Tuesday, March 8, 2016

Scientists still fail to record age and sex of lab mice

NATURE | NEWS
Text-mining analysis finds that studies fall short of best practice — despite guidelines introduced in 2010.

Article toolsThe largest-ever analysis of the quality of mouse studies reveals that as recently as 2014, only around 50% of research papers recorded both the sex and age of the animals used — key details needed for others to assess and reproduce the research1.

ref 1
The analysis, which used software to trawl through the text of more than 15,000 open-access papers published between 1994 and 2014, also reveals the preferences of different research fields. Cardiovascular research tends to use male mice, whereas research on infectious diseases such as HIV and tuberculosis favours female mice, for example.
The study is “the strongest evidence about sex and age bias through biomedical research to date”, say its authors.

Sex matters

Many researchers have pointed out that male and female mice — like men and women — can have different responses to drugs or different behaviours in laboratory experiments. One study last year, for instance, found2 that although inhibiting the function of immune cells called microglia helps to relieve pain in male mice, it doesn’t do so in female mice. The difference might explain why some clinical trials of pain drugs have failed.

CRISPR: gene editing is just the beginning

The real power of the biological tool lies in exploring how genomes work


Maria Sharapova Admits Taking Meldonium, Drug Newly Banned by Tennis

 
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Sharapova Admits to Failing Doping Test

Maria Sharapova said the International Tennis Federation had notified her that she tested positive for a banned substance at the Australian Open in January.
 By THE ASSOCIATED PRESS on Publish DateMarch 7, 2016. Photo by Kevork Djansezian/Getty Images.Watch in Times Video »
Maria Sharapova, a five-time Grand Slam champion and the world’s highest-paid female athlete, announced Monday that she had tested positive for the recently banned drug meldonium at the Australian Open.
The tennis antidoping program confirmed the positive test, which occurred Jan. 26, the day Sharapova lost to Serena Williams in the quarterfinals. Sharapova, who has not played since because of a forearm injury, will be suspended provisionally Saturday pending a ruling in the case.
The commercial fallout was swift. Nike, one of Sharapova’s longtime sponsors, announced in a statement that it was suspending its relationship with her “while the investigation continues.” Sharapova has her own clothing line with Nike, with whom she signed an eight-year extension in 2010 that could reportedly be worth up to $70 million.
Sharapova, a 28-year-old Russian who is one of the world’s most visible sports figures, is by far the most prominent athlete to be barred for meldonium, a drug originally developed in Latvia for heart patients that aids blood flow and is not approved for sale in the United States.
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Friday, March 4, 2016

Brain power

NATURE | EDITORIAL
As brain stimulation finds non-medical uses, now is the time to consider its implications.

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Mopic/Alamy
Where should we draw the line on cognitive enhancement?
It is a cautionary tale for twenty-first-century medicine. Late last year, neurosurgeons in the United States reported odd symptoms in three of their patients. Well into their sixties and seventies, these people complained of headaches, nausea, unstable balance, weak legs, low blood pressure and falling down. Chest X-rays revealed the problem. Two devices implanted into their chests — a pacemaker to help their failing hearts and a battery unit that powered electrodes buried deep inside their heads to control the signature tremors of Parkinson’s disease — had been placed too close together. One machine was interfering with the functioning of the other (M. Sharma et al. Basal Ganglia 6, 19–22; 2016).
From iron lungs and dialysis machines to implantable defibrillators, we are used to technology helping our bodies. Deep-brain stimulation — the electrodes and battery implanted in the patients’ heads — has been helping people with neurological and psychiatric disorders for more than a decade, but it requires quite a commitment. Brain surgery is expensive and not for everybody. The number of people who might benefit is very small given the overall burden posed by mental illness and related problems. This is one reason why there is a lot of interest in cheaper and easier types of brain stimulation, which apply electric current and magnetic fields to the outside of the head.
If these types of brain stimulation are found not to produce much of a difference, then it will not have been for a lack of effort. Academic journals are filling up with case reports and preliminary trials of the technologies to help people with depression, autism spectrum disorders, schizophrenia, obsessive–compulsive disorder, addiction, anxiety and many more cognitive problems. It is early days, but there are enough positive results to draw the attention of people who struggle with such issues or know someone who does. Some of these people want to try it on themselves or their children. An electrical brain stimulator is fairly simple to make, and even simpler to buy from one of the companies that are popping up to sell them online. Self-medication has never been so high-tech.
Many neuroscientists have raised the alarm over do-it-yourself (DIY) brain stimulation, pointing out that it can be unsafe in the short term and might have side effects in the long term. Some want regulation. But there is another, more fundamental, ethical issue that must be confronted. As we report in an Outlook article on page S6 — one of a series of pieces that discuss cognitive enhancement — the use of DIY brain stimulators is not confined to those for whom conventional medicine has failed. A small but growing number of people want to use the devices to improve their natural mental abilities. And in so doing, this community is piggy-backing on scientific studies that suggest that electric currents and magnetic fields could improve academic performance by boosting memory and attention, and perhaps even alter attitudes.
The use of medicines to enhance performance in sport is frowned on, and a clear line has been drawn between taking them to treat and taking them to cheat. Could a similar distinction be made for cognitive-enhancement techniques? Should it be? It’s too soon to answer some of these questions — scientists and doctors must first reach consensus on the effectiveness of the techniques — but it is not too soon to ask them.

Wednesday, March 2, 2016

Campaign Promises

"You're not going to have the drugs coming in, destroying your children. Your kids are going to look all over the place and they're not going to be able to find them."
-- Donald Trump
"I would also get rid of Obamacare. We're going to have something much better."
-- Donald Trump

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 
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.
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.
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.
Original Article
Found by Heather

Tuesday, March 1, 2016

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

Photo
Addyi, the new female libido drug, sometimes known as the “female Viagra.”CreditAllen 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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