Wednesday, March 2, 2016

Group Raising $400,000 to buy MDMA for Phase 3 Trials


A NONPROFIT IS RAISING $400,000 FOR A KILO OF MDMA BY HOSTING “PSYCHEDELIC DINNER” PARTIES





March 1, 2016 3:30 PM By Gigen Mammoser
The Multidisciplinary Association for Psychedelic Studies (MAPS), an American nonprofit organization, is raising $400,000 to buy a kilogram of pure MDMA for clinical trials. The organization is entering Phase 3 trials, which is the final testing period before review and approval by the Food and Drug Administration (FDA). MAPS is aiming for to have MDMA legalized for use in psychotherapy in the United States by 2021.
The organization is now raising funds for their trials through a combination of crowd-funding and hosted "psychedelic dinners" that they hope will encourage people to open up conversation about drugs and help reduce stigma. The project allows people all over the world to host dinners, talk about psychedelics, and collect donations for MAPS' current MDMA research.
With their campaign underway and their 30th anniversary coming up (the organization was founded in 1986—the year after MDMA was criminalized in the US), THUMP spoke to MAPS' communications director Brad Burge about their latest initiative.


All images courtesy of MAPS
THUMP: I think the question that every THUMP reader wants to know is, where do you buy a kilo of pure MDMA?
Brad Burge: You can go to any organic or synthetic chemical manufacturer that manufactures drugs for pharmaceutical companies. The only thing is, you need a Drug Enforcement Agreement [DEA] license and at least one approved study. In MAPS' case, we have regulatory approval from the FDA, the DEA, and ethics boards. The place where we are requesting [the MDMA] from, UK pharmaceutical company Shasun, also has a DEA license.
Read More on THUMP: MDMA Might be Legal for Psychotherapeutic Use by 2021
The $400,000 price tag, is that the the quoted price that the lab gave you for a kilo of pure MDMA?That's approximately the cost. About half of it's the actual manufacturing cost. The other half is just straight-up licensing—paperwork costs, which are especially exorbitant because it's a Schedule 1 drug—meaning it has "no medical use and high potential for abuse."
So at some point there is going to be a big shipment of MDMA coming to the US from the UK and a customs officer is going to be like, "yup, this checks out."Exactly. The reason we have to get a new one is not because our existing batch, which was originally manufactured in 1985, is not pure, it's totally pure. We have about 900 grams left, but we're trying to get regulatory approval for legal pharmaceutical use, so it has to be what's called "good manufacturing practices" certified. That means that every step of the way—all the way to where the original chemicals came from—has been documented for this entire kilo.


Dr. Phil Wolfson, MAPS' principal investigator for ongoing MDMA studies
Manufacturing guidelines have changed since the 80s—is that batch just not certifiable by the same qualifications that exist today?It's as pure as current measuring practices can tell, so, above 99 per cent pure. It's just that it doesn't have the documentation. Essentially what we are paying for is the documentation.
This research that you're doing with the FDA is to put MDMA on the medical market for patients?Absolutely. Our goal is to have FDA approval for MDMA as a legal option drug to be used only with therapy by 2021.
MAPS focuses on the study of psychedelics, whether it's mushrooms or LSD or ayahuasca—categorically-speaking, do psychedelic drugs have something positive to offer?We're a response to the war on drugs in some ways, which "categorically" says that LSD, marijuana, MDMA, ayahuasca, ibogaine, DMT, all of these substances, belong in the same category, which is to say illegal, totally criminalized, stigmatized, and therefore dangerous. We're focused on that categorization and, rather than just lumping them all together and saying we don't even want to look at these compounds, we want to bring them all together and say we do want to explore them.
Read More on THUMP: MDMA as Medicine? A New Film's Controversial Look at the Popular Party Drug
Does criminalization by the DEA affect researchers' access to certain drugs?Even if the drug is Schedule 1, researchers can still legally get access to it. The challenge comes when regulators don't approve research protocols. Regulators are still people and they are still exposed to the same stigmatization and negative propaganda.
[Criminalization] creates challenges both in the minds of regulators and then also in the minds of funders. Also, psychedelics don't have much profit potential in them because many are out of patent.


A dose of MDMA
Could you explain that?If you can put a patent on something, you can profit from it. But LSD and MDMA, for example, are too old to have active patents on them. LSD was first synthesized in 1938 and MDMA in 1912, so those patents have long since expired and you can't re-patent them. Similarly with psilocybin mushrooms and cannabis, you can't patent a plant or a fungus. Although you can patent different methods of processing them. There's not a lot of profit potential there.
There were other crowdfunding efforts for drug research before our campaign, but as far as I know, ours were the first crowdfunding campaigns for psychedelic drug research. We've done four campaigns on Indiegogo. The global psychedelic dinners donations are being processed through [crowd-funding website] Razoo. Our last [campaign] through Indiegogo raised $141,000 for MDMA research.
My reaction seeing something called a "psychedelic dinner" is that it's preaching to the choir, for people who are already interested in the value of MDMA. It's more the outside people who are going "What's that? Are they doing drugs?" that will be hard to reach.Well, it's a strategic consideration. There's so much stigma surrounding psychedelics. To say "psychedelic" already turns a lot of people off. To say "psychedelic" and dress it in rainbows will also turn a lot of people off. We're not trying to connect with people who absolutely want nothing to do with psychedelics. Who we're really encouraging to participate are the people who aren't maybe 100 per cent sure but are willing to explore a little bit.
It's kind of like using the term "marijuana" rather than "cannabis" to reduce the excitement that happens around it—and make psychedelics less of a Woodstock-associated term and more of a therapy-associated term. So far we have 150 people who have signed up in 24 countries.


Part of MAPS' psychedelic dinner conversation "menu"
That number is up from what I saw previously.Yes and 40 per cent of those are people we've never heard of before. We could say that almost half of people who are saying "yes I want to gather people in my home and raise funds for MAPS" are people who are not the choir. They have not donated to us regularly. So in that sense it's been a success so far.
MAPS will host its 30 year anniversary benefit banquet and celebration on April 17, 2016 in Oakland, California. You can purchase tickets for the event or donate to the organization through their website.
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Tuesday, March 1, 2016

‘Female Viagra’ Only Modestly Increases Sexual Satisfaction, Study Finds

By SABRINA TAVERNISE

Addyi, the new female libido drug, sometimes known as the “female Viagra.”Allen G. Breed/Associated Press
WASHINGTON — Half of one satisfying sexual encounter a month. That is the average benefit a woman gets when she takes the new female libido drug, sometimes called the “female Viagra,” researchers reported Monday.
Last year the Food and Drug Administration approved the drug, flibanserin, making it the first drug available to treat low sexual desire in women. It was promoted by a group of women’s rights activists who argued it was unfair that men had numerous drugs to boost sexual function while women had nothing.
But public health groups and some other women’s groups contended that the science did not justify its approval. The drug’s effects were modest, they said, and not worth side effects such as sleepiness, dizziness, fatigue and nausea. And the risk of some side effects increased with alcohol consumption.
In the new study, published in JAMA Internal Medicine, researchers found benefits that were slightly more modest than those submitted to the F.D.A. during the approval process. The researchers analyzed eight studies of about 5,900 women, using a method that involved pooling the data. They concluded that treatment with flibanserin, now marketed as Addyi, resulted in “one-half of an additional sexually satisfying encounter per month.” (The study did not define what “one-half” of a sexually satisfying encounter was.)
That result was not very different from original findings of three clinical trials submitted to the F.D.A. as support for the drug’s approval. Those trials found that once women started taking the drug, they had an average of about one additional satisfying sexual encounter a month, on top of the two to three they were having already. That result lifted the benefits above the bar of being scientifically meaningful, but barely. Still, it was enough for the agency’s approval.
In a statement, Dr. Tage Ramakrishna, the chief medical officer at Valeant, the company that now owns the drug, said that the new analysis confirmed the findings of the clinical trials and “provided little additional context.” He said the way the analysis was done, combining data from a number of different studies, carried “less statistical weight” than the randomized trials .
The drug was approved last June, after twice being rejected by the agency over several years. In the clinical trial results submitted, women taking the drug also reported on monthly questionnaires that they felt more desire, although the difference compared with a placebo was also meager — only about 0.3 points on a scale ranging from 1.2 to 6.0.
Experts who had opposed the drug’s approval said the JAMA analysis, which confirmed that the drug increased the risk of dizziness, sleepiness, nausea and fatigue, underscored the meagerness of the benefit.
“An additional half a satisfying sexual encounter a month — is that meaningful?” asked Dr. Adriane Fugh-Berman, the director of PharmedOut, a project at Georgetown University that questions the influence of drug companies on the practice of medicine. “I think only the women can answer that, but perhaps they already have with their lack of enthusiasm for getting prescriptions.”
The drug is not selling well. As of early January, Addyi was generating only 240 to 290 prescriptions a week, according to a report last week by David Maris, an analyst at Wells Fargo Securities, who cited the prescription tracker IMS Health as the source of the data. Mr. Maris estimated that sales of Addyi were running at a rate of $11 million a year, well below the $100 million to $150 million in sales that Valeant said it hoped to achieve this year.
Still, some said the drug helped. Dr. Lauren Streicher, an associate clinical professor of obstetrics and gynecology at the Feinberg School of Medicine at Northwestern Memorial Hospital in Chicago, said a number of her patients have taken the drug and reported significant increases in libido. None has discontinued use because of side effects, she said.
The analysis was undertaken by researchers in Europe, but one of the study’s authors, Dr. Ellen Laan, an associate professor in the Department of Sexology and Psychosomatic Obstetrics and Gynecology at the Academic Medical Center at the University of Amsterdam, has been an opponent of the drug. Last year, she helped organize a letter to the F.D.A. opposing the approval and signed another letter to Congress that said the argument about gender equality was “misleading and dangerous.”
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Tuesday, February 23, 2016

For Mark Willenbring, Substance Abuse Treatment Begins With Research


Profiles in Science
By GABRIELLE GLASER FEB. 22, 2016
Dr. Mark Willenbring at his Alltyr outpatient clinic for substance abuse in St. Paul. David Bowman for The New York Times
On the rainy fall morning of their first appointment, Dr. Mark Willenbring, a psychiatrist, welcomed a young web designer into his spacious office with a firm handshake and motioned for him to sit. The slender 29-year-old patient, dressed in a plaid shirt, jeans and a baseball cap, slouched into his chair and began pouring out a story of woe stretching back a dozen years.
Addicted to heroin, he had tried more than 20 traditional faith- and abstinence-based rehabilitation programs. In 2009, a brother died of an OxyContin overdose. Last summer, he attempted suicide by swallowing a fistful of Xanax. When he woke up to find he was still alive, he overdosed on heroin.
At a boot camp for troubled teenagers, he said, staffers beat him and withheld food. After he refused to climb a mountain in a team-buildingexercise, they strapped him to a gurney and dragged him up themselves.
The young man in the psychiatrist’s office paused, tears sliding down his cheeks.
“Sounds like a prison camp,” Dr. Willenbring said softly, leaning forward in his chair to pass a box of tissues.


He began explaining the neuroscience of alcohol and drug dependence, 60 percent of which, he said, is attributable to a person’s genetic makeup. Listening intently, the young patient seemed relieved at the idea that his previous failures in rehab might reflect more than a lack of will.
Dr. Willenbring, 66, has repeated this talk hundreds of times. But while scientifically unassailable, it is not what patients usually hear at addiction treatment centers.
Rehabilitation programs largely adhere to the 12-step principles of the 80-year-old Alcoholics Anonymous and its offshoot, Narcotics Anonymous. Addicts have a moral and spiritual defect, they are told; they must abstain from alcohol and drugs and surrender to a higher power to escape substance abuse.

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Friday, February 19, 2016

China finds restaurants using opium poppies in food

  • 22 January 2016
    •  
  • From the sectionChina
Huda Restaurant in Beijing. 22 Jan 2016Image copyrightAP
Image captionThe Huda Restaurant in Beijing says it may have unknowingly bought illegal seasoning
Thirty-five restaurants across China have been found illegally using opium poppies as a seasoning, officials have revealed.
Five are being prosecuted while 30 are under investigation, the China Food and Drug Administration said.
Local authorities are being urged to help investigators find the sources of the poppies, the China Daily reported.
Poppy powder, which contains low amounts of opiates, is banned as a food additive in China.
However, restaurants have previously been caught using it.
In 2012, seven restaurants in Ningxia province were closed for using opium poppies and in Guizhou province in 2004 authorities shut down 215 establishments for similar offences.
One of the businesses affected by the latest crackdown is reported to be the popular Huda Restaurant chain in Beijing.
General manager Hu Ling confirmed the company was under investigation and said it may have unwittingly bought seasoning contaminated with opiates. She declined to comment further.
China has been hit by a series of food scandals in recent years.
In 2014 a Shanghai-based supplier was found to have sold unsanitary and expired chicken meat to food chains including KFC, Starbucks and McDonald's.
In 2008, six children died and more than 300,000 were made ill from milk powder contaminated with melamine, an industrial chemical used to make plastics and fertiliser.
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Wednesday, February 17, 2016

A Parasite, Leopards, and a Primate’s Fear and Survival


Carl Zimmer
MATTER FEB. 11, 2016
A leopard in Moremi National Park in Botswana. Leopards are a predator of chimpanzees.Francois Savigny/Minden Pictures
Many of our primate ancestors probably ended up in the bellies of big cats. How else to explain bite marks on the bones of ancient hominins, the apparent gnawing of leopards or other African felines?
Big cats still pose a threat to primates. In one study of chimpanzees in Ivory Coast, for example, scientists estimated that each chimp ran a 30 percent risk of being attacked by a leopard every year.
A new study suggests that the big cats may be getting some tiny help on the hunt. A parasite infecting the brains of some primates, including perhaps our forebears, may make them less wary.
What does the parasite get out of it? A ride into its feline host.
The parasite is Toxoplasma gondii, a remarkably successful single-celled organism. An estimated 11 percent of Americans have dormant Toxoplasma cysts in their brains; in some countries, the rate is as high as 90 percent. Infection with the parasite poses a serious threat to fetuses and to people with compromised immune systems. But the vast majority of those infected appear to show no serious symptoms. Their healthy immune systems keep the parasite in check.

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Mammals and birds can also be infected. But cats in particular play a crucial part in the life cycle of the parasite: When a cat eats an infected animal, Toxoplasma gondii ends up in its gut. It reproduces there, generating offspring called oocysts that are shed in the cat’s feces. The oocysts can last for months in the environment, where they can be taken up by new hosts.
In the 1990s, scientists discovered that mice and rats infected with Toxoplasma gondii lose their natural fear of cat odors — and in some cases even appear to become attracted to them. It was possible, researchers speculated, that the parasite had evolved an ability to influence the behavior of its rodent hosts, to raise the chances they might be eaten by cats.
Subsequent studies have shown that the parasite can change the wiring of fear-related regions of the rat brain. Robert M. Sapolsky, a biologist at Stanford University, said that these findings led many researchers to see Toxoplasma gondii as a parasite exquisitely adapted to rodents. According to this view, he said, “Toxo being able to infect a zillion nonrodent species is just some sort of irrelevant evolutionary dead end.”
Even so, Toxoplasma gondii can cause intriguing changes in our brains as well. In a 2015 study, for example, researchers found that women infected with the parasite are more aggressive than those without it; infected men behave more impulsively than parasite-free men.
Clémence Poirotte, an evolutionary biologist at the Center for Functional and Evolutionary Ecology in Montpellier, France, wondered if our understanding of Toxoplasma might be limited by the paltry number of species in which its manipulations had been studied. She and her colleagues decided to focus on chimpanzees, running an experiment on 33 apes at a primate research center in Gabon, nine of which had Toxoplasma infections.
Instead of testing the reactions of chimpanzees to the odor of house cats, Ms. Poirotte and her colleagues turned to leopards, their natural predators. A veterinarian at a Gabon zoo supplied them with leopard urine, and they poured drops of it on the fence enclosing the space in which the chimpanzees lived.
Stepping back from the fence, the scientists observed the apes to see how they responded. They also ran the same experiment with urine from three species that are not chimpanzees’ natural predators: humans, lions and tigers.
Sometimes, the chimpanzees would approach the fence and investigate the smell; other times, they would ignore it. Ms. Poirotte and her colleagues found that chimpanzees not infected with Toxoplasma investigated the smell of leopard urine less than the smell of humans.
That’s the sort of behavior you would expect if the smell of leopard urine alarmed the chimpanzees — a healthy instinct that could keep them out of leopard territory and reduce their chances of getting killed.
The Toxoplasma-infected chimpanzees, on the other hand, checked out the leopard urine more often than that of humans, not less. They appeared to have developed the same recklessness observed in Toxoplasma-infected rodents.
“It’s so interesting to see that Toxo seems to have evolved the same manipulation ability in an ape with respect to its natural feline predator,” said Dr. Sapolsky, who was not involved in the new study.
Other experts were also intrigued by the report. But Michael B. Eisen, a biologist at the University of California, Berkeley, said he didn’t think it was powerful enough to rule out other explanations for how the chimpanzees behaved.
There might be innate differences in how the chimpanzees respond to odors, for example, that have nothing to do with being infected with Toxoplasma. “I’d have to file this, at best, in the ‘interesting but nowhere near convincing’ file,” Dr. Eisen said.
Ms. Poirotte acknowledged that it might be possible to tease apart these different possibilities by testing the chimpanzees before and after being infected with Toxoplasma. That would be a very challenging experiment to set up, however.
But the current study provided another piece of evidence that the parasite really was manipulating the chimpanzees. “It works only with leopard urine, and not with other felines which aren’t their natural predator,” Ms. Poirotte said.
That’s the kind of precision you’d expect from a parasite that has evolved a strategy for getting into one particular animal. “It’s so specific that it suggests it’s Toxoplasma causing the behavior modification,” Ms. Poirotte said.
She added that it would be useful now to study Toxoplasma’s effects on other primate species. It may even turn out that our primate ancestors were once the primary targets of the parasite.
When domesticated cats emerged several thousand years ago, the parasite might have expanded into a new host population that favored rodents rather than primates.
“It certainly suggests that Toxo’s behavioral effects in humans may be less of an irrelevant dead end than was always assumed,” Dr. Sapolsky said.
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