Jesus MalverdeJesus Malverde's Journal
Newly married in San Francisco, two men with matching red ties held hands and smiled broadly as they bounded out of City Hall on a recent sunny day.
Though a common enough scene in the Bay Area, the marriage ceremony for this couple was notable for many Chinese people seeing the news: One of the men was Hanscom Smith, the United States consul general in Shanghai. Photographs of his marriage, posted Tuesday on the official Chinese microblog account of the United States consul general, generated interest in China, which does not allow same-sex marriage.
Mr. Smith married Lu Yingzong, or Eric Lu, who is from Taipei, Taiwan, an island that is independently governed but that the Chinese Communist Party claims it rules.
One Chinese Internet user by the name of Daniel Chen Dandan posted an image of a beating heart on a microblog, writing, Respect any type of love.
All the advisers made it back. Keating, a decorated combat veteran and star athlete who decided to enlist after the 9/11 attacks, did not.
Providing new details Wednesday about the operation that took the life of the grandson of prominent financier and World War II pilot Charles Keating Jr., Coalition spokesman Col. Steve Warren said that the clash between ISIS and the Kurdish Peshmerga forces the advisers were assisting was "a big fight, one of the largest we've seen recently."
Keating's death is the third American combat loss since the U.S. redeployed forces to Iraq in the summer of 2014 to advise local forces and conduct Special Operations missions against ISIS. The 31-year-old Special Warfare Operator 1st Class was on his third tour in Iraq.
Avery Collins speaks with the snow-bro drawl typical of many young Coloradans.
With his bloodshot, blue eyes peeking out from under blond curls and a low-slung hat, he could easily fit in with the stoners at a 4/20 festival.
For me, its a spiritual happening, he said recently. Everything is perfect, everything is pure bliss.
But Collins isnt talking about the effects of marijuana. Hes talking about the runners high. The 25-year-old ultramarathoner is a marijuana user, just not the stereotypical couch-locked stoner living on junk food and video games. In the last three years, hes completed 30 ultramarathons five of which were a hundred miles each and a 200-mile race through the Rocky Mountains, which he won with a time of 65 hours.
Avery says that eating cannabis edibles before and during a run, instead of slowing him down, as one might think, actually enhances the experience.
A new study shows that knowledge of government surveillance causes people to self-censor their dissenting opinions online. The research offers a sobering look at the oft-touted "democratizing" effect of social media and Internet access that bolsters minority opinion.
The study, published in Journalism and Mass Communication Quarterly, studied the effects of subtle reminders of mass surveillance on its subjects. The majority of participants reacted by suppressing opinions that they perceived to be in the minority. This research illustrates the silencing effect of participants dissenting opinions in the wake of widespread knowledge of government surveillance, as revealed by whistleblower Edward Snowden in 2013.
The spiral of silence is a well-researched phenomenon in which people suppress unpopular opinions to fit in and avoid social isolation. It has been looked at in the context of social media and the echo-chamber effect, in which we tailor our opinions to fit the online activity of our Facebook and Twitter friends. But this study adds a new layer by explicitly examining how government surveillance affects self-censorship.
Participants in the study were first surveyed about their political beliefs, personality traits and online activity, to create a psychological profile for each person. A random sample group was then subtly reminded of government surveillance, followed by everyone in the study being shown a neutral, fictional headline stating that U.S. airstrikes had targeted the Islamic State in Iraq. Subjects were then asked a series of questions about their attitudes toward the hypothetical news event, such as how they think most Americans would feel about it and whether they would publicly voice their opinion on the topic. The majority of those primed with surveillance information were less likely to speak out about their more nonconformist ideas, including those assessed as less likely to self-censor based on their psychological profile.
Israeli parents wondered why school trips to Auschwitz cost so much. The answer may be price-fixing.
For an Israeli schoolchild, a trip to Poland to see World War II Nazi death camps can be a vital part of their education about the history of the Jewish faith and the Israeli state. For parents, however, it can be an expensive burden.
A few months ago, Israeli authorities began to covertly investigate the differences in prices between a number of tour operators offering these trips. They concluded that something was amiss. Now, the Israel Antitrust Authority has announced that nine tour operator executives have been arrested on suspicion of running a secret price-fixing ring that was aimed at artificially inflating the cost of trips to former Nazi death camps such as Auschwitz.
At least six tour operators are being investigated on suspicion of involvement in the alleged cartel. In some cases, the homes of company executives were searched and property confiscated. According to the publication Haaretz, one of those detained is also suspected of bribery.
The cost of these trips had long caused controversy within Israel. The project to send Israeli schoolchildren to Poland first began in the late 1980s, and it is estimated that about half of the Jewish schools in Israel offer the journeys to their pupils. The trips are sponsored by the Education Ministry and form part of the Holocaust curriculum, with students visiting Auschwitz and other World War II death camps, in addition to learning about the modern-day Jewish community.
1. How is marijuana therapy being used by some members of the medical community?
A. The FDA is aware that marijuana or marijuana-derived products are being used for a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, treatment of spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea. To date, the FDA has not approved a marketing application for a drug product containing or derived from botanical marijuana and has not found any such product to be safe and effective for any indication.
2. Why hasnt the FDA approved marijuana for medical uses?
A. To date, the FDA has not approved a marketing application for marijuana for any indication. The FDA generally evaluates research conducted by manufacturers and other scientific investigators. Our role, as laid out in the Federal Food, Drug, and Cosmetic (FD&C) Act, is to review data submitted to the FDA in an application for approval to assure that the drug product meets the statutory standards for approval.
The FDA has approved Marinol for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol includes the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of marijuana. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.
3. Is marijuana safe for medical use?
A. The FDA has not approved any product containing or derived from botanical marijuana for any indication. This means that the FDA has not found any such product to be safe or effective for the treatment of any disease or condition. Study of marijuana in clinical trial settings is needed to assess the safety and effectiveness of marijuana for medical use.
The FDA will continue to facilitate the work of companies interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medicinal uses of marijuana.
4. How does FDAs role differ from NIH and DEAs role when it comes to the investigation of marijuana for medical use?
A. Conducting clinical research using marijuana involves interactions with several federal agencies. This includes: a registration administered by the Drug Enforcement Administration (DEA); obtaining the marijuana for research from the National Institute on Drug Abuse (NIDA) within the National Institutes of Health; and review of an investigational new drug (IND) application and research protocol by the FDA. Additionally:
As a Schedule I controlled substance under the Controlled Substances Act, DEA provides researchers with a special registration and has certain requirements at the site marijuana will be studied.
NIDA provides research-grade marijuana for scientific study. The agency is responsible for overseeing the cultivation of marijuana for medical research and has contracted with the University of Mississippi to grow marijuana for research at a secure facility. Marijuana of varying strengths and potencies is available.
Researchers work with the FDA and submit an IND application.
5. Does the FDA object to the clinical investigation of marijuana for medical use?
A. No. The FDA believes that scientifically valid research conducted under an IND application is the best way to determine what patients could benefit from the use of drugs derived from marijuana. The FDA supports the conduct of that research by:
Providing information on the process needed to conduct clinical research using marijuana.
Providing information on the specific requirements needed to develop a drug that is derived from a plant such as marijuana. In June 2004, the FDA finalized its Guidance for Industry: Botanical Drug Products, which provides sponsors with guidance on submitting IND applications for botanical drug products.
Providing specific support for investigators interested in conducting clinical research using marijuana and its constituents as a part of the IND process through meetings and regular interactions throughout the drug development process.
Providing general support to investigators to help them understand and follow the procedures to conduct clinical research through the FDA Center for Drug Evaluation and Researchs Small Business and Industry Assistance group.
6. What kind of research is the FDA reviewing when it comes to the efficacy of marijuana?
A. The FDA reviews applications to market drug products to determine whether those drug products are safe and effective for their intended indications. The FDA reviews scientific investigations, including adequate and well-controlled clinical trials, as part of the FDAs drug approval process.
The FDA relies on applicants and scientific investigators to conduct research. Our role, as outlined in the Federal Food, Drug, and Cosmetic Act, is to review data submitted to the FDA in a marketing application to determine whether a proposed drug product meets the statutory standards for approval. Additional information concerning research on the medical use of marijuana is available from the National Institutes of Health, particularly the National Cancer Institute (NCI) and NIDA.
7. How can patients get into expanded access program for marijuana for medical use?
A. Manufacturers may be able to make investigational drugs available to individual patients in certain circumstances through expanded access, as described in the FD&C Act and implementing regulations. For example, GW Pharmaceuticals disclaimer icon is currently making a drug product that contains cannabidiol and that is being developed for seizure disorders available through expanded access. Information about this program can be obtained from the company.
8. Does the FDA have concerns about administering a cannabis product to children?
A. We understand that parents are trying to find treatments for their childrens medical conditions. However, the use of untested drugs can have unpredictable and unintended consequences. Caregivers and patients can be confident that FDA-approved drugs have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they are on the market. The FDA continues to support sound, scientifically-based research into the medicinal uses of drug products containing marijuana or marijuana constituents, and will continue to work with companies interested in bringing safe, effective, and quality products to market.
9. What is FDAs reaction to states that are allowing marijuana to be sold for medical uses without the FDAs approval?
A. The FDA is aware that several states have either passed laws that remove state restrictions on the medical use of marijuana and its derivatives or are considering doing so. In particular, we know that a number of states are interested in allowing access to cannabinoid oil, or cannabidiol, in an attempt to treat childhood epilepsy. It is important to conduct medical research into the safety and effectiveness of marijuana products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of marijuana and its derivatives to provide information on Federal and scientific standards.
10. What is the FDAs position on state Right to Try bills?
A. The FDA has not taken a position on any particular state Right to Try bill. The FDA works with companies to provide patients access to experimental therapies through enrollment in clinical trials or through the expanded access provisions described in the FDAs statute and regulations. The FDA may permit the use of an experimental therapy, but the sponsor company ultimately decides whether or not to provide experimental therapies to patients.
These channels help to protect patients while also allowing for the collection of data necessary to support the FDA approval of safe and effective therapies for use in the broader population. The FDA is strongly supportive of appropriate use of expanded access protocols and stands ready to work with companies that are interested in providing access to experimental drugs.
11. Has the agency received any adverse event reports associated with marijuana for medical conditions?
A. The agency has received reports of adverse events in patients using marijuana to treat medical conditions. The FDA is currently reviewing those reports and will continue to monitor adverse event reports for any safety signals attributable to marijuana and marijuana products, with a focus on serious adverse effects associated with the use of marijuana.
Information from adverse event reports regarding marijuana use is extremely limited; the FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using marijuana and its constituents can come from clinical trials using marijuana that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of marijuana and its constituents is needed. Clinical trials of marijuana conducted under an IND application could collect this important information as a part of the drug development process.
12. Can products that contain cannabidiol be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was "marketed as" a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol. For more information on this provision, including an explanation of the phrase "marketed as," see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
FDA is not aware of any evidence that would call into question its current conclusion that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Interested parties may present the agency with any evidence that they think has bearing on this issue.
13. How did the FDA determine that cannabidiol products are excluded from the dietary supplement definition?
Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act. Under that provision, if an article (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was marketed as a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for cannabidiol.
The existence of substantial clinical investigations regarding cannabidiol has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain disclaimer icon and disclaimer iconGW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDAs regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.
14. Will FDA take enforcement action regarding cannabidiol products that are marketed as dietary supplements?
A. When a product is in violation of the FD&C Act, FDA considers many factors in deciding whether or not to initiate an enforcement action. Those factors include, among other things, agency resources and the threat to the public health. FDA also may consult with its federal and state partners in making decisions about whether to initiate a federal enforcement action.
15. What does the FDA think about making cannabidiol available to children with epilepsy?
A. The FDA understands the interest in making investigational products available to patients while they are being studied for approval, and there are expanded access provisions in both the FDAs statute and its regulations to make this possible.
16. What should I do if my child eats something containing marijuana?
A. It is important to protect children from accidental ingestion of marijuana and its derivative products. FDA recommends that these products are kept out of reach of children to reduce the risk of accidental ingestion.
If the parent or caregiver has a reasonable suspicion that the child ingested products containing marijuana, the child should be taken to a physician or emergency department, especially if the child acts in an unusual way or is/feels sick.
17. Ive seen marijuana products being marketed for pets. Are they safe?
A. FDA has recently become aware of some marijuana products being marketed to treat diseases in animals. We want to stress that FDA has not approved marijuana for any use in animals, and the agency cannot ensure the safety or effectiveness of these products. For these reasons, FDA cautions pet-owners against the use of such products.
18. Can I give my pet marijuana products for medical purposes, such as to relieve the pain of a sick or dying pet?
A. Marijuana needs to be further studied to assess the safety and effectiveness for medical use in animals. To date, FDA has not approved marijuana for any use in animals. If your pet is in pain, we urge you to talk with your veterinarian about appropriate treatment options.
19. I gave my pet marijuana and Im concerned my pet is suffering adverse effects. What should I do?
A. Signs that your pet may be suffering adverse effects from ingesting marijuana may include lethargy, depression, heavy drooling, vomiting, agitation, tremors, and convulsions. If you have concerns that your pet is suffering adverse effects from ingesting marijuana or any substance containing marijuana, consult your veterinarian, local animal emergency hospital or an animal poison control center immediately.
20. Has the agency received any adverse event reports associated with marijuana for animals?
A. While the agency is aware of reports of pets consuming various forms of marijuana, to date, FDA has not directly received any adverse event reports associated with giving marijuana to animals via our safety reporting portals. However, adverse events from accidental ingestion are well-documented in scientific literature. If you feel your animal has suffered from ingesting marijuana, we encourage you to report the adverse event to the FDA. Please visit Reporting Information about Animal Drugs and Devices to learn more about how to report an adverse event related to an animal food or drug.
21. What is FDA doing about marijuana products currently on the market for pets?
A. FDA is currently collecting information about marijuana and marijuana-derived products being marketed for animals. FDA reminds consumers that these products have not been evaluated by FDA for safety and effectiveness, and we recommend that you talk with your veterinarian about appropriate treatment options for your pet.
A woman beheaded in the road. Five headless corpses hanging from cranes. As a documentary exposes the horror of life in Saudi Arabia, why DOES Britain (and the USA) cosy up to this kingdom of savagery?
They belonged to a gang of five robbers, all of whom were publicly beheaded before their corpses were hoisted high in the air, where they remained for days.
The gruesome sight is one scene in a shocking documentary to be aired this week which sheds light on life in Saudi Arabia, one of the worlds bloodiest and most secretive countries.
The film, Saudi Arabia Uncovered, contains harrowing footage of beheadings. A woman dressed in black is held down at the side of a public road by four Saudi policemen, after she has been convicted of killing her stepdaughter.
She is executed with a sword blow to the neck, as she screams: I did not do it.
We have all heard of the brutality of the Saudi regime, but what makes this documentary so chilling is that we see it on camera.
Robyn Griggs Lawrence has a steak recipe so good it'll make you feel high. Literally.
Seared Wagyu New York Strip with Cannabis Rub is just one of more than a hundred gourmet-inclined recipes Lawrence compiled for her Cannabis Kitchen Cookbook, now entering a second printing. Now shes taking her expertise right into readers homes with an online cooking course.
Lawrence, based in Boulder, Colo., is one of many entrepreneurs in the $5.4 billion legal marijuana industry. Unlike pot-repreneurs selling already baked brownies, cookies, and gummies, which may account for almost half of those billions, she is teaching consumers how to make the goods at home. Each dishfrom Baked Artichoke, Crab, and Cannabis Dip to Cannabis Ceviche and High Ho Pottanescafeatures the nation's favorite newly legal ingredient.
Since Cannabis Kitchen's release in September, Lawrence has organized cooking demonstrations at hotels, arranged retreats in Colorado, and filmed that four-part online course. The class, called Cooking with Cannabis: The Fundamentals, will become available online in April to anybody over 21 years of age through the Green Flower Media Academy. Lawrence will cover the basics of the who, why, and how regarding cooking with cannabis, with an emphasis on safety and proper dosing. Because the course offers only information, it will be accessible in any state. We would never suggest or condone using cannabis in states where it isnt legal, she warned. (Editor's note: Since Bloomberg is based in New York, we haven't personally tested any of the recipes below.)
Profile InformationName: Jesus Malverde
Current location: Japan
Member since: Fri May 17, 2013, 10:44 PM
Number of posts: 10,274
About Jesus MalverdeJesús Malverde, sometimes known as the generous bandit or angel of the poor is a folklore hero in the Mexican state of Sinaloa. One day we\'ll live free and no longer in fear. Fear of losing jobs, fear of being raided, your dogs shot, your children kidnapped by the state. Your land stolen, and maybe even your life lost. Fear no more, the times are a changing.
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