food and drug administration

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U.S.: Leaked Documents Expose Why The FDA Says Marijuana Is Not Medicine

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By Derrick Stanley
Hemp News

New uncovered documents give an insider's look at why the federal government does not recognize marijuana as medicine despite the reality that 25 states have legalized the plant for medical use so far. The 118-page document contains memos between the DEA's chief, two FDA officials, the governors of Rhode Island and Washington and several other government officials.

According to the documents, one of the reasons the FDA came to their decision is because “Individuals are taking the substance on their own initiative rather than on the basis of the medical advice from a practitioner licensed by law to administer such substances,” officials wrote in a summary.

The Drug Enforcement Administration rejected two petitions to reschedule marijuana last August. The DEA ruled that the marijuana that millions of Americans rely on in 25 states has “no currently accepted medical use.”

Florida: New Ad Campaign Says Marijuana Isn't Medicine

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By Derrick Stanley
Hemp News

The anti-marijuana group Drug Free Florida released a 30 second ad Thursday which opens with a prescription for Marinol, which the group says offers the same benefits as medical marijuana.

Marinol is a pharmaceutical tetrahydrocannabinol, a drug which contains the principal psychoactive component of cannabis. 

The ad then goes on to slam medical marijuana for not being regulated by the Food and Drug Administration and for not being prescribed by a doctor.

The group says amendment 2 is a “scam” which would make medical marijuana legal. “You don’t smoke medicine,” the ad says, while pictures of young people smoking marijuana flash on the screen. 

The ad is the latest in the fight against Amendment 2, which would legalize medical marijuana in Florida for patients with “debilitating conditions.”

Conditions covered under the amendment would include cancer, epilepsy, glaucoma, HIV/AIDS, and for other conditions which a physician feels using medical marijuana would outweigh the potential health risks for a patient. 

There are differences between Marinol and marijuana. Marinol contains only THC, and can take about an hour to take effect, while smoked or vaporized THC takes effect in a matter of seconds or minutes. Marinol is often used to treat cancer patients, HIV/AIDS patients, and people undergoing chemotherapy.

U.S.: DEA Plans Decision On Rescheduling Marijuana By Mid-Year

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By Steve Elliott
Hemp News

The Drug Enforcement Administration plans to decide whether marijuana should be reclassified under federal law "in the first half of 2016," according to a letter from the DEA to senators.

The agency was responding to a 2015 letter from Sen. Elizabeth Warren (D-Mass.) and seven other Democratic senators urging the federal government to stop blocking research into the medicinal benefits of cannabis.

If marijuana is reclassified at all, it would have to be moved to a "less dangerous" category, because it is currently considered Schedule I under federal law, the category of drugs considered the most dangerous of all. Schedule I drugs, by definition, supposedly have no medical value and a high potential for abuse. The insanity of including cannabis -- which, of course, can be used to treat hundreds of conditions -- should be obvious.

There are five categories (schedules) classifying illegal drugs. Marijuana has been considered Schedule I since Nixon's War On Drugs kicked off in 1971. That means the federal government officially considers marijuana to be just as dangerous as heroin -- and it means the government thinks pot is less dangerous than either cocaine or methamphetamine, both of which are considered Schedule II drugs.

Delaware: Medical Marijuana Research Given Go Ahead

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By Steve Elliott
Hemp News

Delaware lawmakers recently voted to allow facilities in the state to research the potential medical benefits of marijuana.

The vote came more than four years after the Delaware General Assembly legalized medical marijuana, but just days after the the state's very first marijuana dispensary opened in an industrial park west of Wilmington reports Jonathan Starkey at The News Journal.

"Delaware has the opportunity here to be in the forefront pioneering research," said Deb McPherson, one of about 400 state residents who have an ID card allowing them to buy medicinal cannabis to help treat a medical condition. Cancer, Alzheimer's disease, PTSD and conditions causing intractable nausea, severe pain or seizures qualify for medical marijuana in Delaware.

The legislation, signed by Gov. Jack Markell last month, allows facilities that meet FDA standards to initiate research on potential medical benefits of marijuana.

"Since the state has approved the use of marijuana for medical purposes, it makes sense to research what those medical purposes might be," said Jonathan Dworkin, a spokesman for Gov. Markell. "Given recent steps taken by the federal government to remove barriers to medical marijuana research ... we are hopeful that there will be a trend toward allowing more of it."

Kentucky: Baptists Fight Off Push To Legalize Medical Marijuana

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By Steve Elliott
Hemp News

Kentucky Baptists may have won a major legislative victory by helping to defeat a measure in the General Assembly that would have legalized marijuana for medicinal purposes, but they managed to give themselves a public relations black eye in the process, showing themselves to both be out of touch with modern medical research, and severely lacking in compassion, as well.

Almost as distressing as the fact that they were able to stop this compassionate legislation in its tracks is the fact that these heaven-dazed idiots were proud of themselves for doing it.

Legislators finished the 2015 session early Wednesday morning without passing a bill which would have made cannabis available for medical purposes.

Kentucky Baptist Convention Executive Director Paul Chitwood, who apparently was determined to flaunt his ignorance in front of large numbers of people, had called on lawmakers to reject the proposal, claiming Kentucky shouldn't follow the lead of other states that have done the same.

The KBC is Kentucky's largest religious organization, and as such has a powerful voice in the state, where 1 million of the state's 4.4 million residents self identify as Southern Baptists. Those demographics -- which correlate strongly with conservative political positions -- filter into the Legislature, where almost half the Senate and a third of the House identify themselves as Baptists.

Alabama: FDA Gives Approval For Marijuana Oil Study

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By Steve Elliott
Hemp News

The federal Food and Drug Administration has given the University of Alabama at Birmingham the go-ahead to study the use of cannabidiol, a marijuana derivative, to treat seizures.

The university on Wednesday received FDA letters authorizing two studies, one for children and one for adults, according to UAB spokesman Bob Shepard, reports Kim Chandler at the Associated Press.

Parents of children with severe seizure disorders convinced the Alabama Legislature last year to pass a bill authorizing UAB's Department of Neurology to perform a study of cannabidiol (CBD), a nonpsychoactive component of marijuana.

Shepard said the FDA had requested some changes in the studies; those will go before a university review board next month, he said.

"It's hard to put in words the feelings you have as a dad with a daughter that could benefit from this," said Dustin Chandler. The legislation had become known as "Carly's Law" after Chandler's three-year-old daughter, who started having seizures at just eight weeks old.

Carly was eventually diagnosed with the rare genetic disorder CDKL5. Chandler, a police officer in Pelham, frequently appeared before the Legislature to advocate for the bill.

Wisconsin: Law Allowing Marijuana-Derived CBD Oil For Seizures Remains Unusable

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By Steve Elliott
Hemp News

Two months after Wisconsin Governor Scott Walker signed into a law a measure allowing the use of cannabidiol (CBD) oil, a marijuana derivative used to quell seizures without getting patients high, nobody has yet been able to access the medicine.

The bad situation is due at least in part because of obstacles foolishly written into the legislation at the last minute, reports Dana Ferguson at the Journal Sentinel.

"It is frustrating," said Amylynne Santiago Volker of the roadblocks between her nine-year-old son, Nicholas, and the experimental treatment. "It's there in paper, but we can't access it."

Unfortunately, Wisconsin's "CBD-only" law appears as useless as most of the rest passed recently by state legislatures who want to be seen as "doing something" in the face of overwhelming popular support for medicinal cannabis, without having the courage to pass an actual medical marijuana law which could help actual patients.

Gov. Walker on Friday told reporters he "wasn't sure" if his administration could do anything to free up access to CBD, but if more could be done through state legislation, Walker claimed he was "committed to working with lawmakers" to do so.

New York: State Senate Will Determine Fate of Medical Marijuana

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By Steve Elliott
Hemp News

The fate of a medical marijuana bill in New York is still unresolved, where the Assembly has approved legislation, but a similar measure remains stalled in the Senate, despite the votes apparently being there to pass it.

Advocates cheered last week as the Assembly approved the Compassionate Care Act, which would permit authorized patients to possess small amounts of cannabis, reports Karen DeWitt at WRVO. The legislation would also set up licensed dispensaries to grow and sell medical marijuana.

"This is the group that I'm most concerned with, Mr. Speaker," said Assemblyman Kevin Cahill, who voted with the majority of Democrats in favor, saying the measure would give law abiding citizens access to much-needed medicine. "Those people who will not even entertain the notion of the illegal use of marijuana just because it is illegal, not because it is not efficacious."

The measure did win some converts on the Republican side of the aisle. Assemblyman Steve Katz, who had voted against the bill in the past, voted for it this time after being stopped by police for allegedly possessing marijuana. The charges were later dropped, but Katz has become a cannabis advocate, even investing in some businesses operating in states where it is legal.

"Over the past year, I've gone above and beyond to explore the beneficial aspects of medicinal cannabis and the surrounding industry," Katz said.

Pennsylvania: GOP Lawmakers Balk On CBD-Only Medical Marijuana Bill

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By Steve Elliott
Hemp News

Parents in Pennsylvania who want to treat their children's seizures with a marijuana derivative were hopeful after Governor Tom Corbett announced last month he could support a medical study of cannabidiol (CBD). But the program can't begin until the state's House Republican majority supports the move -- and timid GOP party leaders are opposing it, despite the fact that legislatures in states as conservative as Alabama and Mississippi have approved similar legislation.

A majority of GOP members of the House still oppose such a study, according to a spokesman,and don't support authorizing Gov. Corbett's plan to allow children with intractable seizures who are not helped by standard therapies to have supervised access to cannabidiol (CBD), a component of marijuana that does not produce a high, reports Karen Langley at the Pittsburgh Post-Gazette.

The Republican state representatives said they believe the U.S. Food and Drug Administration (FDA) -- not the states -- should decide what is medicine, according to spokesman Steve Miskin, putting the lie to GOP claims of supporting "states' rights."

"That is where the majority of members of our caucus stand," claimed the apparently cold-hearted Miskin. "They do not believe the state should approve pot -- marijuana -- of any sort. At this moment there are no plans to move any type of legislation to legalize the use of any derivative of marijuana."

U.S.: Sativex Gets Fast Track Designation From FDA For Cancer Pain

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By Steve Elliott
Hemp News

Big Pharma continues its moves to take over the medical marijuana industry. GW Pharmaceuticals, a biopharmaceutical company based in the United Kingdom, on Monday announced the the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sativex, an oral spray containing THC and CBD in a 50:50 ratio, for the treatment of pain in patients with advanced cancer.

Sativex is currently in Phase 3 clinical trials for this indication, according to a press release from GW Pharmaceuticals.

The FDA's Fast Track program facilitates the developmental process for drugs intended to treat serious or life-threatening conditions and that have the potential to address "unmet medical needs." A drug program with Fast Track status is given greater access to the FDA for the purpose of speeding up the drug's development, review and potential approval.

"The award of Fast Track designation for Sativex represents important recognition by the FDA of the potential of this medicine to address significant unmet needs in the treatment of cancer pain," said Justin Gover, CEO at GW Pharmaceuticals. "Sativex is the only non-opioid treatment currently in Phase 3 development for patients who do not respond to, or experience negative side effects with opioid medications.

"We are fully committed to delivering the first FDA-approved cannabinoid medicine for these patients who currently have nowhere else to turn," Gover said.

GW is developing Sativex in the U.S. in collaboration with Otsuka Pharmaceutical Co., Ltd.

Arizona: State Senator Blocks Federally Approved Medical Marijuana PTSD Study

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By Steve Elliott
Hemp News

The much-talked-about proposed federally approved study about using marijuana to treat military veterans who have post-traumatic stress disorder (PTSD) made headlines when it got a green light from the federal FDA and the Department of Health and Human Services. It even passed the Arizona House of Representatives (the study would be done at the University of Arizona). But one Arizona State Senator, Kimberly Yee, a Republican from Phoenix, has stopped the study in its tracks.

The study, which organizers say is aimed at veterans suffering from PTSD who have not been helped by other treatments, would not be funded with state tax money, but rather through the sale of medical marijuana cards, reports Steve Krafft at Fox 10 News.

Senator Yee, who chairs the Senate Education Committee, the recipient of the bill, had a hearing scheduled for 9 a.m. on Thursday, but Yee said she would not let them consider the study.

Yee is ignoring the testimony of veterans like Ricard Pereyda, who served as a military policeman in Iraq and now suffers from PTSD. He says cannabis helps him cope with the disorder.

"There are a hundred scenarios in my head at any time and using cannabis quiets that; it allows me to go through my day being productive," Pereyda said.

U.S.: Federal Government Approves Medical Marijuana Research For PTSD

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By Steve Elliott
Hemp News

Medical marijuana advocates won a big victory on Friday when the Obama Administration opened the way for a University of Arizona scientist to research whether cannabis can help military veterans cope with post-traumatic stress disorder (PTSD). The move could lead to more studies into the potential benefits of medicinal cannabis.

Scientists have for years been frustrated by the federal government's intransigence when it comes to approving marijuana research -- unless the study is designed to find harms, rather than benefits, of cannabis. The Arizona study had long ago been approved by the Food and Drug Administration, but under federal rules, such studies can only use federally grown marijuana from the University of Mississippi, report Evan Halper and Cindy Carcamo at The Los Angeles Times. The National Institute on Drug Abuse (NIDA), which oversees that pot farm, is hostile to any studies aimed at examining the benefits of cannabis; NIDA normally only funds studies to find its hazards.

"This is a great day," said Suzanne A. Sisley, the Arizona researcher, who is clinical assistant professor of psychology at the University of Arizona's medical school. She has been trying for three years now to get the study approved.

"The merits of a rigorous scientific trial have finally trumped politics," Sisley said. "We never relented."

Arizona: Marijuana Research Allowed At Universities... If Feds Approve

(Graphic: All Hat No Cattle)By Steve Elliott
Hemp News

Without comment, Arizona Governor Jan Brewer on Tuesday signed into law a bill to allow possession of marijuana on college and university campuses for research. The measure, which takes effect later this year, was made necessary by a bill which Brewer signed last year, officially disallowing pot on campuses (yeah, good luck enforcing that one).

The bill Brewer signed on Tuesday, while leaving intact the ban on marijuana on college campuses, creates an exception for research approved by the FDA, the DEA or the National Institutes on Drug Abuse (NIDA).

And there's the bottleneck. Don't hold your breath, because the DEA never approves research requests, and the NIDA will only approve research designed from the outset to prove the bad effects of marijuana; no medical marijuana research is funded through that notoriously anti-pot agency.

Brewer's spokesman, Matthew Benson, claimed the governor never intended to interfere with legitimate research when she signed the earlier bill, reports Howard Fischer at Capitol Media Services.

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