French drug trial disaster leaves one brain dead, five injured

PARIS | By Matthias Blamont

Fri Jan 15, 2016 11:30am EST

 

An ambulance is seen outside the Emergency Entrance at the CHU de Rennes hospital, in Rennes, France, where six people are in a serious condition after taking part in a medical trial for an unnamed European laboratory to test a new drug, France’s health ministry said January…Reuters/Stephane Mahe

One person has been left brain dead and five others are in serious condition after taking part in a clinical trial in France of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

The medicine involved works by targeting the body’s pain-controlling endocannabinoid system, which is also responsible for the human response to cannabis.

The ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication at a private facility that specializes in carrying out clinical trials.

 

The brain-dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.

The volunteers are all men aged 28 to 49, French Health Minister Marisol Touraine told a news conference. They started taking the drug on Jan 7. One person started feeling ill on Sunday and the other five afterwards.

In total, 90 people have taken part in the trial, taking some dosage of the drug, she said, adding that others took a placebo.

All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

A spokeswoman for the European Medicines Agency in London said it did not have full details of the case but was monitoring the situation.

Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care. One was described as looking like "the elephant man" after his head ballooned. Another lost his fingertips and toes.

"INHERENT RISK"

In the initial Phase I stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.

"Undertaking Phase 1 studies is highly specialist work," said Daniel Hawcutt, a lecturer in clinical pharmacology at Britain’s University of Liverpool.

Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale.

Europe has strict regulations governing the conduct of clinical trials, with Phase I tests subject to particular scrutiny. But Ben Whalley, a professor of neuropharmacology at the University of Reading, said these could only minimize risks, not abolish them.

"There is an inherent risk in exposing people to any new compound," he said.

The 2006 London trial led to the collapse of Germany’s TeGenero, the company developing a medicine known as TGN1412. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.

(Additional reporting by Ben Hirschler, John Irish, Noelle Mennella and Ingrid Melander; Editing by Michel Rose and Larry King)

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Not feeling well? Perhaps you’re ‘marijuana deficient’

Scientists have begun speculating that the root cause of disease conditions such as migraines and irritable bowel syndrome may be endocannabinoid deficiency.

Screen Shot 2015-01-30 at 4.29.30 PM

Source: Alternet, 3.24.10

For several years I have postulated that marijuana is not, in the strict sense of the word, an intoxicant.

As I wrote in the book Marijuana Is Safer: So Why Are We Driving People to Drink? (Chelsea Green, 2009), the word ‘intoxicant’ is derived from the Latin noun toxicum (poison). It’s an appropriate term for alcohol, as ethanol (the psychoactive ingredient in booze) in moderate to high doses is toxic (read: poisonous) to healthy cells and organs.

Of course, booze is hardly the only commonly ingested intoxicant. Take the over-the-counter painkiller acetaminophen (Tylenol). According to the Merck online medical library, acetaminophen poisoning and overdose is “common,” and can result in gastroenteritis (inflammation of the gastrointestinal tract) “within hours” and hepatotoxicity (liver damage) “within one to three days after ingestion.” In fact, less than one year ago the U.S. Food and Drug Administration called for tougher standards and warnings governing the drug’s use because “recent studies indicate that unintentional and intentional overdoses leading to severe hepatotoxicity continue to occur.”

By contrast, the therapeutically active components in marijuana — the cannabinoids — appear to be remarkably non-toxic to healthy cells and organs. This notable lack of toxicity is arguably because cannabinoids mimic compounds our bodies naturally produce — so-called endocannabinoids — that are pivotal for maintaining proper health and homeostasis.

In fact, in recent years scientists have discovered that the production of endocannabinoids (and their interaction with the cannabinoid receptors located throughout the body) play a key role in the regulation of proper appetite, anxiety control, blood pressure, bone mass, reproduction, and motor coordination, among other biological functions.

Just how important is this system in maintaining our health? Here’s a clue: In studies of mice genetically bred to lack a proper endocannabinoid system the most common result is premature death.

Armed with these findings, a handful of scientists have speculated that the root cause of certain disease conditions — including migraine, fibromyalgia, irritable bowel syndrome, and other functional conditions alleviated by clinical cannabis — may be an underlying endocannabinoid deficiency.

Now, much to my pleasant surprise, Fox News Health columnist Chris Kilham has weighed in on this important theory.

Are You Cannabis Deficient?
via Fox News

If the idea of having a marijuana deficiency sounds laughable to you, a growing body of science points at exactly such a possibility.

… [Endocannabinoids] also play a role in proper appetite, feelings of pleasure and well-being, and memory. Interestingly, cannabis also affects these same functions. Cannabis has been used successfully to treat migraine, fibromyalgia, irritable bowel syndrome and glaucoma. So here is the seventy-four thousand dollar question. Does cannabis simply relieve these diseases to varying degrees, or is cannabis actually a medical replacement in cases of deficient [endocannabinoids]?

… The idea of clinical cannabinoid deficiency opens the door to cannabis consumption as an effective medical approach to relief of various types of pain, restoration of appetite in cases in which appetite is compromised, improved visual health in cases of glaucoma, and improved sense of well being among patients suffering from a broad variety of mood disorders. As state and local laws mutate and change in favor of greater tolerance, perhaps cannabis will find it’s proper place in the home medicine chest.

Perhaps. Or maybe at the very least society will cease classifying cannabis as a ‘toxic’ substance when its more appropriate role would appear to more like that of a supplement.

See Also:
Are You Cannabis Deficient?

Cannabinoids: Some bodies like them, some bodies need them

Comments from an earlier version of this article

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Activating cannabinoid brain receptors could replace marijuana for anxiety treatment

Marijuana is the most commonly used illicit drug in the US, and its prevalence among adolescents and young adults has been increasing in recent years. But in a new study published in the journal Cell Reports, researchers say they may have uncovered a potential way to help some individuals stop using marijuana.

In the brain, endocannabinoids usually activate cannabinoid receptors, which are involved in regulating appetite, pain, memory and mood, among other physiological processes.

However, past studies have indicated that individuals with mood and anxiety disorders have reduced levels of endocannabinoids. Since the active ingredient in marijuana – tetrahydrocannabinol (THC) – can also activate the cannabinoid receptors, many people may use the drug to relieve symptoms of such disorders.

But the research team – led by Dr. Sachin Patel, professor of psychiatry and molecular physiology and biophysics at Vanderbilt University in Nashville, TN – says they have found a way to replenish levels of an endocannabinoid called 2-Arachidonoylglycerol (2-AG) in the brain, which may reduce the reliance on marijuana to treat mood and anxiety disorders.

Replenishing 2-AG levels reduced anxiety- and depressive-like behaviors in mice

To reach their findings, Dr. Patel and his team deleted an enzyme in adult male and female mice – called diacylglycerol lipase α (DAGLα) – that usually breaks down 2-AG, creating 2-AG-deficient mouse models.

The researchers say all mice displayed anxiety-like behaviors, while female mice displayed behaviors related to depression. “We were expecting that endocannabinoid deficiency would produce anxiety and depressive-like behaviors, but the female-specific depressive behavior took us by surprise,” Dr. Patel told Medical News Today.

However, the team found that replenishing 2-AG levels in the brains of the mice appeared to reverse anxiety- and depressive-like behaviors. The researchers say their findings indicate that “normalizing 2-AG deficiency could represent a viable […] therapeutic strategy for the treatment of mood and anxiety disorders.”

What is more, Dr. Patel told MNT that, although the technique has not yet been tested in humans, it has the potential to wean some heavy marijuana users off the drug:

“It is very possible that a subset of heavy marijuana users are actually self-medicating symptoms of anxiety or mood disorders.

We think that manipulating the naturally produced cannabinoids, like 2-AG, is likely to have the same anxiety-reducing, mood-elevating capacity without producing as many side effects as synthetic cannabinoids, like marijuana. This approach, then, would eliminate the drive to self-medicate with marijuana.”

Next, Dr. Patel said the team wants to find out exactly how 2-AG deficiency impacts the brain’s ability to regulate mood and anxiety. This, he says, would improve efficiency when the endocannabinoid-replenishing technique reaches clinical testing.

Last month, MNT reported on a study by researchers from the University of California-San Francisco, which suggested that exposure to secondhand marijuana smoke could be just as harmful to health as exposure to secondhand cigarette smoke.

Written by Honor Whiteman

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Study says THC could play an important role in how we process negative emotions

Research suggests marijuana could play an important, beneficial role in how humans experience emotions and mood.

By Kristen Gwynne

August 21, 2013 3:48 PM ET

It’s no secret that marijuana can put a smile on many people’s faces, but research suggests that the drug’s positive effects go beyond just getting high. A 2012 study published in the peer-reviewed academic journal European Neuropsychopharmacology suggests that the brain’s endocannabinoid system – which is activated by THC, the psychoactive ingredient in marijuana – may play an important role in emotional processing, "an essential aspect of appropriate social interactions and interpersonal relationships."

How Harsh Is Your State? Check Out Our State-By-State Weed Map

Specifically, the study’s authors found that participants given THC in a controlled experiment showed lower brain activity in response negative stimuli than did those given placebo.  A bias toward negative stimuli has been linked to mental illnesses like depression, and evidence that THC reduces this effect suggests that the endocannabinoid system could play an important, beneficial role in how humans experience emotions and mood.

Researchers measured test-specific effects of THC administration on about a dozen men who had used marijuana at least four times in the past year, but no more than once a week. Half of them were given THC, the other half placebo; the researchers then showed all the men images of faces with expressions that appeared either "fearful" or "happy." They found that participants given THC showed significantly decreased accuracy in matching facial expressions with negative emotion, but showed about the same accuracy for positive associations. Using brain imaging technology called fMRI, they were also able to watch the effects of THC on the parts of the participants’ brains that process emotion – identifying a "network-wide shift from a bias for negative emotional content towards a bias for positive emotional content."

See the Five Reasons Cops Want to Legalize Marijuana

The researchers concluded that the way the human brain reacts to THC could have significant implications for mental health treatment. "These findings," they wrote, "add to existing evidence that implicate the endocannabinoid system in modulation of emotional reactions, and support a previously suggested role for the endocannabinoid system in abnormal emotional processing associated with various psychiatric disorders."

Related

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Absolute Asinine Laws

 

Life in Prison for Hemp

José Peña brought some roadside weeds home from Kansas. Cops decided it was reefer, and a Texas court sentenced him to life in prison – without the evidence. It took a decade for Peña to get back some of the pieces of his life.

By Jordan Smith, Fri., March 16, 2012

Life in Prison for Hemp

José Peña was tired as he drove south toward Houston on the morning of Sept. 27, 1998. Following a quick trip north to Kansas in a rented van – to pick up the brother of a distant cousin’s son – he was on his way home to Houston, where he lived with his wife and four children. It was the kind of favor Peña often did for friends and family, no matter how distant the relation – and the kind of favor that irritated his wife. "I was tired, and I was trying to get home," the 50-year-old recently recalled. "My wife was mad at me for doing favors for other people" when he could instead be home.

That morning, just before 8am, Peña was cruising south down I-45, a little more than two hours from home. He was driving in the right-hand lane through Leon County when he passed a state trooper sitting in his car on the grass median. He thought nothing of it – just another Texas trooper on a long and nondescript stretch of highway – until he noticed the trooper pull out onto the road and follow him. The officer, Mike Asby, a veteran member of the Texas Department of Public Safety, drove in the left lane until his car was parallel with Peña’s. Peña looked over at Asby. "He pulled up next to me, and I looked at him because I wasn’t not going to make eye contact" with an officer whom Peña thought was definitely checking him out for whatever reason.

Although Peña steadfastly maintains that he wasn’t doing anything wrong or unusual, Asby would later testify that Peña caught his attention because he was driving more slowly than the rest of traffic in a van caked with mud; when the van "weaved across the center stripe and also across the solid yellow line on the shoulder," Asby testified in January 2003, he had to take action. "You’re required to stay in a single lane of traffic," he said. He activated his lights and pulled Peña over.

Within the hour, Peña would be in handcuffs in the back of the trooper’s car, headed to the county jail in Centerville on a charge of marijuana possession. Nearly five years later, Peña would be convicted and sentenced to life in prison for possession of what the state said turned out to be 23.46 pounds of freshly cut marijuana that Peña was transporting in the back of the muddy blue van. Although Asby testified that this was not a normal highway drug bust – "normally," he testified, marijuana moves north from Houston, already "dried out, cured, and ready to be sold" – he was certain that what he found casually laid out in the back of the van was pot because it smelled like pot – and he knows pot when he smells it. "It’s something that you learned in [28] years of experience being on the road?" prosecutor Whitney Smith (now Leon Coun­ty’s elected D.A.) asked Asby.

"Yes, sir," Asby replied.

Just Trust Us

There are at least two problems with the official story of Peña’s arrest and prosecution. First, Peña is adamant – and has been since 1998 – that what he was transporting was not marijuana, but actually hemp, pot’s non-narcotic cousin. Peña says he found the plants growing wild in Kansas and cut them down, thinking that he could use the stems and leaves in the various craft projects he made with leather and wood in his garage workshop; there was no doubt in Peña’s mind that what he was transporting was not marijuana. The second, and eventually more decisive problem with the official story of the Peña bust, is that prior to his trial, officials with the Department of Public Safety lab in Waco, where the plants were taken for testing, completely destroyed all of the case evidence – all 23.46 pounds of plant material – and then also lost the case file with all of the original documentation of the lab’s work on the case. By the time Peña was finally tried – more than four years later – there was absolutely no evidence to show the jury; instead, the state relied completely on the "experience" of Asby and of Waco lab supervisor Charles Mott (now retired) to persuade jurors that what they say they saw and tested was actually marijuana.

It worked.

That is, it worked until late last year, when Peña’s conviction was finally overturned by the Court of Criminal Appeals, the state’s highest criminal court, and Leon County subsequently dismissed the charges for good. In the intervening decade, however, Peña’s case became a political hot potato, catching the attention of judges and lawyers across the state who watched as the 10th Court of Appeals, based in Waco, played tug-of-war with the Austin-based CCA over the power of the Texas Constitution, and whether it affords citizens greater rights and protection against state power than does the U.S. Constitution.

It’s a conflict that has left the state of Texas divided and may mean – at least for the time being – that persons tried for crimes in one part of the state will be afforded greater protection from prosecutorial errors or malfeasance than are others. Frankly, says Keith Hampton, an Austin defense attorney who represented Peña just before his case was dismissed, you just "don’t see this happen very often." Ulti­mate­ly, whether the protections gleaned from the Texas Constitution by the 10th Court will remain in force and be applied to all Texans is still to be determined.

Weeds, Not Weed

Peña had a knack for creating handcrafted leather and wood items that sold like hotcakes, he says, at flea markets in and around Houston. He made personalized shellacked plaques and leather key chains with popular first names spelled out in tiny beads, and at a dollar a key chain, they sold well. So when he first saw the hemp plants growing on the roadside near Manhattan, Kan., they gave him an idea. He would take the plants – which, to an untrained eye, look exactly like marijuana plants – press the leaves, and then use them on plaques or affixed to the small leather wallets that he also had become expert at making. He recognized these as "volunteer" hemp plants – they grow wild across the country, reminders of the days when hemp farming was commonplace and even, during World War II, encouraged by the feds as supporting the war effort. By the Kansas roadside, they were scraggly and abundant. When he pulled into the Tuttle Creek State Park outside Manhattan, and saw the plants growing everywhere, he "loaded … up."

Indeed, Peña thought nothing of the fresh-cut plants that he’d laid out in the back of the blue van he was driving. He knew – partly from experience of having smoked pot when he was younger, and partly because he knew that hemp was once a major agricultural commodity – that the plants were nothing more than weeds that looked like weed.

However, that’s not how Asby saw it. To him, it was clear that one thing, and only one thing, was taking place. Peña was moving a large amount of marijuana to Houston – as unusual as that might be, Asby acknowledged.

Peña repeatedly told Asby that the plants were hemp, and his insistence clearly gave some pause to Asby and the two backup officers who soon joined him. The three men stood next to the van pondering the notion that a plant could look like, but not actually be, marijuana. "I … questioned them, I said, ‘Well, he says it’s not marijuana,’" Asby recalled in court. "I knew that there was a substance called hemp and I was asking them. … And I asked them, ‘You ever heard of something like marijuana, just hemp, that is legal to have?’" he continued. "I don’t know that there is a legal kind. That was the question I was asking the officers: ‘Have you ever heard of this … where marijuana was cut and it turns out to be legal?’"

In the end, Asby was unpersuaded. "I just know marijuana smells like marijuana," he testified in 2003. "And I have never found anything that I thought was marijuana that wasn’t." He cuffed Peña and hauled him off to jail.

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