New on the streets: Drug for nerve pain boosts high for opioid abusers

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Fri, 01/18/2019 - 16:53

 

ATHENS, OHIO – On April 5, Ciera Smith sat in a car parked on the gravel driveway of the Rural Women’s Recovery Program here with a choice to make: Go to jail or enter treatment for her addiction.

Ms. Smith, 22, started abusing drugs when she was 18 years old, enticed by the “good time” she and her friends found in smoking marijuana. She later turned to addictive painkillers, then antianxiety medications such as Xanax and eventually Suboxone, a narcotic often used to replace opioids when treating addiction.

Before stepping out of the car, she decided she needed one more high before treatment. She reached into her purse and then swallowed a handful of gabapentin pills.

Last December, Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is neither an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list that month, surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state.

And it’s not just in Ohio. Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the United States. In May, it was the fifth-most prescribed drug in the nation, according to GoodRx.

Gabapentin is approved by the Food and Drug Administration to treat epilepsy and pain related to nerve damage, called neuropathy. Also known by its brand name, Neurontin, the drug acts as a sedative. It is widely considered nonaddictive and touted by the federal Centers for Disease Control and Prevention as an alternative intervention to opiates for chronic pain. Generally, doctors prescribe no more than 1,800-2,400 mg of gabapentin per day, according to information on the Mayo Clinic’s website.

Gabapentin does not carry the same risk of lethal overdoses as opioids, but drug experts say the effects of using gabapentin for long periods of time or in very high quantities, particularly among such sensitive populations as pregnant women, are not well known.

As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery.

Athens, home to Ohio University, lies in the southeastern corner of the state, which has been ravaged by the opioid epidemic. Despite experience in combating illicit drug use, law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle.

“I don’t know if we have a clear picture of the risk,” said Joe Gay, executive director of Health Recovery Services, a network of substance abuse recovery centers headquartered in Athens.

‘Available to be abused’

A literature review published in 2016 in the journal Addiction found about a fifth of those who abuse opiates misuse gabapentin. A separate 2015 study of adults in Appalachian Kentucky who abused opiates found 15% of participants also misused gabapentin in the past 6 months “to get high.”

In the same year, the drug was involved in 109 overdose deaths in West Virginia, the Charleston Gazette-Mail reported.

Rachel Quivey, an Athens pharmacist, said she noticed signs of gabapentin misuse half a decade ago when patients began picking up the drug several days before their prescription ran out.

“Gabapentin is so readily available,” she said. “That, in my opinion, is where a lot of that danger is. It’s available to be abused.”

In May, Ms. Quivey’s pharmacy filled roughly 33 prescriptions of gabapentin per week, dispensing 90-120 pills for each client.

For customers who arrive with scripts demanding a high dosage of the drug, Ms. Quivey sometimes calls the doctor to discuss her concerns. But many of them aren’t aware of gabapentin misuse, she said.

Even as gabapentin gets restocked regularly on Ms. Quivey’s shelves, the drug’s presence is increasing on the streets of Athens. A 300-milligram pill sells for as little as 75 cents.

Yet, according to Chuck Haegele, field supervisor for the major crimes unit at the Athens City Police Department, law enforcement can do little to stop its spread. That’s because gabapentin is not categorized as a controlled substance. That designation places restrictions on who can possess and dispense the drug.

“There’s really not much we can do at this point,” he said. “If it’s not controlled … it’s not illegal for somebody that’s not prescribed it to possess it.”

Mr. Haegele said he heard about the drug less than 3 months ago when an officer accidentally received a text message from someone offering to sell it. The police force, he said, is still trying to assess the threat of gabapentin.

 

 

Little testing

Nearly anyone arrested and found to struggle with addiction in Athens is given the option to go through a drug-court program to get treatment. But officials said that some exploit the absence of routine exams for gabapentin to get high while testing clean.

Brice Johnson, a probation officer at Athens County Municipal Court, said participants in the municipal court’s substance abuse mentally ill program undergo gabapentin testing only when abuse is suspected. Screenings are not regularly done on every client because gabapentin abuse has not been a concern and the testing adds expense, he said.

The rehab program run through the county prosecutor’s office, called Fresh Start, does test for gabapentin. Its latest round of screenings detected the drug in 5 of its roughly 238 active participants, prosecutor Keller Blackburn said.

Linda Holley, a clinical supervisor at an Athens outpatient program run by the Health Recovery Services, said she suspects at least half of her clients on Suboxone treatment abuse gabapentin. But the center can’t afford to regularly test every participant.

Ms. Holley said she sees clients who are prescribed gabapentin but, because of health privacy laws, she can’t share their status as a person in recovery to an outside provider without written consent. The restrictions give clients in recovery an opportunity to get high using drugs they obtained legally and still pass a drug test.

“With the gabapentin, I wish there were more we could do, but our hands are tied,” she said. “We can’t do anything but educate the client and discourage” them from using such medications.

Ms. Smith visited two separate doctors to secure a prescription. As she rotated through drug court, Narcotics Anonymous meetings, jail for relapsing on cocaine, and house arrest enforced with an ankle bracelet, she said her gabapentin abuse wasn’t detected until she arrived at the residential recovery center.

Today, Ms. Smith sticks to the recovery process. Expecting a baby in early July, her successful completion of the program not only means sobriety but also allows her the opportunity to restore custody of her eldest daughter and raise her children.

She intends to relocate her family away from the friends and routines that helped lead her to addiction and said she will help guide her daughter away from making similar mistakes.

“All I can do is be there and give her the knowledge that I can about addiction,” Ms. Smith said, “and hope that she chooses to go on the right path.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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ATHENS, OHIO – On April 5, Ciera Smith sat in a car parked on the gravel driveway of the Rural Women’s Recovery Program here with a choice to make: Go to jail or enter treatment for her addiction.

Ms. Smith, 22, started abusing drugs when she was 18 years old, enticed by the “good time” she and her friends found in smoking marijuana. She later turned to addictive painkillers, then antianxiety medications such as Xanax and eventually Suboxone, a narcotic often used to replace opioids when treating addiction.

Before stepping out of the car, she decided she needed one more high before treatment. She reached into her purse and then swallowed a handful of gabapentin pills.

Last December, Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is neither an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list that month, surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state.

And it’s not just in Ohio. Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the United States. In May, it was the fifth-most prescribed drug in the nation, according to GoodRx.

Gabapentin is approved by the Food and Drug Administration to treat epilepsy and pain related to nerve damage, called neuropathy. Also known by its brand name, Neurontin, the drug acts as a sedative. It is widely considered nonaddictive and touted by the federal Centers for Disease Control and Prevention as an alternative intervention to opiates for chronic pain. Generally, doctors prescribe no more than 1,800-2,400 mg of gabapentin per day, according to information on the Mayo Clinic’s website.

Gabapentin does not carry the same risk of lethal overdoses as opioids, but drug experts say the effects of using gabapentin for long periods of time or in very high quantities, particularly among such sensitive populations as pregnant women, are not well known.

As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery.

Athens, home to Ohio University, lies in the southeastern corner of the state, which has been ravaged by the opioid epidemic. Despite experience in combating illicit drug use, law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle.

“I don’t know if we have a clear picture of the risk,” said Joe Gay, executive director of Health Recovery Services, a network of substance abuse recovery centers headquartered in Athens.

‘Available to be abused’

A literature review published in 2016 in the journal Addiction found about a fifth of those who abuse opiates misuse gabapentin. A separate 2015 study of adults in Appalachian Kentucky who abused opiates found 15% of participants also misused gabapentin in the past 6 months “to get high.”

In the same year, the drug was involved in 109 overdose deaths in West Virginia, the Charleston Gazette-Mail reported.

Rachel Quivey, an Athens pharmacist, said she noticed signs of gabapentin misuse half a decade ago when patients began picking up the drug several days before their prescription ran out.

“Gabapentin is so readily available,” she said. “That, in my opinion, is where a lot of that danger is. It’s available to be abused.”

In May, Ms. Quivey’s pharmacy filled roughly 33 prescriptions of gabapentin per week, dispensing 90-120 pills for each client.

For customers who arrive with scripts demanding a high dosage of the drug, Ms. Quivey sometimes calls the doctor to discuss her concerns. But many of them aren’t aware of gabapentin misuse, she said.

Even as gabapentin gets restocked regularly on Ms. Quivey’s shelves, the drug’s presence is increasing on the streets of Athens. A 300-milligram pill sells for as little as 75 cents.

Yet, according to Chuck Haegele, field supervisor for the major crimes unit at the Athens City Police Department, law enforcement can do little to stop its spread. That’s because gabapentin is not categorized as a controlled substance. That designation places restrictions on who can possess and dispense the drug.

“There’s really not much we can do at this point,” he said. “If it’s not controlled … it’s not illegal for somebody that’s not prescribed it to possess it.”

Mr. Haegele said he heard about the drug less than 3 months ago when an officer accidentally received a text message from someone offering to sell it. The police force, he said, is still trying to assess the threat of gabapentin.

 

 

Little testing

Nearly anyone arrested and found to struggle with addiction in Athens is given the option to go through a drug-court program to get treatment. But officials said that some exploit the absence of routine exams for gabapentin to get high while testing clean.

Brice Johnson, a probation officer at Athens County Municipal Court, said participants in the municipal court’s substance abuse mentally ill program undergo gabapentin testing only when abuse is suspected. Screenings are not regularly done on every client because gabapentin abuse has not been a concern and the testing adds expense, he said.

The rehab program run through the county prosecutor’s office, called Fresh Start, does test for gabapentin. Its latest round of screenings detected the drug in 5 of its roughly 238 active participants, prosecutor Keller Blackburn said.

Linda Holley, a clinical supervisor at an Athens outpatient program run by the Health Recovery Services, said she suspects at least half of her clients on Suboxone treatment abuse gabapentin. But the center can’t afford to regularly test every participant.

Ms. Holley said she sees clients who are prescribed gabapentin but, because of health privacy laws, she can’t share their status as a person in recovery to an outside provider without written consent. The restrictions give clients in recovery an opportunity to get high using drugs they obtained legally and still pass a drug test.

“With the gabapentin, I wish there were more we could do, but our hands are tied,” she said. “We can’t do anything but educate the client and discourage” them from using such medications.

Ms. Smith visited two separate doctors to secure a prescription. As she rotated through drug court, Narcotics Anonymous meetings, jail for relapsing on cocaine, and house arrest enforced with an ankle bracelet, she said her gabapentin abuse wasn’t detected until she arrived at the residential recovery center.

Today, Ms. Smith sticks to the recovery process. Expecting a baby in early July, her successful completion of the program not only means sobriety but also allows her the opportunity to restore custody of her eldest daughter and raise her children.

She intends to relocate her family away from the friends and routines that helped lead her to addiction and said she will help guide her daughter away from making similar mistakes.

“All I can do is be there and give her the knowledge that I can about addiction,” Ms. Smith said, “and hope that she chooses to go on the right path.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

 

ATHENS, OHIO – On April 5, Ciera Smith sat in a car parked on the gravel driveway of the Rural Women’s Recovery Program here with a choice to make: Go to jail or enter treatment for her addiction.

Ms. Smith, 22, started abusing drugs when she was 18 years old, enticed by the “good time” she and her friends found in smoking marijuana. She later turned to addictive painkillers, then antianxiety medications such as Xanax and eventually Suboxone, a narcotic often used to replace opioids when treating addiction.

Before stepping out of the car, she decided she needed one more high before treatment. She reached into her purse and then swallowed a handful of gabapentin pills.

Last December, Ohio’s Board of Pharmacy began reporting sales of gabapentin prescriptions in its regular monitoring of controlled substances. The drug, which is neither an opioid nor designated a controlled substance by federal authorities, is used to treat nerve pain. But the board found that it was the most prescribed medication on its list that month, surpassing oxycodone by more than 9 million doses. In February, the Ohio Substance Abuse Monitoring Network issued an alert regarding increasing misuse across the state.

And it’s not just in Ohio. Gabapentin’s ability to tackle multiple ailments has helped make it one of the most popular medications in the United States. In May, it was the fifth-most prescribed drug in the nation, according to GoodRx.

Gabapentin is approved by the Food and Drug Administration to treat epilepsy and pain related to nerve damage, called neuropathy. Also known by its brand name, Neurontin, the drug acts as a sedative. It is widely considered nonaddictive and touted by the federal Centers for Disease Control and Prevention as an alternative intervention to opiates for chronic pain. Generally, doctors prescribe no more than 1,800-2,400 mg of gabapentin per day, according to information on the Mayo Clinic’s website.

Gabapentin does not carry the same risk of lethal overdoses as opioids, but drug experts say the effects of using gabapentin for long periods of time or in very high quantities, particularly among such sensitive populations as pregnant women, are not well known.

As providers dole out the drug in mass quantities for conditions such as restless legs syndrome and alcoholism, it is being subverted to a drug of abuse. Gabapentin can enhance the euphoria caused by an opioid and stave off drug withdrawals. In addition, it can bypass the blocking effects of medications used for addiction treatment, enabling patients to get high while in recovery.

Athens, home to Ohio University, lies in the southeastern corner of the state, which has been ravaged by the opioid epidemic. Despite experience in combating illicit drug use, law enforcement officials and drug counselors say the addition of gabapentin adds a new obstacle.

“I don’t know if we have a clear picture of the risk,” said Joe Gay, executive director of Health Recovery Services, a network of substance abuse recovery centers headquartered in Athens.

‘Available to be abused’

A literature review published in 2016 in the journal Addiction found about a fifth of those who abuse opiates misuse gabapentin. A separate 2015 study of adults in Appalachian Kentucky who abused opiates found 15% of participants also misused gabapentin in the past 6 months “to get high.”

In the same year, the drug was involved in 109 overdose deaths in West Virginia, the Charleston Gazette-Mail reported.

Rachel Quivey, an Athens pharmacist, said she noticed signs of gabapentin misuse half a decade ago when patients began picking up the drug several days before their prescription ran out.

“Gabapentin is so readily available,” she said. “That, in my opinion, is where a lot of that danger is. It’s available to be abused.”

In May, Ms. Quivey’s pharmacy filled roughly 33 prescriptions of gabapentin per week, dispensing 90-120 pills for each client.

For customers who arrive with scripts demanding a high dosage of the drug, Ms. Quivey sometimes calls the doctor to discuss her concerns. But many of them aren’t aware of gabapentin misuse, she said.

Even as gabapentin gets restocked regularly on Ms. Quivey’s shelves, the drug’s presence is increasing on the streets of Athens. A 300-milligram pill sells for as little as 75 cents.

Yet, according to Chuck Haegele, field supervisor for the major crimes unit at the Athens City Police Department, law enforcement can do little to stop its spread. That’s because gabapentin is not categorized as a controlled substance. That designation places restrictions on who can possess and dispense the drug.

“There’s really not much we can do at this point,” he said. “If it’s not controlled … it’s not illegal for somebody that’s not prescribed it to possess it.”

Mr. Haegele said he heard about the drug less than 3 months ago when an officer accidentally received a text message from someone offering to sell it. The police force, he said, is still trying to assess the threat of gabapentin.

 

 

Little testing

Nearly anyone arrested and found to struggle with addiction in Athens is given the option to go through a drug-court program to get treatment. But officials said that some exploit the absence of routine exams for gabapentin to get high while testing clean.

Brice Johnson, a probation officer at Athens County Municipal Court, said participants in the municipal court’s substance abuse mentally ill program undergo gabapentin testing only when abuse is suspected. Screenings are not regularly done on every client because gabapentin abuse has not been a concern and the testing adds expense, he said.

The rehab program run through the county prosecutor’s office, called Fresh Start, does test for gabapentin. Its latest round of screenings detected the drug in 5 of its roughly 238 active participants, prosecutor Keller Blackburn said.

Linda Holley, a clinical supervisor at an Athens outpatient program run by the Health Recovery Services, said she suspects at least half of her clients on Suboxone treatment abuse gabapentin. But the center can’t afford to regularly test every participant.

Ms. Holley said she sees clients who are prescribed gabapentin but, because of health privacy laws, she can’t share their status as a person in recovery to an outside provider without written consent. The restrictions give clients in recovery an opportunity to get high using drugs they obtained legally and still pass a drug test.

“With the gabapentin, I wish there were more we could do, but our hands are tied,” she said. “We can’t do anything but educate the client and discourage” them from using such medications.

Ms. Smith visited two separate doctors to secure a prescription. As she rotated through drug court, Narcotics Anonymous meetings, jail for relapsing on cocaine, and house arrest enforced with an ankle bracelet, she said her gabapentin abuse wasn’t detected until she arrived at the residential recovery center.

Today, Ms. Smith sticks to the recovery process. Expecting a baby in early July, her successful completion of the program not only means sobriety but also allows her the opportunity to restore custody of her eldest daughter and raise her children.

She intends to relocate her family away from the friends and routines that helped lead her to addiction and said she will help guide her daughter away from making similar mistakes.

“All I can do is be there and give her the knowledge that I can about addiction,” Ms. Smith said, “and hope that she chooses to go on the right path.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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Sprint to find Zika vaccine could hinge on summer outbreaks

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Fri, 01/18/2019 - 16:34

 

As warmer temperatures herald the arrival of pesky mosquitoes, researchers are feverishly working on several promising vaccines against Zika, a virus notorious for infecting humans through this insect’s bite.

The speed and debilitating effects of last year’s Zika outbreak in the Western Hemisphere prompted a sprint to develop a vaccine. Just a little more than a year after the pandemic was declared a global health emergency, a handful of candidates are undergoing preliminary testing in humans.

Dr. Anthony S. Fauci
But researchers say the uncertainty over whether the Zika epidemic will continue affects their ability to finish testing. They need locations with an active viral outbreak to conduct large-scale human trials and make sure the vaccine actually protects against disease.

“On one hand, you don’t want to see outbreaks of infection,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “But on the other hand, [without that testing] you might have to wait a long time to make sure that the vaccine works.”

All the vaccines currently being tested are in phase I clinical trials, which means they are being tested for safety in a small number of people. According to a review paper published Tuesday in the journal Immunity, the vaccines represent a variety of scientific techniques to thwart the disease, ranging from inactivating the virus to manipulating its DNA.

The NIAID announced Tuesday it is launching yet another phase I trial for a vaccine made out of proteins found in mosquito saliva. The product is intended to trigger a human immune system response to the mosquito’s saliva and any viruses mixed with it. If successful, the product could protect humans against a spectrum of mosquito-transmitted diseases, including Zika.

Col. Nelson Michael, MD, PhD, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research in Silver Spring, Md., and coauthor of the paper, said he expects preliminary reports on the safety of some of the older vaccines in April. As of now, he said, it is impossible to guess which vaccine will prove most effective in providing immunity.

“Sometimes it’s difficult to predict which horse will win the race,” Michael said.

Zika – which is spread from infected people to others by mosquito bites or sexual contact, often infects people without showing symptoms. In some cases, it causes flu-like symptoms, such as fever, muscle aches and joint pain in adults – and, in rare cases, Guillain-Barré syndrome, which can cause temporary paralysis. But it is most notorious for causing some children to be born with microcephaly – a birth defect in which a child’s head is smaller than the average size – if their mothers were exposed to Zika.

The virus garnered international attention after hundreds of cases of disabled babies surfaced in Brazil. It quickly swept through South America and the Caribbean before stopping on the southern coast of the U.S.

The World Health Organization declared the outbreak a “public health emergency of international concern” on Feb. 1, 2016, then ended the alert on Nov. 18.

Vaccines that meet the safety standard in phase I clinical trials undergo subsequent rounds of testing to gauge effectiveness. To measure this, researchers rely on the gold standard of administering the vaccine to large number of individuals already exposed to the virus. However, Zika’s recent arrival to the Western Hemisphere means researchers don’t know whether the virus will become a perennial threat or a one-time explosion.

The uncertainty poses several implications for the surge in Zika vaccine development. A lull in the outbreak could cause significant delays in testing, pushing back the timetable for a commercially available product, Dr. Fauci said.

While researchers can use alternative methods to measure efficacy without large-scale testing, a decline in the circulation of the Zika virus could set progress back by years because the vaccine testing would be ineffective.

“If we don’t get a lot of infections this season in South America and Puerto Rico, it may take years to make sure the vaccine works,” he said.

Dr. Fauci expects to launch the next round of human trials for a DNA vaccine developed by the NIAID next month.

Dr. Michael also worries that a lag in the number of Zika cases could lead the private sector to pull funds from vaccine development. It takes millions of dollars to develop a drug or vaccine, and pharmaceutical companies play a critical role in making and manufacturing them, he said. But those companies have many competing interests, he noted, and if it is hard to test a vaccine this year, the public and private Zika prevention efforts may turn attention elsewhere.

“This is a constant issue where you put your resources,” Dr. Michael said.

So far, signs suggest that the climate could be ripe for Zika again this year. Warmer-than-usual temperatures are affecting areas across the Western Hemisphere, CBS reported, including hotbeds of the Zika outbreaks in Brazil. The higher temperatures increase the voracity of Zika’s main transmitter, the Aedes aegypti mosquito.

In the United States, areas with populations of the Aedes aegypti are closely monitoring their numbers. Last year, Texas and Florida dealt with locally acquired cases of Zika infection.

In Texas, public health officials have monitored mosquito populations throughout the winter to track their numbers and any presence of the virus. Despite unseasonably warm weather, said Chris Van Deusen, spokesman for the Texas Department of State Health Services, they have seen lower numbers of the Aedes aegypti and no cases of Zika.

Mr. Van Deusen said the state is also monitoring the outbreak in Mexico, since heavy traffic across the border increases the possibility of transmission. Officials are expecting another outbreak of locally transmitted cases of disease, Mr. Van Deusen said.

“There’s so many factors that go into it, it’s really impossible to make an ironclad prediction,” he said.

 

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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As warmer temperatures herald the arrival of pesky mosquitoes, researchers are feverishly working on several promising vaccines against Zika, a virus notorious for infecting humans through this insect’s bite.

The speed and debilitating effects of last year’s Zika outbreak in the Western Hemisphere prompted a sprint to develop a vaccine. Just a little more than a year after the pandemic was declared a global health emergency, a handful of candidates are undergoing preliminary testing in humans.

Dr. Anthony S. Fauci
But researchers say the uncertainty over whether the Zika epidemic will continue affects their ability to finish testing. They need locations with an active viral outbreak to conduct large-scale human trials and make sure the vaccine actually protects against disease.

“On one hand, you don’t want to see outbreaks of infection,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “But on the other hand, [without that testing] you might have to wait a long time to make sure that the vaccine works.”

All the vaccines currently being tested are in phase I clinical trials, which means they are being tested for safety in a small number of people. According to a review paper published Tuesday in the journal Immunity, the vaccines represent a variety of scientific techniques to thwart the disease, ranging from inactivating the virus to manipulating its DNA.

The NIAID announced Tuesday it is launching yet another phase I trial for a vaccine made out of proteins found in mosquito saliva. The product is intended to trigger a human immune system response to the mosquito’s saliva and any viruses mixed with it. If successful, the product could protect humans against a spectrum of mosquito-transmitted diseases, including Zika.

Col. Nelson Michael, MD, PhD, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research in Silver Spring, Md., and coauthor of the paper, said he expects preliminary reports on the safety of some of the older vaccines in April. As of now, he said, it is impossible to guess which vaccine will prove most effective in providing immunity.

“Sometimes it’s difficult to predict which horse will win the race,” Michael said.

Zika – which is spread from infected people to others by mosquito bites or sexual contact, often infects people without showing symptoms. In some cases, it causes flu-like symptoms, such as fever, muscle aches and joint pain in adults – and, in rare cases, Guillain-Barré syndrome, which can cause temporary paralysis. But it is most notorious for causing some children to be born with microcephaly – a birth defect in which a child’s head is smaller than the average size – if their mothers were exposed to Zika.

The virus garnered international attention after hundreds of cases of disabled babies surfaced in Brazil. It quickly swept through South America and the Caribbean before stopping on the southern coast of the U.S.

The World Health Organization declared the outbreak a “public health emergency of international concern” on Feb. 1, 2016, then ended the alert on Nov. 18.

Vaccines that meet the safety standard in phase I clinical trials undergo subsequent rounds of testing to gauge effectiveness. To measure this, researchers rely on the gold standard of administering the vaccine to large number of individuals already exposed to the virus. However, Zika’s recent arrival to the Western Hemisphere means researchers don’t know whether the virus will become a perennial threat or a one-time explosion.

The uncertainty poses several implications for the surge in Zika vaccine development. A lull in the outbreak could cause significant delays in testing, pushing back the timetable for a commercially available product, Dr. Fauci said.

While researchers can use alternative methods to measure efficacy without large-scale testing, a decline in the circulation of the Zika virus could set progress back by years because the vaccine testing would be ineffective.

“If we don’t get a lot of infections this season in South America and Puerto Rico, it may take years to make sure the vaccine works,” he said.

Dr. Fauci expects to launch the next round of human trials for a DNA vaccine developed by the NIAID next month.

Dr. Michael also worries that a lag in the number of Zika cases could lead the private sector to pull funds from vaccine development. It takes millions of dollars to develop a drug or vaccine, and pharmaceutical companies play a critical role in making and manufacturing them, he said. But those companies have many competing interests, he noted, and if it is hard to test a vaccine this year, the public and private Zika prevention efforts may turn attention elsewhere.

“This is a constant issue where you put your resources,” Dr. Michael said.

So far, signs suggest that the climate could be ripe for Zika again this year. Warmer-than-usual temperatures are affecting areas across the Western Hemisphere, CBS reported, including hotbeds of the Zika outbreaks in Brazil. The higher temperatures increase the voracity of Zika’s main transmitter, the Aedes aegypti mosquito.

In the United States, areas with populations of the Aedes aegypti are closely monitoring their numbers. Last year, Texas and Florida dealt with locally acquired cases of Zika infection.

In Texas, public health officials have monitored mosquito populations throughout the winter to track their numbers and any presence of the virus. Despite unseasonably warm weather, said Chris Van Deusen, spokesman for the Texas Department of State Health Services, they have seen lower numbers of the Aedes aegypti and no cases of Zika.

Mr. Van Deusen said the state is also monitoring the outbreak in Mexico, since heavy traffic across the border increases the possibility of transmission. Officials are expecting another outbreak of locally transmitted cases of disease, Mr. Van Deusen said.

“There’s so many factors that go into it, it’s really impossible to make an ironclad prediction,” he said.

 

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

 

As warmer temperatures herald the arrival of pesky mosquitoes, researchers are feverishly working on several promising vaccines against Zika, a virus notorious for infecting humans through this insect’s bite.

The speed and debilitating effects of last year’s Zika outbreak in the Western Hemisphere prompted a sprint to develop a vaccine. Just a little more than a year after the pandemic was declared a global health emergency, a handful of candidates are undergoing preliminary testing in humans.

Dr. Anthony S. Fauci
But researchers say the uncertainty over whether the Zika epidemic will continue affects their ability to finish testing. They need locations with an active viral outbreak to conduct large-scale human trials and make sure the vaccine actually protects against disease.

“On one hand, you don’t want to see outbreaks of infection,” said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases. “But on the other hand, [without that testing] you might have to wait a long time to make sure that the vaccine works.”

All the vaccines currently being tested are in phase I clinical trials, which means they are being tested for safety in a small number of people. According to a review paper published Tuesday in the journal Immunity, the vaccines represent a variety of scientific techniques to thwart the disease, ranging from inactivating the virus to manipulating its DNA.

The NIAID announced Tuesday it is launching yet another phase I trial for a vaccine made out of proteins found in mosquito saliva. The product is intended to trigger a human immune system response to the mosquito’s saliva and any viruses mixed with it. If successful, the product could protect humans against a spectrum of mosquito-transmitted diseases, including Zika.

Col. Nelson Michael, MD, PhD, director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research in Silver Spring, Md., and coauthor of the paper, said he expects preliminary reports on the safety of some of the older vaccines in April. As of now, he said, it is impossible to guess which vaccine will prove most effective in providing immunity.

“Sometimes it’s difficult to predict which horse will win the race,” Michael said.

Zika – which is spread from infected people to others by mosquito bites or sexual contact, often infects people without showing symptoms. In some cases, it causes flu-like symptoms, such as fever, muscle aches and joint pain in adults – and, in rare cases, Guillain-Barré syndrome, which can cause temporary paralysis. But it is most notorious for causing some children to be born with microcephaly – a birth defect in which a child’s head is smaller than the average size – if their mothers were exposed to Zika.

The virus garnered international attention after hundreds of cases of disabled babies surfaced in Brazil. It quickly swept through South America and the Caribbean before stopping on the southern coast of the U.S.

The World Health Organization declared the outbreak a “public health emergency of international concern” on Feb. 1, 2016, then ended the alert on Nov. 18.

Vaccines that meet the safety standard in phase I clinical trials undergo subsequent rounds of testing to gauge effectiveness. To measure this, researchers rely on the gold standard of administering the vaccine to large number of individuals already exposed to the virus. However, Zika’s recent arrival to the Western Hemisphere means researchers don’t know whether the virus will become a perennial threat or a one-time explosion.

The uncertainty poses several implications for the surge in Zika vaccine development. A lull in the outbreak could cause significant delays in testing, pushing back the timetable for a commercially available product, Dr. Fauci said.

While researchers can use alternative methods to measure efficacy without large-scale testing, a decline in the circulation of the Zika virus could set progress back by years because the vaccine testing would be ineffective.

“If we don’t get a lot of infections this season in South America and Puerto Rico, it may take years to make sure the vaccine works,” he said.

Dr. Fauci expects to launch the next round of human trials for a DNA vaccine developed by the NIAID next month.

Dr. Michael also worries that a lag in the number of Zika cases could lead the private sector to pull funds from vaccine development. It takes millions of dollars to develop a drug or vaccine, and pharmaceutical companies play a critical role in making and manufacturing them, he said. But those companies have many competing interests, he noted, and if it is hard to test a vaccine this year, the public and private Zika prevention efforts may turn attention elsewhere.

“This is a constant issue where you put your resources,” Dr. Michael said.

So far, signs suggest that the climate could be ripe for Zika again this year. Warmer-than-usual temperatures are affecting areas across the Western Hemisphere, CBS reported, including hotbeds of the Zika outbreaks in Brazil. The higher temperatures increase the voracity of Zika’s main transmitter, the Aedes aegypti mosquito.

In the United States, areas with populations of the Aedes aegypti are closely monitoring their numbers. Last year, Texas and Florida dealt with locally acquired cases of Zika infection.

In Texas, public health officials have monitored mosquito populations throughout the winter to track their numbers and any presence of the virus. Despite unseasonably warm weather, said Chris Van Deusen, spokesman for the Texas Department of State Health Services, they have seen lower numbers of the Aedes aegypti and no cases of Zika.

Mr. Van Deusen said the state is also monitoring the outbreak in Mexico, since heavy traffic across the border increases the possibility of transmission. Officials are expecting another outbreak of locally transmitted cases of disease, Mr. Van Deusen said.

“There’s so many factors that go into it, it’s really impossible to make an ironclad prediction,” he said.

 

 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

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