User login
Safety alert for intragastric balloon systems
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
As past chair of the AGA Center for GI Innovation and Technology, I have been closely following balloon-based obesity devices as they’ve entered the marketplace. The center has welcomed the introduction of these noninvasive devices that can be managed by GIs, and we’ve worked closely with device companies and the FDA for the past several years to ensure these devices were introduced to the market in a safe and efficient manner.
We do not have enough information now to connect these recent patient deaths to these devices. That said, the FDA’s letter reinforces a few important points. Foremost, the fact that complications and adverse events can occur with any procedure. For physicians using intragastric balloons, each patient must be appropriately evaluated prior to the decision to place the balloon, especially for the potential risks of anesthesia and an endoscopic procedure. Patients must be monitored closely during the entire term of treatment, and following the procedure, in order to detect the development of possible complications, and each patient should be instructed to contact his or her physician immediately upon the onset of any unexpected symptoms.
Michael Kochman MD, AGAF, is the Wilmott Family Professor of Medicine, professor of medicine in surgery, gastroenterology division, University of Pennsylvania, Philadelphia.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
The Food and Drug Administration announced a safety alert on Aug. 10, 2017, for liquid-filled intragastric balloon systems, as they have caused five reports of unanticipated deaths that occurred from 2016 to present in patients.
The cause or incidence of patient death is still unknown, and the FDA has not been able to definitively attribute the deaths to the devices or the insertion procedures for these devices. All five reports show that patient deaths occurred within a month or less of balloon placement. In three of the reports, death occurred as soon as 1-3 days after balloon placement. The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment.
The FDA continues to recommend that health care providers closely monitor patients treated with these devices for complications. Any adverse events related to intragastric balloon systems should be reported through MedWatch. The FDA will keep the public informed as new information becomes available.
Read the full safety alert on the FDA’s website.
Helpful schedules ease task of tapering opioids
ESTES PARK, COLO. – Now that the opioid epidemic has formally been declared a national emergency, physicians can expect to encounter growing pressure to taper opioids in their chronic pain patients, Sunny Linnebur, PharmD, predicted at a conference on internal medicine sponsored by the University of Colorado.
As an example of what physicians around the country might expect, she added, Colorado state health officials recently announced that coverage of opioid therapy for Medicaid patients will be reduced. State health officials recommended that physicians taper down their patients’ opioids.
Fortunately, helpful tools for doing so are just a few mouse clicks away, according to Dr. Linnebur, professor of clinical pharmacy at the University of Colorado, Aurora.
Indications for opioid tapering as described in a guide provided by the Centers for Disease Control and Prevention include lack of a sustained or clinically meaningful improvement in pain and functioning as defined, for example, by at least a 30% improvement on the three-item PEG scale; use of opioids at a daily dosage of 50 morphine equivalent doses or more without evidence of benefit; signs of a substance use disorder other than tobacco dependence; warning signs of harms, such as drowsiness, slurred speech, or difficulty controlling use of the medication; patient request; and any situation where the physician deems that the benefits no longer outweigh the risks (www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf).
General principles of tapering opioids as outlined by the CDC include reducing the dosage by about 10% a week at a time – although if a patient has been on opioids for years, then at a slower rate, perhaps 10% per month, may be more appropriate. If a patient has been using a 12.5 mcg/hour fentanyl patch, a switch to an oral opioid is recommended to complete the taper. When the smallest dosage has been reached, the interval between doses can be stretched; and once the medication is being taken less than once per day, it can be stopped.
She highlighted an opioid tapering schedule form developed by experts at the Washington State Health Care Authority as being particularly useful.
“If you type in a patient’s opioid medication and dose, it will give you a week-to-week calendar schedule for tapering,” she explained. “We know that getting patients on the safest dose of opioid is important, but it’s also difficult. This is an objective taper schedule that will prevent the patient from withdrawing from their opioid and hopefully will help in tolerating the reduction.”
Dr. Linnebur reported having no financial conflicts of interest regarding her presentation.
ESTES PARK, COLO. – Now that the opioid epidemic has formally been declared a national emergency, physicians can expect to encounter growing pressure to taper opioids in their chronic pain patients, Sunny Linnebur, PharmD, predicted at a conference on internal medicine sponsored by the University of Colorado.
As an example of what physicians around the country might expect, she added, Colorado state health officials recently announced that coverage of opioid therapy for Medicaid patients will be reduced. State health officials recommended that physicians taper down their patients’ opioids.
Fortunately, helpful tools for doing so are just a few mouse clicks away, according to Dr. Linnebur, professor of clinical pharmacy at the University of Colorado, Aurora.
Indications for opioid tapering as described in a guide provided by the Centers for Disease Control and Prevention include lack of a sustained or clinically meaningful improvement in pain and functioning as defined, for example, by at least a 30% improvement on the three-item PEG scale; use of opioids at a daily dosage of 50 morphine equivalent doses or more without evidence of benefit; signs of a substance use disorder other than tobacco dependence; warning signs of harms, such as drowsiness, slurred speech, or difficulty controlling use of the medication; patient request; and any situation where the physician deems that the benefits no longer outweigh the risks (www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf).
General principles of tapering opioids as outlined by the CDC include reducing the dosage by about 10% a week at a time – although if a patient has been on opioids for years, then at a slower rate, perhaps 10% per month, may be more appropriate. If a patient has been using a 12.5 mcg/hour fentanyl patch, a switch to an oral opioid is recommended to complete the taper. When the smallest dosage has been reached, the interval between doses can be stretched; and once the medication is being taken less than once per day, it can be stopped.
She highlighted an opioid tapering schedule form developed by experts at the Washington State Health Care Authority as being particularly useful.
“If you type in a patient’s opioid medication and dose, it will give you a week-to-week calendar schedule for tapering,” she explained. “We know that getting patients on the safest dose of opioid is important, but it’s also difficult. This is an objective taper schedule that will prevent the patient from withdrawing from their opioid and hopefully will help in tolerating the reduction.”
Dr. Linnebur reported having no financial conflicts of interest regarding her presentation.
ESTES PARK, COLO. – Now that the opioid epidemic has formally been declared a national emergency, physicians can expect to encounter growing pressure to taper opioids in their chronic pain patients, Sunny Linnebur, PharmD, predicted at a conference on internal medicine sponsored by the University of Colorado.
As an example of what physicians around the country might expect, she added, Colorado state health officials recently announced that coverage of opioid therapy for Medicaid patients will be reduced. State health officials recommended that physicians taper down their patients’ opioids.
Fortunately, helpful tools for doing so are just a few mouse clicks away, according to Dr. Linnebur, professor of clinical pharmacy at the University of Colorado, Aurora.
Indications for opioid tapering as described in a guide provided by the Centers for Disease Control and Prevention include lack of a sustained or clinically meaningful improvement in pain and functioning as defined, for example, by at least a 30% improvement on the three-item PEG scale; use of opioids at a daily dosage of 50 morphine equivalent doses or more without evidence of benefit; signs of a substance use disorder other than tobacco dependence; warning signs of harms, such as drowsiness, slurred speech, or difficulty controlling use of the medication; patient request; and any situation where the physician deems that the benefits no longer outweigh the risks (www.cdc.gov/drugoverdose/pdf/clinical_pocket_guide_tapering-a.pdf).
General principles of tapering opioids as outlined by the CDC include reducing the dosage by about 10% a week at a time – although if a patient has been on opioids for years, then at a slower rate, perhaps 10% per month, may be more appropriate. If a patient has been using a 12.5 mcg/hour fentanyl patch, a switch to an oral opioid is recommended to complete the taper. When the smallest dosage has been reached, the interval between doses can be stretched; and once the medication is being taken less than once per day, it can be stopped.
She highlighted an opioid tapering schedule form developed by experts at the Washington State Health Care Authority as being particularly useful.
“If you type in a patient’s opioid medication and dose, it will give you a week-to-week calendar schedule for tapering,” she explained. “We know that getting patients on the safest dose of opioid is important, but it’s also difficult. This is an objective taper schedule that will prevent the patient from withdrawing from their opioid and hopefully will help in tolerating the reduction.”
Dr. Linnebur reported having no financial conflicts of interest regarding her presentation.
EXPERT ANALYSIS FROM THE ANNUAL INTERNAL MEDICINE PROGRAM
FDA advisory committee to consider adjuvant sunitinib for RCC
The Oncologic Drugs Advisory Committee to the Food and Drug Administration will meet on Sept. 19 to discuss a supplemental new drug application for sunitinib (Sutent), for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
Sunitinib is an oral antiangiogenic agent that has been approved for the treatment of advanced RCC since 2006.
The FDA accepted the new drug application in May and is expected to issue a decision by January 2018.
Results for sunitinib as adjuvant treatment have been mixed. No significant differences in disease-free survival or overall survival were found in the phase 3 ASSURE between patients receiving adjuvant sunitinib and those receiving placebo, according to results published in The Lancet. However, adjuvant sunitinib prolonged disease-free survival by 1.2 years, compared with placebo, in the phase 3 S-TRAC trial, presented at the 2016 ESMO Congress and published in the New England Journal of Medicine. S-TRAC results are the basis for the new drug application submitted by Pfizer, Inc., according to a press release.
The advisory committee will consider comments from the public if submitted by Sept. 5, as electronic comments through the electronic filing system or by mail/hand delivery/courier at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The docket number is FDA-2017-N-1063.
The Oncologic Drugs Advisory Committee to the Food and Drug Administration will meet on Sept. 19 to discuss a supplemental new drug application for sunitinib (Sutent), for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
Sunitinib is an oral antiangiogenic agent that has been approved for the treatment of advanced RCC since 2006.
The FDA accepted the new drug application in May and is expected to issue a decision by January 2018.
Results for sunitinib as adjuvant treatment have been mixed. No significant differences in disease-free survival or overall survival were found in the phase 3 ASSURE between patients receiving adjuvant sunitinib and those receiving placebo, according to results published in The Lancet. However, adjuvant sunitinib prolonged disease-free survival by 1.2 years, compared with placebo, in the phase 3 S-TRAC trial, presented at the 2016 ESMO Congress and published in the New England Journal of Medicine. S-TRAC results are the basis for the new drug application submitted by Pfizer, Inc., according to a press release.
The advisory committee will consider comments from the public if submitted by Sept. 5, as electronic comments through the electronic filing system or by mail/hand delivery/courier at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The docket number is FDA-2017-N-1063.
The Oncologic Drugs Advisory Committee to the Food and Drug Administration will meet on Sept. 19 to discuss a supplemental new drug application for sunitinib (Sutent), for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.
Sunitinib is an oral antiangiogenic agent that has been approved for the treatment of advanced RCC since 2006.
The FDA accepted the new drug application in May and is expected to issue a decision by January 2018.
Results for sunitinib as adjuvant treatment have been mixed. No significant differences in disease-free survival or overall survival were found in the phase 3 ASSURE between patients receiving adjuvant sunitinib and those receiving placebo, according to results published in The Lancet. However, adjuvant sunitinib prolonged disease-free survival by 1.2 years, compared with placebo, in the phase 3 S-TRAC trial, presented at the 2016 ESMO Congress and published in the New England Journal of Medicine. S-TRAC results are the basis for the new drug application submitted by Pfizer, Inc., according to a press release.
The advisory committee will consider comments from the public if submitted by Sept. 5, as electronic comments through the electronic filing system or by mail/hand delivery/courier at Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The docket number is FDA-2017-N-1063.
Role of fidaxomicin for C. difficile infection continues to evolve
SAN FRANCISCO– The role of fidaxomicin for treating mild to moderate Clostridium difficile infection is still finding its way, according to Sarah Doernberg, MD.
For now, fidaxomicin, a narrow spectrum macrocyclic antibiotic, may be appropriate for those at high risk for relapse and/or those requiring concomitant antibiotics – but its high price tag may be prohibitive.
“I think a lot of centers have taken the fidaxomicin data, which were based on patients with initial infection or a single relapse, and extrapolated it to patients with multiple relapses,” Dr. Doernberg, medical director of adult antimicrobial stewardship at UCSF Medical Center, said at the UCSF Annual Advances in Internal Medicine meeting.
In a recent analysis, researchers collected real-world data on implementation of fidaxomicin for CDI patients at seven hospitals in the United Kingdom (Eur J Clin Microbiol Infect Dis. 2016 Feb;35[2]:251-9). In two hospitals where fidaxomicin was used as the first-line treatment for all primary and recurrent episodes, the recurrence rate reduced from 10.6% to 3.1% and from 16.3% to 3.1%, with a significant difference in 28-day mortality, from 18.2% to 3.1%; (P less than .05) and 17.3% to 6.3% (P less than .05). In the remaining five hospitals that used fidaxomicin in selected patients only, the changes in recurrence rates and mortality were less marked.
Other studies have found that fidaxomicin has a similar cure rate, compared with vancomycin (around 88%) but a lower recurrence rate (13%-15%, compared with 25%-27%, respectively; see N Engl J Med. 2011 Feb 3;364[5]:422-31). However, the general cost for a course is significantly more, compared with metronidazole and vancomycin, making fidaxomicin less cost effective as a first-line agent in most cases (Clin Infect Dis. 2013 Aug 15; 57[4]:555-61).
“Our guidelines recommend it in patients who have a very high risk for relapse who would not be candidates for fecal transplant down the line, which generally means immunocompromised patients,” Dr. Doernberg said.
Additional considerations when treating CDI include stopping unnecessary antibiotics, shortening the antibiotic course, narrowing the antibiotic spectrum, and stopping acid-suppressive medication when possible, especially proton pump inhibitors. “Do no use anti-peristaltic agents until acute symptoms of CDI improve,” she said.
Dr. Doernberg disclosed that she is a consultant for Actelion. She has also conducted prior research studies with Cerexa, Cubist, and Merck.
SAN FRANCISCO– The role of fidaxomicin for treating mild to moderate Clostridium difficile infection is still finding its way, according to Sarah Doernberg, MD.
For now, fidaxomicin, a narrow spectrum macrocyclic antibiotic, may be appropriate for those at high risk for relapse and/or those requiring concomitant antibiotics – but its high price tag may be prohibitive.
“I think a lot of centers have taken the fidaxomicin data, which were based on patients with initial infection or a single relapse, and extrapolated it to patients with multiple relapses,” Dr. Doernberg, medical director of adult antimicrobial stewardship at UCSF Medical Center, said at the UCSF Annual Advances in Internal Medicine meeting.
In a recent analysis, researchers collected real-world data on implementation of fidaxomicin for CDI patients at seven hospitals in the United Kingdom (Eur J Clin Microbiol Infect Dis. 2016 Feb;35[2]:251-9). In two hospitals where fidaxomicin was used as the first-line treatment for all primary and recurrent episodes, the recurrence rate reduced from 10.6% to 3.1% and from 16.3% to 3.1%, with a significant difference in 28-day mortality, from 18.2% to 3.1%; (P less than .05) and 17.3% to 6.3% (P less than .05). In the remaining five hospitals that used fidaxomicin in selected patients only, the changes in recurrence rates and mortality were less marked.
Other studies have found that fidaxomicin has a similar cure rate, compared with vancomycin (around 88%) but a lower recurrence rate (13%-15%, compared with 25%-27%, respectively; see N Engl J Med. 2011 Feb 3;364[5]:422-31). However, the general cost for a course is significantly more, compared with metronidazole and vancomycin, making fidaxomicin less cost effective as a first-line agent in most cases (Clin Infect Dis. 2013 Aug 15; 57[4]:555-61).
“Our guidelines recommend it in patients who have a very high risk for relapse who would not be candidates for fecal transplant down the line, which generally means immunocompromised patients,” Dr. Doernberg said.
Additional considerations when treating CDI include stopping unnecessary antibiotics, shortening the antibiotic course, narrowing the antibiotic spectrum, and stopping acid-suppressive medication when possible, especially proton pump inhibitors. “Do no use anti-peristaltic agents until acute symptoms of CDI improve,” she said.
Dr. Doernberg disclosed that she is a consultant for Actelion. She has also conducted prior research studies with Cerexa, Cubist, and Merck.
SAN FRANCISCO– The role of fidaxomicin for treating mild to moderate Clostridium difficile infection is still finding its way, according to Sarah Doernberg, MD.
For now, fidaxomicin, a narrow spectrum macrocyclic antibiotic, may be appropriate for those at high risk for relapse and/or those requiring concomitant antibiotics – but its high price tag may be prohibitive.
“I think a lot of centers have taken the fidaxomicin data, which were based on patients with initial infection or a single relapse, and extrapolated it to patients with multiple relapses,” Dr. Doernberg, medical director of adult antimicrobial stewardship at UCSF Medical Center, said at the UCSF Annual Advances in Internal Medicine meeting.
In a recent analysis, researchers collected real-world data on implementation of fidaxomicin for CDI patients at seven hospitals in the United Kingdom (Eur J Clin Microbiol Infect Dis. 2016 Feb;35[2]:251-9). In two hospitals where fidaxomicin was used as the first-line treatment for all primary and recurrent episodes, the recurrence rate reduced from 10.6% to 3.1% and from 16.3% to 3.1%, with a significant difference in 28-day mortality, from 18.2% to 3.1%; (P less than .05) and 17.3% to 6.3% (P less than .05). In the remaining five hospitals that used fidaxomicin in selected patients only, the changes in recurrence rates and mortality were less marked.
Other studies have found that fidaxomicin has a similar cure rate, compared with vancomycin (around 88%) but a lower recurrence rate (13%-15%, compared with 25%-27%, respectively; see N Engl J Med. 2011 Feb 3;364[5]:422-31). However, the general cost for a course is significantly more, compared with metronidazole and vancomycin, making fidaxomicin less cost effective as a first-line agent in most cases (Clin Infect Dis. 2013 Aug 15; 57[4]:555-61).
“Our guidelines recommend it in patients who have a very high risk for relapse who would not be candidates for fecal transplant down the line, which generally means immunocompromised patients,” Dr. Doernberg said.
Additional considerations when treating CDI include stopping unnecessary antibiotics, shortening the antibiotic course, narrowing the antibiotic spectrum, and stopping acid-suppressive medication when possible, especially proton pump inhibitors. “Do no use anti-peristaltic agents until acute symptoms of CDI improve,” she said.
Dr. Doernberg disclosed that she is a consultant for Actelion. She has also conducted prior research studies with Cerexa, Cubist, and Merck.
AT THE ANNUAL ADVANCES IN INTERNAL MEDICINE
Off-the-shelf T cells used to treat viral infections after HSCT
One-size-fits-all T cells designed to recognize and mount an immune response against five common viral pathogens may help to reduce the incidence of severe viral infections and treatment-related deaths in patients who have undergone hematopoietic stem cell transplants (HSCT), investigators reported.
Among 37 evaluable patients who had undergone an allogeneic HSCT, a single infusion of banked virus-specific T cells (VSTs) directed against adenovirus, BK virus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), and human herpesvirus 6 (HHV-6) was associated with a 92% cumulative complete or partial response rate, reported Ifigeneia Tzannou, MD, and her colleagues from Baylor College of Medicine in Houston.
“Although a randomized trial will be required to definitively assess the value of banked VSTs, this study strongly suggests that off-the-shelf, multiple-virus–directed VSTs are a safe and effective broad-spectrum approach to treat severe viral infections after HSCT. These VSTs can be rapidly and cost effectively produced in scalable quantities with excellent long-term stability, which facilitates the broad implementation of this therapy,” they wrote in the Journal of Clinical Oncology (2017 Aug 7. doi: 10.1200/JCO.2017.73.0655).
Although adoptive transfer of VSTs derived from donor stem cells has been shown to protect patients against viral pathogens, the technique is hampered by costs, complexity, the time-consuming manufacturing process, and the need for seropositive donors, Dr. Tzannou and her colleagues pointed out.
“One way to overcome these limitations and to supply antiviral protection to recipients of allogeneic HSCT would be to prepare and cryopreserve banks of VST lines from healthy seropositive donors, which would be available for immediate use as an off-the-shelf product,” they wrote.
They tested this concept in a phase 2 clinical trial in 38 patients with a total of 45 infections.
A single infusion was associated with cumulative complete and partial responses rates of 71% in 7 patients with adenoviral infections, 100% in 16 patients with BK virus infections, 94% in 17 patients with CMV infections, 100% for 2 patients with EBV infections, and 67% for 3 patients with HHV-6 infections.
Seven of the 38 patients received VSTs for two viral infections, and all patients had viral control after a single infusion. All cases of CMV, adenovirus, and EBV infections were cleared from serum. One patient with HHV-6 encephalitis had complete resolution of encephalitis after one infusion and resolution of hemorrhagic cystitis after a second infusion; 14 patients with BK virus–associated hemorrhagic cystitis had clinical improvement or resolution of disease.
The infusions were delivered safely. After infusion, one patient developed recurrent grade 3 gastrointestinal graft versus host disease (GVHD) after a rapid corticosteroid taper, three patients had recurrent grade 1 or 2 skin GVHD, and two patients had de novo skin GVHD. Of the five cases of skin GVHD, four resolved with the administration of topical treatments and one with the reinstitution of corticosteroids after a taper.
“More widespread and earlier use of this modality could minimize both drug-related and virus-associated complications and thereby decrease treatment-related mortality in recipients of allogeneic HSCT,” the investigators wrote.
The study was supported by the National Heart, Lung, and Blood Institute; Conquer Cancer Foundation; and Dan L. Duncan Comprehensive Cancer Center. Dr. Tzannou disclosed having a consulting or advisory role with ViraCyte, and several coauthors reported financial ties with various companies.
One-size-fits-all T cells designed to recognize and mount an immune response against five common viral pathogens may help to reduce the incidence of severe viral infections and treatment-related deaths in patients who have undergone hematopoietic stem cell transplants (HSCT), investigators reported.
Among 37 evaluable patients who had undergone an allogeneic HSCT, a single infusion of banked virus-specific T cells (VSTs) directed against adenovirus, BK virus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), and human herpesvirus 6 (HHV-6) was associated with a 92% cumulative complete or partial response rate, reported Ifigeneia Tzannou, MD, and her colleagues from Baylor College of Medicine in Houston.
“Although a randomized trial will be required to definitively assess the value of banked VSTs, this study strongly suggests that off-the-shelf, multiple-virus–directed VSTs are a safe and effective broad-spectrum approach to treat severe viral infections after HSCT. These VSTs can be rapidly and cost effectively produced in scalable quantities with excellent long-term stability, which facilitates the broad implementation of this therapy,” they wrote in the Journal of Clinical Oncology (2017 Aug 7. doi: 10.1200/JCO.2017.73.0655).
Although adoptive transfer of VSTs derived from donor stem cells has been shown to protect patients against viral pathogens, the technique is hampered by costs, complexity, the time-consuming manufacturing process, and the need for seropositive donors, Dr. Tzannou and her colleagues pointed out.
“One way to overcome these limitations and to supply antiviral protection to recipients of allogeneic HSCT would be to prepare and cryopreserve banks of VST lines from healthy seropositive donors, which would be available for immediate use as an off-the-shelf product,” they wrote.
They tested this concept in a phase 2 clinical trial in 38 patients with a total of 45 infections.
A single infusion was associated with cumulative complete and partial responses rates of 71% in 7 patients with adenoviral infections, 100% in 16 patients with BK virus infections, 94% in 17 patients with CMV infections, 100% for 2 patients with EBV infections, and 67% for 3 patients with HHV-6 infections.
Seven of the 38 patients received VSTs for two viral infections, and all patients had viral control after a single infusion. All cases of CMV, adenovirus, and EBV infections were cleared from serum. One patient with HHV-6 encephalitis had complete resolution of encephalitis after one infusion and resolution of hemorrhagic cystitis after a second infusion; 14 patients with BK virus–associated hemorrhagic cystitis had clinical improvement or resolution of disease.
The infusions were delivered safely. After infusion, one patient developed recurrent grade 3 gastrointestinal graft versus host disease (GVHD) after a rapid corticosteroid taper, three patients had recurrent grade 1 or 2 skin GVHD, and two patients had de novo skin GVHD. Of the five cases of skin GVHD, four resolved with the administration of topical treatments and one with the reinstitution of corticosteroids after a taper.
“More widespread and earlier use of this modality could minimize both drug-related and virus-associated complications and thereby decrease treatment-related mortality in recipients of allogeneic HSCT,” the investigators wrote.
The study was supported by the National Heart, Lung, and Blood Institute; Conquer Cancer Foundation; and Dan L. Duncan Comprehensive Cancer Center. Dr. Tzannou disclosed having a consulting or advisory role with ViraCyte, and several coauthors reported financial ties with various companies.
One-size-fits-all T cells designed to recognize and mount an immune response against five common viral pathogens may help to reduce the incidence of severe viral infections and treatment-related deaths in patients who have undergone hematopoietic stem cell transplants (HSCT), investigators reported.
Among 37 evaluable patients who had undergone an allogeneic HSCT, a single infusion of banked virus-specific T cells (VSTs) directed against adenovirus, BK virus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), and human herpesvirus 6 (HHV-6) was associated with a 92% cumulative complete or partial response rate, reported Ifigeneia Tzannou, MD, and her colleagues from Baylor College of Medicine in Houston.
“Although a randomized trial will be required to definitively assess the value of banked VSTs, this study strongly suggests that off-the-shelf, multiple-virus–directed VSTs are a safe and effective broad-spectrum approach to treat severe viral infections after HSCT. These VSTs can be rapidly and cost effectively produced in scalable quantities with excellent long-term stability, which facilitates the broad implementation of this therapy,” they wrote in the Journal of Clinical Oncology (2017 Aug 7. doi: 10.1200/JCO.2017.73.0655).
Although adoptive transfer of VSTs derived from donor stem cells has been shown to protect patients against viral pathogens, the technique is hampered by costs, complexity, the time-consuming manufacturing process, and the need for seropositive donors, Dr. Tzannou and her colleagues pointed out.
“One way to overcome these limitations and to supply antiviral protection to recipients of allogeneic HSCT would be to prepare and cryopreserve banks of VST lines from healthy seropositive donors, which would be available for immediate use as an off-the-shelf product,” they wrote.
They tested this concept in a phase 2 clinical trial in 38 patients with a total of 45 infections.
A single infusion was associated with cumulative complete and partial responses rates of 71% in 7 patients with adenoviral infections, 100% in 16 patients with BK virus infections, 94% in 17 patients with CMV infections, 100% for 2 patients with EBV infections, and 67% for 3 patients with HHV-6 infections.
Seven of the 38 patients received VSTs for two viral infections, and all patients had viral control after a single infusion. All cases of CMV, adenovirus, and EBV infections were cleared from serum. One patient with HHV-6 encephalitis had complete resolution of encephalitis after one infusion and resolution of hemorrhagic cystitis after a second infusion; 14 patients with BK virus–associated hemorrhagic cystitis had clinical improvement or resolution of disease.
The infusions were delivered safely. After infusion, one patient developed recurrent grade 3 gastrointestinal graft versus host disease (GVHD) after a rapid corticosteroid taper, three patients had recurrent grade 1 or 2 skin GVHD, and two patients had de novo skin GVHD. Of the five cases of skin GVHD, four resolved with the administration of topical treatments and one with the reinstitution of corticosteroids after a taper.
“More widespread and earlier use of this modality could minimize both drug-related and virus-associated complications and thereby decrease treatment-related mortality in recipients of allogeneic HSCT,” the investigators wrote.
The study was supported by the National Heart, Lung, and Blood Institute; Conquer Cancer Foundation; and Dan L. Duncan Comprehensive Cancer Center. Dr. Tzannou disclosed having a consulting or advisory role with ViraCyte, and several coauthors reported financial ties with various companies.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Off-the-shelf virus-specific T-cell preparations can effectively treat infections following HSCT.
Major finding: Banked T cells directed against five common viruses were associated with a 92% cumulative partial or complete response rate.
Data source: Phase 2 clinical trial in 38 patients with viral infections following HSCT.
Disclosures: The study was supported by the National Heart, Lung, and Blood Institute; Conquer Cancer Foundation; and Dan L. Duncan Comprehensive Cancer Center. Dr. Tzannou disclosed having a consulting or advisory role with ViraCyte, and several coauthors reported financial ties with various companies.
The tyranny of E&M reimbursement cuts with same-day procedures
You know, some days the burdens of insurance regulations just wear you down. One example is the automatic 50% cut in your evaluation and management (E&M) reimbursement if you perform any other services on the same patient on the same day.
So how did this all start? In 2004, the Health & Human Services (HHS) Office of the Inspector General (OIG) reported that 35% of claims appended with modifier -25 did not meet the required threshold to be appropriate. In response, the OIG encouraged carriers to reexamine their reviews and policies. Rather than go to the trouble to audit providers and ask for refunds, some private insurers took things a step further and just cut everybody’s reimbursement by 50%.
I’m sure insurers call this “revenue enhancement” or “revenue neutral policy changes.” To my mind, it’s just more “how do we squeeze doctors on a regular basis.” And it’s behavior that is so wrong on so many levels.
One of the reasons dermatology is such a rewarding specialty is that you can usually make the patient better on the same day by diagnosing and dealing with the condition. That incentive is crushed when reductions lower the reimbursement for diagnosing and treating a patient on the same visit to below the overhead costs of rendering the services.
In addition, procedure codes that are billed with an E&M have already been tagged more than 50% of the time, and the value reduced by the relative value update committee upon review. The E&M reduction is built into the payment system for the codes that dermatologists use. The -25 modifier is specifically intended to allow for an evaluation code on the same day as a procedure. This is correct CPT [Current Procedural Terminology] coding convention.
So, how can dermatologists respond to these “takings” by the insurance company?
First, review your contract and see if the insurer is required to follow CPT coding convention. If they are, you have a strong case for insisting on appropriate reimbursement. If they’re not, either renegotiate with them or drop out of these insurance plans. This approach is difficult for most dermatologists affected by these plans, because 25%-40% of the local private insurance market is controlled by these insurers. This situation is a fine example of the problems with oligopolies, and a good reason for opposing market consolidation of insurers, which the American Medical Association did successfully last year by resisting the attempted mergers of Aetna and Humana, and Anthem and Cigna.
Remember that not all patient problems must be dealt with during the same visit. When problems are not emergent, it is not unreasonable to schedule another procedure at a later time. Think back to medical school and the surgery rotation in which “lumps and bumps” were scheduled all week long for Friday afternoon.
Also, turn to your patients and encourage them to complain about unreasonable policies. They are the ones who really are being shortchanged on their insurance coverage. While dermatologists are heavily affected by these reductions, so are ENTs, podiatrists, hematologist/oncologists, and family medicine and internal medicine physicians.
The American Academy of Family Physicians has some interesting material on this topic on their website. They often must deal with preventive care and illness visits for the same patient on the same day. They suggest initiating a dialogue with the patient about multiple visits before a first visit.
The American Academy of Dermatology and the Pennsylvania and New Jersey Dermatological Societies are fighting these policies. Ultimately, this is a contract issue between you and your insurer. And you need to question the value of a contract that presumes indentured servitude.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].
You know, some days the burdens of insurance regulations just wear you down. One example is the automatic 50% cut in your evaluation and management (E&M) reimbursement if you perform any other services on the same patient on the same day.
So how did this all start? In 2004, the Health & Human Services (HHS) Office of the Inspector General (OIG) reported that 35% of claims appended with modifier -25 did not meet the required threshold to be appropriate. In response, the OIG encouraged carriers to reexamine their reviews and policies. Rather than go to the trouble to audit providers and ask for refunds, some private insurers took things a step further and just cut everybody’s reimbursement by 50%.
I’m sure insurers call this “revenue enhancement” or “revenue neutral policy changes.” To my mind, it’s just more “how do we squeeze doctors on a regular basis.” And it’s behavior that is so wrong on so many levels.
One of the reasons dermatology is such a rewarding specialty is that you can usually make the patient better on the same day by diagnosing and dealing with the condition. That incentive is crushed when reductions lower the reimbursement for diagnosing and treating a patient on the same visit to below the overhead costs of rendering the services.
In addition, procedure codes that are billed with an E&M have already been tagged more than 50% of the time, and the value reduced by the relative value update committee upon review. The E&M reduction is built into the payment system for the codes that dermatologists use. The -25 modifier is specifically intended to allow for an evaluation code on the same day as a procedure. This is correct CPT [Current Procedural Terminology] coding convention.
So, how can dermatologists respond to these “takings” by the insurance company?
First, review your contract and see if the insurer is required to follow CPT coding convention. If they are, you have a strong case for insisting on appropriate reimbursement. If they’re not, either renegotiate with them or drop out of these insurance plans. This approach is difficult for most dermatologists affected by these plans, because 25%-40% of the local private insurance market is controlled by these insurers. This situation is a fine example of the problems with oligopolies, and a good reason for opposing market consolidation of insurers, which the American Medical Association did successfully last year by resisting the attempted mergers of Aetna and Humana, and Anthem and Cigna.
Remember that not all patient problems must be dealt with during the same visit. When problems are not emergent, it is not unreasonable to schedule another procedure at a later time. Think back to medical school and the surgery rotation in which “lumps and bumps” were scheduled all week long for Friday afternoon.
Also, turn to your patients and encourage them to complain about unreasonable policies. They are the ones who really are being shortchanged on their insurance coverage. While dermatologists are heavily affected by these reductions, so are ENTs, podiatrists, hematologist/oncologists, and family medicine and internal medicine physicians.
The American Academy of Family Physicians has some interesting material on this topic on their website. They often must deal with preventive care and illness visits for the same patient on the same day. They suggest initiating a dialogue with the patient about multiple visits before a first visit.
The American Academy of Dermatology and the Pennsylvania and New Jersey Dermatological Societies are fighting these policies. Ultimately, this is a contract issue between you and your insurer. And you need to question the value of a contract that presumes indentured servitude.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].
You know, some days the burdens of insurance regulations just wear you down. One example is the automatic 50% cut in your evaluation and management (E&M) reimbursement if you perform any other services on the same patient on the same day.
So how did this all start? In 2004, the Health & Human Services (HHS) Office of the Inspector General (OIG) reported that 35% of claims appended with modifier -25 did not meet the required threshold to be appropriate. In response, the OIG encouraged carriers to reexamine their reviews and policies. Rather than go to the trouble to audit providers and ask for refunds, some private insurers took things a step further and just cut everybody’s reimbursement by 50%.
I’m sure insurers call this “revenue enhancement” or “revenue neutral policy changes.” To my mind, it’s just more “how do we squeeze doctors on a regular basis.” And it’s behavior that is so wrong on so many levels.
One of the reasons dermatology is such a rewarding specialty is that you can usually make the patient better on the same day by diagnosing and dealing with the condition. That incentive is crushed when reductions lower the reimbursement for diagnosing and treating a patient on the same visit to below the overhead costs of rendering the services.
In addition, procedure codes that are billed with an E&M have already been tagged more than 50% of the time, and the value reduced by the relative value update committee upon review. The E&M reduction is built into the payment system for the codes that dermatologists use. The -25 modifier is specifically intended to allow for an evaluation code on the same day as a procedure. This is correct CPT [Current Procedural Terminology] coding convention.
So, how can dermatologists respond to these “takings” by the insurance company?
First, review your contract and see if the insurer is required to follow CPT coding convention. If they are, you have a strong case for insisting on appropriate reimbursement. If they’re not, either renegotiate with them or drop out of these insurance plans. This approach is difficult for most dermatologists affected by these plans, because 25%-40% of the local private insurance market is controlled by these insurers. This situation is a fine example of the problems with oligopolies, and a good reason for opposing market consolidation of insurers, which the American Medical Association did successfully last year by resisting the attempted mergers of Aetna and Humana, and Anthem and Cigna.
Remember that not all patient problems must be dealt with during the same visit. When problems are not emergent, it is not unreasonable to schedule another procedure at a later time. Think back to medical school and the surgery rotation in which “lumps and bumps” were scheduled all week long for Friday afternoon.
Also, turn to your patients and encourage them to complain about unreasonable policies. They are the ones who really are being shortchanged on their insurance coverage. While dermatologists are heavily affected by these reductions, so are ENTs, podiatrists, hematologist/oncologists, and family medicine and internal medicine physicians.
The American Academy of Family Physicians has some interesting material on this topic on their website. They often must deal with preventive care and illness visits for the same patient on the same day. They suggest initiating a dialogue with the patient about multiple visits before a first visit.
The American Academy of Dermatology and the Pennsylvania and New Jersey Dermatological Societies are fighting these policies. Ultimately, this is a contract issue between you and your insurer. And you need to question the value of a contract that presumes indentured servitude.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at [email protected].
Immigration reforms: Repercussions for hospitalists and the health care industry
International medical graduates (IMGs) have been playing a crucial role in clinician staffing needs for U.S. hospitals, especially in hospital medicine and internal medicine. According to a study, IMGs comprise 25% of the total U.S. physician workforce and 36% of internists.1,2 According to data from the 2008 Today’s Hospitalist Compensation & Career Survey, 32% of practicing hospitalists are IMGs.3
Many IMGs come to work in the U.S. via one of three paths. Just like all roads lead to Rome, all visas lead to a permanent residency pathway, eventually based on the country of origin and number of years waiting. The first path is a green card – cases where IMGs were on a visa and within a certain amount of time they received a green card. The second path is J-1 visa waivers for physicians who trained in the U.S. under a J-1 Visa. Typically, physicians on J-1 Visa waivers need to provide their services for a minimum of 3 years working in underserved areas – where there’s a shortage of health professionals – before they can apply for permanent residency.
The third and most popular path is the H-1B visa, which hospitalists traditionally use as a springboard to apply for permanent residency. Studies have shown that IMGs are more likely to practice medicine in rural and underserved areas. In many instances, physicians end up working in these areas for long periods of time.4
The Department of Homeland Security has considered creating another visa pathway for the technology industry, whereby an alien graduating from a U.S. university with an advanced degree in a STEM (Science, Technology, Engineering, and Math) course of study would receive a new visa and pathway to permanent residency. We believe hospitalists and other physicians should also have an expedited pathway to permanent residency. This step benefits both the U.S. health care system and hospitalists in many ways. It increases hospitalists’ portability and flexibility with schedules. With a traditional H-1B visa, hospitalists are bound to work with the one hospital/system that sponsors the H-1B, and would not be able to work at any other hospital without another extension/addendum to current visa status, even in cases where a physician had time off and would like to offer services at another facility. It is a well-known fact that hospitalist teams are understaffed and try to bring on per-diem staff to fill holes in schedules. The majority of hospitalists are working week-on/week-off schedules, and with an expedited pathway to a green card they would be able to work in different hospitals. They would also be able to move to remote places, or “doctor deserts,” and offer their services, helping to ensure the quality and safety of patient care to which all Americans are entitled.
In 2016 alone, around 1,500 H-1B visas were filed for hospitalist physicians.7 Each hospitalist has an average of 15 patient encounters per day, and for 1,500 physicians that amounts to about 4 million patient encounters annually.8 These data account for only new 2016 visa-holding physicians, and do not account for already approved or renewed visas. It would be very challenging to count the number of patient encounters by hospitalists who are on a visa, but 1 billion patient encounters is not overestimating. Recent studies show that quality of care provided by IMGs is not inferior to that of U.S. medical graduates. The study showed that patients cared for by IMGs have lesser mortality, compared with those cared by U.S. medical graduates.9
In this era of hospital medicine, hospitalists are focusing not only on clinical aspects of patient care but also on efficacy, quality of care, and patient safety and satisfaction, and they are working with the Centers for Medicare & Medicaid Services to develop cost-cutting programs to save billions of dollars in health care expenses. This is the primary reason a majority of hospitals are focused on developing a hospitalist track, and encouraging hospitalists to pursue leadership roles in managing hospitals effectively.
The U.S. health care system is starved for hospitalists and primary care physicians, and IMGs will continue to play a pivotal role. Yet IMGs must deal with shifting trends in immigration policy, and in some recent instances immigrant physicians have been asked to leave the U.S. because of immigration reforms.10,11 We would like the Society of Hospital Medicine to take a stand on behalf of IMG hospitalists and ask the U.S. Department of Labor and Homeland Security for an expedited permanent residency pathway for IMG hospitalists. We are certain that our request will get a fair hearing, as the former U.S. surgeon general was a hospitalist and, indeed, an immigrant.
Dr. Medarametla is medical director, Intermediate Care Unit, Baystate Medical Center, Springfield, Mass., and assistant professor of medicine, University of Massachusetts Medical School. Dr. Pamerla is a hospitalist at Wilson Medical Center, Wilson, N.C.
References
1. Educational Commission for Foreign Medical Graduates; ECFMG 2015 Annual Report. April 2016 http://www.ecfmg.org/resources/ECFMG-2015-annual-report.pdf.
2. Pinsky WW. The Importance of International Medical Graduates in the United States. Ann Intern Med. 2017. doi: 10.7326/M17-0505.
3. Hart LG, Skillman SM, Fordyce M, et al. International medical graduate physicians in the United States: changes since 1981. Health Aff. 2007 July/August;26(4):1159-69.
4. Goodfellow A1, Ulloa JG, Dowling PT, et al. Predictors of Primary Care Physician Practice Location in Underserved Urban or Rural Areas in the United States: A Systematic Literature Review. Acad Med. 2016 Sep;91(9):1313-21.
5. https://www.uscis.gov/working-united-states/temporary-workers/h-1b-specialty-occupations-and-fashion-models/h-1b-fiscal-year-fy-2018-cap-season#count
6. https://www.graphiq.com/vlp/bCIqXCpVqF7
7. http://www.myvisajobs.com/Reports/2017-H1B-Visa-Category.aspx?T=JT&P=2
8. Steven M Harris: http://www.the-hospitalist.org/hospitalist/article/125455/appropriate-patient-census-hospital-medicines-holy-grail
9. Tsugawa Y, Jena AB, Orav EJ, Jha AK. Quality of care delivered by general internists in US hospitals who graduated from foreign versus US medical schools: observational study. BMJ. 2017;356:j273.
10. https://www.propublica.org/article/cleveland-clinic-doctor-forced-to-leave-country-after-trump-order
11. http://www.houstonchronicle.com/news/houston-texas/houston/article/Houston-immigrant-doctors-given-24-hours-to-leave-11040259.php
International medical graduates (IMGs) have been playing a crucial role in clinician staffing needs for U.S. hospitals, especially in hospital medicine and internal medicine. According to a study, IMGs comprise 25% of the total U.S. physician workforce and 36% of internists.1,2 According to data from the 2008 Today’s Hospitalist Compensation & Career Survey, 32% of practicing hospitalists are IMGs.3
Many IMGs come to work in the U.S. via one of three paths. Just like all roads lead to Rome, all visas lead to a permanent residency pathway, eventually based on the country of origin and number of years waiting. The first path is a green card – cases where IMGs were on a visa and within a certain amount of time they received a green card. The second path is J-1 visa waivers for physicians who trained in the U.S. under a J-1 Visa. Typically, physicians on J-1 Visa waivers need to provide their services for a minimum of 3 years working in underserved areas – where there’s a shortage of health professionals – before they can apply for permanent residency.
The third and most popular path is the H-1B visa, which hospitalists traditionally use as a springboard to apply for permanent residency. Studies have shown that IMGs are more likely to practice medicine in rural and underserved areas. In many instances, physicians end up working in these areas for long periods of time.4
The Department of Homeland Security has considered creating another visa pathway for the technology industry, whereby an alien graduating from a U.S. university with an advanced degree in a STEM (Science, Technology, Engineering, and Math) course of study would receive a new visa and pathway to permanent residency. We believe hospitalists and other physicians should also have an expedited pathway to permanent residency. This step benefits both the U.S. health care system and hospitalists in many ways. It increases hospitalists’ portability and flexibility with schedules. With a traditional H-1B visa, hospitalists are bound to work with the one hospital/system that sponsors the H-1B, and would not be able to work at any other hospital without another extension/addendum to current visa status, even in cases where a physician had time off and would like to offer services at another facility. It is a well-known fact that hospitalist teams are understaffed and try to bring on per-diem staff to fill holes in schedules. The majority of hospitalists are working week-on/week-off schedules, and with an expedited pathway to a green card they would be able to work in different hospitals. They would also be able to move to remote places, or “doctor deserts,” and offer their services, helping to ensure the quality and safety of patient care to which all Americans are entitled.
In 2016 alone, around 1,500 H-1B visas were filed for hospitalist physicians.7 Each hospitalist has an average of 15 patient encounters per day, and for 1,500 physicians that amounts to about 4 million patient encounters annually.8 These data account for only new 2016 visa-holding physicians, and do not account for already approved or renewed visas. It would be very challenging to count the number of patient encounters by hospitalists who are on a visa, but 1 billion patient encounters is not overestimating. Recent studies show that quality of care provided by IMGs is not inferior to that of U.S. medical graduates. The study showed that patients cared for by IMGs have lesser mortality, compared with those cared by U.S. medical graduates.9
In this era of hospital medicine, hospitalists are focusing not only on clinical aspects of patient care but also on efficacy, quality of care, and patient safety and satisfaction, and they are working with the Centers for Medicare & Medicaid Services to develop cost-cutting programs to save billions of dollars in health care expenses. This is the primary reason a majority of hospitals are focused on developing a hospitalist track, and encouraging hospitalists to pursue leadership roles in managing hospitals effectively.
The U.S. health care system is starved for hospitalists and primary care physicians, and IMGs will continue to play a pivotal role. Yet IMGs must deal with shifting trends in immigration policy, and in some recent instances immigrant physicians have been asked to leave the U.S. because of immigration reforms.10,11 We would like the Society of Hospital Medicine to take a stand on behalf of IMG hospitalists and ask the U.S. Department of Labor and Homeland Security for an expedited permanent residency pathway for IMG hospitalists. We are certain that our request will get a fair hearing, as the former U.S. surgeon general was a hospitalist and, indeed, an immigrant.
Dr. Medarametla is medical director, Intermediate Care Unit, Baystate Medical Center, Springfield, Mass., and assistant professor of medicine, University of Massachusetts Medical School. Dr. Pamerla is a hospitalist at Wilson Medical Center, Wilson, N.C.
References
1. Educational Commission for Foreign Medical Graduates; ECFMG 2015 Annual Report. April 2016 http://www.ecfmg.org/resources/ECFMG-2015-annual-report.pdf.
2. Pinsky WW. The Importance of International Medical Graduates in the United States. Ann Intern Med. 2017. doi: 10.7326/M17-0505.
3. Hart LG, Skillman SM, Fordyce M, et al. International medical graduate physicians in the United States: changes since 1981. Health Aff. 2007 July/August;26(4):1159-69.
4. Goodfellow A1, Ulloa JG, Dowling PT, et al. Predictors of Primary Care Physician Practice Location in Underserved Urban or Rural Areas in the United States: A Systematic Literature Review. Acad Med. 2016 Sep;91(9):1313-21.
5. https://www.uscis.gov/working-united-states/temporary-workers/h-1b-specialty-occupations-and-fashion-models/h-1b-fiscal-year-fy-2018-cap-season#count
6. https://www.graphiq.com/vlp/bCIqXCpVqF7
7. http://www.myvisajobs.com/Reports/2017-H1B-Visa-Category.aspx?T=JT&P=2
8. Steven M Harris: http://www.the-hospitalist.org/hospitalist/article/125455/appropriate-patient-census-hospital-medicines-holy-grail
9. Tsugawa Y, Jena AB, Orav EJ, Jha AK. Quality of care delivered by general internists in US hospitals who graduated from foreign versus US medical schools: observational study. BMJ. 2017;356:j273.
10. https://www.propublica.org/article/cleveland-clinic-doctor-forced-to-leave-country-after-trump-order
11. http://www.houstonchronicle.com/news/houston-texas/houston/article/Houston-immigrant-doctors-given-24-hours-to-leave-11040259.php
International medical graduates (IMGs) have been playing a crucial role in clinician staffing needs for U.S. hospitals, especially in hospital medicine and internal medicine. According to a study, IMGs comprise 25% of the total U.S. physician workforce and 36% of internists.1,2 According to data from the 2008 Today’s Hospitalist Compensation & Career Survey, 32% of practicing hospitalists are IMGs.3
Many IMGs come to work in the U.S. via one of three paths. Just like all roads lead to Rome, all visas lead to a permanent residency pathway, eventually based on the country of origin and number of years waiting. The first path is a green card – cases where IMGs were on a visa and within a certain amount of time they received a green card. The second path is J-1 visa waivers for physicians who trained in the U.S. under a J-1 Visa. Typically, physicians on J-1 Visa waivers need to provide their services for a minimum of 3 years working in underserved areas – where there’s a shortage of health professionals – before they can apply for permanent residency.
The third and most popular path is the H-1B visa, which hospitalists traditionally use as a springboard to apply for permanent residency. Studies have shown that IMGs are more likely to practice medicine in rural and underserved areas. In many instances, physicians end up working in these areas for long periods of time.4
The Department of Homeland Security has considered creating another visa pathway for the technology industry, whereby an alien graduating from a U.S. university with an advanced degree in a STEM (Science, Technology, Engineering, and Math) course of study would receive a new visa and pathway to permanent residency. We believe hospitalists and other physicians should also have an expedited pathway to permanent residency. This step benefits both the U.S. health care system and hospitalists in many ways. It increases hospitalists’ portability and flexibility with schedules. With a traditional H-1B visa, hospitalists are bound to work with the one hospital/system that sponsors the H-1B, and would not be able to work at any other hospital without another extension/addendum to current visa status, even in cases where a physician had time off and would like to offer services at another facility. It is a well-known fact that hospitalist teams are understaffed and try to bring on per-diem staff to fill holes in schedules. The majority of hospitalists are working week-on/week-off schedules, and with an expedited pathway to a green card they would be able to work in different hospitals. They would also be able to move to remote places, or “doctor deserts,” and offer their services, helping to ensure the quality and safety of patient care to which all Americans are entitled.
In 2016 alone, around 1,500 H-1B visas were filed for hospitalist physicians.7 Each hospitalist has an average of 15 patient encounters per day, and for 1,500 physicians that amounts to about 4 million patient encounters annually.8 These data account for only new 2016 visa-holding physicians, and do not account for already approved or renewed visas. It would be very challenging to count the number of patient encounters by hospitalists who are on a visa, but 1 billion patient encounters is not overestimating. Recent studies show that quality of care provided by IMGs is not inferior to that of U.S. medical graduates. The study showed that patients cared for by IMGs have lesser mortality, compared with those cared by U.S. medical graduates.9
In this era of hospital medicine, hospitalists are focusing not only on clinical aspects of patient care but also on efficacy, quality of care, and patient safety and satisfaction, and they are working with the Centers for Medicare & Medicaid Services to develop cost-cutting programs to save billions of dollars in health care expenses. This is the primary reason a majority of hospitals are focused on developing a hospitalist track, and encouraging hospitalists to pursue leadership roles in managing hospitals effectively.
The U.S. health care system is starved for hospitalists and primary care physicians, and IMGs will continue to play a pivotal role. Yet IMGs must deal with shifting trends in immigration policy, and in some recent instances immigrant physicians have been asked to leave the U.S. because of immigration reforms.10,11 We would like the Society of Hospital Medicine to take a stand on behalf of IMG hospitalists and ask the U.S. Department of Labor and Homeland Security for an expedited permanent residency pathway for IMG hospitalists. We are certain that our request will get a fair hearing, as the former U.S. surgeon general was a hospitalist and, indeed, an immigrant.
Dr. Medarametla is medical director, Intermediate Care Unit, Baystate Medical Center, Springfield, Mass., and assistant professor of medicine, University of Massachusetts Medical School. Dr. Pamerla is a hospitalist at Wilson Medical Center, Wilson, N.C.
References
1. Educational Commission for Foreign Medical Graduates; ECFMG 2015 Annual Report. April 2016 http://www.ecfmg.org/resources/ECFMG-2015-annual-report.pdf.
2. Pinsky WW. The Importance of International Medical Graduates in the United States. Ann Intern Med. 2017. doi: 10.7326/M17-0505.
3. Hart LG, Skillman SM, Fordyce M, et al. International medical graduate physicians in the United States: changes since 1981. Health Aff. 2007 July/August;26(4):1159-69.
4. Goodfellow A1, Ulloa JG, Dowling PT, et al. Predictors of Primary Care Physician Practice Location in Underserved Urban or Rural Areas in the United States: A Systematic Literature Review. Acad Med. 2016 Sep;91(9):1313-21.
5. https://www.uscis.gov/working-united-states/temporary-workers/h-1b-specialty-occupations-and-fashion-models/h-1b-fiscal-year-fy-2018-cap-season#count
6. https://www.graphiq.com/vlp/bCIqXCpVqF7
7. http://www.myvisajobs.com/Reports/2017-H1B-Visa-Category.aspx?T=JT&P=2
8. Steven M Harris: http://www.the-hospitalist.org/hospitalist/article/125455/appropriate-patient-census-hospital-medicines-holy-grail
9. Tsugawa Y, Jena AB, Orav EJ, Jha AK. Quality of care delivered by general internists in US hospitals who graduated from foreign versus US medical schools: observational study. BMJ. 2017;356:j273.
10. https://www.propublica.org/article/cleveland-clinic-doctor-forced-to-leave-country-after-trump-order
11. http://www.houstonchronicle.com/news/houston-texas/houston/article/Houston-immigrant-doctors-given-24-hours-to-leave-11040259.php
Be alert for embezzlement
I can almost hear you saying it now: “Here’s a column I can skip! Embezzlement has never been a problem in this office.” Unfortunately, theft from within is way more common in medical offices than most of us suppose – and it often occurs in full view of physicians who are convinced that it cannot happen to them. Most embezzlers are not particularly skillful, nor very good at covering their tracks. But their transgressions can go undetected for years, simply because no one is watching.
A friend’s experience was all too typical: His bookkeeper wrote sizable checks to herself, disguising them in the ledger as payments to vendors commonly used by his practice. Since she also balanced the checkbook, she got away with it for a long time. “It wasn’t at all clever,” he told me, “and I’m embarrassed to admit that it happened to me.” Is it happening to you, too? You won’t know unless you look.
Detecting fraud is an inexact science; there is no textbook approach that one can follow, but a few simple measures will uncover or prevent a large percentage of dishonest behavior:
• Hire honest employees. Check applicants’ references; find out if they are really as good as they look on paper. And for a few dollars, you can screen prospective employees on one of several public information websites to see if they have a criminal record, or have been sued (or are suing others). My columns on hiring and background checks can be found at http://www.mdedge.com/edermatologynews/managing-your-practice.
• Minimize opportunities for dishonesty. Theft and embezzlement are usually products of opportunity; there are many ways to minimize those opportunities. No one person should be in charge of the entire bookkeeping process. The person who enters charges should be different from the one who enters payments. The employee who writes the checks should not balance the checkbook, and so on. Internal audits should be done on a regular basis, and all employees should know that. Your accountant can help with this.
• Reconcile receipts and cash daily. The most common form of embezzlement is simply taking cash out of the till. In a typical scenario, a patient pays a $15 copay in cash; the receptionist records the payment as $5 and pockets the rest. Make sure a receipt is generated for every cash transaction, and that someone other than the person accepting cash reconciles the receipts and the cash daily.
• Insist on separate accounting duties. Another common scam – the one to which my friend fell victim – is false invoices: You think you are paying for supplies and services, but the money is going to an employee. Once again, separation of duties is the key to prevention. One employee should enter invoices into the data system, another should issue the check or make the electronic transfer, and a third should match invoices to goods and services received.
• Verify expense reports. False expense reports are another common form of fraud. When an employee asks for reimbursement of expenses, make sure they are real.
• Safeguard your computers. A major downside of computerization is the facilitation of embezzlement. Data are usually concentrated in one place, accounts can be accessed from remote workstations or off-premises servers, and a paper trail is often eliminated. Your computer vendor should be aware of this, and should have safeguards built into your system. Ask about them. If they aren’t there, ask why.
• Look for “red flags.” Do you have an employee who refuses to take vacations, because someone else will have to look at the books? Does someone insist on approving or entering expenses that are another employee’s responsibility, “just to be nice”? Is an employee suddenly living beyond his or her means?
• Consider bonding your employees. Dishonesty bonds are relatively inexpensive, and you will be assured of some measure of recovery should your safeguards fail. In addition, the mere knowledge that your staff is bonded will frighten off many dishonest applicants.
• Keep in mind that office personnel are not the only ones susceptible to temptation. A colleague recently told me about a per diem physician in his employ who conspired with a receptionist to keep fees collected for cosmetic neurotoxin and filler procedures “off the books,” then split the proceeds among themselves.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected]
I can almost hear you saying it now: “Here’s a column I can skip! Embezzlement has never been a problem in this office.” Unfortunately, theft from within is way more common in medical offices than most of us suppose – and it often occurs in full view of physicians who are convinced that it cannot happen to them. Most embezzlers are not particularly skillful, nor very good at covering their tracks. But their transgressions can go undetected for years, simply because no one is watching.
A friend’s experience was all too typical: His bookkeeper wrote sizable checks to herself, disguising them in the ledger as payments to vendors commonly used by his practice. Since she also balanced the checkbook, she got away with it for a long time. “It wasn’t at all clever,” he told me, “and I’m embarrassed to admit that it happened to me.” Is it happening to you, too? You won’t know unless you look.
Detecting fraud is an inexact science; there is no textbook approach that one can follow, but a few simple measures will uncover or prevent a large percentage of dishonest behavior:
• Hire honest employees. Check applicants’ references; find out if they are really as good as they look on paper. And for a few dollars, you can screen prospective employees on one of several public information websites to see if they have a criminal record, or have been sued (or are suing others). My columns on hiring and background checks can be found at http://www.mdedge.com/edermatologynews/managing-your-practice.
• Minimize opportunities for dishonesty. Theft and embezzlement are usually products of opportunity; there are many ways to minimize those opportunities. No one person should be in charge of the entire bookkeeping process. The person who enters charges should be different from the one who enters payments. The employee who writes the checks should not balance the checkbook, and so on. Internal audits should be done on a regular basis, and all employees should know that. Your accountant can help with this.
• Reconcile receipts and cash daily. The most common form of embezzlement is simply taking cash out of the till. In a typical scenario, a patient pays a $15 copay in cash; the receptionist records the payment as $5 and pockets the rest. Make sure a receipt is generated for every cash transaction, and that someone other than the person accepting cash reconciles the receipts and the cash daily.
• Insist on separate accounting duties. Another common scam – the one to which my friend fell victim – is false invoices: You think you are paying for supplies and services, but the money is going to an employee. Once again, separation of duties is the key to prevention. One employee should enter invoices into the data system, another should issue the check or make the electronic transfer, and a third should match invoices to goods and services received.
• Verify expense reports. False expense reports are another common form of fraud. When an employee asks for reimbursement of expenses, make sure they are real.
• Safeguard your computers. A major downside of computerization is the facilitation of embezzlement. Data are usually concentrated in one place, accounts can be accessed from remote workstations or off-premises servers, and a paper trail is often eliminated. Your computer vendor should be aware of this, and should have safeguards built into your system. Ask about them. If they aren’t there, ask why.
• Look for “red flags.” Do you have an employee who refuses to take vacations, because someone else will have to look at the books? Does someone insist on approving or entering expenses that are another employee’s responsibility, “just to be nice”? Is an employee suddenly living beyond his or her means?
• Consider bonding your employees. Dishonesty bonds are relatively inexpensive, and you will be assured of some measure of recovery should your safeguards fail. In addition, the mere knowledge that your staff is bonded will frighten off many dishonest applicants.
• Keep in mind that office personnel are not the only ones susceptible to temptation. A colleague recently told me about a per diem physician in his employ who conspired with a receptionist to keep fees collected for cosmetic neurotoxin and filler procedures “off the books,” then split the proceeds among themselves.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected]
I can almost hear you saying it now: “Here’s a column I can skip! Embezzlement has never been a problem in this office.” Unfortunately, theft from within is way more common in medical offices than most of us suppose – and it often occurs in full view of physicians who are convinced that it cannot happen to them. Most embezzlers are not particularly skillful, nor very good at covering their tracks. But their transgressions can go undetected for years, simply because no one is watching.
A friend’s experience was all too typical: His bookkeeper wrote sizable checks to herself, disguising them in the ledger as payments to vendors commonly used by his practice. Since she also balanced the checkbook, she got away with it for a long time. “It wasn’t at all clever,” he told me, “and I’m embarrassed to admit that it happened to me.” Is it happening to you, too? You won’t know unless you look.
Detecting fraud is an inexact science; there is no textbook approach that one can follow, but a few simple measures will uncover or prevent a large percentage of dishonest behavior:
• Hire honest employees. Check applicants’ references; find out if they are really as good as they look on paper. And for a few dollars, you can screen prospective employees on one of several public information websites to see if they have a criminal record, or have been sued (or are suing others). My columns on hiring and background checks can be found at http://www.mdedge.com/edermatologynews/managing-your-practice.
• Minimize opportunities for dishonesty. Theft and embezzlement are usually products of opportunity; there are many ways to minimize those opportunities. No one person should be in charge of the entire bookkeeping process. The person who enters charges should be different from the one who enters payments. The employee who writes the checks should not balance the checkbook, and so on. Internal audits should be done on a regular basis, and all employees should know that. Your accountant can help with this.
• Reconcile receipts and cash daily. The most common form of embezzlement is simply taking cash out of the till. In a typical scenario, a patient pays a $15 copay in cash; the receptionist records the payment as $5 and pockets the rest. Make sure a receipt is generated for every cash transaction, and that someone other than the person accepting cash reconciles the receipts and the cash daily.
• Insist on separate accounting duties. Another common scam – the one to which my friend fell victim – is false invoices: You think you are paying for supplies and services, but the money is going to an employee. Once again, separation of duties is the key to prevention. One employee should enter invoices into the data system, another should issue the check or make the electronic transfer, and a third should match invoices to goods and services received.
• Verify expense reports. False expense reports are another common form of fraud. When an employee asks for reimbursement of expenses, make sure they are real.
• Safeguard your computers. A major downside of computerization is the facilitation of embezzlement. Data are usually concentrated in one place, accounts can be accessed from remote workstations or off-premises servers, and a paper trail is often eliminated. Your computer vendor should be aware of this, and should have safeguards built into your system. Ask about them. If they aren’t there, ask why.
• Look for “red flags.” Do you have an employee who refuses to take vacations, because someone else will have to look at the books? Does someone insist on approving or entering expenses that are another employee’s responsibility, “just to be nice”? Is an employee suddenly living beyond his or her means?
• Consider bonding your employees. Dishonesty bonds are relatively inexpensive, and you will be assured of some measure of recovery should your safeguards fail. In addition, the mere knowledge that your staff is bonded will frighten off many dishonest applicants.
• Keep in mind that office personnel are not the only ones susceptible to temptation. A colleague recently told me about a per diem physician in his employ who conspired with a receptionist to keep fees collected for cosmetic neurotoxin and filler procedures “off the books,” then split the proceeds among themselves.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected]
Calculating the Risk of Parkinson-Related Cognitive Deficits
Currently, treatments for Parkinson disease are only effective in improving motor deficits. But the loss of cognitive abilities is just as devastating. About 25% of patients also experience cognitive deficits that impair function. One problem in developing treatments, however, is that patients with cognitive effects vary widely. Being able to predict the chance that someone with Parkinson disease will develop cognitive deficits could be a useful tool, say researchers from Brigham and Women’s Hospital in Boston, Massachusetts, who conducted a study partly funded by the National Institute Neurological Disorders and Stroke. They think they might have created just the tool: a computer-based risk calculator.
The researchers combined data from 3,200 patients with Parkinson disease, representing more than 25,000 individual clinical assessments. They evaluated 7 known clinical and genetic risk factors associated with developing dementia, then used the information to build the risk calculator.
“By allowing clinical researchers to identify and select only patients at high risk for developing dementia, this tool could help in the design of ‘smarter’ trials that require a manageable number of participating patients,” said Clemens Scherzer, MD, the lead investigator.
By improving clinical trial design, the risk calculator could first help in the discovery of new treatments, the researchers say, then help determine which patients would benefit most from those treatments. “Prediction is the first step,” said Dr. Scherzer. “Prevention is the ultimate goal, preventing a dismal prognosis from ever happening.”
Currently, treatments for Parkinson disease are only effective in improving motor deficits. But the loss of cognitive abilities is just as devastating. About 25% of patients also experience cognitive deficits that impair function. One problem in developing treatments, however, is that patients with cognitive effects vary widely. Being able to predict the chance that someone with Parkinson disease will develop cognitive deficits could be a useful tool, say researchers from Brigham and Women’s Hospital in Boston, Massachusetts, who conducted a study partly funded by the National Institute Neurological Disorders and Stroke. They think they might have created just the tool: a computer-based risk calculator.
The researchers combined data from 3,200 patients with Parkinson disease, representing more than 25,000 individual clinical assessments. They evaluated 7 known clinical and genetic risk factors associated with developing dementia, then used the information to build the risk calculator.
“By allowing clinical researchers to identify and select only patients at high risk for developing dementia, this tool could help in the design of ‘smarter’ trials that require a manageable number of participating patients,” said Clemens Scherzer, MD, the lead investigator.
By improving clinical trial design, the risk calculator could first help in the discovery of new treatments, the researchers say, then help determine which patients would benefit most from those treatments. “Prediction is the first step,” said Dr. Scherzer. “Prevention is the ultimate goal, preventing a dismal prognosis from ever happening.”
Currently, treatments for Parkinson disease are only effective in improving motor deficits. But the loss of cognitive abilities is just as devastating. About 25% of patients also experience cognitive deficits that impair function. One problem in developing treatments, however, is that patients with cognitive effects vary widely. Being able to predict the chance that someone with Parkinson disease will develop cognitive deficits could be a useful tool, say researchers from Brigham and Women’s Hospital in Boston, Massachusetts, who conducted a study partly funded by the National Institute Neurological Disorders and Stroke. They think they might have created just the tool: a computer-based risk calculator.
The researchers combined data from 3,200 patients with Parkinson disease, representing more than 25,000 individual clinical assessments. They evaluated 7 known clinical and genetic risk factors associated with developing dementia, then used the information to build the risk calculator.
“By allowing clinical researchers to identify and select only patients at high risk for developing dementia, this tool could help in the design of ‘smarter’ trials that require a manageable number of participating patients,” said Clemens Scherzer, MD, the lead investigator.
By improving clinical trial design, the risk calculator could first help in the discovery of new treatments, the researchers say, then help determine which patients would benefit most from those treatments. “Prediction is the first step,” said Dr. Scherzer. “Prevention is the ultimate goal, preventing a dismal prognosis from ever happening.”
Lenalidomide maintenance prolongs PFS, OS in MM
Lenalidomide maintenance can be considered a standard of care for multiple myeloma (MM) patients who have undergone hematopoietic stem cell transplant (HSCT), according to researchers.
A meta-analysis of data from 3 trials showed that lenalidomide maintenance extended both progression-free survival (PFS) and overall survival (OS) in these patients.
Philip L. McCarthy, MD, of Roswell Park Cancer Institute in Buffalo, New York, and his colleagues reported results of the analysis in the Journal of Clinical Oncology.
The researchers analyzed data from 3 large, randomized trials conducted in the US, France, and Italy. The studies included patients with newly diagnosed MM who underwent autologous HSCT and then received continuous lenalidomide (n=605) or no maintenance/placebo (n=603).
Patient demographics and disease-related characteristics were generally balanced between the treatment groups.
The mean duration of maintenance was 28 months (range, 0-108) in the lenalidomide group and 22 months (range, 0-86) in the control group.
Fewer patients in the lenalidomide group (52.6%) started second-line anti-MM therapy than patients in the control group (70.8%). And the time to second-line anti-MM treatment was longer with lenalidomide than with control (hazard ratio [HR]=0.57; 95% CI, 0.49 to 0.66).
PFS and OS
Patients who received lenalidomide maintenance had significantly longer PFS and OS than patients in the control group.
The median PFS was 52.8 months and 23.5 months, respectively (HR=0.48; 95% CI, 0.41 to 0.55).
The median OS was not reached in the lenalidomide group and was 86.0 months in the control group (HR=0.75; 95% CI, 0.63 to 0.90; P=0.001),
At a median follow-up of 79.5 months, the OS rate was 64% in the lenalidomide group and 54% in the control group. The 7-year OS rates were 62% and 50%, respectively.
Safety
Safety data were not available for the Italian study. In the other 2 studies, 29.1% of patients in the lenalidomide group had treatment-emergent adverse events that led to discontinuation, as did 12.2% of patients in the control group.
Treatment-emergent adverse events leading to treatment discontinuation (in the lenalidomide and control groups, respectively) included neutropenia (2.3% vs 0.2%), thrombocytopenia (1.7% vs 1.1%), general disorders and administration site conditions (4.7% vs 1.5%), neoplasms (4.3% vs 1.0%), skin and subcutaneous tissue disorders (3.4% vs 1.9%), nervous system disorders (3.4% vs 1.7%), gastrointestinal disorders (3.4% vs 0.2%), infections and infestations (1.7% vs 0.8%), and musculoskeletal and connective tissue disorders (1.1% and 1.3%).
There was a higher frequency of second primary malignancies (SPMs) in the lenalidomide group than in the control group.
The incidence of hematologic SPMs occurring before disease progression was 5.3% and 0.8%, respectively. The incidence before and after progression was 6.1% and 2.8%, respectively.
The incidence of solid tumor SPMs occurring before disease progression was 5.8% and 2.0%, respectively. The incidence before and after progression was 7.3% and 4.2%, respectively.
“With this complete and mature data from 3 large, multinational studies, we now have clear evidence that ongoing treatment with lenalidomide can prevent disease progression and extend survival in patients with multiple myeloma who’ve received a stem cell transplant,” Dr McCarthy said.
“All the investigators wish to express enormous gratitude to the patients who took part in these trials. Many others will benefit from their role in this research.” 
Lenalidomide maintenance can be considered a standard of care for multiple myeloma (MM) patients who have undergone hematopoietic stem cell transplant (HSCT), according to researchers.
A meta-analysis of data from 3 trials showed that lenalidomide maintenance extended both progression-free survival (PFS) and overall survival (OS) in these patients.
Philip L. McCarthy, MD, of Roswell Park Cancer Institute in Buffalo, New York, and his colleagues reported results of the analysis in the Journal of Clinical Oncology.
The researchers analyzed data from 3 large, randomized trials conducted in the US, France, and Italy. The studies included patients with newly diagnosed MM who underwent autologous HSCT and then received continuous lenalidomide (n=605) or no maintenance/placebo (n=603).
Patient demographics and disease-related characteristics were generally balanced between the treatment groups.
The mean duration of maintenance was 28 months (range, 0-108) in the lenalidomide group and 22 months (range, 0-86) in the control group.
Fewer patients in the lenalidomide group (52.6%) started second-line anti-MM therapy than patients in the control group (70.8%). And the time to second-line anti-MM treatment was longer with lenalidomide than with control (hazard ratio [HR]=0.57; 95% CI, 0.49 to 0.66).
PFS and OS
Patients who received lenalidomide maintenance had significantly longer PFS and OS than patients in the control group.
The median PFS was 52.8 months and 23.5 months, respectively (HR=0.48; 95% CI, 0.41 to 0.55).
The median OS was not reached in the lenalidomide group and was 86.0 months in the control group (HR=0.75; 95% CI, 0.63 to 0.90; P=0.001),
At a median follow-up of 79.5 months, the OS rate was 64% in the lenalidomide group and 54% in the control group. The 7-year OS rates were 62% and 50%, respectively.
Safety
Safety data were not available for the Italian study. In the other 2 studies, 29.1% of patients in the lenalidomide group had treatment-emergent adverse events that led to discontinuation, as did 12.2% of patients in the control group.
Treatment-emergent adverse events leading to treatment discontinuation (in the lenalidomide and control groups, respectively) included neutropenia (2.3% vs 0.2%), thrombocytopenia (1.7% vs 1.1%), general disorders and administration site conditions (4.7% vs 1.5%), neoplasms (4.3% vs 1.0%), skin and subcutaneous tissue disorders (3.4% vs 1.9%), nervous system disorders (3.4% vs 1.7%), gastrointestinal disorders (3.4% vs 0.2%), infections and infestations (1.7% vs 0.8%), and musculoskeletal and connective tissue disorders (1.1% and 1.3%).
There was a higher frequency of second primary malignancies (SPMs) in the lenalidomide group than in the control group.
The incidence of hematologic SPMs occurring before disease progression was 5.3% and 0.8%, respectively. The incidence before and after progression was 6.1% and 2.8%, respectively.
The incidence of solid tumor SPMs occurring before disease progression was 5.8% and 2.0%, respectively. The incidence before and after progression was 7.3% and 4.2%, respectively.
“With this complete and mature data from 3 large, multinational studies, we now have clear evidence that ongoing treatment with lenalidomide can prevent disease progression and extend survival in patients with multiple myeloma who’ve received a stem cell transplant,” Dr McCarthy said.
“All the investigators wish to express enormous gratitude to the patients who took part in these trials. Many others will benefit from their role in this research.”
Lenalidomide maintenance can be considered a standard of care for multiple myeloma (MM) patients who have undergone hematopoietic stem cell transplant (HSCT), according to researchers.
A meta-analysis of data from 3 trials showed that lenalidomide maintenance extended both progression-free survival (PFS) and overall survival (OS) in these patients.
Philip L. McCarthy, MD, of Roswell Park Cancer Institute in Buffalo, New York, and his colleagues reported results of the analysis in the Journal of Clinical Oncology.
The researchers analyzed data from 3 large, randomized trials conducted in the US, France, and Italy. The studies included patients with newly diagnosed MM who underwent autologous HSCT and then received continuous lenalidomide (n=605) or no maintenance/placebo (n=603).
Patient demographics and disease-related characteristics were generally balanced between the treatment groups.
The mean duration of maintenance was 28 months (range, 0-108) in the lenalidomide group and 22 months (range, 0-86) in the control group.
Fewer patients in the lenalidomide group (52.6%) started second-line anti-MM therapy than patients in the control group (70.8%). And the time to second-line anti-MM treatment was longer with lenalidomide than with control (hazard ratio [HR]=0.57; 95% CI, 0.49 to 0.66).
PFS and OS
Patients who received lenalidomide maintenance had significantly longer PFS and OS than patients in the control group.
The median PFS was 52.8 months and 23.5 months, respectively (HR=0.48; 95% CI, 0.41 to 0.55).
The median OS was not reached in the lenalidomide group and was 86.0 months in the control group (HR=0.75; 95% CI, 0.63 to 0.90; P=0.001),
At a median follow-up of 79.5 months, the OS rate was 64% in the lenalidomide group and 54% in the control group. The 7-year OS rates were 62% and 50%, respectively.
Safety
Safety data were not available for the Italian study. In the other 2 studies, 29.1% of patients in the lenalidomide group had treatment-emergent adverse events that led to discontinuation, as did 12.2% of patients in the control group.
Treatment-emergent adverse events leading to treatment discontinuation (in the lenalidomide and control groups, respectively) included neutropenia (2.3% vs 0.2%), thrombocytopenia (1.7% vs 1.1%), general disorders and administration site conditions (4.7% vs 1.5%), neoplasms (4.3% vs 1.0%), skin and subcutaneous tissue disorders (3.4% vs 1.9%), nervous system disorders (3.4% vs 1.7%), gastrointestinal disorders (3.4% vs 0.2%), infections and infestations (1.7% vs 0.8%), and musculoskeletal and connective tissue disorders (1.1% and 1.3%).
There was a higher frequency of second primary malignancies (SPMs) in the lenalidomide group than in the control group.
The incidence of hematologic SPMs occurring before disease progression was 5.3% and 0.8%, respectively. The incidence before and after progression was 6.1% and 2.8%, respectively.
The incidence of solid tumor SPMs occurring before disease progression was 5.8% and 2.0%, respectively. The incidence before and after progression was 7.3% and 4.2%, respectively.
“With this complete and mature data from 3 large, multinational studies, we now have clear evidence that ongoing treatment with lenalidomide can prevent disease progression and extend survival in patients with multiple myeloma who’ve received a stem cell transplant,” Dr McCarthy said.
“All the investigators wish to express enormous gratitude to the patients who took part in these trials. Many others will benefit from their role in this research.”