision of drugs that have been appraised but not recommended by NICE,” Dr Sullivan said.
“It still provides funding for new drugs awaiting NICE appraisal that have potential benefit. However, the issue here is one of fairness: why should cancer medicines be treated in this way and not all medicines and, indeed, all technologies?”
DLA tablets cure drug-resistant malaria
Researchers have reported that tablets made from dried leaves of the Artemisia annua plant were able to cure malaria in 18 critically ill patients in a clinic in Africa.
When standard malaria medications failed to help the patients, the attending physician at the clinic acted under the compassionate use doctrine and prescribed the unapproved therapy, known as dried-leaf Artemisia (DLA).
Within 5 days, all 18 patients had fully recovered, with lab tests showing no parasites in their blood.
Details on this small trial were published in Phytomedicine.
The trial included 18 patients in the North Kivu province of the Democratic Republic of Congo who showed symptoms of malaria and were originally treated with artemisinin-based combination therapy (ACT).
The patients, who ranged in age from 14 months to 60 years, did not respond to ACT and lapsed into severe malaria.
Seven of the patients had anemia, 6 had convulsions, and 4 had vomiting and diarrhea. One patient, a 5-year-old child, became comatose.
All of the patients were then treated with intravenous artesunate, but they showed no improvement.
As a last resort, doctors turned to DLA. After 5 days of treatment with DLA tablets, all 18 patients fully recovered. Tests showed they had no parasites remaining in their blood.
The researchers said the DLA tablets were well-tolerated, as there were no side effects observed.
“These 18 patients were dying,” said study author Pamela Weathers, PhD, of Worcester Polytechnic Institute in Massachusetts.
“So to see 100% recover, even the child who had lapsed into a coma, was just amazing. It’s a small study, but the results are powerful.”
Dr Weathers noted that more than 100 other drug-resistant patients have been successfully treated with DLA tablets.
She said the superior performance of DLA in comparison to ACT, as well as DLA’s ability to kill drug-resistant parasites and avoid the resistance trap itself, is likely due to the synergistic effects of a complex array of phytochemicals contained in the plant’s leaves.
Several of these phytochemicals are known to have antimalarial properties, and others may act both to enhance the absorption of artemisinin into the bloodstream and bolster its effectiveness against malaria.
In effect, the dried leaves constitute a robust natural combination therapy, one whose benefits surpass those of ACT and other combination drugs.
“We have done a lot of work to understand the biochemistry of these compounds, which include a number of flavonoids and terpenes, so we can better understand the role they play in the pharmacological activity of the dried leaves,” Dr Weathers said.
“The more we learn, the more excited we become about the potential for DLA to be the medication of choice for combating malaria worldwide. Artemisia annua is known to be efficacious against a range of other diseases, including other tropical maladies and certain cancers. So, in our lab, we are already at work investigating the effectiveness of DLA with other diseases.”
Another advantage of DLA over conventional malaria treatments is its low cost and the relative simplicity of its manufacture, Dr Weathers said. When compared to ACT, producing DLA tablets can be accomplished with simpler equipment and a modest amount of training.
Growing Artemisia annua and producing and testing the tablets, Dr Weathers noted, are ideal local business ventures that can provide jobs in impoverished areas and greatly expand access to antimalarial therapy.
In fact, she has already established a supply chain in Africa that includes growing and harvesting high-producing cultivars in East Africa, along with Good Manufacturing Practice processing operations in Uganda where the leaves are dried, pulverized, and homogenized; the powder is compacted into tablets; and the tablets are tested to verify their dosage.
This supply chain helped produce the tablets used to treat the 18 patients in the Democratic Republic of Congo.
Researchers have reported that tablets made from dried leaves of the Artemisia annua plant were able to cure malaria in 18 critically ill patients in a clinic in Africa.
When standard malaria medications failed to help the patients, the attending physician at the clinic acted under the compassionate use doctrine and prescribed the unapproved therapy, known as dried-leaf Artemisia (DLA).
Within 5 days, all 18 patients had fully recovered, with lab tests showing no parasites in their blood.
Details on this small trial were published in Phytomedicine.
The trial included 18 patients in the North Kivu province of the Democratic Republic of Congo who showed symptoms of malaria and were originally treated with artemisinin-based combination therapy (ACT).
The patients, who ranged in age from 14 months to 60 years, did not respond to ACT and lapsed into severe malaria.
Seven of the patients had anemia, 6 had convulsions, and 4 had vomiting and diarrhea. One patient, a 5-year-old child, became comatose.
All of the patients were then treated with intravenous artesunate, but they showed no improvement.
As a last resort, doctors turned to DLA. After 5 days of treatment with DLA tablets, all 18 patients fully recovered. Tests showed they had no parasites remaining in their blood.
The researchers said the DLA tablets were well-tolerated, as there were no side effects observed.
“These 18 patients were dying,” said study author Pamela Weathers, PhD, of Worcester Polytechnic Institute in Massachusetts.
“So to see 100% recover, even the child who had lapsed into a coma, was just amazing. It’s a small study, but the results are powerful.”
Dr Weathers noted that more than 100 other drug-resistant patients have been successfully treated with DLA tablets.
She said the superior performance of DLA in comparison to ACT, as well as DLA’s ability to kill drug-resistant parasites and avoid the resistance trap itself, is likely due to the synergistic effects of a complex array of phytochemicals contained in the plant’s leaves.
Several of these phytochemicals are known to have antimalarial properties, and others may act both to enhance the absorption of artemisinin into the bloodstream and bolster its effectiveness against malaria.
In effect, the dried leaves constitute a robust natural combination therapy, one whose benefits surpass those of ACT and other combination drugs.
“We have done a lot of work to understand the biochemistry of these compounds, which include a number of flavonoids and terpenes, so we can better understand the role they play in the pharmacological activity of the dried leaves,” Dr Weathers said.
“The more we learn, the more excited we become about the potential for DLA to be the medication of choice for combating malaria worldwide. Artemisia annua is known to be efficacious against a range of other diseases, including other tropical maladies and certain cancers. So, in our lab, we are already at work investigating the effectiveness of DLA with other diseases.”
Another advantage of DLA over conventional malaria treatments is its low cost and the relative simplicity of its manufacture, Dr Weathers said. When compared to ACT, producing DLA tablets can be accomplished with simpler equipment and a modest amount of training.
Growing Artemisia annua and producing and testing the tablets, Dr Weathers noted, are ideal local business ventures that can provide jobs in impoverished areas and greatly expand access to antimalarial therapy.
In fact, she has already established a supply chain in Africa that includes growing and harvesting high-producing cultivars in East Africa, along with Good Manufacturing Practice processing operations in Uganda where the leaves are dried, pulverized, and homogenized; the powder is compacted into tablets; and the tablets are tested to verify their dosage.
This supply chain helped produce the tablets used to treat the 18 patients in the Democratic Republic of Congo.
Researchers have reported that tablets made from dried leaves of the Artemisia annua plant were able to cure malaria in 18 critically ill patients in a clinic in Africa.
When standard malaria medications failed to help the patients, the attending physician at the clinic acted under the compassionate use doctrine and prescribed the unapproved therapy, known as dried-leaf Artemisia (DLA).
Within 5 days, all 18 patients had fully recovered, with lab tests showing no parasites in their blood.
Details on this small trial were published in Phytomedicine.
The trial included 18 patients in the North Kivu province of the Democratic Republic of Congo who showed symptoms of malaria and were originally treated with artemisinin-based combination therapy (ACT).
The patients, who ranged in age from 14 months to 60 years, did not respond to ACT and lapsed into severe malaria.
Seven of the patients had anemia, 6 had convulsions, and 4 had vomiting and diarrhea. One patient, a 5-year-old child, became comatose.
All of the patients were then treated with intravenous artesunate, but they showed no improvement.
As a last resort, doctors turned to DLA. After 5 days of treatment with DLA tablets, all 18 patients fully recovered. Tests showed they had no parasites remaining in their blood.
The researchers said the DLA tablets were well-tolerated, as there were no side effects observed.
“These 18 patients were dying,” said study author Pamela Weathers, PhD, of Worcester Polytechnic Institute in Massachusetts.
“So to see 100% recover, even the child who had lapsed into a coma, was just amazing. It’s a small study, but the results are powerful.”
Dr Weathers noted that more than 100 other drug-resistant patients have been successfully treated with DLA tablets.
She said the superior performance of DLA in comparison to ACT, as well as DLA’s ability to kill drug-resistant parasites and avoid the resistance trap itself, is likely due to the synergistic effects of a complex array of phytochemicals contained in the plant’s leaves.
Several of these phytochemicals are known to have antimalarial properties, and others may act both to enhance the absorption of artemisinin into the bloodstream and bolster its effectiveness against malaria.
In effect, the dried leaves constitute a robust natural combination therapy, one whose benefits surpass those of ACT and other combination drugs.
“We have done a lot of work to understand the biochemistry of these compounds, which include a number of flavonoids and terpenes, so we can better understand the role they play in the pharmacological activity of the dried leaves,” Dr Weathers said.
“The more we learn, the more excited we become about the potential for DLA to be the medication of choice for combating malaria worldwide. Artemisia annua is known to be efficacious against a range of other diseases, including other tropical maladies and certain cancers. So, in our lab, we are already at work investigating the effectiveness of DLA with other diseases.”
Another advantage of DLA over conventional malaria treatments is its low cost and the relative simplicity of its manufacture, Dr Weathers said. When compared to ACT, producing DLA tablets can be accomplished with simpler equipment and a modest amount of training.
Growing Artemisia annua and producing and testing the tablets, Dr Weathers noted, are ideal local business ventures that can provide jobs in impoverished areas and greatly expand access to antimalarial therapy.
In fact, she has already established a supply chain in Africa that includes growing and harvesting high-producing cultivars in East Africa, along with Good Manufacturing Practice processing operations in Uganda where the leaves are dried, pulverized, and homogenized; the powder is compacted into tablets; and the tablets are tested to verify their dosage.
This supply chain helped produce the tablets used to treat the 18 patients in the Democratic Republic of Congo.
FDA issues warnings about illegal ‘anticancer’ products
The US Food and Drug Administration (FDA) has posted warning letters addressed to 14 US-based companies illegally selling more than 65 products.
The companies are fraudulently claiming that these products prevent, diagnose, treat, or cure cancer.
The products are being marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs.
“We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a healthcare professional about proper prevention, diagnosis, and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.
The illegally sold products cited in the FDA’s warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics (such as thermography devices).
They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing, or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anticancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction, and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent cancer-related products on websites, social media, and in stores.
Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due, in part, to the ease with which companies can move their marketing operations to new websites.
The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages healthcare professionals and consumers to report adverse reactions associated with these or similar products to the FDA’s MedWatch program.
The US Food and Drug Administration (FDA) has posted warning letters addressed to 14 US-based companies illegally selling more than 65 products.
The companies are fraudulently claiming that these products prevent, diagnose, treat, or cure cancer.
The products are being marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs.
“We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a healthcare professional about proper prevention, diagnosis, and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.
The illegally sold products cited in the FDA’s warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics (such as thermography devices).
They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing, or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anticancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction, and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent cancer-related products on websites, social media, and in stores.
Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due, in part, to the ease with which companies can move their marketing operations to new websites.
The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages healthcare professionals and consumers to report adverse reactions associated with these or similar products to the FDA’s MedWatch program.
The US Food and Drug Administration (FDA) has posted warning letters addressed to 14 US-based companies illegally selling more than 65 products.
The companies are fraudulently claiming that these products prevent, diagnose, treat, or cure cancer.
The products are being marketed and sold without FDA approval, most commonly on websites and social media platforms.
“Consumers should not use these or similar unproven products because they may be unsafe and could prevent a person from seeking an appropriate and potentially life-saving cancer diagnosis or treatment,” said Douglas W. Stearn, director of the Office of Enforcement and Import Operations in the FDA’s Office of Regulatory Affairs.
“We encourage people to remain vigilant whether online or in a store, and avoid purchasing products marketed to treat cancer without any proof they will work. Patients should consult a healthcare professional about proper prevention, diagnosis, and treatment of cancer.”
It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate, or cure diseases without first demonstrating to the FDA that they are safe and effective for their labeled uses.
The illegally sold products cited in the FDA’s warning letters include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics (such as thermography devices).
They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing, or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anticancer claims.
The FDA has requested responses from the 14 companies stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure, injunction, and/or criminal prosecution.
As part of the FDA’s effort to protect consumers from cancer health fraud, the FDA has issued more than 90 warning letters in the past 10 years to companies marketing hundreds of fraudulent cancer-related products on websites, social media, and in stores.
Although many of these companies have stopped selling the products or making fraudulent claims, numerous unsafe and unapproved products continue to be sold directly to consumers due, in part, to the ease with which companies can move their marketing operations to new websites.
The FDA continues to monitor and take action against companies promoting and selling unproven treatments in an effort to minimize the potential dangers to consumers and to educate consumers about the risks.
The FDA encourages healthcare professionals and consumers to report adverse reactions associated with these or similar products to the FDA’s MedWatch program.