Randy Dotinga

SAN DIEGO – Heroin, methamphetamine, and cocaine might not seem to have much in common with germs, but chemist Kim D. Janda, PhD, and his colleagues are trying to trick the human body into looking at them the same way: As invaders who must be conquered.

And what’s the best way to prepare the immune system for a fight? Train it through vaccination – the key to so many victories over viruses and bacteria.

For decades now, Dr. Janda, of the Scripps Research Institute in La Jolla, Calif., and other scientists have tried to develop a vaccine that would blunt the effects of substances of abuse, such as illicit drugs and even tobacco. The idea is to arm the immune system with antibodies that will prevent some or all drug components from breaking through the blood-brain barrier and producing psychoactive reactions.

In a follow-up interview after his presentation at the annual meeting of the College on Problems of Drug Dependence, Dr. Janda spoke about the history of research in this area, the potential workings of a vaccine, and the challenges of moving his own research forward.

Question: What’s the history of scientists’ efforts to develop a vaccine against drugs of abuse?

Answer: People looked at it back in the 1970s, but it didn’t really pan out. It was pretty dormant until we published research about a cocaine vaccine in 1995.

We worked on that for a while, then we looked at methamphetamine, Rohypnol, and opioids. There have been clinical trials for nicotine and cocaine, but they’ve failed.

Q: How are these vaccines expected to work?

A: The idea of the vaccines is that you don’t get high, so you won’t feel the effect of the drugs. They’ll never reach the pleasure centers that they’re supposed to.



Q: Is the idea that everyone would get a vaccine against, say, cocaine or heroin, like we routinely get vaccines against various diseases?

A: For an infectious disease like measles or mumps, you give vaccinations, and herd immunity develops. That’s not the case here. These work in a different manner, and they’re not going to be useful for people who don’t want to get off the drug. Instead, they’re going to be useful for people who want to obtain sobriety. If someone has a weak moment and tries to take the drug to get high, this would hopefully stop that from happening. It could also help overdoses in some cases, since you’re not getting that much drug into the central nervous system where it can cause cardiac arrest.



Q: How often would people be vaccinated?

A: These are vaccines that will be on board for a certain amount of time. We envision 3-4 shots over a 3-month period. You’d come back once a month for 3 months, and you’d be good for maybe 4-6 months.



Q: Where does your research stand now?

A: We’ve made a lot of advances with the opioids, and they’re good enough to put a vaccine in the clinic. I’m still trying to get some more money so we could hopefully move toward a clinical trial. Money is the issue. It’s always the issue. But we have to get up to the plate and take our swings – and find if we’ll strike out or get a hit.

SAN DIEGO – Heroin, methamphetamine, and cocaine might not seem to have much in common with germs, but chemist Kim D. Janda, PhD, and his colleagues are trying to trick the human body into looking at them the same way: As invaders who must be conquered.

And what’s the best way to prepare the immune system for a fight? Train it through vaccination – the key to so many victories over viruses and bacteria.

For decades now, Dr. Janda, of the Scripps Research Institute in La Jolla, Calif., and other scientists have tried to develop a vaccine that would blunt the effects of substances of abuse, such as illicit drugs and even tobacco. The idea is to arm the immune system with antibodies that will prevent some or all drug components from breaking through the blood-brain barrier and producing psychoactive reactions.

In a follow-up interview after his presentation at the annual meeting of the College on Problems of Drug Dependence, Dr. Janda spoke about the history of research in this area, the potential workings of a vaccine, and the challenges of moving his own research forward.

Question: What’s the history of scientists’ efforts to develop a vaccine against drugs of abuse?

Answer: People looked at it back in the 1970s, but it didn’t really pan out. It was pretty dormant until we published research about a cocaine vaccine in 1995.

We worked on that for a while, then we looked at methamphetamine, Rohypnol, and opioids. There have been clinical trials for nicotine and cocaine, but they’ve failed.

Q: How are these vaccines expected to work?

A: The idea of the vaccines is that you don’t get high, so you won’t feel the effect of the drugs. They’ll never reach the pleasure centers that they’re supposed to.



Q: Is the idea that everyone would get a vaccine against, say, cocaine or heroin, like we routinely get vaccines against various diseases?

A: For an infectious disease like measles or mumps, you give vaccinations, and herd immunity develops. That’s not the case here. These work in a different manner, and they’re not going to be useful for people who don’t want to get off the drug. Instead, they’re going to be useful for people who want to obtain sobriety. If someone has a weak moment and tries to take the drug to get high, this would hopefully stop that from happening. It could also help overdoses in some cases, since you’re not getting that much drug into the central nervous system where it can cause cardiac arrest.



Q: How often would people be vaccinated?

A: These are vaccines that will be on board for a certain amount of time. We envision 3-4 shots over a 3-month period. You’d come back once a month for 3 months, and you’d be good for maybe 4-6 months.



Q: Where does your research stand now?

A: We’ve made a lot of advances with the opioids, and they’re good enough to put a vaccine in the clinic. I’m still trying to get some more money so we could hopefully move toward a clinical trial. Money is the issue. It’s always the issue. But we have to get up to the plate and take our swings – and find if we’ll strike out or get a hit.

SAN DIEGO – Heroin, methamphetamine, and cocaine might not seem to have much in common with germs, but chemist Kim D. Janda, PhD, and his colleagues are trying to trick the human body into looking at them the same way: As invaders who must be conquered.

And what’s the best way to prepare the immune system for a fight? Train it through vaccination – the key to so many victories over viruses and bacteria.

For decades now, Dr. Janda, of the Scripps Research Institute in La Jolla, Calif., and other scientists have tried to develop a vaccine that would blunt the effects of substances of abuse, such as illicit drugs and even tobacco. The idea is to arm the immune system with antibodies that will prevent some or all drug components from breaking through the blood-brain barrier and producing psychoactive reactions.

In a follow-up interview after his presentation at the annual meeting of the College on Problems of Drug Dependence, Dr. Janda spoke about the history of research in this area, the potential workings of a vaccine, and the challenges of moving his own research forward.

Question: What’s the history of scientists’ efforts to develop a vaccine against drugs of abuse?

Answer: People looked at it back in the 1970s, but it didn’t really pan out. It was pretty dormant until we published research about a cocaine vaccine in 1995.

We worked on that for a while, then we looked at methamphetamine, Rohypnol, and opioids. There have been clinical trials for nicotine and cocaine, but they’ve failed.

Q: How are these vaccines expected to work?

A: The idea of the vaccines is that you don’t get high, so you won’t feel the effect of the drugs. They’ll never reach the pleasure centers that they’re supposed to.



Q: Is the idea that everyone would get a vaccine against, say, cocaine or heroin, like we routinely get vaccines against various diseases?

A: For an infectious disease like measles or mumps, you give vaccinations, and herd immunity develops. That’s not the case here. These work in a different manner, and they’re not going to be useful for people who don’t want to get off the drug. Instead, they’re going to be useful for people who want to obtain sobriety. If someone has a weak moment and tries to take the drug to get high, this would hopefully stop that from happening. It could also help overdoses in some cases, since you’re not getting that much drug into the central nervous system where it can cause cardiac arrest.



Q: How often would people be vaccinated?

A: These are vaccines that will be on board for a certain amount of time. We envision 3-4 shots over a 3-month period. You’d come back once a month for 3 months, and you’d be good for maybe 4-6 months.



Q: Where does your research stand now?

A: We’ve made a lot of advances with the opioids, and they’re good enough to put a vaccine in the clinic. I’m still trying to get some more money so we could hopefully move toward a clinical trial. Money is the issue. It’s always the issue. But we have to get up to the plate and take our swings – and find if we’ll strike out or get a hit.

ORLANDO – The pancreas is drawing wider interest among scientists: In one study, researchers report that already-shrunken organs keep atrophying in young people with recently diagnosed type 1 diabetes mellitus (T1DM) even as they go through adolescent growth. And another study finds that the pancreas is smaller in first-degree relatives of people with T1DM, especially relatives with pre-T1DM.

“Pancreas volume is a really exciting area of research because it may tell us something about diabetes that we just didn’t understand before,” said pediatric endocrinologist Michael J. Haller, MD, of the University of Florida, Gainesville, in an interview. Dr. Haller is coauthor of the study into pancreas volume in first-degree relatives. That study’s findings, along with the results of a Vanderbilt University/University of Texas study into pancreas volume in early T1DM, were presented at the annual meeting of the American Diabetes Association.

Scientists already know that the pancreas is 40% smaller in people who have lived with T1DM, Dr. Haller said, and “we now know that occurs long before the clinical diagnosis has been made.”

The pancreas volume mystery, he said, revolves around the fact that only 2%-3% of the organ is made up of beta cells, which make insulin. So why is there a 40% reduction in the pancreas overall? “It tells you the other parts of the pancreas are experiencing considerable damage because of the process,” he said.

In the Vanderbilt/UT study, led by Jack Virostko, PhD, at Vanderbilt University, Nashville, Tenn., researchers examined pancreas volume via MRI in patients with recent-onset T1DM (n = 51; mean age = 14 years, range 8-24 years).

The patients had a smaller median pancreas volume (29.6 mL) than similarly aged controls (49.6 mL; n = 51; P less than .001), and the gap held up after adjustment for factors like age, weight, and body mass index.

Pancreas volumes increased in controls over time as the subjects grew, but shrank even more in those with T1DM over the next year (P less than .001).

“Their research suggests there is a bit of ongoing reduction in volume,” Dr. Haller said. “That’s an area of debate in the literature, and additional larger datasets are being collected to prove or disprove that.”

For his study, Dr. Haller and University of Florida colleagues examined pancreas volume in 223 subjects (average age = 20 years; 45% males).

They found that relative pancreas volume was significantly lower vs. age-matched controls in subjects with recent-onset T1DM and in their first-degree relatives, regardless of their T1DM-related autoantibody status. First-degree relatives whose T1DM-related autoantibody status was positive – a sign of pre-T1DM – had smaller pancreas volumes than controls.

“This suggests there’s a stepwise reduction in volume that may help us understand risk better for certain patients,” Dr. Haller said.

In the future, he said, physicians may be able to use pancreas volume to distinguish between patients who otherwise appear to face the same T1DM risk. As a result, he said, they could adjust treatment accordingly.

“The datasets still need to become more robust, but it’s a really translatable kind of research,” he said, especially since it relies on MRIs “that you could use at any hospital.”

SOURCE: Campbell-Thompson ML et al. ADA 2018. Abstract 1816-P; Virostko J et al. ADA 2018. Abstract 233-OR.

ORLANDO – The pancreas is drawing wider interest among scientists: In one study, researchers report that already-shrunken organs keep atrophying in young people with recently diagnosed type 1 diabetes mellitus (T1DM) even as they go through adolescent growth. And another study finds that the pancreas is smaller in first-degree relatives of people with T1DM, especially relatives with pre-T1DM.

“Pancreas volume is a really exciting area of research because it may tell us something about diabetes that we just didn’t understand before,” said pediatric endocrinologist Michael J. Haller, MD, of the University of Florida, Gainesville, in an interview. Dr. Haller is coauthor of the study into pancreas volume in first-degree relatives. That study’s findings, along with the results of a Vanderbilt University/University of Texas study into pancreas volume in early T1DM, were presented at the annual meeting of the American Diabetes Association.

Scientists already know that the pancreas is 40% smaller in people who have lived with T1DM, Dr. Haller said, and “we now know that occurs long before the clinical diagnosis has been made.”

The pancreas volume mystery, he said, revolves around the fact that only 2%-3% of the organ is made up of beta cells, which make insulin. So why is there a 40% reduction in the pancreas overall? “It tells you the other parts of the pancreas are experiencing considerable damage because of the process,” he said.

In the Vanderbilt/UT study, led by Jack Virostko, PhD, at Vanderbilt University, Nashville, Tenn., researchers examined pancreas volume via MRI in patients with recent-onset T1DM (n = 51; mean age = 14 years, range 8-24 years).

The patients had a smaller median pancreas volume (29.6 mL) than similarly aged controls (49.6 mL; n = 51; P less than .001), and the gap held up after adjustment for factors like age, weight, and body mass index.

Pancreas volumes increased in controls over time as the subjects grew, but shrank even more in those with T1DM over the next year (P less than .001).

“Their research suggests there is a bit of ongoing reduction in volume,” Dr. Haller said. “That’s an area of debate in the literature, and additional larger datasets are being collected to prove or disprove that.”

For his study, Dr. Haller and University of Florida colleagues examined pancreas volume in 223 subjects (average age = 20 years; 45% males).

They found that relative pancreas volume was significantly lower vs. age-matched controls in subjects with recent-onset T1DM and in their first-degree relatives, regardless of their T1DM-related autoantibody status. First-degree relatives whose T1DM-related autoantibody status was positive – a sign of pre-T1DM – had smaller pancreas volumes than controls.

“This suggests there’s a stepwise reduction in volume that may help us understand risk better for certain patients,” Dr. Haller said.

In the future, he said, physicians may be able to use pancreas volume to distinguish between patients who otherwise appear to face the same T1DM risk. As a result, he said, they could adjust treatment accordingly.

“The datasets still need to become more robust, but it’s a really translatable kind of research,” he said, especially since it relies on MRIs “that you could use at any hospital.”

SOURCE: Campbell-Thompson ML et al. ADA 2018. Abstract 1816-P; Virostko J et al. ADA 2018. Abstract 233-OR.

ORLANDO – The pancreas is drawing wider interest among scientists: In one study, researchers report that already-shrunken organs keep atrophying in young people with recently diagnosed type 1 diabetes mellitus (T1DM) even as they go through adolescent growth. And another study finds that the pancreas is smaller in first-degree relatives of people with T1DM, especially relatives with pre-T1DM.

“Pancreas volume is a really exciting area of research because it may tell us something about diabetes that we just didn’t understand before,” said pediatric endocrinologist Michael J. Haller, MD, of the University of Florida, Gainesville, in an interview. Dr. Haller is coauthor of the study into pancreas volume in first-degree relatives. That study’s findings, along with the results of a Vanderbilt University/University of Texas study into pancreas volume in early T1DM, were presented at the annual meeting of the American Diabetes Association.

Scientists already know that the pancreas is 40% smaller in people who have lived with T1DM, Dr. Haller said, and “we now know that occurs long before the clinical diagnosis has been made.”

The pancreas volume mystery, he said, revolves around the fact that only 2%-3% of the organ is made up of beta cells, which make insulin. So why is there a 40% reduction in the pancreas overall? “It tells you the other parts of the pancreas are experiencing considerable damage because of the process,” he said.

In the Vanderbilt/UT study, led by Jack Virostko, PhD, at Vanderbilt University, Nashville, Tenn., researchers examined pancreas volume via MRI in patients with recent-onset T1DM (n = 51; mean age = 14 years, range 8-24 years).

The patients had a smaller median pancreas volume (29.6 mL) than similarly aged controls (49.6 mL; n = 51; P less than .001), and the gap held up after adjustment for factors like age, weight, and body mass index.

Pancreas volumes increased in controls over time as the subjects grew, but shrank even more in those with T1DM over the next year (P less than .001).

“Their research suggests there is a bit of ongoing reduction in volume,” Dr. Haller said. “That’s an area of debate in the literature, and additional larger datasets are being collected to prove or disprove that.”

For his study, Dr. Haller and University of Florida colleagues examined pancreas volume in 223 subjects (average age = 20 years; 45% males).

They found that relative pancreas volume was significantly lower vs. age-matched controls in subjects with recent-onset T1DM and in their first-degree relatives, regardless of their T1DM-related autoantibody status. First-degree relatives whose T1DM-related autoantibody status was positive – a sign of pre-T1DM – had smaller pancreas volumes than controls.

“This suggests there’s a stepwise reduction in volume that may help us understand risk better for certain patients,” Dr. Haller said.

In the future, he said, physicians may be able to use pancreas volume to distinguish between patients who otherwise appear to face the same T1DM risk. As a result, he said, they could adjust treatment accordingly.

“The datasets still need to become more robust, but it’s a really translatable kind of research,” he said, especially since it relies on MRIs “that you could use at any hospital.”

SOURCE: Campbell-Thompson ML et al. ADA 2018. Abstract 1816-P; Virostko J et al. ADA 2018. Abstract 233-OR.

ORLANDO – Higher risk translates to higher benefits. That’s the message of a new analysis of the ODYSSEY Outcomes trial in the PCSK9-inhibitor alirocumab that finds people with diabetes gained about twice the reduction in risk of major adverse cardiac events as their non-diabetic counterparts.

“Patients with diabetes and a recent heart attack are at double the risk of a cardiovascular event in the next 3 years as are nondiabetics, despite guideline-based care,” said study presenting author Kausik Ray, MD, ChB, of the School of Public Health of Imperial College London, in an interview. “These patients in our study had LDL of around 89 mg/dL despite high-intensity statins. Current guidelines recommend a goal of LDL of 55 mg/dL in this group. We brought LDL down to around 38 mg/ dL, and showed that by doing this, diabetics derived a greater reduction in the risk of major cardiovascular events. A greater absolute benefit was observed, and a smaller number needed to treat.”

Dr. Ray presented the study findings, a prespecified analysis of results of ODYSSEY Outcomes, at the annual scientific sessions of the American Diabetes Association.

The trial randomly assigned 18,924 patients with recent acute coronary syndrome and LDL cholesterol of at least 70 mg/dL, despite maximum statin therapy, to 75 mg of alirocumab every 2 weeks or placebo. Doses of alirocumab were increased blindly, to 150 mg, to reach LDL cholesterol levels of 25-50 mg/dL.

During a median 2.8 years of follow-up, the overall cumulative rate of major cardiac adverse events (coronary heart disease death, nonfatal MI, ischemic stroke, or hospitalization for unstable angina) occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for an absolute risk reduction of 1.6% and a statistically significant and clinically meaningful 15% reduction in relative risk. The results were presented at the annual scientific sessions of the American College of Cardiology in March.

In the current analysis, in patients with diabetes, the cumulative rate of incidents was 14.1% (380 of 2,693) with alirocumab and 16.4% (452 of 2,751) with placebo, for an ARR of 2.3%.

The ARRs for the prediabetes and normoglycemia groups were both 1.2%.

Dr. Ray noted that there’s no sign that the drug works differently in patients with diabetes. “The drug works in the same way and as effectively in everyone: LDL came down by 64% at 16 weeks in everyone. But absolute risk depends upon absolute risk to start with. So, in higher-risk patients, the absolute benefit is greater.”

According to Dr. Ray, the number needed to treat is 43 over 30 months for people with diabetes and 73 over 30 months for people without diabetes.

Prediman K. Shah, MD, director of the Oppenheimer Atherosclerosis Research Center at Cedars-Sinai Medical Center and professor of medicine at the University of California, Los Angeles, questioned the cost effectiveness of the medication in an interview.

“Even among the diabetics, the absolute risk reduction is about 2%, which is underwhelming considering the high cost,” he said. “If the cost were to drop to levels closer to cost of statins, such a small risk reduction may be worth the expense.”

Insurers have been skeptical of covering alirocumab because of its $14,000/year cost. However, Sanofi and Regeneron, which jointly market alirocumab, announced in March 2018 that they “will offer U.S. payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent Injection (alirocumab) in alignment with a new value assessment for high-risk patients from the [United States].”

In response, Dr. Ray said “the benefits quoted are time-to-first-event, and these are modest. But if you look at recurrent events, which represent the natural course of disease, then the benefits and absolute benefits are greater. These are add-on therapies and will never be used in every single patient at current cost.”

Glen J. Pearson, PharmD, of the University of Alberta, Edmonton, said in an interview that, “while these absolute numbers do seem relatively small, it must be remembered that these patients are already receiving very effective therapies to reduce their risk of future cardiovascular outcomes.”

ODYSSEY Outcomes was funded by Sanofi and Regeneron. The presenter reports various disclosures including consulting and research support relationships with Sanofi and Regeneron. The other study authors report various disclosures. Dr. Pearson reports no relevant disclosures. Dr. Shah reports receiving grant support from Sanofi Regeneron.

SOURCE: Ray K et al. ADA 2018, Abstract 6-LB.

ORLANDO – Higher risk translates to higher benefits. That’s the message of a new analysis of the ODYSSEY Outcomes trial in the PCSK9-inhibitor alirocumab that finds people with diabetes gained about twice the reduction in risk of major adverse cardiac events as their non-diabetic counterparts.

“Patients with diabetes and a recent heart attack are at double the risk of a cardiovascular event in the next 3 years as are nondiabetics, despite guideline-based care,” said study presenting author Kausik Ray, MD, ChB, of the School of Public Health of Imperial College London, in an interview. “These patients in our study had LDL of around 89 mg/dL despite high-intensity statins. Current guidelines recommend a goal of LDL of 55 mg/dL in this group. We brought LDL down to around 38 mg/ dL, and showed that by doing this, diabetics derived a greater reduction in the risk of major cardiovascular events. A greater absolute benefit was observed, and a smaller number needed to treat.”

Dr. Ray presented the study findings, a prespecified analysis of results of ODYSSEY Outcomes, at the annual scientific sessions of the American Diabetes Association.

The trial randomly assigned 18,924 patients with recent acute coronary syndrome and LDL cholesterol of at least 70 mg/dL, despite maximum statin therapy, to 75 mg of alirocumab every 2 weeks or placebo. Doses of alirocumab were increased blindly, to 150 mg, to reach LDL cholesterol levels of 25-50 mg/dL.

During a median 2.8 years of follow-up, the overall cumulative rate of major cardiac adverse events (coronary heart disease death, nonfatal MI, ischemic stroke, or hospitalization for unstable angina) occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for an absolute risk reduction of 1.6% and a statistically significant and clinically meaningful 15% reduction in relative risk. The results were presented at the annual scientific sessions of the American College of Cardiology in March.

In the current analysis, in patients with diabetes, the cumulative rate of incidents was 14.1% (380 of 2,693) with alirocumab and 16.4% (452 of 2,751) with placebo, for an ARR of 2.3%.

The ARRs for the prediabetes and normoglycemia groups were both 1.2%.

Dr. Ray noted that there’s no sign that the drug works differently in patients with diabetes. “The drug works in the same way and as effectively in everyone: LDL came down by 64% at 16 weeks in everyone. But absolute risk depends upon absolute risk to start with. So, in higher-risk patients, the absolute benefit is greater.”

According to Dr. Ray, the number needed to treat is 43 over 30 months for people with diabetes and 73 over 30 months for people without diabetes.

Prediman K. Shah, MD, director of the Oppenheimer Atherosclerosis Research Center at Cedars-Sinai Medical Center and professor of medicine at the University of California, Los Angeles, questioned the cost effectiveness of the medication in an interview.

“Even among the diabetics, the absolute risk reduction is about 2%, which is underwhelming considering the high cost,” he said. “If the cost were to drop to levels closer to cost of statins, such a small risk reduction may be worth the expense.”

Insurers have been skeptical of covering alirocumab because of its $14,000/year cost. However, Sanofi and Regeneron, which jointly market alirocumab, announced in March 2018 that they “will offer U.S. payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent Injection (alirocumab) in alignment with a new value assessment for high-risk patients from the [United States].”

In response, Dr. Ray said “the benefits quoted are time-to-first-event, and these are modest. But if you look at recurrent events, which represent the natural course of disease, then the benefits and absolute benefits are greater. These are add-on therapies and will never be used in every single patient at current cost.”

Glen J. Pearson, PharmD, of the University of Alberta, Edmonton, said in an interview that, “while these absolute numbers do seem relatively small, it must be remembered that these patients are already receiving very effective therapies to reduce their risk of future cardiovascular outcomes.”

ODYSSEY Outcomes was funded by Sanofi and Regeneron. The presenter reports various disclosures including consulting and research support relationships with Sanofi and Regeneron. The other study authors report various disclosures. Dr. Pearson reports no relevant disclosures. Dr. Shah reports receiving grant support from Sanofi Regeneron.

SOURCE: Ray K et al. ADA 2018, Abstract 6-LB.

ORLANDO – Higher risk translates to higher benefits. That’s the message of a new analysis of the ODYSSEY Outcomes trial in the PCSK9-inhibitor alirocumab that finds people with diabetes gained about twice the reduction in risk of major adverse cardiac events as their non-diabetic counterparts.

“Patients with diabetes and a recent heart attack are at double the risk of a cardiovascular event in the next 3 years as are nondiabetics, despite guideline-based care,” said study presenting author Kausik Ray, MD, ChB, of the School of Public Health of Imperial College London, in an interview. “These patients in our study had LDL of around 89 mg/dL despite high-intensity statins. Current guidelines recommend a goal of LDL of 55 mg/dL in this group. We brought LDL down to around 38 mg/ dL, and showed that by doing this, diabetics derived a greater reduction in the risk of major cardiovascular events. A greater absolute benefit was observed, and a smaller number needed to treat.”

Dr. Ray presented the study findings, a prespecified analysis of results of ODYSSEY Outcomes, at the annual scientific sessions of the American Diabetes Association.

The trial randomly assigned 18,924 patients with recent acute coronary syndrome and LDL cholesterol of at least 70 mg/dL, despite maximum statin therapy, to 75 mg of alirocumab every 2 weeks or placebo. Doses of alirocumab were increased blindly, to 150 mg, to reach LDL cholesterol levels of 25-50 mg/dL.

During a median 2.8 years of follow-up, the overall cumulative rate of major cardiac adverse events (coronary heart disease death, nonfatal MI, ischemic stroke, or hospitalization for unstable angina) occurred in 9.5% of the overall population randomized to alirocumab and 11.1% of those on placebo, for an absolute risk reduction of 1.6% and a statistically significant and clinically meaningful 15% reduction in relative risk. The results were presented at the annual scientific sessions of the American College of Cardiology in March.

In the current analysis, in patients with diabetes, the cumulative rate of incidents was 14.1% (380 of 2,693) with alirocumab and 16.4% (452 of 2,751) with placebo, for an ARR of 2.3%.

The ARRs for the prediabetes and normoglycemia groups were both 1.2%.

Dr. Ray noted that there’s no sign that the drug works differently in patients with diabetes. “The drug works in the same way and as effectively in everyone: LDL came down by 64% at 16 weeks in everyone. But absolute risk depends upon absolute risk to start with. So, in higher-risk patients, the absolute benefit is greater.”

According to Dr. Ray, the number needed to treat is 43 over 30 months for people with diabetes and 73 over 30 months for people without diabetes.

Prediman K. Shah, MD, director of the Oppenheimer Atherosclerosis Research Center at Cedars-Sinai Medical Center and professor of medicine at the University of California, Los Angeles, questioned the cost effectiveness of the medication in an interview.

“Even among the diabetics, the absolute risk reduction is about 2%, which is underwhelming considering the high cost,” he said. “If the cost were to drop to levels closer to cost of statins, such a small risk reduction may be worth the expense.”

Insurers have been skeptical of covering alirocumab because of its $14,000/year cost. However, Sanofi and Regeneron, which jointly market alirocumab, announced in March 2018 that they “will offer U.S. payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent Injection (alirocumab) in alignment with a new value assessment for high-risk patients from the [United States].”

In response, Dr. Ray said “the benefits quoted are time-to-first-event, and these are modest. But if you look at recurrent events, which represent the natural course of disease, then the benefits and absolute benefits are greater. These are add-on therapies and will never be used in every single patient at current cost.”

Glen J. Pearson, PharmD, of the University of Alberta, Edmonton, said in an interview that, “while these absolute numbers do seem relatively small, it must be remembered that these patients are already receiving very effective therapies to reduce their risk of future cardiovascular outcomes.”

ODYSSEY Outcomes was funded by Sanofi and Regeneron. The presenter reports various disclosures including consulting and research support relationships with Sanofi and Regeneron. The other study authors report various disclosures. Dr. Pearson reports no relevant disclosures. Dr. Shah reports receiving grant support from Sanofi Regeneron.

SOURCE: Ray K et al. ADA 2018, Abstract 6-LB.

ORLANDO – Longer-term data are providing more evidence of a possible link between maternal diabetes and autism spectrum disorder in their children.

Anny Xiang, PhD, and coathors with Kaiser Permanente of Southern California sought to further understand the possible effect of maternal T1D on offspring’s development of autism spectrum disorder (ASD) by expanding the cohort and timeline of their earlier work (JAMA. 2015;313(14):1425-1434).

The current study includes data on to 419,425 children (51% boys) born at Kaiser Permanente Southern California hospitals from 1995-2012. The children were followed for a median of 6.9 years, through 2017.

A total of 621 children were exposed in utero to T1D , 9,453 to T2D, 11,922 to gestational diabetes diagnosed by 26 weeks, and 24,505 to gestational diabetes diagnosed after 26 weeks.

Across the cohort, 1.3% of children were diagnosed with autism spectrum disorder (ASD). The rate was barely different, at 1.5%, for those whose mothers developed gestational diabetes after 26 weeks. But rates of ASD were higher – 3.1%, 2.5%, 2.1% – among those whose mothers had T1D, T2D, and gestational diabetes that developed at 26 weeks or earlier, respectively. The findings were adjusted for co-founders such as birth year, age at delivery, eduction level and income, Dr. Xiang said at the annual scientific sessions of the American Diabetes Association.

Compared to offspring of mothers without diabetes, ASD was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) mothers with type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes mellitus that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

The numbers remained similar after they were adjusted for smoking during pregnancy and prepregnancy BMI, statistics which were available for about 36% of the subjects, according to the findings which were published simultaneously in JAMA (June 23, 2018. doi:10.1001/jama.2018.7614).

Possible explanations for the link between ASD and maternal diabetes include maternal glycemic control, prematurity, and levels of neonatal hypoglycemia, Dr. Xiang said.

The results do not take into account any paternal risks for offspring developing ASD, which also includes diabetes, Dr. Xiang said, noting that two previous studies linked diabetes in fathers to ASD, although to a lesser extent than diabetes in mothers. (Epidemiology. 2010 Nov;21(6):805-8; Pediatrics. 2009 Aug;124(2):687-94)

The study also doesn’t take breastfeeding into account, Dr. Xiang noted. A 2016 study found that women with T2D were less likely to breastfeed (J Matern Fetal Neonatal Med. 2016;29(15):2513-8), and some research has suggested that breastfeeding may be protective against the development of ASD in children (Nutrition 2012;28(7-8):e27-32).

In addition, the study doesn’t track maternal glucose levels over time.

Session co-chair Peter Damm, MD, professor of obstetrics at the University of Copenhagen, said in an interview that he is impressed by the study. He cautioned, however, that it does not prove a connection.“This not a proof, but it seems likely, or like a possibility,” he said.

One possible explanation for a diabetes/ASD connection is the fact that the fetal brain is evolving throughout pregnancy unlike other body organs, which simply grow after developing in the first trimester, he said. As a result, glucose levels may affect the brain’s development in a unique way compared to other organs.

SOURCE: Xiang A, et al. ADA 2018 Abstract OR-117.

ORLANDO – Longer-term data are providing more evidence of a possible link between maternal diabetes and autism spectrum disorder in their children.

Anny Xiang, PhD, and coathors with Kaiser Permanente of Southern California sought to further understand the possible effect of maternal T1D on offspring’s development of autism spectrum disorder (ASD) by expanding the cohort and timeline of their earlier work (JAMA. 2015;313(14):1425-1434).

The current study includes data on to 419,425 children (51% boys) born at Kaiser Permanente Southern California hospitals from 1995-2012. The children were followed for a median of 6.9 years, through 2017.

A total of 621 children were exposed in utero to T1D , 9,453 to T2D, 11,922 to gestational diabetes diagnosed by 26 weeks, and 24,505 to gestational diabetes diagnosed after 26 weeks.

Across the cohort, 1.3% of children were diagnosed with autism spectrum disorder (ASD). The rate was barely different, at 1.5%, for those whose mothers developed gestational diabetes after 26 weeks. But rates of ASD were higher – 3.1%, 2.5%, 2.1% – among those whose mothers had T1D, T2D, and gestational diabetes that developed at 26 weeks or earlier, respectively. The findings were adjusted for co-founders such as birth year, age at delivery, eduction level and income, Dr. Xiang said at the annual scientific sessions of the American Diabetes Association.

Compared to offspring of mothers without diabetes, ASD was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) mothers with type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes mellitus that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

The numbers remained similar after they were adjusted for smoking during pregnancy and prepregnancy BMI, statistics which were available for about 36% of the subjects, according to the findings which were published simultaneously in JAMA (June 23, 2018. doi:10.1001/jama.2018.7614).

Possible explanations for the link between ASD and maternal diabetes include maternal glycemic control, prematurity, and levels of neonatal hypoglycemia, Dr. Xiang said.

The results do not take into account any paternal risks for offspring developing ASD, which also includes diabetes, Dr. Xiang said, noting that two previous studies linked diabetes in fathers to ASD, although to a lesser extent than diabetes in mothers. (Epidemiology. 2010 Nov;21(6):805-8; Pediatrics. 2009 Aug;124(2):687-94)

The study also doesn’t take breastfeeding into account, Dr. Xiang noted. A 2016 study found that women with T2D were less likely to breastfeed (J Matern Fetal Neonatal Med. 2016;29(15):2513-8), and some research has suggested that breastfeeding may be protective against the development of ASD in children (Nutrition 2012;28(7-8):e27-32).

In addition, the study doesn’t track maternal glucose levels over time.

Session co-chair Peter Damm, MD, professor of obstetrics at the University of Copenhagen, said in an interview that he is impressed by the study. He cautioned, however, that it does not prove a connection.“This not a proof, but it seems likely, or like a possibility,” he said.

One possible explanation for a diabetes/ASD connection is the fact that the fetal brain is evolving throughout pregnancy unlike other body organs, which simply grow after developing in the first trimester, he said. As a result, glucose levels may affect the brain’s development in a unique way compared to other organs.

SOURCE: Xiang A, et al. ADA 2018 Abstract OR-117.

ORLANDO – Longer-term data are providing more evidence of a possible link between maternal diabetes and autism spectrum disorder in their children.

Anny Xiang, PhD, and coathors with Kaiser Permanente of Southern California sought to further understand the possible effect of maternal T1D on offspring’s development of autism spectrum disorder (ASD) by expanding the cohort and timeline of their earlier work (JAMA. 2015;313(14):1425-1434).

The current study includes data on to 419,425 children (51% boys) born at Kaiser Permanente Southern California hospitals from 1995-2012. The children were followed for a median of 6.9 years, through 2017.

A total of 621 children were exposed in utero to T1D , 9,453 to T2D, 11,922 to gestational diabetes diagnosed by 26 weeks, and 24,505 to gestational diabetes diagnosed after 26 weeks.

Across the cohort, 1.3% of children were diagnosed with autism spectrum disorder (ASD). The rate was barely different, at 1.5%, for those whose mothers developed gestational diabetes after 26 weeks. But rates of ASD were higher – 3.1%, 2.5%, 2.1% – among those whose mothers had T1D, T2D, and gestational diabetes that developed at 26 weeks or earlier, respectively. The findings were adjusted for co-founders such as birth year, age at delivery, eduction level and income, Dr. Xiang said at the annual scientific sessions of the American Diabetes Association.

Compared to offspring of mothers without diabetes, ASD was more common in the children of mothers with T1D (adjusted HR=2.36, 95% CI, 1.36-4.12) mothers with type 2 diabetes (AHR= 1.45, 95% CI, 1.24-1.70) and gestational diabetes mellitus that developed by 26 weeks gestation (1.30, 95% CI, 1.12-1.51).

The numbers remained similar after they were adjusted for smoking during pregnancy and prepregnancy BMI, statistics which were available for about 36% of the subjects, according to the findings which were published simultaneously in JAMA (June 23, 2018. doi:10.1001/jama.2018.7614).

Possible explanations for the link between ASD and maternal diabetes include maternal glycemic control, prematurity, and levels of neonatal hypoglycemia, Dr. Xiang said.

The results do not take into account any paternal risks for offspring developing ASD, which also includes diabetes, Dr. Xiang said, noting that two previous studies linked diabetes in fathers to ASD, although to a lesser extent than diabetes in mothers. (Epidemiology. 2010 Nov;21(6):805-8; Pediatrics. 2009 Aug;124(2):687-94)

The study also doesn’t take breastfeeding into account, Dr. Xiang noted. A 2016 study found that women with T2D were less likely to breastfeed (J Matern Fetal Neonatal Med. 2016;29(15):2513-8), and some research has suggested that breastfeeding may be protective against the development of ASD in children (Nutrition 2012;28(7-8):e27-32).

In addition, the study doesn’t track maternal glucose levels over time.

Session co-chair Peter Damm, MD, professor of obstetrics at the University of Copenhagen, said in an interview that he is impressed by the study. He cautioned, however, that it does not prove a connection.“This not a proof, but it seems likely, or like a possibility,” he said.

One possible explanation for a diabetes/ASD connection is the fact that the fetal brain is evolving throughout pregnancy unlike other body organs, which simply grow after developing in the first trimester, he said. As a result, glucose levels may affect the brain’s development in a unique way compared to other organs.

SOURCE: Xiang A, et al. ADA 2018 Abstract OR-117.

NASHVILLE, TENN. – In a sign of the potential complications that can be spawned by B-cell–depleting therapies, a new report found that 5 of 30 patients with relapsing-remitting multiple sclerosis (RRMS) had to discontinue or interrupt long-term treatment with rituximab (Rituxan) because of serious infections such as pneumonia, septic arthritis, and sinusitis.

The findings are a “big lesson to not just focus on opportunistic infections [with Rituxan use] but also consider nonopportunistic infections that could occur,” lead study author Cindy Darius, a registered nurse with the Johns Hopkins Multiple Sclerosis Center (JHMSC), Baltimore, said in an interview. She presented the research at the annual meeting of the Consortium of Multiple Sclerosis Centers.

copyright Zerbor/Thinkstock

• A woman, aged 30 years, whose rituximab regimen was interrupted after 4 years of treatment when she developed recurrent pneumonia.
• A man, aged 42 years, who took rituximab for a year then stopped after developing ringworm and two bouts of Staphylococcus aureus septic arthritis, and who had previously changed from natalizumab (Tysabri) to rituximab after seroconverting to the John Cunningham virus.
• A woman, aged 65 years, with Sjögren’s syndrome who stopped rituximab at 2 years after developing sinusitis, pneumonia, and herpes simplex virus keratitis.
• A woman, aged 38 years, who discontinued rituximab after 2 years because of recurrent urosepsis, sinusitis, and pyrexia of unknown origin.
• A woman, aged 56 years, who stopped rituximab after 2 years following intractable sinusitis and pneumonia that resulted in empyema and required a thoracotomy.

What might be causing the apparent side effects? Ms. Darius pointed out that the patients were already immunocompromised because of previous treatment with first- and/or second-line medications. She added that the complications “may be due to dosing that may be a little too high for the MS population.”

JHMSC is considering whether to give doses of the drug once a year instead of twice annually, she said. “Other providers are cutting the dose in half: Instead of 1,000 mg, they’re giving 500,” she added. “After the patient has been on the medication for a year or two, and you feel the disease process has stabilized, you may want to consider adjusting the dosage.”

Going forward, the researchers wrote that they “plan to determine the incidence of all serious infectious complications related to rituximab use among MS patients attending the JHMSC, and the influence of different dosing protocols between MS providers in this regard.”

No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.

SOURCE: Darius C et al. CMSC 2018, Abstract DX57.

NASHVILLE, TENN. – In a sign of the potential complications that can be spawned by B-cell–depleting therapies, a new report found that 5 of 30 patients with relapsing-remitting multiple sclerosis (RRMS) had to discontinue or interrupt long-term treatment with rituximab (Rituxan) because of serious infections such as pneumonia, septic arthritis, and sinusitis.

The findings are a “big lesson to not just focus on opportunistic infections [with Rituxan use] but also consider nonopportunistic infections that could occur,” lead study author Cindy Darius, a registered nurse with the Johns Hopkins Multiple Sclerosis Center (JHMSC), Baltimore, said in an interview. She presented the research at the annual meeting of the Consortium of Multiple Sclerosis Centers.

copyright Zerbor/Thinkstock

• A woman, aged 30 years, whose rituximab regimen was interrupted after 4 years of treatment when she developed recurrent pneumonia.
• A man, aged 42 years, who took rituximab for a year then stopped after developing ringworm and two bouts of Staphylococcus aureus septic arthritis, and who had previously changed from natalizumab (Tysabri) to rituximab after seroconverting to the John Cunningham virus.
• A woman, aged 65 years, with Sjögren’s syndrome who stopped rituximab at 2 years after developing sinusitis, pneumonia, and herpes simplex virus keratitis.
• A woman, aged 38 years, who discontinued rituximab after 2 years because of recurrent urosepsis, sinusitis, and pyrexia of unknown origin.
• A woman, aged 56 years, who stopped rituximab after 2 years following intractable sinusitis and pneumonia that resulted in empyema and required a thoracotomy.

What might be causing the apparent side effects? Ms. Darius pointed out that the patients were already immunocompromised because of previous treatment with first- and/or second-line medications. She added that the complications “may be due to dosing that may be a little too high for the MS population.”

JHMSC is considering whether to give doses of the drug once a year instead of twice annually, she said. “Other providers are cutting the dose in half: Instead of 1,000 mg, they’re giving 500,” she added. “After the patient has been on the medication for a year or two, and you feel the disease process has stabilized, you may want to consider adjusting the dosage.”

Going forward, the researchers wrote that they “plan to determine the incidence of all serious infectious complications related to rituximab use among MS patients attending the JHMSC, and the influence of different dosing protocols between MS providers in this regard.”

No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.

SOURCE: Darius C et al. CMSC 2018, Abstract DX57.

NASHVILLE, TENN. – In a sign of the potential complications that can be spawned by B-cell–depleting therapies, a new report found that 5 of 30 patients with relapsing-remitting multiple sclerosis (RRMS) had to discontinue or interrupt long-term treatment with rituximab (Rituxan) because of serious infections such as pneumonia, septic arthritis, and sinusitis.

The findings are a “big lesson to not just focus on opportunistic infections [with Rituxan use] but also consider nonopportunistic infections that could occur,” lead study author Cindy Darius, a registered nurse with the Johns Hopkins Multiple Sclerosis Center (JHMSC), Baltimore, said in an interview. She presented the research at the annual meeting of the Consortium of Multiple Sclerosis Centers.

copyright Zerbor/Thinkstock

• A woman, aged 30 years, whose rituximab regimen was interrupted after 4 years of treatment when she developed recurrent pneumonia.
• A man, aged 42 years, who took rituximab for a year then stopped after developing ringworm and two bouts of Staphylococcus aureus septic arthritis, and who had previously changed from natalizumab (Tysabri) to rituximab after seroconverting to the John Cunningham virus.
• A woman, aged 65 years, with Sjögren’s syndrome who stopped rituximab at 2 years after developing sinusitis, pneumonia, and herpes simplex virus keratitis.
• A woman, aged 38 years, who discontinued rituximab after 2 years because of recurrent urosepsis, sinusitis, and pyrexia of unknown origin.
• A woman, aged 56 years, who stopped rituximab after 2 years following intractable sinusitis and pneumonia that resulted in empyema and required a thoracotomy.

What might be causing the apparent side effects? Ms. Darius pointed out that the patients were already immunocompromised because of previous treatment with first- and/or second-line medications. She added that the complications “may be due to dosing that may be a little too high for the MS population.”

JHMSC is considering whether to give doses of the drug once a year instead of twice annually, she said. “Other providers are cutting the dose in half: Instead of 1,000 mg, they’re giving 500,” she added. “After the patient has been on the medication for a year or two, and you feel the disease process has stabilized, you may want to consider adjusting the dosage.”

Going forward, the researchers wrote that they “plan to determine the incidence of all serious infectious complications related to rituximab use among MS patients attending the JHMSC, and the influence of different dosing protocols between MS providers in this regard.”

No study funding was reported, and most study authors reported no relevant disclosures. One author reported receiving National Institutes of Health funding and another reported consulting for Biogen and Genentech.

SOURCE: Darius C et al. CMSC 2018, Abstract DX57.

SAN DIEGO – New research suggests that some patients with substance use disorder are turning to the herbal supplement kratom in an effort to reduce their use of heroin and prescription pain killers.

“Some, but not all, heroin users are utilizing kratom as an opioidlike drug with less risks, primarily as a drug substitute or to help abstain from IV heroin and prescription opiate use,” lead author Kirsten Elin Smith, a PhD student at the University of Louisville and an associate at the University of Kentucky’s Center on Drug and Alcohol Research, said in an interview. “Kratom appears as less risky due to the fact that it is not readily injectable.”

SOURCE: Smith KE et al. CPDD 2018. Drug and Alcohol Depend. 2017 Nov 1. 180:340-8.

SAN DIEGO – New research suggests that some patients with substance use disorder are turning to the herbal supplement kratom in an effort to reduce their use of heroin and prescription pain killers.

“Some, but not all, heroin users are utilizing kratom as an opioidlike drug with less risks, primarily as a drug substitute or to help abstain from IV heroin and prescription opiate use,” lead author Kirsten Elin Smith, a PhD student at the University of Louisville and an associate at the University of Kentucky’s Center on Drug and Alcohol Research, said in an interview. “Kratom appears as less risky due to the fact that it is not readily injectable.”

SOURCE: Smith KE et al. CPDD 2018. Drug and Alcohol Depend. 2017 Nov 1. 180:340-8.

SAN DIEGO – New research suggests that some patients with substance use disorder are turning to the herbal supplement kratom in an effort to reduce their use of heroin and prescription pain killers.

“Some, but not all, heroin users are utilizing kratom as an opioidlike drug with less risks, primarily as a drug substitute or to help abstain from IV heroin and prescription opiate use,” lead author Kirsten Elin Smith, a PhD student at the University of Louisville and an associate at the University of Kentucky’s Center on Drug and Alcohol Research, said in an interview. “Kratom appears as less risky due to the fact that it is not readily injectable.”

SOURCE: Smith KE et al. CPDD 2018. Drug and Alcohol Depend. 2017 Nov 1. 180:340-8.

SAN DIEGO – A pair of small studies suggest that cyber-based interventions with private online meeting areas – like those available on Facebook – could help lift depression and encourage less marijuana use in young people with cannabis use disorder.

“Even individuals who are not looking to quit their use of cannabis have some degree of ambivalence about the extent of their use of it,” said study researcher Suzette Glasner, PhD, in an interview. “When given tools to explore the consequences of their use and change if they want to, they do find reasons and effective ways to change or reduce their use – even if they don’t quit completely.”

SAN DIEGO – A pair of small studies suggest that cyber-based interventions with private online meeting areas – like those available on Facebook – could help lift depression and encourage less marijuana use in young people with cannabis use disorder.

“Even individuals who are not looking to quit their use of cannabis have some degree of ambivalence about the extent of their use of it,” said study researcher Suzette Glasner, PhD, in an interview. “When given tools to explore the consequences of their use and change if they want to, they do find reasons and effective ways to change or reduce their use – even if they don’t quit completely.”

SAN DIEGO – A pair of small studies suggest that cyber-based interventions with private online meeting areas – like those available on Facebook – could help lift depression and encourage less marijuana use in young people with cannabis use disorder.

“Even individuals who are not looking to quit their use of cannabis have some degree of ambivalence about the extent of their use of it,” said study researcher Suzette Glasner, PhD, in an interview. “When given tools to explore the consequences of their use and change if they want to, they do find reasons and effective ways to change or reduce their use – even if they don’t quit completely.”

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – Physicians who receive gifts and free meals from opioid manufacturers prescribe more opioids than do their counterparts, a new study suggests.

A sampling of doctors who reported marketing payments or gifts prescribed more of the drugs the following year even as their colleagues prescribed fewer. Researchers also found signs of a dose-effect relationship between more free meals received and more opioid medications prescribed.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence and recently published, do not prove a link between free meals and the massive, deadly opioid epidemic. And the purpose of pharmaceutical marketing, of course, is to persuade physicians to prescribe medications, the researchers noted. The report was published in JAMA Internal Medicine.

Still, in light of the opioid epidemic, “there’s a national effort to reduce overprescribing. Our database suggests that the pharmaceutical industry may be a counterforce,” lead author and pediatrician Scott E. Hadland, MD, MPH, of Boston University, said in an interview.

The findings suggest “it doesn’t take much money to get doctors to potentially prescribe more opioids,” he added.

SOURCE: Hadland SE et al. JAMA Intern Med. 2018 Jun 1;178(6):861-3.

SAN DIEGO – New research suggests that pregnant users of both cannabis and tobacco may put their unborn children at higher risk of birth defects and small head circumference than if they used either alone.

Researchers also found that 13% of pregnant Medicaid recipients surveyed reported using both cannabis and tobacco within the past month.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence, point to the importance of asking pregnant patients about cannabis use, especially if they smoke tobacco, said study lead author Victoria H. Coleman-Cowger, PhD, of the research organization Battelle, in an interview.

In some cases, in fact, pregnant women might think that marijuana is healthier than regular cigarettes, said Dr. Coleman-Cowger. She observed this phenomenon while conducting a smoking intervention study at a prenatal clinic that largely served poor, African American women.

“I learned that many participants were also smoking cannabis and felt that there was lower risk associated with cannabis use than with tobacco use,” she said. “Some women were decreasing their use of tobacco during pregnancy but increasing their use of cannabis.”

Dr. Coleman-Cowger’s observations at the clinic inspired the new study, which reports the findings of a convenience survey of 500 pregnant women.

The mean age in the group was 28, and 71% were black. Two-thirds were employed, and 29% were college graduates.

By comparison, the 45 women in the co-user group – who reported both cannabis and tobacco use in the past month – were 93% black, 42% employed, and 7% college graduates. (An additional 39 women reported tobacco use only, and 60 reported cannabis use only.)

Co-use also was correlated with “never married, being in the first trimester of pregnancy, not wanting to be pregnant when they were, past-month other substance use, and more frequent use of both cannabis and tobacco than either exclusive group,” Dr. Coleman-Cowger said.

In adjusted models, co-users were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers. Birth defects also were more likely in the co-user group.

The study did not allow researchers to speculate on whether co-use may multiply risk vs. cannabis or tobacco use alone.

Dr. Coleman-Cowger said in light of the small sample size, the results should be interpreted with caution. One possible confounder is quantity of use, she said. “We did not assess quantity of use, but given our finding that frequency of use is higher among the co-use group, it could be that the co-use group is simply using more of each substance and thus impacting the health consequences.”

Current clinical practice guidelines do not suggest screening for cannabis use in pregnant women. But Dr. Coleman-Cowger said it’s “particularly important when tobacco use has been identified, though in states where substance use is considered child abuse, professional judgment should be utilized in terms of the legal implications of asking about use.”

More research is planned to better understand issues like quantity of use, and reasons why pregnant women co-use cannabis and tobacco, Dr. Coleman-Cowger said.

The National Institute on Drug Abuse funded the study, which Dr. Coleman-Cowger said is part of a larger project “to compare and validate screeners that assess prescription drug misuse and illicit drug use during pregnancy.” The study authors report no relevant disclosures.

SAN DIEGO – New research suggests that pregnant users of both cannabis and tobacco may put their unborn children at higher risk of birth defects and small head circumference than if they used either alone.

Researchers also found that 13% of pregnant Medicaid recipients surveyed reported using both cannabis and tobacco within the past month.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence, point to the importance of asking pregnant patients about cannabis use, especially if they smoke tobacco, said study lead author Victoria H. Coleman-Cowger, PhD, of the research organization Battelle, in an interview.

In some cases, in fact, pregnant women might think that marijuana is healthier than regular cigarettes, said Dr. Coleman-Cowger. She observed this phenomenon while conducting a smoking intervention study at a prenatal clinic that largely served poor, African American women.

“I learned that many participants were also smoking cannabis and felt that there was lower risk associated with cannabis use than with tobacco use,” she said. “Some women were decreasing their use of tobacco during pregnancy but increasing their use of cannabis.”

Dr. Coleman-Cowger’s observations at the clinic inspired the new study, which reports the findings of a convenience survey of 500 pregnant women.

The mean age in the group was 28, and 71% were black. Two-thirds were employed, and 29% were college graduates.

By comparison, the 45 women in the co-user group – who reported both cannabis and tobacco use in the past month – were 93% black, 42% employed, and 7% college graduates. (An additional 39 women reported tobacco use only, and 60 reported cannabis use only.)

Co-use also was correlated with “never married, being in the first trimester of pregnancy, not wanting to be pregnant when they were, past-month other substance use, and more frequent use of both cannabis and tobacco than either exclusive group,” Dr. Coleman-Cowger said.

In adjusted models, co-users were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers. Birth defects also were more likely in the co-user group.

The study did not allow researchers to speculate on whether co-use may multiply risk vs. cannabis or tobacco use alone.

Dr. Coleman-Cowger said in light of the small sample size, the results should be interpreted with caution. One possible confounder is quantity of use, she said. “We did not assess quantity of use, but given our finding that frequency of use is higher among the co-use group, it could be that the co-use group is simply using more of each substance and thus impacting the health consequences.”

Current clinical practice guidelines do not suggest screening for cannabis use in pregnant women. But Dr. Coleman-Cowger said it’s “particularly important when tobacco use has been identified, though in states where substance use is considered child abuse, professional judgment should be utilized in terms of the legal implications of asking about use.”

More research is planned to better understand issues like quantity of use, and reasons why pregnant women co-use cannabis and tobacco, Dr. Coleman-Cowger said.

The National Institute on Drug Abuse funded the study, which Dr. Coleman-Cowger said is part of a larger project “to compare and validate screeners that assess prescription drug misuse and illicit drug use during pregnancy.” The study authors report no relevant disclosures.

SAN DIEGO – New research suggests that pregnant users of both cannabis and tobacco may put their unborn children at higher risk of birth defects and small head circumference than if they used either alone.

Researchers also found that 13% of pregnant Medicaid recipients surveyed reported using both cannabis and tobacco within the past month.

The findings, presented at the annual meeting of the College on Problems of Drug Dependence, point to the importance of asking pregnant patients about cannabis use, especially if they smoke tobacco, said study lead author Victoria H. Coleman-Cowger, PhD, of the research organization Battelle, in an interview.

In some cases, in fact, pregnant women might think that marijuana is healthier than regular cigarettes, said Dr. Coleman-Cowger. She observed this phenomenon while conducting a smoking intervention study at a prenatal clinic that largely served poor, African American women.

“I learned that many participants were also smoking cannabis and felt that there was lower risk associated with cannabis use than with tobacco use,” she said. “Some women were decreasing their use of tobacco during pregnancy but increasing their use of cannabis.”

Dr. Coleman-Cowger’s observations at the clinic inspired the new study, which reports the findings of a convenience survey of 500 pregnant women.

The mean age in the group was 28, and 71% were black. Two-thirds were employed, and 29% were college graduates.

By comparison, the 45 women in the co-user group – who reported both cannabis and tobacco use in the past month – were 93% black, 42% employed, and 7% college graduates. (An additional 39 women reported tobacco use only, and 60 reported cannabis use only.)

Co-use also was correlated with “never married, being in the first trimester of pregnancy, not wanting to be pregnant when they were, past-month other substance use, and more frequent use of both cannabis and tobacco than either exclusive group,” Dr. Coleman-Cowger said.

In adjusted models, co-users were more likely (odds ratio, 5.7; P = .05) to give birth to babies with small head circumference than nonusers. The risks of giving birth to babies with small head circumference also were more likely among the tobacco-only users (OR, 4.8; P = .05) and cannabis-only users (OR, 2.0; P = .05), compared with nonusers. Birth defects also were more likely in the co-user group.

The study did not allow researchers to speculate on whether co-use may multiply risk vs. cannabis or tobacco use alone.

Dr. Coleman-Cowger said in light of the small sample size, the results should be interpreted with caution. One possible confounder is quantity of use, she said. “We did not assess quantity of use, but given our finding that frequency of use is higher among the co-use group, it could be that the co-use group is simply using more of each substance and thus impacting the health consequences.”

Current clinical practice guidelines do not suggest screening for cannabis use in pregnant women. But Dr. Coleman-Cowger said it’s “particularly important when tobacco use has been identified, though in states where substance use is considered child abuse, professional judgment should be utilized in terms of the legal implications of asking about use.”

More research is planned to better understand issues like quantity of use, and reasons why pregnant women co-use cannabis and tobacco, Dr. Coleman-Cowger said.

The National Institute on Drug Abuse funded the study, which Dr. Coleman-Cowger said is part of a larger project “to compare and validate screeners that assess prescription drug misuse and illicit drug use during pregnancy.” The study authors report no relevant disclosures.