The Blog of ALAN TRACHTENBERG, MD, MPH, Adj. Assoc. Professor of Community Medicine, George Washington University School of Public Health and Health Services; TOPICS course in "Substance Abuse, Prevention, Intervention & Public Health." Also To Create: General Preventive Medicine & Public Health, Health Policy, Alternative & Complementary Health Practices (ACHP/CAM), Substance Abuse, Chronic Pain, Community Oriented Primary Care (COPC), Epidemiology & Research Methods.
Implants that deliver time-released doses of the anti-addiction medication naltrexone have been touted for preventing drug overdoses, but Australian researchers have found at least five fatal overdoses among implant patients, The Age reported Feb. 5.
Researchers at the University of New South Wales' Drug and Alcohol Research Center said that four men and a woman died from overdoses between 2002 and 2004 despite the implants. The users were suspected of taking large doses of heroin to overcome the blocking effect of the naltrexone.
"The big thing that has been claimed is if you are actively in treatment with naltrexone implants you can't overdose, and the fact of the matter is these people did," said study co-author Louisa Degenhardt.
Another expert said that the patients may have overdosed after the naltrexone wore off. "The problem is when you stop using [naltrexone] you become sensitive to the effects of heroin, so that even much smaller doses of heroin than you used to use could be potentially lethal," said Nick Lintzeris of the addiction-treatment program Turning Point.
Antismoking Ads Backfire, Study Concludes July 23, 2007
Research Summary
Middle-school students who were exposed to the greatest number of antismoking ads were also the most likely to smoke, according to researchers who concluded that such ads can backfire unless constructed carefully.
The Atlanta Journal-Constitution reported July 19 that researchers at the University of Georgia and the University of Wisconsin at Madison said that the survey of 1,700 middle-school students found that ads that warn about the dangers of smoking may unintentionally encourage the rebelliousness of youth.
"They don't want to hear what they should do or not do," said study co-author Hye-Jin Paek. Instead, ads should try to convince young teens that their peers are rejecting smoking so they should, too.
"Rather than saying, 'don't smoke,' it is better to say, 'your friends are listening to this message and not smoking,'" she said. "It doesn't really matter what their peers are actually doing."
"To fathom Hell or soar angelic, just take a pinch of psychedelic." -Humphry Osmond
"There are two major products that come out of Berkley: LSD and UNIX. We don't believe this to be a coincidence." -Jeremy S. Anderson
"Drugs have taught an entire generation of American kids the metric system." -P.J. O'Rourke
"All drugs of any interest to any moderately intelligent person in America are now illegal." -Thomas Szasz
"If addiction is judged by how long a dumb animal will sit pressing a lever to get a 'fix' of something, to its own detriment, then I would conclude that netnews is far more addictive than cocaine." -Rob Stampfli
"Don't do drugs because if you do drugs you'll go to prison, and drugs are really expensive in prison." -John Hardwick
"If God dropped acid, would he see people?" -Steven Wright
"Anyway, no drug, not even alcohol, causes the fundamental ills of society. If we're looking for the source of our troubles, we shouldn't test people for drugs, we should test them for stupidity, ignorance, greed and love of power." -P.J. O'Rourke
"I tried sniffing Coke once, but the ice cubes got stuck in my nose." -Author Unknown
"Did you know America ranks the lowest in education but the highest in drug use? It's nice to be number one, but we can fix that. All we need to do is start the war on education. If it's anywhere near as successful as our war on drugs, in no time we'll all be hooked on phonics." -Leighann Lord
"Avoid all needle drugs - the only dope worth shooting is Richard Nixon." -Abbie Hoffman
"Reality is a crutch for people who can't cope with drugs." -Lily Tomlin
"Drugs may be the road to nowhere, but at least they're the scenic route." -Author Unknown
"Half the modern drugs could well be thrown out the window except that the birds might eat them." -Martin H. Fischer, Fischerisms
"A miracle drug is any drug that will do what the label says it will do." -Eric Hodgins
"I've never had a problem with drugs. I've had problems with the police." -Keith Richards
"It is difficult to live without opium after having known it because it is difficult, after knowing opium, to take earth seriously. And unless one is a saint, it is difficult to live without taking earth seriously." -Jean Cocteau
"I'm in favor of it as long as it's multiple choice." -Kurt Rambis, on drug testing
"It is easy to get a thousand prescriptions but hard to get one single remedy." -Chinese Proverb
"In the 1960s, people took acid to make the world weird. Now the world is weird, and people take Prozac to make it normal." -Author Unknown
"God made pot. Man made beer. Who do you trust?" -Graffiti
"Thou hast the keys of Paradise, oh, just, subtle, and mighty opium!" -Thomas De Quincey, Confessions of an English Opium-Eater, Part II
"I will lift mine eyes unto the pills. Almost everyone takes them, from the humble aspirin to the multi-coloured, king-sized three deckers, which put you to sleep, wake you up, stimulate and soothe you all in one. It is an age of pills. -Malcolm Muggeridge, 1962
"Pharmaceutical companies will soon rule the world if we keep letting them believe we are a happy, functional society so long as all the women are on Prozac, all children on Ritalin, and all men on Viagra." -The Quote Garden
"Cocaine is God's way of saying you're making too much money." -Robin Williams
"I will lift up mine eyes unto the pills. Almost everyone takes them, from the humble aspirin to the multi-coloured, king-sized three deckers, which put you to sleep, wake you up, stimulate and soothe you all in one. It is an age of pills." -Malcolm Muggeridge
"Drugs are very much a part of professional sports today, but when you think about it, golf is the only sport where the players aren't penalized for being on grass." -Bob Hope
"He does not need opium. He has the gift of reverie." -Anais Nin
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 WriterJuly 30, 2007 Her 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.
We had the first meeting of the 2008 course this past week and I have a bright, energetic and diverse group of about 15 students who all seem quite interested in the topic. It was necessary this year to review the basic neurophysiology and pharmacologic priciples, but the group seemed to soak them up readily and now has a good handle on these basics.
This year I did try to post the syllabus on Blackboard, along with a link to the course website and from my Blackboard "Control panel" it looked like I did so. However, since several registered students have not been able to find anything there, I guess it's "back to the drawing board" for me on that. Until I can use Blackboard more reliably, I will have to continue to depend on the website I've been using for the past ten or so years.
This is the first year that I'm also using a blog for the course, or the first time I'm really using a blog for anything. Prior to this, I've been using this space just to post links and items of interest without much in the way of comment. So I'm posting this now and will be very interested to see whether any comments come back from the students, and whether this can develop into a forum for group discussion outside of the class period.
CSAP's Model Programs The SAMHSA Model Programs featured on this site have been rigorously evaluated and have provided solid proof that they have prevented or reduced substance abuse and other related high-risk behaviors. All programs have been reviewed by SAMHSA's National Registry of Evidence-based Programs and Practices (NREPP). This Web site serves as a comprehensive resource for anyone interested in learning about and/or implementing these programs.
CSAP's Northeast CAPT's Database of Effective Prevention Programs CSAP's Northeast CAPT has created an online, searchable database of effective prevention programs approved by a variety of federal and research agencies. The database allows visitors to compare selection criteria across agencies, review information about the sources those agencies used for their evaluations, and find contact information and descriptions of each intervention. CSAP's Western CAPT's Best and Promising Practices 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. U.S. Department of Education's Safe and Drug-Free Schools' Exemplary and Promising Programs The U.S. Department of Education's Safe and Drug-Free Schools Program has used an expert panel process to identify programs that should be promoted nationally as promising or exemplary. A 15-member Expert Panel oversaw a valid and reliable process for identifying effective school-based programs that promote healthy students and safe, disciplined, and drug-free schools. Using this process, the panel identified 9 exemplary and 33 promising programs. Office of Juvenile Justice and Delinquency Prevention (OJJDP) The OJJDP Model Programs Guide is a user-friendly, online portal to scientifically tested and proven programs that address a range of issues across the juvenile justice spectrum. Developed as a tool to support the Title V Community Prevention Grants Program, the Guide has been recently expanded. The Guide now profiles more than 175 prevention and intervention programs and helps communities identify those that best suit their needs. Users can search the Guide's database by program category, target population, risk and protective factors, effectiveness rating, and other parameters. Juvenile justice practitioners are encouraged to take advantage of this helpful resource. Blueprints for Violence Prevention The Center for the Study and Prevention of Violence at the University of Colorado at Boulder, with support from the Centers for Disease Control and Prevention and OJJDP, designed and launched a national violence prevention initiative to identify violence prevention programs that are effective. The project has identified 11 model programs that meet a strict scientific standard of program effectiveness. Another 18 programs have been identified as promising. These interventions have been summarized in a series of "blueprints" that describe their theoretical rationales, core components, evaluation designs and results, and practical implementation experiences across multiple sites.
News Release 2007 Report by Florida Medical Examiners Commission on Drugs Identified in Deceased Persons June 12, 2008 Today, the Florida Department of Law Enforcement (FDLE) and the Florida Medical Examiners Commission released the state’s annual report on Drugs Identified in Deceased Persons. The report contains information compiled from autopsies performed by medical examiners across the state in 2007. During that period, there were more than 168,900 deaths in Florida. Of those, 8,620 individuals were found to have died with one or more of the drugs specified in this report in their bodies.
Medical Examiners specifically collected information on these drugs: Ethyl Alcohol, Amphetamines, Methamphetamines, MDMA (Ecstasy), MDA, MDEA, Alprazolam, Diazepam, Flunitrazepam (Rohypnol), other Benzodiazepines, Cannabinoids, Carisoprodol/Meprobamate, Cocaine, Gamma-Hydroxybutyric Acid (GHB), Inhalants, Ketamine, Fentanyl, Heroin, Hydrocodone, Hydromorphone, Meperidine, Methadone, Morphine, Oxycodone, Propoxyphene, Tramadol, and Phencyclidine (PCP).
The report reveals incidences of Amphetamine, MDA, Meperidine, Methamphetamine and all Methylated Amphetamines decreased when compared with 2006. These decreases include cases in which the drug levels were both lethal and non-lethal.
Incidences of Oxycodone, Methadone, Cocaine, Hydrocodone, Alprazolam, Diazepam, Ethyl Alcohol, and Heroin increased in 2007.
The report indicates the three most frequently occurring drugs found in decedents were Ethyl Alcohol (4,179), all Benzodiazepines (2,627), and Cocaine (2,179). The drugs that caused the most deaths were Cocaine, Methadone, all Benzodiazepines (includes Alprazolam), Oxycodone, Ethyl Alcohol, Hydrocodone, and Morphine. Despite the increase in heroin incidences, deaths caused by heroin still remain lower than in 2005 or any prior year.
The report indicates that prescription drugs (Benzodiazepines, Carisoprodol/Meprobamate, and all Opiods, excluding Heroin) continued to be found more often than illicit drugs in both lethal and non-lethal levels.
“This year’s report again reflects that using drugs often leads to fatal consequences,” said FDLE Commissioner Gerald Bailey. “FDLE and our law enforcement partners are working aggressively to take illegal narcotics off the streets, and to educate Florida’s families about the dangers of the abuse of prescription drugs.”
“The rate of deaths caused by prescription drugs is over three times as high as the rate of deaths caused by all illicit drugs combined,” said Director of the Office of Drug Control Bill Janes. “We have not yet implemented a statewide monitoring plan that will help reduce the problem. The monitoring plan is our priority effort, but that is not enough. We are working to increase awareness among our families by focusing our efforts on communities, schools, businesses, churches, and the media. Prescription drugs are not safe and must be secured. Doctors and pharmacists must help law enforcement identify and stop doctor shoppers. We are also looking for ways to curb illegal internet sales. Only through a comprehensive, coordinated strategy will we be able to reverse this tragic, unacceptable trend.”
The US Food and Drug Administration (FDA) announced in the FederalRegister on January 2 that it has issued a draft guidance to assist thedietary supplement industry in complying with the labeling requirementsof the Dietary Supplement and Nonprescription Drug Consumer ProtectionAct ("the AER Act").1 The AER Act requires marketers of dietarysupplements and over-the-counter (OTC) drugs to maintain records of alladverse events reported to the manufacturer and submit reports to theFDA of those incidents meeting the definition of "serious" adverseevents. Comments regarding this draft guidance must be submitted to theFDA by March 3. According to the draft guidance, dietary supplement labels must includea domestic address or phone number for receiving adverse event reports.The FDA has concluded that this entails either a full US mailing address(complete with street address or post office box number) or a phonenumber with an area code. The FDA further recommends in its guidancethat all dietary supplement labels include a clear, prominent statementinforming consumers that the domestic address or phone number may beused for reporting serious adverse events associated with the product.Although the AER Act went into effect in December of 2007, the FDA hasstated that it intends to exercise enforcement discretion for the newlabeling requirements until January 1, 2009. The requirement to documentadverse events and report serious events to the FDA is currently inforce as of December 22, 2007. Two prominent industry trade organizations have already expressed someconcerns about the recently issued guidance. The American HerbalProducts Association (AHPA) recently stated in a press release that ithas previously gone on record as arguing that a full US mailing addressis unnecessary for product labels.2 AHPA pointed out that long-standingregulations for foods, drugs, medical devices, and cosmetics have heldthat a company's place of business need not include a street address ifit can be found in a city directory. According to AHPA, FDA explainedthat it has suggested a full mailing address because the agency believesconsumers may choose to not submit a report if they believe it would notbe received due to an incomplete address. "This is really quite stunning," stated AHPA President Michael McGuffin,according to the AHPA press release.2 "If FDA is stating that theinformation that has been required on food, drug, medical device andcosmetic labeling since 1938 is somehow inadequate to communicate toconsumers, AHPA assumes that FDA would seek a global change in the lawto address any perceived inadequacy and would not single out thisindustry and the OTC drug industry as targets for its hypothesis." AHPA also objected to FDA's recommendation that companies include astatement about the use of the address or phone number for submittingserious adverse event reports, which AHPA argued "must be seen as awarning statement." "This was not the intent of the law, and the Senate Committee on Health,Education, Labor and Pensions clearly stated in its official report onthis bill that it 'does not require the label to make any statementother than providing the address or phone number,'" said McGuffin.2 The Council for Responsible Nutrition (CRN) has also recently expresseddisappointment with the guidance document, arguing that it too haspreviously gone on record as opposing such changes in labeling. "We are dismayed that FDA has introduced these new labelingrequirements, seemingly out of nowhere, particularly because there is nolegislative authority in the statute for these requirements," said SteveMister, president and CEO of CRN (e-mail, January 10, 2008). "It'sparticularly troubling that the agency has chosen to try to impose theserequirements through a draft guidance. These kinds of sweepingdeviations from the stated intent of Congress at least require fullnotice and comment rulemaking." CRN first learned of FDA officials' interest in changing the labels inthe wake of the passage of the AER law last spring, Mister said. In a letter sent to Robert E. Brackett, PhD, then-director of the Centerfor Food Safety and Applied Nutrition at the FDA in July of 2007, CRNargued then against both the perceived necessity of a full mailingaddress and of adding a statement about the address and phone number'suse for reporting serious adverse events, for reasons similar to thosegiven by AHPA.3 "The primary purpose of this legislation has always been to assureconsumers that when a company receives a complaint of a serious adverseevent, it will provide that information to FDA. The agency has pastedits own agenda onto the intent of Congress and tried to do so withoutusing the proper administrative procedures," said Mister. CRN further commented that such label changes would place an undueburden on industry and that manufacturers would need at least 3 years tochange labels on new products being placed on the market. "We have heard from several of our members that FDA has farunderestimated the financial projections for manufacturers to revisetheir labels," said Mister. "The agency doesn't seem to appreciate thetime and expense involved to make even minor changes to supplementlabeling. Someone, potentially consumers, will have to absorb thesecosts. The agency should reevaluate whether these mandatory changeswould really best serve consumers given these added costs." The FDA released a prior guidance document in October of 2007 concerningthe submission and recordkeeping of serious adverse events of dietarysupplements and OTC drugs required under the AER Act.4 An articlecovering this guidance document was published in the October issue ofHerbalEGram.5 -Courtney Cavaliere
References1US Food and Drug Administration. Draft guidance for industry: questionsand answers regarding the labeling of dietary supplements as required bythe Dietary Supplement and Nonprescription Drug Consumer Protection Act;availability. 73 Federal Register 197. January 2, 2008. Available at:http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2008_register&position=all&page=197. Accessed January 2, 2008.2FDA issues labeling guidance on SAER law [press release]. SilverSpring, MD: American Herbal Products Association; January 2, 2008.3Mister S. Letter to RE. Brackett (CFSAN, FDA). July 31, 2007.4US Food and Drug Administration. Draft guidance for industry: Questionsand answers regarding adverse event reporting and recordkeeping fordietary supplements as required by the Dietary Supplement andNonprescription Drug Consumer Protection Act; availability. 72 FederalRegister 58313. October 15, 2007. Available at:http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/07-5074.pdf. Accessed January 7, 2007.5Cavaliere C. FDA publishes draft guidance on serious adverse eventreports. HerbalEGram. October 2007;4(10). Available at:http://abc.herbalgram.org/site/PageServer?pagename=04_10_SAER_Guidance&JServSessionIdr012=xvjgf745d2.app13a. Accessed January 7, 2008.
Smoking predicts suicidality: Findings from a prospective community study Thomas Bronischa, , , Michael Höflera, b and Roselind Lieba, c aMax-Planck-Institute of Psychiatry, Clinic and Clinical Psychology and Epidemiology, Kraepelinstreet 2-10, 80804 Munich, Germany bTechnical University of Dresden, Clinical Psychology and Psychotherapy, Mommsenstreet 3, 01187 Dresden, Germany cUniversity of Basel, Epidemiology and Health Psychology, Missionsstrasse 60-62, 4055 Basel, Switzerland Received 4 July 2007; revised 10 October 2007; accepted 10 October 2007. Available online 19 November 2007. Abstract Background The temporal relationship between smoking and suicidality is not yet clear. This article examines associations between smoking and suicidality and their temporal ordering of onset. Methods Baseline and four-year follow-up data were used from the Early Developmental Stages of Psychopathology (EDSP) study, a prospective longitudinal study of adolescents and young adults in Munich, Germany. We assessed smoking (occasional and regular), nicotine dependence, suicidal ideation and suicide attempts using the standardized Munich-Composite International Diagnostic Interview (M-CIDI). Results Suicide ideation and suicide attempts were strongly associated with occasional and regular smoking and nicotine dependence at baseline (Odds ratios [OR] range from 1.4 to 16.4). In the prospective analyses, prior occasional, regular smoking and nicotine dependence increased the risk for new onset of suicide ideation (OR range from 1.5 to 2.7) and prior regular smoking and nicotine dependence increased also the risk for onset of suicide attempt(s) (OR range between 3.1 and 4.5). Pre-existing suicidality could not be shown to be associated with subsequent smoking or nicotine dependence. Associations remained stable when participants who fulfilled DSM-IV-criteria for major depression were excluded. Limitations The sample is confined to an age cohort of 14 to 24 years. No completed suicides could be observed. Conclusions The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality.
Keywords: Suicide attempts; Suicide ideas; Smoking; Community study
Article Outline 1. Introduction 2. Methods 2.1. Design 2.2. Sample 2.3. Diagnostic assessment 2.4. Assessment of suicidality 2.5. Definition of smoking and nicotine dependence 2.6. Statistical analyses 3. Results 3.1. Lifetime prevalence of smoking, nicotine dependence and suicidality at baseline 3.2. Baseline associations between smoking behavior and suicidality 3.3. Is the presence of pre-existing smoking related to the risk for onset of suicide ideation and suicide attempts during the four year prospective follow-up interval? 3.4. Does the presence of pre-existing suicidality predict the risk for onset of smoking during the four year follow-up interval? 4. Discussion Role of Funding Source Conflict of interest Acknowledgements References Table 1. Lifetime prevalence of smoking, nicotine dependence and suicidality at baseline (N = 3021) The gender difference is significant at p < .05. Asterisks indicate the group with the higher rate. Odds Ratios females versus males are for suicide ideation OR = 1.6; 95% CI = 1.2–2.0; for suicide attempts OR = 2.3; 95% CI = 1.3–4.1; for occasional smoking OR = 0.6; 95% CI = 0.5–0.8; for non-dependent regular smoking OR = 0.9; 95% CI = 0.7–1.2; and for dependent regular smoking OR = 0.9; 95% CI = 0.7–1.2.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Among the N = 2222 respondents with at least occasional use, N = 7 used exclusively tobacco products other than cigarettes.d Smoked cigarettes daily for at least for weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.e Smoked cigarettes daily for at least for weeks in lifetime and fulfill DSM-IV criteria for nicotine dependence.f Excludes suicide attempt(s). View Within Article Table 2. Baseline associations between smoking status and suicidaliy (N = 3021) N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval. The odds ratio is significant p < .05; all odds ratios are controlled for age and gender, alcohol and drug use.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence.e Excludes suicide attempt(s). View Within Article Table 3. Association between smoking status baseline and new onset of suicide ideation during the four year follow-up period N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval: All analyses were controlled for drug and alcohol use. The odds ratio is significant p < .05; all odds ratios are controlled for age and gender, alcohol and drug use. N = 23 reported attempts.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence. View Within Article Table 4. Associations between smoking status baseline and new onset of suicide attempts during the four year follow-up period N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval: All analyses were controlled for suicide ideation at baseline as well as for drug and alcohol use. The odds ratio is significant p < .05; all odds ratios are controlled for age and gender and alc and drug use.a Never used any tobacco product in lifetime.b Never used any tobacco product on a daily basis for more than four weeks in lifetime.c Smoked cigarettes daily for at least four weeks in lifetime but have never fulfilled DSM-IV criteria for nicotine dependence.d Smoked cigarettes daily for at least four weeks in lifetime and fulfilled DSM-IV criteria for nicotine dependence. View Within Article Table 5. Associations between suicide ideation/attempt(s) at baseline and incident smoking during the four-year follow-up N indicates unweighted number, %w weighted percentages, OR Odds Ratio; CI Confidence Interval; all odds ratios are controlled for age and gender and occasional smoking at baseline. View Within Article Journal of Affective DisordersVolume 108, Issues 1-2, May 2008, Pages 135-145
A controversial program in Pierce County, Wash., that referred drug-court offenders to the Prometa treatment regimen has been shut down over concerns that claims of treatment success had been exaggerated, MSNBC reported Jan. 11.For example, program officials didn't account for no-shows and dropouts, and declared patients "drug free" simply if they did not test positive for drugs in the 60 days prior to the end of the program.County officials last year approved an $800,000 treatment program focused on the Prometa drug cocktail of gabapentin, flumazenil and hydroxyzine, which owner Hythiam Inc. has touted as an effective treatment for methamphetamine and cocaine addiction. The Pierce County program has since been widely cited by Hythiam as proof of the program's legitimacy.In the wake of the county's decision to pull the program's funding, Hythiam's stock fell from more than $8 a share in October to $2.75 per share this week. The company licenses doctors to deliver Prometa to patients, who pay up to $15,000 for the treatment. Prometa has not been approved by the Food and Drug Administration as an anti-addiction drug, however. And an audit in Piece County found that Hythiam and the Pierce County Alliance, which administered the drug-court program, had "greatly exaggerated" Prometa's success rate. "It's clear to me that we are much more involved in a marketing scheme … rather than testing real results," said Pierce County Councilman Shawn Bunney.Hythiam and Pierce County Alliance officials disagreed, saying the program's effectiveness will be demonstrated when research is published later this year. "The people who are using it -- the doctors, patients, administrators, and drug court judges -- are seeing an impact with it, so I think the treatment will carry it at the end of the day," said Hythiam Executive Vice President Richard Anderson."There were some who did well with Prometa, though they had some positive (urinalysis) after receiving treatment," said James Boyle, deputy director of the Pierce County Alliance. "The auditors view those folks as not being successful. What we were trying to explain to them was that not every person who enters chemical dependency treatment will be drug free from Day One. … It's a process over time."Among those promoting Prometa on a national level are Andrea Grubb Barthwell, a former deputy director at the Office of National Drug Control Policy, and retired Judge Karen Freeman-Wilson, former CEO of the nonprofit National Association of Drug Court Professionals (NADCP), who both serve on the company's board of directors.However, current NADCP CEO West Huddleston has refused to accept Hythiam as a corporate sponsor until the company produces more scientific evident to support its claims about Prometa.
Impacts of Drugs on Neurotransmission Vol. 21, No. 4 (October 2007) The defining features of drug intoxication and addiction can be traced to disruptions in cell-to-cell signaling. http://www.nida.nih.gov/NIDA_notes/NNvol21N4/Impacts.html
Animal Experiments In Addiction Science Reference Article Vol. 20, No. 5 (April 2006) To learn how drugs promote abuse and produce addiction, researchers focus on animal behaviors that parallel human drug-related behaviors. http://www.nida.nih.gov/NIDA_notes/NNvol20N5/Reference.html
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.
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.
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).
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."
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Literature search tools (eg, PubMed, available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi;; Toxnet, available at:http://toxnet.nlm.nih.gov/)Clinical guidelines (eg, National Guidelines Clearinghouse, available at: http://www.ngc.gov/; and Primary Care Guidelines,available at: http://medicine.ucsf.edu/resources/guidelines/)
EVIDENCE BASED INFORMATION ON DRUG THERAPY from the Therapeutics Initiative of the Universityof British Columbia in Vancouver, Canada-University of British Columbia:
Every Doc Can Do Research Program Page from the USAFP, including the Every Doc Can Do Research Workbook from the Madigan Fellows and the Clinical Investigations Committee:
NLM's Health Services Technology Assessment Texts (HSTAT)is a searchable collection of large, full-text clinical practice guidelines, technology assessments and health information.
COCHRANE COLLABORATIVE COMPLEMENTARY MEDICINE (CM)FIELD:the Complementary Medicine (CM) Field was established to help promote and facilitate the production of systematic reviews in topics such as acupuncture, massage, chiropractic, herbal medicine, homeopathy and mind-body therapy.
FDA Policy on Science-based Food Labelling (including Dietary Supplements): Better Health Information for Better Nutrition - A major FDA initiative announced in 2002
NAS Report on "The Polygraph and Lie Detection" (2003); Board on Behavioral, Cognitive, and Sensory Sciences and Education (BCSSE), Committee on National Statistics (CNSTAT):
QualityTools?, a clearinghouse for practical, ready-to-use tools for measuring and improving the quality of health care; from the Agency for Healthcare Research and Quality (AHRQ):
