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Probing the nuances of pain management

From CAP Today:

People who develop chronic physical pain often require a combination of the art and science of medicine to reclaim or maintain a normal life. And the clinical laboratory is increasingly weighing in on the scientific side of the pain management equation with testing that can improve the safety and efficacy of opioid and other pain medications.

The lab’s role in pain management includes verifying that patients are taking their prescribed medications as directed and providing therapeutic drug monitoring (drug concentrations) to help determine if the medication is doing what it’s intended to do—“give people relief from pain,” says Paul Jannetto, PhD, assistant professor of pathology and director of clinical chemistry toxicology at the Medical College of Wisconsin in Milwaukee.

The No. 1 reason urine opiate drug screening is done by pain management physicians is to monitor patients for compliance, said Dr. Jannetto in a presentation at the 2008 American Association for Clinical Chemistry meeting. But some clinicians are also using therapeutic drug monitoring and pharmacogenomic testing as part of pain management, especially in difficult cases.

While statistics show that pain testing is underused, says Robert Middleberg, PhD, laboratory director at NMS Laboratories in Willow Grove, Pa., and a consultant to the CAP Toxicology Resource Committee, more and more physicians are interested in it. That’s evident, he adds, by the growing number of pain management labs “sprouting up.” In addition, “insurers are covering the testing at profitable rates for laboratories,” he says, which tells you they see an actuarial benefit to anteing up.

Yet pain management testing is no slam-dunk in terms of always providing easy yes or no answers, even in the realm of urine drug screening, which many physicians require patients who take opioids to undergo continually, Dr. Jannetto said.

On the upside, urine drug screening, which provides a two- to three-day detection window for most opiates, is “fast, automated, inexpensive, and noninvasive” for monitoring patients, he noted. But “screening” is the operative word. The screening tests are typically competitive immunoassays based on competition between drug in the patient’s sample and labeled drug for the antibodies’ binding sites. The antibodies are directed against drug groups or classes—opiates, for example. Thus, they can’t be used to identify or quantitate the concentration of a specific opiate such as morphine, codeine, or heroin. A more specific alternative chemical method (GC/MS) must be used to obtain a confirmed analytical result.

A patient taking prescribed hydrocodone who tests positive on the urine opiate screening assay could have sold that medication and used heroin, morphine, codeine, or even oxycodone, all of which can turn the screening test positive, Dr. Jannetto cautions.

He advises physicians to order confirmatory testing to pinpoint what the patient is really taking in cases, for example, where the person displays erratic behavior in the office or is suspected of diverting the medication.

Confirmatory testing uses mass spectrometry, which, as NMS’ Dr. Middleberg explains, provides “a molecular fingerprint of a compound based on structural characteristics of the substance.” The testing identifies not only the parent drug but also its metabolites, which can be tricky for physicians to interpret without guidance from the laboratory.

Physicians sometimes also receive unexpected negative results from urine drug screens for patients who are supposed to be taking an opioid or other medication. To prevent false-negatives, Dr. Jannetto said, clinicians and labs have to understand what the assays they are using will detect. Interpretation of results must also take into account that urine concentrations can vary extensively with fluid intake and other biological variables. In addition, they should realize that cross-reactivity varies among test manufacturers’ kits.

Oxycodone urine screening assays...cause confusion for the physicians, Dr. Jannetto said, because the lab’s urine opiate screening assay may not cross-react with oxycodone at all or very well. “So doctors will say, ‘My patient is on oxycodone and sometimes tests positive and sometimes not on your assay—what’s going on?’ The answer is that whether the person tests positive may have to do with his or her hydration state and the level of oxyco­done in the urine. The lab actually has a separate oxycodone screen with a lower cutoff that specifically detects oxycodone and its metabolite [oxymorphone],” he said.

Of course, says Gwen McMillin, PhD, the most common reason a drug screen comes back negative is that the patient is not taking the drug or taking it less frequently than prescribed. But “perhaps the patient didn’t realize he had to produce a urine sample until he got to the office, and then drank a lot of fluids to produce the sample,” says Dr. McMillin, assistant professor in the University of Utah Department of Pathology and medical director of toxicology at ARUP Laboratories. “Or the patient could have accelerated metabolism or drug elim­ination, or have an enzyme inducer that’s ramped up his metabolism. In rare cases, a person with Celiac disease or Crohn’s disease might not absorb a medication.”

Some pain patients adulterate their urine samples so they’ll test negative for illicit drugs. Dr. Jannetto sees such samples about five percent of the time in his laboratory. The patient can drink a lot of water to dilute the urine, which drops the drug below the cutoff on a screening assay. The alternative is to add products to the urine that contain acid, nitrites, and various other compounds that interfere with the immunoassays, he said. Third, patients can buy drug-free urine on the Internet.

Pain management physicians typically do not do witnessed urine collections, Dr. Jannetto noted. But simple countermeasures can help flag potentially adulterated samples. You can test the urine-specific gravity to identify very dilute urine, and look at the pH to make sure the patient hasn’t added acid to the sample. “If the pH is less than 3, that’s suspicious.”

Dr. Jannetto routinely advises physicians doing pain management testing to run creatinine on urine samples, which is very cost-effective.

“If the creatinine is less than 20 mg/dL, that person is well hydrated,” which the physician might consider when interpreting negative results, he advised. Some samples his labor­atory receives “have no creatinine [<5 mg/dL], urea, no nothing ...” And that, of course, isn’t human urine.

Urine screening is most vulnerable to sample tampering that affects results. But some forms of adulteration, Dr. Middleberg says, can also affect mass spectrometry results, even when the lab is using state-of-the-art technology. That’s one reason labs do adulteration testing in the form of pH, nitrites, oxidants, and creatinine, he says. Nitrites, which are in products used to adulterate urine testing, “tend to have a particular effect on the ability to measure can­nabinoids in urine by mass spectrometry,” he says, “especially depending on the pH of the urine.”

Urine drug monitoring using mass spectrometry won’t detect patients taking a higher dose of a drug than prescribed, Dr. Middleberg says. The clinician could “attempt to get at that with blood or serum testing, but even there you have to consider [pharmacogenomics] and other pharmacokinetic differences, so it’s never easy.”

While not widely used, therapeutic drug monitoring on blood samples can help physicians manage more complex cases. “Great candidates” for TDM, says Loralie Langman, PhD, associate professor at Mayo College of Medicine and director of the toxicology and drug monitoring laboratory at Mayo Clinic in Rochester, Minn., are patients who are “atypical”—that is, requiring higher or lower doses of a drug or experiencing significant adverse drug reactions.

Physicians who use TDM to troubleshoot, however, will be somewhat in the dark without the patient’s baseline because “what’s toxic in one person may be therapeutic in another,” she notes. Yet that can change for an individual patient as the person develops tolerance to the opioid. “Performing TDM is not a bad idea” when dealing with a drug that doesn’t have a well-established therapeutic range or is known to have a large interpatient variability, especially when compliance is an issue, Dr. Langman says.

As for pharmacogenomic testing, Dr. Jannetto says physicians rarely test for CYP2D6, an enzyme responsible for metabolizing 20 to 25 percent of prescription medication and over-the-counter products. “And in the case of opioids/opiates—oxycodone, hydrocodone, and codeine —it’s an important player.”

A poor metabolizer of CYP2D6, which two to 10 percent of most ethnic groups are, says Dr. Jannetto, will build up higher concentrations of the parent drugs oxycodone or hydro­codone, and may end up with more side effects. “In the case of co­deine, poor metabolizers of CYP2D6 won’t get any pain relief because the analgesic properties of codeine come from its CYP2D6 metabolite morphine.”

As an alternative to doing CYP2D6 genotype testing, the clinician can also identify poor metabolizers by doing TDM. But even if clinicians identify a poor metabolizer, says Dr. Jannetto, there are no formal guidelines for how to adjust the person’s pain medication dosages. Thus, “option B,” he adds, may be to start the person on a low dose of an opioid and titrate it up until the person gets pain relief. Or the clinician could put the person on a medication metabolized by a different enzyme. “Fentanyl is one option, as it’s metabolized by 3A4 and 3A5. Methadone is metabolized by multiple pathways, so that’s another option.”

Other medications a patient is taking can also inhibit CYP2D6, causing the patient to function as a poor metabolizer. For that and other reasons, pain management physicians or those prescribing pain medications should always ask the patient for a complete list of the medications he or she is taking, including over-the-counter medications and herbals, Dr. Jannetto says.

TDM and PGx testing combined not only optimize pain management in some cases but also increase safety for patients and for clinicians medico­legally when prescribing opioids.

The bottom line in pain management, she says, is to treat pain safely and adequately so patients no longer have to do what some in her care have described: “expend a huge amount of energy trying to isolate the pain into a corner of their day or life ... like a lion-tamer having to keep the lion at a distance.”

Posted: 4/30/2009 10:55:00 AM

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Benzodiazepines and Post-ICU Blues

From MedPage Today:

Intensive care patients who suffered multiple organ failure, underwent surgery, or received high doses of benzodiazepine were at significantly increased risk for depressive symptoms six months after ICU discharge, researchers said.

Each of those factors more than doubled the likelihood that ICU survivors would test positive on a standard depression screening after six months, O. Joseph Bienvenu, M.D., Ph.D., of Johns Hopkins University, and colleagues reported online in Critical Care Medicine.

The findings could help clinicians identify former ICU patients who should receive extra monitoring for emergence of depressive symptoms after discharge, Dr. Bienvenu said in an interview.

The prospective study followed 160 consecutive patients with acute lung injury who were admitted to ICUs in four Baltimore area hospitals and survived at least six months after discharge.

At six months, participants were screened with the depression subscale of the Hospital Anxiety and Depression questionnaire, a common screening tool.

Because this seven-item questionnaire is not a bona fide diagnostic instrument, the researchers cautioned that the results indicate depressive symptoms but not clinical depression per se.

Dr. Bienvenu and colleagues found 26% of participants had positive results with the screening.

APACHE scores at ICU admission, length of ICU stay, and duration of mechanical ventilation were not significantly associated with depressive symptom scores, the researchers found.

Dr. Bienvenu said in an interview that the key element may be the maximum severity of illness during an ICU stay. For that, multiple organ failure is a better indicator than APACHE score or length of stay.

He also noted that the benzodiazepine findings should be interpreted cautiously, as the question of causation does not have a clear answer and needs to be studied more directly.

It's unclear, he said, "whether it's causal in some way, for example, by causing more delirium in patients, or really whether it's just a marker of how agitated and emotionally upset patients were while they were critically ill."

Dr. Bienvenu also noted that the study did not address other aspects of participants' psychological health, such as the possible presence of post-traumatic stress or other forms of anxiety.

The researchers said their findings were limited by a lack of detailed information on pre-admission psychiatric history. The study also could have had a selection bias: about 18% of hospital survivors died within six months of acute lung injury and an additional 5 % were lost to follow-up.

Another 15% of potential participants either refused consent or were too sick to provide adequate follow-up data.

Posted: 4/29/2009 10:30:00 AM

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Swine Influenza A (H1N1) Virus Biosafety Guidelines for Laboratory Workers

From the Centers for Disease Control and Prevention:

This guidance is for laboratory workers who may be processing or performing diagnostic testing on clinical specimens from patients with suspected swine influenza A (H1N1) virus infection, or performing viral isolation.

Diagnostic laboratory work on clinical samples from patients who are suspected cases of swine influenza A (H1N1) virus infection should be conducted in a BSL2 laboratory. All sample manipulations should be done inside a biosafety cabinet (BSC).

Viral isolation on clinical specimens from patients who are suspected cases of swine influenza A (H1N1) virus infection should be performed in a BSL2 laboratory with BSL3 practices (enhanced BSL2 conditions).

Additional precautions include:

Recommended Personal Protective Equipment (based on site specific risk assessment )
  • Respiratory protection – fit-tested N95 respirator or higher level of protection.
  • Shoe covers
  • Closed-front gown
  • Double gloves
  • Eye protection (goggles or face shields)
  • All waste disposal procedures should be followed as outlined in your facility standard laboratory operating procedures.
Appropriate disinfectants
  • 70% Ethanol
  • 5% Lysol
  • 10% Bleach
All personnel should self monitor for fever and any symptoms. Symptoms of swine influenza infection include cough, sore throat, vomiting, diarrhea, headache, runny nose, and muscle aches. Any illness should be reported to your supervisor immediately.

For personnel who had unprotected exposure or a known breach in personal protective equipment to clinical material or live virus from a confirmed case of swine influenza A (H1N1), antiviral chemoprophylaxis with zanamivir or oseltamivir for 7 days after exposure can be considered.

Posted: 4/29/2009 10:07:00 AM

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Herbal Treasure Chest; Pharmacologists reveal Salvia Divinorum may have hidden health benefits

From WebWire:

Pharmacologists across the United States are urging governments to halt the outlawing of the drug Salvia Divinorum so that clinical trials on its effects can be carried out. Such trials will aim to identify the health benefits of this hallucinogenic herb, when smoked as it is recreationally across the globe.

It is drug experts such as Dr Mendelson who are excited particularly by the Kappa Opioid receptors within the brain and how they are affected by a compound within Salvia Divinorum called ’Salvinorin A’. This compound is rumoured to have wide ranging health benefits, from easing pain and regulating bowel movements in Irritable Bowel Syndrome (IBS) to boosting the immune system in those who are immuno-compromised. Perhaps if the herb’s potential was insignificant then it being outlawed in states all across America wouldn’t be of such concern, but for a drug to be made illegal when it could help treat HIV positive patients is understandably worrying for the medical industry.

At the present time Salvia is not yet banned in the whole of the US and companies continue to sell to states where the drug remains legal. This also means that clinical trials can be, and still are carried out by professional pharmacologists in certain regions. What the industry is wondering is if there is enough time to gather legal evidence to prove that Salvia has benefits and do these clinical trials have any legal standing against governments who want the herb made illegal? For now, experts are working on how to stop the hallucinogenic effects of Salvia Divinorum on the brain, so that it is not quite such an offensive substance.

Pharmacologists in America are calling for the outlawing of hallucinogenic herb Salvia Divinorum to be postponed, until evidence from clinical trials can prove whether it holds significant health benefits or not. Drugs experts and Salvia Divinorum suppliers are in full support of these clinical trials and are hoping that state governments across the US will consider keeping the herb legal until conclusive evidence is obtained.

Posted: 4/28/2009 11:35:00 AM

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The Miracle of Niacin

From Prevention:

I'd like to share a secret with you--one whose importance cannot be overstated. With this knowledge, you may be able to significantly decrease the chance that you or a loved one will ever die of heart disease.

The "secret" concerns a B vitamin called niacin. When niacin is taken with a statin, the combination reduces heart attack risk by up to 90%, according to a University of Washington study. Medical research has never been more supportive of this treatment, yet very few people know about it, and many primary care doctors don't prescribe it. A few of its impressive benefits:

It raises "good" HDL cholesterol and lowers triglycerides.

It enlarges the smallest, densest, most dangerous particles so they're less likely to damage arteries (although it doesn't lower "bad" LDL cholesterol as significantly as statins do).

And it brings down levels of another harmful component of blood called lipoprotein(a), which is resistant to the benefits of statins, diet, and exercise.

But here's the catch: You can't get enough of these vitamins naturally in your diet to achieve those results. The RDA for niacin is 14 mg for women and 16 mg for men, but to gain the benefit of lowering the chance for heart disease, you need 500 to 2,000 mg. At this dosage, many patients commonly experience flushing--the skin reddens, warms, and sometimes itches. Although this side effect subsides within an hour, the experience can be unpleasant. This is why some doctors hesitate to prescribe niacin.

These symptoms can be minimized if the niacin is taken with aspirin, antihistamines, or a meal. In fact, flushing is a positive sign that blood vessels are dilating in response to the niacin, new research concludes, and patients who flush ultimately raise their HDLs and lower their triglycerides more than those who don't flush. Once patients understand this, they're less likely to be intimidated by the reaction and will continue with treatment.

But before you embrace niacin wholesale, be aware of these considerations:

Make sure you need it. Generally, you're a good candidate for niacin therapy if you're already taking a statin but your triglycerides are above 150 mg/dL and your HDLs are below 45 (for men) and 50 (for women.) Two prescription forms of niacin are available: Niaspan and Niacor. I've prescribed the former for years, and with a little education, patients tolerate it well.

Niacin alone confers no benefit. It is effective only when paired with a statin; it generally isn't prescribed on its own. Soon we'll probably see drugs that combine niacin and a statin in one pill.

Be careful if you have prediabetes or diabetes. Niacin can raise levels of blood glucose. This effect is generally mild, though, and doesn't outweigh its heart-protecting benefits. Nonetheless, consult with your doctor if you begin taking it.

Posted: 4/27/2009 12:28:00 PM

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Low Vitamin D Linked to Severe Asthma

From WebMD:

Low levels of vitamin D may be linked to severity of asthma in children, according to a new study.

The study, published in the American Journal of Respiratory and Critical Care Medicine, examined the blood levels of vitamin D in children with asthma. Lower levels of vitamin D were associated with more severe asthma.

Participants included 616 children with asthma in Costa Rica between the ages of 6 and 14. Of the participants, 175 had insufficient levels of vitamin D.

John Brehm, MD, from Brigham and Women's Hospital, and colleagues found that low vitamin D levels were associated with more asthma hospitalizations in the previous year, more airway hyperactivity in lung function tests, more use of anti-inflammatory asthma medications like inhaled steroids in the previous year, and higher blood levels of allergy markers.

People primarily get vitamin D through their skin, which makes it from sunlight exposure. Also, some foods and supplements are sources of vitamin D. The authors note that because vitamin D deficiency can also be seen in warmer climates with abundant sun exposure, other factors likely also play a role.

The study doesn't establish a cause-effect relationship, but the researchers note that vitamin D may influence asthma in different ways, such as its effect on the immune system and muscle cells of the airways.

Further studies to address the potential benefits of increasing vitamin D supplements for asthma patients may raise important issues, according to an accompanying editorial written by Graham Devereux, MD, of the department of environmental and occupational medicine at the University of Aberdeen.

"Ideally, any intervention study should address the issue of dose; however, studies supplementing with doses above those currently recommended, although scientifically justifiable, will raise ethical and regulatory concerns,” Devereux writes.

Posted: 4/24/2009 9:40:00 AM

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Fixodent Denture Cream Named in Zinc Poisoning Lawsuits


Fixodent denture adhesive is the subject of several lawsuits that allege zinc in the product caused some users to develop neuropathy and other neurological problems. Though zinc has always been used in Fixodent denture cream, it was only recently that it was listed as an ingredient on the product’s label.

More than 35 million Americans use denture creams like Fixodent to keep their dentures in place. Yet the risk of denture cream zinc poisoning is virtually unknown. The Food & Drug Administration (FDA) has not required the manufacturers of these products to warn users of this danger. As a result, many people suffering from neuropathy and other neurological problems are unaware that their symptoms are the result of poisonous zinc denture creams, like Fixodent.

If an individual regularly ingests too much zinc, they might eventually experience copper depletion. People who suffer from chronic low levels of copper in their blood can develop severe neurological problems, including neuropathy. Urinary, bladder and gastrointestinal dysfunction are also common consequences of zinc poisoning.

Often, people use large amounts of Fixodent and other denture adhesives to keep ill fitting dentures in place. Over time, this can cause them to ingest enough zinc to cause copper depletion. This can lead to symptoms like numbness and tingling in hands and feet, balance and coordination problems, and pain and weakness in the extremities. The nerve damage caused by Fixodent zinc poisoning can lead to neuropathy, a debilitating disorder, when it is most severe.

Many lawsuits have been filed on behalf of the victims of denture cream zinc poisoning. One of the most recent was filed on March 13, 2009 in the U.S. District Court for the Southern District of Ohio. The plaintiff in the case, a 45-year-old woman, used Fixodent several times a day for many years to keep dentures in place. According to her lawsuit, she now suffers from many of the symptoms of denture cream zinc poisoning. Tests confirmed abnormally high zinc levels and low copper levels in her blood.

While the plaintiff’s zinc and copper levels did return to normal after she stopped using Fixodent, her lawsuit says the neurological damage that resulted is permanent.

It is important for denture wearers to be aware that the denture cream they use could prove toxic. Those with poor fitting dentures should not rely on Fixodent or similar products to remedy the problem. It is far healthier to seek the help of a dental professional to have dentures refitted.

Posted: 4/23/2009 1:17:00 PM

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EPA Will Mandate Tests On Pesticide Chemicals

From The Washington Post:

The Environmental Protection Agency for the first time will require pesticide manufacturers to test 67 chemicals contained in their products to determine whether they disrupt the endocrine system, which regulates animals' and humans' growth, metabolism and reproduction, the agency said yesterday.

Researchers have raised concerns that chemicals released into the environment interfere with animals' hormone systems, citing problems such as male fish in the Potomac River that are bearing eggs. Known as endocrine disruptors, the chemicals may affect the hormones that humans and animals produce or secrete.

Testing will begin this summer and will focus on whether these chemicals affect estrogen, androgen and thyroid systems. The tests eventually will encompass all pesticide chemicals.

Pesticide industry officials said they had anticipated the move, which was set into motion in 1996 by the passage of the Food Quality Protection Act, and they planned to cooperate on the matter.

"It's been a long time coming," said Jay Vroom, president and chief executive of CropLife America, a major trade association. "For pesticides, we think the likelihood is extremely low we'll have any concerns come to the surface."

Linda Birnbaum, who directs the National Institute of Environmental Health Sciences and the National Toxicology Program, said the program represents "a more organized way to look at" how human exposure to pesticide chemicals could affect such things as bone growth and brain development.

"This is a good beginning," Birnbaum said, adding that scientists need to examine how different hormone disruptors might interact or accumulate in the human body. "It's very important to know: Can certain chemicals, especially chemicals that are out there that people are exposed to, impact our hormone system?"

Although researchers have observed the most visible effects of these chemicals in animals, Birnbaum said it is likely that some humans, depending on their particular sensitivity, could experience similar problems.

Linda Phillips, who manages the Endocrine Disruptor Screening Program, said that it will take about two years to obtain data from the two-tier program, and that it then could take the agency another year to make a final determination about the chemicals' effect on hormone disruption.

Vroom said pesticide manufacturers are "very confident our products will come through with flying colors." He added: "If we do learn something about our products that raises a cause for concern, our industry will be at the table, ready and willing to step forward and take action to mitigate risk."

Posted: 4/22/2009 9:14:00 AM

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I.Q. Harmed by Epilepsy Drug in Utero

From The New York Times:

Pregnant women who took a popular epilepsy drug, also widely used to treat migraines, pain and psychiatric disorders, had children whose I.Q. scores were significantly lower than those whose mothers took a different antiseizure medication, a new study has found.

The drug, valproate, sold generically and under the brand name Depakote, remains the second-most-popular antiseizure medication used for epilepsy, but earlier studies found that use during pregnancy also increased the risk of developmental delays and major malformations.

The risks that other epilepsy drugs may pose are not clear, experts say. While some are likely to be safer than others, there have not been enough studies to guide patients and their doctors. About half of the women who take valproate are not epileptics.

The new study is to be published on Thursday in The New England Journal of Medicine.

Three-year-olds whose mothers had taken valproate during pregnancy had I.Q. scores that were nine points lower on average than children whose mothers had taken a different antiseizure medication, lamotrigine. The I.Q. scores of toddlers whose mothers took valproate were also lower than scores of children whose mothers took two other antiseizure medications, phenytoin and carbamazepine.

Physicians involved in the study warned that valproate should never be the first choice for use in women of childbearing age, though exceptions may be made if a woman’s epileptic seizures cannot be controlled with other available medications.

Some 13,000 to 21,000 babies each year are born to women with epilepsy, and the vast majority are healthy, researchers and advocates emphasized.

Experts warned that women should not stop taking valproate without talking to their doctors.

“It’s important to stress to readers that if they become frightened, they should not simply stop taking the drug, because that can be even more dangerous,” said Eric Hargis, president of the Epilepsy Foundation in Washington.

Posted: 4/16/2009 11:51:00 AM

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Salvia: more powerful than LSD, and legal

From the Telegraph (UK):

In a cluttered living room in south London, Lee Hogan, a sound engineer and part-time disc jockey, perches on the edge of a cheap leather armchair and bends his head towards a glass water pipe. A friend, kneeling on the floor, holds the stem of the pipe and uses a cigarette lighter to burn a tea-smelling herb. The herb glows red, and as it does so, Hogan places his mouth over the aperture of the pipe (better known as a 'bong' to those in the know). He breathes in deeply, taking a lung-full of smoke.

It's the way that many people choose to inhale marijuana, but this weed is far more potent and far more harmful. Hogan is smoking salvia divinorum, a species of sage that also happens to be the most powerful hallucinogenic herb known to man. It's also perfectly legal.

It doesn't take long for the effects to take hold. Seconds after breathing in the smoke, Hogan leans back in his chair and lets out a deep, slightly manic laugh. He hugs himself and starts to giggle. The giggle then transforms into a whimper, which, in turn, becomes a series of high-pitched squeaks. He is trying to talk, but makes no sense whatsoever. Then, mouth hanging wide open, he looks around the room. His eyes have glazed over and he doesn't seem to know where he is. As he slowly manoeuvres himself in his chair, his head rocking from side to side, he looks like a man who has just been hit over the skull by an iron bar.

Watching young people out of their minds on salvia is the latest YouTube sensation and is fuelling the popularity of the herb. But, for those with a clear head, the films – some of which have been viewed more than a million times – are deeply disturbing. Users are reduced to mumbling wrecks, giggling and screaming, gasping and muttering, waving their hands around as they sink into a sofa or crumple to the floor. What we don't see are the visions, lights, swirls and hallucinations that many say they have experienced. Or the nightmarish sense that they are close to death, going insane or under attack. Titles such as Horrible Salvia Trip speak for themselves. 'What we are witnessing is no less than the world's first internet-driven drugs explosion,' says Dr John Mendelson, a San Francisco-based clinical pharmacologist who is conducting medical trials into how the drug works on the brain.

Salvia, a genus of the mint family, is commonly referred to as sage and derives its name from the Latin 'salvere' (to save), so called because of the herb's ancient reputation for healing properties.

Growing to more than 3ft in height, Salvia divinorum ('sage of the seers') has large green leaves and white flowers and is native to the Mazatec region of southern Mexico. The native shamans have for centuries chewed the plant's leaves to induce visions as part of spiritual and healing ceremonies. It remained almost unknown outside the region until Daniel Siebert, a Californian ethnobotanist who was studying the use of herbs in spiritual traditions, came across the plant during his research in the Seventies. Today, it is sold as an extract: the '10x concentrate' is 10 times the potency of the unprocessed leaf.

For his part, Lee Hogan describes his first experience of salvia as the, 'most mind-bending, totally bizzarest, weirdest, strangest experience I have ever had'. It's difficult, he says, to explain the impact that the herb had on his brain. 'I was pulled to my right, into the brain-curve-warp-swirl tunnel is the best I can describe it,' he says. 'My brain, reality as we know it and everything else just sort of fused together and became this swirling tunnel. Endless, infinite. Speaking becomes very difficult, almost impossible.'

In a nod to some kind of 'code of conduct', there are two cardinal rules of the salvia world, and both are spelt out on all the websites and packaging: only take it when seated or lying down in a secure environment; and always have a sober sitter present to look after and reassure the taker.

Hogan insists that the effects are only at their most intense for 10 minutes and that, although the hallucinations can be disturbing, they don't do any permanent damage. But scientists disagree. Research has shown that the herb could trigger serious psychiatric problems. 'I am very concerned about the use and misuse of Salvia divinorum because it contains an active ingredient that can trigger hallucinations,' says Professor Fabrizio Schifano, an expert in drug addiction based at the University of Hertfordshire. 'For some vulnerable individuals, this may mean the onset of a psychotic episode.'

Kathy Chidester has no doubt that Prof Schifano's fears are justified. Three years ago, her 17-year-old son, Brett, committed suicide after smoking salvia.

'The fact that his posthumous drug test showed no signs of drugs led us to believe definitely that the drug had to be salvia, especially since that was all the police found with him. Since it metabolises within 15 minutes, there's no way it would show up on a drug test of any kind. These facts, not suppositions on our part, led us to believe 100 per cent that his salvia use led him to complete psychosis within the last hours of his life, and to his ultimate suicide.'

Soon after Brett's death, Delaware became the first state to impose a full ban on salvia, passing 'Brett's Law', legislation that places the plant in the same category as cocaine and heroin. The greatest concern is that salvia use could trigger mental health conditions such as schizophrenia, particularly among young people in their teens and twenties who may well be unaware that they are prone to psychotic episodes.

Sally D or Magic Mint, as aficionados know it, remains off the radar of most parents, health professionals and law enforcement agencies. But according to the first federal estimates, published last year, of salvia use in the US, about 1.8 million people had tried the drug, including 750,000 in the previous 12 months. Most strikingly, nearly three per cent of males aged 18 to 23, the largest category, had used salvia in the past year – nearly as many as had taken ecstasy and twice as popular as LSD. The US Armed Forces are developing the first urine tests for salvia amid reports about its presence on military bases and ships. And studies at some US universities concluded that up to 7 per cent of students had tried it.

The effect is indisputably mind-altering. But in the scientific, law-enforcement and drug-regulation fields, there is a growing controversy about how to handle salvia's soaring popularity. Is it a basically harmless plant that delivers an extremely strong but short-lived high, open to use and abuse like other low-level psychoactive drugs such as alcohol and nicotine? And would prohibition be a futile gesture, introducing another level of criminality while having little impact on its availability or popularity?

Or is it dangerous and harmful, risking bouts of psychosis in unwitting users? And should the drug be outlawed or restricted, as some US states have recently done, following Delaware's example?

Salvia divinorum has been outlawed or its sale and distribution restricted in Australia, Belgium, Denmark, Estonia, Finland, Italy, Japan, Spain and Sweden. Thirteen states in the US have also passed legislation that ranges from placing it in the most serious narcotics category alongside heroin and cocaine to outlawing its sale and distribution to minors under 18. US federal drug regulators have followed salvia's impact for several years but say they have yet to identify a convincing case to add it to the list of controlled substances. In the scientific community, there is concern that criminalisation could reduce access to the plant and the scope for research, but Californian Republican assemblyman Anthony Adams insists that medical research will not be affected by banning salvia.

He was first made aware of the drug in 2006 when police officers in his district told him they were increasingly finding students in possession of the herb during raids for other offences.

'It was clear to them that salvia was harmful, emotionally and possibly physically, and they were frustrated that there was nothing they could do,' he says. 'So they approached me to ask about the possibility of introducing legislation to ban it. Even if it's non-addictive, you lose your ability to reason, you are incapacitated, you cannot make informed decisions about your behaviour.'

He ran into opposition to calls for an outright ban in the Democratic-run state legislature so offered a compromise bill to make it illegal to sell or distribute the drug to minors. Mrs Chidester flew in to give her moving personal account and the legislation passed comfortably.

Posted: 4/15/2009 3:55:00 PM

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