Saturday

Congressional Hearing on Institutional Review Boards that Oversee Experimental Human Testing for Profit 3/26/2009

http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1552
Institutional Review Boards that Oversee Experimental Human Testing for Profit

The Subcommittee on Oversight and Investigations held a hearing titled, “Institutional Review Boards that Oversee Experimental Human Testing for Profit” at 10:00 a.m. on Thursday, March 26, 2009, in 2123 Rayburn House Office Building. The hearing examined whether institutional review boards (IRBs) and the federal government are adequately protecting human subjects of biomedical research.

Witness List

  • Gregory Kutz, Managing Director, Forensic Audits and Special Investigations, Government Accountability Office
  • Dr. Jerry Menikoff, Director, Office for Human Research Protections, Department of Health and Human Services
  • Dr. Joanne Less, Director, Good Clinical Practice Program, Food and Drug Administration
  • Daniel Dueber, Chief Executive Officer, Coast IRB, LLC

Documents

Video

WMV
Stream or Download

Friday

Pain resource links

Pain resource links

<20021009.pdf>> 
http://www.theacpa.org/documents/ACPA%20Consumer%20Guide%20021009.pdf

LINKS TO CHRONIC PAINSITES AND RESOURCES 
Learning as much as you can about your health condition is part of being an informed consumer and an active partner on your care team. Go to the following ACPA Internet Web Address to find sites that can help you learn more and better manage your chronic pain: http://www.theacpa.org/people/links.asp.

REFERENCES ON THE INTERNET 
MEDICATION RELATED 
1. http://www.webmd.com/drugs

2. http://www.druginfonet.com/drug.htm

3. http://www.pdr.net

4. http://www.medscape.com/druginfo

5. http://www.fda.gov/cder/drug/default.htm

6. http://www.nlm.nih.gov/medlineplus/druginformation.html 
78 American Chronic Pain Association Copyright 2009

7. http://www.healthsquare.com/drugmain.htm

8. http://www.drugs.com/

9. http://www.rxlist.com

10. http://www.medicinenet.com/pdf/popularmedicationsguide.pdf

11. Promoting Pain Relief and Preventing Abuse of Pain Medications: A Critical Balancing Act, A Joint Statement From 21 Health Organizations and the Drug Enforcement Administration: http://www.ampainsoc.org/advocacy/promoting.htm.

12. http://www.mayoclinic.com/health/drug-information/DrugHerbIndex

13. Mayo Clinic Over-the-Counter Pain Reliever Guide:http://www.mayoclinic.com/invoke.cfm?retryCount=1&id=PN00061

14. Nonsteroidal anti-inflammatory drugs (NSAIDs):http://www.stoppain.org/pain_medicine/content/medication/nsaids.asp

15. Adjuvant Medications: http://www.stoppain.org/pain_medicine/content/medication/adjuvants.asp

16. Opioid Analgesics: http://www.stoppain.org/pain_medicine/content/medication/opioids.asp

17. American Society of Health-System Pharmacists:http://www.safemedication.com/

18. eMedicineHealth: http://www.emedicinehealth.com/pain_medications/article_em.htm

19. WebMD: http://www.webmd.com/pain-management/guide/pain-relievers

OTHER REFERENCES 
20. Treatment Options: A Guide for People Living with Pain by the American Pain Foundation can be found athttp://www.painfoundation.org/Publications/TreatmentOptions2006.pdf

Tuesday

Neuroscience: Rethinking rehab

http://www.nature.com/news/2009/090304/full/458025a.html

4 March 2009   Nature 458, 25-27 (2009) 

Neuroscience:  Rethinking rehab

Alcoholics Anonymous and its spin-off programmes have been helping people with addictions for decades. Jim Schnabel talks to the neuroscientists who are looking deeper into the approach.

Jim Schnabel 

In the depths of the Depression, in a Manhattan alcoholism clinic, a ruined Wall Street speculator named Bill Wilson had a vision. His room suddenly blazed "with an indescribably white light" and he experienced euphoria and a godlike "presence", followed by a "great peace"1. Like St Paul after his experience on the road to Damascus, Wilson soon turned away from his old, inebriated life and became an evangelist — preaching a radical, spiritual cure for alcoholism.

That cure grew into the modern addiction rehabilitation industry, which even today is dominated by Wilson's Alcoholics Anonymous (AA) paradigm and its 'twelve-step' approach to recovery. Perhaps unsurprisingly, given its spiritual origins, this approach has had an uneasy relationship with the evidence-based culture of medical research. Both perceive addiction as a chronic disease; but whereas scientists seek rationally targeted interventions to blunt drug cravings, AA and related programmes tend to feature group therapy, tearful confessions and the call to "surrender to a higher power".

In the past few years, however, these two cultures have been finding common ground. Neuroscientists have begun to recognize that some of the most important brain systems impaired in addiction are those in the prefrontal cortex that regulate social cognition, self-monitoring, moral behaviour and other processes that the AA-type approach seems to target. "A lot of the treatment programmes out there are targeting these systems without necessarily knowing that they are doing it," says Nora Volkow, director of the National Institute on Drug Abuse in Bethesda, Maryland.

Researchers are now searching for ways to boost these prefrontal systems even further — not to remove the need for twelve-step and other behaviourally oriented treatment programmes, but to enable people with addictions to get more out of them. "It completely changes the way that we look at medications," Volkow says.

Until recently, addiction researchers focused almost entirely on 'limbic' circuits in the brain that mediate fear and desire. These dopamine-fuelled networks are effectively hijacked by addictive drugs and behaviours so that the person ends up wanting, and compulsively seeking, little else but the next fix. Drugs such as methadone and naltrexone can blunt the activity of these circuits, but they are not a cure. 

Impulse management

While doing neuroimaging studies at the Brookhaven National Laboratory in Upton, New York, in the 1990s, Volkow was one of the first researchers to suggest that abnormalities in the prefrontal cortices of drug users might weaken the systems that normally counteract drug cravings2. Since then, the prefrontal regions and their links to the limbic system have garnered more and more attention, and researchers are now attempting "a very extensive evaluation of how the different areas in the prefrontal cortex participate in the process of drug addiction", Volkow says.

The prefrontal cortex — the most recently evolved set of structures in the brain and the one that most clearly differentiates humans from other species — is the headquarters for the circuits that help shape feelings and behaviour according to long-term goals, moral strictures and social cues. These systems are extensively wired into limbic regions, and are often portrayed as a 'braking' system to resist impulsive behaviour. The slow development of prefrontal structures after birth tracks the maturation of children into adults, and people whose prefrontal areas are damaged by trauma or stroke, for example, seem to have lost some control of the brakes and are apt to be childishly impulsive and uninhibited in their behaviour.

With tools such as psychological tests and brain imaging, researchers have been finding similar braking problems associated with drug use and are starting to tease apart the mechanisms involved. Some have shown that people with drug addictions are poor at monitoring their own behaviour3, making appropriate decisions and inhibiting impulses — and these behavioural findings have been matched to functional magnetic resonance imaging (fMRI) data that show reduced activity in the corresponding prefrontal areas. Animal studies have supported the human ones by showing, for example, that monkeys given cocaine swiftly develop prefrontal impairments4. And other researchers have found that stress, which frequently triggers drug use and relapse in people with addiction, seems to do so at least in part by shutting down prefrontal functions5. "We're really starting to understand the molecular basis of why this cortex falls apart with drugs of abuse, and during stress, and how those two interact," says Amy Arnsten at Yale University School of Medicine in New Haven, Connecticut.

If the cortex falls apart with drug abuse, then it may be impossible to recover from an addiction without putting it back together. In unpublished studies, Hugh Garavan and his colleagues at Trinity College, Dublin, have found that cocaine users and tobacco smokers who go through treatment and are able to stay abstinent for more than a year "seem to show hyperactivity in these prefrontal control centres" in fMRI images. Garavan says that this extra activity seems to be especially prominent during the first few weeks of abstinence, hinting at "a heavy reliance on these prefrontal centres to avoid falling off the wagon".

The recognition that prefrontal systems might need boosting in people with addictions has helped fuel a new interest in whether AA and similar behavioural treatments are already having these kinds of effects. "It behooves us to try to understand how [twelve-step approaches] link to what we're addressing in terms of intervention," Volkow told the annual meeting of the Society for Neuroscience in Washington DC last November. So far, these treatment programmes have been difficult to study formally, says Martin Paulus, a psychiatrist who is researching addiction at the University of California, San Diego. "It's very much a voluntary-based programme, with little standardization, and the whole programme thrives on anonymity."

But much of what is known about the AA approach suggests that it aims to protect or enhance prefrontal circuits. In the protected environment of a rehab centre, drugs and other cues associated with drug taking are gone and stressful situations that suppress prefrontal activity are minimized. Volkow notes that the feeling of ceding control to a higher power is also likely to "enhance your sense of security, decreasing stress and anxiety". Similarly, says Garavan, the confessions of bad behaviour and other "strategies that push users to become more aware of their drug-related actions presumably aim to boost their capacity for self-monitoring, which is largely a prefrontal function".

The social environment in rehab is another factor that works in part through prefrontal systems. "Our brains have evolved to be very sensitive to social cognition and social reinforcers," says Volkow. By putting people with drug addictions into a group with anti-drug values, "you are providing them with a very powerful reinforcer", she says. 

Spiritual control

And then there is religion, which has been shown to have a strong inverse association with drug addiction. Psychologist Michael McCullough, who studies religion and behaviour at the University of Miami in Florida, calls this inverse association "one of the most unsung findings in the entire literature on drug and alcohol abuse". Both adults and children deemed religious by various measures "drink, smoke and do drugs less often", McCullough says. "If they get into trouble with drinking and drugs and smoking, they're more likely to be able to get away from those problems."

McCullough suggests that when a person commits to any cultural system that regulates behaviour, the psychological effort to conform strengthens the brain systems that mediate self-monitoring and self-control. "What makes religion unique, I think, is that the code of conduct isn't just laid down by your parents or your friends or your principal at school, but ostensibly by the individual who is superintending the Universe, so it has an extra moral force." Some religious rituals, he says, have been shown to provoke enhanced activity in prefrontal regions6. "It's as if certain forms of prayer and meditation are pinpointing precisely those [prefrontal] areas of the brain that people rely on to control attention, to control negative emotion and resolve mental conflict."

However the twelve-step strategies actually work on the brain, "there is now excellent documentation that those who attend AA-type programmes regularly do very well by anyone's standard", says Thomas McLellan, director of the Treatment Research Institute in Philadelphia, Pennsylvania. The problem, McLellan says, is that the vast majority of people who enter such programmes do not go regularly — they drop out after a few days or weeks — and are more than likely to relapse.

Anna Rose Childress, a psychiatrist at the University of Pennsylvania School of Medicine in Philadelphia, has encountered a similar resistance to treatment in the crack cocaine users she has studied. In her lab she uses a cognitive behavioural training technique — like "prefrontal pushups", she says — that tries to make these users more aware of their drug-related actions and the consequences. But her studies indicate that "most of our cocaine patients are not great at it".

Results such as these raise what Childress and others call the "chicken or egg question" — is drug use the cause of users' prefrontal problems, or do they have pre-existing defects that make them susceptible to addiction? As Garavan puts it: "A lot of people might be able to enjoy drugs but there's only a certain percentage who actually go on to become addicted. And maybe part of that is because these people lack that prefrontal-mediated control over behaviour."

Some research already links prefrontal-related conditions such as impulsivity and attention deficit hyperactivity disorder (ADHD) to a heightened risk of later drug use. But to really start answering the chicken or egg question, says Childress, "you would need some good large-scale developmental studies for one thing; you would like to look at adolescents before they've ever touched drugs". Garavan and several dozen other European researchers are now participating in a project that aims, in part, to do just that. Known as IMAGEN and begun in late 2007, the five-year, €10-million (US$14-million) project funded by the European Commission will ultimately enrol 2,000 14-year-olds and follow them through their late teens. Principal investigator Gunter Schumann, a psychiatrist at Kings College, London, says that the testing will include fMRI and structural MRI, as well as a full genome scan. He expects to start publishing findings in the next few years.

Quenching the flame

In the meantime, researchers are pursuing other ways to boost prefrontal systems — and medicines for ADHD seem an obvious place to start. Attention-enhancing drugs such as methyl-phenidate and atomoxetine boost the activity of key receptor systems in the prefrontal cortex, in particular those for noradrenaline and dopamine. Some evidence already suggests that patients with ADHD are less likely to go on to abuse drugs if they are receiving medication for their condition7. And earlier this year, a team led by Daina Economidou at the University of Cambridge, UK, reported that atomoxetine helped rats with an ADHD-like impulsivity to resist a relapse to cocaine-seeking8.

The National Institute on Drug Abuse has also been supporting studies of cognitive and behavioural strategies, and Volkow says that she is particularly enthusiastic about an approach that involves "real-time fMRI feedback". Developed by researcher and entrepreneur Christopher deCharms earlier this decade, the technique involves placing drug users in an fMRI machine and showing them a symbolic representation — a flame — of the fMRI-measured brain activity that corresponds to their cravings. The users are then asked to apply their own cognitive exercises, such as imagining their child is with them, to quench their cravings and douse the flame. After half a dozen sessions with this feedback the user will, in principle, develop cognitive circuitry that is more efficient at suppressing craving and that can then be used in ordinary life. A version of the technique, used for pain relief, has already shown some efficacy in a small clinical trial9, and deCharms and his Silicon Valley start-up, Omneuron, are currently running a small trial in smokers — with plans for a follow up with some of Childress's cocaine users.

For some people, even the most sophisticated therapies may not be enough to rescue a prefrontal cortex that has been damaged by genetics, development and perhaps decades of drug use. "It's like somebody who has had a stroke and is paralysed," says psychologist Antoine Bechara at the University of Southern California, "and you tell them, well, you should walk, you should exercise. But the part of the brain that allows them to do that is not there and they just cannot do it."

To Bechara, a more efficient approach would be to protect and strengthen these critical brain regions as they are developing. As an example, he cites preliminary data from a study in China. "There are children who grow up whose parents make all the decisions for them, and others who are encouraged to make decisions and are rewarded or punished for their bad decisions," he says. "The latter children grow up to show better performance on measures of decision making, and there is even a hint of evidence from fMRI that the kids with that latter kind of parenting style have better prefrontal cortex function."


Even for those beyond the influence of parenting style, researchers hope that a little lift in prefrontal efficiency could go a long way. Such a boost, says Paulus, could be "the critical piece that helps prevent the person from getting onto a very destructive pathway".

The question now is how best to give that boost. As researchers come to understand the neural mechanisms of addiction better, the twelve-step approach may give way to more secular strategies. But it seems unlikely that all behavioural approaches will soon be replaced by a pill. "I think most researchers would say, and I know I would say, that medicines should be used in the context of a good behavioural programme," says Childress, "because a person is essentially trying to restructure a lot of behaviour, and the more support that you can provide for that, the better."

Jim Schnabel is a freelance writer based in Maryland. 

References
Wilson, B. Bill W: An Autobiography (Hazelden-Pittman Archives Press, 2000). 
Volkow, N. D. et al. Am. J. Psychiatry 148, 621– 626 (1991). 
Hester, R. , Simões-Franklin, C. & Garavan, H. Neuropsychopharmacology 32, 1974–1984 (2007). 
Olausson, P. et al. Annl NY Acad. Sci. 1121, 610– 638 (2007). 
Hains, A. B. & Arnsten, A. F. Learn. Mem. 15, 551– 564 (2008). 
Azari, N. et al. Eur. J. Neurosci. 13, 1649– 1652 (2001). 
Wilens, T. E. et al. Arch. Pediatr. Adolesc. Med. 162, 916– 921 (2008). 
Economidou, D. et al. Biol. Psychiatry doi:10.1016/j.biopsych.2008.12.008 (2009). 
deCharms, R. C. et al. Proc. Natl Acad. Sci. USA 102, 18626– 18631 (2005).

Varenicline Reduces Alcohol Self-Administration in Heavy-Drinking Smokers

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T4S-4VPV8V2-4&_user=10&_coverDate=02%2F27%2F2009&_alid=878225326&_rdoc=1&_fmt=high&_orig=search&_cdi=4982&_sort=d&_docanchor=&view=c&_ct=3&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=3acaae5cbabb295cc0101c2ae8b9ec51

Varenicline Reduces Alcohol Self-Administration in Heavy-Drinking Smokers

Failed states and failed policies: How to stop the drug wars

http://www.economist.com/printedition/displayStory.cfm?Story_ID=13237193
Failed states and failed policies: How to stop the drug wars
Mar 5th 2009
From The Economist

Prohibition has failed; legalisation is the least bad solution

A HUNDRED years ago a group of foreign diplomats gathered in Shanghai
for the first-ever international effort to ban trade in a narcotic drug.
On February 26th 1909 they agreed to set up the International Opium
Commission-just a few decades after Britain had fought a war with China
to assert its right to peddle the stuff. Many other bans of
mood-altering drugs have followed. In 1998 the UN General Assembly
committed member countries to achieving a "drug-free world" and to
"eliminating or significantly reducing" the production of opium, cocaine
and cannabis by 2008.

That is the kind of promise politicians love to make. It assuages the
sense of moral panic that has been the handmaiden of prohibition for a
century. It is intended to reassure the parents of teenagers across the
world. Yet it is a hugely irresponsible promise, because it cannot be
fulfilled.

Next week ministers from around the world gather in Vienna to set
international drug policy for the next decade. Like first-world-war
generals, many will claim that all that is needed is more of the same.
In fact the war on drugs has been a disaster, creating failed states in
the developing world even as addiction has flourished in the rich world.
By any sensible measure, this 100-year struggle has been illiberal,
murderous and pointless. That is why The Economist continues to believe
that the least bad policy is to legalise drugs.

"Least bad" does not mean good. Legalisation, though clearly better for
producer countries, would bring (different) risks to consumer countries.
As we outline below, many vulnerable drug-takers would suffer. But in
our view, more would gain.

The evidence of failure

Nowadays the UN Office on Drugs and Crime no longer talks about a
drug-free world. Its boast is that the drug market has "stabilised",
meaning that more than 200m people, or almost 5% of the world's adult
population, still take illegal drugs-roughly the same proportion as a
decade ago. (Like most purported drug facts, this one is just an
educated guess: evidential rigour is another casualty of illegality.)
The production of cocaine and opium is probably about the same as it was
a decade ago; that of cannabis is higher. Consumption of cocaine has
declined gradually in the United States from its peak in the early
1980s, but the path is uneven (it remains higher than in the mid-1990s),
and it is rising in many places, including Europe.

This is not for want of effort. The United States alone spends some $40
billion each year on trying to eliminate the supply of drugs. It arrests
1.5m of its citizens each year for drug offences, locking up half a
million of them; tougher drug laws are the main reason why one in five
black American men spend some time behind bars. In the developing world
blood is being shed at an astonishing rate. In Mexico more than 800
policemen and soldiers have been killed since December 2006 (and the
annual overall death toll is running at over 6,000). This week yet
another leader of a troubled drug-ridden country-Guinea Bissau-was
assassinated.

Yet prohibition itself vitiates the efforts of the drug warriors. The
price of an illegal substance is determined more by the cost of
distribution than of production. Take cocaine: the mark-up between coca
field and consumer is more than a hundredfold. Even if dumping
weedkiller on the crops of peasant farmers quadruples the local price of
coca leaves, this tends to have little impact on the street price, which
is set mainly by the risk of getting cocaine into Europe or the United
States.

Nowadays the drug warriors claim to seize close to half of all the
cocaine that is produced. The street price in the United States does
seem to have risen, and the purity seems to have fallen, over the past
year. But it is not clear that drug demand drops when prices rise. On
the other hand, there is plenty of evidence that the drug business
quickly adapts to market disruption. At best, effective repression
merely forces it to shift production sites. Thus opium has moved from
Turkey and Thailand to Myanmar and southern Afghanistan, where it
undermines the West's efforts to defeat the Taliban.

Al Capone, but on a global scale

Indeed, far from reducing crime, prohibition has fostered gangsterism on
a scale that the world has never seen before. According to the UN's
perhaps inflated estimate, the illegal drug industry is worth some $320
billion a year. In the West it makes criminals of otherwise law-abiding
citizens (the current American president could easily have ended up in
prison for his youthful experiments with "blow"). It also makes drugs
more dangerous: addicts buy heavily adulterated cocaine and heroin; many
use dirty needles to inject themselves, spreading HIV; the wretches who
succumb to "crack" or "meth" are outside the law, with only their
pushers to "treat" them. But it is countries in the emerging world that
pay most of the price. Even a relatively developed democracy such as
Mexico now finds itself in a life-or-death struggle against gangsters.
American officials, including a former drug tsar, have publicly worried
about having a "narco state" as their neighbour.

The failure of the drug war has led a few of its braver generals,
especially from Europe and Latin America, to suggest shifting the focus
from locking up people to public health and "harm reduction" (such as
encouraging addicts to use clean needles). This approach would put more
emphasis on public education and the treatment of addicts, and less on
the harassment of peasants who grow coca and the punishment of consumers
of "soft" drugs for personal use. That would be a step in the right
direction. But it is unlikely to be adequately funded, and it does
nothing to take organised crime out of the picture.

Legalisation would not only drive away the gangsters; it would transform
drugs from a law-and-order problem into a public-health problem, which
is how they ought to be treated. Governments would tax and regulate the
drug trade, and use the funds raised (and the billions saved on
law-enforcement) to educate the public about the risks of drug-taking
and to treat addiction. The sale of drugs to minors should remain
banned. Different drugs would command different levels of taxation and
regulation. This system would be fiddly and imperfect, requiring
constant monitoring and hard-to-measure trade-offs. Post-tax prices
should be set at a level that would strike a balance between damping
down use on the one hand, and discouraging a black market and the
desperate acts of theft and prostitution to which addicts now resort to
feed their habits.

Selling even this flawed system to people in producer countries, where
organised crime is the central political issue, is fairly easy. The
tough part comes in the consumer countries, where addiction is the main
political battle. Plenty of American parents might accept that
legalisation would be the right answer for the people of Latin America,
Asia and Africa; they might even see its usefulness in the fight against
terrorism. But their immediate fear would be for their own children.

That fear is based in large part on the presumption that more people
would take drugs under a legal regime. That presumption may be wrong.
There is no correlation between the harshness of drug laws and the
incidence of drug-taking: citizens living under tough regimes (notably
America but also Britain) take more drugs, not fewer. Embarrassed drug
warriors blame this on alleged cultural differences, but even in fairly
similar countries tough rules make little difference to the number of
addicts: harsh Sweden and more liberal Norway have precisely the same
addiction rates. Legalisation might reduce both supply (pushers by
definition push) and demand (part of that dangerous thrill would go).
Nobody knows for certain. But it is hard to argue that sales of any
product that is made cheaper, safer and more widely available would
fall. Any honest proponent of legalisation would be wise to assume that
drug-taking as a whole would rise.

There are two main reasons for arguing that prohibition should be
scrapped all the same. The first is one of liberal principle. Although
some illegal drugs are extremely dangerous to some people, most are not
especially harmful. (Tobacco is more addictive than virtually all of
them.) Most consumers of illegal drugs, including cocaine and even
heroin, take them only occasionally. They do so because they derive
enjoyment from them (as they do from whisky or a Marlboro Light). It is
not the state's job to stop them from doing so.

What about addiction? That is partly covered by this first argument, as
the harm involved is primarily visited upon the user. But addiction can
also inflict misery on the families and especially the children of any
addict, and involves wider social costs. That is why discouraging and
treating addiction should be the priority for drug policy. Hence the
second argument: legalisation offers the opportunity to deal with
addiction properly.

By providing honest information about the health risks of different
drugs, and pricing them accordingly, governments could steer consumers
towards the least harmful ones. Prohibition has failed to prevent the
proliferation of designer drugs, dreamed up in laboratories.
Legalisation might encourage legitimate drug companies to try to improve
the stuff that people take. The resources gained from tax and saved on
repression would allow governments to guarantee treatment to addicts-a
way of making legalisation more politically palatable. The success of
developed countries in stopping people smoking tobacco, which is
similarly subject to tax and regulation, provides grounds for hope.

A calculated gamble, or another century of failure?

This newspaper first argued for legalisation 20 years ago (see article).
Reviewing the evidence again (see article), prohibition seems even more
harmful, especially for the poor and weak of the world. Legalisation
would not drive gangsters completely out of drugs; as with alcohol and
cigarettes, there would be taxes to avoid and rules to subvert. Nor
would it automatically cure failed states like Afghanistan. Our solution
is a messy one; but a century of manifest failure argues for trying it.

Electronic Cigarettes?



Chinese e-cigs gain ground amid safety concerns

BEIJING (AP) — With it's slim white body and glowing amber tip, it can easily pass as a regular cigarette. It even emits what look like curlicues of white smoke. The Ruyan V8, which produces a nicotine-infused mist absorbed directly into the lungs, is just one of a rapidly growing array of electronic cigarettes attracting attention in China, the U.S. and elsewhere — and the scrutiny of world health officials.

Marketed as a healthier alternative to smoking and a potential way to kick the habit, the smokeless smokes have been distributed in swag bags at the British film awards and hawked at an international trade show.

Because no burning is involved, makers say there's no hazardous cocktail of cancer-causing chemicals and gases like those produced by a regular cigarette. There's no secondhand smoke, so they can be used in places where cigarettes are banned, the makers say.

Health authorities are questioning those claims.

The World Health Organization issued a statement in September warning there was no evidence to back up contentions that e-cigarettes are a safe substitute for smoking or a way to help smokers quit.

It also said companies should stop marketing them that way, especially since the product may undermine smoking prevention efforts because they look like the real thing and may lure nonsmokers, including children.

"There is not sufficient evidence that (they) are safe products for human consumption," Timothy O'Leary, a communications officer at the WHO's Tobacco Free Initiative in Geneva, said this week.

The laundry list of WHO's concerns includes the lack of conclusive studies and information about e-cigarette contents and their long-term health effects, he said.

Unlike other nicotine-replacement therapies such as patches for slow delivery through the skin, gum or candy for absorption in the mouth, or inhalers and nasal sprays, e-cigarettes have not gone through rigorous testing, O'Leary said.

Nicotine is highly addictive and causes the release of the "feel good" chemical dopamine when it goes to the brain. It also increases heart rate and blood pressure and restricts blood to the heart muscle.

Ruyan — which means "like smoking" — introduced the world's first electronic cigarette in 2004. It has patented its ultrasonic atomizing technology, in which nicotine is dissolved in a cartridge containing propylene glycol, the liquid that is vaporized in smoke machines in nightclubs or theaters and is commonly used as a solvent in food.

When a person takes a drag on the battery-powered cigarette, the solution is pumped through the atomizer and comes out as an ultrafine spray that resembles smoke.

Hong Kong-based Ruyan contends the technology has been illegally copied by Chinese and foreign companies and is embroiled in several lawsuits. It's also battling questions about the safety of its products.

Most sales take place over the Internet, where hundreds of retailers tout their products. Their easy availability, O'Leary warns, "has elevated this to a pressing issue given its unknown safety and efficacy."

Prices range from about $60 to $240. Kits include battery chargers and cartridges that range in flavors (from fruit to menthol) and nicotine levels (from zero — basically a flavored mist — to 16 milligrams, higher than a regular cigarette.) The National Institutes of Health says regular cigarettes contain about 10 milligrams of nicotine.

On its Web site, Gamucci, a London-based manufacturer, features a woman provocatively displaying one of its e-cigs. "They look like, feel like and taste like traditional tobacco, yet they aren't," the blurb reads. "They are a truly healthier and satisfying alternative. Join the revolution today!"

Smoking Everywhere, a Florida-based company, proclaims it "a much better way to smoke!" while a clip on YouTube features an employee of the NJoy brand promoting its e-cigarettes at CES, the international consumer technology trade show.

Online sales make it even more difficult to regulate the industry, which still falls in a gray area in many countries.

In the U.S., the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly.

He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising.

In Australia, the sale of electronic cigarettes containing nicotine is banned. In Britain, the products appear to be unregulated and are sold in pubs.

Smoking is tightly woven into the fabric of daily life in Ruyan's home turf of China, the world's largest tobacco market where about 2 trillion cigarettes are sold every year.

Tobacco sales, the biggest source of government revenue, brought in $61 billion in the first 11 months of last year, up 18 percent from 2007, the Communist Party's People's Daily newspaper said.

In a country where the cheapest brands of cigarettes cost about 20 cents a pack, the e-cig is far pricier. Ruyan's V8 costs $240 and includes batteries and 20 cartridges of nicotine solution, roughly the same number of puffs as 20 packs of tobacco cigarettes. The line has expanded to include cigars and pipes crafted from agate and rosewood.

Ruyan is suing a Beijing newspaper for questioning its safety and for claiming in 2006 that its products have more nicotine than regular cigarettes.

Miu Nam, Ruyan's executive director, blames the newspaper for a hit in sales and profits but declined to give details.

"We have to restore consumers' confidence, we have to clean up people's doubts," Miu said.

An operator at the Beijing Times refused to transfer calls seeking comment Friday to managers at the newspaper. A reporter said she had heard of the case but would not give any details.

Some international experts back Ruyan's claims its product is safe.

David Sweanor, an adjunct law professor at Ottawa University and former legal counsel of the Non Smokers Rights Association in Canada, said e-cigs have the potential to save lives.

With smoking, "it's the delivery system that's killing people," Sweanor said. "Anytime you suck smoke into your lungs you're going to do yourself a great deal of damage. Nicotine has some slight risks but they are minor compared to the risk of smoke in cigarettes."

Dr. Murray Laugesen, a New Zealand physician involved in tobacco control for 25 years who was commissioned by Ruyan to test its e-cigs, said he found "very little wrong" with them.

"It looks more like a cigarette and feels more like a cigarette than any other device so far and yet it does not cause the harm," he said. "It's the best substitute so far invented for tobacco cigarettes."

In the U.S, both Philip Morris USA and RJ Reynolds have introduced cigarettes that did not burn tobacco, but the technologies were very different from the e-cigarette. Neither has been successful.

In 2006, Philip Morris USA, test-marketed the Accord, which used a heating unit activated by puffing. RJ Reynolds introduced its cigarette, the Premier, in 1987 and still sells the Eclipse, which heats the tobacco rather than burning it. Sales are "not great," said spokesman David Howard.

Li Honglei, a fast-talking 28-year-old public relations manager in Beijing, has been smoking since he was in his teens and desperately wants to quit. He thinks he may have found his answer in Ruyan.

"I was intrigued by this new technology," said the pudgy, bespectacled Li as he surveyed products displayed in glass cases at Ruyan's brightly-lit shop in the capital. "I heard acupuncture is effective as well, but this method sounds more painless."

Associated Press writers Chi-Chi Zhang and Yu Bing in Beijing and Vinnee Tong and Carley Petesch in New York contributed to this report


Video on electronic cigarettes in Asia:
http://video.ap.org/?f=CODEN&pid=YcQ8TsCGUCdKmD41FA6XwdQKkqmzveQB&fg=rss



And a manufacturer of these nicotine delivery devices -- don't miss the "benefits" section!

Monday

NIDA Studies Exercise as Addiction Prevention Tool

http://nihrecord.od.nih.gov/newsletters/2008/07_25_2008/story7.htm
NIDA Studies Exercise as Addiction Prevention Tool

 



It is well known that exercise is an important part of a healthy lifestyle, but can it prevent addiction too?The National Institute on Drug Abuse held a conference in June to explore the possible role for physical activity in substance abuse prevention. As part of this effort, NIDA announced a $4 million grant initiative to spur further research in this emerging area.

More than 100 scientists from around the country gathered for the 2-day conference to: share the state of the science in epidemiology, basic science and intervention research focused on physical activity as a strategy to prevent substance abuse; facilitate the development and testing of new paradigms for prevention; and promote future research in these areas.

“Exercise has been shown to be beneficial in so many areas of physical and mental health,” said Dr. Nora Volkow, NIDA director. “This cross-disciplinary meeting was designed to get scientists thinking creatively about its potential role in substance abuse prevention.”

Presentations targeted the importance of the social context in which physical activity occurs, including school and the natural environment, as well as the relationship of physical activity to physical disorders (obesity), social reward structures (motivation), cognition (attention, impulse control and other motor skills) and mood disorders (depression, stress), all of which may play a role in substance abuse. To facilitate research on the role of exercise, attendees learned about and saw demonstrations of tools that assess physiological responses to exercise and physical activity.

On the second day of the meeting, Sally Squires, the reporter of the Washington Post’s Lean Plate Club, shared insights and feedback from her column on what the public wants to know about physical activity and health. NIHRecord Icon

See Also: 

http://www.drug-rehab.com/exercise-addiction-treatment.htm

Saturday

Low to moderate alcohol consumption in women increases the risk of certain cancers

http://jnci.oxfordjournals.org/cgi/content/abstract/djn514 

Moderate Alcohol Intake and Cancer Incidence in Women

Naomi E. AllenValerie BeralDelphine CasabonneSau Wan Kan,Gillian K. ReevesAnna BrownJane Green
on behalf of the Million Women Study Collaborators

Affiliation of authors: Cancer Epidemiology Unit, University of Oxford, Oxford, UK

Correspondence to: Dr Naomi E. Allen, Cancer Epidemiology Unit, University of Oxford, Richard Doll Building, Oxford OX3 7LF, UK (e-mail: naomi.allen@ceu.ox.ac.uk).

Background: With the exception of breast cancer, little is known about the effect of moderate intakes of alcohol, or of particular types of alcohol, on cancer risk in women.

Methods: A total of 1 280 296 middle-aged women in the United Kingdomenrolled in the Million Women Study were routinely followed for incident cancer. Cox regression models were used to calculate adjusted relative risks and 95% confidence intervals (CIs) for 21 site-specific cancers according to amount and type of alcoholic beverage consumed. All statistical tests were two-sided.

Results: A quarter of the cohort reported drinking no alcohol; 98% of drinkers consumed fewer than 21 drinks per week, with drinkers consuming an average of 10 g alcohol (1 drink) per day. During an average 7.2 years of follow-up per woman 68 775 invasive cancers occurred. Increasing alcohol consumption was associated with increased risks of cancers of the oral cavity and pharynx (increase per 10 g/d = 29%, 95% CI = 14% to 45%, Ptrend < .001), esophagus (22%, 95% CI = 8% to 38%, Ptrend = .002), larynx (44%, 95% CI = 10% to 88%, Ptrend = .008), rectum (10%, 95% CI = 2% to 18%, Ptrend = .02), liver (24%, 95% CI = 2% to 51%, Ptrend = .03), breast (12%, 95% CI = 9% to 14%,Ptrend < .001), and total cancer (6%, 95% CI = 4% to 7%, Ptrend < .001). The trends were similar in women who drank wine exclusively and other consumers of alcohol. For cancers of the upper aerodigestive tract, the alcohol-associated risk was confined to current smokers, with little or no effect of alcohol among never and past smokers(Pheterogeneity < .001). Increasing levels of alcohol consumption were associated with a decreased risk of thyroid cancer (Ptrend = .005), non–Hodgkin lymphoma (Ptrend = .001), and renal cell carcinoma (Ptrend = .03).

Conclusions: Low to moderate alcohol consumption in women increases the risk of certain cancers. For every additional drink regularly consumed per day, the increase in incidence up to age 75 years per 1000 for women in developed countries is estimated to be about 11 for breast cancer, 1 for cancers of the oral cavity and pharynx, 1 for cancer of the rectum, and 0.7 each for cancers of the esophagus, larynx and liver, giving a total excess of about 15 cancers per 1000 women up to age 75.



Context and Caveats

Prior knowledge

With the exception of breast cancer, there was little information on the cancer risks conferred by alcohol consumption in women.

Study design

Prospective cohort study with alcohol consumption determined on the basis of a questionnaire and information on incidence of specific cancers obtained from a national registry. Cox regression models were used to estimate cancer risks associated with alcohol consumption after adjustment for other risk factors.

Contribution

Increasing but moderate alcohol consumption in women was determined to be associated with an increased risk of cancers of the oral cavity and pharynx, esophagus, larynx, rectum, breast, and liver, and with a decreased risk for thyroid cancer, non–Hodgkin lymphoma, and renal cell carcinoma. No differences in cancer risks were observedbetween drinkers of wine only and other consumers of alcohol.

Implications

In middle-aged women, moderate alcohol consumption increases the risk of cancer overall; each additional drink regularly consumed per day may account for approximately 15 excess cancers per 1000 women up to age 75 in this age group in developed countries.

Limitations

The study could not address the risk conferred by heavy sustained drinking due to the composition of the cohort.

From the Editors

 
Manuscript received April 7, 2008; revised October 20, 2008; accepted December 18, 2008.

 Related Articles in JNCI

IN THIS ISSUE 
J Natl Cancer Inst 2009 101: 281. [Extract] [Full Text] [PDF]

Million Women Study Shows Even Moderate Alcohol Consumption Associated with Increased Cancer Risk 
J Natl Cancer Inst 2009 101: 281. [Extract] [Full Text] [PDF]