The U.S. Food and Drug Administration is warning four companies that sell products containing cannabidiol (CBD) to stop making unsubstantiated health claims, such as "combats tumor and cancer cells":
The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer's and other serious diseases.
The companies in question are Greenroads Health, Natural Alchemist, That's Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC.
Also at Bloomberg, The Cannabist, The Hill, NBC, and Newsweek.
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The U.S. Drug Enforcement Agency (DEA) has once again rejected attempts to reschedule cannabis and allow medical cannabis federally:
The Obama administration has denied a bid by two Democratic governors to reconsider how it treats marijuana under federal drug control laws, keeping the drug for now, at least, in the most restrictive category for U.S. law enforcement purposes. Drug Enforcement Administration chief Chuck Rosenberg says the decision is rooted in science. Rosenberg gave "enormous weight" to conclusions by the Food and Drug Administration that marijuana has "no currently accepted medical use in treatment in the United States," and by some measures, it remains highly vulnerable to abuse as the most commonly used illicit drug across the nation.
"This decision isn't based on danger. This decision is based on whether marijuana, as determined by the FDA, is a safe and effective medicine," he said, "and it's not." Marijuana is considered a Schedule I drug under the Controlled Substances Act, alongside heroin and LSD, while other, highly addictive substances including oxycodone and methamphetamine are regulated differently under Schedule II of the law. But marijuana's designation has nothing to do with danger, Rosenberg said.
The Post article notes:
In the words of a 2015 Brookings Institution report, a move to Schedule II "would signal to the medical community that [the Food and Drug Administration and the National Institutes of Health] are ready to take medical marijuana research seriously, and help overcome a government-sponsored chilling effect on research that manifests in direct and indirect ways."
However, the DEA will expand the number of locations federally licensed to grow cannabis for research from the current total of... 1: the University of Mississippi.
Related: Compassionate Investigational New Drug program
Weeks after cannabis legalization was passed by voters in California and other states, pranksters edited the famous Los Angeles Hollywood Sign to read "Hollyweed". This previously occurred in 1976 following the passage of a California law decriminalizing cannabis.
Researchers have found (DOI: 10.2105/AJPH.2016.303577) (DX) that legalization of medical cannabis led to an overall decrease in traffic fatalities among 19 states:
The happy side-effect wasn't uniform, however; only seven states saw significant reductions, while two states saw increases. Nevertheless, the authors of the new report in the American Journal of Public Health argue that the data bucks the common criticism that more pot access should increase car crashes and injuries.
Drops in traffic deaths may, in part, be explained by people swapping alcohol for pot, leading to reduced drunk driving, the study's authors speculated. To back that up, the authors note that the lives spared tended to belong to younger people, particularly 25- to 44-year-olds—an age group frequently involved in alcohol-related traffic deaths.
[Continues...]
64% of Americans now support the legalization of cannabis, an all-time high since Gallup first asked the question in 1969. Also for the first time, a majority of Republicans (51%) support legalization, up from 42% last year:
As efforts to legalize marijuana at the state level continue to yield successes, public opinion, too, has shifted toward greater support. The Department of Justice under the current Republican administration has been perceived as hostile to state-level legalization. But Attorney General Jeff Sessions could find himself out of step with his own party if the current trends continue. Rank-and-file Republicans' views on the issue have evolved just as Democrats' and independents' have, though Republicans remain least likely to support legalizing pot.
Also at NPR, The Hill, NORML, and Reason.
Related: New Attorney General Claims Legal Weed Drives Violent Crime; Statistics be Damned
4/20: The Third Time's Not the Charm
A study has found that people who smoke more cannabis have more sex than those who smoke less or abstain:
Tobacco companies put a lot of effort into giving cigarettes sex appeal, but the more sensual smoke might actually belong to marijuana. Some users have said pot is a natural aphrodisiac, despite scientific literature turning up mixed results on the subject. At the very least, a study published Friday [DOI: 10.1016/j.jsxm.2017.09.005] [DX] in the Journal of Sexual Medicine suggests that people who smoke more weed are having more sex than those who smoke less or abstain. But whether it's cause or effect isn't clear.
The researchers pulled together data from roughly 50,000 people who participated in an annual Centers for Disease Control and Prevention survey during various years between 2002 and 2015. "We reported how often they smoke — monthly, weekly or daily — and how many times they've had sex in the last month," says Dr. Michael Eisenberg, a urologist at Stanford University Medical Center and the senior author on the study. "What we found was compared to never-users, those who reported daily use had about 20 percent more sex. So over the course of a year, they're having sex maybe 20 more times."
Women who consumed marijuana daily had sex 7.1 times a month, on average; for men, it was 6.9 times. Women who didn't use marijuana at all had sex 6 times a month, on average, while men who didn't use marijuana had sex an average of 5.6 times a month.
When the researchers considered other potentially confounding factors, such as alcohol or cocaine use, age, religion or having children, the association between more marijuana and more sex held, Eisenberg says. "It was pretty much every group we studied, this pattern persisted," he says. The more marijuana people smoked, the more they seemed to be having sex.
An Anonymous Coward would like to remind you that he is "not cool enough" to acquire cannabis illegally from drug dealers.
Also at CNN.
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
Also at Ars Technica and STAT News.
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FDA approves country's first medicine made from marijuana
The Food and Drug Administration on Monday approved the country's first drug derived from marijuana, a medication that treats two rare and devastating forms of epilepsy.
The drug, GW Pharmaceuticals' Epidiolex, is made of cannabidiol, or CBD, a component of marijuana that does not give users a high. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.
"This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies," FDA Commissioner Scott Gottlieb said in a statement. "And, the FDA is committed to this kind of careful scientific research and drug development."
The FDA's decision was expected. FDA officials had indicated they supported approving Epidiolex, and an advisory panel had unanimously recommended it get the green light. There was some concern about the drug's effects on the liver, but experts have said this risk could be addressed by doctors as they monitor their patients during treatment.
Before GW can market Epidiolex, though, the Drug Enforcement Administration will have to reclassify CBD, which in this case, because it comes from marijuana, is considered a Schedule I drug, meaning it has no medical value and a high risk of abuse. The agency is expected to do so within 90 days.
Cannabidiol (CBD).
Also at TechCrunch.
Related: FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
World Health Organization Clashes With DEA on CBD; CBD May be an Effective Treatment for Psychosis
UC San Diego to Treat Autism Using Cannabidiol
(Score: 5, Interesting) by Immerman on Thursday November 02 2017, @04:36PM (6 children)
FDA: Cannabis has no accepted medicinal uses.
Researcher: We've shown that it's extremely effective against seizures, Tourette Syndrome, etc., etc., etc., and even has some very promising anti-carcinogenic properties.
FDA: Your independent research does not entitle you to advertise medical claims.
Researcher: Then lets do some FDA approved tests.
FDA: We can't do that, cannabis is completely illegal.
Researcher: Why?
FDA: Because it has no accepted medicinal uses.
And of course in that atmosphere the crackpots and snake-oil salesmen come out of the woodwork as well.
(Score: 2) by Pino P on Thursday November 02 2017, @04:52PM (2 children)
Then do the clinical trials in countries that aren't the United States of America.
(Score: 5, Funny) by bob_super on Thursday November 02 2017, @05:09PM (1 child)
You can't trust Canadians or West Europeans to know what's good for US health.
On the other hand, you can trust food supplement and vitamins manufacturers to claim anything they want about their products without studies, because they are good Americans with a Senator in the family, not evil pot pushers.
(Score: 3, Touché) by Grishnakh on Thursday November 02 2017, @06:04PM
Exactly. This is garbage: the CBD sellers should be able to make any crazy claims they want. If the supplement sellers and chiropractors and naturopathic "doctors" can make unsubstantiated claims about their cure-alls, then anyone else should be allowed to as well. As long as those groups are allowed to push their snake oil, we really shouldn't even have an FDA.
(Score: 2) by DeathMonkey on Thursday November 02 2017, @05:22PM (2 children)
FDA: Cannabis has no accepted medicinal uses.
The DEA schedules drugs, not the FDA.
DEA says marijuana has no medical use; pot remains listed as dangerous [seattletimes.com]
(Score: 4, Informative) by Pino P on Thursday November 02 2017, @05:25PM
The DEA defers to the FDA when de-scheduling Schedule I substances.
(Score: 2) by takyon on Thursday November 02 2017, @05:41PM
https://en.wikipedia.org/wiki/Controlled_Substances_Act [wikipedia.org]
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 3, Informative) by Snow on Thursday November 02 2017, @04:36PM (2 children)
I used to be a 5'2" little black kid, then I started smoking weed, and now I'm 6' and white.
(Score: 0) by Anonymous Coward on Thursday November 02 2017, @05:31PM
* YMMV. Offer not valid in Tennessee.
(Score: 1, Funny) by Anonymous Coward on Thursday November 02 2017, @07:45PM
Yeah, okay, Michael, and now you're dead!
(Score: 3, Interesting) by DannyB on Thursday November 02 2017, @05:49PM (6 children)
Last June I happened to be vacationing in Colorado.
At individual dispensaries people give all kinds of advice to people looking for "treatment" of various things. Some of that advice is appallingly bad.
One peeve that I've kept as a long time pet is the: "it's natural!" as if that means it is necessarily good and something processed or chemically produced is necessarily bad. Dog excrement is natural, but probably not very good medicine. Any modern drugstore is filled with large numbers of "not natural" medicines that for most of human history would have been considered nothing less than absolutely miraculous. Effective, over the counter treatments for many, many common ailments that have afflicted people throughout history. Everything from athlete's foot to runny nose.
If the "product" sold at a dispensary helps you, then good for you! Personally, I found them about as effective as tylenol, and for much worse pain less effective than half a tablet of hydrocodone. And here's the kicker. Hydrocodone, prescribed by a physician is cheap. Cheap. Way cheaper than what the dispensaries are selling. The only drawback that is in the forefront of my mind is the potential for tolerance, then dependence, then addiction.
Motorcycle helmets should be required by law to have airbags inside to protect the rider. What about seatbelts?
(Score: 2) by LoRdTAW on Thursday November 02 2017, @08:00PM (2 children)
But it's so cheap!
(Score: 2) by DannyB on Thursday November 02 2017, @08:10PM (1 child)
Not cheap if you get addicted. In several different senses of not cheap. Only take them if you need them. They are a tool to improve your quality of life, not to get high.
Motorcycle helmets should be required by law to have airbags inside to protect the rider. What about seatbelts?
(Score: 1, Interesting) by Anonymous Coward on Thursday November 02 2017, @09:16PM
The two aren't necessarily mutually exclusive. There are many highs that are safer than scare-oin. Magic mushrooms for example. They can be misused, sure, but getting high for fun is not a bad thing and fun can improve your quality of life. Not everything has to be treated as medicine or a religious experience.
(Score: 2) by Post-Nihilist on Thursday November 02 2017, @09:30PM (2 children)
For inflammation based pain it work better than Tylenol and advil.
Compared to the cadillac of pain relief that is hydrocodone well it is weak and nonaddictive.
For nausea, smoked cannabis is well above any other antiemetic...
Be like us, be different, be a nihilist!!!
(Score: 2) by DannyB on Friday November 03 2017, @01:59PM (1 child)
Since I already take (cheap, 40 year old) prescription NSAIDs, that might explain why it had little effect. I never have nausea because I avoid oxycodone. I suppose if either of my dr's thought I was having any trouble with occasional hydrocodone use, I would be looking for some alternative. Of course, I truly hope the smoked or otherwise ingested weed product helps people who can genuinely benefit from it. I just didn't see any benefit for myself, and especially didn't see it as cost effective.
Of course, there is the getting high thing. But then you end up with Java code that looks like it was written by a Perl programmer.
Motorcycle helmets should be required by law to have airbags inside to protect the rider. What about seatbelts?
(Score: 2) by Post-Nihilist on Friday November 03 2017, @06:27PM
What to you have against with liberal use regexs in my Java code ;)
Be like us, be different, be a nihilist!!!
(Score: 0) by Anonymous Coward on Thursday November 02 2017, @07:34PM (1 child)
go back to raiding housewives for raw milk you jackbooted pieces of shit.
(Score: 0) by Anonymous Coward on Friday November 03 2017, @02:58PM
Go back to drinking snake oil, moron.
(Score: 3, Interesting) by Post-Nihilist on Thursday November 02 2017, @09:17PM (1 child)
https://www.google.ca/patents/US6630507 [google.ca]
That patent is issues to The United States Of America As Represented By The Department Of Health And Human Services... Can you get more hypocritical than that
Be like us, be different, be a nihilist!!!
(Score: 2) by Post-Nihilist on Thursday November 02 2017, @09:46PM
Thinking about it can't those company just give potential customer a copy of this patent?
Be like us, be different, be a nihilist!!!
(Score: 4, Insightful) by digitalaudiorock on Thursday November 02 2017, @11:52PM (1 child)
Too bad they didn't crack down on "Unsubstantiated claims" about Oxy before it made addicts or dead people out of so many...but I guess that would just make too much sense and there's way too much $$ at stake.
(Score: 2) by DannyB on Friday November 03 2017, @02:01PM
Yep. It is amazing that they wouldn't recognize the potential harm and have had better controls or prescribing instructions.
Motorcycle helmets should be required by law to have airbags inside to protect the rider. What about seatbelts?
(Score: 0) by Anonymous Coward on Friday November 03 2017, @12:01AM
Ensuring the quality of ...