AYA cancer survivors have better social support than peers

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AYA cancer survivors have better social support than peers

Photo by Rhoda Baer
Doctor consults with cancer patient and her father

Researchers have developed a new method to measure social networks of adolescent and young adult (AYA) cancer survivors.

This method indicated that AYA cancer survivors often have stronger social networks than their non-cancer peers.

However, the strength of the social network varied by diagnosis, with the lymphoma and leukemia survivors having the greatest support.

These findings were published in Cancer.

“Cancer survivors need healthy social connections, and, to the best of our knowledge, this is the first published study to quantify social networks of adolescent and young adult cancer survivors compared to their peers,” said study author I-Chan Huang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“The study introduces a method we developed and validated for evaluating social networks of these cancer survivors.”

The method, called the functional social network index (FSNI), measures marital status, contact frequency with friends and relatives, and available resources for health support/advice, which includes emotional support, tangible support, physical activity advice, and weight management advice.

The researchers compared the FSNI to a pair of traditional social network indices—density and betweenness centrality.

Density represents the ratio of the existing relationships/connections within a network to all possible relationships/connections. And betweenness centrality represents the ratio of the existing shortest paths between 2 friends/relatives of the study participants to the shortest possible paths between 2 friends/relatives.

Subjects

The researchers used the 3 social network indices to analyze 102 AYA cancer survivors, ages 18 to 30, and 102 young adults with no cancer history who were matched to the survivors by age, sex, and race.

Subjects were recruited from a commercial national Internet survey panel. They reported detailed social connection information with up to 25 friends and relatives.

The cancer survivors were between 15 and 30 years old when their cancer was diagnosed, and all had completed treatment at least 5 years prior.

Results

Neither the density index nor the betweenness centrality index demonstrated significant differences between cancer survivors and controls (all P values were less than 0.05).

However, according to the FSNI, cancer survivors had more available resources for emotional support (beta [b]=3.02; P=0.003), tangible support (b=4.17; P<0.001), physical activity advice (b=3.94; P<0.001), and weight management advice (b=4.10; P<0.001).

“This makes sense,” Dr Huang said. “Because of their cancer, survivors often have strong networks of physicians, friends, and relatives to provide advice and support.”

However, the FSNI showed the strength of cancer survivors’ support network varied by diagnosis.

Lymphoma survivors ranked highest on the FSNI (b=2.765; P=0.02), followed by survivors of leukemia (b=2.542; P=0.03) and solid tumors (b=2.178; P=0.047), with central nervous system malignancies as the reference.

The researchers also found a higher FSNI was associated with better coping skills, including using emotional support (b=0.08; P=0.04), using instrumental support (b=0.12; P<0.001), venting of emotions (b=0.10; P=0.004), positive reframing (b=0.12; P=0.003), planning for the future (b=0.08; P=0.03), participating in religious activities (b=0.16; P<0.001), and less denial (b=0.10; P=0.01) and destructive behavior (b=0.08; P=0.04).

The researchers said long-term follow-up is needed to understand how social networks and social support may change over time.

“Adolescents and young adult cancer survivors are in a transitory stage of independence from parents,” Dr Huang said. “While this study suggests that survivors often report strong social connections, our previous studies have reported that childhood cancer survivors are more likely than their peers to struggle mentally and physically and report issues like distress and loneliness.”

Dr Huang and his colleagues are working to streamline the FSNI to make it easier for healthcare providers to assess support available to cancer survivors of any age.

 

 

Meanwhile, researchers are working to better understand how social connections affect health outcomes in order to design interventions to foster those connections.

“A lack of social connections with friends and relatives is associated with poor quality of life, risky health behaviors, chronic health conditions, and premature death,” Dr Huang said. “Once we identify the mechanism between social connections and health outcomes, we can start designing interventions to use social networks to improve health outcomes of cancer survivors.”

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Photo by Rhoda Baer
Doctor consults with cancer patient and her father

Researchers have developed a new method to measure social networks of adolescent and young adult (AYA) cancer survivors.

This method indicated that AYA cancer survivors often have stronger social networks than their non-cancer peers.

However, the strength of the social network varied by diagnosis, with the lymphoma and leukemia survivors having the greatest support.

These findings were published in Cancer.

“Cancer survivors need healthy social connections, and, to the best of our knowledge, this is the first published study to quantify social networks of adolescent and young adult cancer survivors compared to their peers,” said study author I-Chan Huang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“The study introduces a method we developed and validated for evaluating social networks of these cancer survivors.”

The method, called the functional social network index (FSNI), measures marital status, contact frequency with friends and relatives, and available resources for health support/advice, which includes emotional support, tangible support, physical activity advice, and weight management advice.

The researchers compared the FSNI to a pair of traditional social network indices—density and betweenness centrality.

Density represents the ratio of the existing relationships/connections within a network to all possible relationships/connections. And betweenness centrality represents the ratio of the existing shortest paths between 2 friends/relatives of the study participants to the shortest possible paths between 2 friends/relatives.

Subjects

The researchers used the 3 social network indices to analyze 102 AYA cancer survivors, ages 18 to 30, and 102 young adults with no cancer history who were matched to the survivors by age, sex, and race.

Subjects were recruited from a commercial national Internet survey panel. They reported detailed social connection information with up to 25 friends and relatives.

The cancer survivors were between 15 and 30 years old when their cancer was diagnosed, and all had completed treatment at least 5 years prior.

Results

Neither the density index nor the betweenness centrality index demonstrated significant differences between cancer survivors and controls (all P values were less than 0.05).

However, according to the FSNI, cancer survivors had more available resources for emotional support (beta [b]=3.02; P=0.003), tangible support (b=4.17; P<0.001), physical activity advice (b=3.94; P<0.001), and weight management advice (b=4.10; P<0.001).

“This makes sense,” Dr Huang said. “Because of their cancer, survivors often have strong networks of physicians, friends, and relatives to provide advice and support.”

However, the FSNI showed the strength of cancer survivors’ support network varied by diagnosis.

Lymphoma survivors ranked highest on the FSNI (b=2.765; P=0.02), followed by survivors of leukemia (b=2.542; P=0.03) and solid tumors (b=2.178; P=0.047), with central nervous system malignancies as the reference.

The researchers also found a higher FSNI was associated with better coping skills, including using emotional support (b=0.08; P=0.04), using instrumental support (b=0.12; P<0.001), venting of emotions (b=0.10; P=0.004), positive reframing (b=0.12; P=0.003), planning for the future (b=0.08; P=0.03), participating in religious activities (b=0.16; P<0.001), and less denial (b=0.10; P=0.01) and destructive behavior (b=0.08; P=0.04).

The researchers said long-term follow-up is needed to understand how social networks and social support may change over time.

“Adolescents and young adult cancer survivors are in a transitory stage of independence from parents,” Dr Huang said. “While this study suggests that survivors often report strong social connections, our previous studies have reported that childhood cancer survivors are more likely than their peers to struggle mentally and physically and report issues like distress and loneliness.”

Dr Huang and his colleagues are working to streamline the FSNI to make it easier for healthcare providers to assess support available to cancer survivors of any age.

 

 

Meanwhile, researchers are working to better understand how social connections affect health outcomes in order to design interventions to foster those connections.

“A lack of social connections with friends and relatives is associated with poor quality of life, risky health behaviors, chronic health conditions, and premature death,” Dr Huang said. “Once we identify the mechanism between social connections and health outcomes, we can start designing interventions to use social networks to improve health outcomes of cancer survivors.”

Photo by Rhoda Baer
Doctor consults with cancer patient and her father

Researchers have developed a new method to measure social networks of adolescent and young adult (AYA) cancer survivors.

This method indicated that AYA cancer survivors often have stronger social networks than their non-cancer peers.

However, the strength of the social network varied by diagnosis, with the lymphoma and leukemia survivors having the greatest support.

These findings were published in Cancer.

“Cancer survivors need healthy social connections, and, to the best of our knowledge, this is the first published study to quantify social networks of adolescent and young adult cancer survivors compared to their peers,” said study author I-Chan Huang, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“The study introduces a method we developed and validated for evaluating social networks of these cancer survivors.”

The method, called the functional social network index (FSNI), measures marital status, contact frequency with friends and relatives, and available resources for health support/advice, which includes emotional support, tangible support, physical activity advice, and weight management advice.

The researchers compared the FSNI to a pair of traditional social network indices—density and betweenness centrality.

Density represents the ratio of the existing relationships/connections within a network to all possible relationships/connections. And betweenness centrality represents the ratio of the existing shortest paths between 2 friends/relatives of the study participants to the shortest possible paths between 2 friends/relatives.

Subjects

The researchers used the 3 social network indices to analyze 102 AYA cancer survivors, ages 18 to 30, and 102 young adults with no cancer history who were matched to the survivors by age, sex, and race.

Subjects were recruited from a commercial national Internet survey panel. They reported detailed social connection information with up to 25 friends and relatives.

The cancer survivors were between 15 and 30 years old when their cancer was diagnosed, and all had completed treatment at least 5 years prior.

Results

Neither the density index nor the betweenness centrality index demonstrated significant differences between cancer survivors and controls (all P values were less than 0.05).

However, according to the FSNI, cancer survivors had more available resources for emotional support (beta [b]=3.02; P=0.003), tangible support (b=4.17; P<0.001), physical activity advice (b=3.94; P<0.001), and weight management advice (b=4.10; P<0.001).

“This makes sense,” Dr Huang said. “Because of their cancer, survivors often have strong networks of physicians, friends, and relatives to provide advice and support.”

However, the FSNI showed the strength of cancer survivors’ support network varied by diagnosis.

Lymphoma survivors ranked highest on the FSNI (b=2.765; P=0.02), followed by survivors of leukemia (b=2.542; P=0.03) and solid tumors (b=2.178; P=0.047), with central nervous system malignancies as the reference.

The researchers also found a higher FSNI was associated with better coping skills, including using emotional support (b=0.08; P=0.04), using instrumental support (b=0.12; P<0.001), venting of emotions (b=0.10; P=0.004), positive reframing (b=0.12; P=0.003), planning for the future (b=0.08; P=0.03), participating in religious activities (b=0.16; P<0.001), and less denial (b=0.10; P=0.01) and destructive behavior (b=0.08; P=0.04).

The researchers said long-term follow-up is needed to understand how social networks and social support may change over time.

“Adolescents and young adult cancer survivors are in a transitory stage of independence from parents,” Dr Huang said. “While this study suggests that survivors often report strong social connections, our previous studies have reported that childhood cancer survivors are more likely than their peers to struggle mentally and physically and report issues like distress and loneliness.”

Dr Huang and his colleagues are working to streamline the FSNI to make it easier for healthcare providers to assess support available to cancer survivors of any age.

 

 

Meanwhile, researchers are working to better understand how social connections affect health outcomes in order to design interventions to foster those connections.

“A lack of social connections with friends and relatives is associated with poor quality of life, risky health behaviors, chronic health conditions, and premature death,” Dr Huang said. “Once we identify the mechanism between social connections and health outcomes, we can start designing interventions to use social networks to improve health outcomes of cancer survivors.”

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Of ‘miracles’ and money: Why hemophilia drugs are so expensive

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YUBA CITY, Calif. – When Landon Morris was diagnosed with hemophilia shortly after birth, his mother, Jessica Morris, was devastated. “It was like having your dreams – all the dreams you imagined for your child – just kind of disappear,” she recalled.

Hemophilia, a rare bleeding disorder caused by a gene mutation that prevents blood from clotting properly, is typically passed from mother to son. Ms. Morris’ grandfather had it, and she remembered hearing how painful it was. “It was almost like he was bubble-wrapped,” she said. “He was coddled, because his mom didn’t want him to get hurt.”

But Landon’s life turned out much different than she expected.

“He’s wild. He’s probably sometimes the roughest of them all,” she said, as she watched the 6-year-old race around a park. “He leads a totally normal life. He plays T-ball. He’ll start soccer in the fall. He runs and jumps and wrestles with his brothers.” That’s due almost entirely to his medication – the kind that wasn’t available in his grandfather’s day. For the Morris family, this type of drug – broadly known as clotting factor – is a miracle, helping Landon’s blood clot normally. And its cost is almost entirely covered by his father’s federal employee health plan.

 

 

But for the health care system, such drugs are enormously expensive, among the priciest in the nation. Medications to treat hemophilia cost an average of more than $270,000 annually per patient, according to a 2015 Express Scripts report. If complications arise, that annual price tag can soar above $1 million. The U.S. hemophilia drug market, which serves about 20,000 patients, is worth $4.6 billion a year, according to the investment research firm AllianceBernstein.

Examining the stubbornly high cost of these medications opens a window into why some prescription drugs in the United States – especially those for rare diseases – have stratospheric prices. The short answer: Competition doesn’t do its traditional job of tamping down costs.

Vying for patients

The market for hemophilia medicines in the United States is flooded with 28 different drugs, with another 21 drugs in development. Because blood factor drugs are biological products – in this case, a protein – there are no cheaper copies, called biosimilars, available. Not only do prices rise steadily as each new product comes on the market, demand is growing – and pushing costs upward – as more and more clotting factor is used to prevent bleeding episodes, not just to treat them.

Yet competition has not brought prices down in the way someone “operating at the level of undergrad Econ 101 would expect,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, Boston, who studies prescription drug costs.

The problem is that companies have no incentive to lower prices. Patients generally don’t push back because insurers pay the bulk of the cost. And insurers tend not to object because the market for the drugs – expensive as they are – is small and the patients are especially vulnerable.

 

 

For drug companies, Dr. Avorn said, “it’s a magical formula: Lifesaving drug, child at risk of bleeding to death – it kind of casts anybody who looks at costs into the role of some evil Scrooge-like person.”

“The insurers don’t want to end up on the front page of the newspaper saying Little Timmy bled to death because his drug wasn’t covered,” he said.

Also, because prices are high across the hemophilia market, no drug company wants to be the one to blink first. “They don’t want to get a price war started and end up at a super low price point,” said Edmund Pezalla, a consultant to pharmaceutical companies and former executive at Aetna.

So, these drugmakers compete not on price but clinical benefits – such as how long the drugs’ effects last – and through intensive marketing. The pool of potential customers is so valuable that companies often vie directly for individual patients.

Manufacturers, as well as specialty pharmacies that sell the drugs, hire patients and parents as recruiters and advisers, hold dinners and holiday parties, offer scholarships to patients, and even run summer camps for children with the disease. The Morris family regularly receives such invitations.

Jonathan Ducore, MD, a pediatric hematologist-oncologist at the University of California, Davis, Hemophilia Treatment Center in Sacramento, said some of his patients are persuaded by drug company presentations to switch medications. ”But the real differences between the drugs are limited,” he said.

Dr. Ducore said he tells patients if he thinks they are being misled by drugmakers about what a product will do. “But even though the tactics may seem a little smarmy, if it’s the patient’s choice, you have to go with it,” said Dr. Ducore, who has been Landon’s doctor since the boy was born.

The first clotting factor products, which came onto the market in the mid-1960s, were derived from human blood plasma, with thousands of donations combined to create one batch. This proved disastrous in the 1980s, when donors unwittingly spread HIV into the blood supply. An estimated 4,000 people with hemophilia – about 40 percent of the patient population in the United States – died from AIDS as a result.
 

 

In the 1990s, manufacturers introduced a product that did not carry the disease risk of plasma-based drugs – made by cloning human clotting proteins in animal cells. Companies charged a premium for this ever-more-popular “recombinant factor.”

Recombinant factor is difficult and delicate to make, said Steve Garger, a development scientist at Bayer, which produces two popular factor products at its Berkeley, Calif., plant – including Landon Morris’ drug, Kogenate.

Inside a concrete building on the campus, kidney cells from baby hamsters are grown in stainless-steel vessels called bioreactors, and the clotting factor they produce is then purified in steel tanks kept in cold rooms. Working at full capacity, this factory produces less than a pound of clotting factor each year – but when diluted with other ingredients, it’s enough to treat thousands of patients in 80 countries.

The investment in manufacturing and marketing is only part of the reason for the high cost of the drugs, said Kevin O’Leary, vice president of pricing and contracting at Bayer. Bayer does not simply add up the costs, slap on a profit margin and come up with the price, Mr. O’Leary explained.

Instead, he said, the company begins by talking to insurers, doctors, and patients to get a sense of what value its products bring to the market, especially compared with drugs already available. Bayer then sets a price based on both its investment and the product’s perceived worth. In the end, he said, “we’re charging a price that’s competitive with the other factor products on the market.”

Bayer’s annual sales from its hemophilia drugs were 1.166 billion euros in 2016. That’s the equivalent of about $1.45 billion in the United States.
 

 

Pushing back on costs

In Europe, hemophilia drugs cost less than half what they cost in the United States. That’s because payers – usually governments – request bids and pick products based on cost and quality.

Without pushback from insurers in the United States, “the price of any drug in the U.S. is whatever the market will bear as seen by the manufacturer,” said Dr. Avorn of Harvard.

Recently, a few insurance companies have quietly started to push back on costs. Bayer’s Mr. O’Leary said several insurers have approached the company and demanded rebates in exchange for offering the drug to their customers. Mr. O’Leary would not discuss the details because he said the contracts are confidential.

State Medicaid programs, which provide health insurance to low-income Americans and cover about half of hemophilia patients, already receive significant rebates from hemophilia drug manufacturers.

Michelle Rice, a senior vice president at the National Hemophilia Foundation, said she has been working with several insurers to help them manage costs safely. “We understand the need to control costs, but they can’t impede access to the product a patient needs,” she said.

It is not yet clear whether such efforts will work, let alone spread.

 

 

Sitting at a picnic bench at a park, Jessica Morris pages through Landon’s insurance documents. Over the past year, his care cost over $120,000. She wonders sometimes what would happen if they lost their coverage.

“How much would you be willing to pay to have your child lead a normal life?” she said. “I don’t think that there’s anything we wouldn’t pay or sacrifice for him.”

It’s a problem she prays they’ll never have to face.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of prescription drug development, costs, and pricing is supported by the Laura and John Arnold Foundation.

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YUBA CITY, Calif. – When Landon Morris was diagnosed with hemophilia shortly after birth, his mother, Jessica Morris, was devastated. “It was like having your dreams – all the dreams you imagined for your child – just kind of disappear,” she recalled.

Hemophilia, a rare bleeding disorder caused by a gene mutation that prevents blood from clotting properly, is typically passed from mother to son. Ms. Morris’ grandfather had it, and she remembered hearing how painful it was. “It was almost like he was bubble-wrapped,” she said. “He was coddled, because his mom didn’t want him to get hurt.”

But Landon’s life turned out much different than she expected.

“He’s wild. He’s probably sometimes the roughest of them all,” she said, as she watched the 6-year-old race around a park. “He leads a totally normal life. He plays T-ball. He’ll start soccer in the fall. He runs and jumps and wrestles with his brothers.” That’s due almost entirely to his medication – the kind that wasn’t available in his grandfather’s day. For the Morris family, this type of drug – broadly known as clotting factor – is a miracle, helping Landon’s blood clot normally. And its cost is almost entirely covered by his father’s federal employee health plan.

 

 

But for the health care system, such drugs are enormously expensive, among the priciest in the nation. Medications to treat hemophilia cost an average of more than $270,000 annually per patient, according to a 2015 Express Scripts report. If complications arise, that annual price tag can soar above $1 million. The U.S. hemophilia drug market, which serves about 20,000 patients, is worth $4.6 billion a year, according to the investment research firm AllianceBernstein.

Examining the stubbornly high cost of these medications opens a window into why some prescription drugs in the United States – especially those for rare diseases – have stratospheric prices. The short answer: Competition doesn’t do its traditional job of tamping down costs.

Vying for patients

The market for hemophilia medicines in the United States is flooded with 28 different drugs, with another 21 drugs in development. Because blood factor drugs are biological products – in this case, a protein – there are no cheaper copies, called biosimilars, available. Not only do prices rise steadily as each new product comes on the market, demand is growing – and pushing costs upward – as more and more clotting factor is used to prevent bleeding episodes, not just to treat them.

Yet competition has not brought prices down in the way someone “operating at the level of undergrad Econ 101 would expect,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, Boston, who studies prescription drug costs.

The problem is that companies have no incentive to lower prices. Patients generally don’t push back because insurers pay the bulk of the cost. And insurers tend not to object because the market for the drugs – expensive as they are – is small and the patients are especially vulnerable.

 

 

For drug companies, Dr. Avorn said, “it’s a magical formula: Lifesaving drug, child at risk of bleeding to death – it kind of casts anybody who looks at costs into the role of some evil Scrooge-like person.”

“The insurers don’t want to end up on the front page of the newspaper saying Little Timmy bled to death because his drug wasn’t covered,” he said.

Also, because prices are high across the hemophilia market, no drug company wants to be the one to blink first. “They don’t want to get a price war started and end up at a super low price point,” said Edmund Pezalla, a consultant to pharmaceutical companies and former executive at Aetna.

So, these drugmakers compete not on price but clinical benefits – such as how long the drugs’ effects last – and through intensive marketing. The pool of potential customers is so valuable that companies often vie directly for individual patients.

Manufacturers, as well as specialty pharmacies that sell the drugs, hire patients and parents as recruiters and advisers, hold dinners and holiday parties, offer scholarships to patients, and even run summer camps for children with the disease. The Morris family regularly receives such invitations.

Jonathan Ducore, MD, a pediatric hematologist-oncologist at the University of California, Davis, Hemophilia Treatment Center in Sacramento, said some of his patients are persuaded by drug company presentations to switch medications. ”But the real differences between the drugs are limited,” he said.

Dr. Ducore said he tells patients if he thinks they are being misled by drugmakers about what a product will do. “But even though the tactics may seem a little smarmy, if it’s the patient’s choice, you have to go with it,” said Dr. Ducore, who has been Landon’s doctor since the boy was born.

The first clotting factor products, which came onto the market in the mid-1960s, were derived from human blood plasma, with thousands of donations combined to create one batch. This proved disastrous in the 1980s, when donors unwittingly spread HIV into the blood supply. An estimated 4,000 people with hemophilia – about 40 percent of the patient population in the United States – died from AIDS as a result.
 

 

In the 1990s, manufacturers introduced a product that did not carry the disease risk of plasma-based drugs – made by cloning human clotting proteins in animal cells. Companies charged a premium for this ever-more-popular “recombinant factor.”

Recombinant factor is difficult and delicate to make, said Steve Garger, a development scientist at Bayer, which produces two popular factor products at its Berkeley, Calif., plant – including Landon Morris’ drug, Kogenate.

Inside a concrete building on the campus, kidney cells from baby hamsters are grown in stainless-steel vessels called bioreactors, and the clotting factor they produce is then purified in steel tanks kept in cold rooms. Working at full capacity, this factory produces less than a pound of clotting factor each year – but when diluted with other ingredients, it’s enough to treat thousands of patients in 80 countries.

The investment in manufacturing and marketing is only part of the reason for the high cost of the drugs, said Kevin O’Leary, vice president of pricing and contracting at Bayer. Bayer does not simply add up the costs, slap on a profit margin and come up with the price, Mr. O’Leary explained.

Instead, he said, the company begins by talking to insurers, doctors, and patients to get a sense of what value its products bring to the market, especially compared with drugs already available. Bayer then sets a price based on both its investment and the product’s perceived worth. In the end, he said, “we’re charging a price that’s competitive with the other factor products on the market.”

Bayer’s annual sales from its hemophilia drugs were 1.166 billion euros in 2016. That’s the equivalent of about $1.45 billion in the United States.
 

 

Pushing back on costs

In Europe, hemophilia drugs cost less than half what they cost in the United States. That’s because payers – usually governments – request bids and pick products based on cost and quality.

Without pushback from insurers in the United States, “the price of any drug in the U.S. is whatever the market will bear as seen by the manufacturer,” said Dr. Avorn of Harvard.

Recently, a few insurance companies have quietly started to push back on costs. Bayer’s Mr. O’Leary said several insurers have approached the company and demanded rebates in exchange for offering the drug to their customers. Mr. O’Leary would not discuss the details because he said the contracts are confidential.

State Medicaid programs, which provide health insurance to low-income Americans and cover about half of hemophilia patients, already receive significant rebates from hemophilia drug manufacturers.

Michelle Rice, a senior vice president at the National Hemophilia Foundation, said she has been working with several insurers to help them manage costs safely. “We understand the need to control costs, but they can’t impede access to the product a patient needs,” she said.

It is not yet clear whether such efforts will work, let alone spread.

 

 

Sitting at a picnic bench at a park, Jessica Morris pages through Landon’s insurance documents. Over the past year, his care cost over $120,000. She wonders sometimes what would happen if they lost their coverage.

“How much would you be willing to pay to have your child lead a normal life?” she said. “I don’t think that there’s anything we wouldn’t pay or sacrifice for him.”

It’s a problem she prays they’ll never have to face.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of prescription drug development, costs, and pricing is supported by the Laura and John Arnold Foundation.

 

YUBA CITY, Calif. – When Landon Morris was diagnosed with hemophilia shortly after birth, his mother, Jessica Morris, was devastated. “It was like having your dreams – all the dreams you imagined for your child – just kind of disappear,” she recalled.

Hemophilia, a rare bleeding disorder caused by a gene mutation that prevents blood from clotting properly, is typically passed from mother to son. Ms. Morris’ grandfather had it, and she remembered hearing how painful it was. “It was almost like he was bubble-wrapped,” she said. “He was coddled, because his mom didn’t want him to get hurt.”

But Landon’s life turned out much different than she expected.

“He’s wild. He’s probably sometimes the roughest of them all,” she said, as she watched the 6-year-old race around a park. “He leads a totally normal life. He plays T-ball. He’ll start soccer in the fall. He runs and jumps and wrestles with his brothers.” That’s due almost entirely to his medication – the kind that wasn’t available in his grandfather’s day. For the Morris family, this type of drug – broadly known as clotting factor – is a miracle, helping Landon’s blood clot normally. And its cost is almost entirely covered by his father’s federal employee health plan.

 

 

But for the health care system, such drugs are enormously expensive, among the priciest in the nation. Medications to treat hemophilia cost an average of more than $270,000 annually per patient, according to a 2015 Express Scripts report. If complications arise, that annual price tag can soar above $1 million. The U.S. hemophilia drug market, which serves about 20,000 patients, is worth $4.6 billion a year, according to the investment research firm AllianceBernstein.

Examining the stubbornly high cost of these medications opens a window into why some prescription drugs in the United States – especially those for rare diseases – have stratospheric prices. The short answer: Competition doesn’t do its traditional job of tamping down costs.

Vying for patients

The market for hemophilia medicines in the United States is flooded with 28 different drugs, with another 21 drugs in development. Because blood factor drugs are biological products – in this case, a protein – there are no cheaper copies, called biosimilars, available. Not only do prices rise steadily as each new product comes on the market, demand is growing – and pushing costs upward – as more and more clotting factor is used to prevent bleeding episodes, not just to treat them.

Yet competition has not brought prices down in the way someone “operating at the level of undergrad Econ 101 would expect,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, Boston, who studies prescription drug costs.

The problem is that companies have no incentive to lower prices. Patients generally don’t push back because insurers pay the bulk of the cost. And insurers tend not to object because the market for the drugs – expensive as they are – is small and the patients are especially vulnerable.

 

 

For drug companies, Dr. Avorn said, “it’s a magical formula: Lifesaving drug, child at risk of bleeding to death – it kind of casts anybody who looks at costs into the role of some evil Scrooge-like person.”

“The insurers don’t want to end up on the front page of the newspaper saying Little Timmy bled to death because his drug wasn’t covered,” he said.

Also, because prices are high across the hemophilia market, no drug company wants to be the one to blink first. “They don’t want to get a price war started and end up at a super low price point,” said Edmund Pezalla, a consultant to pharmaceutical companies and former executive at Aetna.

So, these drugmakers compete not on price but clinical benefits – such as how long the drugs’ effects last – and through intensive marketing. The pool of potential customers is so valuable that companies often vie directly for individual patients.

Manufacturers, as well as specialty pharmacies that sell the drugs, hire patients and parents as recruiters and advisers, hold dinners and holiday parties, offer scholarships to patients, and even run summer camps for children with the disease. The Morris family regularly receives such invitations.

Jonathan Ducore, MD, a pediatric hematologist-oncologist at the University of California, Davis, Hemophilia Treatment Center in Sacramento, said some of his patients are persuaded by drug company presentations to switch medications. ”But the real differences between the drugs are limited,” he said.

Dr. Ducore said he tells patients if he thinks they are being misled by drugmakers about what a product will do. “But even though the tactics may seem a little smarmy, if it’s the patient’s choice, you have to go with it,” said Dr. Ducore, who has been Landon’s doctor since the boy was born.

The first clotting factor products, which came onto the market in the mid-1960s, were derived from human blood plasma, with thousands of donations combined to create one batch. This proved disastrous in the 1980s, when donors unwittingly spread HIV into the blood supply. An estimated 4,000 people with hemophilia – about 40 percent of the patient population in the United States – died from AIDS as a result.
 

 

In the 1990s, manufacturers introduced a product that did not carry the disease risk of plasma-based drugs – made by cloning human clotting proteins in animal cells. Companies charged a premium for this ever-more-popular “recombinant factor.”

Recombinant factor is difficult and delicate to make, said Steve Garger, a development scientist at Bayer, which produces two popular factor products at its Berkeley, Calif., plant – including Landon Morris’ drug, Kogenate.

Inside a concrete building on the campus, kidney cells from baby hamsters are grown in stainless-steel vessels called bioreactors, and the clotting factor they produce is then purified in steel tanks kept in cold rooms. Working at full capacity, this factory produces less than a pound of clotting factor each year – but when diluted with other ingredients, it’s enough to treat thousands of patients in 80 countries.

The investment in manufacturing and marketing is only part of the reason for the high cost of the drugs, said Kevin O’Leary, vice president of pricing and contracting at Bayer. Bayer does not simply add up the costs, slap on a profit margin and come up with the price, Mr. O’Leary explained.

Instead, he said, the company begins by talking to insurers, doctors, and patients to get a sense of what value its products bring to the market, especially compared with drugs already available. Bayer then sets a price based on both its investment and the product’s perceived worth. In the end, he said, “we’re charging a price that’s competitive with the other factor products on the market.”

Bayer’s annual sales from its hemophilia drugs were 1.166 billion euros in 2016. That’s the equivalent of about $1.45 billion in the United States.
 

 

Pushing back on costs

In Europe, hemophilia drugs cost less than half what they cost in the United States. That’s because payers – usually governments – request bids and pick products based on cost and quality.

Without pushback from insurers in the United States, “the price of any drug in the U.S. is whatever the market will bear as seen by the manufacturer,” said Dr. Avorn of Harvard.

Recently, a few insurance companies have quietly started to push back on costs. Bayer’s Mr. O’Leary said several insurers have approached the company and demanded rebates in exchange for offering the drug to their customers. Mr. O’Leary would not discuss the details because he said the contracts are confidential.

State Medicaid programs, which provide health insurance to low-income Americans and cover about half of hemophilia patients, already receive significant rebates from hemophilia drug manufacturers.

Michelle Rice, a senior vice president at the National Hemophilia Foundation, said she has been working with several insurers to help them manage costs safely. “We understand the need to control costs, but they can’t impede access to the product a patient needs,” she said.

It is not yet clear whether such efforts will work, let alone spread.

 

 

Sitting at a picnic bench at a park, Jessica Morris pages through Landon’s insurance documents. Over the past year, his care cost over $120,000. She wonders sometimes what would happen if they lost their coverage.

“How much would you be willing to pay to have your child lead a normal life?” she said. “I don’t think that there’s anything we wouldn’t pay or sacrifice for him.”

It’s a problem she prays they’ll never have to face.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente. KHN’s coverage of prescription drug development, costs, and pricing is supported by the Laura and John Arnold Foundation.

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The case for being open-minded about medical marijuana

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– Even if you do not believe in medical cannabis, be open to patients who ask you if it might benefit them, Kevin P. Hill, MD, advised.

“Being willing to talk to your patient about it is important,” said Dr. Hill, of the division of addiction psychiatry at Beth Israel Deaconess Medical Center, Boston, said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Because what will happen is, they’ll say, ‘Look. I need medical marijuana to treat my anxiety.’ Then you can say, ‘Well, I have treatments that work for anxiety that we haven’t tried.’ Maybe you can get them into treatment because of that conversation.”

In his opinion, the appropriate candidate for medical cannabis is someone with a debilitating condition who has failed multiple first- and second-line treatments. “The policy of medical cannabis is ahead of the science,” he noted. “It’s not a good place to be, but now the question becomes: How do we give people what they want while addressing the risks? I think we need to do a better job of that. We can provide a service to patients and colleagues by being informed and thoughtful on the topic.”

Food and Drug Administration–approved cannabinoids to date are dronabinol (Marinol) and nabilone (Cesamet). These agents are approved for nausea and vomiting associated with chemotherapy and for appetite stimulation in wasting illnesses such as AIDS. “Your patients may come to you and say, ‘I think I need medical cannabis for condition X,’ ” said Dr. Hill, who authored the book “Marijuana: The Unbiased Truth About the World’s Most Popular Weed” (Center City, Minn.: Hazelden Publishing, 2015). “Maybe the cannabis plant can outperform the two approved agents that we have. I think we have to be open to that possibility. Maybe they offer some things that dronabinol and nabilone don’t.”

 

 

Medical indications for cannabis in various states include 53 conditions, he said, such as cancer, glaucoma, AIDS, hepatitis C, amyotrophic lateral sclerosis, Crohn’s disease, Parkinson’s disease, and multiple sclerosis. However, data suggest that most people with medical cannabis cards do not have one of those conditions. More than 50 trials of cannabinoids, including cannabis, have been conducted, “and we definitely need a lot more,” Dr. Hill continued. “About half of the studies show positive effects for chronic pain, neuropathic pain, and spasticity associated with MS.”

Resources Dr. Hill recommended for clinicians include a review that he published in JAMA (2015;313[24]:2474-83), and a review of cannabis and pain that he coauthored that was published in the journal Cannabis and Cannabinoid Research (2017;2[1]:96-104), and a free downloadable publication from he National Academies Press entitled “Health Effects of Cannabis and Cannabinoid Research: The Current State of Evidence and Recommendations for Research.” One passage from that document reads as follows: “Despite the extensive changes in policy at the state level and the rapid rise in the use of cannabis both for medical purposes and for recreational use, conclusive evidence regarding the short- and long-term health effects (harms and benefits) of cannabis use remains elusive. A lack of scientific research has resulted in a lack of information on the health implications of cannabis use, which is a significant public health concern for vulnerable populations such as pregnant women and adolescents. Unlike other substances whose use may confer risk, such as alcohol or tobacco, no accepted standards exist to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively.”

Dr. Hill disclosed that he has received research grants from National Institute on Drug Abuse, the Brain and Behavior Research Foundation, the American Lung Association, the Greater Boston Council on Alcoholism, and the Peter G. Dodge Foundation. He also receives book royalties from Hazelden Publishing.

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– Even if you do not believe in medical cannabis, be open to patients who ask you if it might benefit them, Kevin P. Hill, MD, advised.

“Being willing to talk to your patient about it is important,” said Dr. Hill, of the division of addiction psychiatry at Beth Israel Deaconess Medical Center, Boston, said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Because what will happen is, they’ll say, ‘Look. I need medical marijuana to treat my anxiety.’ Then you can say, ‘Well, I have treatments that work for anxiety that we haven’t tried.’ Maybe you can get them into treatment because of that conversation.”

In his opinion, the appropriate candidate for medical cannabis is someone with a debilitating condition who has failed multiple first- and second-line treatments. “The policy of medical cannabis is ahead of the science,” he noted. “It’s not a good place to be, but now the question becomes: How do we give people what they want while addressing the risks? I think we need to do a better job of that. We can provide a service to patients and colleagues by being informed and thoughtful on the topic.”

Food and Drug Administration–approved cannabinoids to date are dronabinol (Marinol) and nabilone (Cesamet). These agents are approved for nausea and vomiting associated with chemotherapy and for appetite stimulation in wasting illnesses such as AIDS. “Your patients may come to you and say, ‘I think I need medical cannabis for condition X,’ ” said Dr. Hill, who authored the book “Marijuana: The Unbiased Truth About the World’s Most Popular Weed” (Center City, Minn.: Hazelden Publishing, 2015). “Maybe the cannabis plant can outperform the two approved agents that we have. I think we have to be open to that possibility. Maybe they offer some things that dronabinol and nabilone don’t.”

 

 

Medical indications for cannabis in various states include 53 conditions, he said, such as cancer, glaucoma, AIDS, hepatitis C, amyotrophic lateral sclerosis, Crohn’s disease, Parkinson’s disease, and multiple sclerosis. However, data suggest that most people with medical cannabis cards do not have one of those conditions. More than 50 trials of cannabinoids, including cannabis, have been conducted, “and we definitely need a lot more,” Dr. Hill continued. “About half of the studies show positive effects for chronic pain, neuropathic pain, and spasticity associated with MS.”

Resources Dr. Hill recommended for clinicians include a review that he published in JAMA (2015;313[24]:2474-83), and a review of cannabis and pain that he coauthored that was published in the journal Cannabis and Cannabinoid Research (2017;2[1]:96-104), and a free downloadable publication from he National Academies Press entitled “Health Effects of Cannabis and Cannabinoid Research: The Current State of Evidence and Recommendations for Research.” One passage from that document reads as follows: “Despite the extensive changes in policy at the state level and the rapid rise in the use of cannabis both for medical purposes and for recreational use, conclusive evidence regarding the short- and long-term health effects (harms and benefits) of cannabis use remains elusive. A lack of scientific research has resulted in a lack of information on the health implications of cannabis use, which is a significant public health concern for vulnerable populations such as pregnant women and adolescents. Unlike other substances whose use may confer risk, such as alcohol or tobacco, no accepted standards exist to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively.”

Dr. Hill disclosed that he has received research grants from National Institute on Drug Abuse, the Brain and Behavior Research Foundation, the American Lung Association, the Greater Boston Council on Alcoholism, and the Peter G. Dodge Foundation. He also receives book royalties from Hazelden Publishing.

dbrunk@frontlinemedcom.com

 

– Even if you do not believe in medical cannabis, be open to patients who ask you if it might benefit them, Kevin P. Hill, MD, advised.

“Being willing to talk to your patient about it is important,” said Dr. Hill, of the division of addiction psychiatry at Beth Israel Deaconess Medical Center, Boston, said at an annual psychopharmacology update held by the Nevada Psychiatric Association. “Because what will happen is, they’ll say, ‘Look. I need medical marijuana to treat my anxiety.’ Then you can say, ‘Well, I have treatments that work for anxiety that we haven’t tried.’ Maybe you can get them into treatment because of that conversation.”

In his opinion, the appropriate candidate for medical cannabis is someone with a debilitating condition who has failed multiple first- and second-line treatments. “The policy of medical cannabis is ahead of the science,” he noted. “It’s not a good place to be, but now the question becomes: How do we give people what they want while addressing the risks? I think we need to do a better job of that. We can provide a service to patients and colleagues by being informed and thoughtful on the topic.”

Food and Drug Administration–approved cannabinoids to date are dronabinol (Marinol) and nabilone (Cesamet). These agents are approved for nausea and vomiting associated with chemotherapy and for appetite stimulation in wasting illnesses such as AIDS. “Your patients may come to you and say, ‘I think I need medical cannabis for condition X,’ ” said Dr. Hill, who authored the book “Marijuana: The Unbiased Truth About the World’s Most Popular Weed” (Center City, Minn.: Hazelden Publishing, 2015). “Maybe the cannabis plant can outperform the two approved agents that we have. I think we have to be open to that possibility. Maybe they offer some things that dronabinol and nabilone don’t.”

 

 

Medical indications for cannabis in various states include 53 conditions, he said, such as cancer, glaucoma, AIDS, hepatitis C, amyotrophic lateral sclerosis, Crohn’s disease, Parkinson’s disease, and multiple sclerosis. However, data suggest that most people with medical cannabis cards do not have one of those conditions. More than 50 trials of cannabinoids, including cannabis, have been conducted, “and we definitely need a lot more,” Dr. Hill continued. “About half of the studies show positive effects for chronic pain, neuropathic pain, and spasticity associated with MS.”

Resources Dr. Hill recommended for clinicians include a review that he published in JAMA (2015;313[24]:2474-83), and a review of cannabis and pain that he coauthored that was published in the journal Cannabis and Cannabinoid Research (2017;2[1]:96-104), and a free downloadable publication from he National Academies Press entitled “Health Effects of Cannabis and Cannabinoid Research: The Current State of Evidence and Recommendations for Research.” One passage from that document reads as follows: “Despite the extensive changes in policy at the state level and the rapid rise in the use of cannabis both for medical purposes and for recreational use, conclusive evidence regarding the short- and long-term health effects (harms and benefits) of cannabis use remains elusive. A lack of scientific research has resulted in a lack of information on the health implications of cannabis use, which is a significant public health concern for vulnerable populations such as pregnant women and adolescents. Unlike other substances whose use may confer risk, such as alcohol or tobacco, no accepted standards exist to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively.”

Dr. Hill disclosed that he has received research grants from National Institute on Drug Abuse, the Brain and Behavior Research Foundation, the American Lung Association, the Greater Boston Council on Alcoholism, and the Peter G. Dodge Foundation. He also receives book royalties from Hazelden Publishing.

dbrunk@frontlinemedcom.com
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Medical associations fight American College of Physicians HBA1c recommendations

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Diabetes and endocrinology associations pushed back against a recent American College of Physicians recommendation to raise the target level of hemoglobin A1c in patients with type 2 diabetes to between 7% and 8% in a statement released Friday, March 9.

The new guideline, which was published in the Annals of Internal Medicine on March 5 “could prevent many patients from receiving the full benefits of long-term glucose control,” according to a joint statement from the Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and American Association of Clinical Endocrinologists.

“The main concern here is this statement is too large to apply to most people with type 2 diabetes,” Grazia Aleppo, MD, chair of the Endocrine Society’s Clinical Affairs Core Committee, said in an interview. “We are all in agreement among the societies to include the ACP’s recommendation on individualizing treatment, but there is a big difference in a 1% HbA1c increase.

“A 7% HbA1c reflects the average of about 154 mg/dL on average, but 8% reflects the average of about 183 mg/dL.”

 

 

With patients without diabetes averaging between 70 and 99 mg/dL, a jump to 183 is concerning for Dr. Aleppo and her colleagues.

The ACP’s recommendations were determined from analysis of four drug therapy trials, which found aiming HbA1c levels at below 7% put patients at risk for hypoglycemia and cardiovascular events.

While the trials themselves were approved by the ADA, AADE, and AACE, associations expressed concern with the exclusion of important data, including the addition of newly diagnosed patients in the test population and more modern medications that reduce the adverse effects mentioned in the ACP’s reasoning for raising the target levels.

The patients participating in the trials were older and could have already had underlying cardiovascular disease, according to Dr. Aleppo. These factors plus a rapid change to their medication to get them below 6.5% could have instigated a cardiovascular response, which would not be as likely for patients in their 40s who are just being diagnosed.
 

 

“A great majority of patients who are seen in the primary care setting usually don’t have advanced diabetes and, in that case, if someone does not have an increased risk for hypoglycemia, which is the concern that the ACP has, they should be kept at the tightest possible control so that when they are much older they have a legacy effect of good control of their disease,” said Dr. Aleppo.** “Also, if you place someone on modern, lower-risk medications that are so much safer today than before, these actually have been shown not only to improve glucose level in high-risk patients, they can actually cause a very big improvement in cardiovascular disease outcomes.”

Sodium-glucose cotransporter 2 inhibitors and glucagonlike peptide-1 receptor agonists are both newer medications with signs of high success, according to Dr. Aleppo.*

At press time the American College of Physicians was unable to provide a statement.
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Diabetes and endocrinology associations pushed back against a recent American College of Physicians recommendation to raise the target level of hemoglobin A1c in patients with type 2 diabetes to between 7% and 8% in a statement released Friday, March 9.

The new guideline, which was published in the Annals of Internal Medicine on March 5 “could prevent many patients from receiving the full benefits of long-term glucose control,” according to a joint statement from the Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and American Association of Clinical Endocrinologists.

“The main concern here is this statement is too large to apply to most people with type 2 diabetes,” Grazia Aleppo, MD, chair of the Endocrine Society’s Clinical Affairs Core Committee, said in an interview. “We are all in agreement among the societies to include the ACP’s recommendation on individualizing treatment, but there is a big difference in a 1% HbA1c increase.

“A 7% HbA1c reflects the average of about 154 mg/dL on average, but 8% reflects the average of about 183 mg/dL.”

 

 

With patients without diabetes averaging between 70 and 99 mg/dL, a jump to 183 is concerning for Dr. Aleppo and her colleagues.

The ACP’s recommendations were determined from analysis of four drug therapy trials, which found aiming HbA1c levels at below 7% put patients at risk for hypoglycemia and cardiovascular events.

While the trials themselves were approved by the ADA, AADE, and AACE, associations expressed concern with the exclusion of important data, including the addition of newly diagnosed patients in the test population and more modern medications that reduce the adverse effects mentioned in the ACP’s reasoning for raising the target levels.

The patients participating in the trials were older and could have already had underlying cardiovascular disease, according to Dr. Aleppo. These factors plus a rapid change to their medication to get them below 6.5% could have instigated a cardiovascular response, which would not be as likely for patients in their 40s who are just being diagnosed.
 

 

“A great majority of patients who are seen in the primary care setting usually don’t have advanced diabetes and, in that case, if someone does not have an increased risk for hypoglycemia, which is the concern that the ACP has, they should be kept at the tightest possible control so that when they are much older they have a legacy effect of good control of their disease,” said Dr. Aleppo.** “Also, if you place someone on modern, lower-risk medications that are so much safer today than before, these actually have been shown not only to improve glucose level in high-risk patients, they can actually cause a very big improvement in cardiovascular disease outcomes.”

Sodium-glucose cotransporter 2 inhibitors and glucagonlike peptide-1 receptor agonists are both newer medications with signs of high success, according to Dr. Aleppo.*

At press time the American College of Physicians was unable to provide a statement.

 

Diabetes and endocrinology associations pushed back against a recent American College of Physicians recommendation to raise the target level of hemoglobin A1c in patients with type 2 diabetes to between 7% and 8% in a statement released Friday, March 9.

The new guideline, which was published in the Annals of Internal Medicine on March 5 “could prevent many patients from receiving the full benefits of long-term glucose control,” according to a joint statement from the Endocrine Society, American Diabetes Association, American Association of Diabetes Educators, and American Association of Clinical Endocrinologists.

“The main concern here is this statement is too large to apply to most people with type 2 diabetes,” Grazia Aleppo, MD, chair of the Endocrine Society’s Clinical Affairs Core Committee, said in an interview. “We are all in agreement among the societies to include the ACP’s recommendation on individualizing treatment, but there is a big difference in a 1% HbA1c increase.

“A 7% HbA1c reflects the average of about 154 mg/dL on average, but 8% reflects the average of about 183 mg/dL.”

 

 

With patients without diabetes averaging between 70 and 99 mg/dL, a jump to 183 is concerning for Dr. Aleppo and her colleagues.

The ACP’s recommendations were determined from analysis of four drug therapy trials, which found aiming HbA1c levels at below 7% put patients at risk for hypoglycemia and cardiovascular events.

While the trials themselves were approved by the ADA, AADE, and AACE, associations expressed concern with the exclusion of important data, including the addition of newly diagnosed patients in the test population and more modern medications that reduce the adverse effects mentioned in the ACP’s reasoning for raising the target levels.

The patients participating in the trials were older and could have already had underlying cardiovascular disease, according to Dr. Aleppo. These factors plus a rapid change to their medication to get them below 6.5% could have instigated a cardiovascular response, which would not be as likely for patients in their 40s who are just being diagnosed.
 

 

“A great majority of patients who are seen in the primary care setting usually don’t have advanced diabetes and, in that case, if someone does not have an increased risk for hypoglycemia, which is the concern that the ACP has, they should be kept at the tightest possible control so that when they are much older they have a legacy effect of good control of their disease,” said Dr. Aleppo.** “Also, if you place someone on modern, lower-risk medications that are so much safer today than before, these actually have been shown not only to improve glucose level in high-risk patients, they can actually cause a very big improvement in cardiovascular disease outcomes.”

Sodium-glucose cotransporter 2 inhibitors and glucagonlike peptide-1 receptor agonists are both newer medications with signs of high success, according to Dr. Aleppo.*

At press time the American College of Physicians was unable to provide a statement.
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Clinical Updates in CGRP

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New study establishes IBD severity index

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Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648). The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.

The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.

Dr. Corey A. Siegel
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course. A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.

A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity. A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
 

 


The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.

Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion. Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.

Crohn’s disease severity was largely dependent on factors related to intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.

This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.

 

 

SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.

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Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648). The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.

The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.

Dr. Corey A. Siegel
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course. A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.

A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity. A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
 

 


The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.

Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion. Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.

Crohn’s disease severity was largely dependent on factors related to intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.

This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.

 

 

SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.

 

Experts have established a severity index for inflammatory bowel disease (IBD), according to results of an analysis published in the journal Gut (doi: 10.1136/gutjnl-2016-312648). The index, conceived by a panel of IBD specialists from the International Organization for the Study of Inflammatory Bowel Diseases, is a step toward the standardization of disease severity definitions in ulcerative colitis and Crohn’s disease.

The panel determined 16 severity attributes for Crohn’s disease and 13 for ulcerative colitis. The analysis found that, in Crohn’s disease, mucosal lesions, fistulas, and abscesses were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein, wrote Corey A. Siegel, MD, MS, of the Dartmouth-Hitchcock Medical Center in Lebanon, N.H., and his coauthors.

Dr. Corey A. Siegel
Investigators used a PubMed literature search to identify three broad elements of disease severity: impact of disease symptoms on daily activities, inflammatory burden, and disease course. A panel of 16 experts then conducted a series of votes to determine which attributes within each domain would be used to assess disease severity. Two sets of attributes were defined as disease markers in Crohn’s disease and ulcerative colitis.

A type of conjoint analysis called adaptive choice-based conjoint was then performed to ascertain how different clinical factors influenced specialists’ decision making and impressions of disease severity. A series of questions was asked, with each response determining subsequent questions, until “ample consistency” was found in their choices.
 

 


The exercise first had participants decide which hypothetical patient profiles met their evaluation criteria; it then showed them two final profiles and asked which was the more severe case. Survey length depended on the consistency of participants’ responses, with those lacking consistency being given more tasks to complete, Dr. Siegel and his colleagues reported.

Respondents completed the exercise three times: first independently without discussion, then after discussion in a group setting with an automated response system, and finally, independently following group discussion. Disease severity indexes were created on a 100-point scale, and average part-worth utility scores were used to determine minimum and maximum scores for each attribute, with zero representing the absence of a symptom.

Crohn’s disease severity was largely dependent on factors related to intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.

This analysis “helps redefine overall disease severity for IBD,” the authors wrote. Once validated, the indexes will offer “both further research opportunities and a practical tool by which to classify overall disease severity of patients and offer appropriate treatment without relying on present symptoms alone,” they added.

 

 

SOURCE: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.

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Key clinical point: Crohn’s disease severity was dependent on intestinal damage, whereas ulcerative colitis disease severity was associated with symptoms and effects on daily life.

Major finding: Sixteen severity attributes were determined for Crohn’s disease, and 13 for ulcerative colitis; in Crohn’s disease, mucosal lesions, fistula, and abscess were the greatest contributors to disease severity at 15.8%, 10.9%, and 9.7%, respectively. In ulcerative colitis, 18.1% of disease severity was attributed to mucosal lesions, 14% to impact on daily activities, and 11.2% to C-reactive protein.

Data source: A conjoint analysis of disease attributes performed by 18 members of the International Organization for the Study of Inflammatory Bowel Diseases.

Disclosures: The study was funded by AbbVie and Tillotts Pharma. The authors disclosed financial relationships with numerous additional pharmaceutical companies.

Source: Siegel CA et al. Gut. 2018 Feb;67(2):244-54.
 

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FDA issues warning to all duodenoscope manufacturers

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The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.

Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.

Read the full press release on the FDA’s website.

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The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.

Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.

Read the full press release on the FDA’s website.

 

The Food and Drug Administration on March 9 issued warning letters to all three duodenoscope manufacturers for failing to comply with the requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.

The warning is part of an ongoing effort to prevent patient infections associated with the transmission of bacteria from contaminated duodenoscopes. The three manufacturers – Olympus, Fujifilm, and Pentax – are required to conduct studies to sample and culture reprocessed duodenoscopes that are in clinical use to learn more about issues that contribute to contamination, and to study human factors to determine how hospital staff who have had training are following the reprocessing instructions. In 2015, the FDA ordered the companies to conduct a postmarket surveillance study to determine whether health care facilities were able to properly clean and disinfect the devices.

Currently, the Olympus manufacturer has failed to start data collection, while both Pentax and Fujifilm have failed to provide sufficient data required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. In addition, Olympus and Pentax have not complied with requirements to assess how well staff members have followed the reprocessing instructions after the human factors studies and Fujifilm has been meeting its requirements for its human factors study only.

“The FDA has taken important steps to improve the reprocessing of duodenoscopes, and we’ve seen a reduction in reports of patient infections, but we need the required postmarket studies to determine whether these measures are being properly implemented in real-world clinical settings and whether we need to take additional action to further improve the safety of these devices,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health in a press release. “We expect these device manufacturers to meet their study obligations to ensure patient safety.”

The companies have until March 24 to submit a plan that outlines how study milestones will be achieved. If the companies fail to respond to the warning letter, the FDA states that they may take additional action, such as seizure, injunction, and civil monetary penalties.

Read the full press release on the FDA’s website.

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Rare Neurological Disease Special Report

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Looking to increase PrEP uptake

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– More than 1.1 million Americans are at substantial risk for HIV and would benefit from preexposure prophylaxis (PrEP), but only 90,000 prescriptions were filled by retail or mail-order pharmacies in the United States from Sept. 2015 to August 2016, according to the Centers for Disease Control and Prevention.

The CDC estimated that 500,340 blacks in the United States have indications for preexposure prophylaxis, but only about 7,000 (less than 1%) filled a prescription during that time. Among an estimated 282,260 Hispanics who might benefit, just about 7,600 (3%) filled prescriptions. Uptake was a bit higher among whites: about 42,000 prescriptions among 303,230 at-risk people (14%).

Dr. Dawn Smith
“These data paint a full-enough picture to say that without a doubt, nearly 6 years after [Food and Drug Administration] approval, we are nowhere near tapping the full potential of PrEP as a hugely powerful HIV prevention tool. Our study makes it clear that there is an urgent need to increase awareness of and access to PrEP, particularly among black and Hispanic populations,” said lead investigator Dawn Smith, MD, a CDC medical epidemiologist.

PrEP uptake might be particularly low among black and Hispanic people because, in addition to the well-known disparities in health care access and other issues: “There’s a stigma with being gay: ‘If I’m taking this drug, does that mean I’m gay?’ ” Dr. Smith said.
 

 


To address the problem, “get more serious about HIV testing. You want to find people who are positive, who need to be on treatment. The second step is to find ways to collect risk-behavior data.” That could be as simple as having the nurse ask a few extra questions before the office visit, or adding a few questions to the intake form, she said at the Conference On Retroviruses And Opportunistic Infections.

“You are trying to help patients acknowledge that they are engaging in behaviors that might have exposed them to HIV, and providers need to be able to hear the answers. One of the problems we have is providers who say ‘my patients aren’t like that,’ or ‘this person is married; I don’t need to ask them.’” Another easy way to find at-risk patients is to look at STD history. If a patient has had syphilis, or two episodes of gonorrhea in the past year, you “need to talk to them about PrEP,” she said.

For black and Hispanic patients, “it’s a higher index of suspicion. For example, you take blood pressure in all your patients, but you are also aware that hypertension is more common in African Americans. So if you’re rushed, you are still going to do a blood pressure in African American patients, but maybe not in the young white jogger; you get that next time.” Especially in high-prevalence HIV settings, “every patient should be aware of PrEP. It should be part of the conversation with everybody,” she said.

The CDC used national pharmacy data and estimates of risky behavior to draw its conclusions. Commercial pharmacies account for maybe 90% of all PrEP prescriptions, so the data slightly underestimate the true use numbers. The more than 1.1 million people included an estimated 813,970 gay and bisexual men, 258,080 heterosexuals, and 72,510 intravenous drug users. The ultimate goal of the work is target PrEP interventions where they are needed most. The agency plans to release state-by-state data soon.

CDC funded the work. Dr. Smith didn’t have any disclosures.

SOURCE: Smith DK et al. 2018 CROI, Abstract 86.

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– More than 1.1 million Americans are at substantial risk for HIV and would benefit from preexposure prophylaxis (PrEP), but only 90,000 prescriptions were filled by retail or mail-order pharmacies in the United States from Sept. 2015 to August 2016, according to the Centers for Disease Control and Prevention.

The CDC estimated that 500,340 blacks in the United States have indications for preexposure prophylaxis, but only about 7,000 (less than 1%) filled a prescription during that time. Among an estimated 282,260 Hispanics who might benefit, just about 7,600 (3%) filled prescriptions. Uptake was a bit higher among whites: about 42,000 prescriptions among 303,230 at-risk people (14%).

Dr. Dawn Smith
“These data paint a full-enough picture to say that without a doubt, nearly 6 years after [Food and Drug Administration] approval, we are nowhere near tapping the full potential of PrEP as a hugely powerful HIV prevention tool. Our study makes it clear that there is an urgent need to increase awareness of and access to PrEP, particularly among black and Hispanic populations,” said lead investigator Dawn Smith, MD, a CDC medical epidemiologist.

PrEP uptake might be particularly low among black and Hispanic people because, in addition to the well-known disparities in health care access and other issues: “There’s a stigma with being gay: ‘If I’m taking this drug, does that mean I’m gay?’ ” Dr. Smith said.
 

 


To address the problem, “get more serious about HIV testing. You want to find people who are positive, who need to be on treatment. The second step is to find ways to collect risk-behavior data.” That could be as simple as having the nurse ask a few extra questions before the office visit, or adding a few questions to the intake form, she said at the Conference On Retroviruses And Opportunistic Infections.

“You are trying to help patients acknowledge that they are engaging in behaviors that might have exposed them to HIV, and providers need to be able to hear the answers. One of the problems we have is providers who say ‘my patients aren’t like that,’ or ‘this person is married; I don’t need to ask them.’” Another easy way to find at-risk patients is to look at STD history. If a patient has had syphilis, or two episodes of gonorrhea in the past year, you “need to talk to them about PrEP,” she said.

For black and Hispanic patients, “it’s a higher index of suspicion. For example, you take blood pressure in all your patients, but you are also aware that hypertension is more common in African Americans. So if you’re rushed, you are still going to do a blood pressure in African American patients, but maybe not in the young white jogger; you get that next time.” Especially in high-prevalence HIV settings, “every patient should be aware of PrEP. It should be part of the conversation with everybody,” she said.

The CDC used national pharmacy data and estimates of risky behavior to draw its conclusions. Commercial pharmacies account for maybe 90% of all PrEP prescriptions, so the data slightly underestimate the true use numbers. The more than 1.1 million people included an estimated 813,970 gay and bisexual men, 258,080 heterosexuals, and 72,510 intravenous drug users. The ultimate goal of the work is target PrEP interventions where they are needed most. The agency plans to release state-by-state data soon.

CDC funded the work. Dr. Smith didn’t have any disclosures.

SOURCE: Smith DK et al. 2018 CROI, Abstract 86.

 

– More than 1.1 million Americans are at substantial risk for HIV and would benefit from preexposure prophylaxis (PrEP), but only 90,000 prescriptions were filled by retail or mail-order pharmacies in the United States from Sept. 2015 to August 2016, according to the Centers for Disease Control and Prevention.

The CDC estimated that 500,340 blacks in the United States have indications for preexposure prophylaxis, but only about 7,000 (less than 1%) filled a prescription during that time. Among an estimated 282,260 Hispanics who might benefit, just about 7,600 (3%) filled prescriptions. Uptake was a bit higher among whites: about 42,000 prescriptions among 303,230 at-risk people (14%).

Dr. Dawn Smith
“These data paint a full-enough picture to say that without a doubt, nearly 6 years after [Food and Drug Administration] approval, we are nowhere near tapping the full potential of PrEP as a hugely powerful HIV prevention tool. Our study makes it clear that there is an urgent need to increase awareness of and access to PrEP, particularly among black and Hispanic populations,” said lead investigator Dawn Smith, MD, a CDC medical epidemiologist.

PrEP uptake might be particularly low among black and Hispanic people because, in addition to the well-known disparities in health care access and other issues: “There’s a stigma with being gay: ‘If I’m taking this drug, does that mean I’m gay?’ ” Dr. Smith said.
 

 


To address the problem, “get more serious about HIV testing. You want to find people who are positive, who need to be on treatment. The second step is to find ways to collect risk-behavior data.” That could be as simple as having the nurse ask a few extra questions before the office visit, or adding a few questions to the intake form, she said at the Conference On Retroviruses And Opportunistic Infections.

“You are trying to help patients acknowledge that they are engaging in behaviors that might have exposed them to HIV, and providers need to be able to hear the answers. One of the problems we have is providers who say ‘my patients aren’t like that,’ or ‘this person is married; I don’t need to ask them.’” Another easy way to find at-risk patients is to look at STD history. If a patient has had syphilis, or two episodes of gonorrhea in the past year, you “need to talk to them about PrEP,” she said.

For black and Hispanic patients, “it’s a higher index of suspicion. For example, you take blood pressure in all your patients, but you are also aware that hypertension is more common in African Americans. So if you’re rushed, you are still going to do a blood pressure in African American patients, but maybe not in the young white jogger; you get that next time.” Especially in high-prevalence HIV settings, “every patient should be aware of PrEP. It should be part of the conversation with everybody,” she said.

The CDC used national pharmacy data and estimates of risky behavior to draw its conclusions. Commercial pharmacies account for maybe 90% of all PrEP prescriptions, so the data slightly underestimate the true use numbers. The more than 1.1 million people included an estimated 813,970 gay and bisexual men, 258,080 heterosexuals, and 72,510 intravenous drug users. The ultimate goal of the work is target PrEP interventions where they are needed most. The agency plans to release state-by-state data soon.

CDC funded the work. Dr. Smith didn’t have any disclosures.

SOURCE: Smith DK et al. 2018 CROI, Abstract 86.

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Key clinical point: To know if patients need PrEP, you first have to ask about at-risk behaviors.

Major finding: About 500,340 blacks have indications for preexposure prophylaxis (PrEP), but only about 7,000 filled a prescription from Sept. 2015-August 2016.

Study details: The findings are based on pharmacy data and estimates of risky behavior.

Disclosures: CDC funded the work. The lead investigator didn’t have any disclosures.

Source: Smith DK et al. 2018 CROI, Abstract 86.

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Unassigned school epinephrine used more than assigned injectors

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At schools in a Texas district, unassigned epinephrine injectors were used more often than assigned ones were, according to results of an analysis.

In the 2015-2016 and 2016-2017 school years, epinephrine was administered to students 31 times at schools in the Austin Independent School District, which began to stock unassigned epinephrine in its schools after state legislators approved a law in 2015 allowing, but not requiring, school districts to do so. In 21 of those cases, or 68% of the time, it was the unassigned stockpile that was used, Kathryn Neupert, MD, said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.

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Dr. Kathryn Neupert
Dr. Neupert and her associates said the findings underscore the public health value of stocking unassigned epinephrine in schools. According to the Food Allergy Research and Education organization, all states but Hawaii had laws at least allowing unassigned epinephrine injectors to be stocked in schools as of 2016, with 12 states requiring it.

She drew attention to the finding that 22% of the time in the study, the epinephrine use involved the unassigned stock for children with no history of anaphylaxis or allergy.

 


“It kind of argues that, for those people that we don’t know have anaphylaxis to anything, it’s definitely important to have it available to them,” reported Dr. Neupert, a resident at the University of Texas, Austin.

In 45% of the cases, epinephrine was administered to children who had a known history of allergic reactions but, for whatever reason, did not have an epinephrine injector assigned to them.

Food was the most common trigger for use of epinephrine, accounting for 48% of the injections, with fragrance at 16%, insect stings at 10%, and exercise and overheating at 7%.

Dr. Neupert and her associates said the frequency with which epinephrine was administered after exposure to a fragrance – seen in about the same amount for unassigned and assigned epinephrine – might signal a need for greater education.

 

SOURCE: AAAAI/WAO Joint Congress Abstract 465.

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At schools in a Texas district, unassigned epinephrine injectors were used more often than assigned ones were, according to results of an analysis.

In the 2015-2016 and 2016-2017 school years, epinephrine was administered to students 31 times at schools in the Austin Independent School District, which began to stock unassigned epinephrine in its schools after state legislators approved a law in 2015 allowing, but not requiring, school districts to do so. In 21 of those cases, or 68% of the time, it was the unassigned stockpile that was used, Kathryn Neupert, MD, said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.

Thomas R. Collins/Frontline Medical News
Dr. Kathryn Neupert
Dr. Neupert and her associates said the findings underscore the public health value of stocking unassigned epinephrine in schools. According to the Food Allergy Research and Education organization, all states but Hawaii had laws at least allowing unassigned epinephrine injectors to be stocked in schools as of 2016, with 12 states requiring it.

She drew attention to the finding that 22% of the time in the study, the epinephrine use involved the unassigned stock for children with no history of anaphylaxis or allergy.

 


“It kind of argues that, for those people that we don’t know have anaphylaxis to anything, it’s definitely important to have it available to them,” reported Dr. Neupert, a resident at the University of Texas, Austin.

In 45% of the cases, epinephrine was administered to children who had a known history of allergic reactions but, for whatever reason, did not have an epinephrine injector assigned to them.

Food was the most common trigger for use of epinephrine, accounting for 48% of the injections, with fragrance at 16%, insect stings at 10%, and exercise and overheating at 7%.

Dr. Neupert and her associates said the frequency with which epinephrine was administered after exposure to a fragrance – seen in about the same amount for unassigned and assigned epinephrine – might signal a need for greater education.

 

SOURCE: AAAAI/WAO Joint Congress Abstract 465.

 

At schools in a Texas district, unassigned epinephrine injectors were used more often than assigned ones were, according to results of an analysis.

In the 2015-2016 and 2016-2017 school years, epinephrine was administered to students 31 times at schools in the Austin Independent School District, which began to stock unassigned epinephrine in its schools after state legislators approved a law in 2015 allowing, but not requiring, school districts to do so. In 21 of those cases, or 68% of the time, it was the unassigned stockpile that was used, Kathryn Neupert, MD, said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.

Thomas R. Collins/Frontline Medical News
Dr. Kathryn Neupert
Dr. Neupert and her associates said the findings underscore the public health value of stocking unassigned epinephrine in schools. According to the Food Allergy Research and Education organization, all states but Hawaii had laws at least allowing unassigned epinephrine injectors to be stocked in schools as of 2016, with 12 states requiring it.

She drew attention to the finding that 22% of the time in the study, the epinephrine use involved the unassigned stock for children with no history of anaphylaxis or allergy.

 


“It kind of argues that, for those people that we don’t know have anaphylaxis to anything, it’s definitely important to have it available to them,” reported Dr. Neupert, a resident at the University of Texas, Austin.

In 45% of the cases, epinephrine was administered to children who had a known history of allergic reactions but, for whatever reason, did not have an epinephrine injector assigned to them.

Food was the most common trigger for use of epinephrine, accounting for 48% of the injections, with fragrance at 16%, insect stings at 10%, and exercise and overheating at 7%.

Dr. Neupert and her associates said the frequency with which epinephrine was administered after exposure to a fragrance – seen in about the same amount for unassigned and assigned epinephrine – might signal a need for greater education.

 

SOURCE: AAAAI/WAO Joint Congress Abstract 465.

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Key clinical point: Unassigned epinephrine was used more often in a Texas school district than assigned epinephrine.

Major finding: Over 2 years, 31 epinephrine injections were administered, and in 68% of the cases, it was the unassigned stock that was used.

Study details: A review of nursing records for the Austin Independent School District.

Disclosures: Dr. Kathryn Neupert had no relevant financial disclosures.

Source: Neupert K et al. Abstract 465.

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