Government and Regulations

The U.S. House of Representatives departs for a 5-week recess after July 31, leaving VA with less than 2 weeks to render a solution to fill the fiscal year (FY) 2015 budget gap before some of its hospital operations are subsequently forced to shut down in August.

VA believes the solution to its problems lies in the Veterans Choice Fund appropriated from the Veterans Access, Choice, and Accountability Act of 2014. On July 13, VA Deputy Secretary Sloan Gibson submitted a request to Congress seeking a transfer of funds from the Choice Program to “continue VA’s efforts to increase veterans’ access to care and life-saving pharmaceuticals.”

Related: Obama and McDonald Call on Congress to Give VA Flexibility

Within the draft legislation, a provision would make up to $3 billion of the Veterans Choice Fund available to legally augment health care delivered by non-VA providers—up to $500 million of which is for hepatitis C treatment—during FY15. If passed, VA could adjust its accounts so that obligations incurred on May 1, 2015, or later by the medical services account could be charged to the Veterans Choice Fund instead.

Thus far, no progress on the bill has been made, although VA leaders met with ranking members of both the House and Senate committees on Veterans Affairs to discuss growing demand and increased access to care.

“VA’s continued lack of transparency and refusal to be forthright with Congress is unacceptable,” blasted Rep. Jeff Miller (R-FL), chairman of the House Committee on Veterans’ Affairs in a statement. “I look forward to discussing with Deputy Secretary Gibson how such a massive shortfall could have come as a surprise to the department, and how to put an end to these frequent cost overruns while ensuring veterans receive the care they have earned.”

So where did the FY15 budget go, and why so fast? According to VA, much of the spending was on hiring medical staff, extending business hours, and boosting productivity in order to provide veterans greater access to care. The VA notes it completed 2.6 million more appointments between June 1, 2014, and May 31, 2015, compared with the same period in 2013 to 2014 and that its health care workload is up 10.5% in both VA facilities and its Care in the Community program.

The U.S. House of Representatives departs for a 5-week recess after July 31, leaving VA with less than 2 weeks to render a solution to fill the fiscal year (FY) 2015 budget gap before some of its hospital operations are subsequently forced to shut down in August.

VA believes the solution to its problems lies in the Veterans Choice Fund appropriated from the Veterans Access, Choice, and Accountability Act of 2014. On July 13, VA Deputy Secretary Sloan Gibson submitted a request to Congress seeking a transfer of funds from the Choice Program to “continue VA’s efforts to increase veterans’ access to care and life-saving pharmaceuticals.”

Related: Obama and McDonald Call on Congress to Give VA Flexibility

Within the draft legislation, a provision would make up to $3 billion of the Veterans Choice Fund available to legally augment health care delivered by non-VA providers—up to $500 million of which is for hepatitis C treatment—during FY15. If passed, VA could adjust its accounts so that obligations incurred on May 1, 2015, or later by the medical services account could be charged to the Veterans Choice Fund instead.

Thus far, no progress on the bill has been made, although VA leaders met with ranking members of both the House and Senate committees on Veterans Affairs to discuss growing demand and increased access to care.

“VA’s continued lack of transparency and refusal to be forthright with Congress is unacceptable,” blasted Rep. Jeff Miller (R-FL), chairman of the House Committee on Veterans’ Affairs in a statement. “I look forward to discussing with Deputy Secretary Gibson how such a massive shortfall could have come as a surprise to the department, and how to put an end to these frequent cost overruns while ensuring veterans receive the care they have earned.”

So where did the FY15 budget go, and why so fast? According to VA, much of the spending was on hiring medical staff, extending business hours, and boosting productivity in order to provide veterans greater access to care. The VA notes it completed 2.6 million more appointments between June 1, 2014, and May 31, 2015, compared with the same period in 2013 to 2014 and that its health care workload is up 10.5% in both VA facilities and its Care in the Community program.

The U.S. House of Representatives departs for a 5-week recess after July 31, leaving VA with less than 2 weeks to render a solution to fill the fiscal year (FY) 2015 budget gap before some of its hospital operations are subsequently forced to shut down in August.

VA believes the solution to its problems lies in the Veterans Choice Fund appropriated from the Veterans Access, Choice, and Accountability Act of 2014. On July 13, VA Deputy Secretary Sloan Gibson submitted a request to Congress seeking a transfer of funds from the Choice Program to “continue VA’s efforts to increase veterans’ access to care and life-saving pharmaceuticals.”

Related: Obama and McDonald Call on Congress to Give VA Flexibility

Within the draft legislation, a provision would make up to $3 billion of the Veterans Choice Fund available to legally augment health care delivered by non-VA providers—up to $500 million of which is for hepatitis C treatment—during FY15. If passed, VA could adjust its accounts so that obligations incurred on May 1, 2015, or later by the medical services account could be charged to the Veterans Choice Fund instead.

Thus far, no progress on the bill has been made, although VA leaders met with ranking members of both the House and Senate committees on Veterans Affairs to discuss growing demand and increased access to care.

“VA’s continued lack of transparency and refusal to be forthright with Congress is unacceptable,” blasted Rep. Jeff Miller (R-FL), chairman of the House Committee on Veterans’ Affairs in a statement. “I look forward to discussing with Deputy Secretary Gibson how such a massive shortfall could have come as a surprise to the department, and how to put an end to these frequent cost overruns while ensuring veterans receive the care they have earned.”

So where did the FY15 budget go, and why so fast? According to VA, much of the spending was on hiring medical staff, extending business hours, and boosting productivity in order to provide veterans greater access to care. The VA notes it completed 2.6 million more appointments between June 1, 2014, and May 31, 2015, compared with the same period in 2013 to 2014 and that its health care workload is up 10.5% in both VA facilities and its Care in the Community program.

“Mortality trends are the gold standard for evidence of progress against cancer,” so it’s good news that cancer-related death rates are continuing to decline, according to the National Cancer Institute’s (NCI’s) Annual Report to the Nation on the Status of Cancer, 1975-2011. Between 2002 and 2011, age-adjusted rates for all cancers combined declined 0.5% for both men and women. Among men, rates have dropped by about 1.8% per year; among women, 1.4%; and among children, roughly 2%.

Related: How Much Is Too Much Cancer Screening?

Death rates during this same 10-year period among men declined for 10 of the 17 most common cancers and among women for 13 of the top cancers. The largest declines in incidence for men were in cancers of the colon and rectum, lung and bronchus, and prostate. Women saw the biggest declines in cancers of the colon, rectum, and cervical spine.

Related: Nivolumab Approved for Expanded Indication

The rate of new cases of lung cancer also continued a downward trend, in sync with the smoking rate. But oral/oropharyngeal cancers have increased among white men, perhaps associated with higher incidence of human papilloma virus, the researchers suggest.

Despite the dropping mortality rates, all is not bright. Thyroid and kidney cancer incidence rates are on the rise in both men and women, although no increase in mortality has been noted. Liver cancer cases and death rates are also increasing; this may reflect, in part, higher rates of hepatitis C and/or behavioral risk factors, such as alcohol abuse, the NCI report says.

Related: Timely Assessment of Cancer Symptoms

The incidence and mortality rates are increasing as well for uterine cancer among whites, blacks, and Asian Pacific Islander women, with the largest increase seen in black women. The cause of the increases is unknown, the report says.

“Mortality trends are the gold standard for evidence of progress against cancer,” so it’s good news that cancer-related death rates are continuing to decline, according to the National Cancer Institute’s (NCI’s) Annual Report to the Nation on the Status of Cancer, 1975-2011. Between 2002 and 2011, age-adjusted rates for all cancers combined declined 0.5% for both men and women. Among men, rates have dropped by about 1.8% per year; among women, 1.4%; and among children, roughly 2%.

Related: How Much Is Too Much Cancer Screening?

Death rates during this same 10-year period among men declined for 10 of the 17 most common cancers and among women for 13 of the top cancers. The largest declines in incidence for men were in cancers of the colon and rectum, lung and bronchus, and prostate. Women saw the biggest declines in cancers of the colon, rectum, and cervical spine.

Related: Nivolumab Approved for Expanded Indication

The rate of new cases of lung cancer also continued a downward trend, in sync with the smoking rate. But oral/oropharyngeal cancers have increased among white men, perhaps associated with higher incidence of human papilloma virus, the researchers suggest.

Despite the dropping mortality rates, all is not bright. Thyroid and kidney cancer incidence rates are on the rise in both men and women, although no increase in mortality has been noted. Liver cancer cases and death rates are also increasing; this may reflect, in part, higher rates of hepatitis C and/or behavioral risk factors, such as alcohol abuse, the NCI report says.

Related: Timely Assessment of Cancer Symptoms

The incidence and mortality rates are increasing as well for uterine cancer among whites, blacks, and Asian Pacific Islander women, with the largest increase seen in black women. The cause of the increases is unknown, the report says.

“Mortality trends are the gold standard for evidence of progress against cancer,” so it’s good news that cancer-related death rates are continuing to decline, according to the National Cancer Institute’s (NCI’s) Annual Report to the Nation on the Status of Cancer, 1975-2011. Between 2002 and 2011, age-adjusted rates for all cancers combined declined 0.5% for both men and women. Among men, rates have dropped by about 1.8% per year; among women, 1.4%; and among children, roughly 2%.

Related: How Much Is Too Much Cancer Screening?

Death rates during this same 10-year period among men declined for 10 of the 17 most common cancers and among women for 13 of the top cancers. The largest declines in incidence for men were in cancers of the colon and rectum, lung and bronchus, and prostate. Women saw the biggest declines in cancers of the colon, rectum, and cervical spine.

Related: Nivolumab Approved for Expanded Indication

The rate of new cases of lung cancer also continued a downward trend, in sync with the smoking rate. But oral/oropharyngeal cancers have increased among white men, perhaps associated with higher incidence of human papilloma virus, the researchers suggest.

Despite the dropping mortality rates, all is not bright. Thyroid and kidney cancer incidence rates are on the rise in both men and women, although no increase in mortality has been noted. Liver cancer cases and death rates are also increasing; this may reflect, in part, higher rates of hepatitis C and/or behavioral risk factors, such as alcohol abuse, the NCI report says.

Related: Timely Assessment of Cancer Symptoms

The incidence and mortality rates are increasing as well for uterine cancer among whites, blacks, and Asian Pacific Islander women, with the largest increase seen in black women. The cause of the increases is unknown, the report says.

Secretary of Defense Ash Carter issued 2 directives on Monday that could change the military’s longstanding policy on transgender service members in a matter of months. 

The first establishes a DoD working group to study over the next 6 months the policy and readiness implications of allowing transgender persons to serve openly. The working group will be led by Acting Under Secretary of Defense for Personnel and Readiness Brad Carson and will be composed of military and civilian personnel representing all military services and the Joint Staff. The working group will report to Deputy Secretary of Defense Bob Work.

Related: AMA Challenges Transgender Troop Policies

“At my direction, the working group will start with the presumption that transgender persons can serve openly without adverse impact on military effectiveness and readiness, unless and except where objective, practical impediments are identified,” stated Secretary Carter.

The second shifts all decision-making authority in all administrative discharges for those diagnosed with gender dysphoria or who identify themselves as transgender elevated to Under Secretary Carson, who will make determinations on all potential separations. Prior to Secretary Carter’s directive, the Army, Air Force, and Navy had independently initiated their own revised transgender discharge policies, effectively making discrimination more difficult throughout their ranks.

Related: Same-Sex Couples Eligible for All VA Benefits

Secretary Carter’s statement comes just 1 month after the American Medical Association announced in its June 8 resolution, “There is no medically valid reason to exclude transgender individuals from service in the U.S. military.”

“Over the last 14 years of conflict, the Department of Defense has proven itself to be a learning organization,” said Secretary Carter. “Throughout this time, transgender men and women in uniform have been there with us, even as they often had to serve in silence alongside their fellow comrades in arms.”

Secretary of Defense Ash Carter issued 2 directives on Monday that could change the military’s longstanding policy on transgender service members in a matter of months. 

The first establishes a DoD working group to study over the next 6 months the policy and readiness implications of allowing transgender persons to serve openly. The working group will be led by Acting Under Secretary of Defense for Personnel and Readiness Brad Carson and will be composed of military and civilian personnel representing all military services and the Joint Staff. The working group will report to Deputy Secretary of Defense Bob Work.

Related: AMA Challenges Transgender Troop Policies

“At my direction, the working group will start with the presumption that transgender persons can serve openly without adverse impact on military effectiveness and readiness, unless and except where objective, practical impediments are identified,” stated Secretary Carter.

The second shifts all decision-making authority in all administrative discharges for those diagnosed with gender dysphoria or who identify themselves as transgender elevated to Under Secretary Carson, who will make determinations on all potential separations. Prior to Secretary Carter’s directive, the Army, Air Force, and Navy had independently initiated their own revised transgender discharge policies, effectively making discrimination more difficult throughout their ranks.

Related: Same-Sex Couples Eligible for All VA Benefits

Secretary Carter’s statement comes just 1 month after the American Medical Association announced in its June 8 resolution, “There is no medically valid reason to exclude transgender individuals from service in the U.S. military.”

“Over the last 14 years of conflict, the Department of Defense has proven itself to be a learning organization,” said Secretary Carter. “Throughout this time, transgender men and women in uniform have been there with us, even as they often had to serve in silence alongside their fellow comrades in arms.”

Secretary of Defense Ash Carter issued 2 directives on Monday that could change the military’s longstanding policy on transgender service members in a matter of months. 

The first establishes a DoD working group to study over the next 6 months the policy and readiness implications of allowing transgender persons to serve openly. The working group will be led by Acting Under Secretary of Defense for Personnel and Readiness Brad Carson and will be composed of military and civilian personnel representing all military services and the Joint Staff. The working group will report to Deputy Secretary of Defense Bob Work.

Related: AMA Challenges Transgender Troop Policies

“At my direction, the working group will start with the presumption that transgender persons can serve openly without adverse impact on military effectiveness and readiness, unless and except where objective, practical impediments are identified,” stated Secretary Carter.

The second shifts all decision-making authority in all administrative discharges for those diagnosed with gender dysphoria or who identify themselves as transgender elevated to Under Secretary Carson, who will make determinations on all potential separations. Prior to Secretary Carter’s directive, the Army, Air Force, and Navy had independently initiated their own revised transgender discharge policies, effectively making discrimination more difficult throughout their ranks.

Related: Same-Sex Couples Eligible for All VA Benefits

Secretary Carter’s statement comes just 1 month after the American Medical Association announced in its June 8 resolution, “There is no medically valid reason to exclude transgender individuals from service in the U.S. military.”

“Over the last 14 years of conflict, the Department of Defense has proven itself to be a learning organization,” said Secretary Carter. “Throughout this time, transgender men and women in uniform have been there with us, even as they often had to serve in silence alongside their fellow comrades in arms.”

Expectant mothers in the U.S. Navy and Marine Corps are now entitled to 18 weeks of paid maternity leave in the first year after childbirth.

The policy triples paid time off for new and expectant mothers in the Navy and Marine Corps from the previously allotted 6 weeks. The change comes just months after President Barack Obama directed all federal government agencies to allow workers to use 6 weeks of paid sick leave to bond with a new child.

Related: Congressional Act Could Boost Maternity Services

According to Secretary of the Navy, Ray Mabus, providing mothers with maternity leave ensures a “safeguard against losing skilled service members.”

Related: Maternal Morbidity: Higher Risks for Minorities

“In the Navy and the Marine Corps, we are continually looking for ways to recruit and retain the best people,” Mabus said in a Navy press release. “We have incredibly talented women who want to serve, and they also want to be mothers and have the time to fulfill that important role the right way. We can do that for them. Meaningful maternity leave when it matters most is one of the best ways that we can support the women who serve our country.”

According to Mabus, providing increased maternity leave allows women to return and stay in their careers while not missing the critical bonding time with a new baby.

Related: Overprescription of Opioids in Women of Childbearing Age

“When the women in our Navy and Marine Corps answer the call to serve, they are making the difficult choice to be away from their children—sometimes for prolonged periods of time—so that they can do the demanding jobs that we ask them to do,” he said.

The change went into effect on Thursday, July 2, but will be retroactive to January 1, 2015.

Expectant mothers in the U.S. Navy and Marine Corps are now entitled to 18 weeks of paid maternity leave in the first year after childbirth.

The policy triples paid time off for new and expectant mothers in the Navy and Marine Corps from the previously allotted 6 weeks. The change comes just months after President Barack Obama directed all federal government agencies to allow workers to use 6 weeks of paid sick leave to bond with a new child.

Related: Congressional Act Could Boost Maternity Services

According to Secretary of the Navy, Ray Mabus, providing mothers with maternity leave ensures a “safeguard against losing skilled service members.”

Related: Maternal Morbidity: Higher Risks for Minorities

“In the Navy and the Marine Corps, we are continually looking for ways to recruit and retain the best people,” Mabus said in a Navy press release. “We have incredibly talented women who want to serve, and they also want to be mothers and have the time to fulfill that important role the right way. We can do that for them. Meaningful maternity leave when it matters most is one of the best ways that we can support the women who serve our country.”

According to Mabus, providing increased maternity leave allows women to return and stay in their careers while not missing the critical bonding time with a new baby.

Related: Overprescription of Opioids in Women of Childbearing Age

“When the women in our Navy and Marine Corps answer the call to serve, they are making the difficult choice to be away from their children—sometimes for prolonged periods of time—so that they can do the demanding jobs that we ask them to do,” he said.

The change went into effect on Thursday, July 2, but will be retroactive to January 1, 2015.

Expectant mothers in the U.S. Navy and Marine Corps are now entitled to 18 weeks of paid maternity leave in the first year after childbirth.

The policy triples paid time off for new and expectant mothers in the Navy and Marine Corps from the previously allotted 6 weeks. The change comes just months after President Barack Obama directed all federal government agencies to allow workers to use 6 weeks of paid sick leave to bond with a new child.

Related: Congressional Act Could Boost Maternity Services

According to Secretary of the Navy, Ray Mabus, providing mothers with maternity leave ensures a “safeguard against losing skilled service members.”

Related: Maternal Morbidity: Higher Risks for Minorities

“In the Navy and the Marine Corps, we are continually looking for ways to recruit and retain the best people,” Mabus said in a Navy press release. “We have incredibly talented women who want to serve, and they also want to be mothers and have the time to fulfill that important role the right way. We can do that for them. Meaningful maternity leave when it matters most is one of the best ways that we can support the women who serve our country.”

According to Mabus, providing increased maternity leave allows women to return and stay in their careers while not missing the critical bonding time with a new baby.

Related: Overprescription of Opioids in Women of Childbearing Age

“When the women in our Navy and Marine Corps answer the call to serve, they are making the difficult choice to be away from their children—sometimes for prolonged periods of time—so that they can do the demanding jobs that we ask them to do,” he said.

The change went into effect on Thursday, July 2, but will be retroactive to January 1, 2015.

SILVER SPRING, MD. – The majority of a Food and Drug Administration Advisory panel agreed that the benefits of adding necitumumab to gemcitabine and cisplatin for patients with squamous non–small cell lung cancer outweighed the risks.

Elizabeth Mechcatie/Frontline Medical News

At the meeting on July 9, the FDA’s Oncologic Drugs Advisory Committee reviewed data from a study that evaluated the anti–epidermal growth factor receptor monoclonal antibody in more than 1,000 patients with stage IV disease. The SQUIRE study was submitted to the FDA by Eli Lilly to support approval of necitumumab for the indication now under review: for use as a first-line treatment, in combination with gemcitabine and cisplatin, for patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human EGFR.

Despite a modest effect on overall survival, a very small but statistically significant effect on progression-free survival, and some safety concerns, 11 of the 12 panelists agreed that the efficacy and safety results of the trial supported a “positive benefit risk assessment” of necitumumab combined with gemcitabine and cisplatin for this group of patients, the main question they were asked by the FDA to discuss. The panel was not asked to specifically vote on whether to recommend approval.

The SQUIRE study, an international phase III study of 1,093 patients with stage IV squamous NSCLC, who had not received chemotherapy for advanced disease, evaluated the safety and efficacy of gemcitabine and cisplatin, with or without necitumumab, administered every 3 weeks, until disease progressed or toxicity became unacceptable, for a maximum of six cycles. The median age of patients was 62 years; they were mostly men and were heavy smokers; 36 patients were enrolled in the United States. (Patients were not selected based on EGFR protein expression but based on tissue pathology.)

Median overall survival (OS), the primary endpoint, was 11.5 months in the necitumumab-treated arm, vs. 9.9 months among controls, a 1.6 month difference that was statistically significant, representing a reduced risk of 16% (hazard ratio, 0.84). Progression-free survival (PFS) was a median of 5.7 months among those in the necitumumab-treated group, vs. 5.5 months, which was also statistically significant and represented a 15% reduced risk (HR, 0.85). There was no significant difference in the objective response rate (ORR), which was 31% among those in the necitumumab arm and 29% among those in the control arm. This is the first study to show an improvement in survival for a first-line treatment for squamous lung cancer, the company officials pointed out.

In the study, there were more venous thromboembolic events (VTEs; 9% vs. 5%) and more cases of sudden death and deaths “not otherwise specified” (2.2% vs. 0.5%) in the necitumumab-treated arm. There were also more cases of hypomagnesemia and skin rashes, and the FDA reviewers pointed out that several cases of sudden death occurred in patients with very low serum magnesium levels. VTEs and sudden or unexplained deaths were also higher among necitumumab-treated patients in another study that evaluated necitumumab in patients with nonsquamous NSCLC, which was stopped early because of the VTE increase; that study found no improvements in OS, PFS or ORR.

Among those agreeing that the risk-benefit assessment was positive, Dr. Michael Menefee of the Mayo Clinic, Jacksonville, Fla., said “Yes was the simple answer, but there are still caveats” regarding toxicity and the magnitude of the overall benefit.

“The survival benefit is modest but it’s real,” said Dr. Deborah Armstrong, the panel chair and professor of oncology, Johns Hopkins University, Baltimore, who also voted positively. She strongly encouraged continuing efforts to manage the toxicities of necitumumab, which she said might improve the risk-benefit balance further.

The panelist who did not agree was Dr. Tito Fojo, a senior investigator and director of the medical oncology fellowship program at the National Cancer Institute. He said that the study did not provide him with enough confidence. Noting it is a very difficult disease to treat, he said, “I just wish the data were much better.” His concerns included the possibility that those in the control arm, who received a median of five treatment cycles may have received less chemotherapy than those in the necitumumab arm, who received a median of six cycles.

Speaking on behalf of Eli Lilly at the meeting, Dr. David Gandara, director of the thoracic oncology program at the University of California Davis Comprehensive Cancer Center, said that although EGFR mutations are rare in squamous NSCLC, “the EGFR pathway itself is biologically relevant.” Necitumumab “attacks that pathway in ways independent of those associated with EGFR tyrosine-kinase inhibitors and independent of EGFR mutation status,” he added.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. The FDA decision is expected by the end of 2015, an Eli Lilly spokesperson said.

[email protected]

SILVER SPRING, MD. – The majority of a Food and Drug Administration Advisory panel agreed that the benefits of adding necitumumab to gemcitabine and cisplatin for patients with squamous non–small cell lung cancer outweighed the risks.

Elizabeth Mechcatie/Frontline Medical News

At the meeting on July 9, the FDA’s Oncologic Drugs Advisory Committee reviewed data from a study that evaluated the anti–epidermal growth factor receptor monoclonal antibody in more than 1,000 patients with stage IV disease. The SQUIRE study was submitted to the FDA by Eli Lilly to support approval of necitumumab for the indication now under review: for use as a first-line treatment, in combination with gemcitabine and cisplatin, for patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human EGFR.

Despite a modest effect on overall survival, a very small but statistically significant effect on progression-free survival, and some safety concerns, 11 of the 12 panelists agreed that the efficacy and safety results of the trial supported a “positive benefit risk assessment” of necitumumab combined with gemcitabine and cisplatin for this group of patients, the main question they were asked by the FDA to discuss. The panel was not asked to specifically vote on whether to recommend approval.

The SQUIRE study, an international phase III study of 1,093 patients with stage IV squamous NSCLC, who had not received chemotherapy for advanced disease, evaluated the safety and efficacy of gemcitabine and cisplatin, with or without necitumumab, administered every 3 weeks, until disease progressed or toxicity became unacceptable, for a maximum of six cycles. The median age of patients was 62 years; they were mostly men and were heavy smokers; 36 patients were enrolled in the United States. (Patients were not selected based on EGFR protein expression but based on tissue pathology.)

Median overall survival (OS), the primary endpoint, was 11.5 months in the necitumumab-treated arm, vs. 9.9 months among controls, a 1.6 month difference that was statistically significant, representing a reduced risk of 16% (hazard ratio, 0.84). Progression-free survival (PFS) was a median of 5.7 months among those in the necitumumab-treated group, vs. 5.5 months, which was also statistically significant and represented a 15% reduced risk (HR, 0.85). There was no significant difference in the objective response rate (ORR), which was 31% among those in the necitumumab arm and 29% among those in the control arm. This is the first study to show an improvement in survival for a first-line treatment for squamous lung cancer, the company officials pointed out.

In the study, there were more venous thromboembolic events (VTEs; 9% vs. 5%) and more cases of sudden death and deaths “not otherwise specified” (2.2% vs. 0.5%) in the necitumumab-treated arm. There were also more cases of hypomagnesemia and skin rashes, and the FDA reviewers pointed out that several cases of sudden death occurred in patients with very low serum magnesium levels. VTEs and sudden or unexplained deaths were also higher among necitumumab-treated patients in another study that evaluated necitumumab in patients with nonsquamous NSCLC, which was stopped early because of the VTE increase; that study found no improvements in OS, PFS or ORR.

Among those agreeing that the risk-benefit assessment was positive, Dr. Michael Menefee of the Mayo Clinic, Jacksonville, Fla., said “Yes was the simple answer, but there are still caveats” regarding toxicity and the magnitude of the overall benefit.

“The survival benefit is modest but it’s real,” said Dr. Deborah Armstrong, the panel chair and professor of oncology, Johns Hopkins University, Baltimore, who also voted positively. She strongly encouraged continuing efforts to manage the toxicities of necitumumab, which she said might improve the risk-benefit balance further.

The panelist who did not agree was Dr. Tito Fojo, a senior investigator and director of the medical oncology fellowship program at the National Cancer Institute. He said that the study did not provide him with enough confidence. Noting it is a very difficult disease to treat, he said, “I just wish the data were much better.” His concerns included the possibility that those in the control arm, who received a median of five treatment cycles may have received less chemotherapy than those in the necitumumab arm, who received a median of six cycles.

Speaking on behalf of Eli Lilly at the meeting, Dr. David Gandara, director of the thoracic oncology program at the University of California Davis Comprehensive Cancer Center, said that although EGFR mutations are rare in squamous NSCLC, “the EGFR pathway itself is biologically relevant.” Necitumumab “attacks that pathway in ways independent of those associated with EGFR tyrosine-kinase inhibitors and independent of EGFR mutation status,” he added.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. The FDA decision is expected by the end of 2015, an Eli Lilly spokesperson said.

[email protected]

SILVER SPRING, MD. – The majority of a Food and Drug Administration Advisory panel agreed that the benefits of adding necitumumab to gemcitabine and cisplatin for patients with squamous non–small cell lung cancer outweighed the risks.

Elizabeth Mechcatie/Frontline Medical News

At the meeting on July 9, the FDA’s Oncologic Drugs Advisory Committee reviewed data from a study that evaluated the anti–epidermal growth factor receptor monoclonal antibody in more than 1,000 patients with stage IV disease. The SQUIRE study was submitted to the FDA by Eli Lilly to support approval of necitumumab for the indication now under review: for use as a first-line treatment, in combination with gemcitabine and cisplatin, for patients with locally advanced or metastatic squamous non–small cell lung cancer (NSCLC). Necitumumab is a recombinant human IgG1 monoclonal antibody that is designed to block the ligand binding site of the human EGFR.

Despite a modest effect on overall survival, a very small but statistically significant effect on progression-free survival, and some safety concerns, 11 of the 12 panelists agreed that the efficacy and safety results of the trial supported a “positive benefit risk assessment” of necitumumab combined with gemcitabine and cisplatin for this group of patients, the main question they were asked by the FDA to discuss. The panel was not asked to specifically vote on whether to recommend approval.

The SQUIRE study, an international phase III study of 1,093 patients with stage IV squamous NSCLC, who had not received chemotherapy for advanced disease, evaluated the safety and efficacy of gemcitabine and cisplatin, with or without necitumumab, administered every 3 weeks, until disease progressed or toxicity became unacceptable, for a maximum of six cycles. The median age of patients was 62 years; they were mostly men and were heavy smokers; 36 patients were enrolled in the United States. (Patients were not selected based on EGFR protein expression but based on tissue pathology.)

Median overall survival (OS), the primary endpoint, was 11.5 months in the necitumumab-treated arm, vs. 9.9 months among controls, a 1.6 month difference that was statistically significant, representing a reduced risk of 16% (hazard ratio, 0.84). Progression-free survival (PFS) was a median of 5.7 months among those in the necitumumab-treated group, vs. 5.5 months, which was also statistically significant and represented a 15% reduced risk (HR, 0.85). There was no significant difference in the objective response rate (ORR), which was 31% among those in the necitumumab arm and 29% among those in the control arm. This is the first study to show an improvement in survival for a first-line treatment for squamous lung cancer, the company officials pointed out.

In the study, there were more venous thromboembolic events (VTEs; 9% vs. 5%) and more cases of sudden death and deaths “not otherwise specified” (2.2% vs. 0.5%) in the necitumumab-treated arm. There were also more cases of hypomagnesemia and skin rashes, and the FDA reviewers pointed out that several cases of sudden death occurred in patients with very low serum magnesium levels. VTEs and sudden or unexplained deaths were also higher among necitumumab-treated patients in another study that evaluated necitumumab in patients with nonsquamous NSCLC, which was stopped early because of the VTE increase; that study found no improvements in OS, PFS or ORR.

Among those agreeing that the risk-benefit assessment was positive, Dr. Michael Menefee of the Mayo Clinic, Jacksonville, Fla., said “Yes was the simple answer, but there are still caveats” regarding toxicity and the magnitude of the overall benefit.

“The survival benefit is modest but it’s real,” said Dr. Deborah Armstrong, the panel chair and professor of oncology, Johns Hopkins University, Baltimore, who also voted positively. She strongly encouraged continuing efforts to manage the toxicities of necitumumab, which she said might improve the risk-benefit balance further.

The panelist who did not agree was Dr. Tito Fojo, a senior investigator and director of the medical oncology fellowship program at the National Cancer Institute. He said that the study did not provide him with enough confidence. Noting it is a very difficult disease to treat, he said, “I just wish the data were much better.” His concerns included the possibility that those in the control arm, who received a median of five treatment cycles may have received less chemotherapy than those in the necitumumab arm, who received a median of six cycles.

Speaking on behalf of Eli Lilly at the meeting, Dr. David Gandara, director of the thoracic oncology program at the University of California Davis Comprehensive Cancer Center, said that although EGFR mutations are rare in squamous NSCLC, “the EGFR pathway itself is biologically relevant.” Necitumumab “attacks that pathway in ways independent of those associated with EGFR tyrosine-kinase inhibitors and independent of EGFR mutation status,” he added.

The FDA usually follows the recommendations of its advisory panels. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. The FDA decision is expected by the end of 2015, an Eli Lilly spokesperson said.

[email protected]

Designers, engineers, and problem solvers in general are all invited to participate in the VA’s Innovation Creation Series for Prosthetics and Assistive Technology. The goal of the program, launched in May, is to come up with creative ways to help veterans and civilians with amputations, tremors, and other disabilities navigate daily life more easily.

Related: Advances in Prosthetics Restore High Levels of Physical Activity

Although the deadline to submit proposed solutions has passed, the Creation Series will culminate on July 28 to 29 during a 2-day “Make-a-thon” event at Hunter Holmes VA Medical Center in Richmond, Virginia. There, designs submitted by the public will be built and tested, including creating a medication pill box that allows the flexibility to hold medications that need to be taken up to 8 times a day with a reminder system for each time medication needs to be taken. Another challenge is to design a device that remotely changes the speed and grip strength of a prosthetic device for veterans with upper extremity injuries.

Related: VA Adaptive Sports Program

To learn more, visit www.innovation.va.gov/challenge.

Designers, engineers, and problem solvers in general are all invited to participate in the VA’s Innovation Creation Series for Prosthetics and Assistive Technology. The goal of the program, launched in May, is to come up with creative ways to help veterans and civilians with amputations, tremors, and other disabilities navigate daily life more easily.

Related: Advances in Prosthetics Restore High Levels of Physical Activity

Although the deadline to submit proposed solutions has passed, the Creation Series will culminate on July 28 to 29 during a 2-day “Make-a-thon” event at Hunter Holmes VA Medical Center in Richmond, Virginia. There, designs submitted by the public will be built and tested, including creating a medication pill box that allows the flexibility to hold medications that need to be taken up to 8 times a day with a reminder system for each time medication needs to be taken. Another challenge is to design a device that remotely changes the speed and grip strength of a prosthetic device for veterans with upper extremity injuries.

Related: VA Adaptive Sports Program

To learn more, visit www.innovation.va.gov/challenge.

Designers, engineers, and problem solvers in general are all invited to participate in the VA’s Innovation Creation Series for Prosthetics and Assistive Technology. The goal of the program, launched in May, is to come up with creative ways to help veterans and civilians with amputations, tremors, and other disabilities navigate daily life more easily.

Related: Advances in Prosthetics Restore High Levels of Physical Activity

Although the deadline to submit proposed solutions has passed, the Creation Series will culminate on July 28 to 29 during a 2-day “Make-a-thon” event at Hunter Holmes VA Medical Center in Richmond, Virginia. There, designs submitted by the public will be built and tested, including creating a medication pill box that allows the flexibility to hold medications that need to be taken up to 8 times a day with a reminder system for each time medication needs to be taken. Another challenge is to design a device that remotely changes the speed and grip strength of a prosthetic device for veterans with upper extremity injuries.

Related: VA Adaptive Sports Program

To learn more, visit www.innovation.va.gov/challenge.

On Monday, a $1.3 million settlement was reached between the U.S. government and the family of the baby who died while undergoing treatment at Tripler Army Medical Center in Honolulu, Hawaii, in 2012, according to an Associated Press report.

The baby, Rachael Reynolds, was brought to the emergency department in October of 2012, when she was 4 months old, for treatment of breathing issues and an upper respiratory infection. Due to severe, irreversible brain injury, which the Reynolds family claims stemmed from the hospital’s negligence, Rachael was taken off life support 4 days after her arrival at the hospital.

After her death, Rachael’s parents filed a lawsuit against the hospital for negligence, alleging that the baby experienced “great physical pain, suffering, discomfort, emotional injuries and distress.”

Assistant U.S. Attorney Harry Yee said the government admits no liability or fault by settling, according to the Associated Press.

Generally, medical malpractice settlements are confidential. However, information can be made public when a government institution is involved.

On Monday, a $1.3 million settlement was reached between the U.S. government and the family of the baby who died while undergoing treatment at Tripler Army Medical Center in Honolulu, Hawaii, in 2012, according to an Associated Press report.

The baby, Rachael Reynolds, was brought to the emergency department in October of 2012, when she was 4 months old, for treatment of breathing issues and an upper respiratory infection. Due to severe, irreversible brain injury, which the Reynolds family claims stemmed from the hospital’s negligence, Rachael was taken off life support 4 days after her arrival at the hospital.

After her death, Rachael’s parents filed a lawsuit against the hospital for negligence, alleging that the baby experienced “great physical pain, suffering, discomfort, emotional injuries and distress.”

Assistant U.S. Attorney Harry Yee said the government admits no liability or fault by settling, according to the Associated Press.

Generally, medical malpractice settlements are confidential. However, information can be made public when a government institution is involved.

On Monday, a $1.3 million settlement was reached between the U.S. government and the family of the baby who died while undergoing treatment at Tripler Army Medical Center in Honolulu, Hawaii, in 2012, according to an Associated Press report.

The baby, Rachael Reynolds, was brought to the emergency department in October of 2012, when she was 4 months old, for treatment of breathing issues and an upper respiratory infection. Due to severe, irreversible brain injury, which the Reynolds family claims stemmed from the hospital’s negligence, Rachael was taken off life support 4 days after her arrival at the hospital.

After her death, Rachael’s parents filed a lawsuit against the hospital for negligence, alleging that the baby experienced “great physical pain, suffering, discomfort, emotional injuries and distress.”

Assistant U.S. Attorney Harry Yee said the government admits no liability or fault by settling, according to the Associated Press.

Generally, medical malpractice settlements are confidential. However, information can be made public when a government institution is involved.

Physicians will have a year to learn how to properly code under ICD-10 before facing potential penalties or withheld payments, according to a joint announcement from the Centers for Medicare & Medicaid Services and the American Medical Association.

During that first year using the new coding system, Medicare will not deny claims based solely on the specificity of diagnosis codes, provided they are in the appropriate family of ICD-10 codes. However, physicians still will not be able to use ICD-9 codes after Sept. 30, 2015.

©Brian Jackson/iStockphoto.com

“This means that Medicare will not deny payment for these unintentional errors as practices become accustomed to ICD-10 coding,” Dr. Steven Stack, AMA president, wrote in a blog post on the AMA website. “This transition period will give physicians and their practice teams time to get up to speed on the more complicated code set.”

Similarly, physicians will not face penalties under the Physician Quality Reporting System, the value-based modifier, or the meaningful use program based on the specificity of diagnosis codes if the appropriate family of ICD-10 codes are used, according to the AMA. Finally, if a Medicare contractor is unable to process a claim due to coding issues, CMS will authorize an advance payment to the physician.

CMS also plans to create an ICD-10 coordination center and appoint an ombudsman to answer questions about claims submission using ICD-10.

“With easy-to-use tools, a new ICD-10 ombudsman, and added flexibility in our claims audit and quality reporting process, CMS is committed to working with the physician community to work through this transition.” Andy Slavitt, CMS Acting Administrator, said in a statement.

[email protected]

Physicians will have a year to learn how to properly code under ICD-10 before facing potential penalties or withheld payments, according to a joint announcement from the Centers for Medicare & Medicaid Services and the American Medical Association.

During that first year using the new coding system, Medicare will not deny claims based solely on the specificity of diagnosis codes, provided they are in the appropriate family of ICD-10 codes. However, physicians still will not be able to use ICD-9 codes after Sept. 30, 2015.

©Brian Jackson/iStockphoto.com

“This means that Medicare will not deny payment for these unintentional errors as practices become accustomed to ICD-10 coding,” Dr. Steven Stack, AMA president, wrote in a blog post on the AMA website. “This transition period will give physicians and their practice teams time to get up to speed on the more complicated code set.”

Similarly, physicians will not face penalties under the Physician Quality Reporting System, the value-based modifier, or the meaningful use program based on the specificity of diagnosis codes if the appropriate family of ICD-10 codes are used, according to the AMA. Finally, if a Medicare contractor is unable to process a claim due to coding issues, CMS will authorize an advance payment to the physician.

CMS also plans to create an ICD-10 coordination center and appoint an ombudsman to answer questions about claims submission using ICD-10.

“With easy-to-use tools, a new ICD-10 ombudsman, and added flexibility in our claims audit and quality reporting process, CMS is committed to working with the physician community to work through this transition.” Andy Slavitt, CMS Acting Administrator, said in a statement.

[email protected]

Physicians will have a year to learn how to properly code under ICD-10 before facing potential penalties or withheld payments, according to a joint announcement from the Centers for Medicare & Medicaid Services and the American Medical Association.

During that first year using the new coding system, Medicare will not deny claims based solely on the specificity of diagnosis codes, provided they are in the appropriate family of ICD-10 codes. However, physicians still will not be able to use ICD-9 codes after Sept. 30, 2015.

©Brian Jackson/iStockphoto.com

“This means that Medicare will not deny payment for these unintentional errors as practices become accustomed to ICD-10 coding,” Dr. Steven Stack, AMA president, wrote in a blog post on the AMA website. “This transition period will give physicians and their practice teams time to get up to speed on the more complicated code set.”

Similarly, physicians will not face penalties under the Physician Quality Reporting System, the value-based modifier, or the meaningful use program based on the specificity of diagnosis codes if the appropriate family of ICD-10 codes are used, according to the AMA. Finally, if a Medicare contractor is unable to process a claim due to coding issues, CMS will authorize an advance payment to the physician.

CMS also plans to create an ICD-10 coordination center and appoint an ombudsman to answer questions about claims submission using ICD-10.

“With easy-to-use tools, a new ICD-10 ombudsman, and added flexibility in our claims audit and quality reporting process, CMS is committed to working with the physician community to work through this transition.” Andy Slavitt, CMS Acting Administrator, said in a statement.

[email protected]

“The VA cannot do it alone.” Secretary of Veterans Affairs Robert A. McDonald is asking Americans everywhere to join the new nationwide initiative Summer of Service and “give back to those who have given so much to our nation.”

Related: Inspiring Americans

The VA will be working with Congress, Veterans Service Organizations, mayors and local communities, private and nonprofit organizations, and VA employees to identify new, innovative ways to support veterans and their families. The VA is seeking to build on the work of more than 350,000 employees and 76,000 volunteers by engaging 100,000 new volunteers, increasing the number of community partners, and recruiting medical professionals to further expand access to care.

Related: United We Serve

To learn more about the needs of a local VA facility, potential volunteers can visit www.volunteer.va.gov or follow #VASummerOfService on Vantage Point, Twitter, Facebook, and Instagram.

“The VA cannot do it alone.” Secretary of Veterans Affairs Robert A. McDonald is asking Americans everywhere to join the new nationwide initiative Summer of Service and “give back to those who have given so much to our nation.”

Related: Inspiring Americans

The VA will be working with Congress, Veterans Service Organizations, mayors and local communities, private and nonprofit organizations, and VA employees to identify new, innovative ways to support veterans and their families. The VA is seeking to build on the work of more than 350,000 employees and 76,000 volunteers by engaging 100,000 new volunteers, increasing the number of community partners, and recruiting medical professionals to further expand access to care.

Related: United We Serve

To learn more about the needs of a local VA facility, potential volunteers can visit www.volunteer.va.gov or follow #VASummerOfService on Vantage Point, Twitter, Facebook, and Instagram.

“The VA cannot do it alone.” Secretary of Veterans Affairs Robert A. McDonald is asking Americans everywhere to join the new nationwide initiative Summer of Service and “give back to those who have given so much to our nation.”

Related: Inspiring Americans

The VA will be working with Congress, Veterans Service Organizations, mayors and local communities, private and nonprofit organizations, and VA employees to identify new, innovative ways to support veterans and their families. The VA is seeking to build on the work of more than 350,000 employees and 76,000 volunteers by engaging 100,000 new volunteers, increasing the number of community partners, and recruiting medical professionals to further expand access to care.

Related: United We Serve

To learn more about the needs of a local VA facility, potential volunteers can visit www.volunteer.va.gov or follow #VASummerOfService on Vantage Point, Twitter, Facebook, and Instagram.