The Centers for Disease Control and Prevention has launched a program aimed at helping states combat and prevent opioid drug overdoses.

The Prescription Drug Overdose: Prevention for States program will be launching in 16 states chosen in a competitive application process. The CDC is committing $20 million in fiscal year 2015, and each state will receive $750,000 to $1 million each year for the next 4 years to advance prevention in several areas, such as enhancing prescription drug–monitoring programs, putting prevention into action in communities nationwide, and investigating the connection between prescription opioid abuse and heroin use, the CDC said in a press release.

In 2013, 16,000 people died from prescription opioid overdoses, four times more than in 1999, with prescription of opioids increasing at the same rate over the same time. Despite more opioids being prescribed, the amount of pain Americans report has not changed. In addition, heroin deaths also have spiked, with the 8,000 heroin overdose deaths nearly three times as many as in 2010.

“The prescription drug overdose epidemic requires a multifaceted approach, and states are key partners in our efforts on the front lines to prevent overdose deaths. With this funding, states can improve their ability to track the problem, work with insurers to help providers make informed prescribing decisions, and take action to combat this epidemic,” U.S. Department of Health & Human Services Secretary Sylvia M. Burwell said in the release.

Find the full CDC press release here.

[email protected]

The Centers for Disease Control and Prevention has launched a program aimed at helping states combat and prevent opioid drug overdoses.

The Prescription Drug Overdose: Prevention for States program will be launching in 16 states chosen in a competitive application process. The CDC is committing $20 million in fiscal year 2015, and each state will receive $750,000 to $1 million each year for the next 4 years to advance prevention in several areas, such as enhancing prescription drug–monitoring programs, putting prevention into action in communities nationwide, and investigating the connection between prescription opioid abuse and heroin use, the CDC said in a press release.

In 2013, 16,000 people died from prescription opioid overdoses, four times more than in 1999, with prescription of opioids increasing at the same rate over the same time. Despite more opioids being prescribed, the amount of pain Americans report has not changed. In addition, heroin deaths also have spiked, with the 8,000 heroin overdose deaths nearly three times as many as in 2010.

“The prescription drug overdose epidemic requires a multifaceted approach, and states are key partners in our efforts on the front lines to prevent overdose deaths. With this funding, states can improve their ability to track the problem, work with insurers to help providers make informed prescribing decisions, and take action to combat this epidemic,” U.S. Department of Health & Human Services Secretary Sylvia M. Burwell said in the release.

Find the full CDC press release here.

[email protected]

The Centers for Disease Control and Prevention has launched a program aimed at helping states combat and prevent opioid drug overdoses.

The Prescription Drug Overdose: Prevention for States program will be launching in 16 states chosen in a competitive application process. The CDC is committing $20 million in fiscal year 2015, and each state will receive $750,000 to $1 million each year for the next 4 years to advance prevention in several areas, such as enhancing prescription drug–monitoring programs, putting prevention into action in communities nationwide, and investigating the connection between prescription opioid abuse and heroin use, the CDC said in a press release.

In 2013, 16,000 people died from prescription opioid overdoses, four times more than in 1999, with prescription of opioids increasing at the same rate over the same time. Despite more opioids being prescribed, the amount of pain Americans report has not changed. In addition, heroin deaths also have spiked, with the 8,000 heroin overdose deaths nearly three times as many as in 2010.

“The prescription drug overdose epidemic requires a multifaceted approach, and states are key partners in our efforts on the front lines to prevent overdose deaths. With this funding, states can improve their ability to track the problem, work with insurers to help providers make informed prescribing decisions, and take action to combat this epidemic,” U.S. Department of Health & Human Services Secretary Sylvia M. Burwell said in the release.

Find the full CDC press release here.

[email protected]

Panobinostat (Farydak)

Photo courtesy of Novartis

The European Commission has approved panobinostat (Farydak) for use in combination with other agents to treat patients with relapsed and/or refractory

multiple myeloma (MM).

The histone deacetylase (HDAC) inhibitor is now approved, in combination with bortezomib and dexamethasone, to treat adults with MM who have received at least 2 prior treatment regimens, including bortezomib and an immunomodulatory agent (IMiD).

The approval marks the first time an HDAC inhibitor with epigenetic activity is available in the European Union (EU). The approval applies to all 28 EU member states plus Iceland, Norway, and Liechtenstein.

The European Commission approved panobinostat based on results of a subgroup analysis of 147 patients in the phase 3 PANORAMA-1 trial.

PANORAMA-1 was a randomized, double-blind, placebo-controlled trial of 768 MM patients. The study showed that, overall, panobinostat plus bortezomib and dexamethasone increased progression-free survival (PFS) by about 4 months when compared to placebo plus bortezomib and dexamethasone.

Full results of the PANORAMA-1 study were published in The Lancet Oncology last year.  Results from the substudy of 147 patients were presented at ASCO 2015.

The 147 patients had relapsed or relapsed and refractory MM and had received 2 or more prior regimens, including bortezomib and an IMiD.

The median PFS benefit in this subgroup increased by 7.8 months in the panobinostat arm compared to the placebo arm. The median PFS was 12.5 months (n=73) and 4.7 months (n=74), respectively (hazard ratio=0.47).

Common grade 3/4 non-hematologic adverse events in the panobinostat arm and placebo arm, respectively, included diarrhea (33.3% vs 15.1%), asthenia/fatigue (26.4% vs 13.7%), and peripheral neuropathy (16.7% vs 6.8%).

The most common grade 3/4 hematologic events in the panobinostat arm and placebo arm, respectively, were thrombocytopenia (68.1% vs 44.4%), lymphopenia (48.6% vs 49.3%), and neutropenia (40.3% vs 16.4%).

Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation, and sinus tachycardia) were reported in 17.6% of panobinostat-treated patients and 9.8% of placebo-treated patients. Syncope was reported in 6.0% and 2.4%, respectively.

The percentage of on-treatment deaths was similar in the panobinostat and placebo arms—6.9% and 6.8%, respectively. But on-treatment deaths not due to the study indication (MM) were reported in 6.8% and 3.2% of patients, respectively.

Panobinostat in combination with bortezomib and dexamethasone is also approved in the US, Chile, and Japan for certain patients with previously treated MM. The exact indication for panobinostat varies by country.

Panobinostat (Farydak)

Photo courtesy of Novartis

The European Commission has approved panobinostat (Farydak) for use in combination with other agents to treat patients with relapsed and/or refractory

multiple myeloma (MM).

The histone deacetylase (HDAC) inhibitor is now approved, in combination with bortezomib and dexamethasone, to treat adults with MM who have received at least 2 prior treatment regimens, including bortezomib and an immunomodulatory agent (IMiD).

The approval marks the first time an HDAC inhibitor with epigenetic activity is available in the European Union (EU). The approval applies to all 28 EU member states plus Iceland, Norway, and Liechtenstein.

The European Commission approved panobinostat based on results of a subgroup analysis of 147 patients in the phase 3 PANORAMA-1 trial.

PANORAMA-1 was a randomized, double-blind, placebo-controlled trial of 768 MM patients. The study showed that, overall, panobinostat plus bortezomib and dexamethasone increased progression-free survival (PFS) by about 4 months when compared to placebo plus bortezomib and dexamethasone.

Full results of the PANORAMA-1 study were published in The Lancet Oncology last year.  Results from the substudy of 147 patients were presented at ASCO 2015.

The 147 patients had relapsed or relapsed and refractory MM and had received 2 or more prior regimens, including bortezomib and an IMiD.

The median PFS benefit in this subgroup increased by 7.8 months in the panobinostat arm compared to the placebo arm. The median PFS was 12.5 months (n=73) and 4.7 months (n=74), respectively (hazard ratio=0.47).

Common grade 3/4 non-hematologic adverse events in the panobinostat arm and placebo arm, respectively, included diarrhea (33.3% vs 15.1%), asthenia/fatigue (26.4% vs 13.7%), and peripheral neuropathy (16.7% vs 6.8%).

The most common grade 3/4 hematologic events in the panobinostat arm and placebo arm, respectively, were thrombocytopenia (68.1% vs 44.4%), lymphopenia (48.6% vs 49.3%), and neutropenia (40.3% vs 16.4%).

Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation, and sinus tachycardia) were reported in 17.6% of panobinostat-treated patients and 9.8% of placebo-treated patients. Syncope was reported in 6.0% and 2.4%, respectively.

The percentage of on-treatment deaths was similar in the panobinostat and placebo arms—6.9% and 6.8%, respectively. But on-treatment deaths not due to the study indication (MM) were reported in 6.8% and 3.2% of patients, respectively.

Panobinostat in combination with bortezomib and dexamethasone is also approved in the US, Chile, and Japan for certain patients with previously treated MM. The exact indication for panobinostat varies by country.

Panobinostat (Farydak)

Photo courtesy of Novartis

The European Commission has approved panobinostat (Farydak) for use in combination with other agents to treat patients with relapsed and/or refractory

multiple myeloma (MM).

The histone deacetylase (HDAC) inhibitor is now approved, in combination with bortezomib and dexamethasone, to treat adults with MM who have received at least 2 prior treatment regimens, including bortezomib and an immunomodulatory agent (IMiD).

The approval marks the first time an HDAC inhibitor with epigenetic activity is available in the European Union (EU). The approval applies to all 28 EU member states plus Iceland, Norway, and Liechtenstein.

The European Commission approved panobinostat based on results of a subgroup analysis of 147 patients in the phase 3 PANORAMA-1 trial.

PANORAMA-1 was a randomized, double-blind, placebo-controlled trial of 768 MM patients. The study showed that, overall, panobinostat plus bortezomib and dexamethasone increased progression-free survival (PFS) by about 4 months when compared to placebo plus bortezomib and dexamethasone.

Full results of the PANORAMA-1 study were published in The Lancet Oncology last year.  Results from the substudy of 147 patients were presented at ASCO 2015.

The 147 patients had relapsed or relapsed and refractory MM and had received 2 or more prior regimens, including bortezomib and an IMiD.

The median PFS benefit in this subgroup increased by 7.8 months in the panobinostat arm compared to the placebo arm. The median PFS was 12.5 months (n=73) and 4.7 months (n=74), respectively (hazard ratio=0.47).

Common grade 3/4 non-hematologic adverse events in the panobinostat arm and placebo arm, respectively, included diarrhea (33.3% vs 15.1%), asthenia/fatigue (26.4% vs 13.7%), and peripheral neuropathy (16.7% vs 6.8%).

The most common grade 3/4 hematologic events in the panobinostat arm and placebo arm, respectively, were thrombocytopenia (68.1% vs 44.4%), lymphopenia (48.6% vs 49.3%), and neutropenia (40.3% vs 16.4%).

Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation, and sinus tachycardia) were reported in 17.6% of panobinostat-treated patients and 9.8% of placebo-treated patients. Syncope was reported in 6.0% and 2.4%, respectively.

The percentage of on-treatment deaths was similar in the panobinostat and placebo arms—6.9% and 6.8%, respectively. But on-treatment deaths not due to the study indication (MM) were reported in 6.8% and 3.2% of patients, respectively.

Panobinostat in combination with bortezomib and dexamethasone is also approved in the US, Chile, and Japan for certain patients with previously treated MM. The exact indication for panobinostat varies by country.

Thrombus

Image by Andre E.X. Brown

The US Food and Drug Administration (FDA) has expanded the approved use of the antiplatelet agent ticagrelor (Brilinta).

The FDA first approved ticagrelor in 2011 to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

Now, the agency has approved a 60 mg dose that can be used long-term. The 60 mg tablet is expected to be available in pharmacies by the end of this month.

The recommended dosing for ticagrelor is a loading dose of 180 mg, followed by 90 mg twice daily during the first year after the ACS event. The drug is combined with aspirin, typically at a loading dose of 325 mg, followed by a daily maintenance dose of 75-100 mg.

After 1 year, patients can now receive ticagrelor at 60 mg twice daily.

The expanded indication for ticagrelor has been approved under FDA Priority Review, a designation granted to medicines with the potential to provide significant improvements in the treatment, prevention, or diagnosis of a disease.

Ticagrelor has been approved in more than 100 countries and is included in 12 major ACS treatment guidelines globally. The drug is under development by AstraZeneca.

Trial results

The FDA’s expanded approval of ticagrelor is based on results of the PEGASUS TIMI-54 trial, a large-scale study involving more than 21,000 patients.

Investigators compared ticagrelor (at 60 mg or 90 mg) plus low-dose aspirin to placebo plus low-dose aspirin in patients who had experienced a heart attack 1 to 3 years prior to study enrollment.

The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. And the investigators found that patients in either ticagrelor arm were significantly less likely to achieve this endpoint.

At 3 years, the proportion of patients meeting the endpoint was 7.85% in the 90 mg group, 7.77% in the 60 mg group, and 9.04% in the placebo group (P=0.008 for 90 mg vs placebo and P=0.004 for 60 mg vs placebo).

Patients receiving ticagrelor also had a significantly higher incidence of major bleeding and dyspnea. The rate of TIMI major bleeding was 2.60% in the 90 mg group, 2.30% in the 60 mg group, and 1.06% in the placebo group (P<0.001 for each ticagrelor dose vs placebo).

The rate of dyspnea was 18.93% in the 90 mg group, 15.84% in 60 mg group, and 6.38% in the placebo group (P<0.001 for both comparisons). The rate of dyspnea leading to treatment discontinuation was 6.5% in the 90 mg group, 4.55% in the 60 mg group, and 0.79% in the placebo group (P<0.001 for both).

Thrombus

Image by Andre E.X. Brown

The US Food and Drug Administration (FDA) has expanded the approved use of the antiplatelet agent ticagrelor (Brilinta).

The FDA first approved ticagrelor in 2011 to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

Now, the agency has approved a 60 mg dose that can be used long-term. The 60 mg tablet is expected to be available in pharmacies by the end of this month.

The recommended dosing for ticagrelor is a loading dose of 180 mg, followed by 90 mg twice daily during the first year after the ACS event. The drug is combined with aspirin, typically at a loading dose of 325 mg, followed by a daily maintenance dose of 75-100 mg.

After 1 year, patients can now receive ticagrelor at 60 mg twice daily.

The expanded indication for ticagrelor has been approved under FDA Priority Review, a designation granted to medicines with the potential to provide significant improvements in the treatment, prevention, or diagnosis of a disease.

Ticagrelor has been approved in more than 100 countries and is included in 12 major ACS treatment guidelines globally. The drug is under development by AstraZeneca.

Trial results

The FDA’s expanded approval of ticagrelor is based on results of the PEGASUS TIMI-54 trial, a large-scale study involving more than 21,000 patients.

Investigators compared ticagrelor (at 60 mg or 90 mg) plus low-dose aspirin to placebo plus low-dose aspirin in patients who had experienced a heart attack 1 to 3 years prior to study enrollment.

The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. And the investigators found that patients in either ticagrelor arm were significantly less likely to achieve this endpoint.

At 3 years, the proportion of patients meeting the endpoint was 7.85% in the 90 mg group, 7.77% in the 60 mg group, and 9.04% in the placebo group (P=0.008 for 90 mg vs placebo and P=0.004 for 60 mg vs placebo).

Patients receiving ticagrelor also had a significantly higher incidence of major bleeding and dyspnea. The rate of TIMI major bleeding was 2.60% in the 90 mg group, 2.30% in the 60 mg group, and 1.06% in the placebo group (P<0.001 for each ticagrelor dose vs placebo).

The rate of dyspnea was 18.93% in the 90 mg group, 15.84% in 60 mg group, and 6.38% in the placebo group (P<0.001 for both comparisons). The rate of dyspnea leading to treatment discontinuation was 6.5% in the 90 mg group, 4.55% in the 60 mg group, and 0.79% in the placebo group (P<0.001 for both).

Thrombus

Image by Andre E.X. Brown

The US Food and Drug Administration (FDA) has expanded the approved use of the antiplatelet agent ticagrelor (Brilinta).

The FDA first approved ticagrelor in 2011 to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).

Now, the agency has approved a 60 mg dose that can be used long-term. The 60 mg tablet is expected to be available in pharmacies by the end of this month.

The recommended dosing for ticagrelor is a loading dose of 180 mg, followed by 90 mg twice daily during the first year after the ACS event. The drug is combined with aspirin, typically at a loading dose of 325 mg, followed by a daily maintenance dose of 75-100 mg.

After 1 year, patients can now receive ticagrelor at 60 mg twice daily.

The expanded indication for ticagrelor has been approved under FDA Priority Review, a designation granted to medicines with the potential to provide significant improvements in the treatment, prevention, or diagnosis of a disease.

Ticagrelor has been approved in more than 100 countries and is included in 12 major ACS treatment guidelines globally. The drug is under development by AstraZeneca.

Trial results

The FDA’s expanded approval of ticagrelor is based on results of the PEGASUS TIMI-54 trial, a large-scale study involving more than 21,000 patients.

Investigators compared ticagrelor (at 60 mg or 90 mg) plus low-dose aspirin to placebo plus low-dose aspirin in patients who had experienced a heart attack 1 to 3 years prior to study enrollment.

The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. And the investigators found that patients in either ticagrelor arm were significantly less likely to achieve this endpoint.

At 3 years, the proportion of patients meeting the endpoint was 7.85% in the 90 mg group, 7.77% in the 60 mg group, and 9.04% in the placebo group (P=0.008 for 90 mg vs placebo and P=0.004 for 60 mg vs placebo).

Patients receiving ticagrelor also had a significantly higher incidence of major bleeding and dyspnea. The rate of TIMI major bleeding was 2.60% in the 90 mg group, 2.30% in the 60 mg group, and 1.06% in the placebo group (P<0.001 for each ticagrelor dose vs placebo).

The rate of dyspnea was 18.93% in the 90 mg group, 15.84% in 60 mg group, and 6.38% in the placebo group (P<0.001 for both comparisons). The rate of dyspnea leading to treatment discontinuation was 6.5% in the 90 mg group, 4.55% in the 60 mg group, and 0.79% in the placebo group (P<0.001 for both).

Patient receiving chemotherapy

Photo by Rhoda Baer

Last March, the US Food and Drug Administration (FDA) issued a statement warning healthcare professionals not to use the chemotherapy drug Treanda Injection (bendamustine hydrochloride) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

Now, the FDA is providing a list of devices that were tested and deemed compatible with the drug (see the tables below).

The devices were tested by Treanda’s manufacturer, Teva Pharmaceuticals.

Treanda is used to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Treanda is available in 2 formulations: a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), and a lyophilized powder, Treanda for Injection (25 mg/vial or 100 mg/vial lyophilized powder).  The information discussed here is referring to compatibility with the solution, Treanda Injection.

Treanda Injection contains N, N-dimethylacetamide (DMA), which is incompatible with devices that contain polycarbonate or ABS. Devices including CSTDs, adapters, and syringes that contain polycarbonate or ABS have been shown to dissolve when they come in contact with DMA in the drug.

This incompatibility leads to device failure, such as leaking, breaking, or operational failure of CSTD components; possible product contamination; and potential serious adverse health consequences to practitioners, such as skin reactions, or to patients, including the risk of small blood vessel blockage if the product is contaminated with dissolved ABS or polycarbonate.

Users should contact device manufacturers prior to using the specific devices listed below to ensure there have been no changes made to the material composition of the devices and that the devices are compatible with Treanda use.

Table 1. The compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, and gloves (based on testing conducted by Teva from February 2015 through June 2015).

*Part numbers reflect a specific size glove used in the compatibility tests.

Table 2. The IV administration set found to be compatible with Treanda Injection after dilution in a 500 mL 0.9% sodium chloride IV infusion bags (based on testing conducted by Teva from February 2015 through June 2015*).

*Compatibility studies did not include testing with 2.5% dextrose/0.45% sodium chloride injection. However, the results of these studies are not expected to change. So either diluent, 0.9% sodium chloride or 2.5% dextrose/0.45% sodium chloride injection, can be used with Treanda injection.

The FDA required label changes for both the solution and the powder formulations of Treanda to include information for safe preparation and handling for IV administration. See the full prescribing information for details.

For more details on the compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, gloves, and IV administration sets, see Teva’s Dear Health Care Provider letter.

Adverse events or quality problems associated with the use of Treanda products can be reported to the FDA’s MedWatch Adverse Event Reporting Program.

Patient receiving chemotherapy

Photo by Rhoda Baer

Last March, the US Food and Drug Administration (FDA) issued a statement warning healthcare professionals not to use the chemotherapy drug Treanda Injection (bendamustine hydrochloride) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

Now, the FDA is providing a list of devices that were tested and deemed compatible with the drug (see the tables below).

The devices were tested by Treanda’s manufacturer, Teva Pharmaceuticals.

Treanda is used to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Treanda is available in 2 formulations: a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), and a lyophilized powder, Treanda for Injection (25 mg/vial or 100 mg/vial lyophilized powder).  The information discussed here is referring to compatibility with the solution, Treanda Injection.

Treanda Injection contains N, N-dimethylacetamide (DMA), which is incompatible with devices that contain polycarbonate or ABS. Devices including CSTDs, adapters, and syringes that contain polycarbonate or ABS have been shown to dissolve when they come in contact with DMA in the drug.

This incompatibility leads to device failure, such as leaking, breaking, or operational failure of CSTD components; possible product contamination; and potential serious adverse health consequences to practitioners, such as skin reactions, or to patients, including the risk of small blood vessel blockage if the product is contaminated with dissolved ABS or polycarbonate.

Users should contact device manufacturers prior to using the specific devices listed below to ensure there have been no changes made to the material composition of the devices and that the devices are compatible with Treanda use.

Table 1. The compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, and gloves (based on testing conducted by Teva from February 2015 through June 2015).

*Part numbers reflect a specific size glove used in the compatibility tests.

Table 2. The IV administration set found to be compatible with Treanda Injection after dilution in a 500 mL 0.9% sodium chloride IV infusion bags (based on testing conducted by Teva from February 2015 through June 2015*).

*Compatibility studies did not include testing with 2.5% dextrose/0.45% sodium chloride injection. However, the results of these studies are not expected to change. So either diluent, 0.9% sodium chloride or 2.5% dextrose/0.45% sodium chloride injection, can be used with Treanda injection.

The FDA required label changes for both the solution and the powder formulations of Treanda to include information for safe preparation and handling for IV administration. See the full prescribing information for details.

For more details on the compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, gloves, and IV administration sets, see Teva’s Dear Health Care Provider letter.

Adverse events or quality problems associated with the use of Treanda products can be reported to the FDA’s MedWatch Adverse Event Reporting Program.

Patient receiving chemotherapy

Photo by Rhoda Baer

Last March, the US Food and Drug Administration (FDA) issued a statement warning healthcare professionals not to use the chemotherapy drug Treanda Injection (bendamustine hydrochloride) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS).

Now, the FDA is providing a list of devices that were tested and deemed compatible with the drug (see the tables below).

The devices were tested by Treanda’s manufacturer, Teva Pharmaceuticals.

Treanda is used to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Treanda is available in 2 formulations: a solution, Treanda Injection (45 mg/0.5 mL or 180 mg/2 mL solution), and a lyophilized powder, Treanda for Injection (25 mg/vial or 100 mg/vial lyophilized powder).  The information discussed here is referring to compatibility with the solution, Treanda Injection.

Treanda Injection contains N, N-dimethylacetamide (DMA), which is incompatible with devices that contain polycarbonate or ABS. Devices including CSTDs, adapters, and syringes that contain polycarbonate or ABS have been shown to dissolve when they come in contact with DMA in the drug.

This incompatibility leads to device failure, such as leaking, breaking, or operational failure of CSTD components; possible product contamination; and potential serious adverse health consequences to practitioners, such as skin reactions, or to patients, including the risk of small blood vessel blockage if the product is contaminated with dissolved ABS or polycarbonate.

Users should contact device manufacturers prior to using the specific devices listed below to ensure there have been no changes made to the material composition of the devices and that the devices are compatible with Treanda use.

Table 1. The compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, and gloves (based on testing conducted by Teva from February 2015 through June 2015).

*Part numbers reflect a specific size glove used in the compatibility tests.

Table 2. The IV administration set found to be compatible with Treanda Injection after dilution in a 500 mL 0.9% sodium chloride IV infusion bags (based on testing conducted by Teva from February 2015 through June 2015*).

*Compatibility studies did not include testing with 2.5% dextrose/0.45% sodium chloride injection. However, the results of these studies are not expected to change. So either diluent, 0.9% sodium chloride or 2.5% dextrose/0.45% sodium chloride injection, can be used with Treanda injection.

The FDA required label changes for both the solution and the powder formulations of Treanda to include information for safe preparation and handling for IV administration. See the full prescribing information for details.

For more details on the compatibility of Treanda Injection with specific CSTDs, syringes, vial adapters, gloves, and IV administration sets, see Teva’s Dear Health Care Provider letter.

Adverse events or quality problems associated with the use of Treanda products can be reported to the FDA’s MedWatch Adverse Event Reporting Program.

Monoclonal antibodies

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ACE910 to prevent bleeding in hemophilia A patients age 12 and older who have factor VIII inhibitors.

ACE910 is the first factor VIIIa-mimetic bispecific antibody to be investigated for the prophylactic treatment of hemophilia A.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

The breakthrough therapy designation for ACE910 was granted based on results of a phase 1 study of ACE910 in patients with severe hemophilia A.

About ACE910

ACE910 is an investigational, humanized, bispecific monoclonal antibody engineered to simultaneously bind factors IXa and X. ACE910 thereby mimics the cofactor function of factor VIII and is designed to promote blood coagulation in hemophilia A patients, regardless of whether they have developed inhibitors to factor VIII.

ACE910 is administered subcutaneously once weekly. As it is distinct in structure from factor VIII, it is not expected to lead to the formation of factor VIII inhibitors.

ACE910 was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Genentech.

ACE910 research

Results of the phase 1 trial suggested that once-weekly, subcutaneous administration of ACE910 can reduce annualized bleeding rates (ABRs) in adults and adolescents with severe hemophilia A, with or without factor VIII inhibitors.

At ISTH 2015 (abstract AS017), researchers presented data on 18 Japanese patients with severe hemophilia A (factor VIII: C<1%, ages 12 to 58 years).

Patients received once-weekly subcutaneous ACE910 at one of the following dose levels: 0.3 mg/kg (cohort 1), 1 mg/kg (cohort 2), or 3 mg/kg (cohort 3). There were 6 patients in each cohort.

The patients were followed for 5.6 months to 18.5 months.

Efficacy

Whether or not they had inhibitors, patients experienced a decrease in ABR with ACE910. The changes in ABR per treatment cohort and according to inhibitor status are as follows:

*One patient did not report bleeding episodes at baseline or during the study.

Safety

There were 93 adverse events. The researchers said all events were of mild or moderate intensity. One patient discontinued ACE910 due to mild injection-site redness.

There were no thromboembolic events, even when ACE910 was given concomitantly with factor VIII products or bypassing agents as episodic treatment for breakthrough bleeds.

Three patients developed anti-ACE910 antibodies, but they did not affect ACE910 pharmacokinetics or pharmacodynamics.

Genentech is planning to initiate a phase 3 trial of ACE910 in patients with hemophilia A and factor VIII inhibitors by the end of 2015, a phase 3 trial in patients without inhibitors in 2016, and a trial in pediatric patients with hemophilia A in 2016.

Monoclonal antibodies

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ACE910 to prevent bleeding in hemophilia A patients age 12 and older who have factor VIII inhibitors.

ACE910 is the first factor VIIIa-mimetic bispecific antibody to be investigated for the prophylactic treatment of hemophilia A.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

The breakthrough therapy designation for ACE910 was granted based on results of a phase 1 study of ACE910 in patients with severe hemophilia A.

About ACE910

ACE910 is an investigational, humanized, bispecific monoclonal antibody engineered to simultaneously bind factors IXa and X. ACE910 thereby mimics the cofactor function of factor VIII and is designed to promote blood coagulation in hemophilia A patients, regardless of whether they have developed inhibitors to factor VIII.

ACE910 is administered subcutaneously once weekly. As it is distinct in structure from factor VIII, it is not expected to lead to the formation of factor VIII inhibitors.

ACE910 was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Genentech.

ACE910 research

Results of the phase 1 trial suggested that once-weekly, subcutaneous administration of ACE910 can reduce annualized bleeding rates (ABRs) in adults and adolescents with severe hemophilia A, with or without factor VIII inhibitors.

At ISTH 2015 (abstract AS017), researchers presented data on 18 Japanese patients with severe hemophilia A (factor VIII: C<1%, ages 12 to 58 years).

Patients received once-weekly subcutaneous ACE910 at one of the following dose levels: 0.3 mg/kg (cohort 1), 1 mg/kg (cohort 2), or 3 mg/kg (cohort 3). There were 6 patients in each cohort.

The patients were followed for 5.6 months to 18.5 months.

Efficacy

Whether or not they had inhibitors, patients experienced a decrease in ABR with ACE910. The changes in ABR per treatment cohort and according to inhibitor status are as follows:

*One patient did not report bleeding episodes at baseline or during the study.

Safety

There were 93 adverse events. The researchers said all events were of mild or moderate intensity. One patient discontinued ACE910 due to mild injection-site redness.

There were no thromboembolic events, even when ACE910 was given concomitantly with factor VIII products or bypassing agents as episodic treatment for breakthrough bleeds.

Three patients developed anti-ACE910 antibodies, but they did not affect ACE910 pharmacokinetics or pharmacodynamics.

Genentech is planning to initiate a phase 3 trial of ACE910 in patients with hemophilia A and factor VIII inhibitors by the end of 2015, a phase 3 trial in patients without inhibitors in 2016, and a trial in pediatric patients with hemophilia A in 2016.

Monoclonal antibodies

Photo by Linda Bartlett

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for ACE910 to prevent bleeding in hemophilia A patients age 12 and older who have factor VIII inhibitors.

ACE910 is the first factor VIIIa-mimetic bispecific antibody to be investigated for the prophylactic treatment of hemophilia A.

Breakthrough therapy designation is designed to accelerate the development and review of medicines that demonstrate early clinical evidence of a substantial improvement over current treatment options for serious diseases.

The breakthrough therapy designation for ACE910 was granted based on results of a phase 1 study of ACE910 in patients with severe hemophilia A.

About ACE910

ACE910 is an investigational, humanized, bispecific monoclonal antibody engineered to simultaneously bind factors IXa and X. ACE910 thereby mimics the cofactor function of factor VIII and is designed to promote blood coagulation in hemophilia A patients, regardless of whether they have developed inhibitors to factor VIII.

ACE910 is administered subcutaneously once weekly. As it is distinct in structure from factor VIII, it is not expected to lead to the formation of factor VIII inhibitors.

ACE910 was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Genentech.

ACE910 research

Results of the phase 1 trial suggested that once-weekly, subcutaneous administration of ACE910 can reduce annualized bleeding rates (ABRs) in adults and adolescents with severe hemophilia A, with or without factor VIII inhibitors.

At ISTH 2015 (abstract AS017), researchers presented data on 18 Japanese patients with severe hemophilia A (factor VIII: C<1%, ages 12 to 58 years).

Patients received once-weekly subcutaneous ACE910 at one of the following dose levels: 0.3 mg/kg (cohort 1), 1 mg/kg (cohort 2), or 3 mg/kg (cohort 3). There were 6 patients in each cohort.

The patients were followed for 5.6 months to 18.5 months.

Efficacy

Whether or not they had inhibitors, patients experienced a decrease in ABR with ACE910. The changes in ABR per treatment cohort and according to inhibitor status are as follows:

*One patient did not report bleeding episodes at baseline or during the study.

Safety

There were 93 adverse events. The researchers said all events were of mild or moderate intensity. One patient discontinued ACE910 due to mild injection-site redness.

There were no thromboembolic events, even when ACE910 was given concomitantly with factor VIII products or bypassing agents as episodic treatment for breakthrough bleeds.

Three patients developed anti-ACE910 antibodies, but they did not affect ACE910 pharmacokinetics or pharmacodynamics.

Genentech is planning to initiate a phase 3 trial of ACE910 in patients with hemophilia A and factor VIII inhibitors by the end of 2015, a phase 3 trial in patients without inhibitors in 2016, and a trial in pediatric patients with hemophilia A in 2016.

LONDON – Statin therapy, given the week before a host of noncardiac surgical procedures, reduced the postoperative risk for death and cardiac complications at 30 days by 17% when compared with no statin use in a large, international observational study.

Results of the prospective VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study showed that the primary composite endpoint of all-cause mortality, myocardial injury after noncardiac surgery (MINS), or stroke at 30 days was 11.8% in a propensity-matched cohort of patients, 2,845 of whom were treated with a statin and 4,492 who were not. The relative risk (RR) for this composite endpoint was 0.83 favoring the use of preoperative statins, with a 95% confidence interval (CI) of 0.73-0.95 and a P value of .007.

Sara Freeman/Frontline Medical News

Perioperative statin vs. no statin use also cut all-cause mortality by 42% (RR, 0.58; 95% CI, 0.40-0.83; P = .003), cardiovascular mortality by 58% (RR, 0.42; 95% CI, 0.23-0.76; P = .004), and MINS by 14% (RR, 0.86; 95% CI, 0.73-0.98; P = .002).

“These study results are hypothesis generating at most,” emphasized Dr. Otavio Berwanger, who presented the findings at the annual congress of the European Society of Cardiology while they were simultaneously published online (Eur Heart J. 2015 Sept. 1. doi: 10.1093/eurheartj/ehv456).

“It is true that, in this large representative cohort of contemporary patients, statins were associated with lower event rates,” added Dr. Berwanger of Hospital do Coração in São Paulo, Brazil, and “together with the previous body of evidence, statins appear to be an interesting and attractive intervention to reduce postoperative events.” A large-scale, randomized trial is needed, however, to answer the question of whether statins should be used preoperatively to prevent postoperative events in noncardiac surgery patients.

Over a 4-year period that started in August 2007, more than 15,000 individuals aged 45 years or older who were undergoing a variety of noncardiac surgical procedures that required regional or a general anesthetic and at least an overnight stay in the hospital were recruited at 12 centers in eight countries in North and South America, Africa, Asia, Australia, and Europe.

One of the objectives of the study was to examine the use of perioperative statins on cardiovascular events at 30 days, and to do this, the VISION investigators identified the patients who had received a statin in the 7 days prior to surgery and then used propensity matching to form a control group of patients that had not received a statin in the week before surgery.

Just under half of the propensity-matched population was male, with an average age of nearly 69 years. Around 70% of the population had hypertension, 9%-10% had a prior stroke, and 13% had active cancer. Surgeries were urgent in about 2% and emergent in 8%. Around a quarter had undergone orthopedic procedures, and 4% were vascular surgeries. Overall, 36% of surgeries were classified as low risk and 39% as other.

One of the limitations of the study, however, is that, despite the propensity matching, there were some variables that remained different between the two groups, with higher rates of coronary artery disease (20% vs. 14%), peripheral vascular disease (8% vs. 5%), diabetes (30% vs. 25%), and preoperative use of aspirin (25% vs. 19%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (53% vs. 48%) in the statin- versus nonstatin-treated patients.

Other limitations are that these data are observational and the use of statins could be just a surrogate for unmeasured confounders that relate to prognosis. Information on the type and dosing of statins also was not obtained, and there was no information collected on potential liver or muscle function side effects.

Nevertheless, the VISION investigators noted in the published paper that the results are consistent with those from other observational studies and prior small-scale, randomized trials and so do add important information. They noted that these data were collected prospectively in a broader range of patients and types of surgeries than has been reported previously. In addition, patients were recruited from several countries and were actively monitored for outcomes and events were centrally adjudicated. VISION is also the only study to report on the effects of statins on MINS.

“Another message from our results is that the use of long-term statins is sub-optimal in high cardiovascular risk patients, who should be on long-term lipid-lowering therapy independently of surgery,” the VISION investigators wrote in their report.

The study was funded by Hamilton Health Sciences Corp. at McMaster University. Dr. Berwanger disclosed receiving research contracts from AstraZeneca, Bayer Healthcare, Amgen, Boehringer-Ingelheim, Pfizer, and Roche Diagnostics.

LONDON – Statin therapy, given the week before a host of noncardiac surgical procedures, reduced the postoperative risk for death and cardiac complications at 30 days by 17% when compared with no statin use in a large, international observational study.

Results of the prospective VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study showed that the primary composite endpoint of all-cause mortality, myocardial injury after noncardiac surgery (MINS), or stroke at 30 days was 11.8% in a propensity-matched cohort of patients, 2,845 of whom were treated with a statin and 4,492 who were not. The relative risk (RR) for this composite endpoint was 0.83 favoring the use of preoperative statins, with a 95% confidence interval (CI) of 0.73-0.95 and a P value of .007.

Sara Freeman/Frontline Medical News

Perioperative statin vs. no statin use also cut all-cause mortality by 42% (RR, 0.58; 95% CI, 0.40-0.83; P = .003), cardiovascular mortality by 58% (RR, 0.42; 95% CI, 0.23-0.76; P = .004), and MINS by 14% (RR, 0.86; 95% CI, 0.73-0.98; P = .002).

“These study results are hypothesis generating at most,” emphasized Dr. Otavio Berwanger, who presented the findings at the annual congress of the European Society of Cardiology while they were simultaneously published online (Eur Heart J. 2015 Sept. 1. doi: 10.1093/eurheartj/ehv456).

“It is true that, in this large representative cohort of contemporary patients, statins were associated with lower event rates,” added Dr. Berwanger of Hospital do Coração in São Paulo, Brazil, and “together with the previous body of evidence, statins appear to be an interesting and attractive intervention to reduce postoperative events.” A large-scale, randomized trial is needed, however, to answer the question of whether statins should be used preoperatively to prevent postoperative events in noncardiac surgery patients.

Over a 4-year period that started in August 2007, more than 15,000 individuals aged 45 years or older who were undergoing a variety of noncardiac surgical procedures that required regional or a general anesthetic and at least an overnight stay in the hospital were recruited at 12 centers in eight countries in North and South America, Africa, Asia, Australia, and Europe.

One of the objectives of the study was to examine the use of perioperative statins on cardiovascular events at 30 days, and to do this, the VISION investigators identified the patients who had received a statin in the 7 days prior to surgery and then used propensity matching to form a control group of patients that had not received a statin in the week before surgery.

Just under half of the propensity-matched population was male, with an average age of nearly 69 years. Around 70% of the population had hypertension, 9%-10% had a prior stroke, and 13% had active cancer. Surgeries were urgent in about 2% and emergent in 8%. Around a quarter had undergone orthopedic procedures, and 4% were vascular surgeries. Overall, 36% of surgeries were classified as low risk and 39% as other.

One of the limitations of the study, however, is that, despite the propensity matching, there were some variables that remained different between the two groups, with higher rates of coronary artery disease (20% vs. 14%), peripheral vascular disease (8% vs. 5%), diabetes (30% vs. 25%), and preoperative use of aspirin (25% vs. 19%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (53% vs. 48%) in the statin- versus nonstatin-treated patients.

Other limitations are that these data are observational and the use of statins could be just a surrogate for unmeasured confounders that relate to prognosis. Information on the type and dosing of statins also was not obtained, and there was no information collected on potential liver or muscle function side effects.

Nevertheless, the VISION investigators noted in the published paper that the results are consistent with those from other observational studies and prior small-scale, randomized trials and so do add important information. They noted that these data were collected prospectively in a broader range of patients and types of surgeries than has been reported previously. In addition, patients were recruited from several countries and were actively monitored for outcomes and events were centrally adjudicated. VISION is also the only study to report on the effects of statins on MINS.

“Another message from our results is that the use of long-term statins is sub-optimal in high cardiovascular risk patients, who should be on long-term lipid-lowering therapy independently of surgery,” the VISION investigators wrote in their report.

The study was funded by Hamilton Health Sciences Corp. at McMaster University. Dr. Berwanger disclosed receiving research contracts from AstraZeneca, Bayer Healthcare, Amgen, Boehringer-Ingelheim, Pfizer, and Roche Diagnostics.

LONDON – Statin therapy, given the week before a host of noncardiac surgical procedures, reduced the postoperative risk for death and cardiac complications at 30 days by 17% when compared with no statin use in a large, international observational study.

Results of the prospective VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study showed that the primary composite endpoint of all-cause mortality, myocardial injury after noncardiac surgery (MINS), or stroke at 30 days was 11.8% in a propensity-matched cohort of patients, 2,845 of whom were treated with a statin and 4,492 who were not. The relative risk (RR) for this composite endpoint was 0.83 favoring the use of preoperative statins, with a 95% confidence interval (CI) of 0.73-0.95 and a P value of .007.

Sara Freeman/Frontline Medical News

Perioperative statin vs. no statin use also cut all-cause mortality by 42% (RR, 0.58; 95% CI, 0.40-0.83; P = .003), cardiovascular mortality by 58% (RR, 0.42; 95% CI, 0.23-0.76; P = .004), and MINS by 14% (RR, 0.86; 95% CI, 0.73-0.98; P = .002).

“These study results are hypothesis generating at most,” emphasized Dr. Otavio Berwanger, who presented the findings at the annual congress of the European Society of Cardiology while they were simultaneously published online (Eur Heart J. 2015 Sept. 1. doi: 10.1093/eurheartj/ehv456).

“It is true that, in this large representative cohort of contemporary patients, statins were associated with lower event rates,” added Dr. Berwanger of Hospital do Coração in São Paulo, Brazil, and “together with the previous body of evidence, statins appear to be an interesting and attractive intervention to reduce postoperative events.” A large-scale, randomized trial is needed, however, to answer the question of whether statins should be used preoperatively to prevent postoperative events in noncardiac surgery patients.

Over a 4-year period that started in August 2007, more than 15,000 individuals aged 45 years or older who were undergoing a variety of noncardiac surgical procedures that required regional or a general anesthetic and at least an overnight stay in the hospital were recruited at 12 centers in eight countries in North and South America, Africa, Asia, Australia, and Europe.

One of the objectives of the study was to examine the use of perioperative statins on cardiovascular events at 30 days, and to do this, the VISION investigators identified the patients who had received a statin in the 7 days prior to surgery and then used propensity matching to form a control group of patients that had not received a statin in the week before surgery.

Just under half of the propensity-matched population was male, with an average age of nearly 69 years. Around 70% of the population had hypertension, 9%-10% had a prior stroke, and 13% had active cancer. Surgeries were urgent in about 2% and emergent in 8%. Around a quarter had undergone orthopedic procedures, and 4% were vascular surgeries. Overall, 36% of surgeries were classified as low risk and 39% as other.

One of the limitations of the study, however, is that, despite the propensity matching, there were some variables that remained different between the two groups, with higher rates of coronary artery disease (20% vs. 14%), peripheral vascular disease (8% vs. 5%), diabetes (30% vs. 25%), and preoperative use of aspirin (25% vs. 19%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (53% vs. 48%) in the statin- versus nonstatin-treated patients.

Other limitations are that these data are observational and the use of statins could be just a surrogate for unmeasured confounders that relate to prognosis. Information on the type and dosing of statins also was not obtained, and there was no information collected on potential liver or muscle function side effects.

Nevertheless, the VISION investigators noted in the published paper that the results are consistent with those from other observational studies and prior small-scale, randomized trials and so do add important information. They noted that these data were collected prospectively in a broader range of patients and types of surgeries than has been reported previously. In addition, patients were recruited from several countries and were actively monitored for outcomes and events were centrally adjudicated. VISION is also the only study to report on the effects of statins on MINS.

“Another message from our results is that the use of long-term statins is sub-optimal in high cardiovascular risk patients, who should be on long-term lipid-lowering therapy independently of surgery,” the VISION investigators wrote in their report.

The study was funded by Hamilton Health Sciences Corp. at McMaster University. Dr. Berwanger disclosed receiving research contracts from AstraZeneca, Bayer Healthcare, Amgen, Boehringer-Ingelheim, Pfizer, and Roche Diagnostics.

One of the best parts of my job is meeting people. You can tell a lot by a patient’s name, age, ethnicity, speech, dress, or number and nature of his or her tattoos. But there is a lot more that you won’t know until you have a conversation, and that’s the part that always surprises me. Every interaction offers an opportunity to learn something unexpected about the patient or about oneself.

I recently met a lovely young patient with chronic pain. She had some challenges, including being morbidly obese and on welfare. She had a scar across her left forearm – a deep, well-executed, self-inflicted wound requiring 16 stitches. She’d done it as a teenager and readily admitted that it was a tough time in her life.

But when I got to asking her social history, she lit up with pride. When she was down on her luck some years ago, she decided to learn sign language. She then started a business to incorporate sign language into programs for children with learning disabilities. That left me in awe but also surprised at myself for being so surprised.

And how about a nun who, in addition to having rheumatoid arthritis, also had complex regional pain syndrome after foot surgery. For a year and a half, all she could talk about was how painful her foot was, how miserable she was – so much so that I dreaded each visit, knowing it would make me feel inadequate. I discovered later on that my one-dimensional view of this person as patient was quite limited. “Nun” is not her job description. Her job is with the Social Justice Advocacy arm of her congregation, and most recently her work has focused on interpreting Pope Francis’s encyclical on climate change to make it accessible to congregants. Again, a pleasant surprise.

I was raised Catholic: Heaven and hell, good and evil, Immanuel Kant’s moral imperative. But to be totally postmodern about it, I have a great appreciation for how, unless I walk in another person’s shoes, I will never fully understand them and therefore cannot be the judge of them. In fact, those judgments speak more about me than they do of the patient. What a treat, then, that with each patient interaction I shine a light on my own spirit, and get to know myself a little bit better.

Let me end with a little tribute to Oliver Sacks, who devoted his life to shining a light on the complexities of his patients’ minds: “People will make a life in their own terms, whether they are deaf or colorblind or autistic or whatever. And their world will be quite as rich and interesting and full as our world.”

Dr. Chan practices rheumatology in Pawtucket, R.I.

One of the best parts of my job is meeting people. You can tell a lot by a patient’s name, age, ethnicity, speech, dress, or number and nature of his or her tattoos. But there is a lot more that you won’t know until you have a conversation, and that’s the part that always surprises me. Every interaction offers an opportunity to learn something unexpected about the patient or about oneself.

I recently met a lovely young patient with chronic pain. She had some challenges, including being morbidly obese and on welfare. She had a scar across her left forearm – a deep, well-executed, self-inflicted wound requiring 16 stitches. She’d done it as a teenager and readily admitted that it was a tough time in her life.

But when I got to asking her social history, she lit up with pride. When she was down on her luck some years ago, she decided to learn sign language. She then started a business to incorporate sign language into programs for children with learning disabilities. That left me in awe but also surprised at myself for being so surprised.

And how about a nun who, in addition to having rheumatoid arthritis, also had complex regional pain syndrome after foot surgery. For a year and a half, all she could talk about was how painful her foot was, how miserable she was – so much so that I dreaded each visit, knowing it would make me feel inadequate. I discovered later on that my one-dimensional view of this person as patient was quite limited. “Nun” is not her job description. Her job is with the Social Justice Advocacy arm of her congregation, and most recently her work has focused on interpreting Pope Francis’s encyclical on climate change to make it accessible to congregants. Again, a pleasant surprise.

I was raised Catholic: Heaven and hell, good and evil, Immanuel Kant’s moral imperative. But to be totally postmodern about it, I have a great appreciation for how, unless I walk in another person’s shoes, I will never fully understand them and therefore cannot be the judge of them. In fact, those judgments speak more about me than they do of the patient. What a treat, then, that with each patient interaction I shine a light on my own spirit, and get to know myself a little bit better.

Let me end with a little tribute to Oliver Sacks, who devoted his life to shining a light on the complexities of his patients’ minds: “People will make a life in their own terms, whether they are deaf or colorblind or autistic or whatever. And their world will be quite as rich and interesting and full as our world.”

Dr. Chan practices rheumatology in Pawtucket, R.I.

One of the best parts of my job is meeting people. You can tell a lot by a patient’s name, age, ethnicity, speech, dress, or number and nature of his or her tattoos. But there is a lot more that you won’t know until you have a conversation, and that’s the part that always surprises me. Every interaction offers an opportunity to learn something unexpected about the patient or about oneself.

I recently met a lovely young patient with chronic pain. She had some challenges, including being morbidly obese and on welfare. She had a scar across her left forearm – a deep, well-executed, self-inflicted wound requiring 16 stitches. She’d done it as a teenager and readily admitted that it was a tough time in her life.

But when I got to asking her social history, she lit up with pride. When she was down on her luck some years ago, she decided to learn sign language. She then started a business to incorporate sign language into programs for children with learning disabilities. That left me in awe but also surprised at myself for being so surprised.

And how about a nun who, in addition to having rheumatoid arthritis, also had complex regional pain syndrome after foot surgery. For a year and a half, all she could talk about was how painful her foot was, how miserable she was – so much so that I dreaded each visit, knowing it would make me feel inadequate. I discovered later on that my one-dimensional view of this person as patient was quite limited. “Nun” is not her job description. Her job is with the Social Justice Advocacy arm of her congregation, and most recently her work has focused on interpreting Pope Francis’s encyclical on climate change to make it accessible to congregants. Again, a pleasant surprise.

I was raised Catholic: Heaven and hell, good and evil, Immanuel Kant’s moral imperative. But to be totally postmodern about it, I have a great appreciation for how, unless I walk in another person’s shoes, I will never fully understand them and therefore cannot be the judge of them. In fact, those judgments speak more about me than they do of the patient. What a treat, then, that with each patient interaction I shine a light on my own spirit, and get to know myself a little bit better.

Let me end with a little tribute to Oliver Sacks, who devoted his life to shining a light on the complexities of his patients’ minds: “People will make a life in their own terms, whether they are deaf or colorblind or autistic or whatever. And their world will be quite as rich and interesting and full as our world.”

Dr. Chan practices rheumatology in Pawtucket, R.I.

The way Dr. Adam Friedman sees it, dermatologists deserve a prominent place at the table when it comes to the treatment of acute and chronic wounds.

“As masters of the integument, we should be central to wound care, whether it be for research, in terms of developing better technologies, medications, approaches, diagnostics, but also in terms of managing these wounds, given the rich breadth of pathophysiology and biology we learn during our residency and maintain during our continuing education as practicing dermatologists,” said Dr. Friedman of the department of dermatology at George Washington University, Washington.

When the Journal of Drugs in Dermatology invited Dr. Friedman to serve as guest editor for a special feature section on wound care for its July 2015 issue, he jumped at the chance “to give the dermatology community a small taste of what’s going on in the wound healing world.”

Currently, he said, there is wide variability in the types of clinicians leading wound care centers in the United States, with dermatologists often sitting on the sidelines. “At one institution, it may be the vascular surgery service, at others it may be the family medicine service or even the emergency medicine department,” said Dr. Friedman, who is an editorial advisor to Dermatology News.

“That’s a big problem, in that there’s no uniformity from one center to the next in terms of who is expected to and should be taking responsibility for the wound healing service at their institutions. The reality is, it should be an interdisciplinary team, which not only involves dermatology but vascular surgery, nutrition, internal medicine, subspecialties of medicine like rheumatology, and rehab medicine. However, what is happening more often than not is that you’re getting just one or two of these elements, which cannot be as effective because you miss out on a broader, holistic view.”

There are two chief reasons why dermatologists aren’t more involved in wound care management, he continued. One stems from a lack of training on the topic. In one of the abstracts from the special JDD wound care section, researchers led by Dr. Emily Stamell Ruiz conducted an online survey of dermatology residents in the United States, to ask them about their preparedness to care for wounds and to assess the amount and type of training devoted to wound care during residency. Of the 175 respondents, 78% and 85% did not feel prepared to manage acute and chronic wounds, respectively, while 77% felt that more education is needed during their residency (J Drugs Dermatol. 2015;14[7]:716-20). “Residents felt that there was a clinical as well as a didactical gap, so they felt that they needed more training both through lectures as well as in clinics,” said Dr. Ruiz of the department of dermatology at Brigham and Women’s Hospital, Boston. “It’s not just a focal problem, it really is a universal curriculum problem. Future reforms to the current dermatology curriculum to include wound care training could help close the gap in wound care training.”

Another reason why dermatologists aren’t more involved in wound care management is the time commitment, said Dr. Friedman, who is also director of translational research at George Washington. The treatment of chronic wounds is “physically and financially burdensome,” he said. “It takes not only yourself being comfortable with managing the whole patient which includes the wound[s] with a side order of comorbidities, but your support staff as well – having nurses who know how to use the different wound dressings and how to help you with debridement. You need the right infrastructure. It also costs a lot on the provider side to manage wounds. You need a setup where you can get these patients in, have support staff to help with the wound dressings once you’ve identified what’s necessary, and be able to move on to the next patient.”

In another manuscript contained in the JDD special section, Dr. Friedman and his associates retrospectively reviewed the characteristics of 51 patients with burn injuries who were seen by seven different dermatologists at the Einstein-Montefiore division of dermatology from April 2010 to July 2014 (J Drugs Dermatol. 2015;14[7]:721-4). It found that the main mechanism of injury was burn from hot metal (22%), followed by contact with hot liquids (18%). It also found that silver sulfadiazine was the most commonly prescribed treatment, “even though there are considerable data illustrating that its use will delay wound closure and healing (J Invest Dermatol. 2015 May;135[5]:1459-62),” Dr. Friedman said. He went on to note that for patients who suffer an acute burn, “the ability to access a dermatologist is somewhat limited because their schedules are heavily booked well in advance, and the format doesn’t allow for these types of emergencies. More often than not they go to the ED or to primary care. That might not necessarily be the right decision because these are physicians who may not have the necessary training in terms of not only proper burn care, but skin care overall.”

Another manuscript in the special section describes a method in which partial thickness wounds were induced by cryosurgery to create wounds that could facilitate wound healing research and development. For the study, researchers led by Dr. Robert Kirsner, interim chairman of the department of dermatology and cutaneous surgery at the University of Miami, used liquid nitrogen spray to induce freeze injuries on the forearms of eight healthy adult volunteers (J. Drugs Dermatol. 2015;14[7]: 734-8). They delivered the spray onto a target area of a 1-cm circular opening at a distance from the cryodevice to the skin of 0.5-1 cm and implemented several freeze-thaw time cycles by administering pulses that ranged from 3-12 seconds.

After a 24-hour follow-up, Dr. Kirsner and his associates observed that freeze times exceeding 5 seconds caused a majority of study participants to develop blisters, while freeze times exceeding 8 seconds caused uniform blister formation. Time to healing among subjects in the 8-second freeze time group was 12-13 days, while time to healing among those in the 12-second time freeze group was 21 days.

“Cryo-induced wound healing is a little bit slower than you’d expect with a scalpel, but that wasn’t really surprising,” Dr. Kirsner said. “The fact that it healed a little bit slower was a pretty good thing because if everything healed too fast then it couldn’t serve as a model to speed or slow epithelialization. We were quite pleased.” He noted that the model “could be used as a safety test for chronic wound treatment and as an efficacy test for acute wound treatment. It’s relatively inexpensive and a relatively simple technique. If you’re developing a product for widespread use, it’s probably a minor cost in the whole development process.”

Other manuscripts in the JDD special section include a preclinical study using a murine multithermal burn model which found that N-acetylcysteine S-nitrosothiol nanoparticles prevent wound expansion and accelerate burn closure, and a practical, systematic approach to using wound dressings for the wound care novice. Dr. Friedman hopes that the special section not only stimulates further interest in wound care, but that it serves as “a call for action. We really need to be more involved in wound care from the acute and chronic perspective,” he said. “Wound centers around the country should be involving dermatologists. We have so much to offer from bench to bedside because the skin is our thing. I hope this is a reminder that we should be part of this picture.”

Dr. Friedman disclosed that he serves as a consultant for Galderma, Biogen, Aveeno, Intraderm, Puracore, La Roche-Posay, Amgen, Pfizer, PHD Skin Care. He also serves as an advisory board member for Nerium International, Valeant, Nano BioMed, MicroCures, and Novartis, and has received research grants from Valeant. Dr. Ruiz and Dr. Kirsner reported no financial disclosures.

[email protected]

The way Dr. Adam Friedman sees it, dermatologists deserve a prominent place at the table when it comes to the treatment of acute and chronic wounds.

“As masters of the integument, we should be central to wound care, whether it be for research, in terms of developing better technologies, medications, approaches, diagnostics, but also in terms of managing these wounds, given the rich breadth of pathophysiology and biology we learn during our residency and maintain during our continuing education as practicing dermatologists,” said Dr. Friedman of the department of dermatology at George Washington University, Washington.

When the Journal of Drugs in Dermatology invited Dr. Friedman to serve as guest editor for a special feature section on wound care for its July 2015 issue, he jumped at the chance “to give the dermatology community a small taste of what’s going on in the wound healing world.”

Currently, he said, there is wide variability in the types of clinicians leading wound care centers in the United States, with dermatologists often sitting on the sidelines. “At one institution, it may be the vascular surgery service, at others it may be the family medicine service or even the emergency medicine department,” said Dr. Friedman, who is an editorial advisor to Dermatology News.

“That’s a big problem, in that there’s no uniformity from one center to the next in terms of who is expected to and should be taking responsibility for the wound healing service at their institutions. The reality is, it should be an interdisciplinary team, which not only involves dermatology but vascular surgery, nutrition, internal medicine, subspecialties of medicine like rheumatology, and rehab medicine. However, what is happening more often than not is that you’re getting just one or two of these elements, which cannot be as effective because you miss out on a broader, holistic view.”

There are two chief reasons why dermatologists aren’t more involved in wound care management, he continued. One stems from a lack of training on the topic. In one of the abstracts from the special JDD wound care section, researchers led by Dr. Emily Stamell Ruiz conducted an online survey of dermatology residents in the United States, to ask them about their preparedness to care for wounds and to assess the amount and type of training devoted to wound care during residency. Of the 175 respondents, 78% and 85% did not feel prepared to manage acute and chronic wounds, respectively, while 77% felt that more education is needed during their residency (J Drugs Dermatol. 2015;14[7]:716-20). “Residents felt that there was a clinical as well as a didactical gap, so they felt that they needed more training both through lectures as well as in clinics,” said Dr. Ruiz of the department of dermatology at Brigham and Women’s Hospital, Boston. “It’s not just a focal problem, it really is a universal curriculum problem. Future reforms to the current dermatology curriculum to include wound care training could help close the gap in wound care training.”

Another reason why dermatologists aren’t more involved in wound care management is the time commitment, said Dr. Friedman, who is also director of translational research at George Washington. The treatment of chronic wounds is “physically and financially burdensome,” he said. “It takes not only yourself being comfortable with managing the whole patient which includes the wound[s] with a side order of comorbidities, but your support staff as well – having nurses who know how to use the different wound dressings and how to help you with debridement. You need the right infrastructure. It also costs a lot on the provider side to manage wounds. You need a setup where you can get these patients in, have support staff to help with the wound dressings once you’ve identified what’s necessary, and be able to move on to the next patient.”

In another manuscript contained in the JDD special section, Dr. Friedman and his associates retrospectively reviewed the characteristics of 51 patients with burn injuries who were seen by seven different dermatologists at the Einstein-Montefiore division of dermatology from April 2010 to July 2014 (J Drugs Dermatol. 2015;14[7]:721-4). It found that the main mechanism of injury was burn from hot metal (22%), followed by contact with hot liquids (18%). It also found that silver sulfadiazine was the most commonly prescribed treatment, “even though there are considerable data illustrating that its use will delay wound closure and healing (J Invest Dermatol. 2015 May;135[5]:1459-62),” Dr. Friedman said. He went on to note that for patients who suffer an acute burn, “the ability to access a dermatologist is somewhat limited because their schedules are heavily booked well in advance, and the format doesn’t allow for these types of emergencies. More often than not they go to the ED or to primary care. That might not necessarily be the right decision because these are physicians who may not have the necessary training in terms of not only proper burn care, but skin care overall.”

Another manuscript in the special section describes a method in which partial thickness wounds were induced by cryosurgery to create wounds that could facilitate wound healing research and development. For the study, researchers led by Dr. Robert Kirsner, interim chairman of the department of dermatology and cutaneous surgery at the University of Miami, used liquid nitrogen spray to induce freeze injuries on the forearms of eight healthy adult volunteers (J. Drugs Dermatol. 2015;14[7]: 734-8). They delivered the spray onto a target area of a 1-cm circular opening at a distance from the cryodevice to the skin of 0.5-1 cm and implemented several freeze-thaw time cycles by administering pulses that ranged from 3-12 seconds.

After a 24-hour follow-up, Dr. Kirsner and his associates observed that freeze times exceeding 5 seconds caused a majority of study participants to develop blisters, while freeze times exceeding 8 seconds caused uniform blister formation. Time to healing among subjects in the 8-second freeze time group was 12-13 days, while time to healing among those in the 12-second time freeze group was 21 days.

“Cryo-induced wound healing is a little bit slower than you’d expect with a scalpel, but that wasn’t really surprising,” Dr. Kirsner said. “The fact that it healed a little bit slower was a pretty good thing because if everything healed too fast then it couldn’t serve as a model to speed or slow epithelialization. We were quite pleased.” He noted that the model “could be used as a safety test for chronic wound treatment and as an efficacy test for acute wound treatment. It’s relatively inexpensive and a relatively simple technique. If you’re developing a product for widespread use, it’s probably a minor cost in the whole development process.”

Other manuscripts in the JDD special section include a preclinical study using a murine multithermal burn model which found that N-acetylcysteine S-nitrosothiol nanoparticles prevent wound expansion and accelerate burn closure, and a practical, systematic approach to using wound dressings for the wound care novice. Dr. Friedman hopes that the special section not only stimulates further interest in wound care, but that it serves as “a call for action. We really need to be more involved in wound care from the acute and chronic perspective,” he said. “Wound centers around the country should be involving dermatologists. We have so much to offer from bench to bedside because the skin is our thing. I hope this is a reminder that we should be part of this picture.”

Dr. Friedman disclosed that he serves as a consultant for Galderma, Biogen, Aveeno, Intraderm, Puracore, La Roche-Posay, Amgen, Pfizer, PHD Skin Care. He also serves as an advisory board member for Nerium International, Valeant, Nano BioMed, MicroCures, and Novartis, and has received research grants from Valeant. Dr. Ruiz and Dr. Kirsner reported no financial disclosures.

[email protected]

The way Dr. Adam Friedman sees it, dermatologists deserve a prominent place at the table when it comes to the treatment of acute and chronic wounds.

“As masters of the integument, we should be central to wound care, whether it be for research, in terms of developing better technologies, medications, approaches, diagnostics, but also in terms of managing these wounds, given the rich breadth of pathophysiology and biology we learn during our residency and maintain during our continuing education as practicing dermatologists,” said Dr. Friedman of the department of dermatology at George Washington University, Washington.

When the Journal of Drugs in Dermatology invited Dr. Friedman to serve as guest editor for a special feature section on wound care for its July 2015 issue, he jumped at the chance “to give the dermatology community a small taste of what’s going on in the wound healing world.”

Currently, he said, there is wide variability in the types of clinicians leading wound care centers in the United States, with dermatologists often sitting on the sidelines. “At one institution, it may be the vascular surgery service, at others it may be the family medicine service or even the emergency medicine department,” said Dr. Friedman, who is an editorial advisor to Dermatology News.

“That’s a big problem, in that there’s no uniformity from one center to the next in terms of who is expected to and should be taking responsibility for the wound healing service at their institutions. The reality is, it should be an interdisciplinary team, which not only involves dermatology but vascular surgery, nutrition, internal medicine, subspecialties of medicine like rheumatology, and rehab medicine. However, what is happening more often than not is that you’re getting just one or two of these elements, which cannot be as effective because you miss out on a broader, holistic view.”

There are two chief reasons why dermatologists aren’t more involved in wound care management, he continued. One stems from a lack of training on the topic. In one of the abstracts from the special JDD wound care section, researchers led by Dr. Emily Stamell Ruiz conducted an online survey of dermatology residents in the United States, to ask them about their preparedness to care for wounds and to assess the amount and type of training devoted to wound care during residency. Of the 175 respondents, 78% and 85% did not feel prepared to manage acute and chronic wounds, respectively, while 77% felt that more education is needed during their residency (J Drugs Dermatol. 2015;14[7]:716-20). “Residents felt that there was a clinical as well as a didactical gap, so they felt that they needed more training both through lectures as well as in clinics,” said Dr. Ruiz of the department of dermatology at Brigham and Women’s Hospital, Boston. “It’s not just a focal problem, it really is a universal curriculum problem. Future reforms to the current dermatology curriculum to include wound care training could help close the gap in wound care training.”

Another reason why dermatologists aren’t more involved in wound care management is the time commitment, said Dr. Friedman, who is also director of translational research at George Washington. The treatment of chronic wounds is “physically and financially burdensome,” he said. “It takes not only yourself being comfortable with managing the whole patient which includes the wound[s] with a side order of comorbidities, but your support staff as well – having nurses who know how to use the different wound dressings and how to help you with debridement. You need the right infrastructure. It also costs a lot on the provider side to manage wounds. You need a setup where you can get these patients in, have support staff to help with the wound dressings once you’ve identified what’s necessary, and be able to move on to the next patient.”

In another manuscript contained in the JDD special section, Dr. Friedman and his associates retrospectively reviewed the characteristics of 51 patients with burn injuries who were seen by seven different dermatologists at the Einstein-Montefiore division of dermatology from April 2010 to July 2014 (J Drugs Dermatol. 2015;14[7]:721-4). It found that the main mechanism of injury was burn from hot metal (22%), followed by contact with hot liquids (18%). It also found that silver sulfadiazine was the most commonly prescribed treatment, “even though there are considerable data illustrating that its use will delay wound closure and healing (J Invest Dermatol. 2015 May;135[5]:1459-62),” Dr. Friedman said. He went on to note that for patients who suffer an acute burn, “the ability to access a dermatologist is somewhat limited because their schedules are heavily booked well in advance, and the format doesn’t allow for these types of emergencies. More often than not they go to the ED or to primary care. That might not necessarily be the right decision because these are physicians who may not have the necessary training in terms of not only proper burn care, but skin care overall.”

Another manuscript in the special section describes a method in which partial thickness wounds were induced by cryosurgery to create wounds that could facilitate wound healing research and development. For the study, researchers led by Dr. Robert Kirsner, interim chairman of the department of dermatology and cutaneous surgery at the University of Miami, used liquid nitrogen spray to induce freeze injuries on the forearms of eight healthy adult volunteers (J. Drugs Dermatol. 2015;14[7]: 734-8). They delivered the spray onto a target area of a 1-cm circular opening at a distance from the cryodevice to the skin of 0.5-1 cm and implemented several freeze-thaw time cycles by administering pulses that ranged from 3-12 seconds.

After a 24-hour follow-up, Dr. Kirsner and his associates observed that freeze times exceeding 5 seconds caused a majority of study participants to develop blisters, while freeze times exceeding 8 seconds caused uniform blister formation. Time to healing among subjects in the 8-second freeze time group was 12-13 days, while time to healing among those in the 12-second time freeze group was 21 days.

“Cryo-induced wound healing is a little bit slower than you’d expect with a scalpel, but that wasn’t really surprising,” Dr. Kirsner said. “The fact that it healed a little bit slower was a pretty good thing because if everything healed too fast then it couldn’t serve as a model to speed or slow epithelialization. We were quite pleased.” He noted that the model “could be used as a safety test for chronic wound treatment and as an efficacy test for acute wound treatment. It’s relatively inexpensive and a relatively simple technique. If you’re developing a product for widespread use, it’s probably a minor cost in the whole development process.”

Other manuscripts in the JDD special section include a preclinical study using a murine multithermal burn model which found that N-acetylcysteine S-nitrosothiol nanoparticles prevent wound expansion and accelerate burn closure, and a practical, systematic approach to using wound dressings for the wound care novice. Dr. Friedman hopes that the special section not only stimulates further interest in wound care, but that it serves as “a call for action. We really need to be more involved in wound care from the acute and chronic perspective,” he said. “Wound centers around the country should be involving dermatologists. We have so much to offer from bench to bedside because the skin is our thing. I hope this is a reminder that we should be part of this picture.”

Dr. Friedman disclosed that he serves as a consultant for Galderma, Biogen, Aveeno, Intraderm, Puracore, La Roche-Posay, Amgen, Pfizer, PHD Skin Care. He also serves as an advisory board member for Nerium International, Valeant, Nano BioMed, MicroCures, and Novartis, and has received research grants from Valeant. Dr. Ruiz and Dr. Kirsner reported no financial disclosures.

[email protected]

Blood samples

Photo by Graham Colm

Researchers studying stored blood samples from Vietnam War veterans found that exposure to the herbicide Agent Orange was associated with a more than 2-fold increased risk of monoclonal gammopathy of undetermined significance (MGUS).

The team studied samples from US Air Force personnel who conducted aerial herbicide spray missions of Agent Orange during the war and compared them to blood samples from other Air Force vets.

The incidence of MGUS among the vets exposed to Agent Orange was low, at about 7%. But they still had twice the rate of MGUS as the other vets.

The researchers said this finding supports the previously discovered link between pesticides and myelomagenesis.

While the cause of MGUS and multiple myeloma (MM) remains largely unclear, studies have reported an elevated risk of MM among farmers and other agricultural workers. And pesticides have been thought to be the basis for these associations.

To further investigate the link, Ola Landgren, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York, and his colleagues conducted their study of Vietnam vets. The team reported the results in JAMA Oncology.

The researchers studied store blood samples from 958 male vets—479 Operation Ranch Hand vets who were involved in aerial herbicide spray missions and 479 Air Force vets who had similar duties in Southeast Asia during the same time period (1962 to 1971) but were not involved in herbicide spray missions.

The overall prevalence of MGUS was 7.1% in the Operation Ranch Hand vets and 3.1% in the comparison vets, which translates to a 2.4-fold increased risk for MGUS in Operation Ranch Hand vets.

The odds ratio—after the researchers adjusted for confounding factors such as race, age, and body mass index—was 2.37 (P=0.007).

Dr Landgren and his colleagues conceded that this study has limitations, including a lack of women and the potential for unknown confounding factors such as family medical history and civilian occupation.

Still, the researchers said their findings support an association between Agent Orange exposure and myelomagenesis.

In a related editorial, Niklhil C. Munshi, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, said this study has implications beyond MGUS and MM.

“It also highlights the importance of tissue banking that allows investigation of a number of unanswered questions using modern methods,” Dr Munshi wrote. “The emphasis now is to store samples from almost every major study with correlative science in mind, and this is essential if we are to understand disease biology, mechanism of response, and resistance to therapy in the era of targeted therapy and precision medicine.”

Blood samples

Photo by Graham Colm

Researchers studying stored blood samples from Vietnam War veterans found that exposure to the herbicide Agent Orange was associated with a more than 2-fold increased risk of monoclonal gammopathy of undetermined significance (MGUS).

The team studied samples from US Air Force personnel who conducted aerial herbicide spray missions of Agent Orange during the war and compared them to blood samples from other Air Force vets.

The incidence of MGUS among the vets exposed to Agent Orange was low, at about 7%. But they still had twice the rate of MGUS as the other vets.

The researchers said this finding supports the previously discovered link between pesticides and myelomagenesis.

While the cause of MGUS and multiple myeloma (MM) remains largely unclear, studies have reported an elevated risk of MM among farmers and other agricultural workers. And pesticides have been thought to be the basis for these associations.

To further investigate the link, Ola Landgren, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York, and his colleagues conducted their study of Vietnam vets. The team reported the results in JAMA Oncology.

The researchers studied store blood samples from 958 male vets—479 Operation Ranch Hand vets who were involved in aerial herbicide spray missions and 479 Air Force vets who had similar duties in Southeast Asia during the same time period (1962 to 1971) but were not involved in herbicide spray missions.

The overall prevalence of MGUS was 7.1% in the Operation Ranch Hand vets and 3.1% in the comparison vets, which translates to a 2.4-fold increased risk for MGUS in Operation Ranch Hand vets.

The odds ratio—after the researchers adjusted for confounding factors such as race, age, and body mass index—was 2.37 (P=0.007).

Dr Landgren and his colleagues conceded that this study has limitations, including a lack of women and the potential for unknown confounding factors such as family medical history and civilian occupation.

Still, the researchers said their findings support an association between Agent Orange exposure and myelomagenesis.

In a related editorial, Niklhil C. Munshi, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, said this study has implications beyond MGUS and MM.

“It also highlights the importance of tissue banking that allows investigation of a number of unanswered questions using modern methods,” Dr Munshi wrote. “The emphasis now is to store samples from almost every major study with correlative science in mind, and this is essential if we are to understand disease biology, mechanism of response, and resistance to therapy in the era of targeted therapy and precision medicine.”

Blood samples

Photo by Graham Colm

Researchers studying stored blood samples from Vietnam War veterans found that exposure to the herbicide Agent Orange was associated with a more than 2-fold increased risk of monoclonal gammopathy of undetermined significance (MGUS).

The team studied samples from US Air Force personnel who conducted aerial herbicide spray missions of Agent Orange during the war and compared them to blood samples from other Air Force vets.

The incidence of MGUS among the vets exposed to Agent Orange was low, at about 7%. But they still had twice the rate of MGUS as the other vets.

The researchers said this finding supports the previously discovered link between pesticides and myelomagenesis.

While the cause of MGUS and multiple myeloma (MM) remains largely unclear, studies have reported an elevated risk of MM among farmers and other agricultural workers. And pesticides have been thought to be the basis for these associations.

To further investigate the link, Ola Landgren, MD, PhD, of Memorial Sloan Kettering Cancer Center in New York, New York, and his colleagues conducted their study of Vietnam vets. The team reported the results in JAMA Oncology.

The researchers studied store blood samples from 958 male vets—479 Operation Ranch Hand vets who were involved in aerial herbicide spray missions and 479 Air Force vets who had similar duties in Southeast Asia during the same time period (1962 to 1971) but were not involved in herbicide spray missions.

The overall prevalence of MGUS was 7.1% in the Operation Ranch Hand vets and 3.1% in the comparison vets, which translates to a 2.4-fold increased risk for MGUS in Operation Ranch Hand vets.

The odds ratio—after the researchers adjusted for confounding factors such as race, age, and body mass index—was 2.37 (P=0.007).

Dr Landgren and his colleagues conceded that this study has limitations, including a lack of women and the potential for unknown confounding factors such as family medical history and civilian occupation.

Still, the researchers said their findings support an association between Agent Orange exposure and myelomagenesis.

In a related editorial, Niklhil C. Munshi, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, said this study has implications beyond MGUS and MM.

“It also highlights the importance of tissue banking that allows investigation of a number of unanswered questions using modern methods,” Dr Munshi wrote. “The emphasis now is to store samples from almost every major study with correlative science in mind, and this is essential if we are to understand disease biology, mechanism of response, and resistance to therapy in the era of targeted therapy and precision medicine.”