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Evidence still lacking that vitamins prevent CVD, cancer: USPSTF
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.
However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.
“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.
“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.
“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.
Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.
“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.
The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.
“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.
On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.
However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.
“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.
But he noted that the task force did not find any significant harms from taking multivitamins.
“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.
Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.
“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
‘Any benefit likely to be small’
In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.
The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.
They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).
“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.
The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.
However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.
The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
Possible benefit for older adults?
Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.
“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”
However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.
She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.
“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.
“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”
A version of this article first appeared on Medscape.com.
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.
However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.
“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.
“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.
“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.
Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.
“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.
The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.
“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.
On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.
However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.
“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.
But he noted that the task force did not find any significant harms from taking multivitamins.
“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.
Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.
“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
‘Any benefit likely to be small’
In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.
The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.
They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).
“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.
The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.
However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.
The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
Possible benefit for older adults?
Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.
“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”
However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.
She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.
“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.
“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”
A version of this article first appeared on Medscape.com.
There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.
However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.
These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.
“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.
“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.
“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.
Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.
“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.
The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.
“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.
On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.
However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.
“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.
But he noted that the task force did not find any significant harms from taking multivitamins.
“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.
Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.
“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
‘Any benefit likely to be small’
In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.
The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.
They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).
“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.
The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.
However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.
The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
Possible benefit for older adults?
Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.
“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”
However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.
She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.
“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.
“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”
A version of this article first appeared on Medscape.com.
FROM JAMA
Add AFib to noncardiac surgery risk evaluation: New support
Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.
But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.
Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.
The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”
“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.
The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.
Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.
The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.
The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.
That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.
Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.
“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.
The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.
Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).
Corresponding 30-day ORs for other events, all significant at P < .001, were:
- 1.31 (95% CI, 1.30-1.33) for heart failure
- 1.40 (95% CI, 1.37-1.43) for stroke
- 1.59 (95% CI, 1.43-1.75) for systemic embolism
- 1.14 (95% CI, 1.13-1.16) for major bleeding
- 0.81 (95% CI, 0.79-0.82) for MI
Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).
The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.
For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.
“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”
Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.
But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.
Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.
The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”
“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.
The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.
Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.
The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.
The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.
That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.
Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.
“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.
The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.
Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).
Corresponding 30-day ORs for other events, all significant at P < .001, were:
- 1.31 (95% CI, 1.30-1.33) for heart failure
- 1.40 (95% CI, 1.37-1.43) for stroke
- 1.59 (95% CI, 1.43-1.75) for systemic embolism
- 1.14 (95% CI, 1.13-1.16) for major bleeding
- 0.81 (95% CI, 0.79-0.82) for MI
Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).
The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.
For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.
“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”
Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.
But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.
Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.
The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”
“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.
The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.
Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.
The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.
The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.
That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.
Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.
“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.
The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.
Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).
Corresponding 30-day ORs for other events, all significant at P < .001, were:
- 1.31 (95% CI, 1.30-1.33) for heart failure
- 1.40 (95% CI, 1.37-1.43) for stroke
- 1.59 (95% CI, 1.43-1.75) for systemic embolism
- 1.14 (95% CI, 1.13-1.16) for major bleeding
- 0.81 (95% CI, 0.79-0.82) for MI
Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).
The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.
For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.
“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”
Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Roe v. Wade overturned, ending 50 years of abortion protections
According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.
Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.
Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.
The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.
The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2.
In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”
The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).
Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.
The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
Trigger laws and bans
When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.
University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.
The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.
Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.
“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”
In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.
Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.
On May 26, Oklahoma Gov. Kevin Stitt signed a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.
Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
Some states protecting rights
At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.
Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.
Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.
B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”
But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
Medication abortions, travel next battle
Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.
Mississippi has also enacted restrictions including the requirement that women meet with a doctor first – and is being sued by pill maker GenBioPro.
Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.
Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.
George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”
He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”
Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”
A version of this article first appeared on Medscape.com.
According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.
Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.
Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.
The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.
The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2.
In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”
The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).
Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.
The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
Trigger laws and bans
When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.
University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.
The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.
Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.
“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”
In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.
Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.
On May 26, Oklahoma Gov. Kevin Stitt signed a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.
Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
Some states protecting rights
At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.
Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.
Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.
B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”
But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
Medication abortions, travel next battle
Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.
Mississippi has also enacted restrictions including the requirement that women meet with a doctor first – and is being sued by pill maker GenBioPro.
Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.
Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.
George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”
He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”
Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”
A version of this article first appeared on Medscape.com.
According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.
Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.
Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.
The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.
The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2.
In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”
The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).
Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.
The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
Trigger laws and bans
When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.
University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.
The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.
Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.
“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”
In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.
Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.
On May 26, Oklahoma Gov. Kevin Stitt signed a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.
Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
Some states protecting rights
At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.
Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.
Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.
B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”
But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
Medication abortions, travel next battle
Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.
Mississippi has also enacted restrictions including the requirement that women meet with a doctor first – and is being sued by pill maker GenBioPro.
Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.
Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.
George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”
He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”
Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”
A version of this article first appeared on Medscape.com.
Deaths rare in tonsillectomy, but some children at more risk
It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.
“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”
The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.
To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.
Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.
In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.
The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.
The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.
The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.
But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).
Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
Findings can help providers advise patients and their families about tonsillectomy risks
Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.
“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.
“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.
Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.
She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.
“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”
The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.
A version of this article first appeared on Medscape.com.
It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.
“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”
The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.
To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.
Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.
In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.
The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.
The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.
The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.
But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).
Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
Findings can help providers advise patients and their families about tonsillectomy risks
Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.
“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.
“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.
Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.
She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.
“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”
The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.
A version of this article first appeared on Medscape.com.
It’s rare for a child to die after a tonsillectomy, but children who die are more likely to have a complex chronic condition such as cerebral palsy or Down syndrome, according to a retrospective cohort study published in JAMA.
“Among children undergoing tonsillectomy, the rate of postoperative death was 7 per 100,000 operations overall, [but] among children with complex chronic conditions, the rate of postoperative death was 117 per 100,000 operations, representing 44% of overall deaths,” write researchers at the University of Wisconsin–Madison. “These findings may inform decisionmaking for pediatric tonsillectomy.”
The rate of death in children after tonsillectomy has been uncertain, the authors write. Specific mortality rates for children at increased risk for complications, including those under 3 years old and those with sleep-disordered breathing or complex chronic conditions, have not been available.
To learn how likely children undergoing tonsillectomy are to die after their surgery, as well as which children are most at risk, lead study author M. Bruce Edmonson, MD, MPH, department of pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, and his colleagues drew data from five states, including ambulatory surgery, inpatient, and emergency department discharge data sets provided by the Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality for California, Florida, Maryland, New York, and Wisconsin.
Participants included 504,262 patients under 21 years of age whose discharge records linked their inpatient or outpatient tonsillectomy, with or without adenoidectomy, with at least 90 days of follow-up.
In a longitudinal analysis, the research team investigated postoperative death within 30 days or during a surgical stay lasting over 30 days. They calculated postoperative mortality per 100,000 operations, both overall and classified by age group, sleep-disordered breathing, and complex chronic conditions.
The 504,262 children ranged in age from 0 to 20 years and underwent a total of 505,182 tonsillectomies. Of these, 10.1% were performed in children aged under 3 years, 28.9% in children with sleep-disordered breathing, and 2.8% in those with complex chronic conditions.
The 36 linked postoperative deaths occurred between 2 and 20.5 days after surgical admission, and 19 (53%) of the deaths occurred after surgical discharge.
The unadjusted mortality rate was 7.04 (95% confidence interval, 4.97-9.98) deaths per 100,000 procedures. In multivariable models, children younger than 3 years and children with sleep-disordered breathing were not significantly more likely to die.
But children with complex chronic conditions were significantly more likely to die than were children without those conditions (117.22 vs. 3.87 deaths per 100,000 procedures, respectively).
Children with complex chronic conditions underwent only 2.8% of all tonsillectomies, but they accounted for 44% of postoperative deaths. Most deaths linked with complex chronic conditions occurred among children with neurologic, neuromuscular, congenital, or genetic disorders.
Findings can help providers advise patients and their families about tonsillectomy risks
Kavita Dedhia, MD, MSHP, attending otolaryngologist, Division of Otolaryngology, Children’s Hospital of Philadelphia, Pennsylvania, told this news organization that she was not surprised by the findings.
“This study suggests that mortality is an extremely rare complication of tonsillectomy, and that children with complex medical conditions are at highest risk,” Dr. Dedhia, who was not involved in the study, said in an email.
“Due to their underlying comorbidities, medically fragile children are considered to be at higher risk while undergoing anesthesia and surgical procedures,” she added.
Dr. Dedhia noted that nonpatient factors the study did not explore may have affected the mortality rates, including each hospital’s experience with managing children with complex medical conditions, as well as whether the hospitals were tertiary care facilities, and pediatric or adult hospitals.
She would like to know what hospital or practice characteristics may have contributed to the mortality risk and whether increased mortality in these patients is limited to tonsillectomy or is also found with other surgical procedures.
“The strength of this study is that it is large and multi-regional and that it informs providers about patient factors impacting mortality in pediatric tonsillectomy,” Dr. Dedhia said. “This study arms surgeons with data to discuss mortality risk with the families of medically complex children undergoing tonsillectomy.”
The study authors and Dr. Dedhia report no relevant financial relationships. Funding information was not provided.
A version of this article first appeared on Medscape.com.
FROM JAMA
FDA orders Juul to stop selling E-cigarettes
The marketing denial order covers all the company’s products in the United States, which means Juul must stop distributing the products and remove everything on the market. That includes the Juul device and flavor replacement pods in the tobacco and menthol flavors.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Robert Califf, MD, the FDA commissioner, said in the announcement.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he said. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
The marketing denial order covers only the commercial distribution and retail sale of Juul’s products and doesn’t restrict consumer possession or use. The FDA “cannot and will not” enforce actions against consumers, the agency said.
The order comes after a 2-year review of the company’s application seeking authorization to continue selling non–fruit-flavored products, such as menthol and tobacco. The FDA determined the application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
Some of Juul’s study findings raised concerns because of “insufficient and conflicting data,” the FDA said, including potentially harmful chemicals leaching from the Juul liquid replacement pods.
“To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods,” the agency said. “However, the [orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
Juul is expected to appeal the FDA’s decision, according to The New York Times.
In recent years, the FDA has reviewed marketing applications from Juul and other e-cigarette companies as anti-tobacco groups have called for new rules to limit products that led to a surge in youth vaping during the past decade. At the same time, advocates of e-cigarettes and nicotine-delivery devices have said the products help adult smokers to quit cigarettes and other tobacco products.
Juul, in particular, has been blamed for fueling the surge in underage vaping due to fruity flavors and hip marketing, according to The Wall Street Journal. The company removed sweet and fruity flavors from shelves in 2019 and has been trying to repair its reputation by limiting its marketing and focusing on adult cigarette smokers.
In 2020, all e-cigarette manufacturers in the United States were required to submit their products for FDA review to stay on the market, the newspaper reported. The agency has been weighing the potential benefits for adult cigarette smokers against the harms for young people.
The FDA banned the sale of fruit- and mint-flavored cartridges and juice pods in 2020, but menthol and tobacco-flavored products were left on the market, according to USA Today. In September 2021, the agency also banned the sale of hundreds of thousands of vaping and e-cigarette products but didn’t rule on Juul.
Meanwhile, the FDA has cleared Reynolds American and NJOY Holdings – two of Juul’s biggest rivals – to keep tobacco-flavored products on the market. Industry experts expected Juul to receive similar clearance, the Journal reported.
Juul, which was at the top of the U.S. e-cigarette market in 2018, has moved to second place behind Reynolds’s Vuse brand, the newspaper reported. The United States represents most of the company’s revenue, though its products are also available in Canada, the United Kingdom, France, Italy, and the Philippines.
Underage vaping has fallen in the United States since federal restrictions raised the legal purchase age for tobacco products to 21 and banned the sale of sweet and fruity cartridges, according to the Journal. Juul’s popularity has also dropped among youth, with other products such as Puff Bar, Vuse, and Smok becoming more popular among e-cigarette users in high school.
In a separate decision announced this week, the FDA is also moving forward with a plan to reduce the amount of nicotine in cigarettes. The decision, which has been years in the making, is aimed at prompting millions of cigarette users to quit smoking or switch to alternatives such as e-cigarettes, as well as limit the number of users who pick up smoking at an early age.
A version of this article first appeared on WebMD.com .
The marketing denial order covers all the company’s products in the United States, which means Juul must stop distributing the products and remove everything on the market. That includes the Juul device and flavor replacement pods in the tobacco and menthol flavors.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Robert Califf, MD, the FDA commissioner, said in the announcement.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he said. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
The marketing denial order covers only the commercial distribution and retail sale of Juul’s products and doesn’t restrict consumer possession or use. The FDA “cannot and will not” enforce actions against consumers, the agency said.
The order comes after a 2-year review of the company’s application seeking authorization to continue selling non–fruit-flavored products, such as menthol and tobacco. The FDA determined the application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
Some of Juul’s study findings raised concerns because of “insufficient and conflicting data,” the FDA said, including potentially harmful chemicals leaching from the Juul liquid replacement pods.
“To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods,” the agency said. “However, the [orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
Juul is expected to appeal the FDA’s decision, according to The New York Times.
In recent years, the FDA has reviewed marketing applications from Juul and other e-cigarette companies as anti-tobacco groups have called for new rules to limit products that led to a surge in youth vaping during the past decade. At the same time, advocates of e-cigarettes and nicotine-delivery devices have said the products help adult smokers to quit cigarettes and other tobacco products.
Juul, in particular, has been blamed for fueling the surge in underage vaping due to fruity flavors and hip marketing, according to The Wall Street Journal. The company removed sweet and fruity flavors from shelves in 2019 and has been trying to repair its reputation by limiting its marketing and focusing on adult cigarette smokers.
In 2020, all e-cigarette manufacturers in the United States were required to submit their products for FDA review to stay on the market, the newspaper reported. The agency has been weighing the potential benefits for adult cigarette smokers against the harms for young people.
The FDA banned the sale of fruit- and mint-flavored cartridges and juice pods in 2020, but menthol and tobacco-flavored products were left on the market, according to USA Today. In September 2021, the agency also banned the sale of hundreds of thousands of vaping and e-cigarette products but didn’t rule on Juul.
Meanwhile, the FDA has cleared Reynolds American and NJOY Holdings – two of Juul’s biggest rivals – to keep tobacco-flavored products on the market. Industry experts expected Juul to receive similar clearance, the Journal reported.
Juul, which was at the top of the U.S. e-cigarette market in 2018, has moved to second place behind Reynolds’s Vuse brand, the newspaper reported. The United States represents most of the company’s revenue, though its products are also available in Canada, the United Kingdom, France, Italy, and the Philippines.
Underage vaping has fallen in the United States since federal restrictions raised the legal purchase age for tobacco products to 21 and banned the sale of sweet and fruity cartridges, according to the Journal. Juul’s popularity has also dropped among youth, with other products such as Puff Bar, Vuse, and Smok becoming more popular among e-cigarette users in high school.
In a separate decision announced this week, the FDA is also moving forward with a plan to reduce the amount of nicotine in cigarettes. The decision, which has been years in the making, is aimed at prompting millions of cigarette users to quit smoking or switch to alternatives such as e-cigarettes, as well as limit the number of users who pick up smoking at an early age.
A version of this article first appeared on WebMD.com .
The marketing denial order covers all the company’s products in the United States, which means Juul must stop distributing the products and remove everything on the market. That includes the Juul device and flavor replacement pods in the tobacco and menthol flavors.
“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” Robert Califf, MD, the FDA commissioner, said in the announcement.
“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he said. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”
The marketing denial order covers only the commercial distribution and retail sale of Juul’s products and doesn’t restrict consumer possession or use. The FDA “cannot and will not” enforce actions against consumers, the agency said.
The order comes after a 2-year review of the company’s application seeking authorization to continue selling non–fruit-flavored products, such as menthol and tobacco. The FDA determined the application “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
Some of Juul’s study findings raised concerns because of “insufficient and conflicting data,” the FDA said, including potentially harmful chemicals leaching from the Juul liquid replacement pods.
“To date, the FDA has not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUUL pods,” the agency said. “However, the [orders] issued today reflect FDA’s determination that there is insufficient evidence to assess the potential toxicological risks of using the JUUL products.”
Juul is expected to appeal the FDA’s decision, according to The New York Times.
In recent years, the FDA has reviewed marketing applications from Juul and other e-cigarette companies as anti-tobacco groups have called for new rules to limit products that led to a surge in youth vaping during the past decade. At the same time, advocates of e-cigarettes and nicotine-delivery devices have said the products help adult smokers to quit cigarettes and other tobacco products.
Juul, in particular, has been blamed for fueling the surge in underage vaping due to fruity flavors and hip marketing, according to The Wall Street Journal. The company removed sweet and fruity flavors from shelves in 2019 and has been trying to repair its reputation by limiting its marketing and focusing on adult cigarette smokers.
In 2020, all e-cigarette manufacturers in the United States were required to submit their products for FDA review to stay on the market, the newspaper reported. The agency has been weighing the potential benefits for adult cigarette smokers against the harms for young people.
The FDA banned the sale of fruit- and mint-flavored cartridges and juice pods in 2020, but menthol and tobacco-flavored products were left on the market, according to USA Today. In September 2021, the agency also banned the sale of hundreds of thousands of vaping and e-cigarette products but didn’t rule on Juul.
Meanwhile, the FDA has cleared Reynolds American and NJOY Holdings – two of Juul’s biggest rivals – to keep tobacco-flavored products on the market. Industry experts expected Juul to receive similar clearance, the Journal reported.
Juul, which was at the top of the U.S. e-cigarette market in 2018, has moved to second place behind Reynolds’s Vuse brand, the newspaper reported. The United States represents most of the company’s revenue, though its products are also available in Canada, the United Kingdom, France, Italy, and the Philippines.
Underage vaping has fallen in the United States since federal restrictions raised the legal purchase age for tobacco products to 21 and banned the sale of sweet and fruity cartridges, according to the Journal. Juul’s popularity has also dropped among youth, with other products such as Puff Bar, Vuse, and Smok becoming more popular among e-cigarette users in high school.
In a separate decision announced this week, the FDA is also moving forward with a plan to reduce the amount of nicotine in cigarettes. The decision, which has been years in the making, is aimed at prompting millions of cigarette users to quit smoking or switch to alternatives such as e-cigarettes, as well as limit the number of users who pick up smoking at an early age.
A version of this article first appeared on WebMD.com .
Aging HIV patients face comorbidities and hospitalizations
Thanks to effective treatment, people with HIV are living longer. But as they age, they face higher rates of age-related comorbidities and hospitalizations, according to a recent study of hospitalized patients.
Decision-makers will need to allocate resources, train providers, and plan ways to manage chronic diseases, such as diabetes and cancer, among geriatric HIV inpatients, according to the authors.
“There will be more [HIV] patients with age-related chronic conditions at an earlier age and who will utilize or will have a unique need for [health care for] these geriatric conditions,” first author Khairul A. Siddiqi, PhD, University of Florida, Gainesville, said in an interview. “Eventually, that may increase inpatient resource utilization and costs.”
The study was published online in HIV Medicine.
Aging with HIV
Analyzing the National Inpatient Sample (NIS) of the Healthcare Cost and Utilization Project, the authors compared characteristics and comorbidities linked to hospital stays among people with HIV (HSWH) to those linked to hospital stays among people without HIV (HSWOH).
The NIS is a database of hospital records that captures 20% of discharges in the United States and covers all payers. Data in this analysis covered the years 2003-2015.
Among HSWH, patients aged 50 or older accounted for an increasing proportion over time, from fewer than 25% in 2003 to over 50% by 2015, the authors found. The subgroup aged 65-80 had risen from 2.39% to 8.63% by 2015.
The authors also studied rates of eight comorbidities, termed HIV-associated non-AIDS (HANA) conditions: cardiovascular, lung, liver, neurologic, and kidney diseases; diabetes; cancer; and bone loss.
The average number of these conditions among both HSWH and HSWOH rose over time. But this change was disproportionately high among HSWH aged 50-64 and those aged 65 and older.
Over the study period, among patients aged 65 or older, six of the eight age-related conditions the researchers studied rose disproportionately among HSWH in comparison with HSWOH; among those aged 50-64, five conditions did so.
The researchers are now building on the current study of HSWH by examining rates of resource utilization, such as MRIs and procedures, Dr. Siddiqi said.
Study limitations included a lack of data from long-term facilities, potential skewing by patients hospitalized multiple times, and the inherent limitations of administrative data.
A unique group of older people
Among people with HIV (PWH) in the United States, nearly half are aged 50 or older. By 2030, this group is expected to account for some 70% of PWH.
“We need to pay attention to what we know about aging generally. It is also important to study aging in this special population, because we don’t necessarily know a lot about that,” Amy Justice, MD, PhD, professor of medicine and of public health at Yale University, New Haven, Conn., said in an interview. Dr. Justice was not involved in the study.
The HIV epidemic has disproportionately affected people of color, men who have sex with men, and people with a history of injection drug use, Dr. Justice said.
“We don’t know about aging with [a] past history of injection drug use. We don’t even know much about aging with hepatitis C, necessarily,” she said. “So there are lots of reasons to pay some attention to this population to try to optimize their care.”
In addition, compared with their non–HIV-affected counterparts, these individuals are more susceptible to HANA comorbidities. They may experience these conditions at a younger age or more severely. Chronic inflammation and polypharmacy may be to blame, said Dr. Justice.
Given the burden of comorbidities and polypharmacy in this patient population, Dr. Siddiqi said, policy makers will need to focus on developing chronic disease management interventions for them.
However, Dr. Justice added, the risk for multimorbidity is higher among people with HIV throughout the age cycle: “It’s not like I turn 50 with HIV and all of a sudden all the wheels come off. There are ways to successfully age with HIV.”
Geriatric HIV expertise needed
Dr. Justice called the study’s analysis a useful addition to the literature and noted its implications for training.
“One of the biggest challenges with this large bolus of folks who are aging with HIV,” she said, “is to what extent should they be cared for by the people who have been caring for them – largely infectious disease docs – and to what extent should we really be transitioning their care to people with more experience with aging.”
Another key question, Dr. Justice said, relates to nursing homes and assisted-living facilities, whose staff may lack experience caring for HIV patients. Training them and hospital-based providers is crucial, in part to avoid key errors, such as missed antiretroviral doses, she said: “We need to really think about how to get non-HIV providers up to speed.”
That may begin by simply making it clear that this population is here.
“A decade ago, HIV patients used to have a lower life expectancy, so all HIV studies used to use 50 years as the cutoff point for [the] older population,” Dr. Siddiqi said. “Now we know they’re living longer.”
Added Dr. Justice: “Previously, people thought aging and HIV were not coincident findings.”
The study was funded by the Office of the Vice President for Research at the University of South Carolina. The authors and Dr. Justice disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Thanks to effective treatment, people with HIV are living longer. But as they age, they face higher rates of age-related comorbidities and hospitalizations, according to a recent study of hospitalized patients.
Decision-makers will need to allocate resources, train providers, and plan ways to manage chronic diseases, such as diabetes and cancer, among geriatric HIV inpatients, according to the authors.
“There will be more [HIV] patients with age-related chronic conditions at an earlier age and who will utilize or will have a unique need for [health care for] these geriatric conditions,” first author Khairul A. Siddiqi, PhD, University of Florida, Gainesville, said in an interview. “Eventually, that may increase inpatient resource utilization and costs.”
The study was published online in HIV Medicine.
Aging with HIV
Analyzing the National Inpatient Sample (NIS) of the Healthcare Cost and Utilization Project, the authors compared characteristics and comorbidities linked to hospital stays among people with HIV (HSWH) to those linked to hospital stays among people without HIV (HSWOH).
The NIS is a database of hospital records that captures 20% of discharges in the United States and covers all payers. Data in this analysis covered the years 2003-2015.
Among HSWH, patients aged 50 or older accounted for an increasing proportion over time, from fewer than 25% in 2003 to over 50% by 2015, the authors found. The subgroup aged 65-80 had risen from 2.39% to 8.63% by 2015.
The authors also studied rates of eight comorbidities, termed HIV-associated non-AIDS (HANA) conditions: cardiovascular, lung, liver, neurologic, and kidney diseases; diabetes; cancer; and bone loss.
The average number of these conditions among both HSWH and HSWOH rose over time. But this change was disproportionately high among HSWH aged 50-64 and those aged 65 and older.
Over the study period, among patients aged 65 or older, six of the eight age-related conditions the researchers studied rose disproportionately among HSWH in comparison with HSWOH; among those aged 50-64, five conditions did so.
The researchers are now building on the current study of HSWH by examining rates of resource utilization, such as MRIs and procedures, Dr. Siddiqi said.
Study limitations included a lack of data from long-term facilities, potential skewing by patients hospitalized multiple times, and the inherent limitations of administrative data.
A unique group of older people
Among people with HIV (PWH) in the United States, nearly half are aged 50 or older. By 2030, this group is expected to account for some 70% of PWH.
“We need to pay attention to what we know about aging generally. It is also important to study aging in this special population, because we don’t necessarily know a lot about that,” Amy Justice, MD, PhD, professor of medicine and of public health at Yale University, New Haven, Conn., said in an interview. Dr. Justice was not involved in the study.
The HIV epidemic has disproportionately affected people of color, men who have sex with men, and people with a history of injection drug use, Dr. Justice said.
“We don’t know about aging with [a] past history of injection drug use. We don’t even know much about aging with hepatitis C, necessarily,” she said. “So there are lots of reasons to pay some attention to this population to try to optimize their care.”
In addition, compared with their non–HIV-affected counterparts, these individuals are more susceptible to HANA comorbidities. They may experience these conditions at a younger age or more severely. Chronic inflammation and polypharmacy may be to blame, said Dr. Justice.
Given the burden of comorbidities and polypharmacy in this patient population, Dr. Siddiqi said, policy makers will need to focus on developing chronic disease management interventions for them.
However, Dr. Justice added, the risk for multimorbidity is higher among people with HIV throughout the age cycle: “It’s not like I turn 50 with HIV and all of a sudden all the wheels come off. There are ways to successfully age with HIV.”
Geriatric HIV expertise needed
Dr. Justice called the study’s analysis a useful addition to the literature and noted its implications for training.
“One of the biggest challenges with this large bolus of folks who are aging with HIV,” she said, “is to what extent should they be cared for by the people who have been caring for them – largely infectious disease docs – and to what extent should we really be transitioning their care to people with more experience with aging.”
Another key question, Dr. Justice said, relates to nursing homes and assisted-living facilities, whose staff may lack experience caring for HIV patients. Training them and hospital-based providers is crucial, in part to avoid key errors, such as missed antiretroviral doses, she said: “We need to really think about how to get non-HIV providers up to speed.”
That may begin by simply making it clear that this population is here.
“A decade ago, HIV patients used to have a lower life expectancy, so all HIV studies used to use 50 years as the cutoff point for [the] older population,” Dr. Siddiqi said. “Now we know they’re living longer.”
Added Dr. Justice: “Previously, people thought aging and HIV were not coincident findings.”
The study was funded by the Office of the Vice President for Research at the University of South Carolina. The authors and Dr. Justice disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Thanks to effective treatment, people with HIV are living longer. But as they age, they face higher rates of age-related comorbidities and hospitalizations, according to a recent study of hospitalized patients.
Decision-makers will need to allocate resources, train providers, and plan ways to manage chronic diseases, such as diabetes and cancer, among geriatric HIV inpatients, according to the authors.
“There will be more [HIV] patients with age-related chronic conditions at an earlier age and who will utilize or will have a unique need for [health care for] these geriatric conditions,” first author Khairul A. Siddiqi, PhD, University of Florida, Gainesville, said in an interview. “Eventually, that may increase inpatient resource utilization and costs.”
The study was published online in HIV Medicine.
Aging with HIV
Analyzing the National Inpatient Sample (NIS) of the Healthcare Cost and Utilization Project, the authors compared characteristics and comorbidities linked to hospital stays among people with HIV (HSWH) to those linked to hospital stays among people without HIV (HSWOH).
The NIS is a database of hospital records that captures 20% of discharges in the United States and covers all payers. Data in this analysis covered the years 2003-2015.
Among HSWH, patients aged 50 or older accounted for an increasing proportion over time, from fewer than 25% in 2003 to over 50% by 2015, the authors found. The subgroup aged 65-80 had risen from 2.39% to 8.63% by 2015.
The authors also studied rates of eight comorbidities, termed HIV-associated non-AIDS (HANA) conditions: cardiovascular, lung, liver, neurologic, and kidney diseases; diabetes; cancer; and bone loss.
The average number of these conditions among both HSWH and HSWOH rose over time. But this change was disproportionately high among HSWH aged 50-64 and those aged 65 and older.
Over the study period, among patients aged 65 or older, six of the eight age-related conditions the researchers studied rose disproportionately among HSWH in comparison with HSWOH; among those aged 50-64, five conditions did so.
The researchers are now building on the current study of HSWH by examining rates of resource utilization, such as MRIs and procedures, Dr. Siddiqi said.
Study limitations included a lack of data from long-term facilities, potential skewing by patients hospitalized multiple times, and the inherent limitations of administrative data.
A unique group of older people
Among people with HIV (PWH) in the United States, nearly half are aged 50 or older. By 2030, this group is expected to account for some 70% of PWH.
“We need to pay attention to what we know about aging generally. It is also important to study aging in this special population, because we don’t necessarily know a lot about that,” Amy Justice, MD, PhD, professor of medicine and of public health at Yale University, New Haven, Conn., said in an interview. Dr. Justice was not involved in the study.
The HIV epidemic has disproportionately affected people of color, men who have sex with men, and people with a history of injection drug use, Dr. Justice said.
“We don’t know about aging with [a] past history of injection drug use. We don’t even know much about aging with hepatitis C, necessarily,” she said. “So there are lots of reasons to pay some attention to this population to try to optimize their care.”
In addition, compared with their non–HIV-affected counterparts, these individuals are more susceptible to HANA comorbidities. They may experience these conditions at a younger age or more severely. Chronic inflammation and polypharmacy may be to blame, said Dr. Justice.
Given the burden of comorbidities and polypharmacy in this patient population, Dr. Siddiqi said, policy makers will need to focus on developing chronic disease management interventions for them.
However, Dr. Justice added, the risk for multimorbidity is higher among people with HIV throughout the age cycle: “It’s not like I turn 50 with HIV and all of a sudden all the wheels come off. There are ways to successfully age with HIV.”
Geriatric HIV expertise needed
Dr. Justice called the study’s analysis a useful addition to the literature and noted its implications for training.
“One of the biggest challenges with this large bolus of folks who are aging with HIV,” she said, “is to what extent should they be cared for by the people who have been caring for them – largely infectious disease docs – and to what extent should we really be transitioning their care to people with more experience with aging.”
Another key question, Dr. Justice said, relates to nursing homes and assisted-living facilities, whose staff may lack experience caring for HIV patients. Training them and hospital-based providers is crucial, in part to avoid key errors, such as missed antiretroviral doses, she said: “We need to really think about how to get non-HIV providers up to speed.”
That may begin by simply making it clear that this population is here.
“A decade ago, HIV patients used to have a lower life expectancy, so all HIV studies used to use 50 years as the cutoff point for [the] older population,” Dr. Siddiqi said. “Now we know they’re living longer.”
Added Dr. Justice: “Previously, people thought aging and HIV were not coincident findings.”
The study was funded by the Office of the Vice President for Research at the University of South Carolina. The authors and Dr. Justice disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HIV MEDICINE
Autoimmune disorder drugs top list of meds linked to headache
DENVER – in a federal side effect database that anyone can contribute to, according to a new study presented at the annual meeting of the American Headache Society.
“Surprising findings included the significant number of immunosuppressants and immunomodulators present in the data,” study lead author Brett Musialowicz, a medical student at Robert Wood Johnson Medical School, New Brunswich, N.J., said in an interview. “Additionally, our data provides evidence that suggests that several medications belonging to these drug classes were less likely to be associated with medication-induced headaches,” raising questions about the mechanism.
Drugs most frequently linked to headaches
The researchers launched their study to better understand headache as a side effect of medication use, Mr. Musialowicz said. They analyzed entries from the Food and Drug Administration’s Adverse Event Reporting System for the period from July 2018 to March 2020 and listed the top 30 most commonly reported medications linked to headaches and their reported odds ratio. According to a website devoted to pharmacovigilance training, ROR refers to “the odds of a certain event occurring with your medicinal product, compared with the odds of the same event occurring with all other medicinal products in the database.”
After generic and brand name data was consolidated, the drug most frequently linked to headaches was apremilast with 8,672 reports, followed by adalimumab (5,357), tofacitinib (4,276), fingolimod (4,123), and etanercept (4,111). These drugs treat autoimmune disorders such as psoriasis, multiple sclerosis, and Crohn’s disease.
The other drugs in the top 15 ranked by frequency are treatments for hepatitis C (4 drugs), pulmonary arterial hypertension (4 drugs), arthritis (1 drug), and asthma (1 drug).
Of the top 30 drugs most frequently linked to headaches, the pulmonary hypertension drug epoprostenol – ranked 23rd – had the highest ROR at 12.8. The next highest were the hepatitis C drugs glecaprevir and pibrentasvir, tied at 10th in the frequency analysis and both with an ROR of 9.4.
“Pulmonary arterial dilators and vasodilators are believed to cause headaches by sensitizing extracranial arteries. Clinical evidence suggests there a vascular component to some types of headache,” Mr. Musialowicz said. “Monoclonal antibodies are suggested to cause headache by means of an immune response. Several monoclonal antibodies are in trials targeting [the calcitonin gene-related peptide] receptor, which is believed to be involved in migraine headache. These trials will help further elucidate the mechanisms of headache and potential drugs to treat these conditions.”
Is the data useful?
Stewart Tepper, MD, a neurologist at Geisel School of Medicine at Dartmouth, Hanover, N.H., who’s familiar with the study findings, discounted the new research in an interview. He noted that any member of the public can contribute to the federal database of adverse effects (drug manufacturers are required to contribute to it), and the data says nothing about denominators.
“It’s not a reasonable way to evaluate adverse effects, to just have everyone and their uncle saying ‘This particular drug did this to me.’ It’s not in any way useful,” he said. However, he added that the database sometimes “gives you a bit of a signal so you can go back and try to get scientifically collected data.”
When asked to respond, study coauthor and neurologist Pengfei (Phil) Zhang, MD, of Robert Wood Johnson Medical School, noted that the FDA created the database “for a reason.” He also noted that the researchers used a statistical analysis technique – ROR – that was invented to adjust for weaknesses in databases.
No study funding is reported. Mr. Musialowicz reported no disclosures. Dr. Zhang has received honorarium from Alder Biopharmaceuticals, Board Vitals, and Fieve Clinical Research. He collaborates with Headache Science Incorporated without receiving financial support, and he has ownership interest in Cymbeline. Another author reports research grant support from the American Epilepsy Society and the New Jersey Health Foundation. Dr. Tepper reported multiple disclosures.
DENVER – in a federal side effect database that anyone can contribute to, according to a new study presented at the annual meeting of the American Headache Society.
“Surprising findings included the significant number of immunosuppressants and immunomodulators present in the data,” study lead author Brett Musialowicz, a medical student at Robert Wood Johnson Medical School, New Brunswich, N.J., said in an interview. “Additionally, our data provides evidence that suggests that several medications belonging to these drug classes were less likely to be associated with medication-induced headaches,” raising questions about the mechanism.
Drugs most frequently linked to headaches
The researchers launched their study to better understand headache as a side effect of medication use, Mr. Musialowicz said. They analyzed entries from the Food and Drug Administration’s Adverse Event Reporting System for the period from July 2018 to March 2020 and listed the top 30 most commonly reported medications linked to headaches and their reported odds ratio. According to a website devoted to pharmacovigilance training, ROR refers to “the odds of a certain event occurring with your medicinal product, compared with the odds of the same event occurring with all other medicinal products in the database.”
After generic and brand name data was consolidated, the drug most frequently linked to headaches was apremilast with 8,672 reports, followed by adalimumab (5,357), tofacitinib (4,276), fingolimod (4,123), and etanercept (4,111). These drugs treat autoimmune disorders such as psoriasis, multiple sclerosis, and Crohn’s disease.
The other drugs in the top 15 ranked by frequency are treatments for hepatitis C (4 drugs), pulmonary arterial hypertension (4 drugs), arthritis (1 drug), and asthma (1 drug).
Of the top 30 drugs most frequently linked to headaches, the pulmonary hypertension drug epoprostenol – ranked 23rd – had the highest ROR at 12.8. The next highest were the hepatitis C drugs glecaprevir and pibrentasvir, tied at 10th in the frequency analysis and both with an ROR of 9.4.
“Pulmonary arterial dilators and vasodilators are believed to cause headaches by sensitizing extracranial arteries. Clinical evidence suggests there a vascular component to some types of headache,” Mr. Musialowicz said. “Monoclonal antibodies are suggested to cause headache by means of an immune response. Several monoclonal antibodies are in trials targeting [the calcitonin gene-related peptide] receptor, which is believed to be involved in migraine headache. These trials will help further elucidate the mechanisms of headache and potential drugs to treat these conditions.”
Is the data useful?
Stewart Tepper, MD, a neurologist at Geisel School of Medicine at Dartmouth, Hanover, N.H., who’s familiar with the study findings, discounted the new research in an interview. He noted that any member of the public can contribute to the federal database of adverse effects (drug manufacturers are required to contribute to it), and the data says nothing about denominators.
“It’s not a reasonable way to evaluate adverse effects, to just have everyone and their uncle saying ‘This particular drug did this to me.’ It’s not in any way useful,” he said. However, he added that the database sometimes “gives you a bit of a signal so you can go back and try to get scientifically collected data.”
When asked to respond, study coauthor and neurologist Pengfei (Phil) Zhang, MD, of Robert Wood Johnson Medical School, noted that the FDA created the database “for a reason.” He also noted that the researchers used a statistical analysis technique – ROR – that was invented to adjust for weaknesses in databases.
No study funding is reported. Mr. Musialowicz reported no disclosures. Dr. Zhang has received honorarium from Alder Biopharmaceuticals, Board Vitals, and Fieve Clinical Research. He collaborates with Headache Science Incorporated without receiving financial support, and he has ownership interest in Cymbeline. Another author reports research grant support from the American Epilepsy Society and the New Jersey Health Foundation. Dr. Tepper reported multiple disclosures.
DENVER – in a federal side effect database that anyone can contribute to, according to a new study presented at the annual meeting of the American Headache Society.
“Surprising findings included the significant number of immunosuppressants and immunomodulators present in the data,” study lead author Brett Musialowicz, a medical student at Robert Wood Johnson Medical School, New Brunswich, N.J., said in an interview. “Additionally, our data provides evidence that suggests that several medications belonging to these drug classes were less likely to be associated with medication-induced headaches,” raising questions about the mechanism.
Drugs most frequently linked to headaches
The researchers launched their study to better understand headache as a side effect of medication use, Mr. Musialowicz said. They analyzed entries from the Food and Drug Administration’s Adverse Event Reporting System for the period from July 2018 to March 2020 and listed the top 30 most commonly reported medications linked to headaches and their reported odds ratio. According to a website devoted to pharmacovigilance training, ROR refers to “the odds of a certain event occurring with your medicinal product, compared with the odds of the same event occurring with all other medicinal products in the database.”
After generic and brand name data was consolidated, the drug most frequently linked to headaches was apremilast with 8,672 reports, followed by adalimumab (5,357), tofacitinib (4,276), fingolimod (4,123), and etanercept (4,111). These drugs treat autoimmune disorders such as psoriasis, multiple sclerosis, and Crohn’s disease.
The other drugs in the top 15 ranked by frequency are treatments for hepatitis C (4 drugs), pulmonary arterial hypertension (4 drugs), arthritis (1 drug), and asthma (1 drug).
Of the top 30 drugs most frequently linked to headaches, the pulmonary hypertension drug epoprostenol – ranked 23rd – had the highest ROR at 12.8. The next highest were the hepatitis C drugs glecaprevir and pibrentasvir, tied at 10th in the frequency analysis and both with an ROR of 9.4.
“Pulmonary arterial dilators and vasodilators are believed to cause headaches by sensitizing extracranial arteries. Clinical evidence suggests there a vascular component to some types of headache,” Mr. Musialowicz said. “Monoclonal antibodies are suggested to cause headache by means of an immune response. Several monoclonal antibodies are in trials targeting [the calcitonin gene-related peptide] receptor, which is believed to be involved in migraine headache. These trials will help further elucidate the mechanisms of headache and potential drugs to treat these conditions.”
Is the data useful?
Stewart Tepper, MD, a neurologist at Geisel School of Medicine at Dartmouth, Hanover, N.H., who’s familiar with the study findings, discounted the new research in an interview. He noted that any member of the public can contribute to the federal database of adverse effects (drug manufacturers are required to contribute to it), and the data says nothing about denominators.
“It’s not a reasonable way to evaluate adverse effects, to just have everyone and their uncle saying ‘This particular drug did this to me.’ It’s not in any way useful,” he said. However, he added that the database sometimes “gives you a bit of a signal so you can go back and try to get scientifically collected data.”
When asked to respond, study coauthor and neurologist Pengfei (Phil) Zhang, MD, of Robert Wood Johnson Medical School, noted that the FDA created the database “for a reason.” He also noted that the researchers used a statistical analysis technique – ROR – that was invented to adjust for weaknesses in databases.
No study funding is reported. Mr. Musialowicz reported no disclosures. Dr. Zhang has received honorarium from Alder Biopharmaceuticals, Board Vitals, and Fieve Clinical Research. He collaborates with Headache Science Incorporated without receiving financial support, and he has ownership interest in Cymbeline. Another author reports research grant support from the American Epilepsy Society and the New Jersey Health Foundation. Dr. Tepper reported multiple disclosures.
AT AHS 2022
Artificial intelligence: The Netflix of cancer treatment
Chemotherapy, now streaming at just $15.99 a month!
It’s a lazy Sunday and you flip on Netflix, looking for something new to watch. There’s an almost-overwhelming number of shows out there, but right at the top of the recommended list is something that strikes your fancy right away. The algorithm behind the scenes is doing its job well, winnowing the universe of content right down to the few things you’ll find relevant, based on what you’ve watched and liked in the past.
Now, the almighty content algorithm is coming for something a little more useful than binge watching obscure 80s sitcoms: cancer treatment.
By plugging the fully sequenced genomes of nearly 10,000 patients with 33 different types of cancer into an algorithm powered by the same sort of artificial intelligence used by Netflix, researchers from London and San Diego found 21 common faults in the chromosomes of tumors, which they called copy number signatures. While cancer is a complex disease, when faults occur in those copy number signatures, the results were similar across the board. If X genetic defect occurs within a tumor, Y result will happen, even across cancer types. For example, tumors whose chromosomes had shattered and reformed had by far the worst disease outcomes.
The eventual hope is that, just as Netflix can predict what you’ll want to watch based on what you’ve already seen, oncologists will be able to predict the course of a cancer, based on the tumor’s early genetic traits, and get ahead of future genetic degradation to prevent the worst outcomes. A sort of “Oh, your tumor has enjoyed The Office. Might we suggest a treatment of 30 Rock” situation. Further research will be required to determine whether or not the cancer algorithm can get us part 2 of “Stranger Things 4” a week early.
Pay criminals, cut crime?
What is the best method for punishing those who commit wrongdoing? Fines? Jail time? Actually, no. A recent study says that financial compensation works best.
In other words, pay them for their actions. Really.
Psychologist Tage S. Rai, PhD, of the University of California, San Diego, Rady School of Management, found that people who hurt others or commit crimes are actually doing it because they think it’s the right thing to do. The results of this study say play at the angle of their morality. When that’s compromised, the offender is less likely to do it again.
Four different experiments were conducted using an online economics game with nearly 1,500 participants. Dr. Rai found that providing a monetary bonus for inflicting a punishment on a third party within the game cut the participants’ willingness to do it again by 50%.
“People punish others to signal their own goodness and receiving compensation might make it seem as though they’re driven by greed rather than justice,” he said.
The big deterrent, though, was negative judgment from peers. People in the study were even more hesitant to inflict harm and gain a profit if they thought they were going to be judged for it.
So maybe the answer to cutting crime isn’t as simple as slapping on a fine. It’s slapping on shame and paying them for it.
A conspiracy of chronobiologic proportions
The Golden State Warriors just won the NBA championship – that much is true – but we’ve got some news that you didn’t get from ESPN. The kind of news that their “partners” from the NBA didn’t want them to report. Unlike most conspiracy theories, however, this one has some science behind it.
In this case, science in the form of a study published in Frontiers in Physiology says that jet lag had a greater effect on the Boston Celtics than it did on the Warriors.
“Eastward travel – where the destination time is later than the origin time – requires the athlete to shorten their day (known as a phase advance). During phase advance, athletes often struggle to fall asleep at an earlier bedtime, leading to sleep loss and, consequently, potential impaired physiological performance and motivation the next day,” senior author Elise Facer-Childs, PhD, of Monash University, Melbourne, said in written statement.
Dr. Facer-Childs and associates took a very close look at 10 seasons’ worth of NBA games – 11,481 games, to be exact – and found “that eastward (but not westward) jet lag was associated with impaired performance for home (but not away) teams.” The existence of a pro-Western bias against teams that traveled eastward for their home games was clear:
- The chance of winning for eastern teams was reduced by 6.0%.
- They grabbed 1.3 fewer rebounds per game.
- Their field goal percentage was 1.2% lower.
And here’s the final nail in the conspiracy coffin: The NBA knew about the jet lag effect and changed the schedule of the finals in 2014 in a way that makes it worse. Before that, the higher-seeded team got two home games, then the lower-seeded team had three at home, followed by two more at the home of the higher seed. Now it’s a 2-2-1-1-1 arrangement that leads to more travel and, of course, more jet lag.
The study was published during the championship series, so the investigators suggested that the Celtics “might benefit from chronobiology-informed strategies designed to mitigate eastward jet lag symptomatology.”
So there you have it, sports fans/conspiracy theorists: You can’t chase Steph Curry around the court for 48 minutes without the right chronobiology-informed strategy. Everyone knows that.
Being hungry can alter your ‘type’
Fasting and being hungry can be a dangerous mix for becoming “hangry” and irritable, but did you know being hungry can also affect your attraction to other people?
Evidence has shown that being hungry can affect important things such as decision-making, memory, cognition, and function. It might affect decision-making in the sense that those six tacos at Taco Bell might win out over grilled chicken breast and veggies at home, but can hunger make you think that the person you just swiped right on isn’t really your type after all?
We’ll leave that up to Valentina Cazzato of Liverpool (England) John Moores University and associates, whose study involved 44 people, of whom 21 were women in their early 20s. The participants were shown computer-generated images of men and women of different sizes. The same background was used for each picture and all the expressions of the models were neutral. Participants were asked to rate each image on how much they liked it. One study was done on participants who had been fasting for 12 hours, and the second was done on those who had just eaten something.
The subjects generally preferred slim models over more rounded ones, but not after fasting. When they were hungry, they found the round human bodies and faces more attractive. So, yes, it’s definitely possible that hunger can alter your attraction to others.
“Future work might seek to elucidate the relationship between physiological states of hunger and shifts in appreciation of the human bodies and whether this relationship might be mediated by individual traits associated with to beholder’s body adiposity,” said researchers.
Chemotherapy, now streaming at just $15.99 a month!
It’s a lazy Sunday and you flip on Netflix, looking for something new to watch. There’s an almost-overwhelming number of shows out there, but right at the top of the recommended list is something that strikes your fancy right away. The algorithm behind the scenes is doing its job well, winnowing the universe of content right down to the few things you’ll find relevant, based on what you’ve watched and liked in the past.
Now, the almighty content algorithm is coming for something a little more useful than binge watching obscure 80s sitcoms: cancer treatment.
By plugging the fully sequenced genomes of nearly 10,000 patients with 33 different types of cancer into an algorithm powered by the same sort of artificial intelligence used by Netflix, researchers from London and San Diego found 21 common faults in the chromosomes of tumors, which they called copy number signatures. While cancer is a complex disease, when faults occur in those copy number signatures, the results were similar across the board. If X genetic defect occurs within a tumor, Y result will happen, even across cancer types. For example, tumors whose chromosomes had shattered and reformed had by far the worst disease outcomes.
The eventual hope is that, just as Netflix can predict what you’ll want to watch based on what you’ve already seen, oncologists will be able to predict the course of a cancer, based on the tumor’s early genetic traits, and get ahead of future genetic degradation to prevent the worst outcomes. A sort of “Oh, your tumor has enjoyed The Office. Might we suggest a treatment of 30 Rock” situation. Further research will be required to determine whether or not the cancer algorithm can get us part 2 of “Stranger Things 4” a week early.
Pay criminals, cut crime?
What is the best method for punishing those who commit wrongdoing? Fines? Jail time? Actually, no. A recent study says that financial compensation works best.
In other words, pay them for their actions. Really.
Psychologist Tage S. Rai, PhD, of the University of California, San Diego, Rady School of Management, found that people who hurt others or commit crimes are actually doing it because they think it’s the right thing to do. The results of this study say play at the angle of their morality. When that’s compromised, the offender is less likely to do it again.
Four different experiments were conducted using an online economics game with nearly 1,500 participants. Dr. Rai found that providing a monetary bonus for inflicting a punishment on a third party within the game cut the participants’ willingness to do it again by 50%.
“People punish others to signal their own goodness and receiving compensation might make it seem as though they’re driven by greed rather than justice,” he said.
The big deterrent, though, was negative judgment from peers. People in the study were even more hesitant to inflict harm and gain a profit if they thought they were going to be judged for it.
So maybe the answer to cutting crime isn’t as simple as slapping on a fine. It’s slapping on shame and paying them for it.
A conspiracy of chronobiologic proportions
The Golden State Warriors just won the NBA championship – that much is true – but we’ve got some news that you didn’t get from ESPN. The kind of news that their “partners” from the NBA didn’t want them to report. Unlike most conspiracy theories, however, this one has some science behind it.
In this case, science in the form of a study published in Frontiers in Physiology says that jet lag had a greater effect on the Boston Celtics than it did on the Warriors.
“Eastward travel – where the destination time is later than the origin time – requires the athlete to shorten their day (known as a phase advance). During phase advance, athletes often struggle to fall asleep at an earlier bedtime, leading to sleep loss and, consequently, potential impaired physiological performance and motivation the next day,” senior author Elise Facer-Childs, PhD, of Monash University, Melbourne, said in written statement.
Dr. Facer-Childs and associates took a very close look at 10 seasons’ worth of NBA games – 11,481 games, to be exact – and found “that eastward (but not westward) jet lag was associated with impaired performance for home (but not away) teams.” The existence of a pro-Western bias against teams that traveled eastward for their home games was clear:
- The chance of winning for eastern teams was reduced by 6.0%.
- They grabbed 1.3 fewer rebounds per game.
- Their field goal percentage was 1.2% lower.
And here’s the final nail in the conspiracy coffin: The NBA knew about the jet lag effect and changed the schedule of the finals in 2014 in a way that makes it worse. Before that, the higher-seeded team got two home games, then the lower-seeded team had three at home, followed by two more at the home of the higher seed. Now it’s a 2-2-1-1-1 arrangement that leads to more travel and, of course, more jet lag.
The study was published during the championship series, so the investigators suggested that the Celtics “might benefit from chronobiology-informed strategies designed to mitigate eastward jet lag symptomatology.”
So there you have it, sports fans/conspiracy theorists: You can’t chase Steph Curry around the court for 48 minutes without the right chronobiology-informed strategy. Everyone knows that.
Being hungry can alter your ‘type’
Fasting and being hungry can be a dangerous mix for becoming “hangry” and irritable, but did you know being hungry can also affect your attraction to other people?
Evidence has shown that being hungry can affect important things such as decision-making, memory, cognition, and function. It might affect decision-making in the sense that those six tacos at Taco Bell might win out over grilled chicken breast and veggies at home, but can hunger make you think that the person you just swiped right on isn’t really your type after all?
We’ll leave that up to Valentina Cazzato of Liverpool (England) John Moores University and associates, whose study involved 44 people, of whom 21 were women in their early 20s. The participants were shown computer-generated images of men and women of different sizes. The same background was used for each picture and all the expressions of the models were neutral. Participants were asked to rate each image on how much they liked it. One study was done on participants who had been fasting for 12 hours, and the second was done on those who had just eaten something.
The subjects generally preferred slim models over more rounded ones, but not after fasting. When they were hungry, they found the round human bodies and faces more attractive. So, yes, it’s definitely possible that hunger can alter your attraction to others.
“Future work might seek to elucidate the relationship between physiological states of hunger and shifts in appreciation of the human bodies and whether this relationship might be mediated by individual traits associated with to beholder’s body adiposity,” said researchers.
Chemotherapy, now streaming at just $15.99 a month!
It’s a lazy Sunday and you flip on Netflix, looking for something new to watch. There’s an almost-overwhelming number of shows out there, but right at the top of the recommended list is something that strikes your fancy right away. The algorithm behind the scenes is doing its job well, winnowing the universe of content right down to the few things you’ll find relevant, based on what you’ve watched and liked in the past.
Now, the almighty content algorithm is coming for something a little more useful than binge watching obscure 80s sitcoms: cancer treatment.
By plugging the fully sequenced genomes of nearly 10,000 patients with 33 different types of cancer into an algorithm powered by the same sort of artificial intelligence used by Netflix, researchers from London and San Diego found 21 common faults in the chromosomes of tumors, which they called copy number signatures. While cancer is a complex disease, when faults occur in those copy number signatures, the results were similar across the board. If X genetic defect occurs within a tumor, Y result will happen, even across cancer types. For example, tumors whose chromosomes had shattered and reformed had by far the worst disease outcomes.
The eventual hope is that, just as Netflix can predict what you’ll want to watch based on what you’ve already seen, oncologists will be able to predict the course of a cancer, based on the tumor’s early genetic traits, and get ahead of future genetic degradation to prevent the worst outcomes. A sort of “Oh, your tumor has enjoyed The Office. Might we suggest a treatment of 30 Rock” situation. Further research will be required to determine whether or not the cancer algorithm can get us part 2 of “Stranger Things 4” a week early.
Pay criminals, cut crime?
What is the best method for punishing those who commit wrongdoing? Fines? Jail time? Actually, no. A recent study says that financial compensation works best.
In other words, pay them for their actions. Really.
Psychologist Tage S. Rai, PhD, of the University of California, San Diego, Rady School of Management, found that people who hurt others or commit crimes are actually doing it because they think it’s the right thing to do. The results of this study say play at the angle of their morality. When that’s compromised, the offender is less likely to do it again.
Four different experiments were conducted using an online economics game with nearly 1,500 participants. Dr. Rai found that providing a monetary bonus for inflicting a punishment on a third party within the game cut the participants’ willingness to do it again by 50%.
“People punish others to signal their own goodness and receiving compensation might make it seem as though they’re driven by greed rather than justice,” he said.
The big deterrent, though, was negative judgment from peers. People in the study were even more hesitant to inflict harm and gain a profit if they thought they were going to be judged for it.
So maybe the answer to cutting crime isn’t as simple as slapping on a fine. It’s slapping on shame and paying them for it.
A conspiracy of chronobiologic proportions
The Golden State Warriors just won the NBA championship – that much is true – but we’ve got some news that you didn’t get from ESPN. The kind of news that their “partners” from the NBA didn’t want them to report. Unlike most conspiracy theories, however, this one has some science behind it.
In this case, science in the form of a study published in Frontiers in Physiology says that jet lag had a greater effect on the Boston Celtics than it did on the Warriors.
“Eastward travel – where the destination time is later than the origin time – requires the athlete to shorten their day (known as a phase advance). During phase advance, athletes often struggle to fall asleep at an earlier bedtime, leading to sleep loss and, consequently, potential impaired physiological performance and motivation the next day,” senior author Elise Facer-Childs, PhD, of Monash University, Melbourne, said in written statement.
Dr. Facer-Childs and associates took a very close look at 10 seasons’ worth of NBA games – 11,481 games, to be exact – and found “that eastward (but not westward) jet lag was associated with impaired performance for home (but not away) teams.” The existence of a pro-Western bias against teams that traveled eastward for their home games was clear:
- The chance of winning for eastern teams was reduced by 6.0%.
- They grabbed 1.3 fewer rebounds per game.
- Their field goal percentage was 1.2% lower.
And here’s the final nail in the conspiracy coffin: The NBA knew about the jet lag effect and changed the schedule of the finals in 2014 in a way that makes it worse. Before that, the higher-seeded team got two home games, then the lower-seeded team had three at home, followed by two more at the home of the higher seed. Now it’s a 2-2-1-1-1 arrangement that leads to more travel and, of course, more jet lag.
The study was published during the championship series, so the investigators suggested that the Celtics “might benefit from chronobiology-informed strategies designed to mitigate eastward jet lag symptomatology.”
So there you have it, sports fans/conspiracy theorists: You can’t chase Steph Curry around the court for 48 minutes without the right chronobiology-informed strategy. Everyone knows that.
Being hungry can alter your ‘type’
Fasting and being hungry can be a dangerous mix for becoming “hangry” and irritable, but did you know being hungry can also affect your attraction to other people?
Evidence has shown that being hungry can affect important things such as decision-making, memory, cognition, and function. It might affect decision-making in the sense that those six tacos at Taco Bell might win out over grilled chicken breast and veggies at home, but can hunger make you think that the person you just swiped right on isn’t really your type after all?
We’ll leave that up to Valentina Cazzato of Liverpool (England) John Moores University and associates, whose study involved 44 people, of whom 21 were women in their early 20s. The participants were shown computer-generated images of men and women of different sizes. The same background was used for each picture and all the expressions of the models were neutral. Participants were asked to rate each image on how much they liked it. One study was done on participants who had been fasting for 12 hours, and the second was done on those who had just eaten something.
The subjects generally preferred slim models over more rounded ones, but not after fasting. When they were hungry, they found the round human bodies and faces more attractive. So, yes, it’s definitely possible that hunger can alter your attraction to others.
“Future work might seek to elucidate the relationship between physiological states of hunger and shifts in appreciation of the human bodies and whether this relationship might be mediated by individual traits associated with to beholder’s body adiposity,” said researchers.
Biden moves to limit nicotine levels in cigarettes
The Department of Health and Human Services posted a notice that details plans for a new rule to create a maximum allowed amount of nicotine in certain tobacco products. The Food and Drug Administration would take the action, the notice said, “to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit.” The product standard would also help keep nonsmokers interested in trying tobacco, mainly youth, from starting to smoke and become regulars.
“Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,” FDA Commissioner Robert Califf, MD, said in a statement.
The FDA, in charge of regulating cigarettes, issues a proposed rule when changes are discussed. That would be followed by a period for public comments before a final rule could be issued.
The proposed rule was first reported by The Washington Post.
The FDA in 2018 published a study in the New England Journal of Medicine that estimated that a potential limit on nicotine in cigarettes could, by the year 2100, prevent more than 33 million people from becoming regular smokers, and prevent the deaths of more than 8 million people from tobacco-related illnesses.
The action to reduce nicotine levels would fit in with President Joe Biden’s goal of reducing cancer death rates by half over 25 years. Each year, according to the American Cancer Society, about 480,000 deaths (about 1 in 5) are related to smoking. Currently, about 34 million American adults still smoke cigarettes.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the proposed rule a “truly game-changing proposal.”
“There is no other single action our country can take that would prevent more young people from becoming addicted to tobacco or have a greater impact on reducing deaths from cancer, cardiovascular disease and respiratory disease,” Mr. Myers said in a statement.
However, he said, “these gains will only be realized if the administration and the FDA demonstrate a full-throated commitment to finalizing and implementing this proposal.”
The FDA proposed the nicotine reduction strategy in talks with the White House and the Department of Health and Human Services early in 2021, according to the Post.
Earlier this year, the FDA issued a proposed rule to ban menthol flavoring in cigarettes. The agency is accepting public comments though July 5.
The action of reducing nicotine levels would likely take years to complete, Mitch Zeller, JD, recently retired director of the FDA Center for Tobacco Products, told the Post.
In 2018, the FDA issued a proposed ruling to set a standard for maximum nicotine levels in cigarettes.
Advocates say the action of slashing nicotine, the active – and addictive – ingredient in cigarettes, would save millions of lives for generations to come. Opponents liken it to the prohibition of alcohol in the 1920s and predict the action will fail.
Others say that if limits are put on nicotine levels, adults should have greater access to noncombustible alternatives.
A version of this article first appeared on WebMD.com.
The Department of Health and Human Services posted a notice that details plans for a new rule to create a maximum allowed amount of nicotine in certain tobacco products. The Food and Drug Administration would take the action, the notice said, “to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit.” The product standard would also help keep nonsmokers interested in trying tobacco, mainly youth, from starting to smoke and become regulars.
“Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,” FDA Commissioner Robert Califf, MD, said in a statement.
The FDA, in charge of regulating cigarettes, issues a proposed rule when changes are discussed. That would be followed by a period for public comments before a final rule could be issued.
The proposed rule was first reported by The Washington Post.
The FDA in 2018 published a study in the New England Journal of Medicine that estimated that a potential limit on nicotine in cigarettes could, by the year 2100, prevent more than 33 million people from becoming regular smokers, and prevent the deaths of more than 8 million people from tobacco-related illnesses.
The action to reduce nicotine levels would fit in with President Joe Biden’s goal of reducing cancer death rates by half over 25 years. Each year, according to the American Cancer Society, about 480,000 deaths (about 1 in 5) are related to smoking. Currently, about 34 million American adults still smoke cigarettes.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the proposed rule a “truly game-changing proposal.”
“There is no other single action our country can take that would prevent more young people from becoming addicted to tobacco or have a greater impact on reducing deaths from cancer, cardiovascular disease and respiratory disease,” Mr. Myers said in a statement.
However, he said, “these gains will only be realized if the administration and the FDA demonstrate a full-throated commitment to finalizing and implementing this proposal.”
The FDA proposed the nicotine reduction strategy in talks with the White House and the Department of Health and Human Services early in 2021, according to the Post.
Earlier this year, the FDA issued a proposed rule to ban menthol flavoring in cigarettes. The agency is accepting public comments though July 5.
The action of reducing nicotine levels would likely take years to complete, Mitch Zeller, JD, recently retired director of the FDA Center for Tobacco Products, told the Post.
In 2018, the FDA issued a proposed ruling to set a standard for maximum nicotine levels in cigarettes.
Advocates say the action of slashing nicotine, the active – and addictive – ingredient in cigarettes, would save millions of lives for generations to come. Opponents liken it to the prohibition of alcohol in the 1920s and predict the action will fail.
Others say that if limits are put on nicotine levels, adults should have greater access to noncombustible alternatives.
A version of this article first appeared on WebMD.com.
The Department of Health and Human Services posted a notice that details plans for a new rule to create a maximum allowed amount of nicotine in certain tobacco products. The Food and Drug Administration would take the action, the notice said, “to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit.” The product standard would also help keep nonsmokers interested in trying tobacco, mainly youth, from starting to smoke and become regulars.
“Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit,” FDA Commissioner Robert Califf, MD, said in a statement.
The FDA, in charge of regulating cigarettes, issues a proposed rule when changes are discussed. That would be followed by a period for public comments before a final rule could be issued.
The proposed rule was first reported by The Washington Post.
The FDA in 2018 published a study in the New England Journal of Medicine that estimated that a potential limit on nicotine in cigarettes could, by the year 2100, prevent more than 33 million people from becoming regular smokers, and prevent the deaths of more than 8 million people from tobacco-related illnesses.
The action to reduce nicotine levels would fit in with President Joe Biden’s goal of reducing cancer death rates by half over 25 years. Each year, according to the American Cancer Society, about 480,000 deaths (about 1 in 5) are related to smoking. Currently, about 34 million American adults still smoke cigarettes.
Matthew Myers, president of the Campaign for Tobacco-Free Kids, called the proposed rule a “truly game-changing proposal.”
“There is no other single action our country can take that would prevent more young people from becoming addicted to tobacco or have a greater impact on reducing deaths from cancer, cardiovascular disease and respiratory disease,” Mr. Myers said in a statement.
However, he said, “these gains will only be realized if the administration and the FDA demonstrate a full-throated commitment to finalizing and implementing this proposal.”
The FDA proposed the nicotine reduction strategy in talks with the White House and the Department of Health and Human Services early in 2021, according to the Post.
Earlier this year, the FDA issued a proposed rule to ban menthol flavoring in cigarettes. The agency is accepting public comments though July 5.
The action of reducing nicotine levels would likely take years to complete, Mitch Zeller, JD, recently retired director of the FDA Center for Tobacco Products, told the Post.
In 2018, the FDA issued a proposed ruling to set a standard for maximum nicotine levels in cigarettes.
Advocates say the action of slashing nicotine, the active – and addictive – ingredient in cigarettes, would save millions of lives for generations to come. Opponents liken it to the prohibition of alcohol in the 1920s and predict the action will fail.
Others say that if limits are put on nicotine levels, adults should have greater access to noncombustible alternatives.
A version of this article first appeared on WebMD.com.
FDA okays cancer drugs faster than EMA. But at what cost?
Over the past decade, the U.S. Food and Drug Administration has approved new cancer drugs twice as fast as the European Medicines Agency (EMA), often using accelerated pathways, a new analysis shows.
Between 2010 and 2019, the FDA approved almost all oncology therapies ahead of the EMA. Drugs entered the United States market about 8 months (241 days) before European market authorization.
“The faster FDA approval process potentially provides earlier access to potentially life-prolonging medications for patients with cancer in the United States,” Ali Raza Khaki, MD, department of oncology, Stanford (Calif.) University School of Medicine, told this news organization. “On the surface, this is a good thing. However, it comes with limitations.”
Earlier drug approval often means greater uncertainty about an agent’s benefit – most notably, whether it will improve a patient’s survival or quality of life. Dr. Khaki pointed to a study published in JAMA Internal Medicine, which found that only 19 of 93 (20%) cancer drugs that had been recently approved through the FDA’s accelerated approval pathway demonstrated an improvement in overall survival.
In the new study, published online in JAMA Network Open, Dr. Khaki and colleagues found that among the 89 cancer drugs approved in the United States and Europe between January 2010 and December 2019, the FDA approved 85 (95%) before European authorization and four (5%) after.
The researchers found that the median FDA review time was half that of the EMA’s (200 vs. 426 days). Furthermore, 64 new drug applications (72%) were submitted to the FDA first, compared with 21 (23%) to the EMA.
Of the drugs approved through an accelerated pathway, three were ultimately pulled from the U.S. market, compared with one in Europe.
“These early drug approvals that later lead to withdrawal expose many more patients to toxicity, including financial toxicity, given the high cost of cancer medications,” Dr. Khaki commented.
In addition, 35 oncology therapies (39%) were approved by the FDA before trial results were published, compared with only eight (9%) by the EMA. Although FDA drug labels contain some information about efficacy and toxicity, scientific publications often have much more, including details about study populations and toxicities.
“Without this information, providers may be limited in their knowledge about patient selection, clinical benefit, and optimal toxicity management,” Dr. Khaki said.
Jeff Allen PhD, president and CEO of the nonprofit Friends of Cancer Research, who wasn’t involved in the study, believes that an FDA approval before publication shouldn’t be “particularly concerning.”
“Peer-reviewed publication is an important component of validating and communicating scientific findings, but the processes and time lines for individual journals can be highly variable,” he said. “I don’t think we would want to see a situation where potential beneficial treatments are held up due to unrelated publication processes.”
The author of an invited commentary in JAMA Network Open had a different take on the study findings.
“A tempting interpretation” of this study is that the FDA is a “superior agency for expedited review times that bring cancer drugs to patients earlier,” Kristina Jenei, BSN, MSc, with the University of British Columbia School of Population and Public Health, writes. In addition, the fact that more drugs were pulled from the market after approval in the United States than in Europe could be interpreted to mean that the system is working as it should.
Although the speed of FDA reviews and the number of subsequent approvals have increased over time, the proportion of cancer drugs that improve survival has declined. In addition, because the FDA’s follow-up of postmarketing studies has been “inconsistent,” a substantial number of cancer drugs that were approved through accelerated pathways have remained on the market for years without confirmation of their benefit.
Although regulatory agencies must balance earlier patient access to novel treatments with evidence that the therapies are effective and safe, “faster review times and approvals are not cause for celebration; better patient outcomes are,” Ms. Jenei writes. “In other words, quality over quantity.”
The study was supported by the National Cancer Institute. Dr. Khaki reported stock ownership from Merck and stock ownership from Sanofi outside the submitted work. Dr. Allen and Ms. Jenei have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Over the past decade, the U.S. Food and Drug Administration has approved new cancer drugs twice as fast as the European Medicines Agency (EMA), often using accelerated pathways, a new analysis shows.
Between 2010 and 2019, the FDA approved almost all oncology therapies ahead of the EMA. Drugs entered the United States market about 8 months (241 days) before European market authorization.
“The faster FDA approval process potentially provides earlier access to potentially life-prolonging medications for patients with cancer in the United States,” Ali Raza Khaki, MD, department of oncology, Stanford (Calif.) University School of Medicine, told this news organization. “On the surface, this is a good thing. However, it comes with limitations.”
Earlier drug approval often means greater uncertainty about an agent’s benefit – most notably, whether it will improve a patient’s survival or quality of life. Dr. Khaki pointed to a study published in JAMA Internal Medicine, which found that only 19 of 93 (20%) cancer drugs that had been recently approved through the FDA’s accelerated approval pathway demonstrated an improvement in overall survival.
In the new study, published online in JAMA Network Open, Dr. Khaki and colleagues found that among the 89 cancer drugs approved in the United States and Europe between January 2010 and December 2019, the FDA approved 85 (95%) before European authorization and four (5%) after.
The researchers found that the median FDA review time was half that of the EMA’s (200 vs. 426 days). Furthermore, 64 new drug applications (72%) were submitted to the FDA first, compared with 21 (23%) to the EMA.
Of the drugs approved through an accelerated pathway, three were ultimately pulled from the U.S. market, compared with one in Europe.
“These early drug approvals that later lead to withdrawal expose many more patients to toxicity, including financial toxicity, given the high cost of cancer medications,” Dr. Khaki commented.
In addition, 35 oncology therapies (39%) were approved by the FDA before trial results were published, compared with only eight (9%) by the EMA. Although FDA drug labels contain some information about efficacy and toxicity, scientific publications often have much more, including details about study populations and toxicities.
“Without this information, providers may be limited in their knowledge about patient selection, clinical benefit, and optimal toxicity management,” Dr. Khaki said.
Jeff Allen PhD, president and CEO of the nonprofit Friends of Cancer Research, who wasn’t involved in the study, believes that an FDA approval before publication shouldn’t be “particularly concerning.”
“Peer-reviewed publication is an important component of validating and communicating scientific findings, but the processes and time lines for individual journals can be highly variable,” he said. “I don’t think we would want to see a situation where potential beneficial treatments are held up due to unrelated publication processes.”
The author of an invited commentary in JAMA Network Open had a different take on the study findings.
“A tempting interpretation” of this study is that the FDA is a “superior agency for expedited review times that bring cancer drugs to patients earlier,” Kristina Jenei, BSN, MSc, with the University of British Columbia School of Population and Public Health, writes. In addition, the fact that more drugs were pulled from the market after approval in the United States than in Europe could be interpreted to mean that the system is working as it should.
Although the speed of FDA reviews and the number of subsequent approvals have increased over time, the proportion of cancer drugs that improve survival has declined. In addition, because the FDA’s follow-up of postmarketing studies has been “inconsistent,” a substantial number of cancer drugs that were approved through accelerated pathways have remained on the market for years without confirmation of their benefit.
Although regulatory agencies must balance earlier patient access to novel treatments with evidence that the therapies are effective and safe, “faster review times and approvals are not cause for celebration; better patient outcomes are,” Ms. Jenei writes. “In other words, quality over quantity.”
The study was supported by the National Cancer Institute. Dr. Khaki reported stock ownership from Merck and stock ownership from Sanofi outside the submitted work. Dr. Allen and Ms. Jenei have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Over the past decade, the U.S. Food and Drug Administration has approved new cancer drugs twice as fast as the European Medicines Agency (EMA), often using accelerated pathways, a new analysis shows.
Between 2010 and 2019, the FDA approved almost all oncology therapies ahead of the EMA. Drugs entered the United States market about 8 months (241 days) before European market authorization.
“The faster FDA approval process potentially provides earlier access to potentially life-prolonging medications for patients with cancer in the United States,” Ali Raza Khaki, MD, department of oncology, Stanford (Calif.) University School of Medicine, told this news organization. “On the surface, this is a good thing. However, it comes with limitations.”
Earlier drug approval often means greater uncertainty about an agent’s benefit – most notably, whether it will improve a patient’s survival or quality of life. Dr. Khaki pointed to a study published in JAMA Internal Medicine, which found that only 19 of 93 (20%) cancer drugs that had been recently approved through the FDA’s accelerated approval pathway demonstrated an improvement in overall survival.
In the new study, published online in JAMA Network Open, Dr. Khaki and colleagues found that among the 89 cancer drugs approved in the United States and Europe between January 2010 and December 2019, the FDA approved 85 (95%) before European authorization and four (5%) after.
The researchers found that the median FDA review time was half that of the EMA’s (200 vs. 426 days). Furthermore, 64 new drug applications (72%) were submitted to the FDA first, compared with 21 (23%) to the EMA.
Of the drugs approved through an accelerated pathway, three were ultimately pulled from the U.S. market, compared with one in Europe.
“These early drug approvals that later lead to withdrawal expose many more patients to toxicity, including financial toxicity, given the high cost of cancer medications,” Dr. Khaki commented.
In addition, 35 oncology therapies (39%) were approved by the FDA before trial results were published, compared with only eight (9%) by the EMA. Although FDA drug labels contain some information about efficacy and toxicity, scientific publications often have much more, including details about study populations and toxicities.
“Without this information, providers may be limited in their knowledge about patient selection, clinical benefit, and optimal toxicity management,” Dr. Khaki said.
Jeff Allen PhD, president and CEO of the nonprofit Friends of Cancer Research, who wasn’t involved in the study, believes that an FDA approval before publication shouldn’t be “particularly concerning.”
“Peer-reviewed publication is an important component of validating and communicating scientific findings, but the processes and time lines for individual journals can be highly variable,” he said. “I don’t think we would want to see a situation where potential beneficial treatments are held up due to unrelated publication processes.”
The author of an invited commentary in JAMA Network Open had a different take on the study findings.
“A tempting interpretation” of this study is that the FDA is a “superior agency for expedited review times that bring cancer drugs to patients earlier,” Kristina Jenei, BSN, MSc, with the University of British Columbia School of Population and Public Health, writes. In addition, the fact that more drugs were pulled from the market after approval in the United States than in Europe could be interpreted to mean that the system is working as it should.
Although the speed of FDA reviews and the number of subsequent approvals have increased over time, the proportion of cancer drugs that improve survival has declined. In addition, because the FDA’s follow-up of postmarketing studies has been “inconsistent,” a substantial number of cancer drugs that were approved through accelerated pathways have remained on the market for years without confirmation of their benefit.
Although regulatory agencies must balance earlier patient access to novel treatments with evidence that the therapies are effective and safe, “faster review times and approvals are not cause for celebration; better patient outcomes are,” Ms. Jenei writes. “In other words, quality over quantity.”
The study was supported by the National Cancer Institute. Dr. Khaki reported stock ownership from Merck and stock ownership from Sanofi outside the submitted work. Dr. Allen and Ms. Jenei have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN