From 2006 to 2016, the prices of self-administered disease-modifying therapies for multiple sclerosis increased markedly, according to an analysis published in JAMA Neurology. The increased prices raise concern “because they demonstrate that the approval of new therapies did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs,” wrote the authors.

Four self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) were available before 2009, and seven new branded DMTs were introduced after that year. Previous research indicated that the prices of DMTs for MS increased at higher rates than the prices of drugs for other disorders. How these price increases affected pharmaceutical spending during the past decade is uncertain, however.

A review of Medicare claims data

Alvaro San-Juan-Rodriguez, PharmD, a fellow in pharmacoeconomics, outcomes, and pharmacoanalytics research at the University of Pittsburgh, and colleagues examined claims data from 2006 to 2016 from a 5% random sample of Medicare beneficiaries. Information for a mean of 2.8 million Medicare beneficiaries per year was available. The researchers extracted all prescription claims for self-administered DMTs for MS (that is, glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and peginterferon beta-1a).

Dr. San-Juan-Rodriguez and associates chose three main outcomes. The first was the annual cost of treatment with each medication, which was based on Medicare Part D prescription claims gross costs and Food and Drug Administration–approved recommended dosing. The second was the market share of each medication, which the researchers defined as the proportion of pharmaceutical spending accounted for by each drug. The third was pharmaceutical spending per 1,000 Medicare beneficiaries for all drugs. The investigators also examined the relative contributions of Medicare Part D Plans’ payments, patients’ out-of-pocket costs, and other payments toward pharmaceutical spending.

Prices defied market expectations

The annual costs of treatment with self-administered DMTs for MS increased more than 300%. The mean annual cost was $18,660 in 2006 and $75,847 in 2016, and the mean annual rate of price increase was 12.8%. “Prices of most self-administered DMTs for MS increased in parallel, defying standard market expectations,” the investigators wrote.

Branded formulations of glatiramer acetate maintained the largest market share throughout the study period, ranging between 32.2% and 48.4%. However, the market share of platform therapies – glatiramer acetate, interferon beta-1a, and interferon beta-1b – decreased significantly from 2006 to 2016. Market shares for brand-name glatiramers declined from 36.7% to 32.2%, for intramuscular interferon beta-1a (30 mcg) from 32.3% to 14.2%, for interferon beta-1b from 18.7% to 4.5%, and for interferon beta-1a (8.8, 22, or 44 mcg) from 12.2% to 8.3%. The market shares of newer therapies, however, increased to 7.9% for fingolimod, 9.0% for teriflunomide, and 19.2% for dimethyl fumarate.

Pharmaceutical spending per 1,000 beneficiaries increased by a factor of 10.2 throughout the study period (from $7,794 to $79,411). Patients’ out-of-pocket spending per 1,000 beneficiaries increased by a factor of 7.2 (from $372 to $2,673). Furthermore, the relative contribution of federal payments toward pharmaceutical spending increased from 68.5% to 73.8%.

“Large increases in drug prices have not been specific to MS drugs,” said Dr. San-Juan-Rodriguez in an interview. “We previously described similar trends in other specialty medications used to treat severe disease states, such as tumor necrosis factor inhibitors [TNFi] for the treatment of rheumatoid arthritis. Yet these increases took place at a slower pace. For instance, list prices of TNFi increased at an average annual rate of 9.9% in the same time period, 2006-2016.

“It is important to acknowledge that rising list prices of drugs may partially reflect competition for rebates,” he added. “Yet the specific reasons behind the faster growth of prices of MS drugs, compared with the prices of drugs used in other disease states, remain uncertain.”

Neurologists should bear in mind that, although generic drugs are substantially cheaper than branded drugs, generic specialty medications do not always reduce costs for Medicare Part D beneficiaries. “On the contrary, due to incentive misalignments created by the Medicare Part D benefit design, beneficiaries using generic drugs such as Glatopa ... may pay more than those using the branded drug,” Dr. San-Juan-Rodriguez said.

What are neurologists’ responsibilities?

Although the original annual price of interferon beta-1b ($10,920) was stunning, physicians now recall it with nostalgia, wrote Daniel M. Hartung, PharmD, associate professor of biostatistics and epidemiology, and Dennis Bourdette, MD, professor of neurology, both at Oregon Health and Science University, Portland, in an accompanying editorial. “The prices for DMTs for MS have risen dramatically over the last 15 years, far outpacing inflation, and now have a mean price of more than $86,000 per year.”

Neurologists should be concerned about these rising prices, Dr. Hartung and Dr. Bourdette wrote. They should feel responsibility toward the health care system that pays for these medications, and toward patients who pay out of their own pockets. “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”

One way for neurologists to address increasing prices is to urge state and federal lawmakers to pass legislation to curb them, they wrote. Neurologists also should reexamine their relationships with pharmaceutical and biotechnology companies. “Remaining silent should not be an option. ... Neurologists should not allow the unfettered increases in price for these drugs to hurt the health care system or patients.”

The Myers Family Foundation and the National Heart, Lung, and Blood Institute funded the research. Several authors are employees of health insurance companies such as the UPMC Health Plan Insurance Services Division and Humana. One author received personal fees from Pfizer that were unrelated to this study.

[email protected]

SOURCEs: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2711; Hartung DM and Bourdette D. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2445.

From 2006 to 2016, the prices of self-administered disease-modifying therapies for multiple sclerosis increased markedly, according to an analysis published in JAMA Neurology. The increased prices raise concern “because they demonstrate that the approval of new therapies did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs,” wrote the authors.

Four self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) were available before 2009, and seven new branded DMTs were introduced after that year. Previous research indicated that the prices of DMTs for MS increased at higher rates than the prices of drugs for other disorders. How these price increases affected pharmaceutical spending during the past decade is uncertain, however.

A review of Medicare claims data

Alvaro San-Juan-Rodriguez, PharmD, a fellow in pharmacoeconomics, outcomes, and pharmacoanalytics research at the University of Pittsburgh, and colleagues examined claims data from 2006 to 2016 from a 5% random sample of Medicare beneficiaries. Information for a mean of 2.8 million Medicare beneficiaries per year was available. The researchers extracted all prescription claims for self-administered DMTs for MS (that is, glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and peginterferon beta-1a).

Dr. San-Juan-Rodriguez and associates chose three main outcomes. The first was the annual cost of treatment with each medication, which was based on Medicare Part D prescription claims gross costs and Food and Drug Administration–approved recommended dosing. The second was the market share of each medication, which the researchers defined as the proportion of pharmaceutical spending accounted for by each drug. The third was pharmaceutical spending per 1,000 Medicare beneficiaries for all drugs. The investigators also examined the relative contributions of Medicare Part D Plans’ payments, patients’ out-of-pocket costs, and other payments toward pharmaceutical spending.

Prices defied market expectations

The annual costs of treatment with self-administered DMTs for MS increased more than 300%. The mean annual cost was $18,660 in 2006 and $75,847 in 2016, and the mean annual rate of price increase was 12.8%. “Prices of most self-administered DMTs for MS increased in parallel, defying standard market expectations,” the investigators wrote.

Branded formulations of glatiramer acetate maintained the largest market share throughout the study period, ranging between 32.2% and 48.4%. However, the market share of platform therapies – glatiramer acetate, interferon beta-1a, and interferon beta-1b – decreased significantly from 2006 to 2016. Market shares for brand-name glatiramers declined from 36.7% to 32.2%, for intramuscular interferon beta-1a (30 mcg) from 32.3% to 14.2%, for interferon beta-1b from 18.7% to 4.5%, and for interferon beta-1a (8.8, 22, or 44 mcg) from 12.2% to 8.3%. The market shares of newer therapies, however, increased to 7.9% for fingolimod, 9.0% for teriflunomide, and 19.2% for dimethyl fumarate.

Pharmaceutical spending per 1,000 beneficiaries increased by a factor of 10.2 throughout the study period (from $7,794 to $79,411). Patients’ out-of-pocket spending per 1,000 beneficiaries increased by a factor of 7.2 (from $372 to $2,673). Furthermore, the relative contribution of federal payments toward pharmaceutical spending increased from 68.5% to 73.8%.

“Large increases in drug prices have not been specific to MS drugs,” said Dr. San-Juan-Rodriguez in an interview. “We previously described similar trends in other specialty medications used to treat severe disease states, such as tumor necrosis factor inhibitors [TNFi] for the treatment of rheumatoid arthritis. Yet these increases took place at a slower pace. For instance, list prices of TNFi increased at an average annual rate of 9.9% in the same time period, 2006-2016.

“It is important to acknowledge that rising list prices of drugs may partially reflect competition for rebates,” he added. “Yet the specific reasons behind the faster growth of prices of MS drugs, compared with the prices of drugs used in other disease states, remain uncertain.”

Neurologists should bear in mind that, although generic drugs are substantially cheaper than branded drugs, generic specialty medications do not always reduce costs for Medicare Part D beneficiaries. “On the contrary, due to incentive misalignments created by the Medicare Part D benefit design, beneficiaries using generic drugs such as Glatopa ... may pay more than those using the branded drug,” Dr. San-Juan-Rodriguez said.

What are neurologists’ responsibilities?

Although the original annual price of interferon beta-1b ($10,920) was stunning, physicians now recall it with nostalgia, wrote Daniel M. Hartung, PharmD, associate professor of biostatistics and epidemiology, and Dennis Bourdette, MD, professor of neurology, both at Oregon Health and Science University, Portland, in an accompanying editorial. “The prices for DMTs for MS have risen dramatically over the last 15 years, far outpacing inflation, and now have a mean price of more than $86,000 per year.”

Neurologists should be concerned about these rising prices, Dr. Hartung and Dr. Bourdette wrote. They should feel responsibility toward the health care system that pays for these medications, and toward patients who pay out of their own pockets. “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”

One way for neurologists to address increasing prices is to urge state and federal lawmakers to pass legislation to curb them, they wrote. Neurologists also should reexamine their relationships with pharmaceutical and biotechnology companies. “Remaining silent should not be an option. ... Neurologists should not allow the unfettered increases in price for these drugs to hurt the health care system or patients.”

The Myers Family Foundation and the National Heart, Lung, and Blood Institute funded the research. Several authors are employees of health insurance companies such as the UPMC Health Plan Insurance Services Division and Humana. One author received personal fees from Pfizer that were unrelated to this study.

[email protected]

SOURCEs: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2711; Hartung DM and Bourdette D. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2445.

From 2006 to 2016, the prices of self-administered disease-modifying therapies for multiple sclerosis increased markedly, according to an analysis published in JAMA Neurology. The increased prices raise concern “because they demonstrate that the approval of new therapies did not ameliorate and could have even contributed to high inflation rates observed for incumbent drugs,” wrote the authors.

Four self-administered disease-modifying therapies (DMTs) for multiple sclerosis (MS) were available before 2009, and seven new branded DMTs were introduced after that year. Previous research indicated that the prices of DMTs for MS increased at higher rates than the prices of drugs for other disorders. How these price increases affected pharmaceutical spending during the past decade is uncertain, however.

A review of Medicare claims data

Alvaro San-Juan-Rodriguez, PharmD, a fellow in pharmacoeconomics, outcomes, and pharmacoanalytics research at the University of Pittsburgh, and colleagues examined claims data from 2006 to 2016 from a 5% random sample of Medicare beneficiaries. Information for a mean of 2.8 million Medicare beneficiaries per year was available. The researchers extracted all prescription claims for self-administered DMTs for MS (that is, glatiramer acetate, interferon beta-1a, interferon beta-1b, fingolimod, teriflunomide, dimethyl fumarate, and peginterferon beta-1a).

Dr. San-Juan-Rodriguez and associates chose three main outcomes. The first was the annual cost of treatment with each medication, which was based on Medicare Part D prescription claims gross costs and Food and Drug Administration–approved recommended dosing. The second was the market share of each medication, which the researchers defined as the proportion of pharmaceutical spending accounted for by each drug. The third was pharmaceutical spending per 1,000 Medicare beneficiaries for all drugs. The investigators also examined the relative contributions of Medicare Part D Plans’ payments, patients’ out-of-pocket costs, and other payments toward pharmaceutical spending.

Prices defied market expectations

The annual costs of treatment with self-administered DMTs for MS increased more than 300%. The mean annual cost was $18,660 in 2006 and $75,847 in 2016, and the mean annual rate of price increase was 12.8%. “Prices of most self-administered DMTs for MS increased in parallel, defying standard market expectations,” the investigators wrote.

Branded formulations of glatiramer acetate maintained the largest market share throughout the study period, ranging between 32.2% and 48.4%. However, the market share of platform therapies – glatiramer acetate, interferon beta-1a, and interferon beta-1b – decreased significantly from 2006 to 2016. Market shares for brand-name glatiramers declined from 36.7% to 32.2%, for intramuscular interferon beta-1a (30 mcg) from 32.3% to 14.2%, for interferon beta-1b from 18.7% to 4.5%, and for interferon beta-1a (8.8, 22, or 44 mcg) from 12.2% to 8.3%. The market shares of newer therapies, however, increased to 7.9% for fingolimod, 9.0% for teriflunomide, and 19.2% for dimethyl fumarate.

Pharmaceutical spending per 1,000 beneficiaries increased by a factor of 10.2 throughout the study period (from $7,794 to $79,411). Patients’ out-of-pocket spending per 1,000 beneficiaries increased by a factor of 7.2 (from $372 to $2,673). Furthermore, the relative contribution of federal payments toward pharmaceutical spending increased from 68.5% to 73.8%.

“Large increases in drug prices have not been specific to MS drugs,” said Dr. San-Juan-Rodriguez in an interview. “We previously described similar trends in other specialty medications used to treat severe disease states, such as tumor necrosis factor inhibitors [TNFi] for the treatment of rheumatoid arthritis. Yet these increases took place at a slower pace. For instance, list prices of TNFi increased at an average annual rate of 9.9% in the same time period, 2006-2016.

“It is important to acknowledge that rising list prices of drugs may partially reflect competition for rebates,” he added. “Yet the specific reasons behind the faster growth of prices of MS drugs, compared with the prices of drugs used in other disease states, remain uncertain.”

Neurologists should bear in mind that, although generic drugs are substantially cheaper than branded drugs, generic specialty medications do not always reduce costs for Medicare Part D beneficiaries. “On the contrary, due to incentive misalignments created by the Medicare Part D benefit design, beneficiaries using generic drugs such as Glatopa ... may pay more than those using the branded drug,” Dr. San-Juan-Rodriguez said.

What are neurologists’ responsibilities?

Although the original annual price of interferon beta-1b ($10,920) was stunning, physicians now recall it with nostalgia, wrote Daniel M. Hartung, PharmD, associate professor of biostatistics and epidemiology, and Dennis Bourdette, MD, professor of neurology, both at Oregon Health and Science University, Portland, in an accompanying editorial. “The prices for DMTs for MS have risen dramatically over the last 15 years, far outpacing inflation, and now have a mean price of more than $86,000 per year.”

Neurologists should be concerned about these rising prices, Dr. Hartung and Dr. Bourdette wrote. They should feel responsibility toward the health care system that pays for these medications, and toward patients who pay out of their own pockets. “Neurologists should be seeking to minimize the financial adverse effects of these therapies as much as they try to minimize physical adverse effects.”

One way for neurologists to address increasing prices is to urge state and federal lawmakers to pass legislation to curb them, they wrote. Neurologists also should reexamine their relationships with pharmaceutical and biotechnology companies. “Remaining silent should not be an option. ... Neurologists should not allow the unfettered increases in price for these drugs to hurt the health care system or patients.”

The Myers Family Foundation and the National Heart, Lung, and Blood Institute funded the research. Several authors are employees of health insurance companies such as the UPMC Health Plan Insurance Services Division and Humana. One author received personal fees from Pfizer that were unrelated to this study.

[email protected]

SOURCEs: San-Juan-Rodriguez A et al. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2711; Hartung DM and Bourdette D. JAMA Neurol. 2019 Aug 26. doi: 10.1001/jamaneurol.2019.2445.

LUGANO, Switzerland – In younger patients with previously untreated mantle cell lymphoma, the chemotherapy-free combination of ibrutinib and rituximab followed by a short course of chemotherapy was associated with an “unprecedented” 3-year progression-free survival rate, investigators in the phase 2 WINDOW-1 trial reported.

Neil Osterweil/MDedge News

Among 50 patients aged 65 years and younger who received ibrutinib and rituximab until they achieved a complete or partial response, followed by four cycles of chemotherapy with rituximab plus hyper-CVAD (cyclophosphamide, vincristine, doxorubicin and dexamethasone) and rituximab plus methotrexate, the 3-year progression-free survival (PFS) rate was 88%, said Michael Wang, MD, from the University of Texas MD Anderson Cancer Center in Houston.

Additionally, for patients with the low-risk features, the 3-year PFS rate was 90%.

“Chemo-free ibrutinib-rituximab induced unprecedented – unprecedented – efficacy before chemo consolidation,” he said at the International Conference on Malignant Lymphoma.

Dr. Wang presented data from an interim analysis of the investigator-initiated single-center trial. Fifty patients aged 65 years or younger with untreated mantle cell lymphoma (MCL), good performance status, and good organ function were enrolled.

The patients were treated with ibrutinib and rituximab for two cycles and then evaluated for response with PET-CT scan, bone marrow biopsy, and for some patients, esophagogastroduodenoscopy (EGD) and colonoscopy with random biopsies.

In the induction phase, patients received ibrutinib daily on days 1-28 and rituximab intravenously over 6-8 hours on days 1, 8, 15, and 22 of cycle 1, and then over 4 hours on day 1 of cycles 3-12. The treatment was repeated every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity, or until patients achieved a complete response.

In the consolidation phase, patients received rituximab IV over 6 hours on day 1; oral or IV dexamethasone on days 1-4; cyclophosphamide IV over 3 hours twice daily on days 2-4; doxorubicin IV over 15-30 minutes on day 5; and vincristine IV over 15-30 minutes on day 5 of cycles one, three, five, and seven. Patients also received rituximab IV over 6 hours on day 1; methotrexate IV over 24 hours on day 2; and cytarabine IV over 2 hours twice daily on days 3 and 4 of cycles two, four, six, and eight. Treatments were repeated every 28 days for up to eight cycles in the absence of disease progression or unacceptable toxicity.

Patients who had a complete response (CR) after two cycles of induction and those who had disease progression on induction went on to consolidation. Patients with partial responses (PR) to induction continued on ibrutinib/rituximab until either the loss of a PR or best response for up to 12 cycles, with those who achieved a CR then moving on to consolidation.

Patients who had a CR after induction received four cycles of R-hyperCVAD, no subsequent stem cell transplant, and no maintenance therapy. Patients who had a PR after induction received two cycles of R-hyperCVAD, were reassessed, and then continued on R-hyperCVAD until CR or for up to eight total cycles.

Patients with either stable disease or progression during R-hyperCVAD were taken off the study.

Of the 50 patients enrolled, all 50 were evaluable for part A (induction), and 48 were evaluable after induction and consolidation (two patients withdrew for personal reasons).

After a median follow-up of 36 months, the overall response rate (ORR) following induction was 100%, consisting of 46 CRs (92%) and four PRs (8%).

In an intention-to-treat analysis (including the two patients who withdrew), the ORR was 96%, consisting of CRs in 47 patients (94%) and a PR in 1 patient (2%).

Neither the median PFS nor median overall survival had been reached at the time of data cutoff, and no patients have died.

Of the 50 enrolled patients, four experienced disease progression after 17, 24, 34, and 35 months of treatment. The patients with disease progression included one with Ki-67 of less than 30%, and three with KI-67 of 30% or greater.

Grade 3-4 toxicities during induction including myelosuppression in 4%; fatigue, myalgia, and rashes in 8% each; and oral mucositis in 4%.

Dr. Wang said that future studies on minimal residual disease and clonal evolution are ongoing, and that data on more patients will be presented at the next annual meeting of the American Society of Hematology, scheduled for December 2019.

He also noted that the WINDOW-2 trial, in which ibrutinib and rituximab are followed by veneotclax and hyper-CVAD chemotherapy in patients with newly diagnosed MCL, is open and rapidly enrolling patients.

The study is supported by the National Cancer Institute. Dr. Wang reported financial relationships with Janssen, Pharmacyclics, and other companies.

SOURCE: Wang M et al. ICML-15, Abstract 12.

LUGANO, Switzerland – In younger patients with previously untreated mantle cell lymphoma, the chemotherapy-free combination of ibrutinib and rituximab followed by a short course of chemotherapy was associated with an “unprecedented” 3-year progression-free survival rate, investigators in the phase 2 WINDOW-1 trial reported.

Neil Osterweil/MDedge News

Among 50 patients aged 65 years and younger who received ibrutinib and rituximab until they achieved a complete or partial response, followed by four cycles of chemotherapy with rituximab plus hyper-CVAD (cyclophosphamide, vincristine, doxorubicin and dexamethasone) and rituximab plus methotrexate, the 3-year progression-free survival (PFS) rate was 88%, said Michael Wang, MD, from the University of Texas MD Anderson Cancer Center in Houston.

Additionally, for patients with the low-risk features, the 3-year PFS rate was 90%.

“Chemo-free ibrutinib-rituximab induced unprecedented – unprecedented – efficacy before chemo consolidation,” he said at the International Conference on Malignant Lymphoma.

Dr. Wang presented data from an interim analysis of the investigator-initiated single-center trial. Fifty patients aged 65 years or younger with untreated mantle cell lymphoma (MCL), good performance status, and good organ function were enrolled.

The patients were treated with ibrutinib and rituximab for two cycles and then evaluated for response with PET-CT scan, bone marrow biopsy, and for some patients, esophagogastroduodenoscopy (EGD) and colonoscopy with random biopsies.

In the induction phase, patients received ibrutinib daily on days 1-28 and rituximab intravenously over 6-8 hours on days 1, 8, 15, and 22 of cycle 1, and then over 4 hours on day 1 of cycles 3-12. The treatment was repeated every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity, or until patients achieved a complete response.

In the consolidation phase, patients received rituximab IV over 6 hours on day 1; oral or IV dexamethasone on days 1-4; cyclophosphamide IV over 3 hours twice daily on days 2-4; doxorubicin IV over 15-30 minutes on day 5; and vincristine IV over 15-30 minutes on day 5 of cycles one, three, five, and seven. Patients also received rituximab IV over 6 hours on day 1; methotrexate IV over 24 hours on day 2; and cytarabine IV over 2 hours twice daily on days 3 and 4 of cycles two, four, six, and eight. Treatments were repeated every 28 days for up to eight cycles in the absence of disease progression or unacceptable toxicity.

Patients who had a complete response (CR) after two cycles of induction and those who had disease progression on induction went on to consolidation. Patients with partial responses (PR) to induction continued on ibrutinib/rituximab until either the loss of a PR or best response for up to 12 cycles, with those who achieved a CR then moving on to consolidation.

Patients who had a CR after induction received four cycles of R-hyperCVAD, no subsequent stem cell transplant, and no maintenance therapy. Patients who had a PR after induction received two cycles of R-hyperCVAD, were reassessed, and then continued on R-hyperCVAD until CR or for up to eight total cycles.

Patients with either stable disease or progression during R-hyperCVAD were taken off the study.

Of the 50 patients enrolled, all 50 were evaluable for part A (induction), and 48 were evaluable after induction and consolidation (two patients withdrew for personal reasons).

After a median follow-up of 36 months, the overall response rate (ORR) following induction was 100%, consisting of 46 CRs (92%) and four PRs (8%).

In an intention-to-treat analysis (including the two patients who withdrew), the ORR was 96%, consisting of CRs in 47 patients (94%) and a PR in 1 patient (2%).

Neither the median PFS nor median overall survival had been reached at the time of data cutoff, and no patients have died.

Of the 50 enrolled patients, four experienced disease progression after 17, 24, 34, and 35 months of treatment. The patients with disease progression included one with Ki-67 of less than 30%, and three with KI-67 of 30% or greater.

Grade 3-4 toxicities during induction including myelosuppression in 4%; fatigue, myalgia, and rashes in 8% each; and oral mucositis in 4%.

Dr. Wang said that future studies on minimal residual disease and clonal evolution are ongoing, and that data on more patients will be presented at the next annual meeting of the American Society of Hematology, scheduled for December 2019.

He also noted that the WINDOW-2 trial, in which ibrutinib and rituximab are followed by veneotclax and hyper-CVAD chemotherapy in patients with newly diagnosed MCL, is open and rapidly enrolling patients.

The study is supported by the National Cancer Institute. Dr. Wang reported financial relationships with Janssen, Pharmacyclics, and other companies.

SOURCE: Wang M et al. ICML-15, Abstract 12.

LUGANO, Switzerland – In younger patients with previously untreated mantle cell lymphoma, the chemotherapy-free combination of ibrutinib and rituximab followed by a short course of chemotherapy was associated with an “unprecedented” 3-year progression-free survival rate, investigators in the phase 2 WINDOW-1 trial reported.

Neil Osterweil/MDedge News

Among 50 patients aged 65 years and younger who received ibrutinib and rituximab until they achieved a complete or partial response, followed by four cycles of chemotherapy with rituximab plus hyper-CVAD (cyclophosphamide, vincristine, doxorubicin and dexamethasone) and rituximab plus methotrexate, the 3-year progression-free survival (PFS) rate was 88%, said Michael Wang, MD, from the University of Texas MD Anderson Cancer Center in Houston.

Additionally, for patients with the low-risk features, the 3-year PFS rate was 90%.

“Chemo-free ibrutinib-rituximab induced unprecedented – unprecedented – efficacy before chemo consolidation,” he said at the International Conference on Malignant Lymphoma.

Dr. Wang presented data from an interim analysis of the investigator-initiated single-center trial. Fifty patients aged 65 years or younger with untreated mantle cell lymphoma (MCL), good performance status, and good organ function were enrolled.

The patients were treated with ibrutinib and rituximab for two cycles and then evaluated for response with PET-CT scan, bone marrow biopsy, and for some patients, esophagogastroduodenoscopy (EGD) and colonoscopy with random biopsies.

In the induction phase, patients received ibrutinib daily on days 1-28 and rituximab intravenously over 6-8 hours on days 1, 8, 15, and 22 of cycle 1, and then over 4 hours on day 1 of cycles 3-12. The treatment was repeated every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity, or until patients achieved a complete response.

In the consolidation phase, patients received rituximab IV over 6 hours on day 1; oral or IV dexamethasone on days 1-4; cyclophosphamide IV over 3 hours twice daily on days 2-4; doxorubicin IV over 15-30 minutes on day 5; and vincristine IV over 15-30 minutes on day 5 of cycles one, three, five, and seven. Patients also received rituximab IV over 6 hours on day 1; methotrexate IV over 24 hours on day 2; and cytarabine IV over 2 hours twice daily on days 3 and 4 of cycles two, four, six, and eight. Treatments were repeated every 28 days for up to eight cycles in the absence of disease progression or unacceptable toxicity.

Patients who had a complete response (CR) after two cycles of induction and those who had disease progression on induction went on to consolidation. Patients with partial responses (PR) to induction continued on ibrutinib/rituximab until either the loss of a PR or best response for up to 12 cycles, with those who achieved a CR then moving on to consolidation.

Patients who had a CR after induction received four cycles of R-hyperCVAD, no subsequent stem cell transplant, and no maintenance therapy. Patients who had a PR after induction received two cycles of R-hyperCVAD, were reassessed, and then continued on R-hyperCVAD until CR or for up to eight total cycles.

Patients with either stable disease or progression during R-hyperCVAD were taken off the study.

Of the 50 patients enrolled, all 50 were evaluable for part A (induction), and 48 were evaluable after induction and consolidation (two patients withdrew for personal reasons).

After a median follow-up of 36 months, the overall response rate (ORR) following induction was 100%, consisting of 46 CRs (92%) and four PRs (8%).

In an intention-to-treat analysis (including the two patients who withdrew), the ORR was 96%, consisting of CRs in 47 patients (94%) and a PR in 1 patient (2%).

Neither the median PFS nor median overall survival had been reached at the time of data cutoff, and no patients have died.

Of the 50 enrolled patients, four experienced disease progression after 17, 24, 34, and 35 months of treatment. The patients with disease progression included one with Ki-67 of less than 30%, and three with KI-67 of 30% or greater.

Grade 3-4 toxicities during induction including myelosuppression in 4%; fatigue, myalgia, and rashes in 8% each; and oral mucositis in 4%.

Dr. Wang said that future studies on minimal residual disease and clonal evolution are ongoing, and that data on more patients will be presented at the next annual meeting of the American Society of Hematology, scheduled for December 2019.

He also noted that the WINDOW-2 trial, in which ibrutinib and rituximab are followed by veneotclax and hyper-CVAD chemotherapy in patients with newly diagnosed MCL, is open and rapidly enrolling patients.

The study is supported by the National Cancer Institute. Dr. Wang reported financial relationships with Janssen, Pharmacyclics, and other companies.

SOURCE: Wang M et al. ICML-15, Abstract 12.

If you work in health care or manage a medical practice, you are aware of all the radical changes in technology, medicine, social values, and interpersonal relations over the past few years and you probably do not expect the next several years to be less stressful and less uncertain. To ensure your practice and your provider’s success, you may need to adjust how your team interacts with patients – starting with the first area of patient interaction.

Patients who seek care for their health problems are looking for some measure of kindness when they approach the window of your office’s receptionist. Many are already apprehensive about their clinical condition and adding to that problem is their concern about the financial impact of their visit on the family’s budget. The medical group’s unwillingness to rethink how it greets patients as they approach the receptionist sets the stage for the patient to feel mishandled or underappreciated.

This initial patient interaction stage must be evaluated and recognized as an area of improvement. If not handled properly, it will significantly affect how a medical practice or provider is graded as a group in the field of patient experience and managing patient expectations. Every medical office needs to recognize that people hold on to negative experiences and are not likely to change their mind after that negative experience. The best way to avoid negative bias is to prevent it from happening in the first place.

Listed below are the five additional patient experience mistakes that can cost your group, if they are not recognized as being priorities for both your staff and your patients.
 

Mistake #1 - Educated patients are taking control of their health care.

When health care is treated like any other paid service, an unhappy patient will move along to a new facility or doctor if they have a bad interaction – whether it is with the doctor or the support staff. Educating, training, or adjusting staff to make changes needed is required to ensure that your staff understands the value of patient appreciation and providing the patient with a positive experience.

Mistake #2 - Patients are customers, and just like customers, patients have options.

It should be recognized that patients are customers who are concerned about their future and do not want to be in a medical practice requesting help. They feel vulnerable and out of their routine comfort zone. Reminding your staff that a patient is a customer who has multiple health care choices, but chose to come to your practice, will help your staff understand the value of providing your patient with a positive experience.

Mistake #3 – Dr. Google is becoming the patient’s best friend.

Research indicates that many patients arrive at the doctor’s office already with some information on their condition. Various websites already have provided the patient with free access to learn about their health condition. Popular medical sites such as WebMD.com give the patient the preliminary education they are looking for, so they are already armed with medical information even before they see the doctor or their support staff.

Mistake # 4 - Surveys are carrying more weight.

Outside surveys are becoming even more popular and are carrying additional weight when combined with various social media outlets. All types of surveys and reviews are being used to measure not only the care the patient received, but also the interpersonal relationship between the patient and the doctor, and the patient’s experience with the medical practice’s support staff. Some surveys cover all levels in the practice area, down to the cleanliness of the reception area or the patient’s treatment area, and even the adequacy of the parking lot. These surveys are conditioning patients to recall their entire experience. With a patient experience plan in place, excellent service becomes second nature and will be recognized by those surveyed.

Mistake #5 - Patient-centered care is customer service, too.

It’s not just about the obvious. Excellent patient (customer) service extends beyond a pleasant demeanor. The patient experience does not start or end at the doctor’s office. Perception is built by gathering information from multiple channels, whether it is through review sites, office visits, or surveys. It is necessary to consider the importance of those channels when looking to build patient loyalty.

To avoid the mistakes listed above, the more progressive medical practices are training their staff to anticipate the customer service needs of their patients, much like other major service industries. By rolling out a patient/customer experience training program, they can prevent these mistakes from ever happening and affecting their potential revenue. This training should focus on integrating the following strategies into their daily work habits to provide their patients with exceptional customer service while they are guests in their practice.

1) Patients are the lifeline to building the future of their practice.

Patients are comparing their health care services to other companies that routinely provide high-end services to their clients. Whether groups like it or not, their front-line personnel are compared to five-star hotel receptionists, who are expected to greet their customers both pleasantly and professionally after a long day of traveling and required business functions. Every medical group must understand that patients have options when they select a medical practice and they expect to be treated with respect and transparency, and not just another person to be cared for at the end of a long day. The same level of service needs to be delivered in the doctor’s office no matter what time of day it is because for that patient, the personal problems and subsequent disposition of the medical staff is not their problem. All they want is someone to listen and help them take care of their medical problem. Their long-term loyalty to the group will be solely dependent on how well each personal interaction is handled. Remember that the patient is a person first and not just a customer. We must approach each patient with humanity first, and then customer service.

2) Be courteous and respectful.

Remind your staff to be courteous, always polite and to use good manners. By treating a patient how they expect to be treated, you are showing the patient that you respect them and care for not only their health but also their feelings. The health care worker must understand that the patient is viewing their interactions with staff and providers as being symbolic of the overall group’s brand identity. The group’s leadership needs to select and train their workforce to recognize their importance in how patients view their clinical offerings and their interactions with the patient.

3) Never show indifference to patients.

Losing patients before they complete their treatment regimen is a significant liability issue for any medical practice. In an article written by Strive Labs CEO and Co-Founder, Scott Hebert, DPT, wrote: “Patient churn is too big of a problem to ignore, and it can have a profound impact on your clinic’s bottom line.” In addition to the rather obvious missed revenue opportunity, a churning patient represents a practice liability, because an unsatisfied patient is significantly more likely to leave you a negative review online — or turn the experience with your practice into a cautionary tale for friends and family members. Either way, it’s bad for business — and your reputation.

4) Don’t contradict, argue, or match wits.

It’s tough for a health care worker who is continually being bombarded in a high-pressure environment to agree to disagree. When a person feels they are right or that their perception is the only logical one, they can be very stubborn in their understanding, and they will dig in their heels. It takes a strong person to allow others to have their opinion and not be judgmental about it. Any customer or patient relations training program to be deployed in a medical office must include skill training to teach the staff member how to diffuse an argument or disagreement. This situation can be dispersed by training your staff to consider the source of the conflict, respect the patient’s perception, and then teach the staff member to tell the patient that they never thought of it that way and ease away from the discussion. Their absence will help diffuse the situation.

5) Tell patients you appreciate their business.

How you relate to a patient will speak volumes to them about how much you appreciate their loyalty, all because they chose your practice for their health care. All patient and customer training programs should include discussions on making eye contact, shaking with a firm grasp, and always closing a personal encounter on a sincere and positive note. Health care workers need to understand that they are in the service business and that the patients they care for have options and they can easily walk out of the medical practice and share any negative experience on social media. Educating and reminding your staff on how easily a patient can leave your practice or share their experience with others, needs to be recognized and discussed at all the group’s town hall meetings.

6) Use plain terms and simple explanations.

We all want to appear to be super intelligent by trying to use complex terms to describe a situation because it creates leverage with the other parties engaged in the conversation. While some of this may be necessary when educating patients on their condition, any additional complex terms can easily annoy or even confuse the patient who is only there seeking help. Health care workers need to talk in a manner that keeps the patients engaged and helps them understand the topic at hand. The worker needs to use every day vernacular examples, so the patient quickly understands the reason that brought them to the clinic and what they need to do to get some relief from what ails them. The phrase “plain and simple” means precisely that – explain the topic using basic and simple terms, so the listener understands it. Using this method when discussing a patient’s condition isn’t just for the patient’s benefit because many confused patients ultimately call the office later in the day only to ask additional questions, which uses your staff’s time.

7) Good manners will get you everywhere.

Emily Post wrote, “Manners are a sensitive awareness of the feelings of others. If you have that awareness, you have good manners, no matter what fork you use.” Proper manners are behaving in a way that is both aware of and considerate of the people around us. A person with good manners treats everyone with kindness and respect. It is knowing how to get along without causing offense or harm, no matter how much the current interaction is going south – especially when you are engaged in a tough conversation.

8) Keep seeing health care as a calling.

All health care workers need to know that their vocation of caring for sick and injured patients is a calling and not just a job and all training programs designed to teach customer service need to stress this point. Practicing your vocation means that you will work hard to eliminate all barriers that exist between the patient and the health care worker. Too often we underestimate the power of a simple touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring – all of which have the potential to turn a life or a bad interaction into a magical moment for both the patient and the health care worker. One that has meaning and a bit of affirmation of the dignity of both individuals interacting to find some common ground.

9) Stay in touch with patients.

The group needs to find ways to keep in contact with their patients, whether it is by giving them tips on how to remain healthy or the need for proactive and preventive medicine. The use of technology and social media, as well as handing out freebies at health fairs, giving patients informational brochures upon discharge, or even cards telling them how to contact the practice in case of emergencies, is quite helpful. Calling your patients is a significant signal that your group values the health and welfare of your patients. A phone call from either the doctor or their assistant goes further than any advertisement when building brand and doctor loyalty.

10) Keep your promises.

Do what you say you are going to do, should be a commonly shared mantra for the medical practice. While changing your mind from time to time when circumstances prevent you from keeping a promise, is just part of being flexible in life, regularly breaking promises to other people isn’t healthy. Here’s how to keep your promises: Pay close attention to your words – every word you communicate (through speaking or writing), as a patient may take your words as a promise. Study your patterns of making promises. Figure out when you tend to make careless promises and study the situations in which you do, so you can understand why you’re promising what you don’t intend to do. Take time and careful consideration before making a promise to someone. Don’t rush yourself into a promise that you won’t be able to keep. Even when you’re in a hurry, you usually don’t have an immediate sense of urgency about promising to do something. Stop yourself before you make a vow, delaying your decision long enough to think it through carefully. The more careful you become about making promises, the easier it will be to keep them.

The last step of deploying a patient/customer service program is handling the change in management that is required to train the staff. Accepting “No, we are not changing any part of the group to meet the needs of our patients better.” is unacceptable. Usually, you will be introducing this program to employees that have been in a group for a while and so to get them to buy into the new ideas will require constant reinforcement. It may take some time to align the focus of the group from the neutral zone to the notion that there are new deliverables that would better serve your patients. The following rules will be helpful when beginning your training program:

Rule #1 – Be consistent. Every policy, procedure, and list of priorities sends a message – make sure it’s the right message.

Rule #2 – Ensure quick successes. Look for ways to get the group’s employees to buy into the program – early on after its deployment.

Rule# 3 – Symbolize the new identity. Make sure the group’s logos and branding support the new identity of the group and the culture change.

Rule #4 – Celebrate all the group’s successes. Make sure the group’s employees recognize the work efforts involved as well as the success the group will enjoy. Stress the fact that the work completed will significantly enhance the care and service levels to the patients, which should feed the ego of the group to do more and more in the future.

And lastly, do not forget how vital the buy-in is of the clinicians of the group. They must be introduced early to the new patient/customer service program and embrace it so that their employees will recognize that these efforts are focused on providing a high quality of care throughout the enterprise. As the French philosopher Albert Schweitzer once stated, “Example is not the main thing in influencing others, it’s the only thing.”
 

References

1. Peters, T. “The Excellence Dividend: Meeting the Tech Tide with Work that Wows and Jobs that Last.” (New York, Vintage Books, 2018).

2. 10 Strategies to Provide Patients with Superior Customer Service. Becker’s Hospital Review 2010 Dec 20.

3. Shell MA, Buell RW. Why anxious customers prefer human customer service. Harvard Business Review 2019 April 15.

4. Matt Brannon. 13 Ways to improve customer services at your medical practice. Blog post Sept 7, 2018.

5. 5 Reasons Why Customer Service Matters in Healthcare. https://www.pointsgroup.com/5-reasons-why-customer-service-matters-in-healthcare/Feb. 25, 2014

6. Senge P, Kleiner A, Roberts C, et al. “The Dance of Change: A fifth discipline resource.” (New York, Doubleday, 1999).

7. Bridges W. “Managing Transitions: Making the Most of Change.” (Boston, Da Capo Books, 2017)

8. Michelli J. “The New Gold Standard – 5 Leadership Principles for Creating the Legendary Customer Experience Courtesy of the Ritz-Carlton Hotel Company.” (New York, McGraw Hill, 2008).

Mr. Turner is chief executive officer of Indianapolis Gastroenterology and Hepatology.

If you work in health care or manage a medical practice, you are aware of all the radical changes in technology, medicine, social values, and interpersonal relations over the past few years and you probably do not expect the next several years to be less stressful and less uncertain. To ensure your practice and your provider’s success, you may need to adjust how your team interacts with patients – starting with the first area of patient interaction.

Patients who seek care for their health problems are looking for some measure of kindness when they approach the window of your office’s receptionist. Many are already apprehensive about their clinical condition and adding to that problem is their concern about the financial impact of their visit on the family’s budget. The medical group’s unwillingness to rethink how it greets patients as they approach the receptionist sets the stage for the patient to feel mishandled or underappreciated.

This initial patient interaction stage must be evaluated and recognized as an area of improvement. If not handled properly, it will significantly affect how a medical practice or provider is graded as a group in the field of patient experience and managing patient expectations. Every medical office needs to recognize that people hold on to negative experiences and are not likely to change their mind after that negative experience. The best way to avoid negative bias is to prevent it from happening in the first place.

Listed below are the five additional patient experience mistakes that can cost your group, if they are not recognized as being priorities for both your staff and your patients.
 

Mistake #1 - Educated patients are taking control of their health care.

When health care is treated like any other paid service, an unhappy patient will move along to a new facility or doctor if they have a bad interaction – whether it is with the doctor or the support staff. Educating, training, or adjusting staff to make changes needed is required to ensure that your staff understands the value of patient appreciation and providing the patient with a positive experience.

Mistake #2 - Patients are customers, and just like customers, patients have options.

It should be recognized that patients are customers who are concerned about their future and do not want to be in a medical practice requesting help. They feel vulnerable and out of their routine comfort zone. Reminding your staff that a patient is a customer who has multiple health care choices, but chose to come to your practice, will help your staff understand the value of providing your patient with a positive experience.

Mistake #3 – Dr. Google is becoming the patient’s best friend.

Research indicates that many patients arrive at the doctor’s office already with some information on their condition. Various websites already have provided the patient with free access to learn about their health condition. Popular medical sites such as WebMD.com give the patient the preliminary education they are looking for, so they are already armed with medical information even before they see the doctor or their support staff.

Mistake # 4 - Surveys are carrying more weight.

Outside surveys are becoming even more popular and are carrying additional weight when combined with various social media outlets. All types of surveys and reviews are being used to measure not only the care the patient received, but also the interpersonal relationship between the patient and the doctor, and the patient’s experience with the medical practice’s support staff. Some surveys cover all levels in the practice area, down to the cleanliness of the reception area or the patient’s treatment area, and even the adequacy of the parking lot. These surveys are conditioning patients to recall their entire experience. With a patient experience plan in place, excellent service becomes second nature and will be recognized by those surveyed.

Mistake #5 - Patient-centered care is customer service, too.

It’s not just about the obvious. Excellent patient (customer) service extends beyond a pleasant demeanor. The patient experience does not start or end at the doctor’s office. Perception is built by gathering information from multiple channels, whether it is through review sites, office visits, or surveys. It is necessary to consider the importance of those channels when looking to build patient loyalty.

To avoid the mistakes listed above, the more progressive medical practices are training their staff to anticipate the customer service needs of their patients, much like other major service industries. By rolling out a patient/customer experience training program, they can prevent these mistakes from ever happening and affecting their potential revenue. This training should focus on integrating the following strategies into their daily work habits to provide their patients with exceptional customer service while they are guests in their practice.

1) Patients are the lifeline to building the future of their practice.

Patients are comparing their health care services to other companies that routinely provide high-end services to their clients. Whether groups like it or not, their front-line personnel are compared to five-star hotel receptionists, who are expected to greet their customers both pleasantly and professionally after a long day of traveling and required business functions. Every medical group must understand that patients have options when they select a medical practice and they expect to be treated with respect and transparency, and not just another person to be cared for at the end of a long day. The same level of service needs to be delivered in the doctor’s office no matter what time of day it is because for that patient, the personal problems and subsequent disposition of the medical staff is not their problem. All they want is someone to listen and help them take care of their medical problem. Their long-term loyalty to the group will be solely dependent on how well each personal interaction is handled. Remember that the patient is a person first and not just a customer. We must approach each patient with humanity first, and then customer service.

2) Be courteous and respectful.

Remind your staff to be courteous, always polite and to use good manners. By treating a patient how they expect to be treated, you are showing the patient that you respect them and care for not only their health but also their feelings. The health care worker must understand that the patient is viewing their interactions with staff and providers as being symbolic of the overall group’s brand identity. The group’s leadership needs to select and train their workforce to recognize their importance in how patients view their clinical offerings and their interactions with the patient.

3) Never show indifference to patients.

Losing patients before they complete their treatment regimen is a significant liability issue for any medical practice. In an article written by Strive Labs CEO and Co-Founder, Scott Hebert, DPT, wrote: “Patient churn is too big of a problem to ignore, and it can have a profound impact on your clinic’s bottom line.” In addition to the rather obvious missed revenue opportunity, a churning patient represents a practice liability, because an unsatisfied patient is significantly more likely to leave you a negative review online — or turn the experience with your practice into a cautionary tale for friends and family members. Either way, it’s bad for business — and your reputation.

4) Don’t contradict, argue, or match wits.

It’s tough for a health care worker who is continually being bombarded in a high-pressure environment to agree to disagree. When a person feels they are right or that their perception is the only logical one, they can be very stubborn in their understanding, and they will dig in their heels. It takes a strong person to allow others to have their opinion and not be judgmental about it. Any customer or patient relations training program to be deployed in a medical office must include skill training to teach the staff member how to diffuse an argument or disagreement. This situation can be dispersed by training your staff to consider the source of the conflict, respect the patient’s perception, and then teach the staff member to tell the patient that they never thought of it that way and ease away from the discussion. Their absence will help diffuse the situation.

5) Tell patients you appreciate their business.

How you relate to a patient will speak volumes to them about how much you appreciate their loyalty, all because they chose your practice for their health care. All patient and customer training programs should include discussions on making eye contact, shaking with a firm grasp, and always closing a personal encounter on a sincere and positive note. Health care workers need to understand that they are in the service business and that the patients they care for have options and they can easily walk out of the medical practice and share any negative experience on social media. Educating and reminding your staff on how easily a patient can leave your practice or share their experience with others, needs to be recognized and discussed at all the group’s town hall meetings.

6) Use plain terms and simple explanations.

We all want to appear to be super intelligent by trying to use complex terms to describe a situation because it creates leverage with the other parties engaged in the conversation. While some of this may be necessary when educating patients on their condition, any additional complex terms can easily annoy or even confuse the patient who is only there seeking help. Health care workers need to talk in a manner that keeps the patients engaged and helps them understand the topic at hand. The worker needs to use every day vernacular examples, so the patient quickly understands the reason that brought them to the clinic and what they need to do to get some relief from what ails them. The phrase “plain and simple” means precisely that – explain the topic using basic and simple terms, so the listener understands it. Using this method when discussing a patient’s condition isn’t just for the patient’s benefit because many confused patients ultimately call the office later in the day only to ask additional questions, which uses your staff’s time.

7) Good manners will get you everywhere.

Emily Post wrote, “Manners are a sensitive awareness of the feelings of others. If you have that awareness, you have good manners, no matter what fork you use.” Proper manners are behaving in a way that is both aware of and considerate of the people around us. A person with good manners treats everyone with kindness and respect. It is knowing how to get along without causing offense or harm, no matter how much the current interaction is going south – especially when you are engaged in a tough conversation.

8) Keep seeing health care as a calling.

All health care workers need to know that their vocation of caring for sick and injured patients is a calling and not just a job and all training programs designed to teach customer service need to stress this point. Practicing your vocation means that you will work hard to eliminate all barriers that exist between the patient and the health care worker. Too often we underestimate the power of a simple touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring – all of which have the potential to turn a life or a bad interaction into a magical moment for both the patient and the health care worker. One that has meaning and a bit of affirmation of the dignity of both individuals interacting to find some common ground.

9) Stay in touch with patients.

The group needs to find ways to keep in contact with their patients, whether it is by giving them tips on how to remain healthy or the need for proactive and preventive medicine. The use of technology and social media, as well as handing out freebies at health fairs, giving patients informational brochures upon discharge, or even cards telling them how to contact the practice in case of emergencies, is quite helpful. Calling your patients is a significant signal that your group values the health and welfare of your patients. A phone call from either the doctor or their assistant goes further than any advertisement when building brand and doctor loyalty.

10) Keep your promises.

Do what you say you are going to do, should be a commonly shared mantra for the medical practice. While changing your mind from time to time when circumstances prevent you from keeping a promise, is just part of being flexible in life, regularly breaking promises to other people isn’t healthy. Here’s how to keep your promises: Pay close attention to your words – every word you communicate (through speaking or writing), as a patient may take your words as a promise. Study your patterns of making promises. Figure out when you tend to make careless promises and study the situations in which you do, so you can understand why you’re promising what you don’t intend to do. Take time and careful consideration before making a promise to someone. Don’t rush yourself into a promise that you won’t be able to keep. Even when you’re in a hurry, you usually don’t have an immediate sense of urgency about promising to do something. Stop yourself before you make a vow, delaying your decision long enough to think it through carefully. The more careful you become about making promises, the easier it will be to keep them.

The last step of deploying a patient/customer service program is handling the change in management that is required to train the staff. Accepting “No, we are not changing any part of the group to meet the needs of our patients better.” is unacceptable. Usually, you will be introducing this program to employees that have been in a group for a while and so to get them to buy into the new ideas will require constant reinforcement. It may take some time to align the focus of the group from the neutral zone to the notion that there are new deliverables that would better serve your patients. The following rules will be helpful when beginning your training program:

Rule #1 – Be consistent. Every policy, procedure, and list of priorities sends a message – make sure it’s the right message.

Rule #2 – Ensure quick successes. Look for ways to get the group’s employees to buy into the program – early on after its deployment.

Rule# 3 – Symbolize the new identity. Make sure the group’s logos and branding support the new identity of the group and the culture change.

Rule #4 – Celebrate all the group’s successes. Make sure the group’s employees recognize the work efforts involved as well as the success the group will enjoy. Stress the fact that the work completed will significantly enhance the care and service levels to the patients, which should feed the ego of the group to do more and more in the future.

And lastly, do not forget how vital the buy-in is of the clinicians of the group. They must be introduced early to the new patient/customer service program and embrace it so that their employees will recognize that these efforts are focused on providing a high quality of care throughout the enterprise. As the French philosopher Albert Schweitzer once stated, “Example is not the main thing in influencing others, it’s the only thing.”
 

References

1. Peters, T. “The Excellence Dividend: Meeting the Tech Tide with Work that Wows and Jobs that Last.” (New York, Vintage Books, 2018).

2. 10 Strategies to Provide Patients with Superior Customer Service. Becker’s Hospital Review 2010 Dec 20.

3. Shell MA, Buell RW. Why anxious customers prefer human customer service. Harvard Business Review 2019 April 15.

4. Matt Brannon. 13 Ways to improve customer services at your medical practice. Blog post Sept 7, 2018.

5. 5 Reasons Why Customer Service Matters in Healthcare. https://www.pointsgroup.com/5-reasons-why-customer-service-matters-in-healthcare/Feb. 25, 2014

6. Senge P, Kleiner A, Roberts C, et al. “The Dance of Change: A fifth discipline resource.” (New York, Doubleday, 1999).

7. Bridges W. “Managing Transitions: Making the Most of Change.” (Boston, Da Capo Books, 2017)

8. Michelli J. “The New Gold Standard – 5 Leadership Principles for Creating the Legendary Customer Experience Courtesy of the Ritz-Carlton Hotel Company.” (New York, McGraw Hill, 2008).

Mr. Turner is chief executive officer of Indianapolis Gastroenterology and Hepatology.

If you work in health care or manage a medical practice, you are aware of all the radical changes in technology, medicine, social values, and interpersonal relations over the past few years and you probably do not expect the next several years to be less stressful and less uncertain. To ensure your practice and your provider’s success, you may need to adjust how your team interacts with patients – starting with the first area of patient interaction.

Patients who seek care for their health problems are looking for some measure of kindness when they approach the window of your office’s receptionist. Many are already apprehensive about their clinical condition and adding to that problem is their concern about the financial impact of their visit on the family’s budget. The medical group’s unwillingness to rethink how it greets patients as they approach the receptionist sets the stage for the patient to feel mishandled or underappreciated.

This initial patient interaction stage must be evaluated and recognized as an area of improvement. If not handled properly, it will significantly affect how a medical practice or provider is graded as a group in the field of patient experience and managing patient expectations. Every medical office needs to recognize that people hold on to negative experiences and are not likely to change their mind after that negative experience. The best way to avoid negative bias is to prevent it from happening in the first place.

Listed below are the five additional patient experience mistakes that can cost your group, if they are not recognized as being priorities for both your staff and your patients.
 

Mistake #1 - Educated patients are taking control of their health care.

When health care is treated like any other paid service, an unhappy patient will move along to a new facility or doctor if they have a bad interaction – whether it is with the doctor or the support staff. Educating, training, or adjusting staff to make changes needed is required to ensure that your staff understands the value of patient appreciation and providing the patient with a positive experience.

Mistake #2 - Patients are customers, and just like customers, patients have options.

It should be recognized that patients are customers who are concerned about their future and do not want to be in a medical practice requesting help. They feel vulnerable and out of their routine comfort zone. Reminding your staff that a patient is a customer who has multiple health care choices, but chose to come to your practice, will help your staff understand the value of providing your patient with a positive experience.

Mistake #3 – Dr. Google is becoming the patient’s best friend.

Research indicates that many patients arrive at the doctor’s office already with some information on their condition. Various websites already have provided the patient with free access to learn about their health condition. Popular medical sites such as WebMD.com give the patient the preliminary education they are looking for, so they are already armed with medical information even before they see the doctor or their support staff.

Mistake # 4 - Surveys are carrying more weight.

Outside surveys are becoming even more popular and are carrying additional weight when combined with various social media outlets. All types of surveys and reviews are being used to measure not only the care the patient received, but also the interpersonal relationship between the patient and the doctor, and the patient’s experience with the medical practice’s support staff. Some surveys cover all levels in the practice area, down to the cleanliness of the reception area or the patient’s treatment area, and even the adequacy of the parking lot. These surveys are conditioning patients to recall their entire experience. With a patient experience plan in place, excellent service becomes second nature and will be recognized by those surveyed.

Mistake #5 - Patient-centered care is customer service, too.

It’s not just about the obvious. Excellent patient (customer) service extends beyond a pleasant demeanor. The patient experience does not start or end at the doctor’s office. Perception is built by gathering information from multiple channels, whether it is through review sites, office visits, or surveys. It is necessary to consider the importance of those channels when looking to build patient loyalty.

To avoid the mistakes listed above, the more progressive medical practices are training their staff to anticipate the customer service needs of their patients, much like other major service industries. By rolling out a patient/customer experience training program, they can prevent these mistakes from ever happening and affecting their potential revenue. This training should focus on integrating the following strategies into their daily work habits to provide their patients with exceptional customer service while they are guests in their practice.

1) Patients are the lifeline to building the future of their practice.

Patients are comparing their health care services to other companies that routinely provide high-end services to their clients. Whether groups like it or not, their front-line personnel are compared to five-star hotel receptionists, who are expected to greet their customers both pleasantly and professionally after a long day of traveling and required business functions. Every medical group must understand that patients have options when they select a medical practice and they expect to be treated with respect and transparency, and not just another person to be cared for at the end of a long day. The same level of service needs to be delivered in the doctor’s office no matter what time of day it is because for that patient, the personal problems and subsequent disposition of the medical staff is not their problem. All they want is someone to listen and help them take care of their medical problem. Their long-term loyalty to the group will be solely dependent on how well each personal interaction is handled. Remember that the patient is a person first and not just a customer. We must approach each patient with humanity first, and then customer service.

2) Be courteous and respectful.

Remind your staff to be courteous, always polite and to use good manners. By treating a patient how they expect to be treated, you are showing the patient that you respect them and care for not only their health but also their feelings. The health care worker must understand that the patient is viewing their interactions with staff and providers as being symbolic of the overall group’s brand identity. The group’s leadership needs to select and train their workforce to recognize their importance in how patients view their clinical offerings and their interactions with the patient.

3) Never show indifference to patients.

Losing patients before they complete their treatment regimen is a significant liability issue for any medical practice. In an article written by Strive Labs CEO and Co-Founder, Scott Hebert, DPT, wrote: “Patient churn is too big of a problem to ignore, and it can have a profound impact on your clinic’s bottom line.” In addition to the rather obvious missed revenue opportunity, a churning patient represents a practice liability, because an unsatisfied patient is significantly more likely to leave you a negative review online — or turn the experience with your practice into a cautionary tale for friends and family members. Either way, it’s bad for business — and your reputation.

4) Don’t contradict, argue, or match wits.

It’s tough for a health care worker who is continually being bombarded in a high-pressure environment to agree to disagree. When a person feels they are right or that their perception is the only logical one, they can be very stubborn in their understanding, and they will dig in their heels. It takes a strong person to allow others to have their opinion and not be judgmental about it. Any customer or patient relations training program to be deployed in a medical office must include skill training to teach the staff member how to diffuse an argument or disagreement. This situation can be dispersed by training your staff to consider the source of the conflict, respect the patient’s perception, and then teach the staff member to tell the patient that they never thought of it that way and ease away from the discussion. Their absence will help diffuse the situation.

5) Tell patients you appreciate their business.

How you relate to a patient will speak volumes to them about how much you appreciate their loyalty, all because they chose your practice for their health care. All patient and customer training programs should include discussions on making eye contact, shaking with a firm grasp, and always closing a personal encounter on a sincere and positive note. Health care workers need to understand that they are in the service business and that the patients they care for have options and they can easily walk out of the medical practice and share any negative experience on social media. Educating and reminding your staff on how easily a patient can leave your practice or share their experience with others, needs to be recognized and discussed at all the group’s town hall meetings.

6) Use plain terms and simple explanations.

We all want to appear to be super intelligent by trying to use complex terms to describe a situation because it creates leverage with the other parties engaged in the conversation. While some of this may be necessary when educating patients on their condition, any additional complex terms can easily annoy or even confuse the patient who is only there seeking help. Health care workers need to talk in a manner that keeps the patients engaged and helps them understand the topic at hand. The worker needs to use every day vernacular examples, so the patient quickly understands the reason that brought them to the clinic and what they need to do to get some relief from what ails them. The phrase “plain and simple” means precisely that – explain the topic using basic and simple terms, so the listener understands it. Using this method when discussing a patient’s condition isn’t just for the patient’s benefit because many confused patients ultimately call the office later in the day only to ask additional questions, which uses your staff’s time.

7) Good manners will get you everywhere.

Emily Post wrote, “Manners are a sensitive awareness of the feelings of others. If you have that awareness, you have good manners, no matter what fork you use.” Proper manners are behaving in a way that is both aware of and considerate of the people around us. A person with good manners treats everyone with kindness and respect. It is knowing how to get along without causing offense or harm, no matter how much the current interaction is going south – especially when you are engaged in a tough conversation.

8) Keep seeing health care as a calling.

All health care workers need to know that their vocation of caring for sick and injured patients is a calling and not just a job and all training programs designed to teach customer service need to stress this point. Practicing your vocation means that you will work hard to eliminate all barriers that exist between the patient and the health care worker. Too often we underestimate the power of a simple touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring – all of which have the potential to turn a life or a bad interaction into a magical moment for both the patient and the health care worker. One that has meaning and a bit of affirmation of the dignity of both individuals interacting to find some common ground.

9) Stay in touch with patients.

The group needs to find ways to keep in contact with their patients, whether it is by giving them tips on how to remain healthy or the need for proactive and preventive medicine. The use of technology and social media, as well as handing out freebies at health fairs, giving patients informational brochures upon discharge, or even cards telling them how to contact the practice in case of emergencies, is quite helpful. Calling your patients is a significant signal that your group values the health and welfare of your patients. A phone call from either the doctor or their assistant goes further than any advertisement when building brand and doctor loyalty.

10) Keep your promises.

Do what you say you are going to do, should be a commonly shared mantra for the medical practice. While changing your mind from time to time when circumstances prevent you from keeping a promise, is just part of being flexible in life, regularly breaking promises to other people isn’t healthy. Here’s how to keep your promises: Pay close attention to your words – every word you communicate (through speaking or writing), as a patient may take your words as a promise. Study your patterns of making promises. Figure out when you tend to make careless promises and study the situations in which you do, so you can understand why you’re promising what you don’t intend to do. Take time and careful consideration before making a promise to someone. Don’t rush yourself into a promise that you won’t be able to keep. Even when you’re in a hurry, you usually don’t have an immediate sense of urgency about promising to do something. Stop yourself before you make a vow, delaying your decision long enough to think it through carefully. The more careful you become about making promises, the easier it will be to keep them.

The last step of deploying a patient/customer service program is handling the change in management that is required to train the staff. Accepting “No, we are not changing any part of the group to meet the needs of our patients better.” is unacceptable. Usually, you will be introducing this program to employees that have been in a group for a while and so to get them to buy into the new ideas will require constant reinforcement. It may take some time to align the focus of the group from the neutral zone to the notion that there are new deliverables that would better serve your patients. The following rules will be helpful when beginning your training program:

Rule #1 – Be consistent. Every policy, procedure, and list of priorities sends a message – make sure it’s the right message.

Rule #2 – Ensure quick successes. Look for ways to get the group’s employees to buy into the program – early on after its deployment.

Rule# 3 – Symbolize the new identity. Make sure the group’s logos and branding support the new identity of the group and the culture change.

Rule #4 – Celebrate all the group’s successes. Make sure the group’s employees recognize the work efforts involved as well as the success the group will enjoy. Stress the fact that the work completed will significantly enhance the care and service levels to the patients, which should feed the ego of the group to do more and more in the future.

And lastly, do not forget how vital the buy-in is of the clinicians of the group. They must be introduced early to the new patient/customer service program and embrace it so that their employees will recognize that these efforts are focused on providing a high quality of care throughout the enterprise. As the French philosopher Albert Schweitzer once stated, “Example is not the main thing in influencing others, it’s the only thing.”
 

References

1. Peters, T. “The Excellence Dividend: Meeting the Tech Tide with Work that Wows and Jobs that Last.” (New York, Vintage Books, 2018).

2. 10 Strategies to Provide Patients with Superior Customer Service. Becker’s Hospital Review 2010 Dec 20.

3. Shell MA, Buell RW. Why anxious customers prefer human customer service. Harvard Business Review 2019 April 15.

4. Matt Brannon. 13 Ways to improve customer services at your medical practice. Blog post Sept 7, 2018.

5. 5 Reasons Why Customer Service Matters in Healthcare. https://www.pointsgroup.com/5-reasons-why-customer-service-matters-in-healthcare/Feb. 25, 2014

6. Senge P, Kleiner A, Roberts C, et al. “The Dance of Change: A fifth discipline resource.” (New York, Doubleday, 1999).

7. Bridges W. “Managing Transitions: Making the Most of Change.” (Boston, Da Capo Books, 2017)

8. Michelli J. “The New Gold Standard – 5 Leadership Principles for Creating the Legendary Customer Experience Courtesy of the Ritz-Carlton Hotel Company.” (New York, McGraw Hill, 2008).

Mr. Turner is chief executive officer of Indianapolis Gastroenterology and Hepatology.

Deferasirox plus deferoxamine is more effective than deferasirox alone for treating iron overload in patients with thalassemia major, according to a single-center study.

Over the course of 1 year of treatment, deferasirox plus deferoxamine significantly increased myocardial T2* and significantly reduced serum ferritin, whereas deferasirox alone had no significant effect on either endpoint. Neither treatment had a significant effect on hepatic iron.

Deferasirox plus deferoxamine caused a significantly greater increase in alanine aminotransferase, aspartate aminotransferase, and bilirubin. Other adverse events were similar between the treatment groups.

Aziz Eghbali, MD, of Arak (Iran) University of Medical Sciences and colleagues described this study in Transfusion and Apheresis Science.

The team conducted a randomized, double-blind trial of patients with thalassemia major. Of the 62 patients enrolled, 55 were randomized and evaluable. At baseline, the mean patient age was 24.5 years, and 67.3% were female.

The patients were randomized to receive oral deferasirox at 30 mg/kg daily either alone (n = 27) or with subcutaneous deferoxamine at 50 mg/kg for 5 days a week (n = 28). In both groups, patients received treatment for 12 months.

There were no significant differences between the groups in baseline characteristics such as myocardial or hepatic iron, transfusion volume, or white blood cell and platelet counts.

Results

The study’s primary endpoints were changes in myocardial T2* and hepatic T2* from baseline to 12 months. Changes in serum ferritin and adverse events were secondary endpoints.

Myocardial T2* decreased slightly in the monotherapy group, from 23.3 plus or minus 7.4 ms at baseline to 22.1 plus or minus 6.9 ms at 12 months (P = .3) but increased significantly in the combination group, from 23.1 plus or minus 7.5 ms to 27.1 plus or minus 7.0 ms (P less than .05). The difference between the groups was significant (P = .01).

There was no significant change in hepatic iron in either group. Hepatic T2* was 7.0 plus or minus 5.6 ms at baseline and 7.0 plus or minus 5.3 ms at 12 months in the monotherapy group (P = .7). In the combination group, hepatic T2* increased from 9.8 plus or minus 8.8 ms to 10.2 plus or minus 8.2 ms (P = .5). The between-group difference was not significant (P = .094).

Serum ferritin decreased from 1,390 plus or minus 816 mcg/ml to 1,085 plus or minus 919 mcg/mL in the monotherapy group (P = .06) and from 1,446 plus or minus 987 mcg/mL to 737 plus or minus 459 mcg/mL in the combination group (P less than .01). The between-group difference was significant (P = .001).

Increases in alanine aminotransferase, aspartate aminotransferase, and bilirubin were significantly greater in the combination group than in the monotherapy group (P less than .05 for all). Combination therapy also prompted an increase in alkaline phosphatase, but this was not significantly greater than in the monotherapy group (P = .3).

Blood urea nitrogen levels increased in both groups, but levels remained within the normal range. There were no increases in serum creatinine in either group.

Rates of mild gastrointestinal adverse events were similar in the monotherapy and combination groups (40% and 39%, respectively), as were rates of transient skin rashes (18% and 14%, respectively).

There were no deaths, and none of the patients stopped treatment because of severe adverse events.

This study was supported by Arak University of Medical Sciences. The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Eghbali A et al. Transfus Apher Sci. 2019 Aug;58(4):429-33.
 

Deferasirox plus deferoxamine is more effective than deferasirox alone for treating iron overload in patients with thalassemia major, according to a single-center study.

Over the course of 1 year of treatment, deferasirox plus deferoxamine significantly increased myocardial T2* and significantly reduced serum ferritin, whereas deferasirox alone had no significant effect on either endpoint. Neither treatment had a significant effect on hepatic iron.

Deferasirox plus deferoxamine caused a significantly greater increase in alanine aminotransferase, aspartate aminotransferase, and bilirubin. Other adverse events were similar between the treatment groups.

Aziz Eghbali, MD, of Arak (Iran) University of Medical Sciences and colleagues described this study in Transfusion and Apheresis Science.

The team conducted a randomized, double-blind trial of patients with thalassemia major. Of the 62 patients enrolled, 55 were randomized and evaluable. At baseline, the mean patient age was 24.5 years, and 67.3% were female.

The patients were randomized to receive oral deferasirox at 30 mg/kg daily either alone (n = 27) or with subcutaneous deferoxamine at 50 mg/kg for 5 days a week (n = 28). In both groups, patients received treatment for 12 months.

There were no significant differences between the groups in baseline characteristics such as myocardial or hepatic iron, transfusion volume, or white blood cell and platelet counts.

Results

The study’s primary endpoints were changes in myocardial T2* and hepatic T2* from baseline to 12 months. Changes in serum ferritin and adverse events were secondary endpoints.

Myocardial T2* decreased slightly in the monotherapy group, from 23.3 plus or minus 7.4 ms at baseline to 22.1 plus or minus 6.9 ms at 12 months (P = .3) but increased significantly in the combination group, from 23.1 plus or minus 7.5 ms to 27.1 plus or minus 7.0 ms (P less than .05). The difference between the groups was significant (P = .01).

There was no significant change in hepatic iron in either group. Hepatic T2* was 7.0 plus or minus 5.6 ms at baseline and 7.0 plus or minus 5.3 ms at 12 months in the monotherapy group (P = .7). In the combination group, hepatic T2* increased from 9.8 plus or minus 8.8 ms to 10.2 plus or minus 8.2 ms (P = .5). The between-group difference was not significant (P = .094).

Serum ferritin decreased from 1,390 plus or minus 816 mcg/ml to 1,085 plus or minus 919 mcg/mL in the monotherapy group (P = .06) and from 1,446 plus or minus 987 mcg/mL to 737 plus or minus 459 mcg/mL in the combination group (P less than .01). The between-group difference was significant (P = .001).

Increases in alanine aminotransferase, aspartate aminotransferase, and bilirubin were significantly greater in the combination group than in the monotherapy group (P less than .05 for all). Combination therapy also prompted an increase in alkaline phosphatase, but this was not significantly greater than in the monotherapy group (P = .3).

Blood urea nitrogen levels increased in both groups, but levels remained within the normal range. There were no increases in serum creatinine in either group.

Rates of mild gastrointestinal adverse events were similar in the monotherapy and combination groups (40% and 39%, respectively), as were rates of transient skin rashes (18% and 14%, respectively).

There were no deaths, and none of the patients stopped treatment because of severe adverse events.

This study was supported by Arak University of Medical Sciences. The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Eghbali A et al. Transfus Apher Sci. 2019 Aug;58(4):429-33.
 

Deferasirox plus deferoxamine is more effective than deferasirox alone for treating iron overload in patients with thalassemia major, according to a single-center study.

Over the course of 1 year of treatment, deferasirox plus deferoxamine significantly increased myocardial T2* and significantly reduced serum ferritin, whereas deferasirox alone had no significant effect on either endpoint. Neither treatment had a significant effect on hepatic iron.

Deferasirox plus deferoxamine caused a significantly greater increase in alanine aminotransferase, aspartate aminotransferase, and bilirubin. Other adverse events were similar between the treatment groups.

Aziz Eghbali, MD, of Arak (Iran) University of Medical Sciences and colleagues described this study in Transfusion and Apheresis Science.

The team conducted a randomized, double-blind trial of patients with thalassemia major. Of the 62 patients enrolled, 55 were randomized and evaluable. At baseline, the mean patient age was 24.5 years, and 67.3% were female.

The patients were randomized to receive oral deferasirox at 30 mg/kg daily either alone (n = 27) or with subcutaneous deferoxamine at 50 mg/kg for 5 days a week (n = 28). In both groups, patients received treatment for 12 months.

There were no significant differences between the groups in baseline characteristics such as myocardial or hepatic iron, transfusion volume, or white blood cell and platelet counts.

Results

The study’s primary endpoints were changes in myocardial T2* and hepatic T2* from baseline to 12 months. Changes in serum ferritin and adverse events were secondary endpoints.

Myocardial T2* decreased slightly in the monotherapy group, from 23.3 plus or minus 7.4 ms at baseline to 22.1 plus or minus 6.9 ms at 12 months (P = .3) but increased significantly in the combination group, from 23.1 plus or minus 7.5 ms to 27.1 plus or minus 7.0 ms (P less than .05). The difference between the groups was significant (P = .01).

There was no significant change in hepatic iron in either group. Hepatic T2* was 7.0 plus or minus 5.6 ms at baseline and 7.0 plus or minus 5.3 ms at 12 months in the monotherapy group (P = .7). In the combination group, hepatic T2* increased from 9.8 plus or minus 8.8 ms to 10.2 plus or minus 8.2 ms (P = .5). The between-group difference was not significant (P = .094).

Serum ferritin decreased from 1,390 plus or minus 816 mcg/ml to 1,085 plus or minus 919 mcg/mL in the monotherapy group (P = .06) and from 1,446 plus or minus 987 mcg/mL to 737 plus or minus 459 mcg/mL in the combination group (P less than .01). The between-group difference was significant (P = .001).

Increases in alanine aminotransferase, aspartate aminotransferase, and bilirubin were significantly greater in the combination group than in the monotherapy group (P less than .05 for all). Combination therapy also prompted an increase in alkaline phosphatase, but this was not significantly greater than in the monotherapy group (P = .3).

Blood urea nitrogen levels increased in both groups, but levels remained within the normal range. There were no increases in serum creatinine in either group.

Rates of mild gastrointestinal adverse events were similar in the monotherapy and combination groups (40% and 39%, respectively), as were rates of transient skin rashes (18% and 14%, respectively).

There were no deaths, and none of the patients stopped treatment because of severe adverse events.

This study was supported by Arak University of Medical Sciences. The researchers reported having no conflicts of interest.

[email protected]

SOURCE: Eghbali A et al. Transfus Apher Sci. 2019 Aug;58(4):429-33.
 

Individuals who are carriers of hemophilia genes and have reduced clotting factor activity have at least a twofold higher risk of joint-related comorbidities, compared with the general population, according to new research.

decade3d/Thinkstock

In a population-based cohort study using patient registry data, Swedish researchers identified 539 potential carriers of impaired factor VIII or IX gene in the X chromosome – 213 of whom had documented factor activity – and paired them with sex‐ and birthdate‐matched controls from the general population.

They found that carriers with reduced factor activity had a 2.3-fold higher risk of a joint diagnosis, compared with the general population (95% confidence interval, 1.1-4.5). Carriers with normal factor activity did not show a statistically significant increase in joint diagnosis hazard, however carriers with unknown factor activity had a 2.4-fold higher risk of joint diagnosis, compared with controls (95% CI, 1.8-3.2). The findings were published in Haemophilia.

By the age of 60 years, around 37% of carriers with reduced or unknown factor activity had received a joint diagnosis, compared with 23% of carriers with normal factor activity.

The most common joint diagnoses across carriers and controls were knee related, including gonarthrosis and internal derangement, but these were more common among carriers. Five carriers also recorded a diagnosis of hemophilic arthropathy or systemic disorders of connective tissue in diseases classified elsewhere.

Researchers also saw a 10-fold higher risk of joint surgery (95% CI, 1.0-3.7) among carriers with reduced factor activity – although the numbers were small – and even among carriers with normal factor activity, there was a nearly twofold higher rate (95% CI, 0.9-4.6), compared with the control population.

Carriers with reduced or unknown factor activity also had a higher risk of outpatient hospitalization, compared with the general population, although no effect was seen in carriers with normal factor activity.

“Although the frequency of joint comorbidities overall was relatively low, our results clearly indicate and confirm a higher burden of joint afflictions, including an earlier age at joint diagnosis, for carriers with reduced or unknown factor activity compared with the general population, as well as more joint surgeries and related hospitalizations,” wrote Mehdi Osooli, PhD, from the Skåne University Hospital in Malmö, Sweden, and his coauthors.

The authors noted that the findings correlated with their earlier research on the incidence of arthropathy among males with mild hemophilia, who have previously been found to have a ninefold higher incidence of arthropathy‐related hospital admissions and a 16‐fold higher incidence of joint disease.

“The relatively higher incidence in the male population compared with the carriers in the current study may be explained by the lower median factor activity level, for example, levels between 5% and 40% in males with mild haemophilia compared with a median overall of 50% in carriers,” they wrote.

All authors declared that they had no conflict of interest related to the study findings. Four of the authors reported financial ties to companies including Novo Nordisk, Shire, and Bayer.

SOURCE: Osooli M et al. Haemophilia. 2019 Aug 14. doi: 10.1111/hae.13831.

Individuals who are carriers of hemophilia genes and have reduced clotting factor activity have at least a twofold higher risk of joint-related comorbidities, compared with the general population, according to new research.

decade3d/Thinkstock

In a population-based cohort study using patient registry data, Swedish researchers identified 539 potential carriers of impaired factor VIII or IX gene in the X chromosome – 213 of whom had documented factor activity – and paired them with sex‐ and birthdate‐matched controls from the general population.

They found that carriers with reduced factor activity had a 2.3-fold higher risk of a joint diagnosis, compared with the general population (95% confidence interval, 1.1-4.5). Carriers with normal factor activity did not show a statistically significant increase in joint diagnosis hazard, however carriers with unknown factor activity had a 2.4-fold higher risk of joint diagnosis, compared with controls (95% CI, 1.8-3.2). The findings were published in Haemophilia.

By the age of 60 years, around 37% of carriers with reduced or unknown factor activity had received a joint diagnosis, compared with 23% of carriers with normal factor activity.

The most common joint diagnoses across carriers and controls were knee related, including gonarthrosis and internal derangement, but these were more common among carriers. Five carriers also recorded a diagnosis of hemophilic arthropathy or systemic disorders of connective tissue in diseases classified elsewhere.

Researchers also saw a 10-fold higher risk of joint surgery (95% CI, 1.0-3.7) among carriers with reduced factor activity – although the numbers were small – and even among carriers with normal factor activity, there was a nearly twofold higher rate (95% CI, 0.9-4.6), compared with the control population.

Carriers with reduced or unknown factor activity also had a higher risk of outpatient hospitalization, compared with the general population, although no effect was seen in carriers with normal factor activity.

“Although the frequency of joint comorbidities overall was relatively low, our results clearly indicate and confirm a higher burden of joint afflictions, including an earlier age at joint diagnosis, for carriers with reduced or unknown factor activity compared with the general population, as well as more joint surgeries and related hospitalizations,” wrote Mehdi Osooli, PhD, from the Skåne University Hospital in Malmö, Sweden, and his coauthors.

The authors noted that the findings correlated with their earlier research on the incidence of arthropathy among males with mild hemophilia, who have previously been found to have a ninefold higher incidence of arthropathy‐related hospital admissions and a 16‐fold higher incidence of joint disease.

“The relatively higher incidence in the male population compared with the carriers in the current study may be explained by the lower median factor activity level, for example, levels between 5% and 40% in males with mild haemophilia compared with a median overall of 50% in carriers,” they wrote.

All authors declared that they had no conflict of interest related to the study findings. Four of the authors reported financial ties to companies including Novo Nordisk, Shire, and Bayer.

SOURCE: Osooli M et al. Haemophilia. 2019 Aug 14. doi: 10.1111/hae.13831.

Individuals who are carriers of hemophilia genes and have reduced clotting factor activity have at least a twofold higher risk of joint-related comorbidities, compared with the general population, according to new research.

decade3d/Thinkstock

In a population-based cohort study using patient registry data, Swedish researchers identified 539 potential carriers of impaired factor VIII or IX gene in the X chromosome – 213 of whom had documented factor activity – and paired them with sex‐ and birthdate‐matched controls from the general population.

They found that carriers with reduced factor activity had a 2.3-fold higher risk of a joint diagnosis, compared with the general population (95% confidence interval, 1.1-4.5). Carriers with normal factor activity did not show a statistically significant increase in joint diagnosis hazard, however carriers with unknown factor activity had a 2.4-fold higher risk of joint diagnosis, compared with controls (95% CI, 1.8-3.2). The findings were published in Haemophilia.

By the age of 60 years, around 37% of carriers with reduced or unknown factor activity had received a joint diagnosis, compared with 23% of carriers with normal factor activity.

The most common joint diagnoses across carriers and controls were knee related, including gonarthrosis and internal derangement, but these were more common among carriers. Five carriers also recorded a diagnosis of hemophilic arthropathy or systemic disorders of connective tissue in diseases classified elsewhere.

Researchers also saw a 10-fold higher risk of joint surgery (95% CI, 1.0-3.7) among carriers with reduced factor activity – although the numbers were small – and even among carriers with normal factor activity, there was a nearly twofold higher rate (95% CI, 0.9-4.6), compared with the control population.

Carriers with reduced or unknown factor activity also had a higher risk of outpatient hospitalization, compared with the general population, although no effect was seen in carriers with normal factor activity.

“Although the frequency of joint comorbidities overall was relatively low, our results clearly indicate and confirm a higher burden of joint afflictions, including an earlier age at joint diagnosis, for carriers with reduced or unknown factor activity compared with the general population, as well as more joint surgeries and related hospitalizations,” wrote Mehdi Osooli, PhD, from the Skåne University Hospital in Malmö, Sweden, and his coauthors.

The authors noted that the findings correlated with their earlier research on the incidence of arthropathy among males with mild hemophilia, who have previously been found to have a ninefold higher incidence of arthropathy‐related hospital admissions and a 16‐fold higher incidence of joint disease.

“The relatively higher incidence in the male population compared with the carriers in the current study may be explained by the lower median factor activity level, for example, levels between 5% and 40% in males with mild haemophilia compared with a median overall of 50% in carriers,” they wrote.

All authors declared that they had no conflict of interest related to the study findings. Four of the authors reported financial ties to companies including Novo Nordisk, Shire, and Bayer.

SOURCE: Osooli M et al. Haemophilia. 2019 Aug 14. doi: 10.1111/hae.13831.

These fellows showcased their commitment to advancing our field through their quality improvement projects presented at DDW® 2019.

Each year during Digestive Disease Week^®, AGA hosts a session titled “Advancing Clinical Practice: GI Fellow-Directed Quality-Improvement Projects.” During the 2019 session, 17 quality improvement initiatives were presented — you can review these abstracts in the July issue of Gastroenterology in the “AGA Section,” www.gastrojournal.org/issue/S0016-5085(19)X0009-8. Kudos to the promising fellows featured below, who all served as lead authors for their QI projects.
 

Manasi Agrawal, MD
Lenox Hill Hospital, New York City
@ManasiAgrawalMD

Jessica Breton, MD
Children’s Hospital of Philadelphia

Adam Faye, MD
Columbia University Medical Center, New York City
@AdamFaye4

Shelly Gurwara, MD
Wake Forest Baptist Health Medical Center, Winston-Salem, N.C.

Afrin Kamal, MD
Stanford University, Calif.

Ani Kardashian, MD
University of California, Los Angeles
@AniKardashianMD

Sonali Palchaudhuri, MD
University of Pennsylvania, Philadelphia
@sopalchaudhuri

Nasim Parsa, MD
University of Missouri Health System, Columbia

Sahil Patel, MD
Drexel University, Philadelphia
@sahilr

Vikram Raghu, MD
Children’s Hospital of Pittsburgh, Pennsylvania

Amit Shah, MD
Children’s Hospital of Philadelphia

Lin Shen, MD
Brigham and Women’s Hospital, Boston
@LinShenMD

Charles Snyder, MD
Icahn School of Medicine at Mount Sinai, New York City

Brian Sullivan, MD
Duke University, Durham, N.C.

Ashley Vachon, MD
University of Colorado Anschutz Medical Campus, Aurora

Ted Walker, MD
Washington University/Barnes Jewish Hospital, St. Louis, Mo.

Xiao Jing Wang, MD
Mayo Clinic, Rochester, Minn.
@IrisWangMD
 

[email protected]

These fellows showcased their commitment to advancing our field through their quality improvement projects presented at DDW® 2019.

Each year during Digestive Disease Week^®, AGA hosts a session titled “Advancing Clinical Practice: GI Fellow-Directed Quality-Improvement Projects.” During the 2019 session, 17 quality improvement initiatives were presented — you can review these abstracts in the July issue of Gastroenterology in the “AGA Section,” www.gastrojournal.org/issue/S0016-5085(19)X0009-8. Kudos to the promising fellows featured below, who all served as lead authors for their QI projects.
 

Manasi Agrawal, MD
Lenox Hill Hospital, New York City
@ManasiAgrawalMD

Jessica Breton, MD
Children’s Hospital of Philadelphia

Adam Faye, MD
Columbia University Medical Center, New York City
@AdamFaye4

Shelly Gurwara, MD
Wake Forest Baptist Health Medical Center, Winston-Salem, N.C.

Afrin Kamal, MD
Stanford University, Calif.

Ani Kardashian, MD
University of California, Los Angeles
@AniKardashianMD

Sonali Palchaudhuri, MD
University of Pennsylvania, Philadelphia
@sopalchaudhuri

Nasim Parsa, MD
University of Missouri Health System, Columbia

Sahil Patel, MD
Drexel University, Philadelphia
@sahilr

Vikram Raghu, MD
Children’s Hospital of Pittsburgh, Pennsylvania

Amit Shah, MD
Children’s Hospital of Philadelphia

Lin Shen, MD
Brigham and Women’s Hospital, Boston
@LinShenMD

Charles Snyder, MD
Icahn School of Medicine at Mount Sinai, New York City

Brian Sullivan, MD
Duke University, Durham, N.C.

Ashley Vachon, MD
University of Colorado Anschutz Medical Campus, Aurora

Ted Walker, MD
Washington University/Barnes Jewish Hospital, St. Louis, Mo.

Xiao Jing Wang, MD
Mayo Clinic, Rochester, Minn.
@IrisWangMD
 

[email protected]

These fellows showcased their commitment to advancing our field through their quality improvement projects presented at DDW® 2019.

Each year during Digestive Disease Week^®, AGA hosts a session titled “Advancing Clinical Practice: GI Fellow-Directed Quality-Improvement Projects.” During the 2019 session, 17 quality improvement initiatives were presented — you can review these abstracts in the July issue of Gastroenterology in the “AGA Section,” www.gastrojournal.org/issue/S0016-5085(19)X0009-8. Kudos to the promising fellows featured below, who all served as lead authors for their QI projects.
 

Manasi Agrawal, MD
Lenox Hill Hospital, New York City
@ManasiAgrawalMD

Jessica Breton, MD
Children’s Hospital of Philadelphia

Adam Faye, MD
Columbia University Medical Center, New York City
@AdamFaye4

Shelly Gurwara, MD
Wake Forest Baptist Health Medical Center, Winston-Salem, N.C.

Afrin Kamal, MD
Stanford University, Calif.

Ani Kardashian, MD
University of California, Los Angeles
@AniKardashianMD

Sonali Palchaudhuri, MD
University of Pennsylvania, Philadelphia
@sopalchaudhuri

Nasim Parsa, MD
University of Missouri Health System, Columbia

Sahil Patel, MD
Drexel University, Philadelphia
@sahilr

Vikram Raghu, MD
Children’s Hospital of Pittsburgh, Pennsylvania

Amit Shah, MD
Children’s Hospital of Philadelphia

Lin Shen, MD
Brigham and Women’s Hospital, Boston
@LinShenMD

Charles Snyder, MD
Icahn School of Medicine at Mount Sinai, New York City

Brian Sullivan, MD
Duke University, Durham, N.C.

Ashley Vachon, MD
University of Colorado Anschutz Medical Campus, Aurora

Ted Walker, MD
Washington University/Barnes Jewish Hospital, St. Louis, Mo.

Xiao Jing Wang, MD
Mayo Clinic, Rochester, Minn.
@IrisWangMD
 

[email protected]

Thank you to the following members who joined us to advocate for some of the most pressing issues facing gastroenterologists and our patients at the 2019 Alliance of Specialty Medicine Fly In. Our advocates met with House and Senate offices to push for reducing prior authorization burdens and minimizing the strict constraints of step therapy protocols.

• Rotonya M. Carr, MD, University of Pennsylvania Health System

• Peter Kaufman, MD, AGAF, Capital Digestive Care, Bethesda, Md.

• Avinash G. Ketwaroo, MD, Baylor College of Medicine, Houston

• Simon C. Mathews, MD, Johns Hopkins Medicine, Baltimore


 

Prior authorization

Prior authorization is a tedious process and management tool that requires physicians to obtain preapproval for medical treatments or tests before rendering care to their patients. Patients experience significant barriers to medically necessary care because of prior authorization requirements for services that are eventually routinely approved. H.R. 3107, the Improving Seniors’ Timely Access to Care Act, would increase transparency and accountability and reduce the burdens of prior authorization.

Step therapy

Step therapy treatment, or “fail first,” requires patients to try and fail medications before insurers agree to cover the initial therapy prescribed by their health care provider. While this protocol may initially act as a cost-containment mechanism, it can ultimately lead to more expensive health care costs because of devastating patient complications. H.R. 2279, the Safe Step Act, would provide a clear and timely appeals process when a patient has been subjected to step therapy.

— @CongressmanRuiz from Cali combats #steptherapy with the bipartisan Safe Step Act (H.R. 2279). #Patients should be given a clear, equitable & transparent appeals process concerning step therapy. Urge your member of Congress to take action:https://t.co/q4ljhuMO9X#specialtydocs pic.twitter.com/B2zvRT6mG5



— AGA (@AmerGastroAssn) July 16, 2019

“Thank you, GI docs. I had colon cancer and a GI surgeon saved my life.” Thank you, @RepMarkGreen, for supporting reducing prior authorization. https://t.co/kc9fWnA8XB #specialtydocs



— AGA (@AmerGastroAssn) July 17, 2019

The Alliance of Specialty Medicine is a coalition of national medical societies representing specialty physicians in the United States.

This conference took place July 15-17, 2019, at the Liaison Washington Capitol Hill in Washington, DC.
 

[email protected]

Thank you to the following members who joined us to advocate for some of the most pressing issues facing gastroenterologists and our patients at the 2019 Alliance of Specialty Medicine Fly In. Our advocates met with House and Senate offices to push for reducing prior authorization burdens and minimizing the strict constraints of step therapy protocols.

• Rotonya M. Carr, MD, University of Pennsylvania Health System

• Peter Kaufman, MD, AGAF, Capital Digestive Care, Bethesda, Md.

• Avinash G. Ketwaroo, MD, Baylor College of Medicine, Houston

• Simon C. Mathews, MD, Johns Hopkins Medicine, Baltimore


 

Prior authorization

Prior authorization is a tedious process and management tool that requires physicians to obtain preapproval for medical treatments or tests before rendering care to their patients. Patients experience significant barriers to medically necessary care because of prior authorization requirements for services that are eventually routinely approved. H.R. 3107, the Improving Seniors’ Timely Access to Care Act, would increase transparency and accountability and reduce the burdens of prior authorization.

Step therapy

Step therapy treatment, or “fail first,” requires patients to try and fail medications before insurers agree to cover the initial therapy prescribed by their health care provider. While this protocol may initially act as a cost-containment mechanism, it can ultimately lead to more expensive health care costs because of devastating patient complications. H.R. 2279, the Safe Step Act, would provide a clear and timely appeals process when a patient has been subjected to step therapy.

— @CongressmanRuiz from Cali combats #steptherapy with the bipartisan Safe Step Act (H.R. 2279). #Patients should be given a clear, equitable & transparent appeals process concerning step therapy. Urge your member of Congress to take action:https://t.co/q4ljhuMO9X#specialtydocs pic.twitter.com/B2zvRT6mG5



— AGA (@AmerGastroAssn) July 16, 2019

“Thank you, GI docs. I had colon cancer and a GI surgeon saved my life.” Thank you, @RepMarkGreen, for supporting reducing prior authorization. https://t.co/kc9fWnA8XB #specialtydocs



— AGA (@AmerGastroAssn) July 17, 2019

The Alliance of Specialty Medicine is a coalition of national medical societies representing specialty physicians in the United States.

This conference took place July 15-17, 2019, at the Liaison Washington Capitol Hill in Washington, DC.
 

[email protected]

Thank you to the following members who joined us to advocate for some of the most pressing issues facing gastroenterologists and our patients at the 2019 Alliance of Specialty Medicine Fly In. Our advocates met with House and Senate offices to push for reducing prior authorization burdens and minimizing the strict constraints of step therapy protocols.

• Rotonya M. Carr, MD, University of Pennsylvania Health System

• Peter Kaufman, MD, AGAF, Capital Digestive Care, Bethesda, Md.

• Avinash G. Ketwaroo, MD, Baylor College of Medicine, Houston

• Simon C. Mathews, MD, Johns Hopkins Medicine, Baltimore


 

Prior authorization

Prior authorization is a tedious process and management tool that requires physicians to obtain preapproval for medical treatments or tests before rendering care to their patients. Patients experience significant barriers to medically necessary care because of prior authorization requirements for services that are eventually routinely approved. H.R. 3107, the Improving Seniors’ Timely Access to Care Act, would increase transparency and accountability and reduce the burdens of prior authorization.

Step therapy

Step therapy treatment, or “fail first,” requires patients to try and fail medications before insurers agree to cover the initial therapy prescribed by their health care provider. While this protocol may initially act as a cost-containment mechanism, it can ultimately lead to more expensive health care costs because of devastating patient complications. H.R. 2279, the Safe Step Act, would provide a clear and timely appeals process when a patient has been subjected to step therapy.

— @CongressmanRuiz from Cali combats #steptherapy with the bipartisan Safe Step Act (H.R. 2279). #Patients should be given a clear, equitable & transparent appeals process concerning step therapy. Urge your member of Congress to take action:https://t.co/q4ljhuMO9X#specialtydocs pic.twitter.com/B2zvRT6mG5



— AGA (@AmerGastroAssn) July 16, 2019

“Thank you, GI docs. I had colon cancer and a GI surgeon saved my life.” Thank you, @RepMarkGreen, for supporting reducing prior authorization. https://t.co/kc9fWnA8XB #specialtydocs



— AGA (@AmerGastroAssn) July 17, 2019

The Alliance of Specialty Medicine is a coalition of national medical societies representing specialty physicians in the United States.

This conference took place July 15-17, 2019, at the Liaison Washington Capitol Hill in Washington, DC.
 

[email protected]

It was the arrival of the second man in his early 20s gasping for air that alarmed Dixie Harris, MD. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.

6okean/iStock/Getty Images Plus

Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Dr. Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.

As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.

As of Aug. 22, 2019, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, 1 of whom has died. Indiana is investigating 24 cases.

Lung doctors said they had seen warning signs for years that vaping could be hazardous as they treated patients. Medically it seemed problematic since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.

“You don’t know what you’re putting into your lungs when you vape,” said Dr. Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”

Off the radar

When e-cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug, and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.

As a result, billions of dollars of vaping products have been sold online, at big-box retailers, and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu, and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market, over the Internet, or beyond.

“It makes it really tough because we don’t know what we’re looking for,” said Ruth Lynfield, MD, the state epidemiologist for Minnesota, where several patients were admitted to the ICU as a result of the illness. She added that, if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.

With e-cigarettes, people can vape – or smoke – nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée, or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.

The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.

Because e-cigarettes aren’t classified as drugs or medical devices, which have well-established FDA databases to track adverse events, doctors say there has been no clear way to report and track health problems related to vaping products.

And this has apparently been the case for years.

Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.

Laura Crotty Alexander, MD, a pulmonologist and researcher with the University of California, San Diego, said she saw her first case about 2 years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.

“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Dr. Alexander said.

She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.

John E. Parker, MD, of West Virginia University, Morgantown, said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Dr. Parker and his team didn’t contact a federal agency, and Dr. Parker said it was unclear whom to call.

Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only 1 lung ailment tied to e-cigarettes between April and June 2019. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.

But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.

“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, PhD, MPH, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”

Regulatory limits

The FDA has had limited authority to regulate e-cigarettes over the years.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.

Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.

It took the agency 6 years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.

By then, it was May 2016, and the e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.

Critics say the FDA took too long to act.

“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, PhD, a University of California, San Francisco, professor in its Center for Tobacco Control Research and Education. “No question.”

The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted 2 years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.

But when Scott Gottlieb, MD, arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.

“I thought e-cigarettes at the time – and I still believe – that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”

Dr. Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.

A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.

Asked about the lung injuries appearing now, Dr. Gottlieb, who left the FDA in April 2019, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”

“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Dr. Gottlieb said.

For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and against a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.

Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold-standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.

But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Dr. Gottlieb said. It may even be better equipped because of its funding.

“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.

Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.

Unknown components

Still, doctors and researchers are concerned about the ingredients in e-cigarettes and how little the public knows about the risks of vaping.

In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.

Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.

The vast majority of the chemicals have been tested only by ingesting them in small quantities because they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.

“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.

Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, PhD, a professor at Duke University, Durham, N.C., says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.

In 2017, when Dr. Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way: “Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long-time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”

At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.

Dr. Jordt said he is frustrated by the delays in the regulatory approval process.

“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”

Kaiser Health News correspondents Cara Anthony, Markian Hawryluk, and Lauren Weber, as well as reporter Victoria Knight contributed to this report. This story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

It was the arrival of the second man in his early 20s gasping for air that alarmed Dixie Harris, MD. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.

6okean/iStock/Getty Images Plus

Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Dr. Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.

As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.

As of Aug. 22, 2019, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, 1 of whom has died. Indiana is investigating 24 cases.

Lung doctors said they had seen warning signs for years that vaping could be hazardous as they treated patients. Medically it seemed problematic since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.

“You don’t know what you’re putting into your lungs when you vape,” said Dr. Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”

Off the radar

When e-cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug, and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.

As a result, billions of dollars of vaping products have been sold online, at big-box retailers, and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu, and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market, over the Internet, or beyond.

“It makes it really tough because we don’t know what we’re looking for,” said Ruth Lynfield, MD, the state epidemiologist for Minnesota, where several patients were admitted to the ICU as a result of the illness. She added that, if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.

With e-cigarettes, people can vape – or smoke – nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée, or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.

The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.

Because e-cigarettes aren’t classified as drugs or medical devices, which have well-established FDA databases to track adverse events, doctors say there has been no clear way to report and track health problems related to vaping products.

And this has apparently been the case for years.

Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.

Laura Crotty Alexander, MD, a pulmonologist and researcher with the University of California, San Diego, said she saw her first case about 2 years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.

“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Dr. Alexander said.

She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.

John E. Parker, MD, of West Virginia University, Morgantown, said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Dr. Parker and his team didn’t contact a federal agency, and Dr. Parker said it was unclear whom to call.

Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only 1 lung ailment tied to e-cigarettes between April and June 2019. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.

But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.

“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, PhD, MPH, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”

Regulatory limits

The FDA has had limited authority to regulate e-cigarettes over the years.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.

Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.

It took the agency 6 years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.

By then, it was May 2016, and the e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.

Critics say the FDA took too long to act.

“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, PhD, a University of California, San Francisco, professor in its Center for Tobacco Control Research and Education. “No question.”

The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted 2 years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.

But when Scott Gottlieb, MD, arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.

“I thought e-cigarettes at the time – and I still believe – that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”

Dr. Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.

A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.

Asked about the lung injuries appearing now, Dr. Gottlieb, who left the FDA in April 2019, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”

“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Dr. Gottlieb said.

For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and against a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.

Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold-standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.

But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Dr. Gottlieb said. It may even be better equipped because of its funding.

“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.

Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.

Unknown components

Still, doctors and researchers are concerned about the ingredients in e-cigarettes and how little the public knows about the risks of vaping.

In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.

Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.

The vast majority of the chemicals have been tested only by ingesting them in small quantities because they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.

“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.

Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, PhD, a professor at Duke University, Durham, N.C., says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.

In 2017, when Dr. Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way: “Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long-time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”

At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.

Dr. Jordt said he is frustrated by the delays in the regulatory approval process.

“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”

Kaiser Health News correspondents Cara Anthony, Markian Hawryluk, and Lauren Weber, as well as reporter Victoria Knight contributed to this report. This story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

It was the arrival of the second man in his early 20s gasping for air that alarmed Dixie Harris, MD. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.

6okean/iStock/Getty Images Plus

Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Dr. Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.

As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.

As of Aug. 22, 2019, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, 1 of whom has died. Indiana is investigating 24 cases.

Lung doctors said they had seen warning signs for years that vaping could be hazardous as they treated patients. Medically it seemed problematic since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.

“You don’t know what you’re putting into your lungs when you vape,” said Dr. Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”

Off the radar

When e-cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug, and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.

As a result, billions of dollars of vaping products have been sold online, at big-box retailers, and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu, and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market, over the Internet, or beyond.

“It makes it really tough because we don’t know what we’re looking for,” said Ruth Lynfield, MD, the state epidemiologist for Minnesota, where several patients were admitted to the ICU as a result of the illness. She added that, if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.

With e-cigarettes, people can vape – or smoke – nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée, or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.

The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.

Because e-cigarettes aren’t classified as drugs or medical devices, which have well-established FDA databases to track adverse events, doctors say there has been no clear way to report and track health problems related to vaping products.

And this has apparently been the case for years.

Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.

Laura Crotty Alexander, MD, a pulmonologist and researcher with the University of California, San Diego, said she saw her first case about 2 years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.

“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Dr. Alexander said.

She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.

John E. Parker, MD, of West Virginia University, Morgantown, said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Dr. Parker and his team didn’t contact a federal agency, and Dr. Parker said it was unclear whom to call.

Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only 1 lung ailment tied to e-cigarettes between April and June 2019. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.

But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.

“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, PhD, MPH, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”

Regulatory limits

The FDA has had limited authority to regulate e-cigarettes over the years.

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.

Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.

It took the agency 6 years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.

By then, it was May 2016, and the e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.

Critics say the FDA took too long to act.

“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, PhD, a University of California, San Francisco, professor in its Center for Tobacco Control Research and Education. “No question.”

The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted 2 years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.

But when Scott Gottlieb, MD, arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.

“I thought e-cigarettes at the time – and I still believe – that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”

Dr. Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.

A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.

Asked about the lung injuries appearing now, Dr. Gottlieb, who left the FDA in April 2019, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.

“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”

Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”

“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Dr. Gottlieb said.

For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and against a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.

Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold-standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.

But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Dr. Gottlieb said. It may even be better equipped because of its funding.

“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.

Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.

Unknown components

Still, doctors and researchers are concerned about the ingredients in e-cigarettes and how little the public knows about the risks of vaping.

In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.

Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.

The vast majority of the chemicals have been tested only by ingesting them in small quantities because they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.

“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.

Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, PhD, a professor at Duke University, Durham, N.C., says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.

In 2017, when Dr. Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way: “Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long-time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”

At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.

Dr. Jordt said he is frustrated by the delays in the regulatory approval process.

“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”

Kaiser Health News correspondents Cara Anthony, Markian Hawryluk, and Lauren Weber, as well as reporter Victoria Knight contributed to this report. This story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

In welcomed news, the House Energy and Commerce Committee approved legislation that would address surprise bills by protecting patients when they access care and aren’t aware that a provider is outside of their insurance network.

The No Surprises Act, H.R. 3630, would allow providers to appeal a federal benchmark payment to an arbiter in cases when the median in-network payment to physicians or hospitals exceeds $1,250. This arbitration provision was included in the bill at the last minute by Reps. Raul Ruiz, D-Calif., and Larry Buschon, R-Ind., to address provider concerns. Without an option for arbitration, physicians would be at a severe disadvantage when negotiating contracts with insurers. AGA supports and will continue to advocate for provisions that give physicians an opportunity to go to arbitration similar to the effective New York state model.

The No Surprises Act also requires the Department of Health and Human Services to study the impact of the legislation, including the adequacy of provider networks, and to establish an audit process for medical contracted rates.

Addressing surprise medical bills and protecting patients has been a priority on Capitol Hill and one that has strong bipartisan support in both chambers of Congress and from President Trump. Since this new House bill also has jurisdiction from the Ways and Means Committee and the Education and Labor Committee, both committees will need to address the bill before it can advance. AGA will keep you updated on the status of this important legislation.
 

[email protected]

In welcomed news, the House Energy and Commerce Committee approved legislation that would address surprise bills by protecting patients when they access care and aren’t aware that a provider is outside of their insurance network.

The No Surprises Act, H.R. 3630, would allow providers to appeal a federal benchmark payment to an arbiter in cases when the median in-network payment to physicians or hospitals exceeds $1,250. This arbitration provision was included in the bill at the last minute by Reps. Raul Ruiz, D-Calif., and Larry Buschon, R-Ind., to address provider concerns. Without an option for arbitration, physicians would be at a severe disadvantage when negotiating contracts with insurers. AGA supports and will continue to advocate for provisions that give physicians an opportunity to go to arbitration similar to the effective New York state model.

The No Surprises Act also requires the Department of Health and Human Services to study the impact of the legislation, including the adequacy of provider networks, and to establish an audit process for medical contracted rates.

Addressing surprise medical bills and protecting patients has been a priority on Capitol Hill and one that has strong bipartisan support in both chambers of Congress and from President Trump. Since this new House bill also has jurisdiction from the Ways and Means Committee and the Education and Labor Committee, both committees will need to address the bill before it can advance. AGA will keep you updated on the status of this important legislation.
 

[email protected]

In welcomed news, the House Energy and Commerce Committee approved legislation that would address surprise bills by protecting patients when they access care and aren’t aware that a provider is outside of their insurance network.

The No Surprises Act, H.R. 3630, would allow providers to appeal a federal benchmark payment to an arbiter in cases when the median in-network payment to physicians or hospitals exceeds $1,250. This arbitration provision was included in the bill at the last minute by Reps. Raul Ruiz, D-Calif., and Larry Buschon, R-Ind., to address provider concerns. Without an option for arbitration, physicians would be at a severe disadvantage when negotiating contracts with insurers. AGA supports and will continue to advocate for provisions that give physicians an opportunity to go to arbitration similar to the effective New York state model.

The No Surprises Act also requires the Department of Health and Human Services to study the impact of the legislation, including the adequacy of provider networks, and to establish an audit process for medical contracted rates.

Addressing surprise medical bills and protecting patients has been a priority on Capitol Hill and one that has strong bipartisan support in both chambers of Congress and from President Trump. Since this new House bill also has jurisdiction from the Ways and Means Committee and the Education and Labor Committee, both committees will need to address the bill before it can advance. AGA will keep you updated on the status of this important legislation.
 

[email protected]