Zohydro to be Manufactured
by Same Company That Makes Addiction Medicine
The newly approved pure hydrocodone product, Zohydro ER
(extended release), will be made by the same company that manufactures
Vivitrol, a drug used to treat patients addicted to opioids or alcohol, The New
York Times reports. The Food and Drug Administration (FDA) approved Zohydro ER
last month for patients with pain that requires daily, around-the-clock,
long-term treatment that cannot be treated with other drugs. Drugs such as
Vicodin contain a combination of hydrocodone and other painkillers such as
acetaminophen. Zohydro is expected to reach the market in early 2014. In
December 2012, a panel of experts assembled by the FDA voted against
recommending approval of Zohydro ER. The panel cited concerns over the
potential for addiction. In the 11-2 vote against approval, the panel said that
while the drug’s maker, Zogenix, had met narrow targets for safety and
efficacy, the painkiller could be used by people addicted to other opioids,
including oxycodone. In 2010, Zogenix bought the right to market Zohydro in the
United States from another company, Elan, the article notes. The following
year, a company named Alkermes, which makes Vivitrol, bought a unit of Elan
that included Zohydro. The deal included the existing agreement with Zogenix.
Some law enforcement agencies and addiction experts have voiced concern that
approval of a pure hydrocodone drug will lead to an increase in overdoses.
PCP-Related Visits to the
Emergency Room Jumped 400% Between 2005 and 2011
PCP-related emergency room visits jumped 400 percent between
2005 and 2011, according to a new report by the Substance Abuse and Mental
Health Services Administration (SAMHSA). PCP (phencyclidine), also known as
“angel dust,” can cause hallucinations when taken at high doses. The number of
PCP-related visits to hospital emergency rooms jumped from 14,825 in 2005, to
75,538 in 2011, Medical News Today reports. The largest increase was seen among
patients ages 25 to 34. In 2011, about two-thirds of PCP-related visits were
made by males, and almost half were made by people ages 25 to 34. Other illegal
drugs, including marijuana, cocaine and heroin, were involved in about half of
PCP-related emergency room visits in 2011. PCP can be snorted, smoked,
injected, or swallowed and is most commonly sold as a powder or liquid and
applied to a leafy material such as mint, parsley, oregano, tobacco, or
marijuana. Many people who use PCP may do it unknowingly because it is often
used as an additive and can be found in marijuana, LSD, or methamphetamine. In
a hospital or detention setting, a person on PCP may become violent or
suicidal, and can become very dangerous to themselves and to others. “This
report is a wake-up call that this dangerous drug may be making a comeback in
communities throughout the nation,” Dr. Peter Delany, Director of SAMHSA’s
Center for Behavioral Health Statistics and Quality, said in a news release.
“PCP is a potentially deadly drug and can have devastating consequences not
only for individuals, but also for families, friends and communities. We must
take steps at every level to combat the spread of this public health threat.”
Addiction Treatment with a
Dark Side
In Demand in Clinics and on the Street, ‘Bupe’ Can Be a
Savior or a Menace.
For Shawn Schneider, a carpenter and rock musician, the
descent into addiction began one Wisconsin winter with a fall from a rooftop
construction site onto the frozen ground below. As the potent pain pills
prescribed for his injuries became his obsessive focus, he lost everything: his
band, his job, his wife, his will to live. Mr. Schneider was staying in his parents’
basement when he washed down 40 sleeping pills with NyQuil and beer. His father
heard him gasping and intervened, a reprieve that led Mr. Schneider into rehab,
not his first program, but the one where he discovered buprenorphine, a
substitute opioid used to treat opioid addiction. In the two years since, by
taking his “bupe” twice daily and meeting periodically with the prescribing
psychiatrist, Mr. Schneider, 38, has rebounded. He is sober, remarried,
employed building houses, half of a new acoustic duo and one of the many
addicts who credit buprenorphine, sold mostly in a compound called Suboxone,
with saving their lives. Continue
reading here.
The benefits and health
risks of beer and wine
More than a few baby boomers imbibed too much during their
misspent youth, leaving them with a lifelong apprehension of what can come from
drinking alcohol. But a raft of medical studies over the past generation shows
that alcohol has proven health benefits, provided you drink in moderation — one
or two drinks a day, three or four days a week. Many doctors say the findings
are no longer in doubt, even if some boomers with long memories continue to be
skeptical. “There’s no question that people who drink moderately have lower
rates of heart attacks, lower rates of diabetes, and live longer,” said Dr.
Eric Rimm, associate professor in the departments of epidemiology and nutrition
at the Harvard School of Public Health in Boston. “If you ask most
cardiologists, they would say drinking in moderation is beneficial.” Even more
interesting: People who only drink occasionally, or on weekends, aren’t likely
to enjoy the same health benefits as those who drink every other day, Rimm
suggested. Alcohol reduces the risk of blood clotting in the 24 hours after
drinking, for example, but not in the days after. Other benefits, such as a
rise in good cholesterol, making it easier to process glucose, are more likely
to extend throughout the week.
Please click here to continue reading.
Alcohol Has Bigger Effect
on People in Middle Age Due to Physical, Lifestyle Changes
Alcohol affects people more in middle age due to physical
and lifestyle changes, according to The Wall Street Journal. As people start to
take more medication in their 40s and 50s, the risk of alcohol and drug
interactions also increases. As people reach middle age, they experience
changes in body composition, brain sensitivity and liver functioning, the
article notes. “All of the effects of alcohol are sort of amplified with age,”
David W. Oslin, a professor of psychiatry at the Perelman School of Medicine at
the University of Pennsylvania, told the newspaper. “Withdrawal is a little bit
more complicated. Hangovers are a little bit more complicated.” Changes in body
composition during middle age result in more alcohol circulating in the
bloodstream. In addition, the liver, which metabolizes alcohol, gets less
efficient as people age. The level of certain enzymes that break down alcohol
decreases. Hormonal changes that women experience during menopause can increase
their sensitivity to alcohol. In middle age, people tend to drink less than
they did when they were younger, notes Robert Pandina, director of the Center
of Alcohol Studies at Rutgers University. So when you do drink “you might have
a more sensitive response to alcohol because you’ve lowered your exposure to
alcohol over all,” he said. Drugs that can interact with alcohol include
heartburn drugs such as Zantac, acetaminophen, and blood thinners like
Coumadin. Mixing blood thinners with alcohol can cause bleeding. “People on
Coumadin shouldn’t really drink at all,” Dr. Oslin noted. Combining alcohol
with some pain medications and benzodiazepines can make a person “more prone to
sedation, more prone to cardiovascular risk and more prone to overdose,” he added.
According to the Centers for Diseases Control and Prevention, about 52 percent
of people ages 45 to 64 had at least 12 drinks in the previous year.
Senate Passes Measure
Establishing System to Track Prescription Drugs
The U.S. Senate this week passed a measure that will
establish a system to track prescription drugs from the time they are
manufactured until they are sold at a drugstore, The News & Observer
reports. The bill awaits President Obama’s signature. Over the next seven
years, The Drug Quality and Security Act calls for drug manufacturers,
repackagers, wholesale distributors and dispensers to pass and hold onto key
information about each drug’s distribution history. The goal is to allow
unit-level product tracing within 10 years. Four years after the law is
enacted, manufacturers will serialize drugs in a consistent way across the
industry, to allow for efficient tracing to respond to recalls and notices of
theft and counterfeiting. “This legislation will improve the safety of
compounded drugs as well as establish an unprecedented tracing system that
will, for the first time ever, track prescription drugs from manufacturing to
distribution, thereby thwarting drug counterfeiters,” Senate Health, Education,
Labor, and Pensions Committee Chairman Tom Harkin of Iowa said in a news
release. “Americans must have the confidence that their drugs—whether obtained
at a hospital, at a doctor’s office, or at the pharmacy counter—are safe, and
that is exactly what this bill does.” John Castellani, President and CEO of the
Pharmaceutical Research and Manufacturers of America, said in a statement, “The
counterfeiting of prescription drugs is on the rise within the United States
but oftentimes goes unnoticed or unreported, leaving many Americans unaware of
this problem. In fact, some experts have cited the counterfeiting of these
medicines as even more lucrative than the trafficking of illegal drugs like
heroin and cocaine. This act will improve the security of the finished drug supply
chain and reduce the impact of the patchwork of state laws related to the
pedigree requirements for drug distribution.”
Poison Control Experts
Warn of Danger From Detergent Capsules That Look Like Candy
Poison control experts are warning parents about single-dose
detergent capsules that look like candy. These products were involved in about
10,000 cases of exposure involving young children, The Wall Street Journal
reports. “Some children who have gotten the product in their mouths have had
excessive vomiting, wheezing and gasping,” the American Association of Poison
Control Centers notes on its website. “Some get very sleepy. Some have had
breathing problems serious enough to need a ventilator to help them breathe.
There have also been reports of corneal abrasions (scratches to the eyes) when
the detergent gets into a child’s eyes.” Last year, single-dose detergent pods
became popular, the article notes. Thousands of children who ate or otherwise
came into contact with laundry pods received medical attention. Some had
breathing problems that required days of hospitalization. A 7-month-old boy in
Florida died in August after eating a laundry detergent capsule. Proctor &
Gamble, which makes Tide Pods, was warned about possible problems three years
ago by officials at an Italian poison control center. They contacted the
company to report children were biting into small packets of the company’s
concentrated liquid detergent called Dash Ecodosi. The poison control officials
recommended making the capsules’ packaging opaque, and more difficult to open.
After the company made the changes, reported poison cases fell by 60 percent
over six months, according to the newspaper. While Proctor & Gamble studied
the problem in Italy, it launched Tide Pods in the United States and Canada in
clear containers. The company said it wanted to see whether making the packages
opaque worked before trying them in North America. It changed the packaging in
the United States and Canada this past spring. Clear packages are now largely
phased out.
Office of the National
Coordinator to help fight Rx drug abuse
Developing standards to bring prescription info from state
databases into EHRs and HIEs
In an effort to combat the prescription drug abuse epidemic,
the Office of the National Coordinator (ONC) has launched a new
interoperability initiative to better link drug monitoring programs with health
IT systems. In a blog post, Jennifer Frazier, ONC's behavioral health subject
matter expert, says the new Standards & Interoperability Framework
Initiative seeks to solve problems related to the lack of common technical
standards and vocabularies that could help prescription drug monitoring
programs "share computable information" with health IT systems. The
PDMP & Health IT Integration framework "will bring together the PDMP
and heath IT communities to establish a standardized approach to retrieve data
stored in the PDMPs and deliver it to EHRs and HIEs," Frazier writes.
Finding a better way to give care providers easy access to PDMP data
"can't happen quickly enough, as clinicians across the country struggle to
fight a growing national public health crisis," she adds. "Opioid
painkillers, such as hydrocodone and oxycodone, are typically the most abused
drugs. Patients are prescribed these drugs to help manage pain from injury or
surgery. When taken as prescribed, these medications are generally safe; but
when misused or abused, they can be highly addictive – even deadly." Please
click here to continue.
New study identifies
spiritual change among adolescents in treatment
A research team hopes that its latest study of factors that
influence good outcomes in adolescents with substance use problems will lead more
clinicians and programs to take a second look at spiritually based treatment
approaches for youths. The study, which will be published next spring in
Alcoholism Treatment Quarterly, found that daily spiritual experiences
(encompassing more than formal religious practices alone) served as a strong
predictor of sobriety in a youth population with complex problems. Strikingly,
while one-third of study participants had self-identified as agnostic or
atheist at the start of the study, two-thirds of those individuals would claim
some spiritual identity two months later, after receiving substance use
treatment. Continue
here.
The bottom of the bottle:
Alcoholism still tough to treat in an era of craft liquor
Evanston’s first craft brewery, Temperance Beer Company,
started churning out batches of booze earlier this year; its first craft
whiskey distillery, FEW Spirits, just won a $250,000 loan from the town for an
expansion project. With 409 craft breweries opening in the U.S. in 2012 alone
and five times as many U.S. micro-distilleries in 2012 as in 2005, it’s clear
that the small-batch liquor industry is booming. For some people, however, one
sip of alcohol is a sip too many. Read on
here.
Researchers identify a
group of 39 genes linked with alcoholism
There is good evidence from studies of families and twins that genetics plays an important role in the development of alcoholism. However, hundreds of genes likely are involved in this complex disorder, with each variant contributing only a very small effect. Thus, identifying individual risk genes is difficult. Using a new approach that combines genome-wide association studies (GWAS) with information about which human proteins interact with one another, researchers from the University of Iowa and Yale University Medical School have identified a group of 39 genes that together are strongly associated with alcoholism. "The discovery of these genes may open a new window into the biological mechanisms underlying this alcoholism disorder," says Shizhong Han, PhD, UI assistant professor of psychiatry and corresponding author of the study, which was published Nov. 21 in the American Journal of Human Genetics. "Eventually, it's our hope that the findings might help to develop drugs to treat or prevent this disorder." Han and his colleagues based their approach for identifying risk genes on the idea that genes may be "guilty by association" of contributing to the disease -- that although many different genes contribute to alcoholism, these genes, or more precisely, their protein products, are not independent of each other. "The proteins made by these genes could be neighbors, or they could be part of the same functional biological pathway," Han explains. "We took advantage of their biological relatedness to identify a network of genes that interact and together contribute to the susceptibility to alcoholism." The team conducted the study by using two large data sets collected for the genetic study of addiction -- the Collaborative Study on the Genetics of Alcoholism (COGA) and the Study of Addiction: Genetics and Environment (SAGE). These data sets document genome-wide common variants information from several thousand people linked to information about these individuals' alcohol dependence or other types of addiction\. The research team analyzed the merged SAGE and COGA datasets for genetic variants associated with alcoholism. No single variant was strongly associated with the condition, but when the researchers integrated information about protein-protein interactions from the Human Protein Interaction Network, they identified a network of 39 genes that was not only enriched for alcoholism-associated genes, but also was collectively strongly associated with alcoholism. This strong association held for both European Americans and African Americans. Furthermore, the team was able to replicate the finding in three additional genetic datasets, two of individuals of European ancestry and one of individuals of African ancestry, suggesting that the findings are robust. To minimize the possibility of the result being a false positive, the researchers also analyzed the gene network for associations with other complex human diseases - bipolar disorder, depressions and diabetes. The gene network was not associated with any of these conditions. In addition to finding the highly statistically significant association between the gene network and alcoholism, many of the genes identified also appear to be biologically relevant to brain processes likely to be affected in alcoholism. For example, the network contains genes for ion channel proteins that appear to be involved in tolerance toward some of the physiological effects of alcohol. Other genes code for proteins involved in general brain processes, including synaptic transmission, ion transport, and transmission of nerve impulses.
There is good evidence from studies of families and twins that genetics plays an important role in the development of alcoholism. However, hundreds of genes likely are involved in this complex disorder, with each variant contributing only a very small effect. Thus, identifying individual risk genes is difficult. Using a new approach that combines genome-wide association studies (GWAS) with information about which human proteins interact with one another, researchers from the University of Iowa and Yale University Medical School have identified a group of 39 genes that together are strongly associated with alcoholism. "The discovery of these genes may open a new window into the biological mechanisms underlying this alcoholism disorder," says Shizhong Han, PhD, UI assistant professor of psychiatry and corresponding author of the study, which was published Nov. 21 in the American Journal of Human Genetics. "Eventually, it's our hope that the findings might help to develop drugs to treat or prevent this disorder." Han and his colleagues based their approach for identifying risk genes on the idea that genes may be "guilty by association" of contributing to the disease -- that although many different genes contribute to alcoholism, these genes, or more precisely, their protein products, are not independent of each other. "The proteins made by these genes could be neighbors, or they could be part of the same functional biological pathway," Han explains. "We took advantage of their biological relatedness to identify a network of genes that interact and together contribute to the susceptibility to alcoholism." The team conducted the study by using two large data sets collected for the genetic study of addiction -- the Collaborative Study on the Genetics of Alcoholism (COGA) and the Study of Addiction: Genetics and Environment (SAGE). These data sets document genome-wide common variants information from several thousand people linked to information about these individuals' alcohol dependence or other types of addiction\. The research team analyzed the merged SAGE and COGA datasets for genetic variants associated with alcoholism. No single variant was strongly associated with the condition, but when the researchers integrated information about protein-protein interactions from the Human Protein Interaction Network, they identified a network of 39 genes that was not only enriched for alcoholism-associated genes, but also was collectively strongly associated with alcoholism. This strong association held for both European Americans and African Americans. Furthermore, the team was able to replicate the finding in three additional genetic datasets, two of individuals of European ancestry and one of individuals of African ancestry, suggesting that the findings are robust. To minimize the possibility of the result being a false positive, the researchers also analyzed the gene network for associations with other complex human diseases - bipolar disorder, depressions and diabetes. The gene network was not associated with any of these conditions. In addition to finding the highly statistically significant association between the gene network and alcoholism, many of the genes identified also appear to be biologically relevant to brain processes likely to be affected in alcoholism. For example, the network contains genes for ion channel proteins that appear to be involved in tolerance toward some of the physiological effects of alcohol. Other genes code for proteins involved in general brain processes, including synaptic transmission, ion transport, and transmission of nerve impulses.
Drug testing is a great
idea. Thanks, Rep. Radel.
Rep. Trey Radel voted in favor of drug-testing the folks who
get food stamps. In that case, why don’t we drug-test all people who get
federal money? Let’s start with members of Congress! Radel, the Florida
Republican whose campaign was heavy on balancing the budget, would be the first
to save the government some money on that plan. The 37-year-old congressman who
describes himself on Twitter as a “Hip Hop Conservative” — whatever that is —
lasted just 10 months in the nation’s capital before his Nose Snow Rewards Card
balance tripped the radar of law enforcement. He was busted last month after
buying $250 worth of cocaine from a federal agent. And it apparently wasn’t his
first time on this particular sleigh ride.
Continue reading here.
What’s So Bad About Casual
Drug Use?
Most people who try cocaine don't go on to become addicts
So Representative Trey Radel, the Republican from Florida, a
self-styled “conservative voice” in Congress, has pleaded guilty to a
misdemeanor charge of cocaine possession. And Toronto’s city council has
stripped Mayor Rob Ford of much of his power after it came out that he had
smoked crack (never mind that Ford’s well-known drunken antics were not cause
for such censure). Rather than arguing whether such figures are hypocrites
(Radel voted in favor of mandatory drug testing for food-stamp beneficiaries)
or debating how they should attempt damage control (he’s also pledged to enter
a substance-abuse program after paying a fine and receiving a year’s
probation), let’s ask a more basic question: What’s so scandalous about casual
drug use? Continue
reading here.
More Than Half of Teens
With Mental Health Disorders Do Not Receive Treatment: Study
More than half of teens in the United States who have mental
health disorders do not receive treatment, according to a new study. The
findings come from an analysis of more than 10,000 teens. Of those teens who do
receive help, most are not treated by a mental health professional, HealthDay
reports. They are treated by pediatricians, school counselors or probation
officers. “It’s still the case in this country that people don’t take
psychiatric conditions as seriously as they should,” lead researcher E. Jane
Costello of Duke University said in a news release. “This, despite the fact
that these conditions are linked to a whole host of other problems.” Overall,
in the past year, 45 percent of teens with psychiatric disorders received some
form of service. The most likely to receive help were those with attention
deficit hyperactivity disorder (74 percent), conduct disorder (73 percent) or
oppositional defiant disorder (71 percent). Those least likely to receive
services were those with phobias (41 percent) and any anxiety disorder (41
percent). Black teens were much less likely than white teens to receive mental
health treatment. There are not enough qualified pediatric mental health
professionals in the United States, Costello said. “We need to train more child
psychiatrists in this country,” she noted. “And those individuals need to be
used strategically, as consultants to the school counselors and others who do
the lion’s share of the work.” The findings appear in the journal Psychiatric
Services.
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