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Does microneedling have a role in aesthetics?
AT MOAS 2017
SAN DIEGO – When Jill S. Waibel, MD, first saw a dermal roller microneedling device around 2004, it reminded her of a weapon that might be conjured up by the character Dr. Kaufman, a professional assassin who appeared in the 1997 James Bond film, “Tomorrow Never Dies.”
“I’m thinking, that thing looks super painful,” Dr. Waibel said at the annual Masters of Aesthetics Symposium.
Patients seek microneedling treatments to rejuvenate skin; to treat acne scarring, other scars, striae, and rhytides; and to improve pigmentation. Its mechanism of action remains elusive. The hypothesis for microneedling’s effects on superficial rhytides, the wound that it creates induces production of new collagen and that multiple tiny wounds in the skin stimulate the release of various growth factors that play a role in collagen synthesis. When used on atrophic scars, the hypothesis is that microneedling breaks apart collagen bundles in the superficial layer of the dermis while inducing production of collagen. Authors of a recent systematic review on the topic found that the procedure showed noteworthy results on its own, particularly when combined with radio-frequency features (J Plast Reconstr Aesthet Surg. 2017 Jun 17. pii: S1748-6815[17]30250-4. doi: 10.1016/j.bjps.2017.06.006).
“However, there were shortcomings with most of the research: There were small numbers of patients, studies that were not randomized, not controlled, and further research is needed to see if microneedling truly works,” said Dr. Waibel, who was not involved with the analysis.
Microneedling devices come in many forms, including manual rollers, fixed-needle rollers, electric-powered pens, and devices with a new light-emitting microneedling technology. Of the five devices currently cleared by the Food and Drug Administration, four feature bipolar radio frequency and insulated needles, while one is a bipolar radio-frequency device (Infini) that contains noninsulated needles. Dr. Waibel favors the electric-powered pens, such as the StrataPen and the Eclipse MicroPen, that enable the user to adjust operating speed and penetration depths from 0.5 mm-3.0 mm, as well as feature disposable needle tips and disposable needles. These devices allow the depth of penetration to be changed according to what part of the face is being treated: “So on thinner areas of the face, like the forehead and the nose, you’re going to treat with a depth of 0.5 mm-1.0 mm, whereas in thicker areas, like the cheeks, you go up to 3.0 mm,” she said. “Typically, we do vertical and horizontal passes, repeating three to six times. When you see pinpoint bleeding, that’s the sign to stop. You can stop prior to that as well.”
One split-face study compared microneedling with nonablative fractional laser in 30 patients with atrophic scars, who underwent five sessions 1 month apart. (Dermatol Surg 2017; 43:S47-56). At 3 months, the side of the face treated with the laser showed a 70% improvement, compared with 30% for the side treated with microneedling (P less than .001). The researchers observed significantly lower pain scores with the laser procedure, but microneedling had a significantly shorter down time. A separate study of 12 healthy adults found that pretreatment with an ablative fractional laser significantly intensifies protoporphyrin IX fluorescence to a larger extent than curettage, microdermabrasion, microneedling, and nonablative fractional laser (JAMA Derm. 2017;153[4]:270-8). “So the message is that lasers are still superior, but there may be a role for microneedling,” Dr. Waibel said.
Since she began dabbling with microneedling in her practice over the past year, Dr. Waibel has found it is a good option for younger patients and for patients who desire little to no recovery time. “These are not expensive procedures for someone who doesn’t have a lot of skin damage,” she said. “It’s also good for difficult indications to improve, like striae. If I charge patients a few hundred dollars for a laser treatment, maybe I can do two or three follow-ups with the microneedle to stimulate collagen. This has become one of my go-tos with the radio-frequency device. I’ll do one fractional ablative laser treatment, then I’ll do two of the radiofrequency microneedle devices 1 and 2 months later. Then I’ll reassess to see what they need next. Or you might tweak [the course of treatment] after isolated laser treatments.”
Using a microneedle device requires meticulous cleaning of the intended treatment area prior to the procedure to avoid introducing bacteria or makeup into the skin. Dr. Waibel uses topical anesthesia for 20-30 minutes and then applies hyaluronic acid gel on the treatment surface to facilitate the gliding action of the device. “The technique involves perpendicular device placement with manual skin traction for smooth delivery of microneedles, going in vertical, horizontal, and oblique motions,” she explained. “Pinpoint bleeding is your guide for the pens. You don’t get pinpoint bleeding with some of the actual devices. Use manual pressure with ice and water to stop the bleeding.”
Contraindications for microneedling include patients with an active infection (such as herpes labialis), acne, and a predisposition for keloid scarring. Caution is advised with concomitant use of topical products of any type during a microneedling procedure because of the risk of granuloma formation. In 2014, researchers published a case series of three patients who developed biopsy-proven foreign body granulomas after the application of topical products during microneedling, including two cases that involved topical vitamin C (JAMA Dermatol 2014;150[1]:68-72).
“These are new devices, and we have new questions,” Dr. Waibel concluded. “I think they have a role, but we don’t fully understand the mechanism of action, and we have to be very careful about putting pharmacology down these channels. We don’t know the best treatment intervals, and we don’t know the best devices,” she added, pointing out that many of the devices have no indications cleared by the FDA yet.
She also noted that the FDA has put a hold on many microneedling devices from being sold in the United States until appropriate safety and efficacy data are collected.
Dr. Waibel disclosed that she has conducted clinical research for Strata Sciences, Aquavit, and Lutronic. She is also a member of the advisory board for Lutronic.
AT MOAS 2017
SAN DIEGO – When Jill S. Waibel, MD, first saw a dermal roller microneedling device around 2004, it reminded her of a weapon that might be conjured up by the character Dr. Kaufman, a professional assassin who appeared in the 1997 James Bond film, “Tomorrow Never Dies.”
“I’m thinking, that thing looks super painful,” Dr. Waibel said at the annual Masters of Aesthetics Symposium.
Patients seek microneedling treatments to rejuvenate skin; to treat acne scarring, other scars, striae, and rhytides; and to improve pigmentation. Its mechanism of action remains elusive. The hypothesis for microneedling’s effects on superficial rhytides, the wound that it creates induces production of new collagen and that multiple tiny wounds in the skin stimulate the release of various growth factors that play a role in collagen synthesis. When used on atrophic scars, the hypothesis is that microneedling breaks apart collagen bundles in the superficial layer of the dermis while inducing production of collagen. Authors of a recent systematic review on the topic found that the procedure showed noteworthy results on its own, particularly when combined with radio-frequency features (J Plast Reconstr Aesthet Surg. 2017 Jun 17. pii: S1748-6815[17]30250-4. doi: 10.1016/j.bjps.2017.06.006).
“However, there were shortcomings with most of the research: There were small numbers of patients, studies that were not randomized, not controlled, and further research is needed to see if microneedling truly works,” said Dr. Waibel, who was not involved with the analysis.
Microneedling devices come in many forms, including manual rollers, fixed-needle rollers, electric-powered pens, and devices with a new light-emitting microneedling technology. Of the five devices currently cleared by the Food and Drug Administration, four feature bipolar radio frequency and insulated needles, while one is a bipolar radio-frequency device (Infini) that contains noninsulated needles. Dr. Waibel favors the electric-powered pens, such as the StrataPen and the Eclipse MicroPen, that enable the user to adjust operating speed and penetration depths from 0.5 mm-3.0 mm, as well as feature disposable needle tips and disposable needles. These devices allow the depth of penetration to be changed according to what part of the face is being treated: “So on thinner areas of the face, like the forehead and the nose, you’re going to treat with a depth of 0.5 mm-1.0 mm, whereas in thicker areas, like the cheeks, you go up to 3.0 mm,” she said. “Typically, we do vertical and horizontal passes, repeating three to six times. When you see pinpoint bleeding, that’s the sign to stop. You can stop prior to that as well.”
One split-face study compared microneedling with nonablative fractional laser in 30 patients with atrophic scars, who underwent five sessions 1 month apart. (Dermatol Surg 2017; 43:S47-56). At 3 months, the side of the face treated with the laser showed a 70% improvement, compared with 30% for the side treated with microneedling (P less than .001). The researchers observed significantly lower pain scores with the laser procedure, but microneedling had a significantly shorter down time. A separate study of 12 healthy adults found that pretreatment with an ablative fractional laser significantly intensifies protoporphyrin IX fluorescence to a larger extent than curettage, microdermabrasion, microneedling, and nonablative fractional laser (JAMA Derm. 2017;153[4]:270-8). “So the message is that lasers are still superior, but there may be a role for microneedling,” Dr. Waibel said.
Since she began dabbling with microneedling in her practice over the past year, Dr. Waibel has found it is a good option for younger patients and for patients who desire little to no recovery time. “These are not expensive procedures for someone who doesn’t have a lot of skin damage,” she said. “It’s also good for difficult indications to improve, like striae. If I charge patients a few hundred dollars for a laser treatment, maybe I can do two or three follow-ups with the microneedle to stimulate collagen. This has become one of my go-tos with the radio-frequency device. I’ll do one fractional ablative laser treatment, then I’ll do two of the radiofrequency microneedle devices 1 and 2 months later. Then I’ll reassess to see what they need next. Or you might tweak [the course of treatment] after isolated laser treatments.”
Using a microneedle device requires meticulous cleaning of the intended treatment area prior to the procedure to avoid introducing bacteria or makeup into the skin. Dr. Waibel uses topical anesthesia for 20-30 minutes and then applies hyaluronic acid gel on the treatment surface to facilitate the gliding action of the device. “The technique involves perpendicular device placement with manual skin traction for smooth delivery of microneedles, going in vertical, horizontal, and oblique motions,” she explained. “Pinpoint bleeding is your guide for the pens. You don’t get pinpoint bleeding with some of the actual devices. Use manual pressure with ice and water to stop the bleeding.”
Contraindications for microneedling include patients with an active infection (such as herpes labialis), acne, and a predisposition for keloid scarring. Caution is advised with concomitant use of topical products of any type during a microneedling procedure because of the risk of granuloma formation. In 2014, researchers published a case series of three patients who developed biopsy-proven foreign body granulomas after the application of topical products during microneedling, including two cases that involved topical vitamin C (JAMA Dermatol 2014;150[1]:68-72).
“These are new devices, and we have new questions,” Dr. Waibel concluded. “I think they have a role, but we don’t fully understand the mechanism of action, and we have to be very careful about putting pharmacology down these channels. We don’t know the best treatment intervals, and we don’t know the best devices,” she added, pointing out that many of the devices have no indications cleared by the FDA yet.
She also noted that the FDA has put a hold on many microneedling devices from being sold in the United States until appropriate safety and efficacy data are collected.
Dr. Waibel disclosed that she has conducted clinical research for Strata Sciences, Aquavit, and Lutronic. She is also a member of the advisory board for Lutronic.
AT MOAS 2017
SAN DIEGO – When Jill S. Waibel, MD, first saw a dermal roller microneedling device around 2004, it reminded her of a weapon that might be conjured up by the character Dr. Kaufman, a professional assassin who appeared in the 1997 James Bond film, “Tomorrow Never Dies.”
“I’m thinking, that thing looks super painful,” Dr. Waibel said at the annual Masters of Aesthetics Symposium.
Patients seek microneedling treatments to rejuvenate skin; to treat acne scarring, other scars, striae, and rhytides; and to improve pigmentation. Its mechanism of action remains elusive. The hypothesis for microneedling’s effects on superficial rhytides, the wound that it creates induces production of new collagen and that multiple tiny wounds in the skin stimulate the release of various growth factors that play a role in collagen synthesis. When used on atrophic scars, the hypothesis is that microneedling breaks apart collagen bundles in the superficial layer of the dermis while inducing production of collagen. Authors of a recent systematic review on the topic found that the procedure showed noteworthy results on its own, particularly when combined with radio-frequency features (J Plast Reconstr Aesthet Surg. 2017 Jun 17. pii: S1748-6815[17]30250-4. doi: 10.1016/j.bjps.2017.06.006).
“However, there were shortcomings with most of the research: There were small numbers of patients, studies that were not randomized, not controlled, and further research is needed to see if microneedling truly works,” said Dr. Waibel, who was not involved with the analysis.
Microneedling devices come in many forms, including manual rollers, fixed-needle rollers, electric-powered pens, and devices with a new light-emitting microneedling technology. Of the five devices currently cleared by the Food and Drug Administration, four feature bipolar radio frequency and insulated needles, while one is a bipolar radio-frequency device (Infini) that contains noninsulated needles. Dr. Waibel favors the electric-powered pens, such as the StrataPen and the Eclipse MicroPen, that enable the user to adjust operating speed and penetration depths from 0.5 mm-3.0 mm, as well as feature disposable needle tips and disposable needles. These devices allow the depth of penetration to be changed according to what part of the face is being treated: “So on thinner areas of the face, like the forehead and the nose, you’re going to treat with a depth of 0.5 mm-1.0 mm, whereas in thicker areas, like the cheeks, you go up to 3.0 mm,” she said. “Typically, we do vertical and horizontal passes, repeating three to six times. When you see pinpoint bleeding, that’s the sign to stop. You can stop prior to that as well.”
One split-face study compared microneedling with nonablative fractional laser in 30 patients with atrophic scars, who underwent five sessions 1 month apart. (Dermatol Surg 2017; 43:S47-56). At 3 months, the side of the face treated with the laser showed a 70% improvement, compared with 30% for the side treated with microneedling (P less than .001). The researchers observed significantly lower pain scores with the laser procedure, but microneedling had a significantly shorter down time. A separate study of 12 healthy adults found that pretreatment with an ablative fractional laser significantly intensifies protoporphyrin IX fluorescence to a larger extent than curettage, microdermabrasion, microneedling, and nonablative fractional laser (JAMA Derm. 2017;153[4]:270-8). “So the message is that lasers are still superior, but there may be a role for microneedling,” Dr. Waibel said.
Since she began dabbling with microneedling in her practice over the past year, Dr. Waibel has found it is a good option for younger patients and for patients who desire little to no recovery time. “These are not expensive procedures for someone who doesn’t have a lot of skin damage,” she said. “It’s also good for difficult indications to improve, like striae. If I charge patients a few hundred dollars for a laser treatment, maybe I can do two or three follow-ups with the microneedle to stimulate collagen. This has become one of my go-tos with the radio-frequency device. I’ll do one fractional ablative laser treatment, then I’ll do two of the radiofrequency microneedle devices 1 and 2 months later. Then I’ll reassess to see what they need next. Or you might tweak [the course of treatment] after isolated laser treatments.”
Using a microneedle device requires meticulous cleaning of the intended treatment area prior to the procedure to avoid introducing bacteria or makeup into the skin. Dr. Waibel uses topical anesthesia for 20-30 minutes and then applies hyaluronic acid gel on the treatment surface to facilitate the gliding action of the device. “The technique involves perpendicular device placement with manual skin traction for smooth delivery of microneedles, going in vertical, horizontal, and oblique motions,” she explained. “Pinpoint bleeding is your guide for the pens. You don’t get pinpoint bleeding with some of the actual devices. Use manual pressure with ice and water to stop the bleeding.”
Contraindications for microneedling include patients with an active infection (such as herpes labialis), acne, and a predisposition for keloid scarring. Caution is advised with concomitant use of topical products of any type during a microneedling procedure because of the risk of granuloma formation. In 2014, researchers published a case series of three patients who developed biopsy-proven foreign body granulomas after the application of topical products during microneedling, including two cases that involved topical vitamin C (JAMA Dermatol 2014;150[1]:68-72).
“These are new devices, and we have new questions,” Dr. Waibel concluded. “I think they have a role, but we don’t fully understand the mechanism of action, and we have to be very careful about putting pharmacology down these channels. We don’t know the best treatment intervals, and we don’t know the best devices,” she added, pointing out that many of the devices have no indications cleared by the FDA yet.
She also noted that the FDA has put a hold on many microneedling devices from being sold in the United States until appropriate safety and efficacy data are collected.
Dr. Waibel disclosed that she has conducted clinical research for Strata Sciences, Aquavit, and Lutronic. She is also a member of the advisory board for Lutronic.
Risk factors for pulmonary hypertension identified in lupus patients
The presence of specific autoantibodies may help to identify the small percentage of patients with systemic lupus erythematosus (SLE) who are at higher risk of developing pulmonary arterial hypertension after SLE diagnosis and may also detect those at lower risk of death, according to findings from a retrospective study of French patients.
Eric Hachulla, MD, of the University of Lille (France) and his coinvestigators reported that 51 SLE patients in the French Pulmonary Hypertension Registry who had a diagnosis of pulmonary arterial hypertension (PAH) confirmed by right heart catheterization were more likely to have the condition if they had anti-SSA and anti-SSB antibodies, compared with a control group of 101 SLE patients without known PAH who were selected from SLE expert centers participating in the registry. Overall, anti-SSA antibodies were present in 62% of PAH patients vs. 40% of non-PAH patients, and anti-SSB antibodies were detected in 27% with PAH, compared with 8% of those without.
Following SLE diagnosis, the 51 SLE patients had a median delay in diagnosis of PAH by about 5 years. Their survival was 89% at 3 years and 84% at 5 years. “Survival appeared to be substantially better than that still observed today in [PAH associated with systemic sclerosis], where estimated 3-year survival is about 50%. Our survival rates are comparable to those reported by Sobanski et al. in the recently published study for the U.K. SLE-PAH cohort (85% at 5 years),” the authors wrote.
In the current study, mortality during 10 years of follow-up was significantly lower among patients who had anti–U1-RNP antibodies than among those who did not (0% vs. 25%; P = .04). This finding of improved survival in patients with anti–U1-RNP antibodies mirrored the results reported in the British SLE-PAH cohort study and a 2016 Chinese study, indicating that “the presence of anti–U1-RNP antibodies appears to be a protective factor in terms of survival.”
Treatment with hydroxychloroquine followed a trend toward increased survival, but was not statistically significant (hazard ratio, 0.31; 95% confidence interval, 0.09-1.11; P = .07).
“These findings must be interpreted with caution due to the small number of untreated patients and require further investigations in other cohorts,” the investigators wrote. But “based on our results on the potential effect of hydroxychloroquine, this treatment might be used in association with the immunosuppressive strategy for SLE-PAH patients.”
Read more of the findings in CHEST (2017 Aug 26. doi: 10.1016/j.chest.2017.08.014).
The presence of specific autoantibodies may help to identify the small percentage of patients with systemic lupus erythematosus (SLE) who are at higher risk of developing pulmonary arterial hypertension after SLE diagnosis and may also detect those at lower risk of death, according to findings from a retrospective study of French patients.
Eric Hachulla, MD, of the University of Lille (France) and his coinvestigators reported that 51 SLE patients in the French Pulmonary Hypertension Registry who had a diagnosis of pulmonary arterial hypertension (PAH) confirmed by right heart catheterization were more likely to have the condition if they had anti-SSA and anti-SSB antibodies, compared with a control group of 101 SLE patients without known PAH who were selected from SLE expert centers participating in the registry. Overall, anti-SSA antibodies were present in 62% of PAH patients vs. 40% of non-PAH patients, and anti-SSB antibodies were detected in 27% with PAH, compared with 8% of those without.
Following SLE diagnosis, the 51 SLE patients had a median delay in diagnosis of PAH by about 5 years. Their survival was 89% at 3 years and 84% at 5 years. “Survival appeared to be substantially better than that still observed today in [PAH associated with systemic sclerosis], where estimated 3-year survival is about 50%. Our survival rates are comparable to those reported by Sobanski et al. in the recently published study for the U.K. SLE-PAH cohort (85% at 5 years),” the authors wrote.
In the current study, mortality during 10 years of follow-up was significantly lower among patients who had anti–U1-RNP antibodies than among those who did not (0% vs. 25%; P = .04). This finding of improved survival in patients with anti–U1-RNP antibodies mirrored the results reported in the British SLE-PAH cohort study and a 2016 Chinese study, indicating that “the presence of anti–U1-RNP antibodies appears to be a protective factor in terms of survival.”
Treatment with hydroxychloroquine followed a trend toward increased survival, but was not statistically significant (hazard ratio, 0.31; 95% confidence interval, 0.09-1.11; P = .07).
“These findings must be interpreted with caution due to the small number of untreated patients and require further investigations in other cohorts,” the investigators wrote. But “based on our results on the potential effect of hydroxychloroquine, this treatment might be used in association with the immunosuppressive strategy for SLE-PAH patients.”
Read more of the findings in CHEST (2017 Aug 26. doi: 10.1016/j.chest.2017.08.014).
The presence of specific autoantibodies may help to identify the small percentage of patients with systemic lupus erythematosus (SLE) who are at higher risk of developing pulmonary arterial hypertension after SLE diagnosis and may also detect those at lower risk of death, according to findings from a retrospective study of French patients.
Eric Hachulla, MD, of the University of Lille (France) and his coinvestigators reported that 51 SLE patients in the French Pulmonary Hypertension Registry who had a diagnosis of pulmonary arterial hypertension (PAH) confirmed by right heart catheterization were more likely to have the condition if they had anti-SSA and anti-SSB antibodies, compared with a control group of 101 SLE patients without known PAH who were selected from SLE expert centers participating in the registry. Overall, anti-SSA antibodies were present in 62% of PAH patients vs. 40% of non-PAH patients, and anti-SSB antibodies were detected in 27% with PAH, compared with 8% of those without.
Following SLE diagnosis, the 51 SLE patients had a median delay in diagnosis of PAH by about 5 years. Their survival was 89% at 3 years and 84% at 5 years. “Survival appeared to be substantially better than that still observed today in [PAH associated with systemic sclerosis], where estimated 3-year survival is about 50%. Our survival rates are comparable to those reported by Sobanski et al. in the recently published study for the U.K. SLE-PAH cohort (85% at 5 years),” the authors wrote.
In the current study, mortality during 10 years of follow-up was significantly lower among patients who had anti–U1-RNP antibodies than among those who did not (0% vs. 25%; P = .04). This finding of improved survival in patients with anti–U1-RNP antibodies mirrored the results reported in the British SLE-PAH cohort study and a 2016 Chinese study, indicating that “the presence of anti–U1-RNP antibodies appears to be a protective factor in terms of survival.”
Treatment with hydroxychloroquine followed a trend toward increased survival, but was not statistically significant (hazard ratio, 0.31; 95% confidence interval, 0.09-1.11; P = .07).
“These findings must be interpreted with caution due to the small number of untreated patients and require further investigations in other cohorts,” the investigators wrote. But “based on our results on the potential effect of hydroxychloroquine, this treatment might be used in association with the immunosuppressive strategy for SLE-PAH patients.”
Read more of the findings in CHEST (2017 Aug 26. doi: 10.1016/j.chest.2017.08.014).
FROM CHEST
Sen. Alexander seeks quick, passable steps to stabilize individual markets
WASHINGTON – Sen. Lamar Alexander (R-Tenn.) wants two quick fixes to stabilize the individual health insurance market so that Congress can come together to craft a long-term solution.
There seems to be “general consensus that we should see what can we do, No. 1, on the cost-sharing payments and, No. 2, on amending 1332 [waiver program] to provide flexibility to the states,” Sen. Alexander*, chairman of the Senate Health, Education, Labor, and Pensions Committee said Sept. 6 after the first of four hearings the committee is holding on creating stability for the individual health insurance market.
Chairman Alexander said that he hopes to have a small, passable legislative proposal ready by Sept. 14, in time to allow insurers to make last-minute adjustments to their individual market bids, which are due to state insurance commissioners by Sept. 20.
Sen. Patty Murray (D-Wash.), the committee’s ranking member, stressed the urgent need to pass a quick fix, noting that insurance premiums could rise as much as 20% higher than they would have, if there is no guarantee on the cost-sharing reduction (CSR) payments.
A panel of state insurance commissioners all agreed with the two proposals, though there were suggestions that the CSR payments should be guaranteed for at least a year, if not longer, beyond 2018, which was when Chairman Alexander suggested the guarantee should sunset.
“The CSR funding issue is the single most critical issue you can address to help stabilize insurance markets in 2018,” Julie Mix McPeak, commissioner of the Tennessee Department of Commerce and Insurance, testified at the hearing. She emphasized that it is not an insurance bailout. “CSR funding ensures that some of our most vulnerable consumers receive assistance for copays and deductibles that are required to be paid under federal law and has the effect of reducing proposed premium increases and has a direct impact on the amount of subsidy assistance provided by the federal government.”
“You must permanently fund the cost-sharing reduction payments,” Mike Kreidler, insurance commissioner for the state of Washington, testified during the hearing. “That is something that is going help a great deal in our marketplace.”
The commissioners also advocated for a reinsurance program.
Ms. McPeak called for Congress to “establish a reinsurance mechanism that would stop losses for individual claims at a specified amount to increase market participation by carriers. For the most immediate impact, this backstop mechanism must be federal, as it would be impossible for many states to develop such a program for the 2018 plan year.”
“I urge you to create a federal reinsurance program this year,” Mr. Kreidler said. “Doing this would show your commitment to stabilizing the market. They worked very well in the state of Washington for the first 3 years we had a reinsurance program. We would like to see it continue and go forward.”
In talking about fixing 1332 waivers, which allow states to develop a specific proposal that works within the parameters of the Affordable Care Act but offers flexibility to create programs that are unique to a state’s needs, Lori Wing-Heier, director of the Alaska Division of Insurance talked about her state’s successful efforts to get a wavier for its reinsurance program.
“The waiver process is somewhat onerous in the fact that there is not a defined application to submit,” Ms. Wing-Heier said, leaving it up to states to make sure they are providing all the requested information. “After that, the part that is stifling states right now is the 6-month waiting period before they receive final approval.”
Other issues were raised by both panelists and senators, including the cost of delivering health care, the cost of prescription drugs, and cuts to marketing budgets, but Chairman Alexander said that he did not want to expand a proposal beyond his two points.
“My whole focus right now is: What can we do to take a couple of steps to stabilize the individual market?” he said, although he suggested that if there were clear consensus on other aspects, they could be considered.
The archived hearing can be viewed on the committee’s website.
CORRECTION, 9/8/17: An earlier version of this story misidentified the HELP Committee chairman.
WASHINGTON – Sen. Lamar Alexander (R-Tenn.) wants two quick fixes to stabilize the individual health insurance market so that Congress can come together to craft a long-term solution.
There seems to be “general consensus that we should see what can we do, No. 1, on the cost-sharing payments and, No. 2, on amending 1332 [waiver program] to provide flexibility to the states,” Sen. Alexander*, chairman of the Senate Health, Education, Labor, and Pensions Committee said Sept. 6 after the first of four hearings the committee is holding on creating stability for the individual health insurance market.
Chairman Alexander said that he hopes to have a small, passable legislative proposal ready by Sept. 14, in time to allow insurers to make last-minute adjustments to their individual market bids, which are due to state insurance commissioners by Sept. 20.
Sen. Patty Murray (D-Wash.), the committee’s ranking member, stressed the urgent need to pass a quick fix, noting that insurance premiums could rise as much as 20% higher than they would have, if there is no guarantee on the cost-sharing reduction (CSR) payments.
A panel of state insurance commissioners all agreed with the two proposals, though there were suggestions that the CSR payments should be guaranteed for at least a year, if not longer, beyond 2018, which was when Chairman Alexander suggested the guarantee should sunset.
“The CSR funding issue is the single most critical issue you can address to help stabilize insurance markets in 2018,” Julie Mix McPeak, commissioner of the Tennessee Department of Commerce and Insurance, testified at the hearing. She emphasized that it is not an insurance bailout. “CSR funding ensures that some of our most vulnerable consumers receive assistance for copays and deductibles that are required to be paid under federal law and has the effect of reducing proposed premium increases and has a direct impact on the amount of subsidy assistance provided by the federal government.”
“You must permanently fund the cost-sharing reduction payments,” Mike Kreidler, insurance commissioner for the state of Washington, testified during the hearing. “That is something that is going help a great deal in our marketplace.”
The commissioners also advocated for a reinsurance program.
Ms. McPeak called for Congress to “establish a reinsurance mechanism that would stop losses for individual claims at a specified amount to increase market participation by carriers. For the most immediate impact, this backstop mechanism must be federal, as it would be impossible for many states to develop such a program for the 2018 plan year.”
“I urge you to create a federal reinsurance program this year,” Mr. Kreidler said. “Doing this would show your commitment to stabilizing the market. They worked very well in the state of Washington for the first 3 years we had a reinsurance program. We would like to see it continue and go forward.”
In talking about fixing 1332 waivers, which allow states to develop a specific proposal that works within the parameters of the Affordable Care Act but offers flexibility to create programs that are unique to a state’s needs, Lori Wing-Heier, director of the Alaska Division of Insurance talked about her state’s successful efforts to get a wavier for its reinsurance program.
“The waiver process is somewhat onerous in the fact that there is not a defined application to submit,” Ms. Wing-Heier said, leaving it up to states to make sure they are providing all the requested information. “After that, the part that is stifling states right now is the 6-month waiting period before they receive final approval.”
Other issues were raised by both panelists and senators, including the cost of delivering health care, the cost of prescription drugs, and cuts to marketing budgets, but Chairman Alexander said that he did not want to expand a proposal beyond his two points.
“My whole focus right now is: What can we do to take a couple of steps to stabilize the individual market?” he said, although he suggested that if there were clear consensus on other aspects, they could be considered.
The archived hearing can be viewed on the committee’s website.
CORRECTION, 9/8/17: An earlier version of this story misidentified the HELP Committee chairman.
WASHINGTON – Sen. Lamar Alexander (R-Tenn.) wants two quick fixes to stabilize the individual health insurance market so that Congress can come together to craft a long-term solution.
There seems to be “general consensus that we should see what can we do, No. 1, on the cost-sharing payments and, No. 2, on amending 1332 [waiver program] to provide flexibility to the states,” Sen. Alexander*, chairman of the Senate Health, Education, Labor, and Pensions Committee said Sept. 6 after the first of four hearings the committee is holding on creating stability for the individual health insurance market.
Chairman Alexander said that he hopes to have a small, passable legislative proposal ready by Sept. 14, in time to allow insurers to make last-minute adjustments to their individual market bids, which are due to state insurance commissioners by Sept. 20.
Sen. Patty Murray (D-Wash.), the committee’s ranking member, stressed the urgent need to pass a quick fix, noting that insurance premiums could rise as much as 20% higher than they would have, if there is no guarantee on the cost-sharing reduction (CSR) payments.
A panel of state insurance commissioners all agreed with the two proposals, though there were suggestions that the CSR payments should be guaranteed for at least a year, if not longer, beyond 2018, which was when Chairman Alexander suggested the guarantee should sunset.
“The CSR funding issue is the single most critical issue you can address to help stabilize insurance markets in 2018,” Julie Mix McPeak, commissioner of the Tennessee Department of Commerce and Insurance, testified at the hearing. She emphasized that it is not an insurance bailout. “CSR funding ensures that some of our most vulnerable consumers receive assistance for copays and deductibles that are required to be paid under federal law and has the effect of reducing proposed premium increases and has a direct impact on the amount of subsidy assistance provided by the federal government.”
“You must permanently fund the cost-sharing reduction payments,” Mike Kreidler, insurance commissioner for the state of Washington, testified during the hearing. “That is something that is going help a great deal in our marketplace.”
The commissioners also advocated for a reinsurance program.
Ms. McPeak called for Congress to “establish a reinsurance mechanism that would stop losses for individual claims at a specified amount to increase market participation by carriers. For the most immediate impact, this backstop mechanism must be federal, as it would be impossible for many states to develop such a program for the 2018 plan year.”
“I urge you to create a federal reinsurance program this year,” Mr. Kreidler said. “Doing this would show your commitment to stabilizing the market. They worked very well in the state of Washington for the first 3 years we had a reinsurance program. We would like to see it continue and go forward.”
In talking about fixing 1332 waivers, which allow states to develop a specific proposal that works within the parameters of the Affordable Care Act but offers flexibility to create programs that are unique to a state’s needs, Lori Wing-Heier, director of the Alaska Division of Insurance talked about her state’s successful efforts to get a wavier for its reinsurance program.
“The waiver process is somewhat onerous in the fact that there is not a defined application to submit,” Ms. Wing-Heier said, leaving it up to states to make sure they are providing all the requested information. “After that, the part that is stifling states right now is the 6-month waiting period before they receive final approval.”
Other issues were raised by both panelists and senators, including the cost of delivering health care, the cost of prescription drugs, and cuts to marketing budgets, but Chairman Alexander said that he did not want to expand a proposal beyond his two points.
“My whole focus right now is: What can we do to take a couple of steps to stabilize the individual market?” he said, although he suggested that if there were clear consensus on other aspects, they could be considered.
The archived hearing can be viewed on the committee’s website.
CORRECTION, 9/8/17: An earlier version of this story misidentified the HELP Committee chairman.
AT A SENATE HELP COMMITTEE HEARING
Can High Frequency Oscillations Help Predict Seizures?
A recently published practical guide can help epilepsy specialists record and interpret high-frequency oscillations (HFOs), which have been implicated as promising markers for the disease. Such biomarkers may help better locate areas in which to perform surgery. Researchers offer the following observations:
- To accurately record HFOs, experts emphasize the importance of low noise recording to reduce artifacts.
- Even under ideal conditions, artifacts can still occur, including muscle contractions, movement, and filtering.
- Magnetoencephalography (MEG) and EEG recordings are capable of recording ripples while intracranial EEG can record ripples, fast ripples, and very high frequency oscillations.
- Nonetheless, MEG and intracranial EEG recordings can also experience artifacts.
- Researchers believe that HFOs represent a new type of electromagnetic biomarker that can detect epileptogenic brain tissue, but several technical barriers need to be overcome before clinicians can use them as tools in community practice.
- Software engineers are in the process of developing HFO filters and automatic detection tools to help bring this technology to market.
Zijlmans M, Worrell GA, Dümpelmann M, et al. How to record high-frequency oscillations in epilepsy: A practical guideline. Epilepsia. 2017;58(8):1305-1315. d
A recently published practical guide can help epilepsy specialists record and interpret high-frequency oscillations (HFOs), which have been implicated as promising markers for the disease. Such biomarkers may help better locate areas in which to perform surgery. Researchers offer the following observations:
- To accurately record HFOs, experts emphasize the importance of low noise recording to reduce artifacts.
- Even under ideal conditions, artifacts can still occur, including muscle contractions, movement, and filtering.
- Magnetoencephalography (MEG) and EEG recordings are capable of recording ripples while intracranial EEG can record ripples, fast ripples, and very high frequency oscillations.
- Nonetheless, MEG and intracranial EEG recordings can also experience artifacts.
- Researchers believe that HFOs represent a new type of electromagnetic biomarker that can detect epileptogenic brain tissue, but several technical barriers need to be overcome before clinicians can use them as tools in community practice.
- Software engineers are in the process of developing HFO filters and automatic detection tools to help bring this technology to market.
Zijlmans M, Worrell GA, Dümpelmann M, et al. How to record high-frequency oscillations in epilepsy: A practical guideline. Epilepsia. 2017;58(8):1305-1315. d
A recently published practical guide can help epilepsy specialists record and interpret high-frequency oscillations (HFOs), which have been implicated as promising markers for the disease. Such biomarkers may help better locate areas in which to perform surgery. Researchers offer the following observations:
- To accurately record HFOs, experts emphasize the importance of low noise recording to reduce artifacts.
- Even under ideal conditions, artifacts can still occur, including muscle contractions, movement, and filtering.
- Magnetoencephalography (MEG) and EEG recordings are capable of recording ripples while intracranial EEG can record ripples, fast ripples, and very high frequency oscillations.
- Nonetheless, MEG and intracranial EEG recordings can also experience artifacts.
- Researchers believe that HFOs represent a new type of electromagnetic biomarker that can detect epileptogenic brain tissue, but several technical barriers need to be overcome before clinicians can use them as tools in community practice.
- Software engineers are in the process of developing HFO filters and automatic detection tools to help bring this technology to market.
Zijlmans M, Worrell GA, Dümpelmann M, et al. How to record high-frequency oscillations in epilepsy: A practical guideline. Epilepsia. 2017;58(8):1305-1315. d
New Insights on High Frequency Oscillations and the Association With Epilepsy
High frequency oscillations (HFOs) in certain regions of the brain have been associated with epilepsy. A recent review of the literature on HFOs is shedding new light on their possible role in the pathophysiology of the disease.
- Advances in recording technology and optogenetics have enhanced researchers’ ability to study HFOs.
- Substrates of HFOs linked to epilepsy have been identified with the help of sophisticated computer models.
- In the past, HFOs have been studied in animals and patients with temporal lobe epilepsy, but HFOs have recently been reported in patients with other types of seizures, including neocortical epilepsy, genetically induced epilepsy, and infantile spasms.
- High resolution in vivo imaging, optogenetics, and chemogenetic techniques are poised to help future investigators gain even deeper insights into the role of HFOs in seizures and epilepsy.
- The reviewers postulate that as investigators gain a better understanding of how HFOs are involved in the pathogenesis of epileptic disorders, it will allow them to better classify these diseases and improve diagnosis and treatment.
Jiruska P, Alvarado-Rojas C, Schevon CA, et al. Update on the mechanisms and roles of high-frequency oscillations in seizures and epileptic disorders. Epilepsia. 2017;58(8):1330-1339.
High frequency oscillations (HFOs) in certain regions of the brain have been associated with epilepsy. A recent review of the literature on HFOs is shedding new light on their possible role in the pathophysiology of the disease.
- Advances in recording technology and optogenetics have enhanced researchers’ ability to study HFOs.
- Substrates of HFOs linked to epilepsy have been identified with the help of sophisticated computer models.
- In the past, HFOs have been studied in animals and patients with temporal lobe epilepsy, but HFOs have recently been reported in patients with other types of seizures, including neocortical epilepsy, genetically induced epilepsy, and infantile spasms.
- High resolution in vivo imaging, optogenetics, and chemogenetic techniques are poised to help future investigators gain even deeper insights into the role of HFOs in seizures and epilepsy.
- The reviewers postulate that as investigators gain a better understanding of how HFOs are involved in the pathogenesis of epileptic disorders, it will allow them to better classify these diseases and improve diagnosis and treatment.
Jiruska P, Alvarado-Rojas C, Schevon CA, et al. Update on the mechanisms and roles of high-frequency oscillations in seizures and epileptic disorders. Epilepsia. 2017;58(8):1330-1339.
High frequency oscillations (HFOs) in certain regions of the brain have been associated with epilepsy. A recent review of the literature on HFOs is shedding new light on their possible role in the pathophysiology of the disease.
- Advances in recording technology and optogenetics have enhanced researchers’ ability to study HFOs.
- Substrates of HFOs linked to epilepsy have been identified with the help of sophisticated computer models.
- In the past, HFOs have been studied in animals and patients with temporal lobe epilepsy, but HFOs have recently been reported in patients with other types of seizures, including neocortical epilepsy, genetically induced epilepsy, and infantile spasms.
- High resolution in vivo imaging, optogenetics, and chemogenetic techniques are poised to help future investigators gain even deeper insights into the role of HFOs in seizures and epilepsy.
- The reviewers postulate that as investigators gain a better understanding of how HFOs are involved in the pathogenesis of epileptic disorders, it will allow them to better classify these diseases and improve diagnosis and treatment.
Jiruska P, Alvarado-Rojas C, Schevon CA, et al. Update on the mechanisms and roles of high-frequency oscillations in seizures and epileptic disorders. Epilepsia. 2017;58(8):1330-1339.
A New Statistical Approach for Variability in Seizure Frequency
Researchers have devised a statistical approach that can take into account the variability in seizure frequency associated with a placebo response. In an article published in Epilepsy Research, Goldenholz et al explain their approach in more detail:
- The researchers compared the traditional 50% responder rate to a new measure called the variability-corrected score or Zv.
- The analysis revealed that the new approach can predict the expected frequency of seizures several months in advance.
- When they compared the 50% responder rates to the variability-corrected score, Zv was more useful in telling the difference between patients who had a placebo response and those who had a genuine response to a therapeutic intervention.
- Because Zv scores were able to generate higher statistical power, the authors theorize that they may allow researchers to conduct randomized clinical trials that use fewer patients and cost less than traditional randomized controlled trials.
Goldenholz DM, Goldenholz SR, Moss R, et al. Does accounting for seizure frequency variability increase clinical trial power? [Published online ahead of pint July 25, 2017]. Epilepsy Res. doi.org/10.1016/j.eplepsyres.2017.07.013
Researchers have devised a statistical approach that can take into account the variability in seizure frequency associated with a placebo response. In an article published in Epilepsy Research, Goldenholz et al explain their approach in more detail:
- The researchers compared the traditional 50% responder rate to a new measure called the variability-corrected score or Zv.
- The analysis revealed that the new approach can predict the expected frequency of seizures several months in advance.
- When they compared the 50% responder rates to the variability-corrected score, Zv was more useful in telling the difference between patients who had a placebo response and those who had a genuine response to a therapeutic intervention.
- Because Zv scores were able to generate higher statistical power, the authors theorize that they may allow researchers to conduct randomized clinical trials that use fewer patients and cost less than traditional randomized controlled trials.
Goldenholz DM, Goldenholz SR, Moss R, et al. Does accounting for seizure frequency variability increase clinical trial power? [Published online ahead of pint July 25, 2017]. Epilepsy Res. doi.org/10.1016/j.eplepsyres.2017.07.013
Researchers have devised a statistical approach that can take into account the variability in seizure frequency associated with a placebo response. In an article published in Epilepsy Research, Goldenholz et al explain their approach in more detail:
- The researchers compared the traditional 50% responder rate to a new measure called the variability-corrected score or Zv.
- The analysis revealed that the new approach can predict the expected frequency of seizures several months in advance.
- When they compared the 50% responder rates to the variability-corrected score, Zv was more useful in telling the difference between patients who had a placebo response and those who had a genuine response to a therapeutic intervention.
- Because Zv scores were able to generate higher statistical power, the authors theorize that they may allow researchers to conduct randomized clinical trials that use fewer patients and cost less than traditional randomized controlled trials.
Goldenholz DM, Goldenholz SR, Moss R, et al. Does accounting for seizure frequency variability increase clinical trial power? [Published online ahead of pint July 25, 2017]. Epilepsy Res. doi.org/10.1016/j.eplepsyres.2017.07.013
Half of young men at-risk for HIV maintained protective PrEP levels with monthly visits
Up to 54% of adolescent men who had sex with men maintained tenofovir disphosphate levels consistent with a high degree of anti-HIV protection while attending monthly clinic visits, but this proportion fell as low as 17% after they switched to quarterly visits, according to the results of a first-of-its-kind 48-week, prospective, multicenter trial.
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (Project PrEPare) evaluated the safety, tolerability, and acceptability of tenofovir disoproxil fumarate and emtricitabine among 78 HIV-negative MSM aged 15-17 years who had condomless anal intercourse with a male of positive or unknown HIV status, had multiple male sex partners, or had other high-risk sexual behaviors or sexually transmitted infections within the previous 6 months. Participants averaged 16.5 years old age, 33% were of mixed race or ethnicity, 29% were African American, 21% were white Hispanic, 14% were white, and 3% were Asian or Pacific Islander. They received one cognitive-behavioral risk-reduction session before starting PrEP and were paid $50-$75 to attend follow-up visits every month for 3 months and then quarterly after that.
While attending monthly visits, between 47% and 54% of participants maintained highly protective levels of tenofovir disphosphate (above 700 fmol/punch, based on dried blood spot tests), but this proportion fell as low as 17% after participants switched to quarterly visits. At week 48, the HIV seroconversion rate was 6.4 per 100 person-years (95% confidence interval, 1.3-8.7), underscoring the need to offer PrEP and behavioral support to this population, the researchers emphasized. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services,” they wrote. “We need to better understand the barriers to adherence and develop more effective ways to enhance adherence for youth who are clinically prescribed PrEP.”
Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
As an adolescent medicine specialist who cares for youth living with and at risk for HIV, I am excited to see data that will help young men at risk for HIV to access and use emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) in their daily lives.
In the United States, the rates of HIV acquisition are highest among adolescent young men who have sex with men (MSM), and data suggest that 40% of young black MSM will acquire HIV by age 40 years unless prevention efforts improve. Clinician barriers to caring for sexual minority men, combined with young men’s having to feel comfortable disclosing their sexual orientation and sexual history to receive counseling about emtricitabine/tenofovir disoproxil fumarate, will mean we will also need to address the institutional, social, and historical factors in medical settings to effectively increase access to PrEP; otherwise, it may further contribute to the HIV inequity among this population.
Clinicians, public health practitioners, and researchers who aim to improve adolescent access to PrEP will need not only to focus on the developmental and cognitive needs of adolescents but also to address the social contexts of stigma, minority stress, and sexual identity that intersect to affect adherence. This work suggests that adolescents may require more frequent visits than is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications.
Renata Arrington-Sanders, MD, MPH, ScM, is at the division of general pediatrics and adolescent medicine, Johns Hopkins University, Baltimore. She reported having no conflicts of interest. These comments are from her editorial (JAMA Ped. 2017 Sep 5. doi: 10.1001/jamapediatrics.2017.2397).
As an adolescent medicine specialist who cares for youth living with and at risk for HIV, I am excited to see data that will help young men at risk for HIV to access and use emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) in their daily lives.
In the United States, the rates of HIV acquisition are highest among adolescent young men who have sex with men (MSM), and data suggest that 40% of young black MSM will acquire HIV by age 40 years unless prevention efforts improve. Clinician barriers to caring for sexual minority men, combined with young men’s having to feel comfortable disclosing their sexual orientation and sexual history to receive counseling about emtricitabine/tenofovir disoproxil fumarate, will mean we will also need to address the institutional, social, and historical factors in medical settings to effectively increase access to PrEP; otherwise, it may further contribute to the HIV inequity among this population.
Clinicians, public health practitioners, and researchers who aim to improve adolescent access to PrEP will need not only to focus on the developmental and cognitive needs of adolescents but also to address the social contexts of stigma, minority stress, and sexual identity that intersect to affect adherence. This work suggests that adolescents may require more frequent visits than is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications.
Renata Arrington-Sanders, MD, MPH, ScM, is at the division of general pediatrics and adolescent medicine, Johns Hopkins University, Baltimore. She reported having no conflicts of interest. These comments are from her editorial (JAMA Ped. 2017 Sep 5. doi: 10.1001/jamapediatrics.2017.2397).
As an adolescent medicine specialist who cares for youth living with and at risk for HIV, I am excited to see data that will help young men at risk for HIV to access and use emtricitabine/tenofovir disoproxil fumarate as pre-exposure prophylaxis (PrEP) in their daily lives.
In the United States, the rates of HIV acquisition are highest among adolescent young men who have sex with men (MSM), and data suggest that 40% of young black MSM will acquire HIV by age 40 years unless prevention efforts improve. Clinician barriers to caring for sexual minority men, combined with young men’s having to feel comfortable disclosing their sexual orientation and sexual history to receive counseling about emtricitabine/tenofovir disoproxil fumarate, will mean we will also need to address the institutional, social, and historical factors in medical settings to effectively increase access to PrEP; otherwise, it may further contribute to the HIV inequity among this population.
Clinicians, public health practitioners, and researchers who aim to improve adolescent access to PrEP will need not only to focus on the developmental and cognitive needs of adolescents but also to address the social contexts of stigma, minority stress, and sexual identity that intersect to affect adherence. This work suggests that adolescents may require more frequent visits than is currently recommended by national guidelines and suggests a need for multiple team members to address structural barriers to accessing PrEP, assist with youths’ interpretation of HIV risk, and support self-efficacy to swallow and adhere to medications.
Renata Arrington-Sanders, MD, MPH, ScM, is at the division of general pediatrics and adolescent medicine, Johns Hopkins University, Baltimore. She reported having no conflicts of interest. These comments are from her editorial (JAMA Ped. 2017 Sep 5. doi: 10.1001/jamapediatrics.2017.2397).
Up to 54% of adolescent men who had sex with men maintained tenofovir disphosphate levels consistent with a high degree of anti-HIV protection while attending monthly clinic visits, but this proportion fell as low as 17% after they switched to quarterly visits, according to the results of a first-of-its-kind 48-week, prospective, multicenter trial.
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (Project PrEPare) evaluated the safety, tolerability, and acceptability of tenofovir disoproxil fumarate and emtricitabine among 78 HIV-negative MSM aged 15-17 years who had condomless anal intercourse with a male of positive or unknown HIV status, had multiple male sex partners, or had other high-risk sexual behaviors or sexually transmitted infections within the previous 6 months. Participants averaged 16.5 years old age, 33% were of mixed race or ethnicity, 29% were African American, 21% were white Hispanic, 14% were white, and 3% were Asian or Pacific Islander. They received one cognitive-behavioral risk-reduction session before starting PrEP and were paid $50-$75 to attend follow-up visits every month for 3 months and then quarterly after that.
While attending monthly visits, between 47% and 54% of participants maintained highly protective levels of tenofovir disphosphate (above 700 fmol/punch, based on dried blood spot tests), but this proportion fell as low as 17% after participants switched to quarterly visits. At week 48, the HIV seroconversion rate was 6.4 per 100 person-years (95% confidence interval, 1.3-8.7), underscoring the need to offer PrEP and behavioral support to this population, the researchers emphasized. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services,” they wrote. “We need to better understand the barriers to adherence and develop more effective ways to enhance adherence for youth who are clinically prescribed PrEP.”
Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
Up to 54% of adolescent men who had sex with men maintained tenofovir disphosphate levels consistent with a high degree of anti-HIV protection while attending monthly clinic visits, but this proportion fell as low as 17% after they switched to quarterly visits, according to the results of a first-of-its-kind 48-week, prospective, multicenter trial.
The Adolescent Medicine Trials Network for HIV/AIDS Interventions (Project PrEPare) evaluated the safety, tolerability, and acceptability of tenofovir disoproxil fumarate and emtricitabine among 78 HIV-negative MSM aged 15-17 years who had condomless anal intercourse with a male of positive or unknown HIV status, had multiple male sex partners, or had other high-risk sexual behaviors or sexually transmitted infections within the previous 6 months. Participants averaged 16.5 years old age, 33% were of mixed race or ethnicity, 29% were African American, 21% were white Hispanic, 14% were white, and 3% were Asian or Pacific Islander. They received one cognitive-behavioral risk-reduction session before starting PrEP and were paid $50-$75 to attend follow-up visits every month for 3 months and then quarterly after that.
While attending monthly visits, between 47% and 54% of participants maintained highly protective levels of tenofovir disphosphate (above 700 fmol/punch, based on dried blood spot tests), but this proportion fell as low as 17% after participants switched to quarterly visits. At week 48, the HIV seroconversion rate was 6.4 per 100 person-years (95% confidence interval, 1.3-8.7), underscoring the need to offer PrEP and behavioral support to this population, the researchers emphasized. “The waning adherence, especially with quarterly visits, demonstrates that more time, attention, and resources may need to be allocated to adolescents who are seeking prevention services,” they wrote. “We need to better understand the barriers to adherence and develop more effective ways to enhance adherence for youth who are clinically prescribed PrEP.”
Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
FROM JAMA PEDIATRICS
Key clinical point: With monthly clinic visits, about half of adolescent men who had sex with men were able to maintain highly protective blood levels of pre-exposure prophylaxis.
Major finding: Up to 54% of participants maintained tenofovir disphosphate levels above 700 fmol/punch when they attended monthly visits, but as few as 17% did so after switching to quarterly visits.
Data source: A multicenter, open-label clinical trial of 78 high-risk men who had sex with men aged 15-17 years.
Disclosures: Gilead Sciences provided the study drugs and helped fund the study. The study was supported by grants from the National Institute of Child Health and Human Development, the National Institutes on Drug Abuse and Mental Health, and the Adolescent Medicine Trials Network for HIV/AIDS Interventions. Dr. Hosek had no disclosures. Two coinvestigators disclosed research support and contract work fees from Gilead.
Progressing rash on boy’s trunk
The FP diagnosed pityriasis rosea based on clinical appearance, which included a herald patch (see arrow) that had preceded the eruption. (A herald patch—a solitary, oval, flesh-colored to salmon-colored lesion with scaling at the border—is seen in less than a quarter of pityriasis rosea cases.)
Pityriasis rosea is a papulosquamous eruption of unknown etiology. It occurs at all ages but is most commonly seen between the ages of 10 to 35. Peak incidence occurs between the ages of 20 to 29. Gender distribution is essentially equal.
Pityriasis rosea lesions vary from oval macules to slightly raised plaques (0.5 - 2 cm in size). They are salmon colored (or hyperpigmented in individuals with dark skin), and typically have a collarette of scaling at the border. There are no systemic symptoms, and itching occurs in about 25% of patients. The eruption resolves without treatment in 8 weeks in 80% of patients, but can last up to 3 to 5 months for some. A topical steroid or first-generation oral antihistamine can be prescribed to relieve pruritus.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Henderson D, Usatine R. Pityriasis rosea. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 896-900.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP diagnosed pityriasis rosea based on clinical appearance, which included a herald patch (see arrow) that had preceded the eruption. (A herald patch—a solitary, oval, flesh-colored to salmon-colored lesion with scaling at the border—is seen in less than a quarter of pityriasis rosea cases.)
Pityriasis rosea is a papulosquamous eruption of unknown etiology. It occurs at all ages but is most commonly seen between the ages of 10 to 35. Peak incidence occurs between the ages of 20 to 29. Gender distribution is essentially equal.
Pityriasis rosea lesions vary from oval macules to slightly raised plaques (0.5 - 2 cm in size). They are salmon colored (or hyperpigmented in individuals with dark skin), and typically have a collarette of scaling at the border. There are no systemic symptoms, and itching occurs in about 25% of patients. The eruption resolves without treatment in 8 weeks in 80% of patients, but can last up to 3 to 5 months for some. A topical steroid or first-generation oral antihistamine can be prescribed to relieve pruritus.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Henderson D, Usatine R. Pityriasis rosea. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 896-900.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
The FP diagnosed pityriasis rosea based on clinical appearance, which included a herald patch (see arrow) that had preceded the eruption. (A herald patch—a solitary, oval, flesh-colored to salmon-colored lesion with scaling at the border—is seen in less than a quarter of pityriasis rosea cases.)
Pityriasis rosea is a papulosquamous eruption of unknown etiology. It occurs at all ages but is most commonly seen between the ages of 10 to 35. Peak incidence occurs between the ages of 20 to 29. Gender distribution is essentially equal.
Pityriasis rosea lesions vary from oval macules to slightly raised plaques (0.5 - 2 cm in size). They are salmon colored (or hyperpigmented in individuals with dark skin), and typically have a collarette of scaling at the border. There are no systemic symptoms, and itching occurs in about 25% of patients. The eruption resolves without treatment in 8 weeks in 80% of patients, but can last up to 3 to 5 months for some. A topical steroid or first-generation oral antihistamine can be prescribed to relieve pruritus.
Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Henderson D, Usatine R. Pityriasis rosea. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013: 896-900.
To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/
You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com
Thomas Edwards
Is pain or dependency driving elevated opioid use among long-term cancer survivors?
Rates of opioid prescribing were about 1.2 times higher overall among cancer survivors up to 10 years after diagnosis, compared with matched controls, with more than threefold higher rates of opioid prescriptions for survivors of some cancers, according to a Canadian population-based cohort study.
Searching for the cause of these elevated rates reveals the complexity of the survivorship experience, and may also point the way to areas where there’s work to be done, according to physicians whose practices touch the lives of cancer survivors.
In a retrospective matched cohort study of participants in the Ontario Health Insurance Plan and the Ontario Drug Benefits Program, Rinku Sutradhar, PhD, of the University of Toronto, and her colleagues, identified patients aged 18-64 who had a cancer diagnosis at least 5 years previously. Patients were included only if they had not had a cancer recurrence or another malignancy. When compared 1:1 to age- and sex-matched controls, the 8,601 cancer survivors had a relative rate of opioid prescribing of 1.220 (95% confidence interval [CI], 1.209-1.232), the investigators reported (Cancer 2017 Aug 17. doi: 10.1002/cncr.30839).
Opioid prescribing rates varied according to the type of cancer the survivor had had, with a relative rate of 3.119 for noncolorectal gastrointestinal cancer survivors and a rate of 2.066 for lung cancer survivors. Individuals with nonprostate genitourinary cancers had a prescribing rate of 1.619. All of these differences were statistically significant.
Elevated prescribing rates were not seen in patients with brain, breast, colorectal, head and neck, or prostate cancers. The relative rate of prescribing for hematologic cancers was 1.383, a difference that approached, but did not quite reach, statistical significance (P = .0512).
When multivariable analysis was used to stratify individuals by length of time since cancer diagnosis, a significantly elevated relative rate of opioid prescribing persisted; for those 5-10 years from diagnosis, the relative rate was 1.190 (95% CI, 1.040-1.362, P = .011), while for those diagnosed at least 10 years ago, the relative rate was 1.244 (95% CI, 1.090-1.420; P = .00118).
Multivariable analysis was also used to control for income, rural residence, and comorbidities. However, the study could capture only opioids that were obtained with a prescription, and could not track whether medications were taken by the person for whom they were prescribed, Dr. Sutradhar and her colleagues said.
Cancer survivors may have a higher prevalence of chronic pain than the general population for reasons related both to their initial diagnosis and the sequelae of treatments such as surgery, chemotherapy, and radiation therapy, the investigators noted, adding, “it is also possible that a higher rate of opioid prescribing among survivors is due to a dependency that originated from opioid use earlier in the disease trajectory.”
Because of the potential for opioid use disorder and the many adverse effects that can be associated with long-term opioid use, they said, “primary care providers who treat cancer survivors should be encouraged to critically examine reasons for lingering opioid use among their patients.”
The oncologist’s perspective
Walter M. Stadler, MD, an oncologist who treats genitourinary and hematologic cancers, also wonders whether it’s pain or dependency that’s driving the increased prescribing rates in cancer survivors.
One opportunity to reassess which medications and treatment modalities are appropriate for the cancer survivor, said Dr. Stadler, is at the point of discharge from oncology care, which usually happens at about the 5-year mark for patients with no evidence of disease. Survivorship has received more attention since the 2005 Institute of Medicine report calling for increased attention to cancer survivors’ ongoing care. However, he said, “it’s not clear that we do a very good job in terms of educating either the patient or their primary care physician in regards to the kinds of things that we expect, the kinds of things that need to be done, or even a good summary of the therapy that was provided.”
There are resources that can help, he said. “That’s why organizations like [the American Society for Clinical Oncology] have put together some more formal survivorship plans that should be provided when patients are transitioned.”
The realities of clinical life can get in the way of implementation, though. Oncologists are already stretched thin, and most electronic health record systems don’t integrate well with survivorship documentation. Finding staff who can spend the time to gather and package all the necessary information can also be a problem: “People are expensive, and none of us have extra cash lying around,” said Dr. Stadler.
Still, he said, “like a lot of good papers, this raises some issues and areas for further investigation.” First, he said, physicians must assess whether cancer survivors are having chronic pain, and then sort things out from there. “What are the pain syndromes – and what are we doing about them? – because it’s not something that’s been well addressed.”
What can primary care offer?
Larissa Nekhlyudov, MD, is an internal medicine physician whose clinical practice straddles two domains. She sees patients, including some cancer survivors, as a primary care provider; she also provides care in a survivorship clinic to adult survivors of childhood cancers. There, she is able to focus more on survivorship care, developing a care plan and communicating with primary care providers about care elements her patients need.
It’s reasonable to think that there might be an increased risk for chronic pain syndromes in some of the types of cancer in which elevated opioid prescribing rates were seen, said Dr. Nekhlyudov. “Maybe this is okay.
“Pain in cancer survivors is so multidimensional that it’s quite possible that some of these cancer survivors – gynecologic, lung, other gastrointestinal, genitourinary – might have peripheral neuropathy, adhesions, and so many potential late effects,” said Dr. Nekhlyudov. “However, narcotics are not necessarily the preferred and the only method to treat this pain,” she said, noting that optimal survivorship care might seek to transition these patients to nonopioid therapies or, at least, a multimodal approach.
When she’s wearing her survivorship care hat, said Dr. Nekhlyudov, managing pain medication isn’t always at the top of the to-do list in an office visit. “It’s certainly not uncommon that patients will have a variety of pain issues. But in the survivorship domain, I think that we don’t take the role of managing their pain medications; that piece belongs, really, to their primary care provider,” she said.
“In many ways, it’s difficult to distinguish how much of their pain is related to their cancer, versus not, and figuring out alternatives,” said Dr. Nekhlyudov, applauding the authors’ recognition of the need for a multimodal approach in cancer survivors with pain. However, she said, “that sounds really great on paper, but it’s really not readily available.”
Even in the resource-rich greater Boston area where she practices, said Dr. Nekhlyudov, “it’s very difficult for cancer patients – and noncancer patients – to get hooked into a multidisciplinary, holistic program for pain.”
Although the long-term perspective is helpful, Dr. Nekhlyudov hopes for research that can help identify at what point, and by whom, the opioids were initiated in the cancer survivor population. “What is their trajectory from the time of diagnosis? Are these patients who are started on narcotics during their cancer treatment, and then continue on forever, or are some of these patients being started later, because of late effects?”
In any case, she said, “one of the key pieces is the ownership for this really belongs with both oncologists and the primary care providers.”
Mental health implications of survivorship
Viewing the issue through the lens of mental health offers a slightly different perspective. Thomas B. Strouse, MD, is a psychiatrist who holds the Maddie Katz Chair in palliative care research and education at the University of California, Los Angeles. He said he laments the current “opioidophobia” that calls into question any long-term opioid prescribing.
Acknowledging that there’s certainly a serious nationwide problem with both prescription and nonprescription opioid abuse, Dr. Strouse said he still finds it unfortunate that the current situation has “reactivated for many people a certain set of reflexes that say that any chronic opioid use is always a bad thing. That’s simply not true,” he said.
“Whether opioids are the right treatment for all of those patients, of course, is an entirely fair question. But it’s unfortunate, or wrong, for everybody to approach this article and to say that we know that for all of these patients, chronic opioid therapy is not appropriate,” he added.
Chronic pain that lingers after cancer treatments affects “a very significant minority of cancer survivors,” he said. It’s also true that the meaning of pain can be different for cancer survivors, said Dr. Strouse. For a cancer survivor, “any new pain is cancer pain until proven otherwise,” he said.
Further, pivoting from the attentive, multidisciplinary, wraparound care often received during cancer treatment to the relatively unsupported survivorship experience can be a rough transition for some. Despite the grim reason for the connection, “frequently, it’s the best experience of patients’ lives from a human relations perspective. … We don’t think enough about the loss that the end of cancer treatment may mean for people who may have otherwise unsatisfactory relationships in their lives,” he said.
Dr. Strouse, who works extensively with cancer survivors, said that the elevated rate of opioid prescribing seen in this study “opens the door to a bigger discussion about the challenges in the relatively empty domain of survivorship.” After discharge from cancer care, patients are all too often left without a navigator to help them through the years when, though their treatment is complete, anxiety, financial and social strain, and pain may linger.
The study, he said, should be a call to physicians for “a more meaningful commitment to understanding the burdens of survivorship, and actually offering meaningful clinical services to those people in an integrated and appropriate way.” This might include determining a patient’s absolute minimum opioid requirement, with a goal of getting the patient off opioids, but also making sure the patient has knowledge of and access to alternative pharmacologic and nonpharmacologic treatments for pain. “That seems like a reasonable approach,” said Dr. Strouse.
None of the study’s authors or the physicians interviewed for commentary had relevant conflicts of interest.
[email protected]
On Twitter @karioakes
Rates of opioid prescribing were about 1.2 times higher overall among cancer survivors up to 10 years after diagnosis, compared with matched controls, with more than threefold higher rates of opioid prescriptions for survivors of some cancers, according to a Canadian population-based cohort study.
Searching for the cause of these elevated rates reveals the complexity of the survivorship experience, and may also point the way to areas where there’s work to be done, according to physicians whose practices touch the lives of cancer survivors.
In a retrospective matched cohort study of participants in the Ontario Health Insurance Plan and the Ontario Drug Benefits Program, Rinku Sutradhar, PhD, of the University of Toronto, and her colleagues, identified patients aged 18-64 who had a cancer diagnosis at least 5 years previously. Patients were included only if they had not had a cancer recurrence or another malignancy. When compared 1:1 to age- and sex-matched controls, the 8,601 cancer survivors had a relative rate of opioid prescribing of 1.220 (95% confidence interval [CI], 1.209-1.232), the investigators reported (Cancer 2017 Aug 17. doi: 10.1002/cncr.30839).
Opioid prescribing rates varied according to the type of cancer the survivor had had, with a relative rate of 3.119 for noncolorectal gastrointestinal cancer survivors and a rate of 2.066 for lung cancer survivors. Individuals with nonprostate genitourinary cancers had a prescribing rate of 1.619. All of these differences were statistically significant.
Elevated prescribing rates were not seen in patients with brain, breast, colorectal, head and neck, or prostate cancers. The relative rate of prescribing for hematologic cancers was 1.383, a difference that approached, but did not quite reach, statistical significance (P = .0512).
When multivariable analysis was used to stratify individuals by length of time since cancer diagnosis, a significantly elevated relative rate of opioid prescribing persisted; for those 5-10 years from diagnosis, the relative rate was 1.190 (95% CI, 1.040-1.362, P = .011), while for those diagnosed at least 10 years ago, the relative rate was 1.244 (95% CI, 1.090-1.420; P = .00118).
Multivariable analysis was also used to control for income, rural residence, and comorbidities. However, the study could capture only opioids that were obtained with a prescription, and could not track whether medications were taken by the person for whom they were prescribed, Dr. Sutradhar and her colleagues said.
Cancer survivors may have a higher prevalence of chronic pain than the general population for reasons related both to their initial diagnosis and the sequelae of treatments such as surgery, chemotherapy, and radiation therapy, the investigators noted, adding, “it is also possible that a higher rate of opioid prescribing among survivors is due to a dependency that originated from opioid use earlier in the disease trajectory.”
Because of the potential for opioid use disorder and the many adverse effects that can be associated with long-term opioid use, they said, “primary care providers who treat cancer survivors should be encouraged to critically examine reasons for lingering opioid use among their patients.”
The oncologist’s perspective
Walter M. Stadler, MD, an oncologist who treats genitourinary and hematologic cancers, also wonders whether it’s pain or dependency that’s driving the increased prescribing rates in cancer survivors.
One opportunity to reassess which medications and treatment modalities are appropriate for the cancer survivor, said Dr. Stadler, is at the point of discharge from oncology care, which usually happens at about the 5-year mark for patients with no evidence of disease. Survivorship has received more attention since the 2005 Institute of Medicine report calling for increased attention to cancer survivors’ ongoing care. However, he said, “it’s not clear that we do a very good job in terms of educating either the patient or their primary care physician in regards to the kinds of things that we expect, the kinds of things that need to be done, or even a good summary of the therapy that was provided.”
There are resources that can help, he said. “That’s why organizations like [the American Society for Clinical Oncology] have put together some more formal survivorship plans that should be provided when patients are transitioned.”
The realities of clinical life can get in the way of implementation, though. Oncologists are already stretched thin, and most electronic health record systems don’t integrate well with survivorship documentation. Finding staff who can spend the time to gather and package all the necessary information can also be a problem: “People are expensive, and none of us have extra cash lying around,” said Dr. Stadler.
Still, he said, “like a lot of good papers, this raises some issues and areas for further investigation.” First, he said, physicians must assess whether cancer survivors are having chronic pain, and then sort things out from there. “What are the pain syndromes – and what are we doing about them? – because it’s not something that’s been well addressed.”
What can primary care offer?
Larissa Nekhlyudov, MD, is an internal medicine physician whose clinical practice straddles two domains. She sees patients, including some cancer survivors, as a primary care provider; she also provides care in a survivorship clinic to adult survivors of childhood cancers. There, she is able to focus more on survivorship care, developing a care plan and communicating with primary care providers about care elements her patients need.
It’s reasonable to think that there might be an increased risk for chronic pain syndromes in some of the types of cancer in which elevated opioid prescribing rates were seen, said Dr. Nekhlyudov. “Maybe this is okay.
“Pain in cancer survivors is so multidimensional that it’s quite possible that some of these cancer survivors – gynecologic, lung, other gastrointestinal, genitourinary – might have peripheral neuropathy, adhesions, and so many potential late effects,” said Dr. Nekhlyudov. “However, narcotics are not necessarily the preferred and the only method to treat this pain,” she said, noting that optimal survivorship care might seek to transition these patients to nonopioid therapies or, at least, a multimodal approach.
When she’s wearing her survivorship care hat, said Dr. Nekhlyudov, managing pain medication isn’t always at the top of the to-do list in an office visit. “It’s certainly not uncommon that patients will have a variety of pain issues. But in the survivorship domain, I think that we don’t take the role of managing their pain medications; that piece belongs, really, to their primary care provider,” she said.
“In many ways, it’s difficult to distinguish how much of their pain is related to their cancer, versus not, and figuring out alternatives,” said Dr. Nekhlyudov, applauding the authors’ recognition of the need for a multimodal approach in cancer survivors with pain. However, she said, “that sounds really great on paper, but it’s really not readily available.”
Even in the resource-rich greater Boston area where she practices, said Dr. Nekhlyudov, “it’s very difficult for cancer patients – and noncancer patients – to get hooked into a multidisciplinary, holistic program for pain.”
Although the long-term perspective is helpful, Dr. Nekhlyudov hopes for research that can help identify at what point, and by whom, the opioids were initiated in the cancer survivor population. “What is their trajectory from the time of diagnosis? Are these patients who are started on narcotics during their cancer treatment, and then continue on forever, or are some of these patients being started later, because of late effects?”
In any case, she said, “one of the key pieces is the ownership for this really belongs with both oncologists and the primary care providers.”
Mental health implications of survivorship
Viewing the issue through the lens of mental health offers a slightly different perspective. Thomas B. Strouse, MD, is a psychiatrist who holds the Maddie Katz Chair in palliative care research and education at the University of California, Los Angeles. He said he laments the current “opioidophobia” that calls into question any long-term opioid prescribing.
Acknowledging that there’s certainly a serious nationwide problem with both prescription and nonprescription opioid abuse, Dr. Strouse said he still finds it unfortunate that the current situation has “reactivated for many people a certain set of reflexes that say that any chronic opioid use is always a bad thing. That’s simply not true,” he said.
“Whether opioids are the right treatment for all of those patients, of course, is an entirely fair question. But it’s unfortunate, or wrong, for everybody to approach this article and to say that we know that for all of these patients, chronic opioid therapy is not appropriate,” he added.
Chronic pain that lingers after cancer treatments affects “a very significant minority of cancer survivors,” he said. It’s also true that the meaning of pain can be different for cancer survivors, said Dr. Strouse. For a cancer survivor, “any new pain is cancer pain until proven otherwise,” he said.
Further, pivoting from the attentive, multidisciplinary, wraparound care often received during cancer treatment to the relatively unsupported survivorship experience can be a rough transition for some. Despite the grim reason for the connection, “frequently, it’s the best experience of patients’ lives from a human relations perspective. … We don’t think enough about the loss that the end of cancer treatment may mean for people who may have otherwise unsatisfactory relationships in their lives,” he said.
Dr. Strouse, who works extensively with cancer survivors, said that the elevated rate of opioid prescribing seen in this study “opens the door to a bigger discussion about the challenges in the relatively empty domain of survivorship.” After discharge from cancer care, patients are all too often left without a navigator to help them through the years when, though their treatment is complete, anxiety, financial and social strain, and pain may linger.
The study, he said, should be a call to physicians for “a more meaningful commitment to understanding the burdens of survivorship, and actually offering meaningful clinical services to those people in an integrated and appropriate way.” This might include determining a patient’s absolute minimum opioid requirement, with a goal of getting the patient off opioids, but also making sure the patient has knowledge of and access to alternative pharmacologic and nonpharmacologic treatments for pain. “That seems like a reasonable approach,” said Dr. Strouse.
None of the study’s authors or the physicians interviewed for commentary had relevant conflicts of interest.
[email protected]
On Twitter @karioakes
Rates of opioid prescribing were about 1.2 times higher overall among cancer survivors up to 10 years after diagnosis, compared with matched controls, with more than threefold higher rates of opioid prescriptions for survivors of some cancers, according to a Canadian population-based cohort study.
Searching for the cause of these elevated rates reveals the complexity of the survivorship experience, and may also point the way to areas where there’s work to be done, according to physicians whose practices touch the lives of cancer survivors.
In a retrospective matched cohort study of participants in the Ontario Health Insurance Plan and the Ontario Drug Benefits Program, Rinku Sutradhar, PhD, of the University of Toronto, and her colleagues, identified patients aged 18-64 who had a cancer diagnosis at least 5 years previously. Patients were included only if they had not had a cancer recurrence or another malignancy. When compared 1:1 to age- and sex-matched controls, the 8,601 cancer survivors had a relative rate of opioid prescribing of 1.220 (95% confidence interval [CI], 1.209-1.232), the investigators reported (Cancer 2017 Aug 17. doi: 10.1002/cncr.30839).
Opioid prescribing rates varied according to the type of cancer the survivor had had, with a relative rate of 3.119 for noncolorectal gastrointestinal cancer survivors and a rate of 2.066 for lung cancer survivors. Individuals with nonprostate genitourinary cancers had a prescribing rate of 1.619. All of these differences were statistically significant.
Elevated prescribing rates were not seen in patients with brain, breast, colorectal, head and neck, or prostate cancers. The relative rate of prescribing for hematologic cancers was 1.383, a difference that approached, but did not quite reach, statistical significance (P = .0512).
When multivariable analysis was used to stratify individuals by length of time since cancer diagnosis, a significantly elevated relative rate of opioid prescribing persisted; for those 5-10 years from diagnosis, the relative rate was 1.190 (95% CI, 1.040-1.362, P = .011), while for those diagnosed at least 10 years ago, the relative rate was 1.244 (95% CI, 1.090-1.420; P = .00118).
Multivariable analysis was also used to control for income, rural residence, and comorbidities. However, the study could capture only opioids that were obtained with a prescription, and could not track whether medications were taken by the person for whom they were prescribed, Dr. Sutradhar and her colleagues said.
Cancer survivors may have a higher prevalence of chronic pain than the general population for reasons related both to their initial diagnosis and the sequelae of treatments such as surgery, chemotherapy, and radiation therapy, the investigators noted, adding, “it is also possible that a higher rate of opioid prescribing among survivors is due to a dependency that originated from opioid use earlier in the disease trajectory.”
Because of the potential for opioid use disorder and the many adverse effects that can be associated with long-term opioid use, they said, “primary care providers who treat cancer survivors should be encouraged to critically examine reasons for lingering opioid use among their patients.”
The oncologist’s perspective
Walter M. Stadler, MD, an oncologist who treats genitourinary and hematologic cancers, also wonders whether it’s pain or dependency that’s driving the increased prescribing rates in cancer survivors.
One opportunity to reassess which medications and treatment modalities are appropriate for the cancer survivor, said Dr. Stadler, is at the point of discharge from oncology care, which usually happens at about the 5-year mark for patients with no evidence of disease. Survivorship has received more attention since the 2005 Institute of Medicine report calling for increased attention to cancer survivors’ ongoing care. However, he said, “it’s not clear that we do a very good job in terms of educating either the patient or their primary care physician in regards to the kinds of things that we expect, the kinds of things that need to be done, or even a good summary of the therapy that was provided.”
There are resources that can help, he said. “That’s why organizations like [the American Society for Clinical Oncology] have put together some more formal survivorship plans that should be provided when patients are transitioned.”
The realities of clinical life can get in the way of implementation, though. Oncologists are already stretched thin, and most electronic health record systems don’t integrate well with survivorship documentation. Finding staff who can spend the time to gather and package all the necessary information can also be a problem: “People are expensive, and none of us have extra cash lying around,” said Dr. Stadler.
Still, he said, “like a lot of good papers, this raises some issues and areas for further investigation.” First, he said, physicians must assess whether cancer survivors are having chronic pain, and then sort things out from there. “What are the pain syndromes – and what are we doing about them? – because it’s not something that’s been well addressed.”
What can primary care offer?
Larissa Nekhlyudov, MD, is an internal medicine physician whose clinical practice straddles two domains. She sees patients, including some cancer survivors, as a primary care provider; she also provides care in a survivorship clinic to adult survivors of childhood cancers. There, she is able to focus more on survivorship care, developing a care plan and communicating with primary care providers about care elements her patients need.
It’s reasonable to think that there might be an increased risk for chronic pain syndromes in some of the types of cancer in which elevated opioid prescribing rates were seen, said Dr. Nekhlyudov. “Maybe this is okay.
“Pain in cancer survivors is so multidimensional that it’s quite possible that some of these cancer survivors – gynecologic, lung, other gastrointestinal, genitourinary – might have peripheral neuropathy, adhesions, and so many potential late effects,” said Dr. Nekhlyudov. “However, narcotics are not necessarily the preferred and the only method to treat this pain,” she said, noting that optimal survivorship care might seek to transition these patients to nonopioid therapies or, at least, a multimodal approach.
When she’s wearing her survivorship care hat, said Dr. Nekhlyudov, managing pain medication isn’t always at the top of the to-do list in an office visit. “It’s certainly not uncommon that patients will have a variety of pain issues. But in the survivorship domain, I think that we don’t take the role of managing their pain medications; that piece belongs, really, to their primary care provider,” she said.
“In many ways, it’s difficult to distinguish how much of their pain is related to their cancer, versus not, and figuring out alternatives,” said Dr. Nekhlyudov, applauding the authors’ recognition of the need for a multimodal approach in cancer survivors with pain. However, she said, “that sounds really great on paper, but it’s really not readily available.”
Even in the resource-rich greater Boston area where she practices, said Dr. Nekhlyudov, “it’s very difficult for cancer patients – and noncancer patients – to get hooked into a multidisciplinary, holistic program for pain.”
Although the long-term perspective is helpful, Dr. Nekhlyudov hopes for research that can help identify at what point, and by whom, the opioids were initiated in the cancer survivor population. “What is their trajectory from the time of diagnosis? Are these patients who are started on narcotics during their cancer treatment, and then continue on forever, or are some of these patients being started later, because of late effects?”
In any case, she said, “one of the key pieces is the ownership for this really belongs with both oncologists and the primary care providers.”
Mental health implications of survivorship
Viewing the issue through the lens of mental health offers a slightly different perspective. Thomas B. Strouse, MD, is a psychiatrist who holds the Maddie Katz Chair in palliative care research and education at the University of California, Los Angeles. He said he laments the current “opioidophobia” that calls into question any long-term opioid prescribing.
Acknowledging that there’s certainly a serious nationwide problem with both prescription and nonprescription opioid abuse, Dr. Strouse said he still finds it unfortunate that the current situation has “reactivated for many people a certain set of reflexes that say that any chronic opioid use is always a bad thing. That’s simply not true,” he said.
“Whether opioids are the right treatment for all of those patients, of course, is an entirely fair question. But it’s unfortunate, or wrong, for everybody to approach this article and to say that we know that for all of these patients, chronic opioid therapy is not appropriate,” he added.
Chronic pain that lingers after cancer treatments affects “a very significant minority of cancer survivors,” he said. It’s also true that the meaning of pain can be different for cancer survivors, said Dr. Strouse. For a cancer survivor, “any new pain is cancer pain until proven otherwise,” he said.
Further, pivoting from the attentive, multidisciplinary, wraparound care often received during cancer treatment to the relatively unsupported survivorship experience can be a rough transition for some. Despite the grim reason for the connection, “frequently, it’s the best experience of patients’ lives from a human relations perspective. … We don’t think enough about the loss that the end of cancer treatment may mean for people who may have otherwise unsatisfactory relationships in their lives,” he said.
Dr. Strouse, who works extensively with cancer survivors, said that the elevated rate of opioid prescribing seen in this study “opens the door to a bigger discussion about the challenges in the relatively empty domain of survivorship.” After discharge from cancer care, patients are all too often left without a navigator to help them through the years when, though their treatment is complete, anxiety, financial and social strain, and pain may linger.
The study, he said, should be a call to physicians for “a more meaningful commitment to understanding the burdens of survivorship, and actually offering meaningful clinical services to those people in an integrated and appropriate way.” This might include determining a patient’s absolute minimum opioid requirement, with a goal of getting the patient off opioids, but also making sure the patient has knowledge of and access to alternative pharmacologic and nonpharmacologic treatments for pain. “That seems like a reasonable approach,” said Dr. Strouse.
None of the study’s authors or the physicians interviewed for commentary had relevant conflicts of interest.
[email protected]
On Twitter @karioakes