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August 21, 2007
Scientists Drug - Test Whole Cities
By THE ASSOCIATED PRESS
Filed at 9:08 p.m. ET
WASHINGTON (AP) -- Researchers have figured out how to give an entire
community a drug test using just a teaspoon of wastewater from a city's
sewer plant.
The test wouldn't be used to finger any single person as a drug user.
But it would help federal law enforcement and other agencies track the
spread of dangerous drugs, like methamphetamines, across the country.
Oregon State University scientists tested 10 unnamed American cities for
remnants of drugs, both legal and illegal, from wastewater streams. They
were able to show that they could get a good snapshot of what people are
taking.
''It's a community urinalysis,'' said Caleb Banta-Green, a University of
Washington drug abuse researcher who was part of the Oregon State team.
The scientists presented their results Tuesday at a meeting of the
American Chemical Society in Boston.
Two federal agencies have taken samples from U.S. waterways to see if
drug testing a whole city is doable, but they haven't gotten as far as
the Oregon researchers.
One of the early results of the new study showed big differences in
methamphetamine use city to city. One urban area with a gambling
industry had meth levels more than five times higher than other cities.
Yet methamphetamine levels were virtually nonexistent in some smaller
Midwestern locales, said Jennifer Field, the lead researcher and a
professor of environmental toxicology at Oregon State.
The ingredient Americans consume and excrete the most was caffeine,
Field said.
Cities in the experiment ranged from 17,000 to 600,000 in population,
but Field declined to identify them, saying that could harm her
relationship with the sewage plant operators.
She plans to start a survey for drugs in the wastewater of at least 40
Oregon communities.
The science behind the testing is simple. Nearly every drug -- legal and
illicit -- that people take leaves the body. That waste goes into
toilets and then into wastewater treatment plants.
''Wastewater facilities are wonderful places to understand what humans
consume and excrete,'' Field said.
In the study presented Tuesday, one teaspoon of untreated sewage water
from each of the cities was tested for 15 different drugs. Field said
researchers can't calculate how many people in a town are using drugs.
She said that one fairly affluent community scored low for illicit drugs
except for cocaine. Cocaine and ecstasy tended to peak on weekends and
drop on weekdays, she said, while methamphetamine and prescription drugs
were steady throughout the week.
Field said her study suggests that a key tool currently used by drug
abuse researchers -- self-reported drug questionnaires -- underestimates
drug use.
''We have so few indicators of current use,'' said Jane Maxwell of the
Addiction Research Institute at the University of Texas, who wasn't part
of the study. ''This could be a very interesting new indicator.''
David Murray, chief scientist for U.S. Office of National Drug Control
Policy, said the idea interests his agency.
Murray said the U.S. Environmental Protection Agency is testing federal
wastewater samples just to see if that's a good method for monitoring
drug use. But he didn't know how many tests were conducted or where.
The EPA will ''flush out the details'' on testing, Benjamin Grumbles
joked. The EPA assistant administrator said the agency is already
looking at the problem of potential harm to rivers and lakes from legal
pharmaceuticals.
The idea of testing on a citywide basis for drugs makes sense, as long
as it doesn't violate people's privacy, said Tom Angell of the Students
for Sensible Drug Policy, a Washington-based group that wants looser
drug laws.
''This seems to be less offensive than individualized testing,'' he
said.
Sunday
Dutch Consider Magic Mushroom Ban-Aug. 08, 2007
Wednesday, Aug. 08, 2007
Dutch Consider Magic Mushroom Ban
http://www.time.com/time/printout/0,8816,1650873,00.html
By Joost van Egmond/Amsterdam
Time Magazine
When Amsterdam police found a disoriented French tourist in his van last
month with his slain dog beside him, he told them he had wanted to free
the animal's mind. He also said he had ingested magic mushrooms, which
contain the hallucinogen psilocybin. The incident played into a running
debate over whether the Netherlands' famously liberal drug laws are too
lax with psychedelic mushrooms. Also in July, a Danish tourist raced his
car through a campsite, and a 19-year old man from Iceland jumped out of
a window; both had taken magic mushrooms, known in Dutch as "paddos," as
had a French teenager who jumped off a bridge to her death in March.
Since then, most parties in the Dutch parliament have been calling for a
clampdown on magic mushrooms. In dried form, the fungi are already
prohibited, but fresh mushrooms can still be legally sold in the
Netherlands. The country's public health minister, Ab Klink, has so far
steered clear of banning psilocybin mushrooms altogether, in part
because his ministry considers it legally problematic to ban a product
that grows naturally. But in May he commissioned fresh research into the
risks of "paddo" use, and has said he would consider the results, due
next month, in deciding how to act.
This being the Netherlands, critics say even that measured reaction is
too precipitous. They argue that while "paddo" use may have been
involved in serious incidents, it's too easy to single out the drug as
the cause of them. Municipal heath services determined that the man who
killed his dog had a psychosis unrelated to the drug, and the Danish
racer consumed alcohol and smoked marijuana before taking his "paddo."
Amsterdam municipal heath services report that the number of
mushroom-related incidents, while rising, is still dwarfed by problems
caused by alcohol. Advocates of a ban counter that the easy availability
of magic mushrooms amounts to an invitation to further tragedies.
There is general agreement, however, that foreigners seem to have more
trouble with 'shrooms that the Dutch themselves do. In Amsterdam, some
90 percent of ambulance dispatches related to magic mushroom use this
year were for foreign visitors, especially from Britain, trailed at a
distance by Italy, the U.S. and France. "Most problems are caused by
foreigners who come here on cheap flights to take as many drugs as they
can find," says Guy Boels, chairman of VLOS, an association of Dutch
magic mushrooms retailers. "They hardly sleep, they drink alcohol and
smoke pot as much as they can and then take a paddo on top of that."
Boels says the risks of reckless behavior are quite small as long as
paddos are not mixed with alcohol or drugs. Still, VLOS supports a
proposed regulation to ban the sale of the mushrooms to minors and calls
for a registration system to identify "weekend tourists." For now, that
watchful but tolerant approach is getting the endorsement of Dutch
public heath experts. Unless the new research commissioned by the
minister arrives at new insights, the government appears more likely to
play the regulation card than to support a total ban on magic mushrooms.
Dutch Consider Magic Mushroom Ban
http://www.time.com/time/printout/0,8816,1650873,00.html
By Joost van Egmond/Amsterdam
Time Magazine
When Amsterdam police found a disoriented French tourist in his van last
month with his slain dog beside him, he told them he had wanted to free
the animal's mind. He also said he had ingested magic mushrooms, which
contain the hallucinogen psilocybin. The incident played into a running
debate over whether the Netherlands' famously liberal drug laws are too
lax with psychedelic mushrooms. Also in July, a Danish tourist raced his
car through a campsite, and a 19-year old man from Iceland jumped out of
a window; both had taken magic mushrooms, known in Dutch as "paddos," as
had a French teenager who jumped off a bridge to her death in March.
Since then, most parties in the Dutch parliament have been calling for a
clampdown on magic mushrooms. In dried form, the fungi are already
prohibited, but fresh mushrooms can still be legally sold in the
Netherlands. The country's public health minister, Ab Klink, has so far
steered clear of banning psilocybin mushrooms altogether, in part
because his ministry considers it legally problematic to ban a product
that grows naturally. But in May he commissioned fresh research into the
risks of "paddo" use, and has said he would consider the results, due
next month, in deciding how to act.
This being the Netherlands, critics say even that measured reaction is
too precipitous. They argue that while "paddo" use may have been
involved in serious incidents, it's too easy to single out the drug as
the cause of them. Municipal heath services determined that the man who
killed his dog had a psychosis unrelated to the drug, and the Danish
racer consumed alcohol and smoked marijuana before taking his "paddo."
Amsterdam municipal heath services report that the number of
mushroom-related incidents, while rising, is still dwarfed by problems
caused by alcohol. Advocates of a ban counter that the easy availability
of magic mushrooms amounts to an invitation to further tragedies.
There is general agreement, however, that foreigners seem to have more
trouble with 'shrooms that the Dutch themselves do. In Amsterdam, some
90 percent of ambulance dispatches related to magic mushroom use this
year were for foreign visitors, especially from Britain, trailed at a
distance by Italy, the U.S. and France. "Most problems are caused by
foreigners who come here on cheap flights to take as many drugs as they
can find," says Guy Boels, chairman of VLOS, an association of Dutch
magic mushrooms retailers. "They hardly sleep, they drink alcohol and
smoke pot as much as they can and then take a paddo on top of that."
Boels says the risks of reckless behavior are quite small as long as
paddos are not mixed with alcohol or drugs. Still, VLOS supports a
proposed regulation to ban the sale of the mushrooms to minors and calls
for a registration system to identify "weekend tourists." For now, that
watchful but tolerant approach is getting the endorsement of Dutch
public heath experts. Unless the new research commissioned by the
minister arrives at new insights, the government appears more likely to
play the regulation card than to support a total ban on magic mushrooms.
Human-subjects research: Trial and error
http://www.nature.com/nature/journal/v448/n7153/full/448530a.htmlNews Feature Nature 448, 530-532 (2 August 2007)
Human-subjects research: Trial and error
Heidi Ledford1
The ethics committees that oversee research done in humans have beenattacked from all sides. Heidi Ledford recounts the struggle to come upwith alternatives.Fourteen years of treating people with tuberculosis has taught physicianWilliam Burman what to expect when a patient walks through his door.Tuberculosis is not typically a disease of the well-heeled. Manypatients in the United States are foreign born. English is their secondlanguage. Fewer than half have completed a high-school education, andmany have spent time in jails or homeless shelters.So when Burman, of the University of Colorado in Denver, joined in twostudies run by the Tuberculosis Trials Consortium, he knew that theconsent forms needed to cater to people with an eighth-grade readinglevel (comprehensible to an educated 13-year-old). The trials involvedmultiple institutions, and the forms were sent to 39 institutionalreview boards (IRBs) - committees designed to determine whether aproposed experiment is ethically sound. The final approvals came in 346days later, but what the IRBs sent back, Burman found disturbing."The consent forms were longer. The language was more complex," Burmansays. "And errors were inserted at a surprising frequency." In one case,a potential negative side effect of the treatment had been accidentallyedited out. Burman responded to the problem as any researcher would: hestudied it. He had an independent panel review the changes. Thereviewers found that 85% of the changes did not affect the meaning ofthe consent forms, but that the average reading level had jumped fromthat of an eighth grader to that of a twelfth grader (around 17 yearsold)1. His results confirmed something he'd suspected for some time. "Istarted to think about what was happening and it just seemed like thesystem was flawed." It was time to change the system.Burman is not alone. In the 40 years since their birth (see 'Time forethics'), IRBs, also known as research ethics committees, have facedcriticism from all sides. They're too slow, or too hasty,overprotective, or they flout basic safety. They're bureaucratic,wasteful and unavoidable. So, what are researchers to do? The will forchange exists, says Sarah Greene, a researcher at the Group HealthCenter for Health Studies in Seattle, Washington. But recent attempts tofix the system have struggled to gain a foothold.Figure 1: Time for ethicsHigh resolution image and legend (221K)Obstacle courseIn many countries, a complex network of local ethics committees handlesthe approval of research on humans. This focus on local resources allowscommittees to account for specific laws or cultural concerns in aparticular region. But it leads to problems in multicentre trials, suchas Burman's, which are becoming more frequent. When IRBs were firstfounded, multicentre trials were almost unheard of. A 1998 report2 fromthe inspector-general of the US Department of Health and Human Servicesin Washington DC stated that a rise in the number of multicentre studieswas throwing the system into crisis. And a recent analysis3 showed thatfive of 20 trials seeking IRB approval reported significant delays as aresult of IRB negotiations. Seventeen noted inconsistencies both inIRBs' review process and in their recommendations. In one case,negotiations between 65 IRBs delayed the study by a year.More frighteningly, the cumbersome system could even endanger the healthof the studies' participants. The higher the hurdles - and the moreunfair they seem - the less inclined researchers will be to jump them."It's slow and frustrating to researchers," says Ezekiel Emanuel, chairof the US Department of Bioethics at the National Institutes of Healthin Bethesda, Maryland. Researchers have reported that they are morelikely to violate the regulations set by ethics committee if they feelthat they or their application have been mishandled4.And even though IRBs are made up mostly of volunteers, they areexpensive to run. In 2002, the median cost of running an IRB, takinginto account the time spent by IRB members, was $742,000; the maximumwas over $4 million5. So, for every protocol they assess, they charge afee to cover support staff, facilities, and outside consulting. Thesefees are typically pulled from grants as part of the institutionaloverhead, or as direct charges to commercial sponsors, and they averagejust over US$1000 (ref. 5).A proposed solution to the copious problems with IRBs is outsourcing,especially for multicentre studies, to some form of centralized review.That movement has met with resistance from those who say that localreview provides valuable local context. But Burman counters that localcontext had little bearing on the changes in his consent forms. In histrials, only 1.5% of the tweaks to the consent forms were made toaccount for local context1.Risky processBut that's not enough to rule out the importance of local review arguesDavid Wynes, vice-president for research administration at EmoryUniversity in Atlanta, Georgia. "I agree that the vast majority ofchanges are editorial, but I think there's a value in an institutionhaving a process for identifying when local context is an issue," hesays. "You might have to review a hundred protocols before you can seethe value of local context. Is it OK if only 1% of the time you putsubjects at risk?"Is it OK if only 1% of the time you put subjects at risk?David WynesBurman argues that expertise with a specific patient group or diseaseshould trump local context from detached review boards. "The local IRBsdon't know the patients I take care of, because if they did, the lastthing they would do is increase the length of the consent form and makethe language more complex," he says. Instead, Burman and his colleagueshave worked to create a designated panel at the Centers for DiseaseControl and Prevention (CDC) in Atlanta, Georgia, which keeps track ofdisease epidemiology in the United States, to review all tuberculosisstudies.Top trumpsBut a centralized system will work only if the local boards are notallowed to overrule the decision of the central board, says Emanuel.It's a lesson, he adds, that the United Kingdom has had to learn thehard way.In 1997, the United Kingdom created a system of regional review boardsin which trials needed approval from just one board to proceed. In 2000,the system was brought under the auspices of the Central Office ofResearch Ethics Committees (COREC), based in London. The trouble was,local ethics committees refused to surrender control, and instead ofexpediting review, COREC had created a new layer of bureaucracy."Researchers were very upset with the way things were going," says EmmaCave, a lecturer at the Leeds School of Law, UK. "They thought theregulations were making the United Kingdom a bad place for research." InApril, Britain dissolved COREC in favour of the new National ResearchEthics Service, and changed the regulations to restrict the ability oflocal ethics committees to change the protocol approved by the nationaloffice.In 2001, the US National Cancer Institute (NCI) in Bethesda, Maryland,launched a similar experiment - a central review board to review allNCI-funded research on humans. Local review boards retained the power todo a full review, but could opt instead for an expedited review in whichthey merely adjust for local context. (The NCI formed a similar reviewboard for paediatric studies in 2004.)The project immediately ran into trouble. The central board spent toomuch effort on scientifically reviewing proposals that had already beenreviewed by the granting arm of NCI, says Richard Schilsky, chairman ofCancer and Leukemia Group B, an NCI-sponsored cancer clinical trialsgroup. And at first, few local IRBs were willing to cede control to thecentral review board. "The concept is good," says Schilsky, "but thedevil has been in the details of the implementation."Since 2001, the number of participating institutions has climbed to 300.More than half of those have accepted the reviews of NCI's centralboard; the remainder are still developing ways to incorporate thecentral boards review into their own review process.. But Schilsky saysthat only about 20% of the institutions involved in his clinical-trialsgroup - the largest in the United States - have signed on. The resultwas similar to what happened in Britain, adding to the bureaucracy.Schilsky estimates that the system has added two to three months to thetime it takes to activate a new study.Lainie Ross, a paediatrician and member of the IRB at the University ofChicago Medical School, says that she is opposed to surrendering localcontrol. "A national IRB could fail to recognize different needs ofdifferent communities. I'm not just going to accept someone else's wordfor it."A national IRB could fail to recognize different needs of differentcommunities.Lainie RossWithout fail, IRB members interviewed by Nature who were opposed toceding control to a centralized board cited concerns about patientsafety as their main reason. But Emanuel, who has also served on an IRB,says that there's another cause for concern. "There are no good datasuggesting that there are local factors that are ethically relevant,"says Emanuel. "It's really liability that's driving this."Vulnerable populationsLiability is a thorny issue for local IRBs contemplating handing overcontrol to NCI's central IRB, says Wynes. If a participant in a clinicaltrial felt that he or she were unjustly harmed during the course of theresearch, they could not hold the NCI legally responsible because it isa branch of the federal government. That leaves the local IRB legallyvulnerable, says Clint Hermes, general council at St. Jude Children'sResearch Hospital in Memphis, Tennessee.It is rare, but IRBs and even individual IRB members have been sued inthe past. Bioethicist Arthur Caplan at the University of Pennsylvania inPhiladelphia says that he has served on two IRBs that were sued butstill thinks it's important to have a mechanism in place to holdnegligent IRBs accountable.D. PARKINSMeanwhile, a profitable industry in private, commercial IRBs has sprungup. Although commercial IRBs can provide a sense of security by assuminglegal liability, the institution doing the experiment will bear ultimateresponsibility. But partial indemnity seems sufficient to comfort manyresearchers: commercial IRBs serve hundreds of companies, hospitals andresearch institutions. In 2005, the consulting firm Deloitte namedChesapeake Research Review of Columbia, Maryland - a commercial IRB andconsulting service - as one of the fastest-growing technology companiesin North America. The firm increased its revenues by 244% in five years,to reach nearly $5.5 million in 2004.Proponents of commercial IRBs say that larger companies have goodreputations for speedy turnaround and thorough reviews. Several,including the two largest players, Chesapeake Research Review andWestern IRB in Olympia, Washington, have been officially accredited bythe Association for the Accreditation of Human Research ProtectionPrograms in Washington DC. Such societies provide a stamp of approvalfor IRBs, providing oversight and standardization to the field.Financial gainStill, others worry about the potential conflict of interest inherent tocommercial IRBs, who could benefit financially from pleasing theircustomers and passing protocols with minimal fuss. "I'm a littlecautious about this drive towards commercial IRBs," says Richard Bianco,associate vice-president for regulatory affairs at the University ofMinnesota in Minneapolis, and a 15-year IRB veteran. Nevertheless,Bianco and other critics acknowledge that local IRBs also have aconflict of interest - clinical trials can bring in serious cash andprestige to the institutions they serve, and IRB members that are alsoscientists at the institution may feel pressured to approve a trial."I'm somewhat surprised that no one has ever pushed to reform theprivate side of IRBs," says Caplan. "It's growing like crazy. Industryhires them because they're fast and efficient. It doesn't mean thatthey're right."Industry hires private IRBs because they're fast and efficient. Itdoesn't mean that they're right.Arthur CaplanBianco also says that his colleagues have been under "intense pressure"by industry collaborators to relinquish control to commercial IRBs. Sometrial sponsors, he says, even issue ultimatums: use the commercial IRBthat we recommend or don't participate in the trial. "That waspressure," says Bianco. "But I've been around a long time. You come toknow what to ignore." None of those threats ever came to fruition, hesays.ADVERTISEMENTFor others, initial scepticism of commercial IRBs has given way toacceptance. "When I first came across independent IRBs, I questionedthem, too," says Wynes. "But I've taken the time to get to know how theyoperate, and my comfort level has changed." In November 2005, whileWynes was still at the University of Iowa in Iowa City, he helped theuniversity to switch to outsourcing industry-sponsored trials to WesternIRB. Prices vary, but outsourcing to industry can cost twice as much asprocessing the application in-house, although commercial IRBs typicallyboast a quicker turnaround time. Whereas many commercial IRBs aim toreview applications within a week of their receipt, non-commercial IRBsmay meet only once a month.Some see commercial IRBs as a stop-gap measure in lieu of realregulatory change. But despite the roadblocks, substantial change isinevitable, says Emanuel. The lingering problem, he adds, is that itwill probably take a new scandal to push reform to the top of theagenda. "I think we're just one accident away, but it will still takethe accident," he says. "In my opinion, that's the sad fact."See Editorial, page 511.Top of pageReferencesBurman, W. et al. Control. Clin. Trials 24, 245-255 (2003).Office of the Inspector General, Department of Health and HumanServices. Institutional review boards: a time for reform. (US GovernmentPrinting Office, Washington, DC, 1998).Greene, S. M. & Geiger, A. M. J. Clin. Epidemiol. 59, 784-790 (2006).Keith-Spiegel, P. & Koocher, G. P. Ethics Behav. 15, 339-349 (2005).Sugarman, J. et al. N. Engl. J. Med. 352, 1825-1827 (2005).
Human-subjects research: Trial and error
Heidi Ledford1
The ethics committees that oversee research done in humans have beenattacked from all sides. Heidi Ledford recounts the struggle to come upwith alternatives.Fourteen years of treating people with tuberculosis has taught physicianWilliam Burman what to expect when a patient walks through his door.Tuberculosis is not typically a disease of the well-heeled. Manypatients in the United States are foreign born. English is their secondlanguage. Fewer than half have completed a high-school education, andmany have spent time in jails or homeless shelters.So when Burman, of the University of Colorado in Denver, joined in twostudies run by the Tuberculosis Trials Consortium, he knew that theconsent forms needed to cater to people with an eighth-grade readinglevel (comprehensible to an educated 13-year-old). The trials involvedmultiple institutions, and the forms were sent to 39 institutionalreview boards (IRBs) - committees designed to determine whether aproposed experiment is ethically sound. The final approvals came in 346days later, but what the IRBs sent back, Burman found disturbing."The consent forms were longer. The language was more complex," Burmansays. "And errors were inserted at a surprising frequency." In one case,a potential negative side effect of the treatment had been accidentallyedited out. Burman responded to the problem as any researcher would: hestudied it. He had an independent panel review the changes. Thereviewers found that 85% of the changes did not affect the meaning ofthe consent forms, but that the average reading level had jumped fromthat of an eighth grader to that of a twelfth grader (around 17 yearsold)1. His results confirmed something he'd suspected for some time. "Istarted to think about what was happening and it just seemed like thesystem was flawed." It was time to change the system.Burman is not alone. In the 40 years since their birth (see 'Time forethics'), IRBs, also known as research ethics committees, have facedcriticism from all sides. They're too slow, or too hasty,overprotective, or they flout basic safety. They're bureaucratic,wasteful and unavoidable. So, what are researchers to do? The will forchange exists, says Sarah Greene, a researcher at the Group HealthCenter for Health Studies in Seattle, Washington. But recent attempts tofix the system have struggled to gain a foothold.Figure 1: Time for ethicsHigh resolution image and legend (221K)Obstacle courseIn many countries, a complex network of local ethics committees handlesthe approval of research on humans. This focus on local resources allowscommittees to account for specific laws or cultural concerns in aparticular region. But it leads to problems in multicentre trials, suchas Burman's, which are becoming more frequent. When IRBs were firstfounded, multicentre trials were almost unheard of. A 1998 report2 fromthe inspector-general of the US Department of Health and Human Servicesin Washington DC stated that a rise in the number of multicentre studieswas throwing the system into crisis. And a recent analysis3 showed thatfive of 20 trials seeking IRB approval reported significant delays as aresult of IRB negotiations. Seventeen noted inconsistencies both inIRBs' review process and in their recommendations. In one case,negotiations between 65 IRBs delayed the study by a year.More frighteningly, the cumbersome system could even endanger the healthof the studies' participants. The higher the hurdles - and the moreunfair they seem - the less inclined researchers will be to jump them."It's slow and frustrating to researchers," says Ezekiel Emanuel, chairof the US Department of Bioethics at the National Institutes of Healthin Bethesda, Maryland. Researchers have reported that they are morelikely to violate the regulations set by ethics committee if they feelthat they or their application have been mishandled4.And even though IRBs are made up mostly of volunteers, they areexpensive to run. In 2002, the median cost of running an IRB, takinginto account the time spent by IRB members, was $742,000; the maximumwas over $4 million5. So, for every protocol they assess, they charge afee to cover support staff, facilities, and outside consulting. Thesefees are typically pulled from grants as part of the institutionaloverhead, or as direct charges to commercial sponsors, and they averagejust over US$1000 (ref. 5).A proposed solution to the copious problems with IRBs is outsourcing,especially for multicentre studies, to some form of centralized review.That movement has met with resistance from those who say that localreview provides valuable local context. But Burman counters that localcontext had little bearing on the changes in his consent forms. In histrials, only 1.5% of the tweaks to the consent forms were made toaccount for local context1.Risky processBut that's not enough to rule out the importance of local review arguesDavid Wynes, vice-president for research administration at EmoryUniversity in Atlanta, Georgia. "I agree that the vast majority ofchanges are editorial, but I think there's a value in an institutionhaving a process for identifying when local context is an issue," hesays. "You might have to review a hundred protocols before you can seethe value of local context. Is it OK if only 1% of the time you putsubjects at risk?"Is it OK if only 1% of the time you put subjects at risk?David WynesBurman argues that expertise with a specific patient group or diseaseshould trump local context from detached review boards. "The local IRBsdon't know the patients I take care of, because if they did, the lastthing they would do is increase the length of the consent form and makethe language more complex," he says. Instead, Burman and his colleagueshave worked to create a designated panel at the Centers for DiseaseControl and Prevention (CDC) in Atlanta, Georgia, which keeps track ofdisease epidemiology in the United States, to review all tuberculosisstudies.Top trumpsBut a centralized system will work only if the local boards are notallowed to overrule the decision of the central board, says Emanuel.It's a lesson, he adds, that the United Kingdom has had to learn thehard way.In 1997, the United Kingdom created a system of regional review boardsin which trials needed approval from just one board to proceed. In 2000,the system was brought under the auspices of the Central Office ofResearch Ethics Committees (COREC), based in London. The trouble was,local ethics committees refused to surrender control, and instead ofexpediting review, COREC had created a new layer of bureaucracy."Researchers were very upset with the way things were going," says EmmaCave, a lecturer at the Leeds School of Law, UK. "They thought theregulations were making the United Kingdom a bad place for research." InApril, Britain dissolved COREC in favour of the new National ResearchEthics Service, and changed the regulations to restrict the ability oflocal ethics committees to change the protocol approved by the nationaloffice.In 2001, the US National Cancer Institute (NCI) in Bethesda, Maryland,launched a similar experiment - a central review board to review allNCI-funded research on humans. Local review boards retained the power todo a full review, but could opt instead for an expedited review in whichthey merely adjust for local context. (The NCI formed a similar reviewboard for paediatric studies in 2004.)The project immediately ran into trouble. The central board spent toomuch effort on scientifically reviewing proposals that had already beenreviewed by the granting arm of NCI, says Richard Schilsky, chairman ofCancer and Leukemia Group B, an NCI-sponsored cancer clinical trialsgroup. And at first, few local IRBs were willing to cede control to thecentral review board. "The concept is good," says Schilsky, "but thedevil has been in the details of the implementation."Since 2001, the number of participating institutions has climbed to 300.More than half of those have accepted the reviews of NCI's centralboard; the remainder are still developing ways to incorporate thecentral boards review into their own review process.. But Schilsky saysthat only about 20% of the institutions involved in his clinical-trialsgroup - the largest in the United States - have signed on. The resultwas similar to what happened in Britain, adding to the bureaucracy.Schilsky estimates that the system has added two to three months to thetime it takes to activate a new study.Lainie Ross, a paediatrician and member of the IRB at the University ofChicago Medical School, says that she is opposed to surrendering localcontrol. "A national IRB could fail to recognize different needs ofdifferent communities. I'm not just going to accept someone else's wordfor it."A national IRB could fail to recognize different needs of differentcommunities.Lainie RossWithout fail, IRB members interviewed by Nature who were opposed toceding control to a centralized board cited concerns about patientsafety as their main reason. But Emanuel, who has also served on an IRB,says that there's another cause for concern. "There are no good datasuggesting that there are local factors that are ethically relevant,"says Emanuel. "It's really liability that's driving this."Vulnerable populationsLiability is a thorny issue for local IRBs contemplating handing overcontrol to NCI's central IRB, says Wynes. If a participant in a clinicaltrial felt that he or she were unjustly harmed during the course of theresearch, they could not hold the NCI legally responsible because it isa branch of the federal government. That leaves the local IRB legallyvulnerable, says Clint Hermes, general council at St. Jude Children'sResearch Hospital in Memphis, Tennessee.It is rare, but IRBs and even individual IRB members have been sued inthe past. Bioethicist Arthur Caplan at the University of Pennsylvania inPhiladelphia says that he has served on two IRBs that were sued butstill thinks it's important to have a mechanism in place to holdnegligent IRBs accountable.D. PARKINSMeanwhile, a profitable industry in private, commercial IRBs has sprungup. Although commercial IRBs can provide a sense of security by assuminglegal liability, the institution doing the experiment will bear ultimateresponsibility. But partial indemnity seems sufficient to comfort manyresearchers: commercial IRBs serve hundreds of companies, hospitals andresearch institutions. In 2005, the consulting firm Deloitte namedChesapeake Research Review of Columbia, Maryland - a commercial IRB andconsulting service - as one of the fastest-growing technology companiesin North America. The firm increased its revenues by 244% in five years,to reach nearly $5.5 million in 2004.Proponents of commercial IRBs say that larger companies have goodreputations for speedy turnaround and thorough reviews. Several,including the two largest players, Chesapeake Research Review andWestern IRB in Olympia, Washington, have been officially accredited bythe Association for the Accreditation of Human Research ProtectionPrograms in Washington DC. Such societies provide a stamp of approvalfor IRBs, providing oversight and standardization to the field.Financial gainStill, others worry about the potential conflict of interest inherent tocommercial IRBs, who could benefit financially from pleasing theircustomers and passing protocols with minimal fuss. "I'm a littlecautious about this drive towards commercial IRBs," says Richard Bianco,associate vice-president for regulatory affairs at the University ofMinnesota in Minneapolis, and a 15-year IRB veteran. Nevertheless,Bianco and other critics acknowledge that local IRBs also have aconflict of interest - clinical trials can bring in serious cash andprestige to the institutions they serve, and IRB members that are alsoscientists at the institution may feel pressured to approve a trial."I'm somewhat surprised that no one has ever pushed to reform theprivate side of IRBs," says Caplan. "It's growing like crazy. Industryhires them because they're fast and efficient. It doesn't mean thatthey're right."Industry hires private IRBs because they're fast and efficient. Itdoesn't mean that they're right.Arthur CaplanBianco also says that his colleagues have been under "intense pressure"by industry collaborators to relinquish control to commercial IRBs. Sometrial sponsors, he says, even issue ultimatums: use the commercial IRBthat we recommend or don't participate in the trial. "That waspressure," says Bianco. "But I've been around a long time. You come toknow what to ignore." None of those threats ever came to fruition, hesays.ADVERTISEMENTFor others, initial scepticism of commercial IRBs has given way toacceptance. "When I first came across independent IRBs, I questionedthem, too," says Wynes. "But I've taken the time to get to know how theyoperate, and my comfort level has changed." In November 2005, whileWynes was still at the University of Iowa in Iowa City, he helped theuniversity to switch to outsourcing industry-sponsored trials to WesternIRB. Prices vary, but outsourcing to industry can cost twice as much asprocessing the application in-house, although commercial IRBs typicallyboast a quicker turnaround time. Whereas many commercial IRBs aim toreview applications within a week of their receipt, non-commercial IRBsmay meet only once a month.Some see commercial IRBs as a stop-gap measure in lieu of realregulatory change. But despite the roadblocks, substantial change isinevitable, says Emanuel. The lingering problem, he adds, is that itwill probably take a new scandal to push reform to the top of theagenda. "I think we're just one accident away, but it will still takethe accident," he says. "In my opinion, that's the sad fact."See Editorial, page 511.Top of pageReferencesBurman, W. et al. Control. Clin. Trials 24, 245-255 (2003).Office of the Inspector General, Department of Health and HumanServices. Institutional review boards: a time for reform. (US GovernmentPrinting Office, Washington, DC, 1998).Greene, S. M. & Geiger, A. M. J. Clin. Epidemiol. 59, 784-790 (2006).Keith-Spiegel, P. & Koocher, G. P. Ethics Behav. 15, 339-349 (2005).Sugarman, J. et al. N. Engl. J. Med. 352, 1825-1827 (2005).
Heed the warning on the vial: "Do not snort Blow."
Remember that "Cocaine" energy drink that got pulled from the market?Now there's "Blow".Website and news story follow below.-------
http://www.iloveblow.com/-------
http://www.philly.com/philly/health_and_science/20070709_Its_Blow__an_energy_drink_.html
Blow is a white energy powder, with plenty of caffeine, and is designed to mix in drinks, particularly alcoholic.Erika GebelPhiladelphia InquirerIt's a white powder, it'll keep you wired all night, and it's called Blow.But it's not cocaine. It's a crystalline energy drink, a sweet mix like Kool-Aid, aimed at the bar scene."Our product is not designed to be an illicit-drug alternative," says Logan Gola, the brains behind Blow. Still, it arrived at The Inquirer in a faux dusty box. Inside were vials of Blow, a toy credit card, and a mirror. (But no dollar bill.)The new mix is being peddled to a market that is hooked: Energy-drink sales increased by 50 percent between 2005 and 2006, according to the Beverage Marketing Corp.Blow, like most energy drinks, includes a cavalcade of impressive-sounding ingredients - taurine, B vitamins, inositol, L-carnitine - but the tried-and-true upper is the ever-present caffeine. Perhaps too much."There have been alarming rates of all these health problems associated with high caffeine," said Lisa Hark, director of the Nutrition Education and Prevention Program at the University of Pennsylvania. To find out how much is too much, go to www.energyfiend.com's death-by-caffeine calculator.Then there's the booze issue. Red Bull, the flagship energy drink, is often mixed with vodka or taken with a shot of the liqueur Jägermeister, the widely guzzled "Jäger Bomb." In the April 2006 issue of Alcoholism: Clinical & Experimental Research, researchers reported that drinking Red Bull made subjects feel less drunk, but not act less drunk.The impact of a drink mix like Blow forges new territory. It cuts out the liquid middleman and can be dissolved directly into any cocktail. "It's being sold in liquor stores," said Lauren Seal, Blow promoter. "People have put it in anything: shots, vodka-based cocktails, gin."But heed the warning on the vial: "Do not snort Blow."
Thursday
Monday
LA TIMES: This is your brain on love - When you're attracted to someone, is your gray matter talking sense -- or just hooked?
This is your brain on loveWhen you're attracted to someone, is your gray matter talking sense -- or just hooked? Scientists take a rational look.
By Susan BrinkLos Angeles Times Staff Writer
July 30, 2007Her front brain is telling her he's trouble. Look at the facts, it says. He's never made a commitment, he drinks too much, he can't hold down a job.But her middle brain won't listen. Man, it swoons, he looks great in those jeans, his black hair curls onto his forehead so adorably, and when he drags on a cigarette, he's so bad he's good.His front brain is lecturing, too: She's flirting with every guy in the place, and she can drink even you under the table, it says. His mid-brain is unresponsive, distracted by her legs, her blouse and her come-hither stare."What could you be thinking?" their front brains demand.Their middle brains, each on a quest for reward, pay no heed.Alas, when it comes to choosing mates, smart neurons can make dumb choices. Sure, if the brain's owner is in her 40s and has been around the block a few times, she might grab her bag and scram. If the guy has reached seasoned middle age, he might think twice about that cleavage-baring temptress. Wisdom -- at least a little -- does come with experience.But if the objects of desire are in their 20s, all bets are off. A lot will depend on the influence of Mom and Dad's marriage, the gossip and urgings of friends, and whether life experience has convinced these two brains that what they're looking at is attractive. She just might sidle over to Mr. Wrong and bat her eyes. And he could well give in to temptation.And so the dance of attraction, infatuation and ultimately love begins.It's a dance that holds many mysteries, to psychologists as well as to the willing participants. Science is just beginning to parse the inner workings of the brain in love, examining the blissful or ruinous fall from a medley of perspectives: neural systems, chemical messengers and the biology of reward.It was only in 2000 that two London scientists selected 70 people, all in the early sizzle of love, and rolled them into the giant cylinder of a functional magnetic resonance imaging scanner, or fMRI. The images they got are thought to be science's first pictures of the brain in love.The pictures were a revelation, and others have followed, showing that romantic love is a lot like addiction to alcohol or drugs. The brain is playing a trick, necessary for evolution, by associating something that just happened with pleasure and attributing the feeling to that magnificent specimen right before your eyes.All animals mate: The most primitive system in the brain, one that even reptiles have, knows it needs to reproduce. Turtles do it but then lay their eggs in the sand and head back to sea, never seeing their mate again.Human brains are considerably more complicated, with additional neural systems that seek romance, others that want comfort and companionship, and others that are just out for a roll in the hay.Yet the chemistry between two people isn't just a matter of molecules careening around the brain, dictating feelings like some game of neuro-billiards. Attraction also involves personal history. "Our parents have an effect on us," says Helen Fisher, evolutionary anthropologist at Rutgers University who studies human attraction. "So does the school system, television, timing, mystery."Every book ever read, and every movie ever wept through, starts charting a course toward the chosen one.The love dance"Love," that one small word, stands for a hodgepodge of feelings and drives: lust, romance, passion, attachment, commitment and contentment. Studying this brew is made harder because the pathways aren't totally distinct. Lust and romance, for example, have some overlapping biology, even though they are not the same thing.Similarly, the dance that leads, if we're lucky, to a stable commitment moves through several key steps.First comes initial attraction, the spark. If someone's going to pick one person out of the billions of opposite-sex humans out there, it's this step that starts things rolling.Next comes the wild, dizzying infatuation of romance -- a unique magic between two people who can't stop thinking about each other. The brain uses its chemical arsenal to focus our attention on one person, forsaking all others."Everyone knows what that feels like. This is one of the great mysteries. It's the love potion No. 9, the click factor, interpersonal chemistry," says Gian Gonzaga, senior research scientist at eHarmony Labs.The passion lasts at least for a few months, two to four years tops, says relationship researcher Arthur Aron, psychologist at the State University of New York at Stony Brook.As it fades, something more stable takes over: the steady pair-bonding of what's called companionate love. It's a heartier variety, characterized by tenderness, affection and stability over the long haul. Far less is known about the brains of people celebrating their silver anniversaries or more, but researchers are beginning to recruit such couples to find out.When Kelly and Robert Iblings of Calabasas had their first face-to-face meeting after a month of corresponding online, all signs of a spark were there. Kelly, 30, recalls thinking "Wow!" Robert, 33, thought Kelly was beautiful. "I love his height," Kelly says of Robert's 6-foot-4 frame. "And those eyes. He's quite handsome. I mean, look at him. He's cute. He's hot.""She's very cute," Robert says. "And I like the way she laughs."Their brains' signals were in sync, and it was good.It probably didn't hurt that they were a little bit nervous about meeting each other.For years, scientists have known that attraction is more likely to happen when people are aroused, be it through laughter, anxiety or fear. Aron tested that theory in 1974 on the gorgeous but spine-chilling heights of the Capilano Canyon Suspension Bridge in Vancouver, British Columbia -- a 5-foot wide, 450-foot, wobbly, swaying length of wooden slats and wire cable suspended 230 feet above rocks and shallow rapids.His research team waited as unsuspecting men, between ages 18 and 35 and unaccompanied by women, crossed over. About halfway across the bridge, each man ran into an attractive young woman claiming to be doing research on beautiful places. She asked him a few questions and gave him her phone number in case he had follow-up questions.The experiment was repeated upriver on a bridge that was wide and sturdy and only 10 feet above a small rivulet. The same attractive coed met the men, brandishing the same questionnaire.The result? Men crossing the scary bridge rated the woman on the Capilano bridge more attractive. And about half the men who met her called her afterward. Only two of 16 men on the stable bridge called.Fear got their attention and aroused emotional centers in the brain. "People are more likely to feel aroused in a scary setting," Aron says. "It's pretty simple. You're feeling physiologically aroused, and it's ambiguous why. Then you see an attractive person, and you think, 'Oh, that's why.' "In a laboratory, Aron tested his arousal theory further by having people run in place for 10 minutes, and compared them with people who didn't run. Those who had exercised were more attracted to good-looking people in photographs than those who had been sedentary.Any kind of physiological arousal would probably do the trick, Aron concludes from his studies. Couples who ride roller coasters, laugh at a really funny comedian or escape a burning building together get an emotional jolt and could attribute the feeling to the attractiveness of the other.The forces of attraction are in many ways mysterious, but scientists know certain things. Studies have shown that women prefer men with symmetrical faces and that men like a certain waist-to-hip ratio in their mates. One study even found that women, when they sniffed men's T-shirts, were attracted to certain kinds of body odors.That initial spark can flash and fade. Or it can become a flame and then a fire, a rush of exhilaration, yearning, hunger and sense of complete union that scientists know as passionate love.Key to this state of seeing a person as a soul mate instead of a one-night stand is the limbic system, nestled deep within the brain between the neocortex (the region responsible for reason and intellect) and the reptilian brain (responsible for primitive instincts). Altered levels of dopamine, norepinephrine and serotonin -- neurotransmitters also associated with arousal -- wield their influence.But passionate love is something far stronger than that first sizzle of chemistry. "It's a drive to win life's greatest prize, the right mating partner," Fisher says. It is also, she adds, an addiction.People in the early throes of passionate love, she says, can think of little else. They describe sleeplessness, loss of appetite, feelings of euphoria, and they're willing to take exceptional risks for the loved one.Brain areas governing reward, craving, obsession, recklessness and habit all play their part in the trickery.In an experiment published as a chapter in a 2006 book, "Evolutionary Cognitive Neuroscience," Fisher found 17 people who were in relationships for an average of seven months. She knew they were in love from their answers to what researchers call the Passionate Love Scale. They all said they'd feel deep despair if their lover left, and they yearned to know all there was to know about the loved one.She put these lovesick, enraptured people in an fMRI to see what areas of their brains got active when they saw a photograph of their beloved ones."We found some remarkable things," she said. "We saw activity in the ventral tegmental area and other regions of the brain's reward system associated with motivation, elation and focused attention." It's the same part of the brain that presumably is active when a smoker reaches for a cigarette or when gamblers think they're going to win the lottery. No wonder it's as hard to say no to the feeling of romantic arousal as it would be to say no to a windfall in the millions. The brain has seen what it wants, and it's going to get it."At that point, you really wouldn't notice if he had three heads," Fisher says. "Or you'd notice, but you'd choose to overlook it."Other studies also suggest that the brain in the first throes of love is much like a brain on drugs.Lucy Brown, professor of neuroscience at the Albert Einstein College of Medicine, has also taken fMRI images of people in the early days of a new love. In a study reported in the July 2005, Journal of Neurophysiology, she too found key activity in the ventral tegmental area. "That's the area that's also active when a cocaine addict gets an IV injection of cocaine," Brown says. "It's not a craving. It's a high."You see someone, you click, and you're euphoric. And in response, your ventral tegmental area uses chemical messengers such as dopamine, serotonin and oxytocin to send signals racing to a part of the brain called the nucleus accumbens with the good news, telling it to start craving."The other person becomes a goal in your life," Brown says. He or she becomes a goal you might die without and would pack up and move across the country for. That one person begins to stand out as the one and only.Biologically, the cravings and pleasure unleashed are as strong as any drug. Surely such a goal is worth taking risks for, and other alterations in the brain help ensure that the lovelorn will do just that. Certain regions, scientists have found, are being deactivated, such as within the amygdala, associated with fear. "That's why you can do such insane things when you're in love," Fisher says. "You would never otherwise dream of driving across the country in 13 hours, but for love, you would."Sooner or later, excited brain messages reach the caudate nucleus, a dopamine-rich area where unconscious habits and skills, such as the ability to ride a bike, are stored.The attraction signal turns the love object into a habit, and then an obsession. According to a 1999 study in the journal Psychological Medicine, people newly in love have serotonin levels 40% lower than normal people do -- just like people with obsessive-compulsive disorders.Experiments in other mammals add to the human chemical findings. Female prairie voles, for example, develop a distinct preference for a specific male after mating, and the preference is associated with a 50% increase in dopamine in the nucleus accumbens.But when the monogamous vole is injected with a dopamine antagonist, blocking the activity of the chemical, she'll readily dump her partner for another.Using their headsKelly and Robert Iblings, now married for nine months, are fascinated by all this talk of nucleus accumbens, addiction and primitive mating instincts. Sure, they admit, they found each other attractive. But they were also making use of their front brains' sharp thinking skills. They were remembering painful past lessons and looking for signs of compatibility.They had each survived an earlier, failed engagement, and they knew what they were looking for this time around. They were listening to their front brains as they told them to look for compatibility, stability, shared values and commitment.From their first e-mail exchanges through eHarmony, an Internet dating service, the Iblings each felt they had found a unique mate. She liked to travel. So did he. They both love books and learning, have similar religious beliefs and come from loving, intact families. She no sooner sent an e-mail telling him about an exhibit she saw on a business trip to New York than he sent a message back telling her he knew of the exhibit because he had bought a book on it the day before.Coincidence, or soul mate?The front brain certainly gets involved as it ponders all of life's experiences and past mistakes, researchers say -- but not just the front brain. The nucleus accumbens, virtual swamp of dopamine that it is, is also holder of memories. Its quest for reward is influenced by childhood experiences, friends, previous failed engagements or the jerk who cheated on you. The sum of those experiences make some people attracted to a prince or a frog, a princess or a shrew.And, as it happens, practical matters such as whether a couple both like piña coladas and getting caught in the rain do matter in igniting passionate love.A research project headed by eHarmony Labs' Gonzaga interviewed 1,200 dating and newlywed couples. The results, reported in the July issue of the Journal of Personality and Social Psychology, found that those who reported similar interests and feelings were more satisfied. "Those who reported chemistry said they felt at ease, relaxed, connected. They knew they had some things in common," he says. "Chemistry is more than just being hot or handsome."Clearly, in the matters of love, the stars were aligned for the Iblings. When they met, they were ready for each other. But they were also attracted to each other. The chemistry was there. Most relationship researchers think it has to be.They had what it took to kick-start the relationship with an undeniable urgency, allowing two people to give up the candy store of other choices and commit to each other.Odds are that in two to four years, this urgency will fade -- and the couple will, if all goes well, settle in for the long haul with companionate love. Such peoples' lives are entwined, as are their property and bank accounts, and they begin to answer questionnaires differently. The rush and the urgency is gone, but they feel committed, emotionally close and stable.It is the state that many desire, yet it is the least studied. There's a reason for that. Most studies of couples are of college students and young newlyweds.Brown, however, has recently recruited volunteers for a study of people 40 to 65 who have been together for many years. She'll put them in fMRIs to see where love resides after the urgency fades. "It's unknown, the extent to which these original brain motivations are still active," she says. "Or whether companionate love has turned more cortical, more conscious thinking, more evaluative." Her first volunteers had their brains scanned this month.The free fall of love's first rush can happen at any age, whether people are 20 or 70, says Elaine Hatfield, psychology professor at the University of Hawaii and relationship researcher.What differs is that the older people get, the more memories they harbor of joy and trust, rejection and disappointment. And as people learn from experience, the front brain, with its logic and reason, probably gets a greater say."When you are young, passion and hope are so strong that's it's almost impossible to stop loving someone," Hatfield says. "After you've been kicked around by life, however, you start to have a dual response to handsome con men: 'Wow!' and 'Arrrrrrgh!'"It takes not will power but painful experience to make us wise."Somehow, it all comes together, for better or for worse, the sum total of what's found in the mating dance of the ancient reptilian brain, the passion of the limbic brain and the logic of the neocortex.Oh, what a ride
Wednesday
Searchable database of practice shown to be effective in preventing substance abuse or antecedents (http://casat.unr.edu/bestpractices/search.php)
This searchable database includes practices that have been shown to be effective in preventing substance abuse and/or the risk factors for substance abuse. Information is provided regarding training, technical assistance and/or materials that facilitate replication of each practice.
Use the check boxes to indicate on which variable(s) you would like to conduct a search of evidence based drug prevention interventions. When you click the button near the bottom of the page ("Find Matching Practices"), an 'OR' search will be completed. Select as many attributes that interest you. The results will be ranked based on how many programs have matching attributes to the criteria you specify.
Other useful SAMHSA prevention sites:
http://captus.samhsa.gov/
http://prevtech.samhsa.gov/
Use the check boxes to indicate on which variable(s) you would like to conduct a search of evidence based drug prevention interventions. When you click the button near the bottom of the page ("Find Matching Practices"), an 'OR' search will be completed. Select as many attributes that interest you. The results will be ranked based on how many programs have matching attributes to the criteria you specify.
Other useful SAMHSA prevention sites:
http://captus.samhsa.gov/
http://prevtech.samhsa.gov/
Tuesday
"Stoners in the Mist"
"Stoners in the Mist" is a new ONDCP website: http://www.abovetheinfluence.com/stoners/#
New from Join Together (http://www.jointogether.org)
House Committee Approves Addiction/Mental Health Parity Bill In a historic move, the House Education and Labor Committee voted 33-9 to approve a strong mental-health and addiction parity bill, setting the stage for a possible House floor vote on the measure this fall.
U.S. Mayors Declare Drug War a Failure The mayors of America's cities have unanimously approved a resolution stating that the drug war 'has failed' and calling for a harm-reduction oriented approach to drug policy that focuses on public health. The U.S. Conference of Mayors adopted the resolution during its June 21-26 annual meeting in Los Angeles, calling for a "new bottom line" in drug policy that "concentrates more fully on reducing the negative consequences associated with drug abuse, while ensuring that our policies do not exacerbate these problems or create new social problems of their own; establishes quantifiable, short- and long-term objectives for drug policy; saves taxpayers money; and holds state and federal agencies responsible."
Wednesday
Wonder Drug Inspires Deep, Unwavering Love Of Pharmaceutical Companies
http://www.theonion.com/content/node/46032
Wonder Drug Inspires Deep, Unwavering Love Of Pharmaceutical Companies
March 6, 2006 | Issue 42.10
NEW YORK-The Food and Drug Administration today approved the sale of the
drug PharmAmorin, a prescription tablet developed by Pfizer to treat
chronic
distrust of large prescription-drug manufacturers.
Pfizer executives characterized the FDA's approval as a "godsend" for
sufferers of independent-thinking-related mental-health disorders.
Enlarge Image
PharmAmorin, now relieving distrust of large pharmaceutical
conglomerates in
pharmacies nationwide.
"Many individuals today lack the deep, abiding affection for drug makers
that is found in healthy people, such as myself," Pfizer CEO Hank
McKinnell
said. "These tragic disorders are reaching epidemic levels, and as a
company
dedicated to promoting the health, well-being, and long life of our
company's public image, it was imperative that we did something to
combat
them."
Although many psychotropic drugs impart a generalized feeling of
well-being,
PharmAmorin is the first to induce and focus intense feelings of
affection
externally, toward for-profit drug makers. Pfizer representatives say
that,
if taken regularly, PharmAmorin can increase affection for and trust in
its
developers by as much as 96.5 percent.
"Out of a test group of 180, 172 study participants reported a dramatic
rise
in their passion for pharmaceutical companies," said Pfizer director of
clinical research Suzanne Frost. "And 167 asked their doctors about a
variety of prescription medications they had seen on TV."
Frost said a small percentage of test subjects showed an interest in
becoming lobbyists for one of the top five pharmaceutical companies, and
several browsed eBay for drug-company apparel.
PharmAmorin, available in 100-, 200-, and 400-mg tablets, is classified
as a
critical-thinking inhibitor, a family of drugs that holds great promise
for
the estimated 20 million Americans who suffer from Free-Thinking
Disorder.
Pfizer will also promote PharmAmorin in an aggressive, $34.6 million
print
and televised ad campaign.
One TV ad, set to debut during next Sunday's 60 Minutes telecast, shows
a
woman relaxing in her living room and reading a newspaper headlined
"Newest
Drug Company Scandal Undermines Public Trust." The camera zooms into the
tangled neural matter of her brain, revealing a sticky black substance
and a
purplish gas.
The narrator says, "She may show no symptoms, but in her brain,
irrational
fear and dislike of global pharmaceutical manufacturers is overwhelming
her
very peace of mind."
After a brief summary of PharmAmorin's benefits, the commercial
concludes
with the woman flying a kite across a sunny green meadow, the Pfizer
headquarters gleaming in the background.
PharmAmorin is the first drug of its kind, but Pfizer will soon face
competition from rival pharmaceutical giant Bristol-Myers Squibb. The
company is developing its own pro-pharmaceutical-company medication,
Brismysquibicin, which will induce warm feelings not just for drug
corporations in general, but solely for Bristol-Myers Squibb.
"A PharmAmorin user could find himself gravitating toward the products
of a
GlaxoSmithKline or Eli Lilly," BMS spokesman Andrew Fike said. "This
could
seriously impede the patient's prescription-drug-market acceptance, or
worse, Pfizer's profits in the long run."
"Brismysquibicin will be cheaper to produce and therefore far more
affordable to those on fixed incomes," Fike added.
The news of an affordable skepticism-inhibitor was welcomed by New York
physician Christine Blake-Mann, who runs a free clinic in Spanish
Harlem.
"A lot of my patients are very leery of the medical establishment,"
Blake-Mann said. "This will help them feel better about it, and save
money
at the same time."
PharmAmorin's side effects include nausea, upset stomach, and ignoring
the
side effects of prescription drug medication.
Wonder Drug Inspires Deep, Unwavering Love Of Pharmaceutical Companies
March 6, 2006 | Issue 42.10
NEW YORK-The Food and Drug Administration today approved the sale of the
drug PharmAmorin, a prescription tablet developed by Pfizer to treat
chronic
distrust of large prescription-drug manufacturers.
Pfizer executives characterized the FDA's approval as a "godsend" for
sufferers of independent-thinking-related mental-health disorders.
Enlarge Image
PharmAmorin, now relieving distrust of large pharmaceutical
conglomerates in
pharmacies nationwide.
"Many individuals today lack the deep, abiding affection for drug makers
that is found in healthy people, such as myself," Pfizer CEO Hank
McKinnell
said. "These tragic disorders are reaching epidemic levels, and as a
company
dedicated to promoting the health, well-being, and long life of our
company's public image, it was imperative that we did something to
combat
them."
Although many psychotropic drugs impart a generalized feeling of
well-being,
PharmAmorin is the first to induce and focus intense feelings of
affection
externally, toward for-profit drug makers. Pfizer representatives say
that,
if taken regularly, PharmAmorin can increase affection for and trust in
its
developers by as much as 96.5 percent.
"Out of a test group of 180, 172 study participants reported a dramatic
rise
in their passion for pharmaceutical companies," said Pfizer director of
clinical research Suzanne Frost. "And 167 asked their doctors about a
variety of prescription medications they had seen on TV."
Frost said a small percentage of test subjects showed an interest in
becoming lobbyists for one of the top five pharmaceutical companies, and
several browsed eBay for drug-company apparel.
PharmAmorin, available in 100-, 200-, and 400-mg tablets, is classified
as a
critical-thinking inhibitor, a family of drugs that holds great promise
for
the estimated 20 million Americans who suffer from Free-Thinking
Disorder.
Pfizer will also promote PharmAmorin in an aggressive, $34.6 million
and televised ad campaign.
One TV ad, set to debut during next Sunday's 60 Minutes telecast, shows
a
woman relaxing in her living room and reading a newspaper headlined
"Newest
Drug Company Scandal Undermines Public Trust." The camera zooms into the
tangled neural matter of her brain, revealing a sticky black substance
and a
purplish gas.
The narrator says, "She may show no symptoms, but in her brain,
irrational
fear and dislike of global pharmaceutical manufacturers is overwhelming
her
very peace of mind."
After a brief summary of PharmAmorin's benefits, the commercial
concludes
with the woman flying a kite across a sunny green meadow, the Pfizer
headquarters gleaming in the background.
PharmAmorin is the first drug of its kind, but Pfizer will soon face
competition from rival pharmaceutical giant Bristol-Myers Squibb. The
company is developing its own pro-pharmaceutical-company medication,
Brismysquibicin, which will induce warm feelings not just for drug
corporations in general, but solely for Bristol-Myers Squibb.
"A PharmAmorin user could find himself gravitating toward the products
of a
GlaxoSmithKline or Eli Lilly," BMS spokesman Andrew Fike said. "This
could
seriously impede the patient's prescription-drug-market acceptance, or
worse, Pfizer's profits in the long run."
"Brismysquibicin will be cheaper to produce and therefore far more
affordable to those on fixed incomes," Fike added.
The news of an affordable skepticism-inhibitor was welcomed by New York
physician Christine Blake-Mann, who runs a free clinic in Spanish
Harlem.
"A lot of my patients are very leery of the medical establishment,"
Blake-Mann said. "This will help them feel better about it, and save
money
at the same time."
PharmAmorin's side effects include nausea, upset stomach, and ignoring
the
side effects of prescription drug medication.
Tuesday
Slides from Session 2
Several students have asked: "I was wondering if you could post the powerpoint slides for session 2 of Public Health 209.27 so I can study them for the quiz on Thursday?"
The answer is that they're in the same pdf handout file with the slides from the first session. I won't be finished w/them until this week:
OVERVIEW OF SUBSTANCE ABUSE IN PUBLIC HEALTH
The answer is that they're in the same pdf handout file with the slides from the first session. I won't be finished w/them until this week:
OVERVIEW OF SUBSTANCE ABUSE IN PUBLIC HEALTH
Friday
GW Substance Abuse Class, So Far
Things seem to be going well so far, in this year's GW course on substance abuse. There was some confusion on my part about the location of the course: When the room assignment was changed, I updated the website but forgot to update my syllabus printout. Then when I printed out the syllabus to bring to class for the students, it had the wrong room and thst's where I went.
This is my first foray into the interactive world of blogging; so I hope that some of this year's students do give me some comments or responses here. I'm very interested in whether the blog can be used to fscilitate an electronic class discussion between class sessions.
This is my first foray into the interactive world of blogging; so I hope that some of this year's students do give me some comments or responses here. I'm very interested in whether the blog can be used to fscilitate an electronic class discussion between class sessions.
Thursday
DSM-V Research Agenda: Substance Abuse/Psychosis Comorbidity
DSM-V Research Agenda: Substance Abuse/Psychosis Comorbidity
http://schizophreniabulletin.oxfordjournals.org/cgi/content/abstract/33/4/947
Bruce J. Rounsaville1,2 2 VA CT Healthcare System, 950 Campbell Avenue (151D), West Haven, CT 06516
For diagnosis of patients with comorbid psychotic symptoms and substance use disorders (SUDs), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, makes clear distinctions between independent psychotic disorders (eg, bipolar disorder, schizophrenia) and substance-induced syndromes (eg, delirium, dementias). Most substance-induced psychotic symptoms are considered to be short lived and to resolve with sustained abstinence along with other symptoms of substance intoxication and withdrawal. These guidelines are challenged by practical difficulties in distinguishing between substance-induced and independent psychoses and by mounting evidence that marijuana use may be a contributing cause of schizophrenia. To inform the diagnostic distinction between substance-induced vs independent psychotic symptoms, 2 kinds of information could be sought from longitudinal research: (a) identification of early markers that clearly differentiate the 2 conditions and (b) more precise information about duration of psychotic symptoms induced by different substances. Evidence of this type could emerge from reanalysis of existing data from large-scale longitudinal studies of community samples. To inform possible nosological changes related to the possible schizophrenia-inducing role of marijuana (eg, designating a "cannabis-induced" subtype), a wide range of research evidence will be needed to clarify the relationship between effects of cannabis and schizophrenia symptoms. Ultimately, the ideal psychiatric nomenclature will define syndromes on the basis of established etiology and/or pathophysiology. Given the strong association between SUDs and psychotic disorders, research on the neurobiology of psychotic disorders could fruitfully include subjects with comorbid SUDs to shed light on shared etiology and pathophysiology.
Schizophrenia Bulletin 2007 33(4):947-952; doi:10.1093/schbul/sbm054;
Schizophrenia Bulletin Advance Access originally published online on June 7, 2007
1 To whom correspondence should be addressed; tel: 203-937-3486, fax: 203-937-3869, e-mail: bruce.rounsavill@yale.edu
Keywords: DSM-V / psychosis / substance use disorders / psychiatric diagnosis / psychiatric epidemiology / alcohol
http://schizophreniabulletin.oxfordjournals.org/cgi/content/abstract/33/4/947
Bruce J. Rounsaville1,2 2 VA CT Healthcare System, 950 Campbell Avenue (151D), West Haven, CT 06516
For diagnosis of patients with comorbid psychotic symptoms and substance use disorders (SUDs), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, makes clear distinctions between independent psychotic disorders (eg, bipolar disorder, schizophrenia) and substance-induced syndromes (eg, delirium, dementias). Most substance-induced psychotic symptoms are considered to be short lived and to resolve with sustained abstinence along with other symptoms of substance intoxication and withdrawal. These guidelines are challenged by practical difficulties in distinguishing between substance-induced and independent psychoses and by mounting evidence that marijuana use may be a contributing cause of schizophrenia. To inform the diagnostic distinction between substance-induced vs independent psychotic symptoms, 2 kinds of information could be sought from longitudinal research: (a) identification of early markers that clearly differentiate the 2 conditions and (b) more precise information about duration of psychotic symptoms induced by different substances. Evidence of this type could emerge from reanalysis of existing data from large-scale longitudinal studies of community samples. To inform possible nosological changes related to the possible schizophrenia-inducing role of marijuana (eg, designating a "cannabis-induced" subtype), a wide range of research evidence will be needed to clarify the relationship between effects of cannabis and schizophrenia symptoms. Ultimately, the ideal psychiatric nomenclature will define syndromes on the basis of established etiology and/or pathophysiology. Given the strong association between SUDs and psychotic disorders, research on the neurobiology of psychotic disorders could fruitfully include subjects with comorbid SUDs to shed light on shared etiology and pathophysiology.
Schizophrenia Bulletin 2007 33(4):947-952; doi:10.1093/schbul/sbm054;
Schizophrenia Bulletin Advance Access originally published online on June 7, 2007
1 To whom correspondence should be addressed; tel: 203-937-3486, fax: 203-937-3869, e-mail: bruce.rounsavill@yale.edu
Keywords: DSM-V / psychosis / substance use disorders / psychiatric diagnosis / psychiatric epidemiology / alcohol
Is Cocaine Desire Reduced by N-Acetylcysteine?
http://ajp.psychiatryonline.org/cgi/content/abstract/164/7/1115
OBJECTIVE: Animal models suggest that N-acetylcysteine inhibits cocaine-seeking. The present pilot study evaluated whether N-acetylcysteine would suppress reactivity to cocaine-related cues in cocaine-dependent humans. METHOD: In this double-blind, placebo-controlled trial, 15 participants received N-acetylcysteine or placebo during a 3-day hospitalization. Participants were crossed over to receive the opposite condition on a second, identical 3-day stay occurring 4 days later. During each hospital stay, participants completed a cue-reactivity procedure that involved collecting psychophysical and subjective data in response to slides depicting cocaine and cocaine use. RESULTS: While taking N-acetylcysteine, participants reported less desire to use and less interest in response to cocaine slides and watched cocaine slides for less time. CONCLUSIONS: The inhibition of cocaine cue reactivity is consistent with existing preclinical data and supports the use of N-acetylcysteine as a treatment for cocaine dependence.
Am J Psychiatry 164:1115-1117, July 2007doi: 10.1176/appi.ajp.164.7.1115
Steven D. LaRowe, Ph.D., Hugh Myrick, M.D., Sarra Hedden, M.S., Pascale Mardikian, M.D., Michael Saladin, Ph.D., Aimee McRae, Pharm.D., Kathleen Brady, M.D., Ph.D., Peter W. Kalivas, Ph.D. and Robert Malcolm, M.D.
OBJECTIVE: Animal models suggest that N-acetylcysteine inhibits cocaine-seeking. The present pilot study evaluated whether N-acetylcysteine would suppress reactivity to cocaine-related cues in cocaine-dependent humans. METHOD: In this double-blind, placebo-controlled trial, 15 participants received N-acetylcysteine or placebo during a 3-day hospitalization. Participants were crossed over to receive the opposite condition on a second, identical 3-day stay occurring 4 days later. During each hospital stay, participants completed a cue-reactivity procedure that involved collecting psychophysical and subjective data in response to slides depicting cocaine and cocaine use. RESULTS: While taking N-acetylcysteine, participants reported less desire to use and less interest in response to cocaine slides and watched cocaine slides for less time. CONCLUSIONS: The inhibition of cocaine cue reactivity is consistent with existing preclinical data and supports the use of N-acetylcysteine as a treatment for cocaine dependence.
Am J Psychiatry 164:1115-1117, July 2007doi: 10.1176/appi.ajp.164.7.1115
Steven D. LaRowe, Ph.D., Hugh Myrick, M.D., Sarra Hedden, M.S., Pascale Mardikian, M.D., Michael Saladin, Ph.D., Aimee McRae, Pharm.D., Kathleen Brady, M.D., Ph.D., Peter W. Kalivas, Ph.D. and Robert Malcolm, M.D.
Tuesday
Symptoms of Tobacco Dependence After Brief Intermittent Use -- Archives of Pediatrics and Adolescent Medicine
_________________________________________________________________________________ Symptoms of Tobacco Dependence After Brief Intermittent Use -- Archives of Pediatrics and Adolescent Medicine
http://www.mdlinx.com/PsychLinx/newsl-article.cfm/1905225
DiFranza, J.R., et al. - To extend the findings of the first Development and Assessment of Nicotine Dependence in Youth study by using diagnostic criteria for tobacco dependence and a biochemical measure of nicotine intake...Conclusion: The most susceptible youths lose autonomy over tobacco within a day or 2 of first inhaling from a cigarette. The appearance of tobacco withdrawal symptoms and failed attempts at cessation can precede daily smoking; ICD-10–defined dependence can precede daily smoking and typically appears before consumption reaches 2 cigarettes per day...
The Development and Assessment of Nicotine Dependence in Youth–2 Study
Joseph R. DiFranza, MD; Judith A. Savageau, MPH; Kenneth Fletcher, PhD; Jennifer O’Loughlin, PhD; Lori Pbert, PhD; Judith K. Ockene, PhD; Ann D. McNeill, PhD; Jennifer Hazelton, BA; Karen Friedman, BA; Gretchen Dussault, BA; Connie Wood, MSW; Robert J. Wellman, PhD
Arch Pediatr Adolesc Med. 2007;161:704-710.
Objective:To extend the findings of the first Development and Assessment of Nicotine Dependence in Youth study by using diagnostic criteria for tobacco dependence and a biochemical measure of nicotine intake. The first study found that symptoms of dependence commonly appeared soon after the onset of intermittent smoking.
Design:A 4-year prospective study.
Setting: Public schools in 6 Massachusetts communities.
Participants: A cohort of 1246 sixth-grade students.
Interventions: Eleven interviews.
Main Outcome Measures: Loss of autonomy over tobacco as measured by the Hooked on Nicotine Checklist, and tobacco dependence as defined in International Classification of Diseases, 10th Revision (ICD-10).
Results: Among the 217 inhalers, 127 lost autonomy over their tobacco use, 10% having done so within 2 days and 25% having done so within 30 days of first inhaling from a cigarette; half had lost autonomy by the time they were smoking 7 cigarettes per month. Among the 83 inhalers who developed ICD-10–defined dependence, half had done so by the time they were smoking 46 cigarettes per month. At the interview following the onset of ICD-10–defined dependence, the median salivary cotinine concentration of current smokers was 5.35 ng/mL, a level that falls well below the cutoff used to distinguish active from passive smokers.
Conclusions: The most susceptible youths lose autonomy over tobacco within a day or 2 of first inhaling from a cigarette. The appearance of tobacco withdrawal symptoms and failed attempts at cessation can precede daily smoking; ICD-10–defined dependence can precede daily smoking and typically appears before consumption reaches 2 cigarettes per day.
http://www.mdlinx.com/PsychLinx/newsl-article.cfm/1905225
DiFranza, J.R., et al. - To extend the findings of the first Development and Assessment of Nicotine Dependence in Youth study by using diagnostic criteria for tobacco dependence and a biochemical measure of nicotine intake...Conclusion: The most susceptible youths lose autonomy over tobacco within a day or 2 of first inhaling from a cigarette. The appearance of tobacco withdrawal symptoms and failed attempts at cessation can precede daily smoking; ICD-10–defined dependence can precede daily smoking and typically appears before consumption reaches 2 cigarettes per day...
The Development and Assessment of Nicotine Dependence in Youth–2 Study
Joseph R. DiFranza, MD; Judith A. Savageau, MPH; Kenneth Fletcher, PhD; Jennifer O’Loughlin, PhD; Lori Pbert, PhD; Judith K. Ockene, PhD; Ann D. McNeill, PhD; Jennifer Hazelton, BA; Karen Friedman, BA; Gretchen Dussault, BA; Connie Wood, MSW; Robert J. Wellman, PhD
Arch Pediatr Adolesc Med. 2007;161:704-710.
Objective:To extend the findings of the first Development and Assessment of Nicotine Dependence in Youth study by using diagnostic criteria for tobacco dependence and a biochemical measure of nicotine intake. The first study found that symptoms of dependence commonly appeared soon after the onset of intermittent smoking.
Design:A 4-year prospective study.
Setting: Public schools in 6 Massachusetts communities.
Participants: A cohort of 1246 sixth-grade students.
Interventions: Eleven interviews.
Main Outcome Measures: Loss of autonomy over tobacco as measured by the Hooked on Nicotine Checklist, and tobacco dependence as defined in International Classification of Diseases, 10th Revision (ICD-10).
Results: Among the 217 inhalers, 127 lost autonomy over their tobacco use, 10% having done so within 2 days and 25% having done so within 30 days of first inhaling from a cigarette; half had lost autonomy by the time they were smoking 7 cigarettes per month. Among the 83 inhalers who developed ICD-10–defined dependence, half had done so by the time they were smoking 46 cigarettes per month. At the interview following the onset of ICD-10–defined dependence, the median salivary cotinine concentration of current smokers was 5.35 ng/mL, a level that falls well below the cutoff used to distinguish active from passive smokers.
Conclusions: The most susceptible youths lose autonomy over tobacco within a day or 2 of first inhaling from a cigarette. The appearance of tobacco withdrawal symptoms and failed attempts at cessation can precede daily smoking; ICD-10–defined dependence can precede daily smoking and typically appears before consumption reaches 2 cigarettes per day.
Monday
NIAAA Identifies Five Subtypes of Alcohol Dependence
NIAAA Identifies Five Subtypes of Alcohol Dependence For the first time, federal researchers have broken down the disease of alcoholism dependence into five distinct subtypes, which experts say should help provide more targeted treatment for problem drinkers.
Researchers Identify Alcoholism Subtypes
Analyses of a national sample of individuals with alcohol dependence (alcoholism) reveal five distinct subtypes of the disease, according to a new study by scientists at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health (NIH).
"Our findings should help dispel the popular notion of the ‘typical alcoholic,’” notes first author Howard B. Moss, M.D., NIAAA Associate Director for Clinical and Translational Research. “We find that young adults comprise the largest group of alcoholics in this country, and nearly 20 percent of alcoholics are highly functional and well-educated with good incomes. More than half of the alcoholics in the United States have no multigenerational family history of the disease, suggesting that their form of alcoholism was unlikely to have genetic causes.”
“Clinicians have long recognized diverse manifestations of alcoholism,” adds NIAAA Director Ting-Kai Li, M.D, “and researchers have tried to understand why some alcoholics improve with specific medications and psychotherapies while others do not. The classification system described in this study will have broad application in both clinical and research settings.” A report of the study is now available online in the journal Drug and Alcohol Dependence.
Previous efforts to identify alcoholism subtypes focused primarily on individuals who were hospitalized or otherwise receiving treatment for their alcoholism. However, recent reports from NIAAA’s National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a nationally representative epidemiological study of alcohol, drug, and mental disorders in the United States, suggest that only about one-fourth of individuals with alcoholism have ever received treatment. Thus, a substantial proportion of people with alcoholism were not represented in the samples previously used to define subtypes of this disease.
In the current study, Dr. Moss and colleagues applied advanced statistical methods to data from the NESARC. Their analyses focused on the 1,484 NESARC survey respondents who met diagnostic criteria for alcohol dependence, and included individuals in treatment as well as those not seeking treatment. The researchers identified unique subtypes of alcoholism based on respondents’ family history of alcoholism, age of onset of regular drinking and alcohol problems, symptom patterns of alcohol dependence and abuse, and the presence of additional substance abuse and mental disorders:
Young Adult subtype: 31.5 percent of U.S. alcoholics. Young adult drinkers, with relatively low rates of co-occurring substance abuse and other mental disorders, a low rate of family alcoholism, and who rarely seek any kind of help for their drinking.
Young Antisocial subtype: 21 percent of U.S. alcoholics. Tend to be in their mid-twenties, had early onset of regular drinking, and alcohol problems. More than half come from families with alcoholism, and about half have a psychiatric diagnosis of Antisocial Personality Disorder. Many have major depression, bipolar disorder, and anxiety problems. More than 75 percent smoked cigarettes and marijuana, and many also had cocaine and opiate addictions. More than one-third of these alcoholics seek help for their drinking.
Functional subtype: 19.5 percent of U.S. alcoholics. Typically middle-aged, well-educated, with stable jobs and families. About one-third have a multigenerational family history of alcoholism, about one-quarter had major depressive illness sometime in their lives, and nearly 50 percent were smokers.
Intermediate Familial subtype: 19 percent of U.S. alcoholics. Middle-aged, with about 50 percent from families with multigenerational alcoholism. Almost half have had clinical depression, and 20 percent have had bipolar disorder. Most of these individuals smoked cigarettes, and nearly one in five had problems with cocaine and marijuana use. Only 25 percent ever sought treatment for their problem drinking.
Chronic Severe subtype: 9 percent of U.S. alcoholics. Comprised mostly of middle-aged individuals who had early onset of drinking and alcohol problems, with high rates of Antisocial Personality Disorder and criminality. Almost 80 percent come from families with multigenerational alcoholism. They have the highest rates of other psychiatric disorders including depression, bipolar disorder, and anxiety disorders as well as high rates of smoking, and marijuana, cocaine, and opiate dependence. Two-thirds of these alcoholics seek help for their drinking problems, making them the most prevalent type of alcoholic in treatment.
The NIAAA subtypes report is published online in the journal Drug and Alcohol Dependence.
Reference:Moss, HB, Chen, CM, Yi, HY. (2007) Subtypes of alcohol dependence in a nationally representative sample. Drug and Alcohol Dependence, Article in Press, Corrected Proof; available online June 26, 2007; doi: 10.1016/j.drugalcdep.2007.05.016.
Other Items From Join together:
Health Plans Use Internet to Give Information, Not Counseling
12-Step Treatment More Effective than Alternative, Study Says
National Conference on Pain, Opioids, and Addiction
Study Shows Most Treatment Effective Against Alcoholism
Addiction: Why Can't They Just Stop?
National Directory of Drug and Alcohol Abuse Treatment Programs 2006
Researchers Identify Alcoholism Subtypes
Analyses of a national sample of individuals with alcohol dependence (alcoholism) reveal five distinct subtypes of the disease, according to a new study by scientists at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health (NIH).
"Our findings should help dispel the popular notion of the ‘typical alcoholic,’” notes first author Howard B. Moss, M.D., NIAAA Associate Director for Clinical and Translational Research. “We find that young adults comprise the largest group of alcoholics in this country, and nearly 20 percent of alcoholics are highly functional and well-educated with good incomes. More than half of the alcoholics in the United States have no multigenerational family history of the disease, suggesting that their form of alcoholism was unlikely to have genetic causes.”
“Clinicians have long recognized diverse manifestations of alcoholism,” adds NIAAA Director Ting-Kai Li, M.D, “and researchers have tried to understand why some alcoholics improve with specific medications and psychotherapies while others do not. The classification system described in this study will have broad application in both clinical and research settings.” A report of the study is now available online in the journal Drug and Alcohol Dependence.
Previous efforts to identify alcoholism subtypes focused primarily on individuals who were hospitalized or otherwise receiving treatment for their alcoholism. However, recent reports from NIAAA’s National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), a nationally representative epidemiological study of alcohol, drug, and mental disorders in the United States, suggest that only about one-fourth of individuals with alcoholism have ever received treatment. Thus, a substantial proportion of people with alcoholism were not represented in the samples previously used to define subtypes of this disease.
In the current study, Dr. Moss and colleagues applied advanced statistical methods to data from the NESARC. Their analyses focused on the 1,484 NESARC survey respondents who met diagnostic criteria for alcohol dependence, and included individuals in treatment as well as those not seeking treatment. The researchers identified unique subtypes of alcoholism based on respondents’ family history of alcoholism, age of onset of regular drinking and alcohol problems, symptom patterns of alcohol dependence and abuse, and the presence of additional substance abuse and mental disorders:
Young Adult subtype: 31.5 percent of U.S. alcoholics. Young adult drinkers, with relatively low rates of co-occurring substance abuse and other mental disorders, a low rate of family alcoholism, and who rarely seek any kind of help for their drinking.
Young Antisocial subtype: 21 percent of U.S. alcoholics. Tend to be in their mid-twenties, had early onset of regular drinking, and alcohol problems. More than half come from families with alcoholism, and about half have a psychiatric diagnosis of Antisocial Personality Disorder. Many have major depression, bipolar disorder, and anxiety problems. More than 75 percent smoked cigarettes and marijuana, and many also had cocaine and opiate addictions. More than one-third of these alcoholics seek help for their drinking.
Functional subtype: 19.5 percent of U.S. alcoholics. Typically middle-aged, well-educated, with stable jobs and families. About one-third have a multigenerational family history of alcoholism, about one-quarter had major depressive illness sometime in their lives, and nearly 50 percent were smokers.
Intermediate Familial subtype: 19 percent of U.S. alcoholics. Middle-aged, with about 50 percent from families with multigenerational alcoholism. Almost half have had clinical depression, and 20 percent have had bipolar disorder. Most of these individuals smoked cigarettes, and nearly one in five had problems with cocaine and marijuana use. Only 25 percent ever sought treatment for their problem drinking.
Chronic Severe subtype: 9 percent of U.S. alcoholics. Comprised mostly of middle-aged individuals who had early onset of drinking and alcohol problems, with high rates of Antisocial Personality Disorder and criminality. Almost 80 percent come from families with multigenerational alcoholism. They have the highest rates of other psychiatric disorders including depression, bipolar disorder, and anxiety disorders as well as high rates of smoking, and marijuana, cocaine, and opiate dependence. Two-thirds of these alcoholics seek help for their drinking problems, making them the most prevalent type of alcoholic in treatment.
The NIAAA subtypes report is published online in the journal Drug and Alcohol Dependence.
Reference:Moss, HB, Chen, CM, Yi, HY. (2007) Subtypes of alcohol dependence in a nationally representative sample. Drug and Alcohol Dependence, Article in Press, Corrected Proof; available online June 26, 2007; doi: 10.1016/j.drugalcdep.2007.05.016.
Other Items From Join together:
Health Plans Use Internet to Give Information, Not Counseling
12-Step Treatment More Effective than Alternative, Study Says
National Conference on Pain, Opioids, and Addiction
Study Shows Most Treatment Effective Against Alcoholism
Addiction: Why Can't They Just Stop?
National Directory of Drug and Alcohol Abuse Treatment Programs 2006
Gaming junkies get no diagnosis: AMA report on video game "Addiction"
www.ama-assn.org/ama1/pub/upload/mm/467/csaph12a07.doc
http://www.latimes.com/business/la-fi-addict28jun28,0,6082192.story?coll=la-home-center
Gaming junkies get no diagnosis
By Alex PhamLA Times Staff WriterJune 28, 2007
Video-game buffs might feel hooked on their favorite titles, but theywon't be officially addicted anytime soon.Saying the issue needed more study, the American Medical Assn. onWednesday scaled back a controversial proposal that sought to declareexcessive video-game playing a mental disorder akin to pathologicalgambling.The association also decided against urging parents to limit to twohours a day the amount of time their kids play video games, watchtelevision and surf the Internet."While more study is needed on the addictive potential of video games,the AMA remains concerned about the behavioral, health and societaleffects of video-game and Internet overuse," Dr. Ronald M. Davis, theassociation's president, said in a statement from its annual meeting inChicago. "We urge parents to closely monitor their children's use ofvideo games and the Internet."The 250,000-member physician organization drew national headlines lastweek by pressing forward on a proposal to "strongly encourage" thatvideo-game addiction be labeled a formal disorder. The proposal wouldhave asked the American Psychiatric Assn. to consider including"video-game addiction as a formal diagnostic disorder" in the Diagnosticand Statistical Manual of Mental Disorders, considered by experts to bethe authoritative handbook on mental illness.Instead, the medical association Wednesday removed the word "addiction"and decided to simply forward its report expressing concerns about"video-game overuse" to the psychiatric group, which is revising itsmental-health manual.Maressa Hecht Orzack, director of the computer-addiction studies centerat McLean Hospital in Belmont, Mass., said the word choice wasirrelevant."The fact is, it's a behavior that's out of control," Orzack said,noting that some of her patients have trouble with school, work andtheir relationships because of their game-playing habits. "Whether youcall it addiction, overuse or excessive use, it's the same thing. It's acondition that interferes with a person's mental health."But some in the video-game industry, including the EntertainmentSoftware Assn., were pleased with the toned-down language. The tradegroup for the $30-billion game industry "supports mental-health experts,the APA and others within the AMA who agree that it would be prematureto conclude that video-game 'addiction' is a mental disorder," saidMichael Gallagher, its president.Industry executives were less happy with another recommendation in thereport approved Wednesday: The physicians' organization plans to lobbythe Federal Trade Commission to improve the current voluntary video-gamerating system, which is now run by the industry-funded EntertainmentSoftware Rating Board."We would like to see a ratings system that better alerts parents to thecontent of the video game and recommended age of the player, so they candecide whether or not their child should be playing it," the AMA's Davissaid.The board defended its system, which assigns ratings based on the levelof violence or sexual innuendo in games.The medical group's proposal to review the ratings system "seems todisregard the fact that the vast majority of parents are satisfied withthe ESRB ratings and use them regularly to choose games for theirchildren," ratings board President Patricia Vance said in a statement.
http://www.latimes.com/business/la-fi-addict28jun28,0,6082192.story?coll=la-home-center
Gaming junkies get no diagnosis
By Alex PhamLA Times Staff WriterJune 28, 2007
Video-game buffs might feel hooked on their favorite titles, but theywon't be officially addicted anytime soon.Saying the issue needed more study, the American Medical Assn. onWednesday scaled back a controversial proposal that sought to declareexcessive video-game playing a mental disorder akin to pathologicalgambling.The association also decided against urging parents to limit to twohours a day the amount of time their kids play video games, watchtelevision and surf the Internet."While more study is needed on the addictive potential of video games,the AMA remains concerned about the behavioral, health and societaleffects of video-game and Internet overuse," Dr. Ronald M. Davis, theassociation's president, said in a statement from its annual meeting inChicago. "We urge parents to closely monitor their children's use ofvideo games and the Internet."The 250,000-member physician organization drew national headlines lastweek by pressing forward on a proposal to "strongly encourage" thatvideo-game addiction be labeled a formal disorder. The proposal wouldhave asked the American Psychiatric Assn. to consider including"video-game addiction as a formal diagnostic disorder" in the Diagnosticand Statistical Manual of Mental Disorders, considered by experts to bethe authoritative handbook on mental illness.Instead, the medical association Wednesday removed the word "addiction"and decided to simply forward its report expressing concerns about"video-game overuse" to the psychiatric group, which is revising itsmental-health manual.Maressa Hecht Orzack, director of the computer-addiction studies centerat McLean Hospital in Belmont, Mass., said the word choice wasirrelevant."The fact is, it's a behavior that's out of control," Orzack said,noting that some of her patients have trouble with school, work andtheir relationships because of their game-playing habits. "Whether youcall it addiction, overuse or excessive use, it's the same thing. It's acondition that interferes with a person's mental health."But some in the video-game industry, including the EntertainmentSoftware Assn., were pleased with the toned-down language. The tradegroup for the $30-billion game industry "supports mental-health experts,the APA and others within the AMA who agree that it would be prematureto conclude that video-game 'addiction' is a mental disorder," saidMichael Gallagher, its president.Industry executives were less happy with another recommendation in thereport approved Wednesday: The physicians' organization plans to lobbythe Federal Trade Commission to improve the current voluntary video-gamerating system, which is now run by the industry-funded EntertainmentSoftware Rating Board."We would like to see a ratings system that better alerts parents to thecontent of the video game and recommended age of the player, so they candecide whether or not their child should be playing it," the AMA's Davissaid.The board defended its system, which assigns ratings based on the levelof violence or sexual innuendo in games.The medical group's proposal to review the ratings system "seems todisregard the fact that the vast majority of parents are satisfied withthe ESRB ratings and use them regularly to choose games for theirchildren," ratings board President Patricia Vance said in a statement.
Gene Variant Increases Risk for Alcoholism Following Childhood Abuse
Gene Variant Increases Risk for Alcoholism Following Childhood Abuse Contact: NIAAA Press Office, 301-443-3860 Date: 6/26/2007 Girls who suffered childhood sexual abuse are more likely to develop alcoholism later in life if they possess a particular variant of a gene involved in the body's response to stress, according to a new study led by researchers at the National Institute on Alcohol Abuse and Alcoholism (NIAAA), part of the National Institutes of Health (NIH). The new finding could help explain why some individuals are more resilient to profound childhood trauma than others."With this study we see yet again that nature and nurture often work together, not independently, to influence our overall health and well-being," says NIH Director Elias A. Zerhouni, M.D."This finding underscores the central role that gene-environment interactions play in the pathogenesis of complex diseases such as alcoholism," adds NIAAA Director Ting-Kai Li, M.D. A report of the study appears in the June 26, 2007 advance online publication of "Molecular Psychiatry".Previous studies have shown that childhood sexual abuse increases the risk for numerous mental health problems in adulthood. However not all abused children develop such problems, a likely indication that genetic factors also play a role. Recent studies have linked the monoamine oxidase A (MAOA) gene with adverse behavioral outcomes stemming from childhood mistreatment."MAOA is an enzyme that metabolizes various neurotransmitters that regulate the body's response to stress," explains first author Francesca Ducci, M.D., a visiting fellow in NIAAA's Laboratory of Neurogenetics in Bethesda, Maryland. DNA variations occur within a regulatory area -- the MAOA-linked polymorphic region (MAOA-LPR) -- of the MAOA gene. Two such MAOA-LPR variants occur most frequently and result in high or low MAOA enzyme activity. In a recent study, researchers found that maltreated boys who possessed the low activity MAOA-LPR variant were more likely to develop behavior problems than boys with the high activity variant."Our aim was to test whether this low activity variant influences the impact of childhood sexual abuse on alcoholism and antisocial personality disorder (ASPD) in women," says Dr. Ducci.She and her colleagues analyzed DNA samples from a group of American Indian women living in a community in which rates of alcoholism and ASPD are about six times higher than the average rates among all U.S. women. Childhood sexual abuse is also prevalent in this population, reported by about half of the women in the community, compared with a U.S. average of 13 percent."The high rates of sexual abuse and alcoholism in this population make it particularly suitable for studying the interaction of genes and stressful environmental exposures," explains senior author David Goldman, M.D., chief of the NIAAA Laboratory of Neurogenetics.Analyses of MAOA-LPR genotypes in this study revealed that women who had been sexually abused in childhood were much more likely to develop alcoholism and antisocial behavior if they had the low activity variant whereas the high activity variant was protective. In contrast, there was no relationship between alcoholism, antisocial behavior and MAOA-LPR genotype among non-abused women."Our findings show that MAOA seems to moderate the impact of childhood trauma on adult psychopathology in females in the same way as previously shown among males," says Dr. Ducci. "The MAOA-LPR low activity allele appears to confer increased vulnerability to the adverse psychosocial consequences of childhood sexual abuse."Dr. Ducci and her colleagues suggest that the effect of MAOA on the hippocampus, a brain region which is involved in the processing of emotional experience, may underlie the interaction between MAOA and childhood trauma. They note that previous research showed that people with the low activity variant at the MAOA-LPR locus have hyperactivation of the hippocampus when retrieving negative emotional information.Other co-authors of the study include Mary-Anne Enoch, M.D., Colin Hodgkinson, Ph.D. and Ke Xu, MD, Ph.D., of the NIAAA Laboratory of Neurogenetics, Mario Catena, MD, of the Department of Psychiatry, University of Pisa, Italy, and Robert W. Robin, Ph.D., of the Center for the Prevention and Resolution of Violence in Tucson, Arizona.
Wednesday
FDA Announces Final Rule Establishing Current Good ManufacturingPractices forDietary Supplements
June 22, 2000
The Food and Drug Administration (FDA) today announced its final ruleestablishing current good manufacturing practices (cGMPs) for dietarysupplements.In the Dietary Supplement Health and Education Act of 1994 (DSHEA),Congressgave the Secretary of Health and Human Services and, by delegation, FDAauthority to issue regulations establishing cGMPs for dietarysupplements. The GMPs will require that dietary supplements are produced in a qualitymanner,are not adulterated with contaminants or impurities, and are accuratelylabeledto reflect the ingredients in the product. The cGMPs apply to alldomestic andforeign companies that manufacture, package, or hold dietary supplementsintended for sale in U.S. commerce, including those involved with theactivitiesof testing, quality control, packaging, labeling, and distributing.In a companion document, FDA is also announcing today an interim finalrule(IFR) that outlines a petition process for manufacturers to request anexemptionto the cGMP requirement for 100 percent identity testing of specificdietaryingredients. If the manufacturer can provide sufficient documentationthat thesupplier maintains appropriate in-process manufacturing controls and hasconsistently produced the dietary ingredient over a period of time, themanufacturer may be exempted from the testing requirement. FDA issolicitingcomment from the public on the IFR. There will be a 90-day commentperiod.Written comments may be submitted to the Dockets Management Branch(HFA-305),Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville,MD 20852or on line at:http://www.fda.gov/dockets/ecommentsAdditional information regarding the cGMPs is available through theCFSANwebsite athttp://www.cfsan.fda.gov/~dms/supplmnt.html.NOTE:* TO GET PAST ISSUES OF FDA-DSFL, go to Electronic InformationNetworks:http://www.cfsan.fda.gov/~dms/infonet.html.********************************FDA Web Page Addresses:* Dietary Supplements http://www.cfsan.fda.gov/~dms/supplmnt.html* Food Labeling and Nutrition http://www.cfsan.fda.gov/label.html* Infant Formula http://www.cfsan.fda.gov/~dms/inf-toc.html* Qualified Health Claims http://www.cfsan.fda.gov/~dms/lab-qhc.html* Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/list.htmlOther Federal Government Links:* Federal Trade Commission http://www.ftc.gov/* Office of Dietary Supplements, NIH http://dietary-supplements.info.nih.gov/* US Department of Agriculture - Food Safety and Inspection Service http://www.fsis.usda.gov/ - Food and Nutrition Service http://www.fns.usda.gov/fns/Non-Federal Government Links:* National Academy of Sciences http://www.iom.edu/CMS/3788.aspx
The Food and Drug Administration (FDA) today announced its final ruleestablishing current good manufacturing practices (cGMPs) for dietarysupplements.In the Dietary Supplement Health and Education Act of 1994 (DSHEA),Congressgave the Secretary of Health and Human Services and, by delegation, FDAauthority to issue regulations establishing cGMPs for dietarysupplements. The GMPs will require that dietary supplements are produced in a qualitymanner,are not adulterated with contaminants or impurities, and are accuratelylabeledto reflect the ingredients in the product. The cGMPs apply to alldomestic andforeign companies that manufacture, package, or hold dietary supplementsintended for sale in U.S. commerce, including those involved with theactivitiesof testing, quality control, packaging, labeling, and distributing.In a companion document, FDA is also announcing today an interim finalrule(IFR) that outlines a petition process for manufacturers to request anexemptionto the cGMP requirement for 100 percent identity testing of specificdietaryingredients. If the manufacturer can provide sufficient documentationthat thesupplier maintains appropriate in-process manufacturing controls and hasconsistently produced the dietary ingredient over a period of time, themanufacturer may be exempted from the testing requirement. FDA issolicitingcomment from the public on the IFR. There will be a 90-day commentperiod.Written comments may be submitted to the Dockets Management Branch(HFA-305),Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville,MD 20852or on line at:http://www.fda.gov/dockets/ecommentsAdditional information regarding the cGMPs is available through theCFSANwebsite athttp://www.cfsan.fda.gov/~dms/supplmnt.html.NOTE:* TO GET PAST ISSUES OF FDA-DSFL, go to Electronic InformationNetworks:http://www.cfsan.fda.gov/~dms/infonet.html.********************************FDA Web Page Addresses:* Dietary Supplements http://www.cfsan.fda.gov/~dms/supplmnt.html* Food Labeling and Nutrition http://www.cfsan.fda.gov/label.html* Infant Formula http://www.cfsan.fda.gov/~dms/inf-toc.html* Qualified Health Claims http://www.cfsan.fda.gov/~dms/lab-qhc.html* Center for Food Safety and Applied Nutrition http://www.cfsan.fda.gov/list.htmlOther Federal Government Links:* Federal Trade Commission http://www.ftc.gov/* Office of Dietary Supplements, NIH http://dietary-supplements.info.nih.gov/* US Department of Agriculture - Food Safety and Inspection Service http://www.fsis.usda.gov/ - Food and Nutrition Service http://www.fns.usda.gov/fns/Non-Federal Government Links:* National Academy of Sciences http://www.iom.edu/CMS/3788.aspx
Sunday
Psychedelic Medicine (Book review)
---http://www.greenwood.com/catalog/C9023.aspxPsychedelic Medicine (two volumes)List Price: $200.00To order, visit http://www.greenwood.com/, call 1-800-225-5800Description:Psychedelic substances present in nature have been used by humans acrosshundreds of years to produce mind-altering changes in thought, mood, andperception--changes we do not experience otherwise except rarely indreams, religious exaltation, or psychosis. U.S. scientists werestudying the practical and therapeutic uses for hallucinogens, includingLSD and mescaline, in the 1950s and 1960s supplied by largemanufacturers including Sandoz.But the government took steps to ban all human consumption ofhallucinogens, and thus the research. By the 1970s, all human testingwas stopped. Medical concerns were not the issue, the ban was motivatedby social concerns, not the least of which were created by legendaryresearcher Timothy Leary, a psychologist who advocated free use ofhallucinogens by all who desired.Nationwide, however, a cadre of scholars and researchers has persistedin pushing the federal government to again allow human testing. And themoratorium has been lifted. The FDA has begun approving hallucinogenicresearch using human subjects. In these groundbreaking volumes, topresearchers explain the testing and research underway to use - under theguidance of a trained provider - psychedelic substances for betterphysical and mental health.Experts including physicians and psychiatrists at some of the mostrespected medical schools in the nation, show how psychedelics mayalleviate symptoms or spur cures for disorders from AIDS to arthritis topost traumatic stress disorder. Spiritual uses are also addressed andthe perceived benefits described. Medical and legal issues fortherapeutic uses are also presented. The psychedelic drugs explained inthese pages for potential health use include: LSD, Ayahuasca,Psyilocybin, Peyote, MDMA, Marijauana.---------Volume I: Psychedelic Medicine: Social, Clinical and Legal PerspectivesThomas B. RobertsEditor's Overview of Psychedelic Medicines Volume 1.Michael WinkelmanSection I: The Social and Clinical ContextChapter 1: Therapeutic Bases of Psychedelic Medicines: PsychointegrativeEffects. Michael WinkelmanChapter 2: The Healing Vine: Ayahuasca as Medicine in the 21st Century.Dennis McKennaChapter 3: Contemporary Psychedelic Therapy: An Overview. Torsten PassieChapter 4: Therapeutic Guidelines: Dangers and Contra-Indications inTherapeutic Applications of Hallucinogens. Ede FrecskaSection II: Medical ApplicationsChapter 5: Response of Cluster Headaches to Psilocybin and LSD. AndrewSewell & John H. HalpernChapter 6: Psilocybin Treatment of Obsessive- Compulsive Disorder. F. A.Moreno & P. L. DelgadoChapter 7: Therapeutic Uses of MDMA. George Greer & Requa TolbertChapter 8: MDMA-Assisted Psychotherapy for the Treatment ofPosttraumatic Stress Disorder. Michael MithoeferChapter 9: Psychedelic Drugs for the Treatment of Depression. MichaelMontagneChapter 10: Marijuana and AIDS. Donald AbramsChapter 11: The Use of Psilocybin in Patients with Advanced Cancer andExistential Anxiety. C. GrobSection III: Legal Aspects of the Medical UseChapter 12: Psychedelic Medicine and the Law. Richard BoireChapter 13: The Legal Bases for Religious Peyote Use. Kevin FeeneyChapter 14: The Supreme Court's Psychedelic Case. Alberto Groisman &Marlene de RiosChapter 15: Conclusions. Michael Winkelman & Thomas B. Roberts-------Volume II: Psychedelic Medicine: Addictions Medicine and TranspersonalHealingPreface- Lancet EditorialChapter 1: Introduction ? The Adventure Continues. Thomas B. RobertsSection I: Treating Substance AbuseChapter 2: Hallucinogens in the Treatment of Alcoholism and OtherAddictions. J. H. HalpernChapter 3: Addiction, Despair, and the Soul: Psychedelic Psychotherapy.R. Yensen & D. DryerChapter 4: The Therapeutic Use of Peyote in the Native American Church.Joseph CalabreseChapter 5: Ibogaine and Substance Abuse Rehabilitation. Kenneth R.Alper & Howard LotsofChapter 6: Ketamine Psychedelic Psychotherapy. Evgeny Krupitsky & EliKolpChapter 7: Ayahuasca Treatment of Cocaine-Paste Addiction. JacquesMabitSection II: Guidelines for Psychotherapeutic ApplicationsChapter 8: The Ten Lessons of Psychedelic Psychotherapy? Rediscovered.Neal M. GoldsmithChapter 9: Therapeutic Guidelines from Shamanic Traditions. MichaelWinkelmanChapter 10: Common Processes in Psychospiritual Change. Sean HouseChapter 11: Preliminary Remarks on Interpreting Resistance toPsychedelic Insights. Dan MerkurSection III: Transpersonal Dimension of Healing with PsychedelicMedicinesChapter 12: Psychedelics in Psychological Health and Growth. RogerWalsh & Charles GrobChapter 13: Psilocybin Can Occasion Mystical-type Experiences HavingSubstantial and Sustained Personal Meaning and Spiritual Significance.R. Griffiths, W. Richards, U. McCann & R. Jesse.Chapter 14: Remarkable Healing During Psychedelic Psychotherapy.Stanislav GrofChapter 15: Transpersonal Healing with Hallucinogens. Roger Marsden &David LukoffChapter 16: Conclusions and Future Recommendations: The Wider Contexts.Thomas B. RobertsAuthor biographiesIndex---------Endorsement From Harriet de Wit, PhDProfessor, Department of PsychiatryThe University of Chicago:These books are a comprehensive and scholarly review of the currentstatus of the therapeutic potential of hallucinogens. The contributorsrepresent an outstanding group of scientists, scholars and clinicians,most of whom have had direct experience using and administering thesedrugs in either therapeutic or religious contexts. The result is animpressive collection. The authors provide scholarly historical reviewsof the use of these drugs, as well as detailed instructions and advicefor the clinician on how to administer these drugs safely andeffectively in a therapeutic context. The authors provide a balancedview and acknowledge the many risks and pitfalls of improper use ofthese drugs. Likely to be of interest to scientists, clergy, mentalhealth professionals, and anyone interested in the mind. It provides anup to date review of the status of hallucinogens in modern medicine, aswell as a historical review of their status in the past. It is highlyrecommended.Endorsement From Professor Jonathan D. Moreno,University of Pennsylvania Center for Bioethics:Until they were caught up in the cultural revolution of the 1960s,hallucinogens were being seriously examined by top researchers for theirpotential to alleviate many human ills. The contributors to thesevolumes make a persuasive case that science should now do more to pursuethese questions.Endorsement From Stephen Ross, M.D.Assistant Clinical Professor, Psychiatry, NYU School of MedicineDirector, Division of Alcoholism and Drug Abuse, Bellevue HospitalAssociate Director, Addiction Psychiatry Fellowship, NYU School ofMedicine:Roberts and Winkelman have assembled one of the most impressive andcomprehensive collections of writings in the field of psychedelicmedicine. The chapters, written by first-rate academic scholars, arerigorous and clear. The topics range from neuroscience to the legal,spiritual, medicinal, and ethical implications of using this novel classof agents. This work is an invaluable resource for educators,clinicians, and policy makers who are interested in rejuvenating thefield of psychedelic research.Endorsement From Nicholas V. Cozzi, Ph.D.Department of PharmacologyUniversity of Wisconsin School of Medicine and Public Health:These volumes present fresh ideas for using psychedelic drugs astherapeutic agents to treat some of the most intractable ofpsychological ailments. As the authors make clear, the ability of thesesubstances to facilitate direct experiential access to our deepestthoughts, feelings, and spirituality makes them uniquely suited for thispurpose. Undoubtedly, their amazing healing potential has yet to befully realized. Thanks to these forward-thinking educators, researchers,and clinicians, we now have new paths to explore in the cure for olddiseases.
NYT: Pain doc as pusher?
NYT: Pain doc as pusher?
http://www.nytimes.com/2007/06/17/magazine/17pain-t.html
June 17, 2007
Cover Story: When Is a Pain Doctor a Drug Pusher?
By TINA ROSENBERG Correction Appended
Ronald McIver is a prisoner in a medium-security federal compound in Butner, N.C. He is 63 years old, of medium height and overweight, with a white Santa Claus beard, white hair and a calm, direct and intelligent manner. He is serving 30 years for drug trafficking, and so will likely live there the rest of his life. McIver (pronounced mi-KEE-ver) has not been convicted of drug trafficking in the classic sense. He is a doctor who for years treated patients suffering from chronic pain. At the Pain Therapy Center, his small storefront office not far from Main Street in Greenwood, S.C., he cracked backs, gave trigger-point injections and put patients through physical therapy. He administered ultrasound and gravity-inversion therapy and devised exercise regimens. And he wrote prescriptions for high doses of opioid drugs like OxyContin.
McIver was a particularly aggressive pain doctor. Pain can be measured only by how patients say they feel: on a scale from 0 to 10, a report of 0 signifies the absence of pain; 10 is unbearable pain. Many pain doctors will try to reduce a patient\'s pain to the level of 5. McIver tried for a 2. He prescribed more, and sooner, than most doctors.\u003cbr /\>\u003cbr /\>Some of his patients sold their pills. Some abused them. One man, Larry Shealy, died with high doses of opioids that McIver had prescribed him in his bloodstream. In April 2005, McIver was convicted in federal court of one count of conspiracy to distribute controlled substances and eight counts of distribution. (He was also acquitted of six counts of distribution.) The jury also found that Shealy was killed by the drugs McIver prescribed. McIver is serving concurrent sentences of 20 years for distribution and 30 years for dispensing drugs that resulted in Shealy\'s death. His appeals to the U.S. Court of Appeals for the Fourth Circuit and the Supreme Court were rejected.\u003cbr /\>\u003cbr /\>McIver\'s case is not simply the story of a narcotics conviction. It has enormous relevance to the lives of the one in five adult Americans who, according to a 2005 survey by Stanford University Medical Center, ABC News and USA Today, reported they suffered from chronic pain - pain lasting for several months or longer. According to a 2003 study in The Journal of the American Medical Association, pain costs American workers more than $61 billion a year in lost productive time - and that doesn\'t include medical bills.\u003cbr /\>\u003cbr /\>Contrary to the old saw, pain kills. A body in pain produces high levels of hormones that cause stress to the heart and lungs. Pain can cause blood pressure to spike, leading to heart attacks and strokes. Pain can also consume so much of the body\'s energy that the immune system degrades. Severe chronic pain sometimes leads to suicide. There are, of course, many ways to treat pain: some pain sufferers respond well to surgery, physical therapy, ultrasound, acupuncture, trigger-point injections, meditation or over-the-counter painkillers like Advil (ibuprofen) or Tylenol (acetaminophen). But for many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.\u003cbr /\>",1]
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McIver was a particularly aggressive pain doctor. Pain can be measured only by how patients say they feel: on a scale from 0 to 10, a report of 0 signifies the absence of pain; 10 is unbearable pain. Many pain doctors will try to reduce a patient's pain to the level of 5. McIver tried for a 2. He prescribed more, and sooner, than most doctors.Some of his patients sold their pills. Some abused them. One man, Larry Shealy, died with high doses of opioids that McIver had prescribed him in his bloodstream. In April 2005, McIver was convicted in federal court of one count of conspiracy to distribute controlled substances and eight counts of distribution. (He was also acquitted of six counts of distribution.) The jury also found that Shealy was killed by the drugs McIver prescribed. McIver is serving concurrent sentences of 20 years for distribution and 30 years for dispensing drugs that resulted in Shealy's death. His appeals to the U.S. Court of Appeals for the Fourth Circuit and the Supreme Court were rejected.McIver's case is not simply the story of a narcotics conviction. It has enormous relevance to the lives of the one in five adult Americans who, according to a 2005 survey by Stanford University Medical Center, ABC News and USA Today, reported they suffered from chronic pain - pain lasting for several months or longer. According to a 2003 study in The Journal of the American Medical Association, pain costs American workers more than $61 billion a year in lost productive time - and that doesn't include medical bills.Contrary to the old saw, pain kills. A body in pain produces high levels of hormones that cause stress to the heart and lungs. Pain can cause blood pressure to spike, leading to heart attacks and strokes. Pain can also consume so much of the body's energy that the immune system degrades. Severe chronic pain sometimes leads to suicide. There are, of course, many ways to treat pain: some pain sufferers respond well to surgery, physical therapy, ultrasound, acupuncture, trigger-point injections, meditation or over-the-counter painkillers like Advil (ibuprofen) or Tylenol (acetaminophen). But for many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.
Video\u003cbr /\>More Video »\u003cbr /\>It\'s a false choice. Virtually everyone who takes opioids will become physically dependent on them, which means that withdrawal symptoms like nausea and sweats can occur if usage ends abruptly. But tapering off gradually allows most people to avoid those symptoms, and physical dependence is not the same thing as addiction. Addiction - which is defined by cravings, loss of control and a psychological compulsion to take a drug even when it is harmful - occurs in patients with a predisposition (biological or otherwise) to become addicted. At the very least, these include just below 10 percent of Americans, the number estimated by the United States Department of Health and Human Services to have active substance-abuse problems. Even a predisposition to addiction, however, doesn\'t mean a patient will become addicted to opioids. Vast numbers do not. Pain patients without prior abuse problems most likely run little risk. "Someone who has never abused alcohol or other drugs would be extremely unlikely to become addicted to opioid pain medicines, particularly if he or she is older," says Russell K. Portenoy, chairman of pain medicine and palliative care at Beth Israel Medical Center in New York and a leading authority on the treatment of pain.\u003cbr /\>\u003cbr /\>The other popular misconception is that a high dose of opioids is always a dangerous dose. Even many doctors assume it; but they are nonetheless incorrect. It is true that high doses can cause respiratory failure in people who are not already taking the drugs. But that same high dose will not cause respiratory failure in someone whose drug levels have been increased gradually over time, a process called titration. For individuals who are properly titrated and monitored, there is no ceiling on opioid dosage. In this sense, high-dose prescription opioids can be safer than taking high doses of aspirin, Tylenol or Advil, which cause organ damage in high doses, regardless of how those doses are administered. (Every year, an estimated 5,000 to 6,000 Americans die from gastrointestinal bleeding associated with drugs like ibuprofen or aspirin, according to a paper published in The American Journal of Gastroenterology.)\u003cbr /\>",1]
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VideoMore Video »It's a false choice. Virtually everyone who takes opioids will become physically dependent on them, which means that withdrawal symptoms like nausea and sweats can occur if usage ends abruptly. But tapering off gradually allows most people to avoid those symptoms, and physical dependence is not the same thing as addiction. Addiction - which is defined by cravings, loss of control and a psychological compulsion to take a drug even when it is harmful - occurs in patients with a predisposition (biological or otherwise) to become addicted. At the very least, these include just below 10 percent of Americans, the number estimated by the United States Department of Health and Human Services to have active substance-abuse problems. Even a predisposition to addiction, however, doesn't mean a patient will become addicted to opioids. Vast numbers do not. Pain patients without prior abuse problems most likely run little risk. "Someone who has never abused alcohol or other drugs would be extremely unlikely to become addicted to opioid pain medicines, particularly if he or she is older," says Russell K. Portenoy, chairman of pain medicine and palliative care at Beth Israel Medical Center in New York and a leading authority on the treatment of pain.The other popular misconception is that a high dose of opioids is always a dangerous dose. Even many doctors assume it; but they are nonetheless incorrect. It is true that high doses can cause respiratory failure in people who are not already taking the drugs. But that same high dose will not cause respiratory failure in someone whose drug levels have been increased gradually over time, a process called titration. For individuals who are properly titrated and monitored, there is no ceiling on opioid dosage. In this sense, high-dose prescription opioids can be safer than taking high doses of aspirin, Tylenol or Advil, which cause organ damage in high doses, regardless of how those doses are administered. (Every year, an estimated 5,000 to 6,000 Americans die from gastrointestinal bleeding associated with drugs like ibuprofen or aspirin, according to a paper published in The American Journal of Gastroenterology.)
Still, doctors who put patients on long-term high-dose opioids must be very careful. They must monitor the patients often to ensure that the drugs are being used correctly and that side effects like constipation and mental cloudiness are not too severe. Doctors should also not automatically assume that if small doses aren\'t working, that high doses will - opioids don\'t help everyone. And research indicates that in some cases, high doses of opioids can lose their effectiveness and that some patients are better off if they take drug "holidays" or alternate between different medicines. Pain doctors also concede that more studies are needed to determine the safety of long-term opioid use.\u003cbr /\>\u003cbr /\>But with careful treatment, many patients whose opioid levels are increased gradually can function well on high doses for years. "Dose alone says nothing about proper medical practice," Portenoy says. "Very few patients require doses that exceed even 200 milligrams of OxyContin on a daily basis. Having said this, pain specialists are very familiar with a subpopulation of patients who require higher doses to gain effect. I myself have several patients who take more than 1,000 milligrams of OxyContin or its equivalent every day. One is a high-functioning executive who is pain-free most of the time, and the others have a level of pain control that allows a reasonable quality of life."\u003cbr /\>\u003cbr /\>All modern pain-management textbooks advocate "titration to effect" - in other words, in cases where opioids are helping, gradually increasing the dosage until either the pain is acceptably controlled or the side effects begin to outweigh the pain-relief benefits. But the vast majority of doctors don\'t practice what the textbooks counsel. In part, this is because of the stigma associated with high-dose opioids, the fear that patients will become addicted and the fact that careful monitoring is very time-consuming. And most doctors have received virtually no training in medical school about managing pain: many hold the same misconceptions about addiction and dosage as the general public.\u003cbr /\>",1]
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Still, doctors who put patients on long-term high-dose opioids must be very careful. They must monitor the patients often to ensure that the drugs are being used correctly and that side effects like constipation and mental cloudiness are not too severe. Doctors should also not automatically assume that if small doses aren't working, that high doses will - opioids don't help everyone. And research indicates that in some cases, high doses of opioids can lose their effectiveness and that some patients are better off if they take drug "holidays" or alternate between different medicines. Pain doctors also concede that more studies are needed to determine the safety of long-term opioid use.But with careful treatment, many patients whose opioid levels are increased gradually can function well on high doses for years. "Dose alone says nothing about proper medical practice," Portenoy says. "Very few patients require doses that exceed even 200 milligrams of OxyContin on a daily basis. Having said this, pain specialists are very familiar with a subpopulation of patients who require higher doses to gain effect. I myself have several patients who take more than 1,000 milligrams of OxyContin or its equivalent every day. One is a high-functioning executive who is pain-free most of the time, and the others have a level of pain control that allows a reasonable quality of life."All modern pain-management textbooks advocate "titration to effect" - in other words, in cases where opioids are helping, gradually increasing the dosage until either the pain is acceptably controlled or the side effects begin to outweigh the pain-relief benefits. But the vast majority of doctors don't practice what the textbooks counsel. In part, this is because of the stigma associated with high-dose opioids, the fear that patients will become addicted and the fact that careful monitoring is very time-consuming. And most doctors have received virtually no training in medical school about managing pain: many hold the same misconceptions about addiction and dosage as the general public.
And even pain specialists can be conservative. Sean E. Greenwood died in August at age 50 of a cerebral hemorrhage that his wife, Siobhan Reynolds, attributes to untreated pain. Greenwood was seeing various pain specialists. What makes his undertreatment especially remarkable is that he and his wife founded the Pain Relief Network, an advocacy group that has been the most vocal opponent of prosecutions of doctors and financed part of the legal defense of many pain doctors. "Here I am - I know everyone, and even I couldn\'t get him care that didn\'t first regard him as a potential criminal," Reynolds said.\u003cbr /\>\u003cbr /\>According to the pharmaceutical research company IMS Health, prescriptions for opioids have risen over the past few years. They are used now more than ever before. Yet study after study has concluded that pain is still radically undertreated. The Stanford University Medical Center survey found that only 50 percent of chronic-pain sufferers who had spoken to a doctor about their pain got sufficient relief. According to the American Pain Society, an advocacy group, fewer than half of cancer patients in pain get adequate pain relief.\u003cbr /\>\u003cbr /\>Several states are now preparing new opioid-dosing guidelines that may inadvertently worsen undertreatment. This year, the state of Washington advised nonspecialist doctors that daily opioid doses should not exceed the equivalent of 120 milligrams of oral morphine daily - for oxycodone or OxyContin, that\'s just 80 milligrams per day - without the patient\'s also consulting a pain specialist. Along with the guidelines, officials published a statewide directory of such specialists. It contains 12 names. "There are just not enough pain specialists," says Scott M. Fishman, chief of pain medicine at the University of California at Davis and a past president of the American Academy of Pain Medicine. And the guidelines may keep nonspecialists from prescribing higher doses. "Many doctors will assume that if the state of Washington suggests this level of care, then it is unacceptable to proceed otherwise," Fishman says.\u003cbr /\>",1]
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And even pain specialists can be conservative. Sean E. Greenwood died in August at age 50 of a cerebral hemorrhage that his wife, Siobhan Reynolds, attributes to untreated pain. Greenwood was seeing various pain specialists. What makes his undertreatment especially remarkable is that he and his wife founded the Pain Relief Network, an advocacy group that has been the most vocal opponent of prosecutions of doctors and financed part of the legal defense of many pain doctors. "Here I am - I know everyone, and even I couldn't get him care that didn't first regard him as a potential criminal," Reynolds said.According to the pharmaceutical research company IMS Health, prescriptions for opioids have risen over the past few years. They are used now more than ever before. Yet study after study has concluded that pain is still radically undertreated. The Stanford University Medical Center survey found that only 50 percent of chronic-pain sufferers who had spoken to a doctor about their pain got sufficient relief. According to the American Pain Society, an advocacy group, fewer than half of cancer patients in pain get adequate pain relief.Several states are now preparing new opioid-dosing guidelines that may inadvertently worsen undertreatment. This year, the state of Washington advised nonspecialist doctors that daily opioid doses should not exceed the equivalent of 120 milligrams of oral morphine daily - for oxycodone or OxyContin, that's just 80 milligrams per day - without the patient's also consulting a pain specialist. Along with the guidelines, officials published a statewide directory of such specialists. It contains 12 names. "There are just not enough pain specialists," says Scott M. Fishman, chief of pain medicine at the University of California at Davis and a past president of the American Academy of Pain Medicine. And the guidelines may keep nonspecialists from prescribing higher doses. "Many doctors will assume that if the state of Washington suggests this level of care, then it is unacceptable to proceed otherwise," Fishman says.
In addition to medical considerations real or imagined, there is another deterrent to opioid use: fear. According to the D.E.A., 71 doctors were arrested last year for crimes related to "diversion" - the leakage of prescription medicine into illegal drug markets. The D.E.A. also opened 735 investigations of doctors, and an investigation alone can be enough to put a doctor out of business, as doctors can lose their licenses and practices and have their homes, offices and cars seized even if no federal criminal charges are ever filed. Both figures - arrests and investigations - have risen steadily over the last few years.\u003cbr /\>\u003cbr /\>Opioid drugs have been used to treat pain for decades, mostly for acute postsurgical pain or the pain of cancer patients. But in January 1996, Purdue Pharma helped increase the use of these drugs by introducing OxyContin - oxycodone with a time-release mechanism. Oncologists and pain doctors were the principal prescribers of opioids. But Purdue introduced the drug with an aggressive marketing campaign promoting OxyContin to general practitioners and the idea of opioid pain relief to doctors and consumers. The product\'s time-release mechanism, Purdue claimed, allowed steadier pain relief and deterred abuse.\u003cbr /\>\u003cbr /\>Many pain sufferers found that OxyContin gave them better relief than they ever had before. But Purdue misrepresented the drug\'s potential for abuse. Last month, the company and three of its executives pleaded guilty to federal charges that they misled doctors and patients. The company agreed to pay $600 million in fines; and the executives, a total of $34.5 million. The pill\'s time-release mechanism turned out to be easily circumvented by crushing the pill and snorting or injecting the resulting powder. By the late 1990s, OxyContin abuse was devastating small towns throughout Appalachia and rural New England. Pharmaceuticals, mainly opioids, are still widely abused - now more so than any illegal drug except marijuana. In 2005, according to the government\'s National Survey on Drug Use and Health, 6.4 million Americans, many of them teenagers, had abused pharmaceuticals recently. Most got the drug from friends or family - often, in the case of teenagers, from their parents\' medicine cabinets.\u003cbr /\>",1]
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In addition to medical considerations real or imagined, there is another deterrent to opioid use: fear. According to the D.E.A., 71 doctors were arrested last year for crimes related to "diversion" - the leakage of prescription medicine into illegal drug markets. The D.E.A. also opened 735 investigations of doctors, and an investigation alone can be enough to put a doctor out of business, as doctors can lose their licenses and practices and have their homes, offices and cars seized even if no federal criminal charges are ever filed. Both figures - arrests and investigations - have risen steadily over the last few years.Opioid drugs have been used to treat pain for decades, mostly for acute postsurgical pain or the pain of cancer patients. But in January 1996, Purdue Pharma helped increase the use of these drugs by introducing OxyContin - oxycodone with a time-release mechanism. Oncologists and pain doctors were the principal prescribers of opioids. But Purdue introduced the drug with an aggressive marketing campaign promoting OxyContin to general practitioners and the idea of opioid pain relief to doctors and consumers. The product's time-release mechanism, Purdue claimed, allowed steadier pain relief and deterred abuse.Many pain sufferers found that OxyContin gave them better relief than they ever had before. But Purdue misrepresented the drug's potential for abuse. Last month, the company and three of its executives pleaded guilty to federal charges that they misled doctors and patients. The company agreed to pay $600 million in fines; and the executives, a total of $34.5 million. The pill's time-release mechanism turned out to be easily circumvented by crushing the pill and snorting or injecting the resulting powder. By the late 1990s, OxyContin abuse was devastating small towns throughout Appalachia and rural New England. Pharmaceuticals, mainly opioids, are still widely abused - now more so than any illegal drug except marijuana. In 2005, according to the government's National Survey on Drug Use and Health, 6.4 million Americans, many of them teenagers, had abused pharmaceuticals recently. Most got the drug from friends or family - often, in the case of teenagers, from their parents' medicine cabinets.
At the time the OxyContin epidemic emerged, the D.E.A. had far more experience seizing illegal drugs like cocaine and heroin. According to Mark Caverly, the head of the liaison and policy section for the D.E.A.\'s Office of Diversion Control, the OxyContin epidemic, however, required the agency to step up its antidiversion efforts. In 2001 the D.E.A. established the OxyContin Action Plan. The D.E.A. dispatched investigators to the most troubled states and trained local law-enforcement officials.\u003cbr /\>\u003cbr /\>The basis of the physician-patient relationship is trust. Trust is especially valued by pain patients, who often have long experience of being treated like criminals or hysterics. But when prescribing opioids, a physician\'s trust is easily abused. Pain doctors dispense drugs with a high street value that are attractive to addicts. All pain doctors encounter scammers; some doctors estimate that as many as 20 percent of their patients are selling their medicine or are addicted to opioids or other drugs. Experts are virtually unanimous in agreeing that even addicts who are suffering pain can be successfully treated with opioids. Indeed, opioids can be lifesaving for addicts - witness the methadone maintenance therapy given to heroin addicts. But treating addicts requires extra care.\u003cbr /\>\u003cbr /\>Identifying the scammers is especially tricky because there is no objective test for pain - it doesn\'t show up on an X-ray. In one British study, half the respondents who complained of lower-back pain had normal M.R.I.\'s. Conversely, a third of those with no pain showed disk degeneration on their M.R.I.\'s. The study suggested there could be a profound disconnection between what an M.R.I. sees and what a patient feels.\u003cbr /\>\u003cbr /\>There are red flags that indicate possible abuse or diversion: patients who drive long distances to see the doctor, or ask for specific drugs by name, or claim to need more and more of them. But people with real pain also occasionally do these things. The doctor\'s dilemma is how to stop the diverters without condemning other patients to suffer unnecessarily, since a drug diverter and a legitimate patient can look very much alike. The dishonest prescriber and the honest one can also look alike. Society has a parallel dilemma: how to stop drug-dealing doctors without discouraging real ones and worsening America\'s undertreatment of pain.\u003cbr /\>",1]
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At the time the OxyContin epidemic emerged, the D.E.A. had far more experience seizing illegal drugs like cocaine and heroin. According to Mark Caverly, the head of the liaison and policy section for the D.E.A.'s Office of Diversion Control, the OxyContin epidemic, however, required the agency to step up its antidiversion efforts. In 2001 the D.E.A. established the OxyContin Action Plan. The D.E.A. dispatched investigators to the most troubled states and trained local law-enforcement officials.The basis of the physician-patient relationship is trust. Trust is especially valued by pain patients, who often have long experience of being treated like criminals or hysterics. But when prescribing opioids, a physician's trust is easily abused. Pain doctors dispense drugs with a high street value that are attractive to addicts. All pain doctors encounter scammers; some doctors estimate that as many as 20 percent of their patients are selling their medicine or are addicted to opioids or other drugs. Experts are virtually unanimous in agreeing that even addicts who are suffering pain can be successfully treated with opioids. Indeed, opioids can be lifesaving for addicts - witness the methadone maintenance therapy given to heroin addicts. But treating addicts requires extra care.Identifying the scammers is especially tricky because there is no objective test for pain - it doesn't show up on an X-ray. In one British study, half the respondents who complained of lower-back pain had normal M.R.I.'s. Conversely, a third of those with no pain showed disk degeneration on their M.R.I.'s. The study suggested there could be a profound disconnection between what an M.R.I. sees and what a patient feels.There are red flags that indicate possible abuse or diversion: patients who drive long distances to see the doctor, or ask for specific drugs by name, or claim to need more and more of them. But people with real pain also occasionally do these things. The doctor's dilemma is how to stop the diverters without condemning other patients to suffer unnecessarily, since a drug diverter and a legitimate patient can look very much alike. The dishonest prescriber and the honest one can also look alike. Society has a parallel dilemma: how to stop drug-dealing doctors without discouraging real ones and worsening America's undertreatment of pain.
In July 2002, an insurance agent was sifting through records in Columbia, S.C., and paused at the file of one Larry Shealy. Shealy was getting OxyContin from a doctor named Ronald McIver - a lot of it. "The amounts were incredible; it jumped out in my face," the agent, who spoke on condition of anonymity, told me. "He was either selling them or taking so much he couldn\'t live." The agent did two things. He recommended to Shealy\'s employers that they exclude OxyContin coverage from their health insurance plan - which they did. And he called the D.E.A. Two days later, a D.E.A. agent showed up in the insurance agent\'s office with an administrative subpoena to collect Shealy\'s file.\u003cbr /\>\u003cbr /\>McIver wanted to be a doctor all his life, two of his daughters told me. But he taught and traveled for years before he finally enrolled at Michigan State University to become a D.O., or doctor of osteopathy, a more holistic alternative to a traditional medical education. (Osteopaths can do everything that traditional M.D.\'s can do, including prescribe opioids.) He began practicing pain medicine in the late 1980s. He had a practice in Florence, S.C., which ended when he declared bankruptcy in 2000. He moved to Greenwood to start over, establishing his new office in a storefront next to a chiropractor.\u003cbr /\>\u003cbr /\>McIver was, by the account of his patients, an unusual doctor in the age of the 10-minute managed-care visit. He usually saw about 6 to 12 patients each day. One patient I spoke with - who never got high-dose opioids - said that his first visit with McIver lasted four hours, and in subsequent visits he spent an hour or more doing various therapies. Many patients said their visits lasted an hour. Patients taking opioids had to sign a pain contract and bring their pills in at each visit to be counted.\u003cbr /\>\u003cbr /\>Many doctors take little interest in the administrative side of their practices, but McIver\'s neglect was epic. To save money, he employed mostly family. His wife, Carolyn, whose only medical training was from her husband, served as his assistant, giving shots and administering therapies. "His doctor\'s office did not resemble my family\'s doctor\'s office," said Sgt. Bobby Grogan, who was the investigator on the case for the Greenwood County Sheriff. While McIver\'s treatment rooms were normal, his and his wife\'s offices - off limits to patients - were a mess, according to pictures presented at McIver\'s trial by Adam Roberson, the D.E.A.\'s principal investigator. Used syringes, for example, overflowed their storage box. "His patient records were manila envelopes stuffed with receipts," Grogan told me.\u003cbr /\>",1]
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In July 2002, an insurance agent was sifting through records in Columbia, S.C., and paused at the file of one Larry Shealy. Shealy was getting OxyContin from a doctor named Ronald McIver - a lot of it. "The amounts were incredible; it jumped out in my face," the agent, who spoke on condition of anonymity, told me. "He was either selling them or taking so much he couldn't live." The agent did two things. He recommended to Shealy's employers that they exclude OxyContin coverage from their health insurance plan - which they did. And he called the D.E.A. Two days later, a D.E.A. agent showed up in the insurance agent's office with an administrative subpoena to collect Shealy's file.McIver wanted to be a doctor all his life, two of his daughters told me. But he taught and traveled for years before he finally enrolled at Michigan State University to become a D.O., or doctor of osteopathy, a more holistic alternative to a traditional medical education. (Osteopaths can do everything that traditional M.D.'s can do, including prescribe opioids.) He began practicing pain medicine in the late 1980s. He had a practice in Florence, S.C., which ended when he declared bankruptcy in 2000. He moved to Greenwood to start over, establishing his new office in a storefront next to a chiropractor.McIver was, by the account of his patients, an unusual doctor in the age of the 10-minute managed-care visit. He usually saw about 6 to 12 patients each day. One patient I spoke with - who never got high-dose opioids - said that his first visit with McIver lasted four hours, and in subsequent visits he spent an hour or more doing various therapies. Many patients said their visits lasted an hour. Patients taking opioids had to sign a pain contract and bring their pills in at each visit to be counted.Many doctors take little interest in the administrative side of their practices, but McIver's neglect was epic. To save money, he employed mostly family. His wife, Carolyn, whose only medical training was from her husband, served as his assistant, giving shots and administering therapies. "His doctor's office did not resemble my family's doctor's office," said Sgt. Bobby Grogan, who was the investigator on the case for the Greenwood County Sheriff. While McIver's treatment rooms were normal, his and his wife's offices - off limits to patients - were a mess, according to pictures presented at McIver's trial by Adam Roberson, the D.E.A.'s principal investigator. Used syringes, for example, overflowed their storage box. "His patient records were manila envelopes stuffed with receipts," Grogan told me.
When I interviewed him in prison recently, McIver told me that his records were complete but scattered. He said that he and his wife, distracted by a series of family tragedies, had employed a series of temporary receptionists who had botched the filing. He and his wife were trying to piece them together. "The records were probably half in the office and half at home for me to work on at night," he said. "I kept a box in the back of the car I worked on while Carolyn drove."\u003cbr /\>\u003cbr /\>Leslie Smith first came to see McIver in the fall of 2001. Smith was in his mid-40s and lived in Chapin, a small town near Columbia, a 60-mile drive from Greenwood. He filled out a medical-history form and told McIver that his wrists hurt so badly that he was getting only three or four hours\' sleep a night. He also said that a previous doctor helped him by prescribing OxyContin, and he mentioned the name of a doctor he said referred him. McIver examined Smith\'s wrists. Smith walked out with an opioid prescription and an appointment to come back the next week.\u003cbr /\>\u003cbr /\>Smith\'s wrists did not hurt him, as he testified at McIver\'s trial. He was addicted to OxyContin and Dilaudid, which he injected. He complained of wrist pain because it was plausible: he had injured one wrist previously, requiring an operation that left scars, and he had arthritis in the other. Until June 2002, Smith kept getting prescriptions.\u003cbr /\>\u003cbr /\>Smith saw McIver every few weeks. He testified that he had track marks on his arm at the time but always wore long sleeves to cover them. He said McIver never saw them. McIver put him on an electric nerve stimulator every visit for 15 or 30 minutes on each hand and did osteopathic manipulations. He prescribed exercises. Smith bought a nerve-stimulator machine to use at home and told McIver it was helping. At McIver\'s request he filled out a pain chart and reported that his pain rated a 5 or 6 upon awakening, reached 7 during the day and occasionally hit 9. "I answered all the questions exactly like I thought he\'d want to hear them answered," Smith testified. At one point McIver found a syringe in Smith\'s pocket. Smith told McIver that he was going fishing later that day and that he used the syringe as part of his fishing equipment. That apparently satisfied McIver, who testified that his grandfather kept syringes in his tackle box to pump air into his bait.\u003cbr /\>",1]
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When I interviewed him in prison recently, McIver told me that his records were complete but scattered. He said that he and his wife, distracted by a series of family tragedies, had employed a series of temporary receptionists who had botched the filing. He and his wife were trying to piece them together. "The records were probably half in the office and half at home for me to work on at night," he said. "I kept a box in the back of the car I worked on while Carolyn drove."Leslie Smith first came to see McIver in the fall of 2001. Smith was in his mid-40s and lived in Chapin, a small town near Columbia, a 60-mile drive from Greenwood. He filled out a medical-history form and told McIver that his wrists hurt so badly that he was getting only three or four hours' sleep a night. He also said that a previous doctor helped him by prescribing OxyContin, and he mentioned the name of a doctor he said referred him. McIver examined Smith's wrists. Smith walked out with an opioid prescription and an appointment to come back the next week.Smith's wrists did not hurt him, as he testified at McIver's trial. He was addicted to OxyContin and Dilaudid, which he injected. He complained of wrist pain because it was plausible: he had injured one wrist previously, requiring an operation that left scars, and he had arthritis in the other. Until June 2002, Smith kept getting prescriptions.Smith saw McIver every few weeks. He testified that he had track marks on his arm at the time but always wore long sleeves to cover them. He said McIver never saw them. McIver put him on an electric nerve stimulator every visit for 15 or 30 minutes on each hand and did osteopathic manipulations. He prescribed exercises. Smith bought a nerve-stimulator machine to use at home and told McIver it was helping. At McIver's request he filled out a pain chart and reported that his pain rated a 5 or 6 upon awakening, reached 7 during the day and occasionally hit 9. "I answered all the questions exactly like I thought he'd want to hear them answered," Smith testified. At one point McIver found a syringe in Smith's pocket. Smith told McIver that he was going fishing later that day and that he used the syringe as part of his fishing equipment. That apparently satisfied McIver, who testified that his grandfather kept syringes in his tackle box to pump air into his bait.
Smith filled some of his prescriptions at the Hawthorne Pharmacy in West Columbia. There, Addison Livingston, the pharmacist, got suspicious. He noticed that Smith sometimes came in with other patients of McIver\'s, despite the fact that McIver worked nearly two hours\' drive away. The patients obviously knew each other and would pick up large opioid prescriptions, paying cash and asking for brand-name drugs. Livingston called McIver, who confirmed he had written the prescriptions. At one point, McIver told Livingston that he, too, was suspicious, and that he had sent a letter about Smith to the state\'s Bureau of Drug Control.\u003cbr /\>\u003cbr /\>In February 2002, McIver wrote to Larry McElrath, a B.D.C. inspector, who read the letter at the trial. "Dear Larry," it read, "There are several people out of the Columbia/Chapin area who have aroused my curiosity about their use and possible misuse of medications. Some are referred by [another doctor] and seem legitimate. . . . They all pay cash despite some of them having insurance with prescription cards. . . . When they are in the office, they sometimes make a show of not knowing each other. . . . The situation is made complicated by the fact that each has some real pathology with objective findings that would justify the use of opiates if their pains are as bad as they say. I have given them the benefit of the doubt, but I\'m becoming less inclined to do so. I would appreciate it if you could make some discrete inquiries and let me know whether my concerns are justified. . . . I certainly don\'t want to refuse help to someone who needs it. On the other hand, I want even less to be implicated in diversion or other improprieties." He listed their names and Social Security numbers.\u003cbr /\>\u003cbr /\>McElrath did nothing with the letter. "It\'s incumbent upon the physician to have a trust with his patients," McElrath testified at the trial. "Here there was nothing that I could assume or conclude that any crimes had been committed."\u003cbr /\>\u003cbr /\>Smith was the most damning of the several patients who testified against McIver. (Smith and the other patients mentioned here did not agree to be interviewed for this article, as they are suing McIver for alleged overprescription of addictive drugs. Such suits often prosper after successful criminal convictions, as civil suits are easier to win.) Smith had a confederate in Seth Boyer, who lived in Chapin and followed a similar pattern in his dealings with McIver: he exaggerated pains in his foot, never provided records from a previous doctor and had needle tracks that he later testified McIver never saw. At one point, Boyer told McIver that he had spilled a bottle of liquid OxyFast, another opioid. (In reality, Boyer had injected it.) McIver wrote him a prescription for a replacement - apparently a violation of his standard pain-medication contract, which had a "no early refills" stipulation.\u003cbr /\>",1]
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Smith filled some of his prescriptions at the Hawthorne Pharmacy in West Columbia. There, Addison Livingston, the pharmacist, got suspicious. He noticed that Smith sometimes came in with other patients of McIver's, despite the fact that McIver worked nearly two hours' drive away. The patients obviously knew each other and would pick up large opioid prescriptions, paying cash and asking for brand-name drugs. Livingston called McIver, who confirmed he had written the prescriptions. At one point, McIver told Livingston that he, too, was suspicious, and that he had sent a letter about Smith to the state's Bureau of Drug Control.In February 2002, McIver wrote to Larry McElrath, a B.D.C. inspector, who read the letter at the trial. "Dear Larry," it read, "There are several people out of the Columbia/Chapin area who have aroused my curiosity about their use and possible misuse of medications. Some are referred by [another doctor] and seem legitimate. . . . They all pay cash despite some of them having insurance with prescription cards. . . . When they are in the office, they sometimes make a show of not knowing each other. . . . The situation is made complicated by the fact that each has some real pathology with objective findings that would justify the use of opiates if their pains are as bad as they say. I have given them the benefit of the doubt, but I'm becoming less inclined to do so. I would appreciate it if you could make some discrete inquiries and let me know whether my concerns are justified. . . . I certainly don't want to refuse help to someone who needs it. On the other hand, I want even less to be implicated in diversion or other improprieties." He listed their names and Social Security numbers.McElrath did nothing with the letter. "It's incumbent upon the physician to have a trust with his patients," McElrath testified at the trial. "Here there was nothing that I could assume or conclude that any crimes had been committed."Smith was the most damning of the several patients who testified against McIver. (Smith and the other patients mentioned here did not agree to be interviewed for this article, as they are suing McIver for alleged overprescription of addictive drugs. Such suits often prosper after successful criminal convictions, as civil suits are easier to win.) Smith had a confederate in Seth Boyer, who lived in Chapin and followed a similar pattern in his dealings with McIver: he exaggerated pains in his foot, never provided records from a previous doctor and had needle tracks that he later testified McIver never saw. At one point, Boyer told McIver that he had spilled a bottle of liquid OxyFast, another opioid. (In reality, Boyer had injected it.) McIver wrote him a prescription for a replacement - apparently a violation of his standard pain-medication contract, which had a "no early refills" stipulation.
But McIver ended up discharging Boyer in June 2002, when Boyer altered a prescription so he could fill it three days early. He wrote McIver three pleading letters of protest, to no avail. "I was looking for an excuse to discharge them, and with Seth I found it," McIver told me. "I needed more than suspicion. With Les, he never actually did anything that allowed me to say, \'O.K., here\'s that concrete piece of evidence.\' "\u003cbr /\>\u003cbr /\>McIver may have felt he needed more proof, but medically he probably had enough. Pain specialists told me that doctors can stop prescribing a drug whenever the risks outweigh the benefits, which includes the risk of abuse.\u003cbr /\>\u003cbr /\>Another drug-dealing patient of McIver\'s was Kyle Barnes. She testified that she suffered from fibromyalgia, a chronic-pain syndrome, but exaggerated her pain to get higher levels of OxyContin and Roxicodone. She was addicted to those drugs before she began seeing McIver in July 2001. She also brought no medical records and drove three hours to each appointment. She got prescriptions on her second visit, during which McIver also did osteopathic manipulations and massage.\u003cbr /\>\u003cbr /\>Barnes was in real pain. McIver did several different therapies at each visit. He set up an appointment for her at a sleep clinic, sent her for X-rays and put a cast on her wrist. He knew she had trouble paying for her medicines, and he contacted Purdue Pharma to see if she qualified for reduced-price drugs. She kept claiming the drugs were not helping enough and was soon taking 16 times the dose of OxyContin she took when she first saw him. One tip-off in her case should have been that she paid thousands of dollars a month in cash for her prescriptions, even though she was on Medicaid. She told McIver that her father and boyfriend were helping her buy them, which she later testified was partly true. But most of her income came from selling some of the drugs he prescribed, she testified. In December 2003, McIver told her that he would stop treating her unless she took a drug screen. She did nothing. Three weeks later he told her again. She never returned.\u003cbr /\>",1]
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But McIver ended up discharging Boyer in June 2002, when Boyer altered a prescription so he could fill it three days early. He wrote McIver three pleading letters of protest, to no avail. "I was looking for an excuse to discharge them, and with Seth I found it," McIver told me. "I needed more than suspicion. With Les, he never actually did anything that allowed me to say, 'O.K., here's that concrete piece of evidence.' "McIver may have felt he needed more proof, but medically he probably had enough. Pain specialists told me that doctors can stop prescribing a drug whenever the risks outweigh the benefits, which includes the risk of abuse.Another drug-dealing patient of McIver's was Kyle Barnes. She testified that she suffered from fibromyalgia, a chronic-pain syndrome, but exaggerated her pain to get higher levels of OxyContin and Roxicodone. She was addicted to those drugs before she began seeing McIver in July 2001. She also brought no medical records and drove three hours to each appointment. She got prescriptions on her second visit, during which McIver also did osteopathic manipulations and massage.Barnes was in real pain. McIver did several different therapies at each visit. He set up an appointment for her at a sleep clinic, sent her for X-rays and put a cast on her wrist. He knew she had trouble paying for her medicines, and he contacted Purdue Pharma to see if she qualified for reduced-price drugs. She kept claiming the drugs were not helping enough and was soon taking 16 times the dose of OxyContin she took when she first saw him. One tip-off in her case should have been that she paid thousands of dollars a month in cash for her prescriptions, even though she was on Medicaid. She told McIver that her father and boyfriend were helping her buy them, which she later testified was partly true. But most of her income came from selling some of the drugs he prescribed, she testified. In December 2003, McIver told her that he would stop treating her unless she took a drug screen. She did nothing. Three weeks later he told her again. She never returned.
Another patient whose story was particularly troubling was Barbee Brown. Brown was not a drug seeker but a genuine pain patient seeking relief from Reflex Sympathetic Dystrophy. McIver gave her very high doses of OxyContin right away, before she produced any records from other doctors. This was especially disturbing, because she had been addicted to crack cocaine for three months in the year before she came to him.\u003cbr /\>\u003cbr /\>Brown saw McIver at least twice a week for six weeks. He did a thorough physical exam and took a complete history. He used many different kinds of therapies. But he also started her - someone who had never taken opioids - on 40-milligram pills of OxyContin and allowed her to control her own dosing schedule. "As long as you are not having side effects, do not be afraid to take the doses you need to get out of pain," he wrote to her. It was the same advice he gave many patients. "The number of milligrams does not matter. What matters is the number on the 0-to-10 scale."\u003cbr /\>\u003cbr /\>The medicine helped. Brown testified that she ranked her pain at 9 or 10 when she first got to McIver. After seeing him, it dropped to a 4. Her pain diary, which appears to be sincere, had various passages giving thanks that she met McIver. Brown did not become addicted. But allowing an opioid-naïve recovering crack addict to start on high-dose pills and control her own dosage, and telling her that her dosage didn\'t matter, seems reckless.\u003cbr /\>\u003cbr /\>McIver\'s 30-year sentence was the result of the death of Larry Shealy, a 56-year-old man who suffered intense back and knee pain, in addition to many other health problems. He first came to see McIver in February 2002, with full referrals and records. He was on OxyContin before seeing McIver but complained that his pain was still terrible, so McIver doubled his dose. This allowed Shealy to go back to work in an auto body shop.\u003cbr /\>\u003cbr /\>Shealy was not a careful patient. A month after he started with McIver, he took 15 OxyContin tablets in one day instead of the 6 he was prescribed. He was not harmed, but McIver testified that he asked Shealy to bring his family in so he could explain the dosing to them. At one point, McIver tried to taper down the OxyContin and replace it with methadone, but Shealy complained that the methadone made him drowsy. Shealy\'s son, David, an auto mechanic, testified that the OxyContin pain relief also came at a price. He said he felt his father was overmedicated - often sleepy. Once, his father backed his truck into a tree.\u003cbr /\>",1]
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Another patient whose story was particularly troubling was Barbee Brown. Brown was not a drug seeker but a genuine pain patient seeking relief from Reflex Sympathetic Dystrophy. McIver gave her very high doses of OxyContin right away, before she produced any records from other doctors. This was especially disturbing, because she had been addicted to crack cocaine for three months in the year before she came to him.Brown saw McIver at least twice a week for six weeks. He did a thorough physical exam and took a complete history. He used many different kinds of therapies. But he also started her - someone who had never taken opioids - on 40-milligram pills of OxyContin and allowed her to control her own dosing schedule. "As long as you are not having side effects, do not be afraid to take the doses you need to get out of pain," he wrote to her. It was the same advice he gave many patients. "The number of milligrams does not matter. What matters is the number on the 0-to-10 scale."The medicine helped. Brown testified that she ranked her pain at 9 or 10 when she first got to McIver. After seeing him, it dropped to a 4. Her pain diary, which appears to be sincere, had various passages giving thanks that she met McIver. Brown did not become addicted. But allowing an opioid-naïve recovering crack addict to start on high-dose pills and control her own dosage, and telling her that her dosage didn't matter, seems reckless.McIver's 30-year sentence was the result of the death of Larry Shealy, a 56-year-old man who suffered intense back and knee pain, in addition to many other health problems. He first came to see McIver in February 2002, with full referrals and records. He was on OxyContin before seeing McIver but complained that his pain was still terrible, so McIver doubled his dose. This allowed Shealy to go back to work in an auto body shop.Shealy was not a careful patient. A month after he started with McIver, he took 15 OxyContin tablets in one day instead of the 6 he was prescribed. He was not harmed, but McIver testified that he asked Shealy to bring his family in so he could explain the dosing to them. At one point, McIver tried to taper down the OxyContin and replace it with methadone, but Shealy complained that the methadone made him drowsy. Shealy's son, David, an auto mechanic, testified that the OxyContin pain relief also came at a price. He said he felt his father was overmedicated - often sleepy. Once, his father backed his truck into a tree.
Shealy died in his sleep early on the morning of May 29, 2003. He had OxyContin pills in his stomach, and his bloodstream contained alprazolam - Xanax - as well. The pathologist at McIver\'s trial testified that the levels of drugs were consistent with the prescriptions McIver had been writing - the high levels that so alarmed the insurance agent. Shealy was taking five 80-milligram tablets of OxyContin every 12 hours, plus up to six 30-milligram tablets of Roxicodone every 4 hours for breakthrough pain, plus as much as 2 milligrams of alprazolam every 8 hours. The prosecution\'s toxicologist, Demi Garvin, concluded that the OxyContin and Roxicodone caused Shealy\'s death by respiratory depression. The pathologist testified that she looked up this dosage and found it to be a fatal level.\u003cbr /\>\u003cbr /\>But there is reason for doubt. According to Shealy\'s prescriptions, he had been taking the same dosage for at least two months, and possibly much longer. Pain specialists say that respiratory depression is extremely unlikely when dosage is consistent. In her testimony, Garvin agreed that what would be a toxic level in an opioid-naïve patient would be safe for someone titrated up properly. But she said she could not conclude he had been properly titrated, in part because she had not seen his medical records. Garvin declined to talk about the Shealy case with me because she is a witness for the Shealy family in their planned civil suit against McIver. But in a deposition for that lawsuit, she appeared to back away from blaming the OxyContin. She described her view as: "Hey, there\'s a red flag here. This can certainly be your cause of death, but you need to go further in exploring whether or not it is."\u003cbr /\>\u003cbr /\>There was something else that might have caused Shealy\'s death: he suffered from advanced congestive heart failure. The pathologist testified that he had 90 percent blockage in one coronary artery and 50 percent in another, and a greatly enlarged heart and other organs. He had a scar on the back wall of his heart that indicated he at one time suffered a heart attack. Opioids do not worsen heart disease and would likely have helped, because pain causes stress to the heart.\u003cbr /\>",1]
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Shealy died in his sleep early on the morning of May 29, 2003. He had OxyContin pills in his stomach, and his bloodstream contained alprazolam - Xanax - as well. The pathologist at McIver's trial testified that the levels of drugs were consistent with the prescriptions McIver had been writing - the high levels that so alarmed the insurance agent. Shealy was taking five 80-milligram tablets of OxyContin every 12 hours, plus up to six 30-milligram tablets of Roxicodone every 4 hours for breakthrough pain, plus as much as 2 milligrams of alprazolam every 8 hours. The prosecution's toxicologist, Demi Garvin, concluded that the OxyContin and Roxicodone caused Shealy's death by respiratory depression. The pathologist testified that she looked up this dosage and found it to be a fatal level.But there is reason for doubt. According to Shealy's prescriptions, he had been taking the same dosage for at least two months, and possibly much longer. Pain specialists say that respiratory depression is extremely unlikely when dosage is consistent. In her testimony, Garvin agreed that what would be a toxic level in an opioid-naïve patient would be safe for someone titrated up properly. But she said she could not conclude he had been properly titrated, in part because she had not seen his medical records. Garvin declined to talk about the Shealy case with me because she is a witness for the Shealy family in their planned civil suit against McIver. But in a deposition for that lawsuit, she appeared to back away from blaming the OxyContin. She described her view as: "Hey, there's a red flag here. This can certainly be your cause of death, but you need to go further in exploring whether or not it is."There was something else that might have caused Shealy's death: he suffered from advanced congestive heart failure. The pathologist testified that he had 90 percent blockage in one coronary artery and 50 percent in another, and a greatly enlarged heart and other organs. He had a scar on the back wall of his heart that indicated he at one time suffered a heart attack. Opioids do not worsen heart disease and would likely have helped, because pain causes stress to the heart.
The testimonies of the patients Smith, Boyer and Barnes were the parts of the trial that most directly addressed the question of whether McIver intentionally wrote prescriptions for a nonmedical purpose. This is the relevant legal test for the statute under which he was prosecuted. Several Supreme Court and district court cases have made it clear that under the Controlled Substances Act, a doctor is guilty of a crime if he intentionally acts as a drug pusher.\u003cbr /\>\u003cbr /\>The judge in the McIver case, Henry F. Floyd, told the jurors that bad prescribing is the standard for malpractice, a civil matter. "That is not what we are talking about," he said. "We\'re not talking about this physician acting better or worse than other physicians." If McIver was a bad doctor - but still a doctor, with intent to treat patients - he was innocent. "If you find that a defendant acted in good faith in dispensing the drugs charged in this indictment, then you must find that defendant not guilty," Floyd said. But Floyd also told the jury to take bad doctoring into account in deciding McIver\'s intent.\u003cbr /\>\u003cbr /\>This instruction - that bad doctoring does not prove intent but could be considered when weighing his intent - is subtle and potentially extremely confusing. It apparently confused the jurors. I spoke to two jurors, who told me their own views and characterized the jury discussion. The overwhelming factor, they said, was that McIver prescribed too much - the very red flag that alerted the insurance agent and set the case in motion.\u003cbr /\>\u003cbr /\>The jurors I spoke with said that by far the most important testimony came from Steven Storick, a pain-management doctor in Columbia and the government\'s expert witness. Reviewing the records of patient after patient, Storick consistently testified that there were too many drugs. "This amount of medication is just extremely high in a situation like this," he said of one patient. This is "excessive," he said of another. "That\'s just an extremely high dose of drug," he said of a third. Storick, who declined to be interviewed for this article, testified that if he had a patient who exhibited no objective evidence of pain, he would not prescribe opioids. He would not have titrated patients as rapidly as McIver did or given them discretion. He disagreed with McIver\'s position that a doctor should try to bring a patient\'s chronic pain down to a level of 2. He would stop titrating when a patient reached 5 out of 10.\u003cbr /\>\u003cbr /\>The jurors took Storick\'s caution to heart, in part, they told me, because it resonated with their own experience with opioids and fears of addiction. I asked Jo Handy, a tall, elegant woman who is now 39 and a real estate agent outside Greenville, why McIver was convicted. "It was the excessive prescriptions," she said in a\u003cbr /\>\u003cbr /\>\u003cbr /\>\u003c/div\>",0]
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The testimonies of the patients Smith, Boyer and Barnes were the parts of the trial that most directly addressed the question of whether McIver intentionally wrote prescriptions for a nonmedical purpose. This is the relevant legal test for the statute under which he was prosecuted. Several Supreme Court and district court cases have made it clear that under the Controlled Substances Act, a doctor is guilty of a crime if he intentionally acts as a drug pusher.The judge in the McIver case, Henry F. Floyd, told the jurors that bad prescribing is the standard for malpractice, a civil matter. "That is not what we are talking about," he said. "We're not talking about this physician acting better or worse than other physicians." If McIver was a bad doctor - but still a doctor, with intent to treat patients - he was innocent. "If you find that a defendant acted in good faith in dispensing the drugs charged in this indictment, then you must find that defendant not guilty," Floyd said. But Floyd also told the jury to take bad doctoring into account in deciding McIver's intent.This instruction - that bad doctoring does not prove intent but could be considered when weighing his intent - is subtle and potentially extremely confusing. It apparently confused the jurors. I spoke to two jurors, who told me their own views and characterized the jury discussion. The overwhelming factor, they said, was that McIver prescribed too much - the very red flag that alerted the insurance agent and set the case in motion.The jurors I spoke with said that by far the most important testimony came from Steven Storick, a pain-management doctor in Columbia and the government's expert witness. Reviewing the records of patient after patient, Storick consistently testified that there were too many drugs. "This amount of medication is just extremely high in a situation like this," he said of one patient. This is "excessive," he said of another. "That's just an extremely high dose of drug," he said of a third. Storick, who declined to be interviewed for this article, testified that if he had a patient who exhibited no objective evidence of pain, he would not prescribe opioids. He would not have titrated patients as rapidly as McIver did or given them discretion. He disagreed with McIver's position that a doctor should try to bring a patient's chronic pain down to a level of 2. He would stop titrating when a patient reached 5 out of 10.The jurors took Storick's caution to heart, in part, they told me, because it resonated with their own experience with opioids and fears of addiction. I asked Jo Handy, a tall, elegant woman who is now 39 and a real estate agent outside Greenville, why McIver was convicted. "It was the excessive prescriptions," she said in a
http://www.nytimes.com/2007/06/17/magazine/17pain-t.html
June 17, 2007
Cover Story: When Is a Pain Doctor a Drug Pusher?
By TINA ROSENBERG Correction Appended
Ronald McIver is a prisoner in a medium-security federal compound in Butner, N.C. He is 63 years old, of medium height and overweight, with a white Santa Claus beard, white hair and a calm, direct and intelligent manner. He is serving 30 years for drug trafficking, and so will likely live there the rest of his life. McIver (pronounced mi-KEE-ver) has not been convicted of drug trafficking in the classic sense. He is a doctor who for years treated patients suffering from chronic pain. At the Pain Therapy Center, his small storefront office not far from Main Street in Greenwood, S.C., he cracked backs, gave trigger-point injections and put patients through physical therapy. He administered ultrasound and gravity-inversion therapy and devised exercise regimens. And he wrote prescriptions for high doses of opioid drugs like OxyContin.
McIver was a particularly aggressive pain doctor. Pain can be measured only by how patients say they feel: on a scale from 0 to 10, a report of 0 signifies the absence of pain; 10 is unbearable pain. Many pain doctors will try to reduce a patient\'s pain to the level of 5. McIver tried for a 2. He prescribed more, and sooner, than most doctors.\u003cbr /\>\u003cbr /\>Some of his patients sold their pills. Some abused them. One man, Larry Shealy, died with high doses of opioids that McIver had prescribed him in his bloodstream. In April 2005, McIver was convicted in federal court of one count of conspiracy to distribute controlled substances and eight counts of distribution. (He was also acquitted of six counts of distribution.) The jury also found that Shealy was killed by the drugs McIver prescribed. McIver is serving concurrent sentences of 20 years for distribution and 30 years for dispensing drugs that resulted in Shealy\'s death. His appeals to the U.S. Court of Appeals for the Fourth Circuit and the Supreme Court were rejected.\u003cbr /\>\u003cbr /\>McIver\'s case is not simply the story of a narcotics conviction. It has enormous relevance to the lives of the one in five adult Americans who, according to a 2005 survey by Stanford University Medical Center, ABC News and USA Today, reported they suffered from chronic pain - pain lasting for several months or longer. According to a 2003 study in The Journal of the American Medical Association, pain costs American workers more than $61 billion a year in lost productive time - and that doesn\'t include medical bills.\u003cbr /\>\u003cbr /\>Contrary to the old saw, pain kills. A body in pain produces high levels of hormones that cause stress to the heart and lungs. Pain can cause blood pressure to spike, leading to heart attacks and strokes. Pain can also consume so much of the body\'s energy that the immune system degrades. Severe chronic pain sometimes leads to suicide. There are, of course, many ways to treat pain: some pain sufferers respond well to surgery, physical therapy, ultrasound, acupuncture, trigger-point injections, meditation or over-the-counter painkillers like Advil (ibuprofen) or Tylenol (acetaminophen). But for many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.\u003cbr /\>",1]
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McIver was a particularly aggressive pain doctor. Pain can be measured only by how patients say they feel: on a scale from 0 to 10, a report of 0 signifies the absence of pain; 10 is unbearable pain. Many pain doctors will try to reduce a patient's pain to the level of 5. McIver tried for a 2. He prescribed more, and sooner, than most doctors.Some of his patients sold their pills. Some abused them. One man, Larry Shealy, died with high doses of opioids that McIver had prescribed him in his bloodstream. In April 2005, McIver was convicted in federal court of one count of conspiracy to distribute controlled substances and eight counts of distribution. (He was also acquitted of six counts of distribution.) The jury also found that Shealy was killed by the drugs McIver prescribed. McIver is serving concurrent sentences of 20 years for distribution and 30 years for dispensing drugs that resulted in Shealy's death. His appeals to the U.S. Court of Appeals for the Fourth Circuit and the Supreme Court were rejected.McIver's case is not simply the story of a narcotics conviction. It has enormous relevance to the lives of the one in five adult Americans who, according to a 2005 survey by Stanford University Medical Center, ABC News and USA Today, reported they suffered from chronic pain - pain lasting for several months or longer. According to a 2003 study in The Journal of the American Medical Association, pain costs American workers more than $61 billion a year in lost productive time - and that doesn't include medical bills.Contrary to the old saw, pain kills. A body in pain produces high levels of hormones that cause stress to the heart and lungs. Pain can cause blood pressure to spike, leading to heart attacks and strokes. Pain can also consume so much of the body's energy that the immune system degrades. Severe chronic pain sometimes leads to suicide. There are, of course, many ways to treat pain: some pain sufferers respond well to surgery, physical therapy, ultrasound, acupuncture, trigger-point injections, meditation or over-the-counter painkillers like Advil (ibuprofen) or Tylenol (acetaminophen). But for many people in severe chronic pain, an opioid (an opiumlike compound) like OxyContin, Dilaudid, Vicodin, Percocet, oxycodone, methadone or morphine is the only thing that allows them to get out of bed. Yet most doctors prescribe opioids conservatively, and many patients and their families are just as cautious as their doctors. Men, especially, will simply tough it out, reasoning that pain is better than addiction.
Video\u003cbr /\>More Video »\u003cbr /\>It\'s a false choice. Virtually everyone who takes opioids will become physically dependent on them, which means that withdrawal symptoms like nausea and sweats can occur if usage ends abruptly. But tapering off gradually allows most people to avoid those symptoms, and physical dependence is not the same thing as addiction. Addiction - which is defined by cravings, loss of control and a psychological compulsion to take a drug even when it is harmful - occurs in patients with a predisposition (biological or otherwise) to become addicted. At the very least, these include just below 10 percent of Americans, the number estimated by the United States Department of Health and Human Services to have active substance-abuse problems. Even a predisposition to addiction, however, doesn\'t mean a patient will become addicted to opioids. Vast numbers do not. Pain patients without prior abuse problems most likely run little risk. "Someone who has never abused alcohol or other drugs would be extremely unlikely to become addicted to opioid pain medicines, particularly if he or she is older," says Russell K. Portenoy, chairman of pain medicine and palliative care at Beth Israel Medical Center in New York and a leading authority on the treatment of pain.\u003cbr /\>\u003cbr /\>The other popular misconception is that a high dose of opioids is always a dangerous dose. Even many doctors assume it; but they are nonetheless incorrect. It is true that high doses can cause respiratory failure in people who are not already taking the drugs. But that same high dose will not cause respiratory failure in someone whose drug levels have been increased gradually over time, a process called titration. For individuals who are properly titrated and monitored, there is no ceiling on opioid dosage. In this sense, high-dose prescription opioids can be safer than taking high doses of aspirin, Tylenol or Advil, which cause organ damage in high doses, regardless of how those doses are administered. (Every year, an estimated 5,000 to 6,000 Americans die from gastrointestinal bleeding associated with drugs like ibuprofen or aspirin, according to a paper published in The American Journal of Gastroenterology.)\u003cbr /\>",1]
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VideoMore Video »It's a false choice. Virtually everyone who takes opioids will become physically dependent on them, which means that withdrawal symptoms like nausea and sweats can occur if usage ends abruptly. But tapering off gradually allows most people to avoid those symptoms, and physical dependence is not the same thing as addiction. Addiction - which is defined by cravings, loss of control and a psychological compulsion to take a drug even when it is harmful - occurs in patients with a predisposition (biological or otherwise) to become addicted. At the very least, these include just below 10 percent of Americans, the number estimated by the United States Department of Health and Human Services to have active substance-abuse problems. Even a predisposition to addiction, however, doesn't mean a patient will become addicted to opioids. Vast numbers do not. Pain patients without prior abuse problems most likely run little risk. "Someone who has never abused alcohol or other drugs would be extremely unlikely to become addicted to opioid pain medicines, particularly if he or she is older," says Russell K. Portenoy, chairman of pain medicine and palliative care at Beth Israel Medical Center in New York and a leading authority on the treatment of pain.The other popular misconception is that a high dose of opioids is always a dangerous dose. Even many doctors assume it; but they are nonetheless incorrect. It is true that high doses can cause respiratory failure in people who are not already taking the drugs. But that same high dose will not cause respiratory failure in someone whose drug levels have been increased gradually over time, a process called titration. For individuals who are properly titrated and monitored, there is no ceiling on opioid dosage. In this sense, high-dose prescription opioids can be safer than taking high doses of aspirin, Tylenol or Advil, which cause organ damage in high doses, regardless of how those doses are administered. (Every year, an estimated 5,000 to 6,000 Americans die from gastrointestinal bleeding associated with drugs like ibuprofen or aspirin, according to a paper published in The American Journal of Gastroenterology.)
Still, doctors who put patients on long-term high-dose opioids must be very careful. They must monitor the patients often to ensure that the drugs are being used correctly and that side effects like constipation and mental cloudiness are not too severe. Doctors should also not automatically assume that if small doses aren\'t working, that high doses will - opioids don\'t help everyone. And research indicates that in some cases, high doses of opioids can lose their effectiveness and that some patients are better off if they take drug "holidays" or alternate between different medicines. Pain doctors also concede that more studies are needed to determine the safety of long-term opioid use.\u003cbr /\>\u003cbr /\>But with careful treatment, many patients whose opioid levels are increased gradually can function well on high doses for years. "Dose alone says nothing about proper medical practice," Portenoy says. "Very few patients require doses that exceed even 200 milligrams of OxyContin on a daily basis. Having said this, pain specialists are very familiar with a subpopulation of patients who require higher doses to gain effect. I myself have several patients who take more than 1,000 milligrams of OxyContin or its equivalent every day. One is a high-functioning executive who is pain-free most of the time, and the others have a level of pain control that allows a reasonable quality of life."\u003cbr /\>\u003cbr /\>All modern pain-management textbooks advocate "titration to effect" - in other words, in cases where opioids are helping, gradually increasing the dosage until either the pain is acceptably controlled or the side effects begin to outweigh the pain-relief benefits. But the vast majority of doctors don\'t practice what the textbooks counsel. In part, this is because of the stigma associated with high-dose opioids, the fear that patients will become addicted and the fact that careful monitoring is very time-consuming. And most doctors have received virtually no training in medical school about managing pain: many hold the same misconceptions about addiction and dosage as the general public.\u003cbr /\>",1]
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Still, doctors who put patients on long-term high-dose opioids must be very careful. They must monitor the patients often to ensure that the drugs are being used correctly and that side effects like constipation and mental cloudiness are not too severe. Doctors should also not automatically assume that if small doses aren't working, that high doses will - opioids don't help everyone. And research indicates that in some cases, high doses of opioids can lose their effectiveness and that some patients are better off if they take drug "holidays" or alternate between different medicines. Pain doctors also concede that more studies are needed to determine the safety of long-term opioid use.But with careful treatment, many patients whose opioid levels are increased gradually can function well on high doses for years. "Dose alone says nothing about proper medical practice," Portenoy says. "Very few patients require doses that exceed even 200 milligrams of OxyContin on a daily basis. Having said this, pain specialists are very familiar with a subpopulation of patients who require higher doses to gain effect. I myself have several patients who take more than 1,000 milligrams of OxyContin or its equivalent every day. One is a high-functioning executive who is pain-free most of the time, and the others have a level of pain control that allows a reasonable quality of life."All modern pain-management textbooks advocate "titration to effect" - in other words, in cases where opioids are helping, gradually increasing the dosage until either the pain is acceptably controlled or the side effects begin to outweigh the pain-relief benefits. But the vast majority of doctors don't practice what the textbooks counsel. In part, this is because of the stigma associated with high-dose opioids, the fear that patients will become addicted and the fact that careful monitoring is very time-consuming. And most doctors have received virtually no training in medical school about managing pain: many hold the same misconceptions about addiction and dosage as the general public.
And even pain specialists can be conservative. Sean E. Greenwood died in August at age 50 of a cerebral hemorrhage that his wife, Siobhan Reynolds, attributes to untreated pain. Greenwood was seeing various pain specialists. What makes his undertreatment especially remarkable is that he and his wife founded the Pain Relief Network, an advocacy group that has been the most vocal opponent of prosecutions of doctors and financed part of the legal defense of many pain doctors. "Here I am - I know everyone, and even I couldn\'t get him care that didn\'t first regard him as a potential criminal," Reynolds said.\u003cbr /\>\u003cbr /\>According to the pharmaceutical research company IMS Health, prescriptions for opioids have risen over the past few years. They are used now more than ever before. Yet study after study has concluded that pain is still radically undertreated. The Stanford University Medical Center survey found that only 50 percent of chronic-pain sufferers who had spoken to a doctor about their pain got sufficient relief. According to the American Pain Society, an advocacy group, fewer than half of cancer patients in pain get adequate pain relief.\u003cbr /\>\u003cbr /\>Several states are now preparing new opioid-dosing guidelines that may inadvertently worsen undertreatment. This year, the state of Washington advised nonspecialist doctors that daily opioid doses should not exceed the equivalent of 120 milligrams of oral morphine daily - for oxycodone or OxyContin, that\'s just 80 milligrams per day - without the patient\'s also consulting a pain specialist. Along with the guidelines, officials published a statewide directory of such specialists. It contains 12 names. "There are just not enough pain specialists," says Scott M. Fishman, chief of pain medicine at the University of California at Davis and a past president of the American Academy of Pain Medicine. And the guidelines may keep nonspecialists from prescribing higher doses. "Many doctors will assume that if the state of Washington suggests this level of care, then it is unacceptable to proceed otherwise," Fishman says.\u003cbr /\>",1]
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And even pain specialists can be conservative. Sean E. Greenwood died in August at age 50 of a cerebral hemorrhage that his wife, Siobhan Reynolds, attributes to untreated pain. Greenwood was seeing various pain specialists. What makes his undertreatment especially remarkable is that he and his wife founded the Pain Relief Network, an advocacy group that has been the most vocal opponent of prosecutions of doctors and financed part of the legal defense of many pain doctors. "Here I am - I know everyone, and even I couldn't get him care that didn't first regard him as a potential criminal," Reynolds said.According to the pharmaceutical research company IMS Health, prescriptions for opioids have risen over the past few years. They are used now more than ever before. Yet study after study has concluded that pain is still radically undertreated. The Stanford University Medical Center survey found that only 50 percent of chronic-pain sufferers who had spoken to a doctor about their pain got sufficient relief. According to the American Pain Society, an advocacy group, fewer than half of cancer patients in pain get adequate pain relief.Several states are now preparing new opioid-dosing guidelines that may inadvertently worsen undertreatment. This year, the state of Washington advised nonspecialist doctors that daily opioid doses should not exceed the equivalent of 120 milligrams of oral morphine daily - for oxycodone or OxyContin, that's just 80 milligrams per day - without the patient's also consulting a pain specialist. Along with the guidelines, officials published a statewide directory of such specialists. It contains 12 names. "There are just not enough pain specialists," says Scott M. Fishman, chief of pain medicine at the University of California at Davis and a past president of the American Academy of Pain Medicine. And the guidelines may keep nonspecialists from prescribing higher doses. "Many doctors will assume that if the state of Washington suggests this level of care, then it is unacceptable to proceed otherwise," Fishman says.
In addition to medical considerations real or imagined, there is another deterrent to opioid use: fear. According to the D.E.A., 71 doctors were arrested last year for crimes related to "diversion" - the leakage of prescription medicine into illegal drug markets. The D.E.A. also opened 735 investigations of doctors, and an investigation alone can be enough to put a doctor out of business, as doctors can lose their licenses and practices and have their homes, offices and cars seized even if no federal criminal charges are ever filed. Both figures - arrests and investigations - have risen steadily over the last few years.\u003cbr /\>\u003cbr /\>Opioid drugs have been used to treat pain for decades, mostly for acute postsurgical pain or the pain of cancer patients. But in January 1996, Purdue Pharma helped increase the use of these drugs by introducing OxyContin - oxycodone with a time-release mechanism. Oncologists and pain doctors were the principal prescribers of opioids. But Purdue introduced the drug with an aggressive marketing campaign promoting OxyContin to general practitioners and the idea of opioid pain relief to doctors and consumers. The product\'s time-release mechanism, Purdue claimed, allowed steadier pain relief and deterred abuse.\u003cbr /\>\u003cbr /\>Many pain sufferers found that OxyContin gave them better relief than they ever had before. But Purdue misrepresented the drug\'s potential for abuse. Last month, the company and three of its executives pleaded guilty to federal charges that they misled doctors and patients. The company agreed to pay $600 million in fines; and the executives, a total of $34.5 million. The pill\'s time-release mechanism turned out to be easily circumvented by crushing the pill and snorting or injecting the resulting powder. By the late 1990s, OxyContin abuse was devastating small towns throughout Appalachia and rural New England. Pharmaceuticals, mainly opioids, are still widely abused - now more so than any illegal drug except marijuana. In 2005, according to the government\'s National Survey on Drug Use and Health, 6.4 million Americans, many of them teenagers, had abused pharmaceuticals recently. Most got the drug from friends or family - often, in the case of teenagers, from their parents\' medicine cabinets.\u003cbr /\>",1]
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In addition to medical considerations real or imagined, there is another deterrent to opioid use: fear. According to the D.E.A., 71 doctors were arrested last year for crimes related to "diversion" - the leakage of prescription medicine into illegal drug markets. The D.E.A. also opened 735 investigations of doctors, and an investigation alone can be enough to put a doctor out of business, as doctors can lose their licenses and practices and have their homes, offices and cars seized even if no federal criminal charges are ever filed. Both figures - arrests and investigations - have risen steadily over the last few years.Opioid drugs have been used to treat pain for decades, mostly for acute postsurgical pain or the pain of cancer patients. But in January 1996, Purdue Pharma helped increase the use of these drugs by introducing OxyContin - oxycodone with a time-release mechanism. Oncologists and pain doctors were the principal prescribers of opioids. But Purdue introduced the drug with an aggressive marketing campaign promoting OxyContin to general practitioners and the idea of opioid pain relief to doctors and consumers. The product's time-release mechanism, Purdue claimed, allowed steadier pain relief and deterred abuse.Many pain sufferers found that OxyContin gave them better relief than they ever had before. But Purdue misrepresented the drug's potential for abuse. Last month, the company and three of its executives pleaded guilty to federal charges that they misled doctors and patients. The company agreed to pay $600 million in fines; and the executives, a total of $34.5 million. The pill's time-release mechanism turned out to be easily circumvented by crushing the pill and snorting or injecting the resulting powder. By the late 1990s, OxyContin abuse was devastating small towns throughout Appalachia and rural New England. Pharmaceuticals, mainly opioids, are still widely abused - now more so than any illegal drug except marijuana. In 2005, according to the government's National Survey on Drug Use and Health, 6.4 million Americans, many of them teenagers, had abused pharmaceuticals recently. Most got the drug from friends or family - often, in the case of teenagers, from their parents' medicine cabinets.
At the time the OxyContin epidemic emerged, the D.E.A. had far more experience seizing illegal drugs like cocaine and heroin. According to Mark Caverly, the head of the liaison and policy section for the D.E.A.\'s Office of Diversion Control, the OxyContin epidemic, however, required the agency to step up its antidiversion efforts. In 2001 the D.E.A. established the OxyContin Action Plan. The D.E.A. dispatched investigators to the most troubled states and trained local law-enforcement officials.\u003cbr /\>\u003cbr /\>The basis of the physician-patient relationship is trust. Trust is especially valued by pain patients, who often have long experience of being treated like criminals or hysterics. But when prescribing opioids, a physician\'s trust is easily abused. Pain doctors dispense drugs with a high street value that are attractive to addicts. All pain doctors encounter scammers; some doctors estimate that as many as 20 percent of their patients are selling their medicine or are addicted to opioids or other drugs. Experts are virtually unanimous in agreeing that even addicts who are suffering pain can be successfully treated with opioids. Indeed, opioids can be lifesaving for addicts - witness the methadone maintenance therapy given to heroin addicts. But treating addicts requires extra care.\u003cbr /\>\u003cbr /\>Identifying the scammers is especially tricky because there is no objective test for pain - it doesn\'t show up on an X-ray. In one British study, half the respondents who complained of lower-back pain had normal M.R.I.\'s. Conversely, a third of those with no pain showed disk degeneration on their M.R.I.\'s. The study suggested there could be a profound disconnection between what an M.R.I. sees and what a patient feels.\u003cbr /\>\u003cbr /\>There are red flags that indicate possible abuse or diversion: patients who drive long distances to see the doctor, or ask for specific drugs by name, or claim to need more and more of them. But people with real pain also occasionally do these things. The doctor\'s dilemma is how to stop the diverters without condemning other patients to suffer unnecessarily, since a drug diverter and a legitimate patient can look very much alike. The dishonest prescriber and the honest one can also look alike. Society has a parallel dilemma: how to stop drug-dealing doctors without discouraging real ones and worsening America\'s undertreatment of pain.\u003cbr /\>",1]
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At the time the OxyContin epidemic emerged, the D.E.A. had far more experience seizing illegal drugs like cocaine and heroin. According to Mark Caverly, the head of the liaison and policy section for the D.E.A.'s Office of Diversion Control, the OxyContin epidemic, however, required the agency to step up its antidiversion efforts. In 2001 the D.E.A. established the OxyContin Action Plan. The D.E.A. dispatched investigators to the most troubled states and trained local law-enforcement officials.The basis of the physician-patient relationship is trust. Trust is especially valued by pain patients, who often have long experience of being treated like criminals or hysterics. But when prescribing opioids, a physician's trust is easily abused. Pain doctors dispense drugs with a high street value that are attractive to addicts. All pain doctors encounter scammers; some doctors estimate that as many as 20 percent of their patients are selling their medicine or are addicted to opioids or other drugs. Experts are virtually unanimous in agreeing that even addicts who are suffering pain can be successfully treated with opioids. Indeed, opioids can be lifesaving for addicts - witness the methadone maintenance therapy given to heroin addicts. But treating addicts requires extra care.Identifying the scammers is especially tricky because there is no objective test for pain - it doesn't show up on an X-ray. In one British study, half the respondents who complained of lower-back pain had normal M.R.I.'s. Conversely, a third of those with no pain showed disk degeneration on their M.R.I.'s. The study suggested there could be a profound disconnection between what an M.R.I. sees and what a patient feels.There are red flags that indicate possible abuse or diversion: patients who drive long distances to see the doctor, or ask for specific drugs by name, or claim to need more and more of them. But people with real pain also occasionally do these things. The doctor's dilemma is how to stop the diverters without condemning other patients to suffer unnecessarily, since a drug diverter and a legitimate patient can look very much alike. The dishonest prescriber and the honest one can also look alike. Society has a parallel dilemma: how to stop drug-dealing doctors without discouraging real ones and worsening America's undertreatment of pain.
In July 2002, an insurance agent was sifting through records in Columbia, S.C., and paused at the file of one Larry Shealy. Shealy was getting OxyContin from a doctor named Ronald McIver - a lot of it. "The amounts were incredible; it jumped out in my face," the agent, who spoke on condition of anonymity, told me. "He was either selling them or taking so much he couldn\'t live." The agent did two things. He recommended to Shealy\'s employers that they exclude OxyContin coverage from their health insurance plan - which they did. And he called the D.E.A. Two days later, a D.E.A. agent showed up in the insurance agent\'s office with an administrative subpoena to collect Shealy\'s file.\u003cbr /\>\u003cbr /\>McIver wanted to be a doctor all his life, two of his daughters told me. But he taught and traveled for years before he finally enrolled at Michigan State University to become a D.O., or doctor of osteopathy, a more holistic alternative to a traditional medical education. (Osteopaths can do everything that traditional M.D.\'s can do, including prescribe opioids.) He began practicing pain medicine in the late 1980s. He had a practice in Florence, S.C., which ended when he declared bankruptcy in 2000. He moved to Greenwood to start over, establishing his new office in a storefront next to a chiropractor.\u003cbr /\>\u003cbr /\>McIver was, by the account of his patients, an unusual doctor in the age of the 10-minute managed-care visit. He usually saw about 6 to 12 patients each day. One patient I spoke with - who never got high-dose opioids - said that his first visit with McIver lasted four hours, and in subsequent visits he spent an hour or more doing various therapies. Many patients said their visits lasted an hour. Patients taking opioids had to sign a pain contract and bring their pills in at each visit to be counted.\u003cbr /\>\u003cbr /\>Many doctors take little interest in the administrative side of their practices, but McIver\'s neglect was epic. To save money, he employed mostly family. His wife, Carolyn, whose only medical training was from her husband, served as his assistant, giving shots and administering therapies. "His doctor\'s office did not resemble my family\'s doctor\'s office," said Sgt. Bobby Grogan, who was the investigator on the case for the Greenwood County Sheriff. While McIver\'s treatment rooms were normal, his and his wife\'s offices - off limits to patients - were a mess, according to pictures presented at McIver\'s trial by Adam Roberson, the D.E.A.\'s principal investigator. Used syringes, for example, overflowed their storage box. "His patient records were manila envelopes stuffed with receipts," Grogan told me.\u003cbr /\>",1]
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In July 2002, an insurance agent was sifting through records in Columbia, S.C., and paused at the file of one Larry Shealy. Shealy was getting OxyContin from a doctor named Ronald McIver - a lot of it. "The amounts were incredible; it jumped out in my face," the agent, who spoke on condition of anonymity, told me. "He was either selling them or taking so much he couldn't live." The agent did two things. He recommended to Shealy's employers that they exclude OxyContin coverage from their health insurance plan - which they did. And he called the D.E.A. Two days later, a D.E.A. agent showed up in the insurance agent's office with an administrative subpoena to collect Shealy's file.McIver wanted to be a doctor all his life, two of his daughters told me. But he taught and traveled for years before he finally enrolled at Michigan State University to become a D.O., or doctor of osteopathy, a more holistic alternative to a traditional medical education. (Osteopaths can do everything that traditional M.D.'s can do, including prescribe opioids.) He began practicing pain medicine in the late 1980s. He had a practice in Florence, S.C., which ended when he declared bankruptcy in 2000. He moved to Greenwood to start over, establishing his new office in a storefront next to a chiropractor.McIver was, by the account of his patients, an unusual doctor in the age of the 10-minute managed-care visit. He usually saw about 6 to 12 patients each day. One patient I spoke with - who never got high-dose opioids - said that his first visit with McIver lasted four hours, and in subsequent visits he spent an hour or more doing various therapies. Many patients said their visits lasted an hour. Patients taking opioids had to sign a pain contract and bring their pills in at each visit to be counted.Many doctors take little interest in the administrative side of their practices, but McIver's neglect was epic. To save money, he employed mostly family. His wife, Carolyn, whose only medical training was from her husband, served as his assistant, giving shots and administering therapies. "His doctor's office did not resemble my family's doctor's office," said Sgt. Bobby Grogan, who was the investigator on the case for the Greenwood County Sheriff. While McIver's treatment rooms were normal, his and his wife's offices - off limits to patients - were a mess, according to pictures presented at McIver's trial by Adam Roberson, the D.E.A.'s principal investigator. Used syringes, for example, overflowed their storage box. "His patient records were manila envelopes stuffed with receipts," Grogan told me.
When I interviewed him in prison recently, McIver told me that his records were complete but scattered. He said that he and his wife, distracted by a series of family tragedies, had employed a series of temporary receptionists who had botched the filing. He and his wife were trying to piece them together. "The records were probably half in the office and half at home for me to work on at night," he said. "I kept a box in the back of the car I worked on while Carolyn drove."\u003cbr /\>\u003cbr /\>Leslie Smith first came to see McIver in the fall of 2001. Smith was in his mid-40s and lived in Chapin, a small town near Columbia, a 60-mile drive from Greenwood. He filled out a medical-history form and told McIver that his wrists hurt so badly that he was getting only three or four hours\' sleep a night. He also said that a previous doctor helped him by prescribing OxyContin, and he mentioned the name of a doctor he said referred him. McIver examined Smith\'s wrists. Smith walked out with an opioid prescription and an appointment to come back the next week.\u003cbr /\>\u003cbr /\>Smith\'s wrists did not hurt him, as he testified at McIver\'s trial. He was addicted to OxyContin and Dilaudid, which he injected. He complained of wrist pain because it was plausible: he had injured one wrist previously, requiring an operation that left scars, and he had arthritis in the other. Until June 2002, Smith kept getting prescriptions.\u003cbr /\>\u003cbr /\>Smith saw McIver every few weeks. He testified that he had track marks on his arm at the time but always wore long sleeves to cover them. He said McIver never saw them. McIver put him on an electric nerve stimulator every visit for 15 or 30 minutes on each hand and did osteopathic manipulations. He prescribed exercises. Smith bought a nerve-stimulator machine to use at home and told McIver it was helping. At McIver\'s request he filled out a pain chart and reported that his pain rated a 5 or 6 upon awakening, reached 7 during the day and occasionally hit 9. "I answered all the questions exactly like I thought he\'d want to hear them answered," Smith testified. At one point McIver found a syringe in Smith\'s pocket. Smith told McIver that he was going fishing later that day and that he used the syringe as part of his fishing equipment. That apparently satisfied McIver, who testified that his grandfather kept syringes in his tackle box to pump air into his bait.\u003cbr /\>",1]
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When I interviewed him in prison recently, McIver told me that his records were complete but scattered. He said that he and his wife, distracted by a series of family tragedies, had employed a series of temporary receptionists who had botched the filing. He and his wife were trying to piece them together. "The records were probably half in the office and half at home for me to work on at night," he said. "I kept a box in the back of the car I worked on while Carolyn drove."Leslie Smith first came to see McIver in the fall of 2001. Smith was in his mid-40s and lived in Chapin, a small town near Columbia, a 60-mile drive from Greenwood. He filled out a medical-history form and told McIver that his wrists hurt so badly that he was getting only three or four hours' sleep a night. He also said that a previous doctor helped him by prescribing OxyContin, and he mentioned the name of a doctor he said referred him. McIver examined Smith's wrists. Smith walked out with an opioid prescription and an appointment to come back the next week.Smith's wrists did not hurt him, as he testified at McIver's trial. He was addicted to OxyContin and Dilaudid, which he injected. He complained of wrist pain because it was plausible: he had injured one wrist previously, requiring an operation that left scars, and he had arthritis in the other. Until June 2002, Smith kept getting prescriptions.Smith saw McIver every few weeks. He testified that he had track marks on his arm at the time but always wore long sleeves to cover them. He said McIver never saw them. McIver put him on an electric nerve stimulator every visit for 15 or 30 minutes on each hand and did osteopathic manipulations. He prescribed exercises. Smith bought a nerve-stimulator machine to use at home and told McIver it was helping. At McIver's request he filled out a pain chart and reported that his pain rated a 5 or 6 upon awakening, reached 7 during the day and occasionally hit 9. "I answered all the questions exactly like I thought he'd want to hear them answered," Smith testified. At one point McIver found a syringe in Smith's pocket. Smith told McIver that he was going fishing later that day and that he used the syringe as part of his fishing equipment. That apparently satisfied McIver, who testified that his grandfather kept syringes in his tackle box to pump air into his bait.
Smith filled some of his prescriptions at the Hawthorne Pharmacy in West Columbia. There, Addison Livingston, the pharmacist, got suspicious. He noticed that Smith sometimes came in with other patients of McIver\'s, despite the fact that McIver worked nearly two hours\' drive away. The patients obviously knew each other and would pick up large opioid prescriptions, paying cash and asking for brand-name drugs. Livingston called McIver, who confirmed he had written the prescriptions. At one point, McIver told Livingston that he, too, was suspicious, and that he had sent a letter about Smith to the state\'s Bureau of Drug Control.\u003cbr /\>\u003cbr /\>In February 2002, McIver wrote to Larry McElrath, a B.D.C. inspector, who read the letter at the trial. "Dear Larry," it read, "There are several people out of the Columbia/Chapin area who have aroused my curiosity about their use and possible misuse of medications. Some are referred by [another doctor] and seem legitimate. . . . They all pay cash despite some of them having insurance with prescription cards. . . . When they are in the office, they sometimes make a show of not knowing each other. . . . The situation is made complicated by the fact that each has some real pathology with objective findings that would justify the use of opiates if their pains are as bad as they say. I have given them the benefit of the doubt, but I\'m becoming less inclined to do so. I would appreciate it if you could make some discrete inquiries and let me know whether my concerns are justified. . . . I certainly don\'t want to refuse help to someone who needs it. On the other hand, I want even less to be implicated in diversion or other improprieties." He listed their names and Social Security numbers.\u003cbr /\>\u003cbr /\>McElrath did nothing with the letter. "It\'s incumbent upon the physician to have a trust with his patients," McElrath testified at the trial. "Here there was nothing that I could assume or conclude that any crimes had been committed."\u003cbr /\>\u003cbr /\>Smith was the most damning of the several patients who testified against McIver. (Smith and the other patients mentioned here did not agree to be interviewed for this article, as they are suing McIver for alleged overprescription of addictive drugs. Such suits often prosper after successful criminal convictions, as civil suits are easier to win.) Smith had a confederate in Seth Boyer, who lived in Chapin and followed a similar pattern in his dealings with McIver: he exaggerated pains in his foot, never provided records from a previous doctor and had needle tracks that he later testified McIver never saw. At one point, Boyer told McIver that he had spilled a bottle of liquid OxyFast, another opioid. (In reality, Boyer had injected it.) McIver wrote him a prescription for a replacement - apparently a violation of his standard pain-medication contract, which had a "no early refills" stipulation.\u003cbr /\>",1]
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Smith filled some of his prescriptions at the Hawthorne Pharmacy in West Columbia. There, Addison Livingston, the pharmacist, got suspicious. He noticed that Smith sometimes came in with other patients of McIver's, despite the fact that McIver worked nearly two hours' drive away. The patients obviously knew each other and would pick up large opioid prescriptions, paying cash and asking for brand-name drugs. Livingston called McIver, who confirmed he had written the prescriptions. At one point, McIver told Livingston that he, too, was suspicious, and that he had sent a letter about Smith to the state's Bureau of Drug Control.In February 2002, McIver wrote to Larry McElrath, a B.D.C. inspector, who read the letter at the trial. "Dear Larry," it read, "There are several people out of the Columbia/Chapin area who have aroused my curiosity about their use and possible misuse of medications. Some are referred by [another doctor] and seem legitimate. . . . They all pay cash despite some of them having insurance with prescription cards. . . . When they are in the office, they sometimes make a show of not knowing each other. . . . The situation is made complicated by the fact that each has some real pathology with objective findings that would justify the use of opiates if their pains are as bad as they say. I have given them the benefit of the doubt, but I'm becoming less inclined to do so. I would appreciate it if you could make some discrete inquiries and let me know whether my concerns are justified. . . . I certainly don't want to refuse help to someone who needs it. On the other hand, I want even less to be implicated in diversion or other improprieties." He listed their names and Social Security numbers.McElrath did nothing with the letter. "It's incumbent upon the physician to have a trust with his patients," McElrath testified at the trial. "Here there was nothing that I could assume or conclude that any crimes had been committed."Smith was the most damning of the several patients who testified against McIver. (Smith and the other patients mentioned here did not agree to be interviewed for this article, as they are suing McIver for alleged overprescription of addictive drugs. Such suits often prosper after successful criminal convictions, as civil suits are easier to win.) Smith had a confederate in Seth Boyer, who lived in Chapin and followed a similar pattern in his dealings with McIver: he exaggerated pains in his foot, never provided records from a previous doctor and had needle tracks that he later testified McIver never saw. At one point, Boyer told McIver that he had spilled a bottle of liquid OxyFast, another opioid. (In reality, Boyer had injected it.) McIver wrote him a prescription for a replacement - apparently a violation of his standard pain-medication contract, which had a "no early refills" stipulation.
But McIver ended up discharging Boyer in June 2002, when Boyer altered a prescription so he could fill it three days early. He wrote McIver three pleading letters of protest, to no avail. "I was looking for an excuse to discharge them, and with Seth I found it," McIver told me. "I needed more than suspicion. With Les, he never actually did anything that allowed me to say, \'O.K., here\'s that concrete piece of evidence.\' "\u003cbr /\>\u003cbr /\>McIver may have felt he needed more proof, but medically he probably had enough. Pain specialists told me that doctors can stop prescribing a drug whenever the risks outweigh the benefits, which includes the risk of abuse.\u003cbr /\>\u003cbr /\>Another drug-dealing patient of McIver\'s was Kyle Barnes. She testified that she suffered from fibromyalgia, a chronic-pain syndrome, but exaggerated her pain to get higher levels of OxyContin and Roxicodone. She was addicted to those drugs before she began seeing McIver in July 2001. She also brought no medical records and drove three hours to each appointment. She got prescriptions on her second visit, during which McIver also did osteopathic manipulations and massage.\u003cbr /\>\u003cbr /\>Barnes was in real pain. McIver did several different therapies at each visit. He set up an appointment for her at a sleep clinic, sent her for X-rays and put a cast on her wrist. He knew she had trouble paying for her medicines, and he contacted Purdue Pharma to see if she qualified for reduced-price drugs. She kept claiming the drugs were not helping enough and was soon taking 16 times the dose of OxyContin she took when she first saw him. One tip-off in her case should have been that she paid thousands of dollars a month in cash for her prescriptions, even though she was on Medicaid. She told McIver that her father and boyfriend were helping her buy them, which she later testified was partly true. But most of her income came from selling some of the drugs he prescribed, she testified. In December 2003, McIver told her that he would stop treating her unless she took a drug screen. She did nothing. Three weeks later he told her again. She never returned.\u003cbr /\>",1]
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But McIver ended up discharging Boyer in June 2002, when Boyer altered a prescription so he could fill it three days early. He wrote McIver three pleading letters of protest, to no avail. "I was looking for an excuse to discharge them, and with Seth I found it," McIver told me. "I needed more than suspicion. With Les, he never actually did anything that allowed me to say, 'O.K., here's that concrete piece of evidence.' "McIver may have felt he needed more proof, but medically he probably had enough. Pain specialists told me that doctors can stop prescribing a drug whenever the risks outweigh the benefits, which includes the risk of abuse.Another drug-dealing patient of McIver's was Kyle Barnes. She testified that she suffered from fibromyalgia, a chronic-pain syndrome, but exaggerated her pain to get higher levels of OxyContin and Roxicodone. She was addicted to those drugs before she began seeing McIver in July 2001. She also brought no medical records and drove three hours to each appointment. She got prescriptions on her second visit, during which McIver also did osteopathic manipulations and massage.Barnes was in real pain. McIver did several different therapies at each visit. He set up an appointment for her at a sleep clinic, sent her for X-rays and put a cast on her wrist. He knew she had trouble paying for her medicines, and he contacted Purdue Pharma to see if she qualified for reduced-price drugs. She kept claiming the drugs were not helping enough and was soon taking 16 times the dose of OxyContin she took when she first saw him. One tip-off in her case should have been that she paid thousands of dollars a month in cash for her prescriptions, even though she was on Medicaid. She told McIver that her father and boyfriend were helping her buy them, which she later testified was partly true. But most of her income came from selling some of the drugs he prescribed, she testified. In December 2003, McIver told her that he would stop treating her unless she took a drug screen. She did nothing. Three weeks later he told her again. She never returned.
Another patient whose story was particularly troubling was Barbee Brown. Brown was not a drug seeker but a genuine pain patient seeking relief from Reflex Sympathetic Dystrophy. McIver gave her very high doses of OxyContin right away, before she produced any records from other doctors. This was especially disturbing, because she had been addicted to crack cocaine for three months in the year before she came to him.\u003cbr /\>\u003cbr /\>Brown saw McIver at least twice a week for six weeks. He did a thorough physical exam and took a complete history. He used many different kinds of therapies. But he also started her - someone who had never taken opioids - on 40-milligram pills of OxyContin and allowed her to control her own dosing schedule. "As long as you are not having side effects, do not be afraid to take the doses you need to get out of pain," he wrote to her. It was the same advice he gave many patients. "The number of milligrams does not matter. What matters is the number on the 0-to-10 scale."\u003cbr /\>\u003cbr /\>The medicine helped. Brown testified that she ranked her pain at 9 or 10 when she first got to McIver. After seeing him, it dropped to a 4. Her pain diary, which appears to be sincere, had various passages giving thanks that she met McIver. Brown did not become addicted. But allowing an opioid-naïve recovering crack addict to start on high-dose pills and control her own dosage, and telling her that her dosage didn\'t matter, seems reckless.\u003cbr /\>\u003cbr /\>McIver\'s 30-year sentence was the result of the death of Larry Shealy, a 56-year-old man who suffered intense back and knee pain, in addition to many other health problems. He first came to see McIver in February 2002, with full referrals and records. He was on OxyContin before seeing McIver but complained that his pain was still terrible, so McIver doubled his dose. This allowed Shealy to go back to work in an auto body shop.\u003cbr /\>\u003cbr /\>Shealy was not a careful patient. A month after he started with McIver, he took 15 OxyContin tablets in one day instead of the 6 he was prescribed. He was not harmed, but McIver testified that he asked Shealy to bring his family in so he could explain the dosing to them. At one point, McIver tried to taper down the OxyContin and replace it with methadone, but Shealy complained that the methadone made him drowsy. Shealy\'s son, David, an auto mechanic, testified that the OxyContin pain relief also came at a price. He said he felt his father was overmedicated - often sleepy. Once, his father backed his truck into a tree.\u003cbr /\>",1]
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Another patient whose story was particularly troubling was Barbee Brown. Brown was not a drug seeker but a genuine pain patient seeking relief from Reflex Sympathetic Dystrophy. McIver gave her very high doses of OxyContin right away, before she produced any records from other doctors. This was especially disturbing, because she had been addicted to crack cocaine for three months in the year before she came to him.Brown saw McIver at least twice a week for six weeks. He did a thorough physical exam and took a complete history. He used many different kinds of therapies. But he also started her - someone who had never taken opioids - on 40-milligram pills of OxyContin and allowed her to control her own dosing schedule. "As long as you are not having side effects, do not be afraid to take the doses you need to get out of pain," he wrote to her. It was the same advice he gave many patients. "The number of milligrams does not matter. What matters is the number on the 0-to-10 scale."The medicine helped. Brown testified that she ranked her pain at 9 or 10 when she first got to McIver. After seeing him, it dropped to a 4. Her pain diary, which appears to be sincere, had various passages giving thanks that she met McIver. Brown did not become addicted. But allowing an opioid-naïve recovering crack addict to start on high-dose pills and control her own dosage, and telling her that her dosage didn't matter, seems reckless.McIver's 30-year sentence was the result of the death of Larry Shealy, a 56-year-old man who suffered intense back and knee pain, in addition to many other health problems. He first came to see McIver in February 2002, with full referrals and records. He was on OxyContin before seeing McIver but complained that his pain was still terrible, so McIver doubled his dose. This allowed Shealy to go back to work in an auto body shop.Shealy was not a careful patient. A month after he started with McIver, he took 15 OxyContin tablets in one day instead of the 6 he was prescribed. He was not harmed, but McIver testified that he asked Shealy to bring his family in so he could explain the dosing to them. At one point, McIver tried to taper down the OxyContin and replace it with methadone, but Shealy complained that the methadone made him drowsy. Shealy's son, David, an auto mechanic, testified that the OxyContin pain relief also came at a price. He said he felt his father was overmedicated - often sleepy. Once, his father backed his truck into a tree.
Shealy died in his sleep early on the morning of May 29, 2003. He had OxyContin pills in his stomach, and his bloodstream contained alprazolam - Xanax - as well. The pathologist at McIver\'s trial testified that the levels of drugs were consistent with the prescriptions McIver had been writing - the high levels that so alarmed the insurance agent. Shealy was taking five 80-milligram tablets of OxyContin every 12 hours, plus up to six 30-milligram tablets of Roxicodone every 4 hours for breakthrough pain, plus as much as 2 milligrams of alprazolam every 8 hours. The prosecution\'s toxicologist, Demi Garvin, concluded that the OxyContin and Roxicodone caused Shealy\'s death by respiratory depression. The pathologist testified that she looked up this dosage and found it to be a fatal level.\u003cbr /\>\u003cbr /\>But there is reason for doubt. According to Shealy\'s prescriptions, he had been taking the same dosage for at least two months, and possibly much longer. Pain specialists say that respiratory depression is extremely unlikely when dosage is consistent. In her testimony, Garvin agreed that what would be a toxic level in an opioid-naïve patient would be safe for someone titrated up properly. But she said she could not conclude he had been properly titrated, in part because she had not seen his medical records. Garvin declined to talk about the Shealy case with me because she is a witness for the Shealy family in their planned civil suit against McIver. But in a deposition for that lawsuit, she appeared to back away from blaming the OxyContin. She described her view as: "Hey, there\'s a red flag here. This can certainly be your cause of death, but you need to go further in exploring whether or not it is."\u003cbr /\>\u003cbr /\>There was something else that might have caused Shealy\'s death: he suffered from advanced congestive heart failure. The pathologist testified that he had 90 percent blockage in one coronary artery and 50 percent in another, and a greatly enlarged heart and other organs. He had a scar on the back wall of his heart that indicated he at one time suffered a heart attack. Opioids do not worsen heart disease and would likely have helped, because pain causes stress to the heart.\u003cbr /\>",1]
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Shealy died in his sleep early on the morning of May 29, 2003. He had OxyContin pills in his stomach, and his bloodstream contained alprazolam - Xanax - as well. The pathologist at McIver's trial testified that the levels of drugs were consistent with the prescriptions McIver had been writing - the high levels that so alarmed the insurance agent. Shealy was taking five 80-milligram tablets of OxyContin every 12 hours, plus up to six 30-milligram tablets of Roxicodone every 4 hours for breakthrough pain, plus as much as 2 milligrams of alprazolam every 8 hours. The prosecution's toxicologist, Demi Garvin, concluded that the OxyContin and Roxicodone caused Shealy's death by respiratory depression. The pathologist testified that she looked up this dosage and found it to be a fatal level.But there is reason for doubt. According to Shealy's prescriptions, he had been taking the same dosage for at least two months, and possibly much longer. Pain specialists say that respiratory depression is extremely unlikely when dosage is consistent. In her testimony, Garvin agreed that what would be a toxic level in an opioid-naïve patient would be safe for someone titrated up properly. But she said she could not conclude he had been properly titrated, in part because she had not seen his medical records. Garvin declined to talk about the Shealy case with me because she is a witness for the Shealy family in their planned civil suit against McIver. But in a deposition for that lawsuit, she appeared to back away from blaming the OxyContin. She described her view as: "Hey, there's a red flag here. This can certainly be your cause of death, but you need to go further in exploring whether or not it is."There was something else that might have caused Shealy's death: he suffered from advanced congestive heart failure. The pathologist testified that he had 90 percent blockage in one coronary artery and 50 percent in another, and a greatly enlarged heart and other organs. He had a scar on the back wall of his heart that indicated he at one time suffered a heart attack. Opioids do not worsen heart disease and would likely have helped, because pain causes stress to the heart.
The testimonies of the patients Smith, Boyer and Barnes were the parts of the trial that most directly addressed the question of whether McIver intentionally wrote prescriptions for a nonmedical purpose. This is the relevant legal test for the statute under which he was prosecuted. Several Supreme Court and district court cases have made it clear that under the Controlled Substances Act, a doctor is guilty of a crime if he intentionally acts as a drug pusher.\u003cbr /\>\u003cbr /\>The judge in the McIver case, Henry F. Floyd, told the jurors that bad prescribing is the standard for malpractice, a civil matter. "That is not what we are talking about," he said. "We\'re not talking about this physician acting better or worse than other physicians." If McIver was a bad doctor - but still a doctor, with intent to treat patients - he was innocent. "If you find that a defendant acted in good faith in dispensing the drugs charged in this indictment, then you must find that defendant not guilty," Floyd said. But Floyd also told the jury to take bad doctoring into account in deciding McIver\'s intent.\u003cbr /\>\u003cbr /\>This instruction - that bad doctoring does not prove intent but could be considered when weighing his intent - is subtle and potentially extremely confusing. It apparently confused the jurors. I spoke to two jurors, who told me their own views and characterized the jury discussion. The overwhelming factor, they said, was that McIver prescribed too much - the very red flag that alerted the insurance agent and set the case in motion.\u003cbr /\>\u003cbr /\>The jurors I spoke with said that by far the most important testimony came from Steven Storick, a pain-management doctor in Columbia and the government\'s expert witness. Reviewing the records of patient after patient, Storick consistently testified that there were too many drugs. "This amount of medication is just extremely high in a situation like this," he said of one patient. This is "excessive," he said of another. "That\'s just an extremely high dose of drug," he said of a third. Storick, who declined to be interviewed for this article, testified that if he had a patient who exhibited no objective evidence of pain, he would not prescribe opioids. He would not have titrated patients as rapidly as McIver did or given them discretion. He disagreed with McIver\'s position that a doctor should try to bring a patient\'s chronic pain down to a level of 2. He would stop titrating when a patient reached 5 out of 10.\u003cbr /\>\u003cbr /\>The jurors took Storick\'s caution to heart, in part, they told me, because it resonated with their own experience with opioids and fears of addiction. I asked Jo Handy, a tall, elegant woman who is now 39 and a real estate agent outside Greenville, why McIver was convicted. "It was the excessive prescriptions," she said in a\u003cbr /\>\u003cbr /\>\u003cbr /\>\u003c/div\>",0]
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The testimonies of the patients Smith, Boyer and Barnes were the parts of the trial that most directly addressed the question of whether McIver intentionally wrote prescriptions for a nonmedical purpose. This is the relevant legal test for the statute under which he was prosecuted. Several Supreme Court and district court cases have made it clear that under the Controlled Substances Act, a doctor is guilty of a crime if he intentionally acts as a drug pusher.The judge in the McIver case, Henry F. Floyd, told the jurors that bad prescribing is the standard for malpractice, a civil matter. "That is not what we are talking about," he said. "We're not talking about this physician acting better or worse than other physicians." If McIver was a bad doctor - but still a doctor, with intent to treat patients - he was innocent. "If you find that a defendant acted in good faith in dispensing the drugs charged in this indictment, then you must find that defendant not guilty," Floyd said. But Floyd also told the jury to take bad doctoring into account in deciding McIver's intent.This instruction - that bad doctoring does not prove intent but could be considered when weighing his intent - is subtle and potentially extremely confusing. It apparently confused the jurors. I spoke to two jurors, who told me their own views and characterized the jury discussion. The overwhelming factor, they said, was that McIver prescribed too much - the very red flag that alerted the insurance agent and set the case in motion.The jurors I spoke with said that by far the most important testimony came from Steven Storick, a pain-management doctor in Columbia and the government's expert witness. Reviewing the records of patient after patient, Storick consistently testified that there were too many drugs. "This amount of medication is just extremely high in a situation like this," he said of one patient. This is "excessive," he said of another. "That's just an extremely high dose of drug," he said of a third. Storick, who declined to be interviewed for this article, testified that if he had a patient who exhibited no objective evidence of pain, he would not prescribe opioids. He would not have titrated patients as rapidly as McIver did or given them discretion. He disagreed with McIver's position that a doctor should try to bring a patient's chronic pain down to a level of 2. He would stop titrating when a patient reached 5 out of 10.The jurors took Storick's caution to heart, in part, they told me, because it resonated with their own experience with opioids and fears of addiction. I asked Jo Handy, a tall, elegant woman who is now 39 and a real estate agent outside Greenville, why McIver was convicted. "It was the excessive prescriptions," she said in a
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