Cocaine sentencing report
http://www.ussc.gov/r_congress/cocaine2007.pdf
New report to Congress from the US Sentencing Commission on cocaine.
Wednesday
Opioid Antagonism of Cannabinoid Effects: Differences between Marijuana Smokers and Nonmarijuana Smokers
opioid-cannabinoid system interaction
http://www.nature.com/npp/journal/v32/n6/full/1301243a.html
Neuropsychopharmacology (2007) 32, 1391-1403
Opioid Antagonism of Cannabinoid Effects: Differences between Marijuana Smokers and Nonmarijuana Smokers
Margaret Haney
ABSTRACT
In non-human animals, opioid antagonists block the reinforcing and
discriminative-stimulus effects of 9-tetrahydrocannabinol (THC), while
in human marijuana smokers, naltrexone (50 mg) enhances the reinforcing
and subjective effects of THC.
The objective of this study was to test a lower, more opioid-selective
dose of naltrexone (12 mg) in combination with THC. The influence of
marijuana-use history and sex was also investigated.
Naltrexone (0, 12 mg) was administered 30 min before oral THC (0-40 mg)
or methadone (0-10 mg) capsules, and subjective effects, task
performance, pupillary diameter, and cardiovascular parameters were
assessed in marijuana smoking (Study 1; n=22) and in nonmarijuana
smoking (Study 2; n=21) men and women.
The results show that in marijuana smokers, low-dose naltrexone blunted
the intoxicating effects of a low THC dose (20 mg), while increasing
ratings of anxiety at a higher THC dose (40 mg).
In nonmarijuana smokers, low-dose naltrexone shifted THC's effects in
the opposite direction, enhancing the intoxicating effects of a low THC
dose (2.5 mg) and decreasing anxiety ratings following a high dose of
THC (10 mg).
There were no sex differences in these interactions, although among
nonmarijuana smokers, men were more sensitive to the effects of THC
alone than women.
To conclude, a low, opioid-selective dose of naltrexone blunted THC
intoxication in marijuana smokers, while in nonmarijuana smokers,
naltrexone enhanced THC intoxication.
These data demonstrate that the interaction between opioid antagonists
and cannabinoid agonists varies as a function of marijuana use history.
http://www.nature.com/npp/journal/v32/n6/full/1301243a.html
Neuropsychopharmacology (2007) 32, 1391-1403
Opioid Antagonism of Cannabinoid Effects: Differences between Marijuana Smokers and Nonmarijuana Smokers
Margaret Haney
ABSTRACT
In non-human animals, opioid antagonists block the reinforcing and
discriminative-stimulus effects of 9-tetrahydrocannabinol (THC), while
in human marijuana smokers, naltrexone (50 mg) enhances the reinforcing
and subjective effects of THC.
The objective of this study was to test a lower, more opioid-selective
dose of naltrexone (12 mg) in combination with THC. The influence of
marijuana-use history and sex was also investigated.
Naltrexone (0, 12 mg) was administered 30 min before oral THC (0-40 mg)
or methadone (0-10 mg) capsules, and subjective effects, task
performance, pupillary diameter, and cardiovascular parameters were
assessed in marijuana smoking (Study 1; n=22) and in nonmarijuana
smoking (Study 2; n=21) men and women.
The results show that in marijuana smokers, low-dose naltrexone blunted
the intoxicating effects of a low THC dose (20 mg), while increasing
ratings of anxiety at a higher THC dose (40 mg).
In nonmarijuana smokers, low-dose naltrexone shifted THC's effects in
the opposite direction, enhancing the intoxicating effects of a low THC
dose (2.5 mg) and decreasing anxiety ratings following a high dose of
THC (10 mg).
There were no sex differences in these interactions, although among
nonmarijuana smokers, men were more sensitive to the effects of THC
alone than women.
To conclude, a low, opioid-selective dose of naltrexone blunted THC
intoxication in marijuana smokers, while in nonmarijuana smokers,
naltrexone enhanced THC intoxication.
These data demonstrate that the interaction between opioid antagonists
and cannabinoid agonists varies as a function of marijuana use history.
LA Times on student drug testing
LA Times on student drug testing
http://www.latimes.com/la-he-drugtesting21may21,0,7094993.story?coll=la-home-middleright
Put to the test
More schools are asking students to take drug tests, saying it gives
them a reason to 'say no.' Addiction experts contend results are
unreliable.
By Shari Roan
LA Times Staff Writer
May 21, 2007
ONCE a year or so, Roy Tialavea is summoned from his classes at
Oceanside High School to report to the athletic director's office
bathroom. He receives a urine specimen cup and heads for a stall.
The 17-year-old is unruffled. Random drug testing has been going on for
two years at the school. He's used to it. "I don't use drugs so I don't
have to worry about getting caught," he says.
His mother, Robyn, thinks her son steers clear of drugs and alcohol.
But, she says, no parent can know for sure what a teenager is up to.
"If he doesn't like testing, I really don't care," she says. "I think
it's a wonderful tool. It creates the fear that they could be tested."
Call it the 2007 version of "just say no."
Concerned with high rates of adolescent substance abuse, hundreds of
middle schools and high schools nationwide have quietly begun testing
some or all students for drugs - to the dismay of some health and
addiction experts.
Although less than 5% of all high schools have such programs, testing is
now common in schools throughout Texas, Florida, Kentucky and parts of
California. In Southern California, many private high schools have
implemented drug testing, as have several public school districts in
Orange County and San Diego. Nationwide, as many as 1,000 schools have
established programs, according to the White House Office of National
Drug Control Policy.
The number of schools administering drug tests is expected to grow.
Federal funding for school drug testing increased 400% between 2003 and
2006. The Bush administration spent $8.6 million on such programs last
year and has requested $17.9 million for fiscal year 2008.
"This is the best new idea to reduce the onset of drug use," says Dr.
Robert L. DuPont, president of the Institute for Behavior and Health, a
nonprofit drug policy organization that has studied school testing.
"About half of high school seniors have used an illicit drug by the time
they graduate and about one-quarter are regular users by the time they
graduate. Those figures are worrisome."
School-based drug testing gives kids a reason to say no, say DuPont and
other proponents. The tests are meant to identify students who are using
and guide them into counseling or treatment programs before they develop
addictions.
But health officials, by and large, oppose school-based drug testing.
NAADAC, the Assn. for Addiction Professionals, has released a statement
critical of such programs. And in March, the American Academy of
Pediatrics cautioned against random school-based drug testing until more
research is completed. The two groups are among those who say testing is
not reliable enough, violates trust between adults and teens and is not
set up to deal effectively with students who have positive results.
Though adults debate testing's merits, students at some high schools
hand over urine specimen cups as comfortably as they turn in late
library books.
"Kids pretty much know who does drugs and who doesn't," says Alex
Podobas, a senior at San Clemente High School, which has had voluntary
testing for several years. "But no one says, 'Oh, you're a pothead' when
you get called out for testing."
Screening kids for marijuana, cocaine, amphetamines and other illegal
drugs at school is an offshoot of two decades of experience with
workplace and military drug testing, experts say. Testing methods have
improved during that time to reduce the number of false test results
while providing greater privacy and confidentiality, says DuPont.
And though substance abuse among teens has dropped in the last decade,
parents and school administrators still consider the rates unacceptably
high. Just over 20% of eighth-graders and about half of all high school
seniors say they have taken an illicit drug, according to 2006 data from
Monitoring the Future, the University of Michigan's nationwide annual
survey. About 30% of high school seniors say they have been drunk in the
last month.
Little faith is put in traditional classroom drug education programs to
further drive down substance abuse rates, says Jennifer Kern of the Drug
Policy Alliance, a New York City-based organization that focuses on a
harm-reduction approach to drug education.
"People are overwhelmed and are looking for new approaches," she says.
"A lot of the concern comes from a good place. We haven't done a good
job preventing substance abuse."
School drug testing got its biggest boost in 2002 when the Supreme Court
ruled that schools may conduct random drug tests among students who wish
to participate in school-sponsored extracurricular activities, such as
sports, marching band or debate team.
"Fifteen years ago, school drug testing was too controversial," says
John P. Walters, director of the White House Office of National Drug
Control Policy. "People thought the test was going to throw kids out of
school or give them a criminal record. The Supreme Court decision was an
enormously positive step."
But critics say the court's decision opened the floodgates for programs
that have not been studiously researched or properly evaluated.
"If you look on the surface, drug testing seems like a good idea; a
simple thing to do," says Dr. Sharon Levy, director of the Adolescent
Substance Abuse Program at Children's Hospital Boston. "It's only when
you sit down and look at it closely that it really starts to unravel a
bit."
Chief among the pediatricians' complaints is the reliability of testing.
A study published in April in the journal Pediatrics found a substantial
risk of error even when drug testing was performed as part of an
established adolescent substance abuse program. In the study, Levy and
her colleagues reviewed 710 random urine tests from 110 teens and
compared the results with confirmatory lab tests. (Initial screening
samples should be confirmed with a second, more rigorous, analysis -
something most school programs say they do.) They found 12% of the tests
were subject to misinterpretation. For example, some of the urine
samples were diluted (despite rigorous collection procedures designed to
prevent kids from cheating) and could not be interpreted properly.
Further, of the samples, 21% were positive due to legitimate
prescription drug use, Levy says. And several samples that were found in
confirmatory testing to be positive for the painkiller OxyContin - a
popular drug of abuse among teens - were identified as negative in the
initial screen.
"Drug testing is premature policy," says Levy. "We need to understand
the combination of risks and costs compared to the benefits. That hasn't
been done at all."
Further, critics say, the drug testing panels used by schools are
typically those used in the workplace - screens for marijuana,
amphetamines, cocaine, opiates and PCP. The panels usually do not assess
alcohol or other drugs kids may be likely to use, such as inhalants,
OxyContin and Ecstasy. Standard urine tests only detect use that has
occurred in the last 48 to 72 hours.
Negative screens may mislead parents, school personnel and the community
from searching for a truer picture of adolescent drug and alcohol use,
Kern says.
"Parents can say 'OK, the schools are doing testing, we'll know what is
going on,' " she says. "But drug testing gives you very little
information. It can give parents a false sense of security."
Even the belief that testing deters kids from using drugs or gives them
a peer-worthy reason to say no has not been proven, Kern says. A 2003
study by the University of Michigan surveying 76,000 students found no
difference in marijuana or other illicit drug use in schools with
testing compared with those without programs.
Podobas, the San Clemente senior, says few students fear being caught.
The tests don't pick up all drugs and are administered too infrequently
to worry teens, he says. Others have learned to beat the system by
sharing a clean urine sample when called to the bathrooms in groups. "I
don't think it has lessened the number of kids using drugs," says
Podobas, although he thinks some kids use less frequently than they
otherwise would.
Others critics of the program say school drug testing can make teens
feel guilty before being proven innocent. While many programs - such as
several in Orange County - only test students if they and their parents
consent, kids may feel that adults distrust them, Kern says.
"There may be unintended consequences to drug testing," says Dr. Howard
Taras, a pediatrics professor at UC San Diego, who studies school health
issues. "Kids may be deterred from joining a sport or extracurricular
activity because they will be tested. Those are the kids that most need
extracurricular activities. They may not get engaged in math or science
but they may get engaged by a sport or dance class."
Proponents of drug testing say such shortcomings simply don't exist in
most schools. The programs, they say, are diligent about collection
procedures and lab analysis, privacy issues and follow-up for kids found
to have used drugs.
"Where are they finding these programs doing the bad things?" says
DuPont of the critics. A study by his office of nine programs found all
were following testing protocols and handling kids with positive tests
nonpunitively.
Even if testing programs aren't perfect, recent research on the effect
of drug use on adolescent brains warrants an aggressive approach to the
problem, Walters says. Studies show that heavy drug use during
adolescence may permanently damage parts of the brain related to
learning and memory. People who avoid drinking and using drugs before
age 21 are far less likely to abuse drugs or develop an addiction later.
"This is an area where doing the right thing for our kids is durable,"
Walters says. "We can change the face of substance abuse for
generations."
Students feel secure knowing that adults are savvy about drug use in
their schools, proponents add. "Middle and high school kids are aware of
their peers who are involved in drinking and drugging," says Walters.
"They will frequently ask 'Why do we look the other way? Why do we allow
this to happen?' In schools with random drug testing, they feel safe."
Local school administrators say programs have drawn little protest from
parents and students.
In Oceanside Unified School District, which is in its second year of
testing all high school students who wish to participate in sports,
community focus groups are held on a regular basis to gauge reaction.
The program is funded through the Office of National Drug Control
Policy.
"Our community has always been cooperative, and I think it's because we
included them in the process when we were developing the program," says
Tim Ware, the district's school intervention manager. "I think our kids
have reacted better than anyone. It's part of what we do."
One of the few complaints, he says, is that athletes feel they are being
singled out and that all students should be randomly tested.
A more common approach to testing, at least in California, are voluntary
programs in which both the students agree to enroll in random testing
with parental consent. Jon Hamro, athletic director and secondary
teaching assistant principal of San Clemente High School, launched one
of the state's first school-based testing programs in 2001. The program
has expanded to each high school in the Capistrano Unified School
District, which encompasses much of south Orange County. Recently three
district middle schools began offering testing.
The voluntary nature of the program has taken the steam out of would-be
objectors, Hamro says. Samples are collected by an outside lab and the
results shared with the student's parents - not school officials.
Students with positive results are not punished.
"We took a tack of how can we do this where there are no privacy issues
and yet it's a powerful tool to dissuade kids from using," he says.
"It's invisible to the administration, but it's very visible to the
kids."
At San Clemente High School, just over half of the school's 3,100
students are enrolled. Students testing positive are referred to either
fee-for-service or free counseling, including confidential counseling on
campus.
A survey conducted of 2,500 students at the high school last year showed
the program is having an effect, Hamro says. Almost 60% of the students
said the decision on whether or not to enroll in the program prompted a
discussion at home about substance abuse. Almost 60% of the students
said that the program should continue and 48% said it made it easier for
them to avoid using drugs. Just over one-quarter said testing had
reduced their frequency of drug use.
The study will be published in June in the American School Board
Journal.
Even those who disagree about the merits of school-based drug testing
agree that more research should be done to evaluate whether the programs
reduce drug use and help students who are caught using.
"There are these two sides and they can argue until they are blue in the
face," says Taras. "But until you study it, you can't really say
anything about it."
Schools, however, may not wait for academia to weigh in, especially if
the federal government extends money for testing programs.
"I actually believe that what you'll see is a rapid adoption of this,"
says Walters. "In a relatively short period of time we're going to look
back and say 'Why did it take us so long to do this?' This is safe and
it's enormously powerful."
*
------------------------------------------------------------------------
--------
shari.roan@latimes.com
*
(INFOBOX BELOW)
Screening varies from school to school
Schools vary widely in how they conduct drug testing.
* Deciding when and whom to test: Some schools only test students when
there is a suspicion of drug use. A growing number, however, utilize
random, "suspicionless" testing of a large group of students. In some
schools, only students who volunteer for the program and whose parents
consent are tested. Other schools screen all students who wish to
participate in extracurricular activities, such as sports and clubs.
* How testing is conducted: Some schools purchase tests kits and make
them available to parents. Other schools use outside testing labs to
randomly select students, conduct the tests and report back only to
parents - barring school personnel from learning the results. In still
other places, school personnel gather samples, send the results to labs
for assessment and receive the results back at school. School officials
then contact parents.
* Handling positive results: In some cases, the results are made
available to parents only, and it is their choice on how - or whether -
to act. Some labs are under contract to give parents a list of
drug-treatment and counseling resources in the community. Some schools
choose to provide the student's family with references. Many programs
with random, voluntary testing stress that students with positive tests
should be treated nonpunitively. Little is known about the outcome of
students who test positive in terms of whether follow-up counseling is
obtained and is successful.
* Technology and costs: Initial screenings are often done using urine
samples. Saliva, hair, sweat and blood tests can also be used but vary
in cost and reliability. Screening tests for a five-drug urine panel
typically cost $15 to $30 per student, according to the White House
Office of National Drug Control Policy. Many schools finance drug
testing on their own or through fundraisers or community donations.
Others apply for federal grants.
**
Testing resources
For more information on school-based drug testing, as well as arguments
for and against testing, go to:
* White House Office of National Drug Control Policy - the Bush
administration's case for testing, how it works and how to get
information on federal grants. http://www.randomstudentdrugtesting.org
* Monitoring the Future survey - the most recent statistical analysis
of adolescent drug use in the United States, from the University of
Michigan's annual survey. http://www.monitoringthefuture.org
* NAADAC (Assn. for Addiction Professionals) - this nonprofit
organization's policy statement on school-based drug testing.
naadac.org/documents/display.phpDocumentID102
* Institute for Behavior and Health - information for communities,
educators, parents and students on adolescent drug use and testing,
including how to implement testing programs, from an organization that
studies drug prevention and treatment strategies and advocates school
drug testing. http://www.PreventionNotPunishment.org
* Drug Policy Alliance - research on drug testing policies from a
nonprofit group that opposes school-based testing.
http://www.drugpolicy.org
* American Academy of Pediatrics - the most recent policy statement
from the AAP on student drug testing:
aappolicy.aappublications.org/cgi/content/full/pediatrics119/3/627<252>
http://www.latimes.com/la-he-drugtesting21may21,0,7094993.story?coll=la-home-middleright
Put to the test
More schools are asking students to take drug tests, saying it gives
them a reason to 'say no.' Addiction experts contend results are
unreliable.
By Shari Roan
LA Times Staff Writer
May 21, 2007
ONCE a year or so, Roy Tialavea is summoned from his classes at
Oceanside High School to report to the athletic director's office
bathroom. He receives a urine specimen cup and heads for a stall.
The 17-year-old is unruffled. Random drug testing has been going on for
two years at the school. He's used to it. "I don't use drugs so I don't
have to worry about getting caught," he says.
His mother, Robyn, thinks her son steers clear of drugs and alcohol.
But, she says, no parent can know for sure what a teenager is up to.
"If he doesn't like testing, I really don't care," she says. "I think
it's a wonderful tool. It creates the fear that they could be tested."
Call it the 2007 version of "just say no."
Concerned with high rates of adolescent substance abuse, hundreds of
middle schools and high schools nationwide have quietly begun testing
some or all students for drugs - to the dismay of some health and
addiction experts.
Although less than 5% of all high schools have such programs, testing is
now common in schools throughout Texas, Florida, Kentucky and parts of
California. In Southern California, many private high schools have
implemented drug testing, as have several public school districts in
Orange County and San Diego. Nationwide, as many as 1,000 schools have
established programs, according to the White House Office of National
Drug Control Policy.
The number of schools administering drug tests is expected to grow.
Federal funding for school drug testing increased 400% between 2003 and
2006. The Bush administration spent $8.6 million on such programs last
year and has requested $17.9 million for fiscal year 2008.
"This is the best new idea to reduce the onset of drug use," says Dr.
Robert L. DuPont, president of the Institute for Behavior and Health, a
nonprofit drug policy organization that has studied school testing.
"About half of high school seniors have used an illicit drug by the time
they graduate and about one-quarter are regular users by the time they
graduate. Those figures are worrisome."
School-based drug testing gives kids a reason to say no, say DuPont and
other proponents. The tests are meant to identify students who are using
and guide them into counseling or treatment programs before they develop
addictions.
But health officials, by and large, oppose school-based drug testing.
NAADAC, the Assn. for Addiction Professionals, has released a statement
critical of such programs. And in March, the American Academy of
Pediatrics cautioned against random school-based drug testing until more
research is completed. The two groups are among those who say testing is
not reliable enough, violates trust between adults and teens and is not
set up to deal effectively with students who have positive results.
Though adults debate testing's merits, students at some high schools
hand over urine specimen cups as comfortably as they turn in late
library books.
"Kids pretty much know who does drugs and who doesn't," says Alex
Podobas, a senior at San Clemente High School, which has had voluntary
testing for several years. "But no one says, 'Oh, you're a pothead' when
you get called out for testing."
Screening kids for marijuana, cocaine, amphetamines and other illegal
drugs at school is an offshoot of two decades of experience with
workplace and military drug testing, experts say. Testing methods have
improved during that time to reduce the number of false test results
while providing greater privacy and confidentiality, says DuPont.
And though substance abuse among teens has dropped in the last decade,
parents and school administrators still consider the rates unacceptably
high. Just over 20% of eighth-graders and about half of all high school
seniors say they have taken an illicit drug, according to 2006 data from
Monitoring the Future, the University of Michigan's nationwide annual
survey. About 30% of high school seniors say they have been drunk in the
last month.
Little faith is put in traditional classroom drug education programs to
further drive down substance abuse rates, says Jennifer Kern of the Drug
Policy Alliance, a New York City-based organization that focuses on a
harm-reduction approach to drug education.
"People are overwhelmed and are looking for new approaches," she says.
"A lot of the concern comes from a good place. We haven't done a good
job preventing substance abuse."
School drug testing got its biggest boost in 2002 when the Supreme Court
ruled that schools may conduct random drug tests among students who wish
to participate in school-sponsored extracurricular activities, such as
sports, marching band or debate team.
"Fifteen years ago, school drug testing was too controversial," says
John P. Walters, director of the White House Office of National Drug
Control Policy. "People thought the test was going to throw kids out of
school or give them a criminal record. The Supreme Court decision was an
enormously positive step."
But critics say the court's decision opened the floodgates for programs
that have not been studiously researched or properly evaluated.
"If you look on the surface, drug testing seems like a good idea; a
simple thing to do," says Dr. Sharon Levy, director of the Adolescent
Substance Abuse Program at Children's Hospital Boston. "It's only when
you sit down and look at it closely that it really starts to unravel a
bit."
Chief among the pediatricians' complaints is the reliability of testing.
A study published in April in the journal Pediatrics found a substantial
risk of error even when drug testing was performed as part of an
established adolescent substance abuse program. In the study, Levy and
her colleagues reviewed 710 random urine tests from 110 teens and
compared the results with confirmatory lab tests. (Initial screening
samples should be confirmed with a second, more rigorous, analysis -
something most school programs say they do.) They found 12% of the tests
were subject to misinterpretation. For example, some of the urine
samples were diluted (despite rigorous collection procedures designed to
prevent kids from cheating) and could not be interpreted properly.
Further, of the samples, 21% were positive due to legitimate
prescription drug use, Levy says. And several samples that were found in
confirmatory testing to be positive for the painkiller OxyContin - a
popular drug of abuse among teens - were identified as negative in the
initial screen.
"Drug testing is premature policy," says Levy. "We need to understand
the combination of risks and costs compared to the benefits. That hasn't
been done at all."
Further, critics say, the drug testing panels used by schools are
typically those used in the workplace - screens for marijuana,
amphetamines, cocaine, opiates and PCP. The panels usually do not assess
alcohol or other drugs kids may be likely to use, such as inhalants,
OxyContin and Ecstasy. Standard urine tests only detect use that has
occurred in the last 48 to 72 hours.
Negative screens may mislead parents, school personnel and the community
from searching for a truer picture of adolescent drug and alcohol use,
Kern says.
"Parents can say 'OK, the schools are doing testing, we'll know what is
going on,' " she says. "But drug testing gives you very little
information. It can give parents a false sense of security."
Even the belief that testing deters kids from using drugs or gives them
a peer-worthy reason to say no has not been proven, Kern says. A 2003
study by the University of Michigan surveying 76,000 students found no
difference in marijuana or other illicit drug use in schools with
testing compared with those without programs.
Podobas, the San Clemente senior, says few students fear being caught.
The tests don't pick up all drugs and are administered too infrequently
to worry teens, he says. Others have learned to beat the system by
sharing a clean urine sample when called to the bathrooms in groups. "I
don't think it has lessened the number of kids using drugs," says
Podobas, although he thinks some kids use less frequently than they
otherwise would.
Others critics of the program say school drug testing can make teens
feel guilty before being proven innocent. While many programs - such as
several in Orange County - only test students if they and their parents
consent, kids may feel that adults distrust them, Kern says.
"There may be unintended consequences to drug testing," says Dr. Howard
Taras, a pediatrics professor at UC San Diego, who studies school health
issues. "Kids may be deterred from joining a sport or extracurricular
activity because they will be tested. Those are the kids that most need
extracurricular activities. They may not get engaged in math or science
but they may get engaged by a sport or dance class."
Proponents of drug testing say such shortcomings simply don't exist in
most schools. The programs, they say, are diligent about collection
procedures and lab analysis, privacy issues and follow-up for kids found
to have used drugs.
"Where are they finding these programs doing the bad things?" says
DuPont of the critics. A study by his office of nine programs found all
were following testing protocols and handling kids with positive tests
nonpunitively.
Even if testing programs aren't perfect, recent research on the effect
of drug use on adolescent brains warrants an aggressive approach to the
problem, Walters says. Studies show that heavy drug use during
adolescence may permanently damage parts of the brain related to
learning and memory. People who avoid drinking and using drugs before
age 21 are far less likely to abuse drugs or develop an addiction later.
"This is an area where doing the right thing for our kids is durable,"
Walters says. "We can change the face of substance abuse for
generations."
Students feel secure knowing that adults are savvy about drug use in
their schools, proponents add. "Middle and high school kids are aware of
their peers who are involved in drinking and drugging," says Walters.
"They will frequently ask 'Why do we look the other way? Why do we allow
this to happen?' In schools with random drug testing, they feel safe."
Local school administrators say programs have drawn little protest from
parents and students.
In Oceanside Unified School District, which is in its second year of
testing all high school students who wish to participate in sports,
community focus groups are held on a regular basis to gauge reaction.
The program is funded through the Office of National Drug Control
Policy.
"Our community has always been cooperative, and I think it's because we
included them in the process when we were developing the program," says
Tim Ware, the district's school intervention manager. "I think our kids
have reacted better than anyone. It's part of what we do."
One of the few complaints, he says, is that athletes feel they are being
singled out and that all students should be randomly tested.
A more common approach to testing, at least in California, are voluntary
programs in which both the students agree to enroll in random testing
with parental consent. Jon Hamro, athletic director and secondary
teaching assistant principal of San Clemente High School, launched one
of the state's first school-based testing programs in 2001. The program
has expanded to each high school in the Capistrano Unified School
District, which encompasses much of south Orange County. Recently three
district middle schools began offering testing.
The voluntary nature of the program has taken the steam out of would-be
objectors, Hamro says. Samples are collected by an outside lab and the
results shared with the student's parents - not school officials.
Students with positive results are not punished.
"We took a tack of how can we do this where there are no privacy issues
and yet it's a powerful tool to dissuade kids from using," he says.
"It's invisible to the administration, but it's very visible to the
kids."
At San Clemente High School, just over half of the school's 3,100
students are enrolled. Students testing positive are referred to either
fee-for-service or free counseling, including confidential counseling on
campus.
A survey conducted of 2,500 students at the high school last year showed
the program is having an effect, Hamro says. Almost 60% of the students
said the decision on whether or not to enroll in the program prompted a
discussion at home about substance abuse. Almost 60% of the students
said that the program should continue and 48% said it made it easier for
them to avoid using drugs. Just over one-quarter said testing had
reduced their frequency of drug use.
The study will be published in June in the American School Board
Journal.
Even those who disagree about the merits of school-based drug testing
agree that more research should be done to evaluate whether the programs
reduce drug use and help students who are caught using.
"There are these two sides and they can argue until they are blue in the
face," says Taras. "But until you study it, you can't really say
anything about it."
Schools, however, may not wait for academia to weigh in, especially if
the federal government extends money for testing programs.
"I actually believe that what you'll see is a rapid adoption of this,"
says Walters. "In a relatively short period of time we're going to look
back and say 'Why did it take us so long to do this?' This is safe and
it's enormously powerful."
*
------------------------------------------------------------------------
--------
shari.roan@latimes.com
*
(INFOBOX BELOW)
Screening varies from school to school
Schools vary widely in how they conduct drug testing.
* Deciding when and whom to test: Some schools only test students when
there is a suspicion of drug use. A growing number, however, utilize
random, "suspicionless" testing of a large group of students. In some
schools, only students who volunteer for the program and whose parents
consent are tested. Other schools screen all students who wish to
participate in extracurricular activities, such as sports and clubs.
* How testing is conducted: Some schools purchase tests kits and make
them available to parents. Other schools use outside testing labs to
randomly select students, conduct the tests and report back only to
parents - barring school personnel from learning the results. In still
other places, school personnel gather samples, send the results to labs
for assessment and receive the results back at school. School officials
then contact parents.
* Handling positive results: In some cases, the results are made
available to parents only, and it is their choice on how - or whether -
to act. Some labs are under contract to give parents a list of
drug-treatment and counseling resources in the community. Some schools
choose to provide the student's family with references. Many programs
with random, voluntary testing stress that students with positive tests
should be treated nonpunitively. Little is known about the outcome of
students who test positive in terms of whether follow-up counseling is
obtained and is successful.
* Technology and costs: Initial screenings are often done using urine
samples. Saliva, hair, sweat and blood tests can also be used but vary
in cost and reliability. Screening tests for a five-drug urine panel
typically cost $15 to $30 per student, according to the White House
Office of National Drug Control Policy. Many schools finance drug
testing on their own or through fundraisers or community donations.
Others apply for federal grants.
**
Testing resources
For more information on school-based drug testing, as well as arguments
for and against testing, go to:
* White House Office of National Drug Control Policy - the Bush
administration's case for testing, how it works and how to get
information on federal grants. http://www.randomstudentdrugtesting.org
* Monitoring the Future survey - the most recent statistical analysis
of adolescent drug use in the United States, from the University of
Michigan's annual survey. http://www.monitoringthefuture.org
* NAADAC (Assn. for Addiction Professionals) - this nonprofit
organization's policy statement on school-based drug testing.
naadac.org/documents/display.phpDocumentID102
* Institute for Behavior and Health - information for communities,
educators, parents and students on adolescent drug use and testing,
including how to implement testing programs, from an organization that
studies drug prevention and treatment strategies and advocates school
drug testing. http://www.PreventionNotPunishment.org
* Drug Policy Alliance - research on drug testing policies from a
nonprofit group that opposes school-based testing.
http://www.drugpolicy.org
* American Academy of Pediatrics - the most recent policy statement
from the AAP on student drug testing:
aappolicy.aappublications.org/cgi/content/full/pediatrics119/3/627<252>
Lower syringe sharing and re-use after syringe legalization in Rhode Island
needle exchange in RI vs. MA
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T63-4NBRYFX-1&_user=861681&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000046147&_version=1&_urlVersion=0&_userid=861681&md5=8782a5059338af9c4f043db077c
b4221
Drug and Alcohol Dependence
Volume 89, Issues 2-3, 10 July 2007, Pages 292-297
Lower syringe sharing and re-use after syringe legalization in Rhode
Island
Josiah D. Richa et al.
ABSTRACT
Increased access to sterile syringes reduces the transmission of HIV,
viral hepatitis and other infectious diseases, without increasing
injection drug use.
In Rhode Island, in 2000, syringes were legalized to reduce spread of
disease but remained outlawed in Massachusetts until 2006.
Drug users undergoing inpatient detoxification in Rhode Island and
Massachusetts were surveyed about their syringe usage between October
2001 and August 2003. Two hundred forty-seven Rhode Island, and 226
Massachusetts inpatients completed surveys.
Of these, 61% (n = 151) from Rhode Island and 46% (n = 105) from
Massachusetts reported injecting within 6 months.
Respondents from Rhode Island reported reusing a syringe in the last 30
days less often than Massachusetts respondents (0.35 versus 0.50; 95% CI
on difference 0.01-0.29).
Syringe re-use and sharing among drug injectors in Rhode Island was
markedly lower than in Massachusetts.
This difference is attributed at least in part to the legalization of
non-prescription sterile syringes in Rhode Island in 2000.
Laws and policies that increase legal syringe availability can decrease
injection related transmission of HIV and other infectious diseases.
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T63-4NBRYFX-1&_user=861681&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000046147&_version=1&_urlVersion=0&_userid=861681&md5=8782a5059338af9c4f043db077c
b4221
Drug and Alcohol Dependence
Volume 89, Issues 2-3, 10 July 2007, Pages 292-297
Lower syringe sharing and re-use after syringe legalization in Rhode
Island
Josiah D. Richa et al.
ABSTRACT
Increased access to sterile syringes reduces the transmission of HIV,
viral hepatitis and other infectious diseases, without increasing
injection drug use.
In Rhode Island, in 2000, syringes were legalized to reduce spread of
disease but remained outlawed in Massachusetts until 2006.
Drug users undergoing inpatient detoxification in Rhode Island and
Massachusetts were surveyed about their syringe usage between October
2001 and August 2003. Two hundred forty-seven Rhode Island, and 226
Massachusetts inpatients completed surveys.
Of these, 61% (n = 151) from Rhode Island and 46% (n = 105) from
Massachusetts reported injecting within 6 months.
Respondents from Rhode Island reported reusing a syringe in the last 30
days less often than Massachusetts respondents (0.35 versus 0.50; 95% CI
on difference 0.01-0.29).
Syringe re-use and sharing among drug injectors in Rhode Island was
markedly lower than in Massachusetts.
This difference is attributed at least in part to the legalization of
non-prescription sterile syringes in Rhode Island in 2000.
Laws and policies that increase legal syringe availability can decrease
injection related transmission of HIV and other infectious diseases.
Giant to limit access to DXM Grocer joins effort to prevent abuse of cough medication
http://www.baltimoresun.com/business/bal-bz.cough16may16,0,6393827.story?coll=bal-home-headlines
Giant to limit access to DXM Grocer joins effort to prevent abuse of cough medication
By M. William Salganik
Baltimore Sun reporter
May 16, 2007
Joining other retailers and chain pharmacies, Giant Food announced
yesterday that it won't sell certain types of cough medicine to
customers under 18 because the products have been abused by teenagers.
Beginning Sunday, Giant and other grocery chains owned by Royal Ahold NV
will limit sales of products containing dextromethorphan (DXM), a common
ingredient in cough and cold syrups, lozenges and pills.
"It's similar to buying cigarettes - if the cashier has a question, we
will ask for verification," said Jamie Miller, manager of public affairs
for Landover-based Giant Food Inc., which has 186 supermarkets in
Maryland and nearby states.
Among more than 100 products containing DXM are Robitussin Maximum
Strength Cough Suppressant, Sucrets 8 Hour Cough Suppressant and Vicks
44 Cough Relief, according to the National Institutes of Health. Those
brands also have products that do not contain DXM.
The Food and Drug Administration issued a warning in 2005 that five
teenagers died in cases "that may be associated with the consumption of
powered DXM," although it said the ingredient, when used as directed, is
"generally safe and effective."
Concerns over DXM heated up this spring when drug counselors on Long
Island reported nine teenagers hospitalized in one month after abusing
over-the-counter cough medicines, according to Newsday.
The importance of the action against DXM is a reminder that legal drugs,
even over-the-counter drugs, aren't safe if they're misused, said
Michael M. Gimbel, director of substance abuse education for the
Sheppard Pratt Health System. "When I go out to talk to parents, I have
my bottle of cough medicine," he said. Pharmacies have also restricted
sales of products containing pseudoephedrine, an over-the-counter
decongestant that can be used in the manufacture of methamphetamines.
"It's a sad state of affairs," Gimbel said. "We're slowly but surely
emptying the shelves of our pharmacies of over-the-counter medicines."
"As soon as we find out what the kids are up to and do something about
it, three days later, they're onto something else," he said.
Gimbel, and state and Baltimore health officials, said there is no
indication that DXM use is a particular problem in this area.
Dr. Peter Cohen, medical director of the state health department's
alcohol and drug abuse administration, said the state did not have any
figures tracking DXM abuse in Maryland and that it was "not high
prevalence compared to other substances."
Dr. Joshua Sharfstein, Baltimore health commissioner, said he had talked
to police, school health staff and drug abuse treatment providers, and
"so far, in Baltimore, it's not hitting our radar screens."
Sharfstein added that the city health department, after consulting with
pediatricians, doesn't recommend cough medicines containing DXM for
children under age 6, even when used as directed, because "there is not
an adequate margin of safety and they are not effective."
Nationally, a survey released in December by the University of Michigan
reported that 4 percent of 8th-graders, 5 percent of 10th- graders and 7
percent of high school seniors said they had used cough or cold
medicines to get high.
Abuse can occur either by concentrating DXM into powdered form or by
taking large amounts of the cough syrups.
"It isn't someone taking a few more tablespoons or a couple more pills -
it's 25 to 50 times the recommended dose," said Elizabeth Funderburk,
communications director for the Consumer Healthcare Products
Association, the trade association for manufacturers of over-the-counter
medications.
Gimbel and Cohen said that in large doses, DXM can produce feelings of
euphoria, but also disorientation and hallucinations. They said DXM can
be particularly dangerous when combined with other drugs or alcohol or
if used while driving.
Several states - including Maryland - have considered legislation this
year limiting sales of DXM to adults, but none has yet done so,
according to Kevin Nicholson, vice president for pharmacy regulatory
affairs for the National Association of Chain Drug Stores. His trade
association is also supporting similar federal legislation.
While DXM sales are not restricted by law, most large chain stores have
imposed voluntary restrictions, Nicholson said.
Among the stores that restrict the sale of products containing DXM are
Rite Aid, Wal-Mart, CVS, Target, Walgreens, Brooks, Eckerd and Costco,
according to Nicholson, with most adopting the policies since the FDA
warning two years ago. Safeway put DXM age restrictions in place in
March, said spokesman Greg TenEyck.
Although there haven't been widespread reports of abuse in this area,
"We were kind of taking the lead from the Food and Drug Administration,"
said Miller, the Giant spokesman.
Giant to limit access to DXM Grocer joins effort to prevent abuse of cough medication
By M. William Salganik
Baltimore Sun reporter
May 16, 2007
Joining other retailers and chain pharmacies, Giant Food announced
yesterday that it won't sell certain types of cough medicine to
customers under 18 because the products have been abused by teenagers.
Beginning Sunday, Giant and other grocery chains owned by Royal Ahold NV
will limit sales of products containing dextromethorphan (DXM), a common
ingredient in cough and cold syrups, lozenges and pills.
"It's similar to buying cigarettes - if the cashier has a question, we
will ask for verification," said Jamie Miller, manager of public affairs
for Landover-based Giant Food Inc., which has 186 supermarkets in
Maryland and nearby states.
Among more than 100 products containing DXM are Robitussin Maximum
Strength Cough Suppressant, Sucrets 8 Hour Cough Suppressant and Vicks
44 Cough Relief, according to the National Institutes of Health. Those
brands also have products that do not contain DXM.
The Food and Drug Administration issued a warning in 2005 that five
teenagers died in cases "that may be associated with the consumption of
powered DXM," although it said the ingredient, when used as directed, is
"generally safe and effective."
Concerns over DXM heated up this spring when drug counselors on Long
Island reported nine teenagers hospitalized in one month after abusing
over-the-counter cough medicines, according to Newsday.
The importance of the action against DXM is a reminder that legal drugs,
even over-the-counter drugs, aren't safe if they're misused, said
Michael M. Gimbel, director of substance abuse education for the
Sheppard Pratt Health System. "When I go out to talk to parents, I have
my bottle of cough medicine," he said. Pharmacies have also restricted
sales of products containing pseudoephedrine, an over-the-counter
decongestant that can be used in the manufacture of methamphetamines.
"It's a sad state of affairs," Gimbel said. "We're slowly but surely
emptying the shelves of our pharmacies of over-the-counter medicines."
"As soon as we find out what the kids are up to and do something about
it, three days later, they're onto something else," he said.
Gimbel, and state and Baltimore health officials, said there is no
indication that DXM use is a particular problem in this area.
Dr. Peter Cohen, medical director of the state health department's
alcohol and drug abuse administration, said the state did not have any
figures tracking DXM abuse in Maryland and that it was "not high
prevalence compared to other substances."
Dr. Joshua Sharfstein, Baltimore health commissioner, said he had talked
to police, school health staff and drug abuse treatment providers, and
"so far, in Baltimore, it's not hitting our radar screens."
Sharfstein added that the city health department, after consulting with
pediatricians, doesn't recommend cough medicines containing DXM for
children under age 6, even when used as directed, because "there is not
an adequate margin of safety and they are not effective."
Nationally, a survey released in December by the University of Michigan
reported that 4 percent of 8th-graders, 5 percent of 10th- graders and 7
percent of high school seniors said they had used cough or cold
medicines to get high.
Abuse can occur either by concentrating DXM into powdered form or by
taking large amounts of the cough syrups.
"It isn't someone taking a few more tablespoons or a couple more pills -
it's 25 to 50 times the recommended dose," said Elizabeth Funderburk,
communications director for the Consumer Healthcare Products
Association, the trade association for manufacturers of over-the-counter
medications.
Gimbel and Cohen said that in large doses, DXM can produce feelings of
euphoria, but also disorientation and hallucinations. They said DXM can
be particularly dangerous when combined with other drugs or alcohol or
if used while driving.
Several states - including Maryland - have considered legislation this
year limiting sales of DXM to adults, but none has yet done so,
according to Kevin Nicholson, vice president for pharmacy regulatory
affairs for the National Association of Chain Drug Stores. His trade
association is also supporting similar federal legislation.
While DXM sales are not restricted by law, most large chain stores have
imposed voluntary restrictions, Nicholson said.
Among the stores that restrict the sale of products containing DXM are
Rite Aid, Wal-Mart, CVS, Target, Walgreens, Brooks, Eckerd and Costco,
according to Nicholson, with most adopting the policies since the FDA
warning two years ago. Safeway put DXM age restrictions in place in
March, said spokesman Greg TenEyck.
Although there haven't been widespread reports of abuse in this area,
"We were kind of taking the lead from the Food and Drug Administration,"
said Miller, the Giant spokesman.
Inhaling cannabis without the smoke Study shows vaporizer delivers marijuana 'safely and effectively'
http://www.nature.com/news/2007/070508/full/070508-11.html
Nature
11 May 2007
Inhaling cannabis without the smoke Study shows vaporizer delivers marijuana 'safely and effectively'
Arran Frood
Vaporizing cannabis leaves instead of burning them can release the drug's active ingredient just as effectively - while avoiding the harmful toxins inhaled through smoking the drug, according to a pilot study.
The result could be good news for those who choose to use marijuana medicinally.
The potential benefits of marijuana include pain relief for multiple-sclerosis sufferers, a treatment for glaucoma, as an appetite stimulant for AIDS patients and an anti-nausea agent for people on chemotherapy. But smoking isn't a good method of drug delivery because the harmful effects - such as lung cancer and heart disease - outweigh the likely merits of marijuana for all but terminal cases.
Rather than smoking, some use the leaves to make tea or cakes for consumption. But this means that the active agents are metabolized by the liver rather than entering the bloodstream unaltered. Others have focused on extracting active ingredients such as tetrahydrocannabinol (THC) and delivering them alone in a pill or oral spray. However, many think that the isolated ingredients are not as effective as the whole plant, and it is more difficult to customize the dose for each individual with a pill.
Hot stuff
Donald Abrams of the University of California, San Francisco, and his team decided to investigate the benefits of the 'Volcano', a commercially available vaporizer. The device heats marijuana leaves to a temperature between 180 and 200 °C so that THC is released from oils on the surface of the leaf but no actual combustion takes place.
Previous studies have shown that harmful toxins released through smoking cannabis such as carbon monoxide, benzene and a host of compounds known as polycyclic aromatic hydrocarbons (many of which are known carcinogens) are not produced by such devices.
Abrams' study is the first to compare the effects of smoking and vaporizing cannabis on human subjects. "We were able to deliver more-or-less equivalent amounts of THC into the bloodstream," he says. The main difference between the two delivery methods was that THC seemed to be absorbed into the bloodstream faster when using the vaporizer1. "The pharmacological and physiological effects were comparable," he says, although a larger study would be needed to prove that they are biologically equivalent.
Slow burn
The first studies to highlight the advantages of using vaporizers for cannabis were published more than five years ago, but the pace of research has been slow, partly because there is only one source of research-approved marijuana in the United States - the National Institute on Drug Abuse (NIDA) - which critics accuse of dictating research along a political agenda. A legal ruling this February recommended that the US Drug Enforcement Administration (DEA) end NIDA's monopoly on the production of marijuana for research approved by the US Food and Drug Administration and by the DEA.
Laura Bell of the Multiple Sclerosis Society in the UK says that her society supports cannabinoid research for people with multiple sclerosis. "Smoking cannabis results in exposure to many toxic chemicals," she says. "We welcome research into better and safer delivery methods."
Cannabis leaf is not the only substrate suited to a vaporizer. Other herbal preparations, such as eucalyptus and chamomile can also be used, or any plant with medicinal properties in the volatile compounds of its leaves.
Nature
11 May 2007
Inhaling cannabis without the smoke Study shows vaporizer delivers marijuana 'safely and effectively'
Arran Frood
Vaporizing cannabis leaves instead of burning them can release the drug's active ingredient just as effectively - while avoiding the harmful toxins inhaled through smoking the drug, according to a pilot study.
The result could be good news for those who choose to use marijuana medicinally.
The potential benefits of marijuana include pain relief for multiple-sclerosis sufferers, a treatment for glaucoma, as an appetite stimulant for AIDS patients and an anti-nausea agent for people on chemotherapy. But smoking isn't a good method of drug delivery because the harmful effects - such as lung cancer and heart disease - outweigh the likely merits of marijuana for all but terminal cases.
Rather than smoking, some use the leaves to make tea or cakes for consumption. But this means that the active agents are metabolized by the liver rather than entering the bloodstream unaltered. Others have focused on extracting active ingredients such as tetrahydrocannabinol (THC) and delivering them alone in a pill or oral spray. However, many think that the isolated ingredients are not as effective as the whole plant, and it is more difficult to customize the dose for each individual with a pill.
Hot stuff
Donald Abrams of the University of California, San Francisco, and his team decided to investigate the benefits of the 'Volcano', a commercially available vaporizer. The device heats marijuana leaves to a temperature between 180 and 200 °C so that THC is released from oils on the surface of the leaf but no actual combustion takes place.
Previous studies have shown that harmful toxins released through smoking cannabis such as carbon monoxide, benzene and a host of compounds known as polycyclic aromatic hydrocarbons (many of which are known carcinogens) are not produced by such devices.
Abrams' study is the first to compare the effects of smoking and vaporizing cannabis on human subjects. "We were able to deliver more-or-less equivalent amounts of THC into the bloodstream," he says. The main difference between the two delivery methods was that THC seemed to be absorbed into the bloodstream faster when using the vaporizer1. "The pharmacological and physiological effects were comparable," he says, although a larger study would be needed to prove that they are biologically equivalent.
Slow burn
The first studies to highlight the advantages of using vaporizers for cannabis were published more than five years ago, but the pace of research has been slow, partly because there is only one source of research-approved marijuana in the United States - the National Institute on Drug Abuse (NIDA) - which critics accuse of dictating research along a political agenda. A legal ruling this February recommended that the US Drug Enforcement Administration (DEA) end NIDA's monopoly on the production of marijuana for research approved by the US Food and Drug Administration and by the DEA.
Laura Bell of the Multiple Sclerosis Society in the UK says that her society supports cannabinoid research for people with multiple sclerosis. "Smoking cannabis results in exposure to many toxic chemicals," she says. "We welcome research into better and safer delivery methods."
Cannabis leaf is not the only substrate suited to a vaporizer. Other herbal preparations, such as eucalyptus and chamomile can also be used, or any plant with medicinal properties in the volatile compounds of its leaves.
BOOK REVIEW: 'Pharmako Gnosis'
-----------
http://www.latimes.com/features/books/la-bk-green13may13,1,3334407.story
?coll=la-books-headlines&ctrack=1&cset=true
BOOK REVIEW
'Pharmako Gnosis' by Dale Pendell
If Homer had been a drug connoisseur, his epic poems would have sounded
like this.
By Emily Green
Emily Green is a Los Angeles-based freelance writer.
May 13, 2007
Los Angelese Times
DALE PENDELL has the kind of counterculture bona fides that either kill
you or make you eccentric. He was in the Bay Area leading up to the
Summer of Love. In 14 years living in and out of the Sierra, he
botanized with old miners, hooked up with Gary Snyder, started a poetry
journal and published Allen Ginsberg. He did just about every drug with
a street value until 1989, when he curbed taking them, the better to be
able to write about them. "Pharmako Poeia," the first of a trilogy,
appeared in 1995; the second, "Pharmako Dynamis" in 2002; and the third,
"Pharmako Gnosis," last year. If there has ever been a more sustained
but unremarked effort to shock, it would be hard to find. All three
books have gone largely unnoticed.
It's a shame. They could not be more collectible, particularly volumes
one and two. It might have been the style. They were conceived as epic
poems, shifting freely between poetry, chemistry, taxonomy and bouts of
backchat. It might have been censorship. Perhaps the book-reviewing
world Just Said No. More likely, Pendell has bet his career on a subject
that exists in a twilight beyond polite conversation. He writes in a
country where doing drugs is so basic to youth that it might as well be
curricular, and denying having done them is just as basic a rite of
passage into adulthood.
For those interested in some recidivism, the books are helpfully
arranged by high. Volume one is devoted to dreamy stuff: alcohol,
absinthe, heroin and pot. Volume two's about speed: caffeine,
amphetamines, cocaine, Ecstasy and more. Volume three, it's a trip. It's
about psilocybin, mescal, peyote and LSD.
Every subject has its perils. Compared with the first two books, the
third is blurry and grandiose. One wonders whether the wine taster
forgot to spit. The best line about acid is a closing fillip in which he
remarks on "a certain sparkle." There are even baseball stories -
including the legendary one about Pirates pitcher Dock Ellis throwing a
1970 no-hitter against the San Diego Padres after taking a tab of acid.
Every so often you think Pendell's in earnest sociological mode, as when
he delivers a list of uses of peyote, until you arrive at the entry "a
good reason to get people together and enjoy each other." Dangling acid
before the inexperienced, he taunts, "Pop a ten strip!" (That's enough
to have a football team dancing to "Swan Lake.") "You deserve such joy!"
he baits. "You deserve release from so many years of encrusted cynicism.
You have worn your pain as a hair shirt, a burden-basket trumped and
creased on your forehead. Lay it down. Give it to Jesus. Give it to
Buddha. Give it to the great psychedelic Earth, and let the Earth
respond and accept you just as you are. You deserve it." Then his alter
egos, protestants all, appear:
And now, O Arbiters of Responsibility, what do I deserve?
A flogging, I'd say.
He wishes. What he got instead was stony silence from the daylight world
of modern America.
http://www.latimes.com/features/books/la-bk-green13may13,1,3334407.story
?coll=la-books-headlines&ctrack=1&cset=true
BOOK REVIEW
'Pharmako Gnosis' by Dale Pendell
If Homer had been a drug connoisseur, his epic poems would have sounded
like this.
By Emily Green
Emily Green is a Los Angeles-based freelance writer.
May 13, 2007
Los Angelese Times
DALE PENDELL has the kind of counterculture bona fides that either kill
you or make you eccentric. He was in the Bay Area leading up to the
Summer of Love. In 14 years living in and out of the Sierra, he
botanized with old miners, hooked up with Gary Snyder, started a poetry
journal and published Allen Ginsberg. He did just about every drug with
a street value until 1989, when he curbed taking them, the better to be
able to write about them. "Pharmako Poeia," the first of a trilogy,
appeared in 1995; the second, "Pharmako Dynamis" in 2002; and the third,
"Pharmako Gnosis," last year. If there has ever been a more sustained
but unremarked effort to shock, it would be hard to find. All three
books have gone largely unnoticed.
It's a shame. They could not be more collectible, particularly volumes
one and two. It might have been the style. They were conceived as epic
poems, shifting freely between poetry, chemistry, taxonomy and bouts of
backchat. It might have been censorship. Perhaps the book-reviewing
world Just Said No. More likely, Pendell has bet his career on a subject
that exists in a twilight beyond polite conversation. He writes in a
country where doing drugs is so basic to youth that it might as well be
curricular, and denying having done them is just as basic a rite of
passage into adulthood.
For those interested in some recidivism, the books are helpfully
arranged by high. Volume one is devoted to dreamy stuff: alcohol,
absinthe, heroin and pot. Volume two's about speed: caffeine,
amphetamines, cocaine, Ecstasy and more. Volume three, it's a trip. It's
about psilocybin, mescal, peyote and LSD.
Every subject has its perils. Compared with the first two books, the
third is blurry and grandiose. One wonders whether the wine taster
forgot to spit. The best line about acid is a closing fillip in which he
remarks on "a certain sparkle." There are even baseball stories -
including the legendary one about Pirates pitcher Dock Ellis throwing a
1970 no-hitter against the San Diego Padres after taking a tab of acid.
Every so often you think Pendell's in earnest sociological mode, as when
he delivers a list of uses of peyote, until you arrive at the entry "a
good reason to get people together and enjoy each other." Dangling acid
before the inexperienced, he taunts, "Pop a ten strip!" (That's enough
to have a football team dancing to "Swan Lake.") "You deserve such joy!"
he baits. "You deserve release from so many years of encrusted cynicism.
You have worn your pain as a hair shirt, a burden-basket trumped and
creased on your forehead. Lay it down. Give it to Jesus. Give it to
Buddha. Give it to the great psychedelic Earth, and let the Earth
respond and accept you just as you are. You deserve it." Then his alter
egos, protestants all, appear:
And now, O Arbiters of Responsibility, what do I deserve?
A flogging, I'd say.
He wishes. What he got instead was stony silence from the daylight world
of modern America.
FDA - MedWatch - OxyContin - Illegal Promotion By Manufacturer
Date: Thu, 10 May 2007 15:54:56 -0400
From: CDER MEDWATCH LISTSERV
Subject: FDA - MedWatch - OxyContin - Illegal Promotion By Manufacturer
May Cause Health Risks For Consumers
MedWatch - The FDA Safety Information and Adverse Event Reporting
Program
FDA informed healthcare professionals of criminal charges and civil
liabilities brought against Purdue Frederick in connection with several
illegal schemes to promote, market and sell OxyContin, a powerful
prescription pain reliever that the company produces. The manufacturer's
sales force was trained to make false claims about the product to
healthcare professionals, thereby, misbranding OxyContin by illegally
promoting the drug as being less addictive, less subject to abuse, and
less likely to cause tolerance and withdrawal than other pain
medications. These practices falsely promote the product and may cause
health risks for consumers.
Read the complete 2007 Safety summary, including a link to the FDA Press
Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin
From: CDER MEDWATCH LISTSERV
Subject: FDA - MedWatch - OxyContin - Illegal Promotion By Manufacturer
May Cause Health Risks For Consumers
MedWatch - The FDA Safety Information and Adverse Event Reporting
Program
FDA informed healthcare professionals of criminal charges and civil
liabilities brought against Purdue Frederick in connection with several
illegal schemes to promote, market and sell OxyContin, a powerful
prescription pain reliever that the company produces. The manufacturer's
sales force was trained to make false claims about the product to
healthcare professionals, thereby, misbranding OxyContin by illegally
promoting the drug as being less addictive, less subject to abuse, and
less likely to cause tolerance and withdrawal than other pain
medications. These practices falsely promote the product and may cause
health risks for consumers.
Read the complete 2007 Safety summary, including a link to the FDA Press
Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#OxyContin
Alcohol's Effects Tough on Brain
http://www.medpagetoday.com/MeetingCoverage/AANMeeting/tb2/5559?pfc=101&spc=222
Alcohol's Effects Tough on Brain
By Neil Osterweil, Senior Associate Editor, MedPage Today
Reviewed by Rubeen K. Israni, M.D., Fellow, Renal-Electrolyte and Hypertension Division, University of Pennsylvania School of Medicine
May 03, 2007
BOSTON, May 3 -- Heavy drinking takes a toll on brain size, with a shrinking effect equivalent to about one to two years of brain aging for every higher level of alcohol consumption, investigators reported here.
Action Points
§ Explain to patients who ask that alcohol in moderation is thought to be protective against heart disease and stroke, but this study suggests that heavy drinking may accelerate the decline in brain volume normally seen with aging. The clinical significance of this finding is uncertain, but may suggest greater risk for cognitive decline in heavy imbibers.
§ Explain that this cross-sectional study found no benefit to the brain from even light drinking.
§ This study was published as an abstract and presented as a poster and orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
Even light drinking had no beneficial effect on brain aging, unlike an often-reported cardiovascular benefit found from mild levels of alcohol, reported Carol Ann Paul, M.S., a senior instructor at Wellesley College in Wellesley, Mass.
The cross-sectional study of more than 1,800 patients was designed to determine whether the cardiovascular benefits associated with light-to-moderate alcohol consumption could also be seen in the brain, said Paul at the American Academy of Neurology meeting here.
Those who reported more than 14 alcoholic drinks per week had a significantly smaller brain volume compared with non-drinkers.
"Brain volume normally declines with age and that's often accompanied by cognitive impairment in the later stages," she said. "So brain volume is some sort of indicator of brain capacity."
She and her colleagues took advantage of MRI scans acquired from 1999 to 2002 from 1,839 non-demented participants in the Framingham Offspring Study, which itself is an offspring of the Framingham Heart Study.
They divided the participants into five categories on the basis of self-reported alcohol consumption frequency: abstainers, former drinkers, low drinkers (one to seven drinks per week), moderate drinkers (eight to 14 drinks per week), and heavy drinkers (more than 14 drinks per week).
The authors made pair-wise comparisons of mean total cranial volumes across the various groups, and created multivariate linear regression models to see whether there was an association between brain size and alcohol consumption. They controlled their analyses for age, gender, body mass index, height, educational level attained, and Framingham Stroke Risk Profile. They also looked at the longitudinal history of alcohol consumption from 1987 to 2001 to see whether there were associations with total cranial volume.
"I found that unlike what I had hypothesized, there was no beneficial effect of alcohol on brain volume," Paul said. "In addition, I found that there was a slightly more strong effect in women than in men, and on the preliminary longitudinal studies, it seemed that people who had been heavy drinkers throughout the 12-year period we looked at, had significantly decreased brain volume in comparison to the others."
Specifically, the authors found a reduction in brain volume of 0.25% for every additional category of alcohol consumption. In contrast, the average age-related decline in brain volume is 0.19% per year, she noted.
Gender modified the alcohol-brain volume relationship significantly (P=0.0029), with men having a slightly lower downward slope than women, meaning that brain volume decreased more in women than men across categories of alcohol consumption.
The authors also detected a significant negative correlation between alcohol consumption and brain volume among women in their 70's (P= 0.013), and in the longitudinal analysis, they found that heavy drinking was negatively associated with brain volume (P=0.005, -0.026).
"Each drink category is approximately equivalent to one-to-two years of aging," Paul said, adding that the effect was linear across the categories from low to high.
She suggested that although alcohol consumption in moderation has beneficial effects on the cardiovascular system, it may be found to be associated with deleterious effects on neurons and neural circuitry.
Neither funding sources nor author conflicts of interest were reported.
Complete AAN Coverage
Primary source: American Academy of Neurology 2007 Annual Meeting
Source reference:
Paul CA et al. "The Effect of Alcohol Consumption on Total Brain Volume: The Framingham Heart Study." Abstract P05.030, presented May 2.
Alcohol's Effects Tough on Brain
By Neil Osterweil, Senior Associate Editor, MedPage Today
Reviewed by Rubeen K. Israni, M.D., Fellow, Renal-Electrolyte and Hypertension Division, University of Pennsylvania School of Medicine
May 03, 2007
BOSTON, May 3 -- Heavy drinking takes a toll on brain size, with a shrinking effect equivalent to about one to two years of brain aging for every higher level of alcohol consumption, investigators reported here.
Action Points
§ Explain to patients who ask that alcohol in moderation is thought to be protective against heart disease and stroke, but this study suggests that heavy drinking may accelerate the decline in brain volume normally seen with aging. The clinical significance of this finding is uncertain, but may suggest greater risk for cognitive decline in heavy imbibers.
§ Explain that this cross-sectional study found no benefit to the brain from even light drinking.
§ This study was published as an abstract and presented as a poster and orally at a conference. These data and conclusions should be considered to be preliminary as they have not yet been reviewed and published in a peer-reviewed publication.
Even light drinking had no beneficial effect on brain aging, unlike an often-reported cardiovascular benefit found from mild levels of alcohol, reported Carol Ann Paul, M.S., a senior instructor at Wellesley College in Wellesley, Mass.
The cross-sectional study of more than 1,800 patients was designed to determine whether the cardiovascular benefits associated with light-to-moderate alcohol consumption could also be seen in the brain, said Paul at the American Academy of Neurology meeting here.
Those who reported more than 14 alcoholic drinks per week had a significantly smaller brain volume compared with non-drinkers.
"Brain volume normally declines with age and that's often accompanied by cognitive impairment in the later stages," she said. "So brain volume is some sort of indicator of brain capacity."
She and her colleagues took advantage of MRI scans acquired from 1999 to 2002 from 1,839 non-demented participants in the Framingham Offspring Study, which itself is an offspring of the Framingham Heart Study.
They divided the participants into five categories on the basis of self-reported alcohol consumption frequency: abstainers, former drinkers, low drinkers (one to seven drinks per week), moderate drinkers (eight to 14 drinks per week), and heavy drinkers (more than 14 drinks per week).
The authors made pair-wise comparisons of mean total cranial volumes across the various groups, and created multivariate linear regression models to see whether there was an association between brain size and alcohol consumption. They controlled their analyses for age, gender, body mass index, height, educational level attained, and Framingham Stroke Risk Profile. They also looked at the longitudinal history of alcohol consumption from 1987 to 2001 to see whether there were associations with total cranial volume.
"I found that unlike what I had hypothesized, there was no beneficial effect of alcohol on brain volume," Paul said. "In addition, I found that there was a slightly more strong effect in women than in men, and on the preliminary longitudinal studies, it seemed that people who had been heavy drinkers throughout the 12-year period we looked at, had significantly decreased brain volume in comparison to the others."
Specifically, the authors found a reduction in brain volume of 0.25% for every additional category of alcohol consumption. In contrast, the average age-related decline in brain volume is 0.19% per year, she noted.
Gender modified the alcohol-brain volume relationship significantly (P=0.0029), with men having a slightly lower downward slope than women, meaning that brain volume decreased more in women than men across categories of alcohol consumption.
The authors also detected a significant negative correlation between alcohol consumption and brain volume among women in their 70's (P= 0.013), and in the longitudinal analysis, they found that heavy drinking was negatively associated with brain volume (P=0.005, -0.026).
"Each drink category is approximately equivalent to one-to-two years of aging," Paul said, adding that the effect was linear across the categories from low to high.
She suggested that although alcohol consumption in moderation has beneficial effects on the cardiovascular system, it may be found to be associated with deleterious effects on neurons and neural circuitry.
Neither funding sources nor author conflicts of interest were reported.
Complete AAN Coverage
Primary source: American Academy of Neurology 2007 Annual Meeting
Source reference:
Paul CA et al. "The Effect of Alcohol Consumption on Total Brain Volume: The Framingham Heart Study." Abstract P05.030, presented May 2.
Saturday
Lancet on piperazine Adverse Events
Lancet on piperazine AEs
Two papers: one on a piperazine ED visit and the other a commentary
-------------
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4NKCD9Y-18&_user=861681&_coverDate=05%2F04%2F2007&_rdoc=1&_fmt=full&_orig=browse&_cdi=4886&_sort=d&_docanchor=&view=c&_ct=1&_acct=C000046147&_version=1&_urlVersion=0&_userid=861681&md5=ce218b61dfc43491ead6fb867504e5cb
The Lancet Volume 369, Issue 9571,
28 April 2007-4 May 2007, Page 1490
Case Report
Collapse, reported seizure—and an unexpected pill
David M Wood, Paul I Dargan, Jennifer Button, David W Holt, Hanna Ovaska, John Ramsey and Alison L Jones
In May, 2006, on a Bank Holiday weekend, an 18-year-old woman presented to an inner-city London emergency department. She had been at a nightclub with friends and purchased tablets, which she understood to be Ecstasy or amphetamines, from a dealer. After ingesting five tablets, she collapsed in the nightclub and appeared to have a seizure lasting 10 min. On arrival in the emergency department, she was agitated and had dilated pupils (8 mm), sinus tachycardia (156 bpm), and a blood pressure of 150/51 mm Hg. Her score on the Glasgow coma scale was 15 and she was apyrexial (35·9°C). She had no significant past medical history and was on no regular medication.
She was one of seven patients to attend the department that night with a similar presentation. We therefore considered it possible that she had taken a contaminated drug, or a substance not previously sold in the area; and we took a serum sample for analysis, in addition to treating the patient symptomatically with intravenous benzodiazepines (4 mg lorazepam followed by 15 mg diazepam). After 12 h, she was asymptomatic and discharged with advice to avoid recreational drugs. The serum sample was analysed by gas chromatography with mass-spectrometric detection (GCMS); 1-benzylpiperazine was detected at a concentration of 2·5 mg/L. Toxicological screening of the same serum sample did not detect the presence of other piperazines, other drugs, or ethanol. A tablet purchased by the patient (figure) was also analysed, and found to contain 1-benzylpiperazine.
1-benzylpiperazine is one of the piperazine family of drugs, initially developed as veterinary anthelmintic agents in the 1950s. Its chemical structure is similar to that of amphetamine.1 Piperazines are marketed in the UK, where they are legally available in shops and over the internet, as having similar effects to controlled recreational drugs; pills containing piperazines are known as “pep pills”.2 No reliable data are available on the consumption of piperazines in the UK, although one manufacturer claims that “over 20 million pills have been consumed in New Zealand with no deaths, or significant lasting injuries”.2 However, in initial clinical trials of 1-benzylpiperazine, adverse effects similar to those of amphetamines were noted.3 A prospective study in New Zealand identified adverse effects including nausea, vomiting, tachycardia, hypertension, anxiety, and agitation among 80 patients presenting to emergency departments after 1-benzylpiperazine ingestion.4 Seizures were reported in 15 (19%), at up to 8 h after ingestion. Three patients had potentially life-threatening recurrent seizures; ingestion of 1-benzylpiperazine by these patients was confirmed by toxicological screening of their urine. Other potentially serious adverse effects included QTc prolongation (QTc duration 430–490 ms in 32 patients) and hyponatraemia (serum sodium concentration 118 mmol/L and serum osmolality 242 mmol/kg) in one patient. Clinicians should be aware of the potential presenting features of piperazine toxicity, particularly because commercially available urine toxicological screening kits for drugs of abuse may not detect piperazines. All patients with strongly suspected or reported ingestion of 1-benzylpiperazine should have an initial baseline ECG, to seek features of cardiotoxicity. They should be observed for up to 8 h after ingestion, because the onset of seizures can be delayed. Initial treatment should be based on the clinical presentation. Further management can require the advice of a clinical toxicologist.
References
1 M Wikstrom, P Holmgren and J Ahlner, A2 (N-benzylpiperazine) a new drug of abuse in Sweden, J Anal Toxicol 28 (2004), pp. 67–70. View Record in Scopus Cited By in Scopus
2 Spiritualhigh.co.uk – Staying Safe on PEP Pillshttp://www.spiritualhigh.co.uk/information/drug-harm-minimisation-and-legal-highs/staying-safe-on-pep-pills/3-7-7-19 (accessed April 2, 2007)..
3 C Bye, AD Munro-Faure, AW Peck and PA Young, A comparison of the effects of 1-benzylpiperazine and dexamphetamine on human performance tests, Eur J Clin Pharmacol 6 (1973), pp. 163–169. Full Text via CrossRef View Record in Scopus Cited By in Scopus
4 P Gee, S Richardson, W Woltersdorf and G Moore, Toxic effects of BZP-based herbal party pills in humans: a prospective study in Christchurch, New Zealand, N Z Med J 118 (2005), p. U1784.
---------------
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4NKCD9Y-8&_user=861681&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000046147&_version=1&_urlVersion=0&_userid=861681&md5=052f888a3af245e97f046b0a6e64f7db
Comment
Piperazine designer drugs of abuse
Roland F Staack
In today's Lancet, David Wood and colleagues report on the first case of poisoning with 1-benzylpiperazine (BZP) in the UK.1 This case report is a valuable contribution to the development of a better understanding of the toxicity of this new drug of abuse. To date, only a few cases of poisonings and deaths with BZP have been reported.2, 3 and 4 However, in these reports, no detailed clinical data were given, the cases were polydrug intoxications, or only limited analytical toxicological analysis was available. The case reported by Wood and colleagues describes for the first time the clinical symptoms of an acute mono-intoxication with BZP, which was confirmed by toxicological analysis.
BZP is the most prevalent compound of a new class of designer drugs of abuse called piperazines (figure). Besides BZP and 1-(3,4-methylenedioxybenzyl)piperazine (MDBP), there are the phenylpiperazine derivatives: 1-(3-trifluoromethylphenyl)piperazine (TFMPP), 1-(3-chlorophenyl)piperazine (mCPP), and 1-(4-methoxyphenyl)piperazine (MeOPP).5
The amfetaminergic effects of BZP have been known since the 1970s. A mixture of BZP and TFMPP mimics the molecular mechanism of 3,4-methylenedioxymethamfetamine (MDMA, ecstasy).3, 5, 6, 7 and 8 The phenylpiperazines are well-characterised serotonergic compounds, which is also the reason for the use of 1-(3-chlorophenyl)piperazine (mCPP) as a probe drug in psychiatric research.5, 6 and 7 Commonly, piperazines are sold as party pills in the form of tablets, capsules, or powders on the black drug-market and in so-called headshops or over the internet. They are also found in tablets sold as ecstasy or amfetamine. Generally, piperazine blends are consumed. Besides the most prevalent mixture of BZP with TFMPP, there are also blends of up to four different piperazines (named X4). Furthermore, mixtures of piperazines with other drugs of abuse, such as ecstasy or cocaine, have been reported.6 and 7 Since the end of the 1990s, piperazines are often proffered as a legal and safe alternative to amfetamine-derived drugs. The discussion on their legal status is ongoing in many countries. However, some countries (eg, the USA, Australia, Japan, and some European countries) already control BZP under drug control or equivalent legislation.6, 7 and 9 Thus the claimed advantage of legality is not given anymore in these countries. In March, 2007, in the UK, the Medicines and Healthcare products Regulatory Agency declared the selling of BZP products illegal.10 Predictably, the legal measures started a kind of cat-and-mouse play. Instead of BZP, other, not yet scheduled, piperazines, mainly mCPP, increasingly appeared on the market.
The widespread use of piperazines with only a low record of attributable toxicity is stated by activists as proof of safety for legalisation of these drugs. However, from a toxicological point of view, such a stance cannot be affirmed. In view of the similar pharmacological modes of action of piperazines and amfetamines, similar toxicity has to be assumed. This assumption is supported by the reported cases of piperazine poisonings1, 2, 3 and 4 and by the occurrence of serotonin syndromes in a clinical study.11
Special attention should be paid here to polydrug use. Synergistic effects of piperazine blends have been described.8 Furthermore, particularly the phenylpiperazines are extensively metabolised, mainly by the polymorphically expressed cytochrome P450 2D6 (CYP2D6) which might result in an increased risk of toxic side-effects for CYP2D6 poor-metabolisers.5 In addition, these compounds are liable for drug–drug interactions with inhibitors or other substrates of this enzyme (eg, MDMA, cocaine), which might similarly increase the risk of toxicity, especially because piperazines seem to have a narrow safety margin.6, 8 and 11
The low record of reported poisonings with piperazines has also to be put into perspective. Many clinicians are not aware of newer classes of drugs of abuse. Piperazines and amfetamines are similarly marketed, consumed by the same population, and show similar pharmacological symptoms. Therefore a piperazine poisoning can easily be wrongly diagnosed as an amfetamine poisoning. Furthermore, piperazines are not detected by routinely used immunochemical screening procedures for drugs of abuse, but require an appropriate toxicological analysis (eg, by gas-chromatography mass-spectrometry).12 and 13
Hence Wood and colleagues' case report is an excellent example to raise clinicians' awareness of newer drugs of abuse and substantiates the importance of a sound toxicological analysis for a correct clinical diagnosis. As a result, more cases of abuse of new designer drugs will be detected, which in turn will yield data essential for a toxicological risk assessment. Besides piperazines, there are also further new classes of designer drugs of abuse, such as phenethylamines (2C-series), α-pyrrolidinophenones, and new phencyclidine derivatives.5 and 9
References
1 DM Wood, PI Dargan and J Button et al., Pills, collapse, and a negative drug screen, Lancet 369 (2007), p. 1490. SummaryPlus Full Text + Links PDF (73 K)
2 C Balmelli, H Kupferschmidt, K Rentsch and M Schneemann, Fatal brain edema after ingestion of ecstasy and benzylpiperazine, Dtsch Med Wochenschr 126 (2001), pp. 809–811. Full Text via CrossRef View Record in Scopus Cited By in Scopus
3 P Gee, S Richardson, W Woltersdorf and G Moore, Toxic effects of BZP-based herbal party pills in humans: a prospective study in Christchurch, New Zealand, N Z Med J 118 (2005), p. U1784.
4 M Wikström, P Holmgren and J Ahlner, A2 (N-benzylpiperazine) a new drug of abuse in Sweden, J Anal Toxicol 28 (2004), pp. 67–70. View Record in Scopus Cited By in Scopus
5 RF Staack and HH Maurer, Metabolism of designer drugs of abuse, Curr Drug Metab 6 (2005), pp. 259–274. Full Text via CrossRef View Record in Scopus Cited By in Scopus
6 European Monitroing Centre for Drugs and Drug Addiction, Europol-EMCDDA Joint Report on a new psychoactive substance: 1-benzylpiperazine (BZP)http://www.emcdda.europa.eu/?nnodeID=1346 (March 23, 2007) (accessed April 17, 2007)..
7 European Monitroing Centre for Drugs and Drug Addiction, Europol-EMCDDA Joint Report on a new psychoactive substance: 1-(3-chlorophenyl)piperazine (mCPP)http://www.emcdda.europa.eu/?nnodeID=1346 (March 23, 2007) (accessed April 17, 2007)..
8 MH Baumann, RD Clark, AG Budzynski, JS Partilla, BE Blough and RB Rothman, N-substituted piperazines abused by humans mimic the molecular mechanism of 3,4-methylenedioxymethamphetamine (MDMA, or ‘Ecstasy’), Neuropsychopharmacology 30 (2005), pp. 550–560. Full Text via CrossRef View Record in Scopus Cited By in Scopus
9 Anonymous, Schedules of controlled substances; placement of 2,5-dimethoxy-4-(n)-propylthiophenethylamine and N-benzylpiperazine into Schedule I of the Controlled Substances Act. Final rule, Fed Regist 69 (2004), pp. 12794–12797.
10 MHRA, Press release: benzylpiperazine (PEP) pills are dangerous and illegalhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030603&ssTargetNodeId=389 (March 20, 2007) (accessed April 17, 2007)..
11 T Klaassen, KL Ho Pian, HG Westenberg, JA den Boer and HM van Praag, Serotonin syndrome after challenge with the 5-HT agonist meta-chlorophenylpiperazine, Psychiatry Res 79 (1998), pp. 207–212. Abstract Full Text + Links PDF (73 K) View Record in Scopus Cited By in Scopus
12 HH Maurer, Position of chromatographic techniques in screening for detection of drugs or poisons in clinical and forensic toxicology and/or doping control, Clin Chem Lab Med 42 (2004), pp. 1310–1324. Full Text via CrossRef View Record in Scopus Cited By in Scopus
13 FT Peters, S Schaefer, RF Staack, T Kraemer and HH Maurer, Screening for and validated quantification of amphetamines and of amphetamine- and piperazine-derived designer drugs in human blood plasma by gas chromatography/mass spectrometry, J Mass Spectrom 38 (2003), pp. 659–676. Full Text via CrossRef View Record in Scopus Cited By in Scopus
Two papers: one on a piperazine ED visit and the other a commentary
-------------
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4NKCD9Y-18&_user=861681&_coverDate=05%2F04%2F2007&_rdoc=1&_fmt=full&_orig=browse&_cdi=4886&_sort=d&_docanchor=&view=c&_ct=1&_acct=C000046147&_version=1&_urlVersion=0&_userid=861681&md5=ce218b61dfc43491ead6fb867504e5cb
The Lancet Volume 369, Issue 9571,
28 April 2007-4 May 2007, Page 1490
Case Report
Collapse, reported seizure—and an unexpected pill
David M Wood, Paul I Dargan, Jennifer Button, David W Holt, Hanna Ovaska, John Ramsey and Alison L Jones
In May, 2006, on a Bank Holiday weekend, an 18-year-old woman presented to an inner-city London emergency department. She had been at a nightclub with friends and purchased tablets, which she understood to be Ecstasy or amphetamines, from a dealer. After ingesting five tablets, she collapsed in the nightclub and appeared to have a seizure lasting 10 min. On arrival in the emergency department, she was agitated and had dilated pupils (8 mm), sinus tachycardia (156 bpm), and a blood pressure of 150/51 mm Hg. Her score on the Glasgow coma scale was 15 and she was apyrexial (35·9°C). She had no significant past medical history and was on no regular medication.
She was one of seven patients to attend the department that night with a similar presentation. We therefore considered it possible that she had taken a contaminated drug, or a substance not previously sold in the area; and we took a serum sample for analysis, in addition to treating the patient symptomatically with intravenous benzodiazepines (4 mg lorazepam followed by 15 mg diazepam). After 12 h, she was asymptomatic and discharged with advice to avoid recreational drugs. The serum sample was analysed by gas chromatography with mass-spectrometric detection (GCMS); 1-benzylpiperazine was detected at a concentration of 2·5 mg/L. Toxicological screening of the same serum sample did not detect the presence of other piperazines, other drugs, or ethanol. A tablet purchased by the patient (figure) was also analysed, and found to contain 1-benzylpiperazine.
1-benzylpiperazine is one of the piperazine family of drugs, initially developed as veterinary anthelmintic agents in the 1950s. Its chemical structure is similar to that of amphetamine.1 Piperazines are marketed in the UK, where they are legally available in shops and over the internet, as having similar effects to controlled recreational drugs; pills containing piperazines are known as “pep pills”.2 No reliable data are available on the consumption of piperazines in the UK, although one manufacturer claims that “over 20 million pills have been consumed in New Zealand with no deaths, or significant lasting injuries”.2 However, in initial clinical trials of 1-benzylpiperazine, adverse effects similar to those of amphetamines were noted.3 A prospective study in New Zealand identified adverse effects including nausea, vomiting, tachycardia, hypertension, anxiety, and agitation among 80 patients presenting to emergency departments after 1-benzylpiperazine ingestion.4 Seizures were reported in 15 (19%), at up to 8 h after ingestion. Three patients had potentially life-threatening recurrent seizures; ingestion of 1-benzylpiperazine by these patients was confirmed by toxicological screening of their urine. Other potentially serious adverse effects included QTc prolongation (QTc duration 430–490 ms in 32 patients) and hyponatraemia (serum sodium concentration 118 mmol/L and serum osmolality 242 mmol/kg) in one patient. Clinicians should be aware of the potential presenting features of piperazine toxicity, particularly because commercially available urine toxicological screening kits for drugs of abuse may not detect piperazines. All patients with strongly suspected or reported ingestion of 1-benzylpiperazine should have an initial baseline ECG, to seek features of cardiotoxicity. They should be observed for up to 8 h after ingestion, because the onset of seizures can be delayed. Initial treatment should be based on the clinical presentation. Further management can require the advice of a clinical toxicologist.
References
1 M Wikstrom, P Holmgren and J Ahlner, A2 (N-benzylpiperazine) a new drug of abuse in Sweden, J Anal Toxicol 28 (2004), pp. 67–70. View Record in Scopus Cited By in Scopus
2 Spiritualhigh.co.uk – Staying Safe on PEP Pillshttp://www.spiritualhigh.co.uk/information/drug-harm-minimisation-and-legal-highs/staying-safe-on-pep-pills/3-7-7-19 (accessed April 2, 2007)..
3 C Bye, AD Munro-Faure, AW Peck and PA Young, A comparison of the effects of 1-benzylpiperazine and dexamphetamine on human performance tests, Eur J Clin Pharmacol 6 (1973), pp. 163–169. Full Text via CrossRef View Record in Scopus Cited By in Scopus
4 P Gee, S Richardson, W Woltersdorf and G Moore, Toxic effects of BZP-based herbal party pills in humans: a prospective study in Christchurch, New Zealand, N Z Med J 118 (2005), p. U1784.
---------------
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4NKCD9Y-8&_user=861681&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000046147&_version=1&_urlVersion=0&_userid=861681&md5=052f888a3af245e97f046b0a6e64f7db
Comment
Piperazine designer drugs of abuse
Roland F Staack
In today's Lancet, David Wood and colleagues report on the first case of poisoning with 1-benzylpiperazine (BZP) in the UK.1 This case report is a valuable contribution to the development of a better understanding of the toxicity of this new drug of abuse. To date, only a few cases of poisonings and deaths with BZP have been reported.2, 3 and 4 However, in these reports, no detailed clinical data were given, the cases were polydrug intoxications, or only limited analytical toxicological analysis was available. The case reported by Wood and colleagues describes for the first time the clinical symptoms of an acute mono-intoxication with BZP, which was confirmed by toxicological analysis.
BZP is the most prevalent compound of a new class of designer drugs of abuse called piperazines (figure). Besides BZP and 1-(3,4-methylenedioxybenzyl)piperazine (MDBP), there are the phenylpiperazine derivatives: 1-(3-trifluoromethylphenyl)piperazine (TFMPP), 1-(3-chlorophenyl)piperazine (mCPP), and 1-(4-methoxyphenyl)piperazine (MeOPP).5
The amfetaminergic effects of BZP have been known since the 1970s. A mixture of BZP and TFMPP mimics the molecular mechanism of 3,4-methylenedioxymethamfetamine (MDMA, ecstasy).3, 5, 6, 7 and 8 The phenylpiperazines are well-characterised serotonergic compounds, which is also the reason for the use of 1-(3-chlorophenyl)piperazine (mCPP) as a probe drug in psychiatric research.5, 6 and 7 Commonly, piperazines are sold as party pills in the form of tablets, capsules, or powders on the black drug-market and in so-called headshops or over the internet. They are also found in tablets sold as ecstasy or amfetamine. Generally, piperazine blends are consumed. Besides the most prevalent mixture of BZP with TFMPP, there are also blends of up to four different piperazines (named X4). Furthermore, mixtures of piperazines with other drugs of abuse, such as ecstasy or cocaine, have been reported.6 and 7 Since the end of the 1990s, piperazines are often proffered as a legal and safe alternative to amfetamine-derived drugs. The discussion on their legal status is ongoing in many countries. However, some countries (eg, the USA, Australia, Japan, and some European countries) already control BZP under drug control or equivalent legislation.6, 7 and 9 Thus the claimed advantage of legality is not given anymore in these countries. In March, 2007, in the UK, the Medicines and Healthcare products Regulatory Agency declared the selling of BZP products illegal.10 Predictably, the legal measures started a kind of cat-and-mouse play. Instead of BZP, other, not yet scheduled, piperazines, mainly mCPP, increasingly appeared on the market.
The widespread use of piperazines with only a low record of attributable toxicity is stated by activists as proof of safety for legalisation of these drugs. However, from a toxicological point of view, such a stance cannot be affirmed. In view of the similar pharmacological modes of action of piperazines and amfetamines, similar toxicity has to be assumed. This assumption is supported by the reported cases of piperazine poisonings1, 2, 3 and 4 and by the occurrence of serotonin syndromes in a clinical study.11
Special attention should be paid here to polydrug use. Synergistic effects of piperazine blends have been described.8 Furthermore, particularly the phenylpiperazines are extensively metabolised, mainly by the polymorphically expressed cytochrome P450 2D6 (CYP2D6) which might result in an increased risk of toxic side-effects for CYP2D6 poor-metabolisers.5 In addition, these compounds are liable for drug–drug interactions with inhibitors or other substrates of this enzyme (eg, MDMA, cocaine), which might similarly increase the risk of toxicity, especially because piperazines seem to have a narrow safety margin.6, 8 and 11
The low record of reported poisonings with piperazines has also to be put into perspective. Many clinicians are not aware of newer classes of drugs of abuse. Piperazines and amfetamines are similarly marketed, consumed by the same population, and show similar pharmacological symptoms. Therefore a piperazine poisoning can easily be wrongly diagnosed as an amfetamine poisoning. Furthermore, piperazines are not detected by routinely used immunochemical screening procedures for drugs of abuse, but require an appropriate toxicological analysis (eg, by gas-chromatography mass-spectrometry).12 and 13
Hence Wood and colleagues' case report is an excellent example to raise clinicians' awareness of newer drugs of abuse and substantiates the importance of a sound toxicological analysis for a correct clinical diagnosis. As a result, more cases of abuse of new designer drugs will be detected, which in turn will yield data essential for a toxicological risk assessment. Besides piperazines, there are also further new classes of designer drugs of abuse, such as phenethylamines (2C-series), α-pyrrolidinophenones, and new phencyclidine derivatives.5 and 9
References
1 DM Wood, PI Dargan and J Button et al., Pills, collapse, and a negative drug screen, Lancet 369 (2007), p. 1490. SummaryPlus Full Text + Links PDF (73 K)
2 C Balmelli, H Kupferschmidt, K Rentsch and M Schneemann, Fatal brain edema after ingestion of ecstasy and benzylpiperazine, Dtsch Med Wochenschr 126 (2001), pp. 809–811. Full Text via CrossRef View Record in Scopus Cited By in Scopus
3 P Gee, S Richardson, W Woltersdorf and G Moore, Toxic effects of BZP-based herbal party pills in humans: a prospective study in Christchurch, New Zealand, N Z Med J 118 (2005), p. U1784.
4 M Wikström, P Holmgren and J Ahlner, A2 (N-benzylpiperazine) a new drug of abuse in Sweden, J Anal Toxicol 28 (2004), pp. 67–70. View Record in Scopus Cited By in Scopus
5 RF Staack and HH Maurer, Metabolism of designer drugs of abuse, Curr Drug Metab 6 (2005), pp. 259–274. Full Text via CrossRef View Record in Scopus Cited By in Scopus
6 European Monitroing Centre for Drugs and Drug Addiction, Europol-EMCDDA Joint Report on a new psychoactive substance: 1-benzylpiperazine (BZP)http://www.emcdda.europa.eu/?nnodeID=1346 (March 23, 2007) (accessed April 17, 2007)..
7 European Monitroing Centre for Drugs and Drug Addiction, Europol-EMCDDA Joint Report on a new psychoactive substance: 1-(3-chlorophenyl)piperazine (mCPP)http://www.emcdda.europa.eu/?nnodeID=1346 (March 23, 2007) (accessed April 17, 2007)..
8 MH Baumann, RD Clark, AG Budzynski, JS Partilla, BE Blough and RB Rothman, N-substituted piperazines abused by humans mimic the molecular mechanism of 3,4-methylenedioxymethamphetamine (MDMA, or ‘Ecstasy’), Neuropsychopharmacology 30 (2005), pp. 550–560. Full Text via CrossRef View Record in Scopus Cited By in Scopus
9 Anonymous, Schedules of controlled substances; placement of 2,5-dimethoxy-4-(n)-propylthiophenethylamine and N-benzylpiperazine into Schedule I of the Controlled Substances Act. Final rule, Fed Regist 69 (2004), pp. 12794–12797.
10 MHRA, Press release: benzylpiperazine (PEP) pills are dangerous and illegalhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030603&ssTargetNodeId=389 (March 20, 2007) (accessed April 17, 2007)..
11 T Klaassen, KL Ho Pian, HG Westenberg, JA den Boer and HM van Praag, Serotonin syndrome after challenge with the 5-HT agonist meta-chlorophenylpiperazine, Psychiatry Res 79 (1998), pp. 207–212. Abstract Full Text + Links PDF (73 K) View Record in Scopus Cited By in Scopus
12 HH Maurer, Position of chromatographic techniques in screening for detection of drugs or poisons in clinical and forensic toxicology and/or doping control, Clin Chem Lab Med 42 (2004), pp. 1310–1324. Full Text via CrossRef View Record in Scopus Cited By in Scopus
13 FT Peters, S Schaefer, RF Staack, T Kraemer and HH Maurer, Screening for and validated quantification of amphetamines and of amphetamine- and piperazine-derived designer drugs in human blood plasma by gas chromatography/mass spectrometry, J Mass Spectrom 38 (2003), pp. 659–676. Full Text via CrossRef View Record in Scopus Cited By in Scopus
Sentencing Commission on cocaine/crack
Sentencing Commish on cocaine/crack
http://www.ussc.gov/PRESS/rel0407.htm
In addition to those earlier actions, the Commission unanimously
announced today that it will submit to Congress on or before May 15,
2007, a report on federal cocaine sentencing policy. The report will set
forth current data and information that continue to support the
Commission's consistently held position that the 100-to-1 crack-powder
drug quantity ratio significantly undermines various congressional
objectives set forth in the Sentencing Reform Act and elsewhere. The
Commission also will make recommendations to Congress in the report for
modifications to the statutory penalties for crack cocaine offenses. At
today's meeting, the Commission expressed its firm desire that this
report will facilitate prompt congressional action addressing the
100-to-1 crack-powder drug quantity ratio.
The Commission also voted today to promulgate an amendment that modifies
the penalties for crack cocaine offenses. The Commission described the
problems associated with the 100-to-1 drug quantity ratio as so urgent
and compelling that it promulgated the guideline amendment as a measure
to alleviate some of those problems.
The statutory penalties for crack cocaine offenses require a five-year
mandatory minimum sentence for a first-time trafficking offense
involving 5 grams or more of crack cocaine, and a ten-year mandatory
minimum penalty for a first-time trafficking offense involving 50 grams
or more of crack cocaine. When Congress established these penalties in
1986, the Commission responded by incorporating the statutory mandatory
minimum sentences into the guidelines to provide guideline sentencing
ranges that are above the statutory mandatory minimum penalties.
First-time offenses involving 5 grams or more of crack cocaine receive a
sentencing guideline range of 63 to 78 months, and first-time offenses
involving 50 grams or more of crack cocaine receive a sentencing
guideline range of 121 to 151 months, before accounting for other
relevant factors under the guidelines.
The Commission's amendment modifies the guideline drug quantity
thresholds to provide guideline sentencing ranges that include the
statutory mandatory minimum penalties for crack cocaine offenses.
Accordingly, under the amendment, a first-time trafficking offense
involving 5 grams of crack cocaine will receive a guideline sentencing
range of 51 to 63 months, and a first-time trafficking offense involving
50 grams or more of crack cocaine will receive a guideline sentencing
range of 97 to 121 months, before accounting for other relevant factors
under the guidelines. Under the statutory mandatory minimum penalties,
however, a five- and ten-year sentence will still be required,
respectively. As a result, the Commission's amendment provides some
relief to crack cocaine offenders impacted by the disparity created by
federal cocaine sentencing policy.
The Commission emphasized and expressed its strong view that the
amendment is only a partial solution to some of the problems associated
with the 100-to-1 drug quantity ratio. Any comprehensive solution to the
100-to-1 drug quantity ratio would require appropriate legislative
action by Congress.
The text of the Commission's amendments and its accompanying 2007 report
to Congress, Cocaine and Federal Sentencing Policy, will be available in
the coming weeks on the Commission's website, www.ussc.gov.
http://www.ussc.gov/PRESS/rel0407.htm
In addition to those earlier actions, the Commission unanimously
announced today that it will submit to Congress on or before May 15,
2007, a report on federal cocaine sentencing policy. The report will set
forth current data and information that continue to support the
Commission's consistently held position that the 100-to-1 crack-powder
drug quantity ratio significantly undermines various congressional
objectives set forth in the Sentencing Reform Act and elsewhere. The
Commission also will make recommendations to Congress in the report for
modifications to the statutory penalties for crack cocaine offenses. At
today's meeting, the Commission expressed its firm desire that this
report will facilitate prompt congressional action addressing the
100-to-1 crack-powder drug quantity ratio.
The Commission also voted today to promulgate an amendment that modifies
the penalties for crack cocaine offenses. The Commission described the
problems associated with the 100-to-1 drug quantity ratio as so urgent
and compelling that it promulgated the guideline amendment as a measure
to alleviate some of those problems.
The statutory penalties for crack cocaine offenses require a five-year
mandatory minimum sentence for a first-time trafficking offense
involving 5 grams or more of crack cocaine, and a ten-year mandatory
minimum penalty for a first-time trafficking offense involving 50 grams
or more of crack cocaine. When Congress established these penalties in
1986, the Commission responded by incorporating the statutory mandatory
minimum sentences into the guidelines to provide guideline sentencing
ranges that are above the statutory mandatory minimum penalties.
First-time offenses involving 5 grams or more of crack cocaine receive a
sentencing guideline range of 63 to 78 months, and first-time offenses
involving 50 grams or more of crack cocaine receive a sentencing
guideline range of 121 to 151 months, before accounting for other
relevant factors under the guidelines.
The Commission's amendment modifies the guideline drug quantity
thresholds to provide guideline sentencing ranges that include the
statutory mandatory minimum penalties for crack cocaine offenses.
Accordingly, under the amendment, a first-time trafficking offense
involving 5 grams of crack cocaine will receive a guideline sentencing
range of 51 to 63 months, and a first-time trafficking offense involving
50 grams or more of crack cocaine will receive a guideline sentencing
range of 97 to 121 months, before accounting for other relevant factors
under the guidelines. Under the statutory mandatory minimum penalties,
however, a five- and ten-year sentence will still be required,
respectively. As a result, the Commission's amendment provides some
relief to crack cocaine offenders impacted by the disparity created by
federal cocaine sentencing policy.
The Commission emphasized and expressed its strong view that the
amendment is only a partial solution to some of the problems associated
with the 100-to-1 drug quantity ratio. Any comprehensive solution to the
100-to-1 drug quantity ratio would require appropriate legislative
action by Congress.
The text of the Commission's amendments and its accompanying 2007 report
to Congress, Cocaine and Federal Sentencing Policy, will be available in
the coming weeks on the Commission's website, www.ussc.gov.
Tuesday
Depression and the Initiation of Alcohol and Othr Drug Use among Youths Aged 12 to 17
The NSDUH Report May 3, 2007: Depression and the Initiation of Alcohol and Othr Drug Use among Youths Aged 12 to 17
In 2005, 8.8 percent of youths aged 12 to 17 (2.2 million persons) experienced at least one major depressive episode (MDE) in the past year. Among youths aged 12 to 17 who were at risk for alcohol initiation (i.e., those who had never used alcohol previously), those who experienced a past year MDE were twice as likely to have initiated alcohol use in the past year as those who did not have a past year MDE (29.2 vs. 14.5 percent). Among youths who were at risk for illicit drug initiation, those who experienced a past year MDE were over twice as likely to have initiated use of an illicit drug as those who had not experienced an MDE in the past year (16.1 vs. 6.9 percent).
The Good News:
Most children and youths do not drink alcohol. In fact, nearly 60 percent of youths ages 12-17 have never had a drink.
Delaying Onset Is Key:
Those who start drinking alcohol before age 15 are five times more likely to have alcohol problems later in life than those who begin drinking at age 21 or older.
Easy Access to Alcohol:
In a recent national survey, a little more than 60 percent of eighth graders said alcohol was "fairly easy" or "very easy" to get. In one study, 9.6 percent of 12-year-olds reported using alcohol at least once in their lifetimes. By age 13 the percentage doubles, and by age 15 it is over 50 percent.
In 2005, 8.8 percent of youths aged 12 to 17 (2.2 million persons) experienced at least one major depressive episode (MDE) in the past year. Among youths aged 12 to 17 who were at risk for alcohol initiation (i.e., those who had never used alcohol previously), those who experienced a past year MDE were twice as likely to have initiated alcohol use in the past year as those who did not have a past year MDE (29.2 vs. 14.5 percent). Among youths who were at risk for illicit drug initiation, those who experienced a past year MDE were over twice as likely to have initiated use of an illicit drug as those who had not experienced an MDE in the past year (16.1 vs. 6.9 percent).
The Good News:
Most children and youths do not drink alcohol. In fact, nearly 60 percent of youths ages 12-17 have never had a drink.
Delaying Onset Is Key:
Those who start drinking alcohol before age 15 are five times more likely to have alcohol problems later in life than those who begin drinking at age 21 or older.
Easy Access to Alcohol:
In a recent national survey, a little more than 60 percent of eighth graders said alcohol was "fairly easy" or "very easy" to get. In one study, 9.6 percent of 12-year-olds reported using alcohol at least once in their lifetimes. By age 13 the percentage doubles, and by age 15 it is over 50 percent.
Monday
Analysis of UK Drug Problem by Peter Reuter and Alex Stevens
Analysis of UK Drug Problem
http://www.ukdpc.org.uk/docs/UKDPC%20drug%20policy%20review.pdf
by
Peter Reuter and Alex Stevens
http://www.ukdpc.org.uk/docs/UKDPC%20drug%20policy%20review.pdf
by
Peter Reuter and Alex Stevens
Saturday
FDA bans "Cocaine" (Street Drug Alternatives)
http://www.fda.gov/foi/warning_letters/b6312d.htm
WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED April 4, 2007 James KirbySenior Partner/FounderRedux Beverages, LLC41605 Elm Street, #6Murrieta, CA 92562
Dear Mr. Kirby:
The Food and Drug Administration conducted an inspection of your firm, Drink Reboot, on February 14, 2007. This letter concerns your firm's marketing of the product "Cocaine" as a dietary supplement on your website, http://www.drinkcocaine.co/. According to information on your website, Cocaine is marketed as an alternative to an illicit street drug, and certain ingredients contained therein are intended to prevent, treat, or cure disease conditions.As explained in greater detail below, dietary supplements are products that e intended to supplement the diet . Street drug alternatives, i.e., products that claim to mimic he effects of recreational drugs, are not intended to supplement the diet and, as a result, cannot lawfully be marketed as dietary supplements.In addition, a dietary supplement may not bear claims that it prevents or treats a disease, except for authorized health claims about reducing the risk of a disease. Other disease prevention and treatment claims render the product a drug subject to the drug requirements of the Food, Drug, and Cosmetic Act (Act).The following statements that are noted on your product container or on your website demonstrate that your product is intended as an alternative to an illicit street drug:"The Legal Alternative"The product name is "Cocaine," and the letters in the product name appear to be spelled out in a white granular substance that resembles cocaine powder."Speed in a Can""Liquid Cocaine""Cocaine - Instant Rush.""The question you have to ask yourself is: "Can I handle the rush?"This beverage should be consumed by responsible adults. Failure to adhere to this warning may result in excess excitement, stamina, . . . and possible feeling of euphoria."The following statements on your website about an ingredient of "Cocaine" demonstrate that your product is intended to treat or prevent certain diseases:*"Inositol -... reduces cholesterol in the blood; it helps prevent hardening of the arteries, and may protect nerve fibers from excess glucose damage. Inositol has a natural calming effect and may be used in the treatment of anxiety, depression, and obsessive-compulsive disorder without the side effects of prescription medications."Street Drug AlternativesFDA has become aware of the proliferation of various diet supplement products that are being manufactured, marketed, or distributed as alternatives to illicit street drugs. Street drug alternatives are not intended to supplement the diet. 21 U.S.C. 321(ff). Accordingly, street drug alternatives do not qualify as dietary supplements. See United States v. Undetermined Quantities of Articles of Drugs, 145 F. Supp. 2d 692 (D. Md. 2001). In March of 2000, FDA made available a guidance for industry on street drug alternatives. This document contains additional information and is available at http://www.fda.gov/cder/guidance/index.htmDisease ClaimsYour product, Cocaine, is a drug, as defined by Section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, 21 U.S.C. §§ 321(g), 321(ff), and 343(r)(6). Moreover, this product is a new drug, as defined by Section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under Sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of Cocaine without an approved application violates these provisions of the Act.Furthermore, because this product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use this product safely for its intended uses. Thus, Cocaine's labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under Section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1).The above violations are not intended to be an all-inclusive list of deficiencies. It is your responsibility to ensure that the drug products that you manufacture or distribute meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer.Please address your written response to the attention of:Pamela B. SchweikertDirector, Compliance BranchUnited States Food and Drug Administration19701 FairchildIrvine, CA 92612-2506If you have any questions about the content of this letter please contact Mr. John J. Stamp at (949) 608-4464.Sincerely yours,/S/Alonza E. CruseDistrict DirectorCc: California Board of Pharmacy1625 N, Market Blvd.Suite N219Sacramento, CA 95834
http://www.fda.gov/cder/guidance/3602fnl.htm
Guidance for Industry
Street Drug Alternatives
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)March 2000Compliance
[Acrobat Version of this Document]
Additional copies of this Guidance are available from:Office of Training and CommunicationsDivision of Communications ManagementDrug Information Branch, HFD-210Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers Lane, Rockville, MD 20857(Phone 301-827-4573)
Guidance for Industry
Street Drug Alternatives
I. Introduction
This guidance is intended for those persons who are manufacturing, marketing, or distributing alternatives to illicit street drugs. FDA considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of sections 505 and 502 of the Federal Food, Drug, and Cosmetic Act (the Act). Such violations may result in regulatory action, including seizure and injunction.
II. BACKGROUND
The Agency has become aware of the proliferation of various products that are being manufactured, marketed, or distributed as alternatives to illicit street drugs (street drug alternatives). FDA is concerned that these products are being abused by individuals, including minors, and pose a potential threat to the public health.
Street drug alternatives are generally labeled as containing botanicals, and some are also labeled as containing other ingredients, such as vitamins, minerals, or amino acids. They are marketed under a variety of brand names with claims implying that these products mimic the effects of controlled substances. Many of these products are promoted on the Internet and in counterculture magazines as alternatives to illicit street drugs such as MDMA (4-methyl-2, dimethoxyamphetamine), a methamphetamine analogue, also known as ecstasy, XTC, and X. Other examples of products whose names imply street drug alternative use are e-Ludes, Hextacy, and Herbal Koke.
These products are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations) and have potential for abuse. FDA considers these street drug alternatives to be unapproved new drugs and misbranded drugs under sections 505 and 502 of the Act.
FDA is also aware that some of these street drug alternatives are being marketed as dietary supplements. FDA does not consider street drug alternatives to be dietary supplements. The term dietary supplement as defined in section 201(ff) of the Act means, inter alia, a product "intended to supplement the diet." While the Act does not elaborate on the meaning of this phrase, many congressional findings, set forth in the Dietary Supplement Health and Education Act of 1994, suggest that dietary supplements are intended to be used to augment the diet to promote health and reduce the risk of disease. FDA does not believe that street drug alternatives are intended to be used to augment the diet to promote health or reduce the risk of disease. Moreover, FDA considers the diet to be composed of usual food and drink that may be designed to meet specific nutritional requirements. Illicit street drugs are not food or drink, and neither they, nor alternative street drugs, can be said to supplement the diet. Rather, these products are intended to be used for recreational purposes to effect psychological states (e.g., to get high, to promote euphoria, or to induce hallucinations). Accordingly, street drug alternatives are not intended to supplement the diet and are not dietary supplements. This position is consistent with that set forth at 62 Fed. Reg. 30678, 30699-700 (June 4, 1997).
III. POLICY
FDA considers any product that is promoted as a street drug alternative to be an unapproved new drug and a misbranded drug in violation of sections 505 and 502 of the Federal Food, Drug, and Cosmetic Act. Such violations may result in regulatory action, including seizure and injunction
Ginger Jake and the blues: a tragic song of poisoning.
Jake Leg
Depression-era drinkers of illicit ginger alcohol foundit numbed more than just their worries
“I CAN’T EAT, I CAN’T TALK,” complained blues artists the Allen Brothers in 1930. “Been drinking mean jake, Lord,” they bemoaned. “Now I can’t walk.” The song was titled “The Jake Walk Blues,” and the Allen Brothers weren’t the first performers to address this peculiar, depression-era malady: It’s widely believed that a blues singer named Ishmon Bracey actually diagnosed the source of the infirmity, which consists of potentially crippling paralysis of the legs, in his song “Jake Liquor Blues.” The problem was jake, which was a nickname for Jamaican Ginger extract.
The extract was used for its medicinal qualities since the 19th century in the United States, as it is reputed to help relieve nausea and diarrhea. With the passing of the Volstead Act in 1919, the production of all commercial alcohol was forbidden in the United States, but for one important exception: medicinal products. Jake, which had a 70 percent alcohol content and was available at any corner drugstore, became a popular beverage. It was inexpensive and mixed well with soft drinks such as Coca Cola; additionally it was useful as an additive to bathtub gins and moonshines to mask the harsh, acidic taste of these illicit beverages. Because of jake’s low price, it was particularly popular among White working class and African-American tipplers. These would be the group hardest hit when jake suddenly turned poisonous.
The Food and Drug division of the U.S. Department of Agriculture got wise to the growing popularity of Jamaican Ginger extract. By March of 1930, the extract was no longer legal. But, in the latter days of the Prohibition, illicit alcohol manufacturers took such bans as something of a dare. In particular, Harry Gross, the president of a Boston-based firm called Hub Products, decided that Jamaican Ginger extract couldn’t go by way of the street grates.
In late January, 1930, along with a chemist friend, Gross found that by adding triorthocresylphosphate phosphate, (TOCP) to Jamaican Ginger extract, it would essentially hide any signs of significant alcohol from government tests. TOCP was an industrial chemical, a “plasticizer” added to materials such as plastics to keep them pliable. The addition was tasteless, odorless, and colorless, and thought to be harmless. It wasn’t. TOCP proved to had one significant side effect: It killed cells in the central nervous system, particularly the spinal cord.
The first sign of Jamaican ginger poisoning was a paralysis of the lower extremities known as “Jake leg.” If victims of Jake Leg had to get from one place to another, they strode by way of the “Jake Walk”, a distinctive gait of high-knees and sloppy, ground slapping steps. There are no records of people overdosing or dying as a result of Jamaican Ginger paralysis, but for some the effects never completely wore off. Estimates range between 50,000 and 100,000 people having been permanently crippled with partial paralysis.
The source of the poisoning was quickly tracked down and taken off the market, and Harry Gross himself was punished with a two-year prison sentence. As the victims of Jake Leg were mostly poor and migratory workers, their plight quickly fell from public view, but for a dozen or so blues and folk songs that essayed their condition.
Jamaican Ginger is still widely available and remains a popular folk remedy. Many products are made with it as a defining ingredient, including tea candles and ginger beer. In fact, there is a French cocktail that called for mango, rum, and ginger extract (minus TOCP, of course). This fruity mixture might well cause an embarrassing loss of control of the lower extremities, but we promise this: it’ll be temporary. (Courtney Mault)
JAKE LEG.(outbreak of paralysis in 1930s)
Source: The New Yorker
Publication Date: 15-SEP-03
Author: Baum, Dan
Dr. John Morgan, a professor at the City University of New York Medical School, likes to call himself a pharmaco-ethnomusicologist. His first love is early-American vernacular music, and his apartment, on the Upper West Side, is stacked with ancient records. Some years back, Morgan was listening to the Allen Brothers' "Jake Walk Blues," released in 1930. In a kazoo-backed Tennessee twang, the brothers sang, "I can't eat, I can't talk, drinking mean jake, Lord, I can't walk." The lyrics pinballed through Morgan's memory and lit up twice. First was a lecture he'd heard in medical school, in 1961: a professor had mentioned a strange paralysis called "jake walk" that he had observed during his residency in Cincinnati in the thirties. Next was a face from Morgan's childhood in Ohio, that of a legless beggar called Nigger John. Nigger John had had the "jake leg," Morgan recalled his mother telling him. She had said it in a way that discouraged further inquiry. Stout and bearded, Morgan, who is sixty-three, delicately set the arm of a turntable on a thick, spinning record, and after a moment's hiss we heard what sounded like pure despair. "Ishmon Bracey, one of the Mississippi greats," Morgan whispered. From seven decades back, Bracey wailed, "Jake leg, jake leg, what in the world you trying to do? Seems like everybody in the city's messed up on account of drinking you." Morgan has collected a number of songs about the jake leg or the jake walk. "From them we learn that some new kind of paralysis appeared in 1930," he said. "No songs mention it before then." He began bending back blunt fingers. "The paralysis was brought on by drinking something called 'jake.' It afflicted enough souls to instigate an entire subset of folk music. Blacks and whites were affected. It rendered men impotent. And it was no longer inspiring musicians by 1934, which meant it was a cataclysmic but discrete event." He sat back and spread his hands. "Behold the study, through folk music, of a substance-induced epidemic," he said. "Pharmaco-ethnomusicology." Morgan has been researching the jake leg on and off for twenty-seven years. He has put together a CD collection of seventeen tunes mentioning it, including one by Gene Autry, and he has written half a dozen medical-journal articles on the subject. In the nineteen-seventies, he interviewed a number of the epidemic's surviving victims and collected his data, a teeming bazaar of anecdote and chemistry, in a huge manuscript that has been gathering dust for years. He also has a filthy carton full of clippings. With a little prodding, he agreed to turn all the material over to me. "I'm not giving up on the story myself," he said. "I just don't mind someone else telling it, too." As far as we know, the outbreak was first detected in Oklahoma City, by Ephraim Goldfain, a thirty-four-year-old physician who had emigrated from Romania as a child and had put himself through medical school by operating a streetcar. He was bookishly handsome, with swept-back red hair, a cleft chin, and round horn-rimmed glasses. With a few partners, he ran a thirty-five-bed clinic called the Reconstruction Hospital. On February 27, 1930, a man whose name is lost to history staggered in off the street. The patient's feet dangled like a marionette's, so that walking involved swinging them forward and slapping them onto the floor. He told Goldfain that he had strained himself lifting an automobile, and a couple of days later his calves had begun to tingle. Then his legs went useless below the knee. He wasn't in any pain, he said, but he could barely get around. Sudden paralysis in those days usually meant polio, but to Goldfain, who recounted the patient's history in a medical journal, this didn't look like polio. He didn't pay much attention to the story about lifting the car. Goldfain thought the man's symptoms suggested lead poisoning. He ordered blood and spinal-fluid tests. They came back negative. Later that day, another man appeared, exhibiting the same bizarre palsy. And then another. By the end of the day, Goldfain's clinic had admitted five patients with the distinctive paralysis. One of them, a podiatrist, claimed he had caught the illness from his own patients, and handed Goldfain a list of the ones who had gone foot-floppy in the past few days. The list had sixty-five names. Oklahoma in 1930 was a hard-luck place. Thanks to price-killing oversupplies of wheat and cotton, its people had gotten a head start on the Depression. The same day that Goldfain saw his five patients, the American Hospital Association criticized Oklahoma City's medical preparedness, noting that it had fewer hospital beds per capita than any other city of its size. Now it was struggling with what looked like a full-blown epidemic. In one frenetic day, Goldfain visited thirty men on the podiatrist's list, and in the succeeding weeks followed up with other visits. The men's feet dangled, their legs hung dead below the knee. Some could get around on crutches, some couldn't make their legs move at all, some could use neither their legs nor their hands. Goldfain knew at once that this was no contagion. No children were sick, and hardly any women. The men Goldfain saw all lived in a seedy part of town known for bootlegging. They struck him as being ashamed...
Ginger Jake and the blues: a tragic song of poisoning.
Vet Hum Toxicol. 1995 Jun;37(3):252-4.
Ginger Jake and the blues: a tragic song of poisoning.
Woolf AD.
Massachusetts Poison Control System, Boston 02115, USA.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=7571360&query_hl=4&itool=pubmed_DocSum Prohibition, "The Noble Experiment", ushered in speakeasys, gangsters and bathtub gin in the 1920s. For many Americans, however, it led to a period of joblessness, hard times, and austerity. The story of Jamaican Ginger ("Jake") poisoning, in which batches of a cheap, alcoholic tonic were laced with tri-ortho cresyl phosphate (TOCP) is one of cynical despicable behavior on the part of those responsible and a tragic enduring legacy for the invisible group of Americans who were victimized. TOCP, a potent organophosphate, caused an axonal dying-back neuropathy affecting mainly large muscle groups. Jake poisoning struck about 50,000 adults, mostly poor middle-aged vagrants with little medical care or social standing. Their symptoms and stories were told not only in medical journals but also in song. Hillbilly jazzmen sang of the "Jake Leg Blues" with a resignation to the fate of their own undoing, brought on by the intemperance of a wasted life. The postscript is grim--those responsible received little punishment; many who drank "Jake" were left both uncompensated and crippled by irreversible paralysis.
Depression-era drinkers of illicit ginger alcohol foundit numbed more than just their worries
“I CAN’T EAT, I CAN’T TALK,” complained blues artists the Allen Brothers in 1930. “Been drinking mean jake, Lord,” they bemoaned. “Now I can’t walk.” The song was titled “The Jake Walk Blues,” and the Allen Brothers weren’t the first performers to address this peculiar, depression-era malady: It’s widely believed that a blues singer named Ishmon Bracey actually diagnosed the source of the infirmity, which consists of potentially crippling paralysis of the legs, in his song “Jake Liquor Blues.” The problem was jake, which was a nickname for Jamaican Ginger extract.
The extract was used for its medicinal qualities since the 19th century in the United States, as it is reputed to help relieve nausea and diarrhea. With the passing of the Volstead Act in 1919, the production of all commercial alcohol was forbidden in the United States, but for one important exception: medicinal products. Jake, which had a 70 percent alcohol content and was available at any corner drugstore, became a popular beverage. It was inexpensive and mixed well with soft drinks such as Coca Cola; additionally it was useful as an additive to bathtub gins and moonshines to mask the harsh, acidic taste of these illicit beverages. Because of jake’s low price, it was particularly popular among White working class and African-American tipplers. These would be the group hardest hit when jake suddenly turned poisonous.
The Food and Drug division of the U.S. Department of Agriculture got wise to the growing popularity of Jamaican Ginger extract. By March of 1930, the extract was no longer legal. But, in the latter days of the Prohibition, illicit alcohol manufacturers took such bans as something of a dare. In particular, Harry Gross, the president of a Boston-based firm called Hub Products, decided that Jamaican Ginger extract couldn’t go by way of the street grates.
In late January, 1930, along with a chemist friend, Gross found that by adding triorthocresylphosphate phosphate, (TOCP) to Jamaican Ginger extract, it would essentially hide any signs of significant alcohol from government tests. TOCP was an industrial chemical, a “plasticizer” added to materials such as plastics to keep them pliable. The addition was tasteless, odorless, and colorless, and thought to be harmless. It wasn’t. TOCP proved to had one significant side effect: It killed cells in the central nervous system, particularly the spinal cord.
The first sign of Jamaican ginger poisoning was a paralysis of the lower extremities known as “Jake leg.” If victims of Jake Leg had to get from one place to another, they strode by way of the “Jake Walk”, a distinctive gait of high-knees and sloppy, ground slapping steps. There are no records of people overdosing or dying as a result of Jamaican Ginger paralysis, but for some the effects never completely wore off. Estimates range between 50,000 and 100,000 people having been permanently crippled with partial paralysis.
The source of the poisoning was quickly tracked down and taken off the market, and Harry Gross himself was punished with a two-year prison sentence. As the victims of Jake Leg were mostly poor and migratory workers, their plight quickly fell from public view, but for a dozen or so blues and folk songs that essayed their condition.
Jamaican Ginger is still widely available and remains a popular folk remedy. Many products are made with it as a defining ingredient, including tea candles and ginger beer. In fact, there is a French cocktail that called for mango, rum, and ginger extract (minus TOCP, of course). This fruity mixture might well cause an embarrassing loss of control of the lower extremities, but we promise this: it’ll be temporary. (Courtney Mault)
JAKE LEG.(outbreak of paralysis in 1930s)
Source: The New Yorker
Publication Date: 15-SEP-03
Author: Baum, Dan
Dr. John Morgan, a professor at the City University of New York Medical School, likes to call himself a pharmaco-ethnomusicologist. His first love is early-American vernacular music, and his apartment, on the Upper West Side, is stacked with ancient records. Some years back, Morgan was listening to the Allen Brothers' "Jake Walk Blues," released in 1930. In a kazoo-backed Tennessee twang, the brothers sang, "I can't eat, I can't talk, drinking mean jake, Lord, I can't walk." The lyrics pinballed through Morgan's memory and lit up twice. First was a lecture he'd heard in medical school, in 1961: a professor had mentioned a strange paralysis called "jake walk" that he had observed during his residency in Cincinnati in the thirties. Next was a face from Morgan's childhood in Ohio, that of a legless beggar called Nigger John. Nigger John had had the "jake leg," Morgan recalled his mother telling him. She had said it in a way that discouraged further inquiry. Stout and bearded, Morgan, who is sixty-three, delicately set the arm of a turntable on a thick, spinning record, and after a moment's hiss we heard what sounded like pure despair. "Ishmon Bracey, one of the Mississippi greats," Morgan whispered. From seven decades back, Bracey wailed, "Jake leg, jake leg, what in the world you trying to do? Seems like everybody in the city's messed up on account of drinking you." Morgan has collected a number of songs about the jake leg or the jake walk. "From them we learn that some new kind of paralysis appeared in 1930," he said. "No songs mention it before then." He began bending back blunt fingers. "The paralysis was brought on by drinking something called 'jake.' It afflicted enough souls to instigate an entire subset of folk music. Blacks and whites were affected. It rendered men impotent. And it was no longer inspiring musicians by 1934, which meant it was a cataclysmic but discrete event." He sat back and spread his hands. "Behold the study, through folk music, of a substance-induced epidemic," he said. "Pharmaco-ethnomusicology." Morgan has been researching the jake leg on and off for twenty-seven years. He has put together a CD collection of seventeen tunes mentioning it, including one by Gene Autry, and he has written half a dozen medical-journal articles on the subject. In the nineteen-seventies, he interviewed a number of the epidemic's surviving victims and collected his data, a teeming bazaar of anecdote and chemistry, in a huge manuscript that has been gathering dust for years. He also has a filthy carton full of clippings. With a little prodding, he agreed to turn all the material over to me. "I'm not giving up on the story myself," he said. "I just don't mind someone else telling it, too." As far as we know, the outbreak was first detected in Oklahoma City, by Ephraim Goldfain, a thirty-four-year-old physician who had emigrated from Romania as a child and had put himself through medical school by operating a streetcar. He was bookishly handsome, with swept-back red hair, a cleft chin, and round horn-rimmed glasses. With a few partners, he ran a thirty-five-bed clinic called the Reconstruction Hospital. On February 27, 1930, a man whose name is lost to history staggered in off the street. The patient's feet dangled like a marionette's, so that walking involved swinging them forward and slapping them onto the floor. He told Goldfain that he had strained himself lifting an automobile, and a couple of days later his calves had begun to tingle. Then his legs went useless below the knee. He wasn't in any pain, he said, but he could barely get around. Sudden paralysis in those days usually meant polio, but to Goldfain, who recounted the patient's history in a medical journal, this didn't look like polio. He didn't pay much attention to the story about lifting the car. Goldfain thought the man's symptoms suggested lead poisoning. He ordered blood and spinal-fluid tests. They came back negative. Later that day, another man appeared, exhibiting the same bizarre palsy. And then another. By the end of the day, Goldfain's clinic had admitted five patients with the distinctive paralysis. One of them, a podiatrist, claimed he had caught the illness from his own patients, and handed Goldfain a list of the ones who had gone foot-floppy in the past few days. The list had sixty-five names. Oklahoma in 1930 was a hard-luck place. Thanks to price-killing oversupplies of wheat and cotton, its people had gotten a head start on the Depression. The same day that Goldfain saw his five patients, the American Hospital Association criticized Oklahoma City's medical preparedness, noting that it had fewer hospital beds per capita than any other city of its size. Now it was struggling with what looked like a full-blown epidemic. In one frenetic day, Goldfain visited thirty men on the podiatrist's list, and in the succeeding weeks followed up with other visits. The men's feet dangled, their legs hung dead below the knee. Some could get around on crutches, some couldn't make their legs move at all, some could use neither their legs nor their hands. Goldfain knew at once that this was no contagion. No children were sick, and hardly any women. The men Goldfain saw all lived in a seedy part of town known for bootlegging. They struck him as being ashamed...
Ginger Jake and the blues: a tragic song of poisoning.
Vet Hum Toxicol. 1995 Jun;37(3):252-4.
Ginger Jake and the blues: a tragic song of poisoning.
Woolf AD.
Massachusetts Poison Control System, Boston 02115, USA.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=7571360&query_hl=4&itool=pubmed_DocSum Prohibition, "The Noble Experiment", ushered in speakeasys, gangsters and bathtub gin in the 1920s. For many Americans, however, it led to a period of joblessness, hard times, and austerity. The story of Jamaican Ginger ("Jake") poisoning, in which batches of a cheap, alcoholic tonic were laced with tri-ortho cresyl phosphate (TOCP) is one of cynical despicable behavior on the part of those responsible and a tragic enduring legacy for the invisible group of Americans who were victimized. TOCP, a potent organophosphate, caused an axonal dying-back neuropathy affecting mainly large muscle groups. Jake poisoning struck about 50,000 adults, mostly poor middle-aged vagrants with little medical care or social standing. Their symptoms and stories were told not only in medical journals but also in song. Hillbilly jazzmen sang of the "Jake Leg Blues" with a resignation to the fate of their own undoing, brought on by the intemperance of a wasted life. The postscript is grim--those responsible received little punishment; many who drank "Jake" were left both uncompensated and crippled by irreversible paralysis.
Inter-University Consortium and ECA
http://webapp.icpsr.umich.edu/cocoon/ICPSR-STUDY/06153.xml
Also:
http://www.icpsr.umich.edu/cocoon/ICPSR/THESAURUS/subject.xml?mode=entry&entry=drug%20abuseInter-University
Consortium for Political and Social Research (ICPSR)Drug Abuse Data Archives
ICPSR maintains and provides access to a vast archive of socialscience data for research and instruction. To ensure that dataresources are available to future generations of scholars, ICPSRpreserves data, migrating them to new storage media as changes intechnology warrant.
Also:
http://www.icpsr.umich.edu/cocoon/ICPSR/THESAURUS/subject.xml?mode=entry&entry=drug%20abuseInter-University
Consortium for Political and Social Research (ICPSR)Drug Abuse Data Archives
ICPSR maintains and provides access to a vast archive of socialscience data for research and instruction. To ensure that dataresources are available to future generations of scholars, ICPSRpreserves data, migrating them to new storage media as changes intechnology warrant.
60 Minutes: pharmaceutical industry
http://www.cbsnews.com/stories/2007/03/29/60minutes/printable2625305.sht
ml
Under The Influence
NEW YORK, April 1, 2007
CBS - 60 Minutes
If you have ever wondered why the cost of prescription drugs in the
United States are the highest in the world or why it's illegal to import
cheaper drugs from Canada or Mexico, you need look no further than the
pharmaceutical lobby and its influence in Washington, D.C.
According to a new report by the Center for Public Integrity,
congressmen are outnumbered two to one by lobbyists for an industry that
spends roughly a $100 million a year in campaign contributions and
lobbying expenses to protect its profits.
One reason those profits have exceeded Wall Street expectations is the
Medicare prescription drug bill. It was passed three-and-a-half years
ago, but as 60 Minutes correspondent Steve Kroft reports, its effects
are still reverberating through the halls of Congress, providing a
window into how the lobby works.
------------------------------------------------------------------------
The unorthodox roll call on one of the most expensive bills ever placed
before the House of Representatives began in the middle of the night,
long after most people in Washington had switched off C-SPAN and gone to
sleep.
The only witnesses were congressional staffers, hundreds of lobbyists,
and U.S. Representatives like Dan Burton, R-Ind., and Walter Jones,
R-N.C.
"The pharmaceutical lobbyists wrote the bill," says Jones. "The bill was
over 1,000 pages. And it got to the members of the House that morning,
and we voted for it at about 3 a.m. in the morning."
Why did the vote finally take place at 3 a.m.?
"Well, I think a lot of the shenanigans that were going on that night,
they didn't want on national television in primetime," according to
Burton.
"I've been in politics for 22 years," says Jones, "and it was the
ugliest night I have ever seen in 22 years."
The legislation was the cornerstone of Republican's domestic agenda and
would extend limited prescription drugs coverage under Medicare to 41
million Americans, including 13 million who had never been covered
before.
At an estimated cost of just under $400 billion over 10 years, it was
the largest entitlement program in more than 40 years, and the debate
broke down along party lines.
But when it came time cast ballots, the Republican leadership discovered
that a number of key Republican congressmen had defected and joined the
Democrats, arguing that the bill was too expensive and a sellout to the
drug companies. Burton and Jones were among them.
"They're suppose to have 15 minutes to leave the voting machines open
and it was open for almost three hours," Burton explains. "The votes
were there to defeat the bill for two hours and 45 minutes and we had
leaders going around and gathering around individuals, trying to twist
their arms to get them to change their votes."
Jones says the arm-twisting was horrible.
"We had a good friend from Michigan, Nick Smith, and they threatened to
work against his son who wanted to run for his seat when he retired," he
recalls. "I saw a woman, a member of the House, a lady, crying when they
came around her, trying to get her to change her votes. It was -it was
ugly."
When the prescription drug bill finally passed shortly before dawn, in
the longest roll call in the history of the House of Representatives,
much of the credit went to former Congressman Billy Tauzin, R-La., who
steered it through the house.
"It's just a messy process," Tauzin says. "I mean, the old adage about
if you like sausage or laws, you should not watch either one of them
being made is true. It's a messy process."
Tauzin says that the voting machines were open for three hours "because
the vote wasn't finished."
As for arms being twisted? "People were being talked to," he says.
And of Walter Jones' comment that it was the "ugliest night" he had
"ever seen in politics in 22 years?"
"Well, he's a young member," counters Tauzin with a laugh. "Had he been
around for 25 years, he'd have seen some uglier nights."
It certainly wasn't ugly for the drug lobby which invested more than $10
million in campaign contributions during the last election and has been
a source of lucrative employment opportunities for congressmen when they
leave office.
Former senators Dennis Deconcini, D-Ariz., and Steve Symms, R-Idaho, and
former congressmen like Tom Downey, D-N.Y.; Vic Fazio, D-Calif.; Bill
Paxon, R-N.Y., and former House Minority Leader Robert Michel, R-Ill.,
all registered as lobbyists for the drug industry and worked on the
prescription drug bill.
"I can tell you that when the bill passed, there were better than 1,000
pharmaceutical lobbyists working on this," says Rep. John Dingell,
D-Mich.
Dingell has been in Congress for 52 years and is the new chairman of the
House Energy and Commerce Committee which shares jurisdiction over
Medicare. He says the bill would not have passed without the efforts of
the drug lobby.
"There is probably a lotta truth in it that the bill was stacked in
their benefit. And it's probably also true that it was written by their
lobbyists," he says.
Says Jones: "You couldn't even walk to the steps of the Capitol without
having somebody, maybe one or two, coming up to you to say, 'Can't you
change your vote? Can't you vote for this bill?' "
Why was the drug lobby was so interested in this bill and what did it
have to gain? Ron Pollack the executive director of Families USA, a
nonpartisan health care watchdog group, says it all boiled down to a key
provision in the legislation.
It prohibited Medicare and the federal government from using its vast
purchasing power to negotiate lower prices directly from the drug
companies.
"The key goal was to make sure there'd be no interference in the drug
companies' abilities to charge high prices and to continue to increase
those prices," says Pollack.
Pollack says there's no question that this was prompted by the
pharmaceutical lobby.
"They were the ones who wanted to make sure Medicare could charge high
prices and to continue to increase those prices," he said.
The drug industry says that competition among private insurance plans
that service the Medicare program help keep prices low. But Families USA
reported in a January study that Medicare patients are being charged
nearly 60 percent more for the top 20 drugs than veterans pay under a
program run by the U.S. Department of Veterans Affairs.
For example, Lipitor, a popular cholesterol drug, the cheapest Medicare
price is $785 for a years supply - 50 percent more than the VA's price
of $520.
For Zocor, another cholesterol drug, the best Medicare price is $1,485
for a years supply. The same drug only costs $127 a year under the VA's
plan.
------------------------------------------------------------------------
Read the full Families USA report
------------------------------------------------------------------------
Pollack says the VA successfully negotiates with the drug companies on
price.
"Medicare could do the same thing," he says, "but Medicare is prohibited
from doing that as a result of this new Medicare legislation."
"What was the logic? Or what was the idea, the rationale behind not
giving the government the ability to negotiate drug prices?" asks Kroft.
Burton says it was simply that the drug companies didn't want it.
"They wanted to make as much as money as possible. And if there's
negotiation, like there is in other countries around the world, then
they're gonna have their profit margin reduced," he says.
Before the vote, Congress was told the program would cost a whopping
$395 billion over the first 10 years. In fact, Medicare officials
already knew it was going to cost a lot more.
Burton said he and others were misled.
"Within two weeks after the bill was passed, everybody knew it was gonna
cost well over $500 billion," he says. "And many members of the Congress
[who] had voted for it said, 'I would never have voted for it had I
known that.' "
Medicare Chief Actuary Richard Foster later told Congress that he
revised the cost estimate to $534 before the vote, but was told to
withhold the new numbers if he wanted to keep his job.
During a Congressional hearing, Foster stated: "It struck me there was a
political basis for making that decision. I considered that
inappropriate and, in fact, unethical."
Foster said the person who told him to withhold Congress from getting
the revised estimates was Medicare boss Tom Scully.
Scully was the administration's lead negotiator on the prescription drug
bill, and at the time was also negotiating a job for himself with a
high-powered Washington law firm, where he became a lobbyist with the
pharmaceutical industry.
"He was negotiating for his job at the same time that the Medicare
legislation was being considered. He wound up taking this job 10 days
after the president signed this legislation," says Pollack.
It is but one example of the incestuous relationship between Congress
and the industry, and just one of the reasons the pharmaceutical lobby
almost never loses a political battle that affects its bottom line.
Former Congressman Billy Tauzin, who helped push the prescription drug
bill through the House, didn't disagree.
Has the bill been good for the drug industry?
"It's been good for the patients whom the drug industry represents ..."
Tauzin says. "In terms of profits - [for the drug companies] and
volumes, yes."
Says Kroft: "Your old friend, John Dingell, says that of the 1,500 bills
over the last 8 years dealing with pharmaceutical issues, the drug
companies almost, without exception, have gotten what they wanted."
"Yeah ... I would think he's correct. They've done fairly well," replies
Tauzin.
Why has this lobby been so successful? The former congressman says he
believes it's because they stood for the right things.
If Tauzin sounds a lot like a lobbyist for the drug industry, that's
because now he is.
Just a few months after the prescription drug bill passed, Tauzin began
discussions with the pharmaceutical industry to become its chief
lobbyist in Washington. He says it was one of several lucrative offers
he's received just before he got some very bad news.
"I got a call from a doctor in Bethesda who said, 'You got cancer. And
it's extremely rare. And it could kill ya.' And then everything
changed," Tauzin says.
Tauzin had a cancerous tumor removed from his intestines and was treated
with a new medicine, called Avastin, that had never been used before on
that form of cancer.
The treatment was successful, and as a result Tauzin says he felt he
owed his life to the drug industry. After serving out his congressional
term, he accepted a $2 million-a-year job dollar as president of PhRMA -
Pharmaceutical Research and Manufacturers of America.
"There was an extraordinary moment when my wife literally looked me in
the eye and said, 'Look, you're gonna do well wherever you go, Billy ...
You got a lot a great offers ... And maybe you oughta think about
working for the people that struggle everyday to try to invent the
medicines that save lives like yours.'
"And that was a pretty important moment in my life," Tauzin says. "And
it was the moment I decided that this was the work I wanted to do -
headaches and all."
Jones and Burton agree that the perception of Tauzin's move is not good.
"I mean, when you're pushing so hard for a bill that's controversial and
you have to keep the machine open for three hours to get the one vote
necessary to pass it, and then, within a matter of months you go to work
for the industry that's gonna benefit from it, it does cause you some
concern," says Burton.
They are not the only ones cynical about the decision.
"You push this bill through that produces a windfall for the drug
companies. And then a short time later, you go to work for the drug
lobby at a salary of $2 million. That doesn't look good," says Kroft.
"There was nothing I could've done in my life after leaving Congress
that wouldn't have had - I didn't have some impact on in 25 years in
Congress ... If that looks bad to you, have at it," Tauzin says. "That's
the truth."
In fairness to Tauzin and former Medicare chief Tom Scully, they weren't
the only public officials involved with the prescription drug bill who
later went to work for the pharmaceutical industry.
Just before the vote, Tauzin cited the people who had been most helpful
in getting it passed. Among them:
* John McManus, the staff director of the Ways and Means
subcommittee on Health. Within a few months, he left Congress and
started his own lobbying firm. Among his new clients was PhRMA, Pfizer,
Eli Lilly and Merck.
* Linda Fishman, from the majority side of the Finance Committee,
left to become a lobbyist with the drug manufacturer Amgen.
* Pat Morrisey, chief of staff of the Energy and Commerce
Committee, took a job lobbying for drug companies Novartis and
Hoffman-La Roche.
* Jeremy Allen went to Johnson and Johnson.
* Kathleen Weldon went to lobby for Biogen, a Bio-tech company.
* Jim Barnette left to lobby for Hoffman-La Roche.
In all, at least 15 congressional staffers, congressmen and federal
officials left to go to work for the pharmaceutical industry, whose
profits were increased by several billion dollars.
"I mean, they - they have unlimited resources. Unlimited," Burton says.
"And when they push real hard to get something accomplished in the
Congress of the United States, they can get it done."
In January, one of the first things the new Democratic House of
Representatives did was to make it mandatory for Medicare to negotiate
lower prices with the drug companies.
A similar measure faces stiff opposition in the Senate, where the drug
lobby is spending millions of dollars to defeat it. The president has
already announced that if the bill passes, he will veto it.
ml
Under The Influence
NEW YORK, April 1, 2007
CBS - 60 Minutes
If you have ever wondered why the cost of prescription drugs in the
United States are the highest in the world or why it's illegal to import
cheaper drugs from Canada or Mexico, you need look no further than the
pharmaceutical lobby and its influence in Washington, D.C.
According to a new report by the Center for Public Integrity,
congressmen are outnumbered two to one by lobbyists for an industry that
spends roughly a $100 million a year in campaign contributions and
lobbying expenses to protect its profits.
One reason those profits have exceeded Wall Street expectations is the
Medicare prescription drug bill. It was passed three-and-a-half years
ago, but as 60 Minutes correspondent Steve Kroft reports, its effects
are still reverberating through the halls of Congress, providing a
window into how the lobby works.
------------------------------------------------------------------------
The unorthodox roll call on one of the most expensive bills ever placed
before the House of Representatives began in the middle of the night,
long after most people in Washington had switched off C-SPAN and gone to
sleep.
The only witnesses were congressional staffers, hundreds of lobbyists,
and U.S. Representatives like Dan Burton, R-Ind., and Walter Jones,
R-N.C.
"The pharmaceutical lobbyists wrote the bill," says Jones. "The bill was
over 1,000 pages. And it got to the members of the House that morning,
and we voted for it at about 3 a.m. in the morning."
Why did the vote finally take place at 3 a.m.?
"Well, I think a lot of the shenanigans that were going on that night,
they didn't want on national television in primetime," according to
Burton.
"I've been in politics for 22 years," says Jones, "and it was the
ugliest night I have ever seen in 22 years."
The legislation was the cornerstone of Republican's domestic agenda and
would extend limited prescription drugs coverage under Medicare to 41
million Americans, including 13 million who had never been covered
before.
At an estimated cost of just under $400 billion over 10 years, it was
the largest entitlement program in more than 40 years, and the debate
broke down along party lines.
But when it came time cast ballots, the Republican leadership discovered
that a number of key Republican congressmen had defected and joined the
Democrats, arguing that the bill was too expensive and a sellout to the
drug companies. Burton and Jones were among them.
"They're suppose to have 15 minutes to leave the voting machines open
and it was open for almost three hours," Burton explains. "The votes
were there to defeat the bill for two hours and 45 minutes and we had
leaders going around and gathering around individuals, trying to twist
their arms to get them to change their votes."
Jones says the arm-twisting was horrible.
"We had a good friend from Michigan, Nick Smith, and they threatened to
work against his son who wanted to run for his seat when he retired," he
recalls. "I saw a woman, a member of the House, a lady, crying when they
came around her, trying to get her to change her votes. It was -it was
ugly."
When the prescription drug bill finally passed shortly before dawn, in
the longest roll call in the history of the House of Representatives,
much of the credit went to former Congressman Billy Tauzin, R-La., who
steered it through the house.
"It's just a messy process," Tauzin says. "I mean, the old adage about
if you like sausage or laws, you should not watch either one of them
being made is true. It's a messy process."
Tauzin says that the voting machines were open for three hours "because
the vote wasn't finished."
As for arms being twisted? "People were being talked to," he says.
And of Walter Jones' comment that it was the "ugliest night" he had
"ever seen in politics in 22 years?"
"Well, he's a young member," counters Tauzin with a laugh. "Had he been
around for 25 years, he'd have seen some uglier nights."
It certainly wasn't ugly for the drug lobby which invested more than $10
million in campaign contributions during the last election and has been
a source of lucrative employment opportunities for congressmen when they
leave office.
Former senators Dennis Deconcini, D-Ariz., and Steve Symms, R-Idaho, and
former congressmen like Tom Downey, D-N.Y.; Vic Fazio, D-Calif.; Bill
Paxon, R-N.Y., and former House Minority Leader Robert Michel, R-Ill.,
all registered as lobbyists for the drug industry and worked on the
prescription drug bill.
"I can tell you that when the bill passed, there were better than 1,000
pharmaceutical lobbyists working on this," says Rep. John Dingell,
D-Mich.
Dingell has been in Congress for 52 years and is the new chairman of the
House Energy and Commerce Committee which shares jurisdiction over
Medicare. He says the bill would not have passed without the efforts of
the drug lobby.
"There is probably a lotta truth in it that the bill was stacked in
their benefit. And it's probably also true that it was written by their
lobbyists," he says.
Says Jones: "You couldn't even walk to the steps of the Capitol without
having somebody, maybe one or two, coming up to you to say, 'Can't you
change your vote? Can't you vote for this bill?' "
Why was the drug lobby was so interested in this bill and what did it
have to gain? Ron Pollack the executive director of Families USA, a
nonpartisan health care watchdog group, says it all boiled down to a key
provision in the legislation.
It prohibited Medicare and the federal government from using its vast
purchasing power to negotiate lower prices directly from the drug
companies.
"The key goal was to make sure there'd be no interference in the drug
companies' abilities to charge high prices and to continue to increase
those prices," says Pollack.
Pollack says there's no question that this was prompted by the
pharmaceutical lobby.
"They were the ones who wanted to make sure Medicare could charge high
prices and to continue to increase those prices," he said.
The drug industry says that competition among private insurance plans
that service the Medicare program help keep prices low. But Families USA
reported in a January study that Medicare patients are being charged
nearly 60 percent more for the top 20 drugs than veterans pay under a
program run by the U.S. Department of Veterans Affairs.
For example, Lipitor, a popular cholesterol drug, the cheapest Medicare
price is $785 for a years supply - 50 percent more than the VA's price
of $520.
For Zocor, another cholesterol drug, the best Medicare price is $1,485
for a years supply. The same drug only costs $127 a year under the VA's
plan.
------------------------------------------------------------------------
Read the full Families USA report
------------------------------------------------------------------------
Pollack says the VA successfully negotiates with the drug companies on
price.
"Medicare could do the same thing," he says, "but Medicare is prohibited
from doing that as a result of this new Medicare legislation."
"What was the logic? Or what was the idea, the rationale behind not
giving the government the ability to negotiate drug prices?" asks Kroft.
Burton says it was simply that the drug companies didn't want it.
"They wanted to make as much as money as possible. And if there's
negotiation, like there is in other countries around the world, then
they're gonna have their profit margin reduced," he says.
Before the vote, Congress was told the program would cost a whopping
$395 billion over the first 10 years. In fact, Medicare officials
already knew it was going to cost a lot more.
Burton said he and others were misled.
"Within two weeks after the bill was passed, everybody knew it was gonna
cost well over $500 billion," he says. "And many members of the Congress
[who] had voted for it said, 'I would never have voted for it had I
known that.' "
Medicare Chief Actuary Richard Foster later told Congress that he
revised the cost estimate to $534 before the vote, but was told to
withhold the new numbers if he wanted to keep his job.
During a Congressional hearing, Foster stated: "It struck me there was a
political basis for making that decision. I considered that
inappropriate and, in fact, unethical."
Foster said the person who told him to withhold Congress from getting
the revised estimates was Medicare boss Tom Scully.
Scully was the administration's lead negotiator on the prescription drug
bill, and at the time was also negotiating a job for himself with a
high-powered Washington law firm, where he became a lobbyist with the
pharmaceutical industry.
"He was negotiating for his job at the same time that the Medicare
legislation was being considered. He wound up taking this job 10 days
after the president signed this legislation," says Pollack.
It is but one example of the incestuous relationship between Congress
and the industry, and just one of the reasons the pharmaceutical lobby
almost never loses a political battle that affects its bottom line.
Former Congressman Billy Tauzin, who helped push the prescription drug
bill through the House, didn't disagree.
Has the bill been good for the drug industry?
"It's been good for the patients whom the drug industry represents ..."
Tauzin says. "In terms of profits - [for the drug companies] and
volumes, yes."
Says Kroft: "Your old friend, John Dingell, says that of the 1,500 bills
over the last 8 years dealing with pharmaceutical issues, the drug
companies almost, without exception, have gotten what they wanted."
"Yeah ... I would think he's correct. They've done fairly well," replies
Tauzin.
Why has this lobby been so successful? The former congressman says he
believes it's because they stood for the right things.
If Tauzin sounds a lot like a lobbyist for the drug industry, that's
because now he is.
Just a few months after the prescription drug bill passed, Tauzin began
discussions with the pharmaceutical industry to become its chief
lobbyist in Washington. He says it was one of several lucrative offers
he's received just before he got some very bad news.
"I got a call from a doctor in Bethesda who said, 'You got cancer. And
it's extremely rare. And it could kill ya.' And then everything
changed," Tauzin says.
Tauzin had a cancerous tumor removed from his intestines and was treated
with a new medicine, called Avastin, that had never been used before on
that form of cancer.
The treatment was successful, and as a result Tauzin says he felt he
owed his life to the drug industry. After serving out his congressional
term, he accepted a $2 million-a-year job dollar as president of PhRMA -
Pharmaceutical Research and Manufacturers of America.
"There was an extraordinary moment when my wife literally looked me in
the eye and said, 'Look, you're gonna do well wherever you go, Billy ...
You got a lot a great offers ... And maybe you oughta think about
working for the people that struggle everyday to try to invent the
medicines that save lives like yours.'
"And that was a pretty important moment in my life," Tauzin says. "And
it was the moment I decided that this was the work I wanted to do -
headaches and all."
Jones and Burton agree that the perception of Tauzin's move is not good.
"I mean, when you're pushing so hard for a bill that's controversial and
you have to keep the machine open for three hours to get the one vote
necessary to pass it, and then, within a matter of months you go to work
for the industry that's gonna benefit from it, it does cause you some
concern," says Burton.
They are not the only ones cynical about the decision.
"You push this bill through that produces a windfall for the drug
companies. And then a short time later, you go to work for the drug
lobby at a salary of $2 million. That doesn't look good," says Kroft.
"There was nothing I could've done in my life after leaving Congress
that wouldn't have had - I didn't have some impact on in 25 years in
Congress ... If that looks bad to you, have at it," Tauzin says. "That's
the truth."
In fairness to Tauzin and former Medicare chief Tom Scully, they weren't
the only public officials involved with the prescription drug bill who
later went to work for the pharmaceutical industry.
Just before the vote, Tauzin cited the people who had been most helpful
in getting it passed. Among them:
* John McManus, the staff director of the Ways and Means
subcommittee on Health. Within a few months, he left Congress and
started his own lobbying firm. Among his new clients was PhRMA, Pfizer,
Eli Lilly and Merck.
* Linda Fishman, from the majority side of the Finance Committee,
left to become a lobbyist with the drug manufacturer Amgen.
* Pat Morrisey, chief of staff of the Energy and Commerce
Committee, took a job lobbying for drug companies Novartis and
Hoffman-La Roche.
* Jeremy Allen went to Johnson and Johnson.
* Kathleen Weldon went to lobby for Biogen, a Bio-tech company.
* Jim Barnette left to lobby for Hoffman-La Roche.
In all, at least 15 congressional staffers, congressmen and federal
officials left to go to work for the pharmaceutical industry, whose
profits were increased by several billion dollars.
"I mean, they - they have unlimited resources. Unlimited," Burton says.
"And when they push real hard to get something accomplished in the
Congress of the United States, they can get it done."
In January, one of the first things the new Democratic House of
Representatives did was to make it mandatory for Medicare to negotiate
lower prices with the drug companies.
A similar measure faces stiff opposition in the Senate, where the drug
lobby is spending millions of dollars to defeat it. The president has
already announced that if the bill passes, he will veto it.
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