A Ketamine-Like Drug Is the First New Antidepressant to Get FDA Approval in Years

Julia Belluz, writing for Vox:

Ketamine, which has long been used as an anesthetic, has increasingly been tried off-label by psychiatrists as a last-ditch effort to treat the 12 to 20 percent of adults with depression who don’t respond to other antidepressant medications or treatments.

Building on years of preliminary research about ketamine’s potential benefits for depression, Johnson & Johnson developed a drug called esketamine, sold under the brand name Spravato. The nasal spray is designed to alleviate depressive symptoms within hours — much faster than the other antidepressants on the market, such as Prozac, which can take weeks or months to act.

In February, an FDA panel determined, in a 14-2 vote, that esketamine’s benefits outweigh its risks and recommended that the agency approve the drug. The approval came on Tuesday, the first new antidepressant type to be greenlit by the agency in decades.

At first glance this may sound like good news, but weekly supervised administrations of esketamine will only be available for:

  1. Adults suffering from treatment-resistant depression,

  2. Who are also taking another oral anti-depressant, and

  3. Have access to a certified clinic where patients can be monitored for two hours after taking the drug.

Oh, and it’s going to be prohibitively expensive for most. While street ketamine is relatively expensive (typically $70-100 per gram), these nasal spray esketamine treatments will cost patients “anywhere between $2,360 to $2,540 a month.”

And the controversy doesn’t end there, either. Some physicians like psychiatrist Erik Messamore have a few problems with this news:

We’ve known since at least 2006 that ketamine (old, cheap, generic ketamine) rapidly shrink depressive symptoms. The antidepressant response occurs in a matter of hours and can last for up to a week after a single dose. […]

We didn’t need eskatamine, really. We just needed a way to get 2006 medical science discoveries into clinical practice in less than 13 years. […]

-Without FDA approval, insurance companies will find a convenient excuse not to cover treatments – even if medical science shows that the treatment is useful.

-Only pharmaceutical companies have enough money to get the FDA to look at data and opine on effectiveness.

-Pharmaceutical companies won’t spend a dime to ask the FDA to review generic drugs like ketamine (or natural products like fish oil)

-We do not have organizations [that] are reliably willing to review non-industry-sponsored science and make recommendations about when a generic drug or natural product should move into clinical practice.

Similar issues are emerging in the psilocybin space right now too. In the midst of all the excitement with psychedelic drugs being medicalized, we should remain aware of the potential problems we face with only allowing certain populations of people have access to these tools—and with letting Big Pharma reap all of the profits that should instead be going toward the brave people who belong to a movement the industry has fiercely attempted to stave off for decades.


Marijuana Use Before Sex Leads to More Satisfying Orgasms, Study Finds

Kimberly Lawson, writing for Marijuana Moment:

Want a more satisfying time in the bedroom? A quick toke or two may do the trick, according to a new study in the journal Sexual Medicine.

While scientific evidence about the effects of marijuana use on sexual functioning is limited, there’s plenty of anecdotal claims online about cannabis improving libido, arousal and orgasm. So researchers decided to investigate, publishing one of the largest studies on the issue to date.

After reading the title of this post, you’re probably thinking to yourself, “…no duh.” Well, the results may not be all that surprising, but this is really intriguing research. There’s still plenty more to learn about how cannabis affects sex, but preliminary studies like this one are laying the foundation that is needed to even get around to performing more rigorous research.


FDA Flooded With Comments Urging That Marijuana Be Reclassified

Kyle Jaeger, writing for Marijuana Moment:

In the last few days, nearly 700 people have submitted comments to the Food and Drug Administration (FDA) supporting the rescheduling of marijuana.

The FDA opened the public comment period on Friday to gather input ahead of a United Nations meeting on global drug policy, where the U.S. representative will have the opportunity to cast a vote on World Health Organization (WHO) recommendations to reschedule cannabis, THC and CBD under international drug treaties.

So far, the federal agency has been flooded with comments that overwhelmingly endorse a cannabis reclassification. Support for the policy change has been nearly unanimous, but the reasoning behind those sentiments varied.

The deadline for this round of comments is March 14th, so make sure you submit yours before it’s too late. Last time the FDA asked for input on this issue, more than 20,000 people submitted their feedback. As a community, we should shoot for even more this time around. Tell the FDA what you think about rescheduling cannabis today.


Legal Cannabis Has Created 211,000 Full-Time Jobs in America

Bruce Barcott, writing for Leafly:

Over the past three months Leafly’s data team, working in partnership with Whitney Economics, has gone state-by-state to tally the total number of direct, full-time jobs in the state-legal cannabis industry.

There are now more than 211,000 cannabis jobs across the United States. More than 64,000 of those jobs were added in 2018. That’s enough people to fill Chicago’s Soldier Field, with 3,000 more tailgating outside.

Legal cannabis is currently the greatest job-creation machine in America. The cannabis workforce increased 21% in 2017. It gained another 44% in 2018. We expect at least another 20% growth in jobs in 2019. That would represent a 110% growth in cannabis jobs in just three years.

When the country chooses to finally legalize cannabis at the federal level, we will definitely have plenty of opportunities for people to find meaningful work.


A New Chapter in the Science of Psychedelic Microdosing

Haley Weiss, writing for The Atlantic:

The purported benefits of microdosing psychedelics are as numerous as the research is sparse. The technique, which involves ingesting small amounts of LSD, mushrooms, or other hallucinogenic drugs every three or four days, has made headlines for its popularity as a “productivity hack” among the Silicon Valley elite. But anecdotal endorsements of microdosing claim that the routine can lead to a whole variety of benefits, including heightened emotional sensitivity, athletic performance, and creativity; and relief from symptoms of anxiety, depression, OCD, PTSD, and chronic pain—all without resulting in any sort of trip.

In a lab setting, meanwhile, these effects have hardly been studied. Microdosing straddles a line between homeopathic remedy and experimental biohacking as a promising tool that hasn’t yet made its way through the clinical system’s rigorous checks and balances. Now a new study published Monday in the journal ACS Chemical Neuroscience provides the first biological evidence that psychedelic microdosing could have unique therapeutic effects that differ from the effects of a full dose.

New research found that microdosing DMT produced positive effects on mood and anxiety in rats without impacting working memory or social interaction. This is exciting news.

However, the study also found that the female rats experienced a decrease in dendritic-spine density, while the male rats were unaffected. This is concerning because it could indicate that these minuscule doses of the drug may have caused certain damage to this particular area of the brain. What’s odd is that bigger doses of DMT haven’t produced this cytotoxic effect.

So while microdosing may be able to assist with mental health issues, more research will need to be conducted to determine exactly what is going on with the female rats.