Tag Archives: FDA

What You Can Do to FREE Sam Girod


What You Can Do to FREE Sam Girod

Please do whatever you can! The Backstory The FDA is trying to put Sam in jail for 58 YEARS for a labeling infraction. Basic story here: http://www.davidgumpert.com/2783-2

Indictment here with explanations: http://www.kyfreepress.com/2017/01/fda-girod-indictment/

Local CBS affiliate story here: http://www.wkyt.com/content/news/WKYT-Investigation-Amish-farmer-in-jail-awaiting-trial-facing-time-in-federal-prison-411915635.html

 

What You Can Do

1. We beg President Trump to issue an immediate pardon for Sam. Please sign this petition: http://bit.ly/freeamishsam. Sam’s trial is in 4 weeks.

2. An email to Trump could only help: https://www.whitehouse.gov/contact

3. We sincerely hope that Atty General Sessions will step in and stop this gov’t abuse. A quick email to him will help: https://www.justice.gov/contact-us

4. Call or email your legislators, all of them. Your U.S. Senators and House Reps as well as your state legislators, even if you don’t live in KY. Just do a search on your legislator’s name and you’ll find a phone number or email address.

5. Donate to Sam’s legal fees: https://www.gofundme.com/supportsamnow

6. Attend Sam’s trial on 2/27/17 at 9am at the Federal Courthouse, 101 Barr Street, Lexington, KY. It’s slated to go for four days. Even if you can’t stay very long, a presence at any time will be helpful. Probably earlier is better, but any time.

 

The FDA has been going after small farmers for decades and if they haven’t been doing so in your state, they will soon. What’s to stop them?

For evidence of FDA and USDA abuses, watch Farmageddon on Amazon or Netflix. This has been going on for far too long and it’s time to stop it. Only YOU and I can do that!

Just lately these agencies have been particularly venomous toward the Amish. Reining in federal agencies is a huge promise made by almost every politician of late. Let’s hold them to it!!!

Recent Articles:

KY Amish Farmer Jailed over a Salve Label; the FDA Wants Him Jailed for Life

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KY Amish Farmer Jailed over a Salve Label; the FDA Wants Him Jailed for Life


By Sally Oh on January 15, 2017

Girod indictment: Sam's 3 products: chickweed salve, bloodroot salve and an essential oil blend

I know it sounds like I made up a terribly inflammatory headline… but it’s not JUST inflammatory. It’s true, the Girod indictment is below.

Amish farmer Sam Girod of Owingsville makes 3 products: a chickweed salve, a bloodroot salve and an essential oil blend called Sine Eze. The photo of the 3 products was just taken on my iPad on my desk. You can find similar products online. In fact, you’ll find the recipes online. You can make these products in your kitchen, it’s not rocket science.

A few years ago, the FDA came after Sam for labeling crimes — Sam said his salves could cure certain things and that’s a big FDA no-no. Sam immediately fixed the labels as per FDA demands.

But then the FDA fixated on him and just would not let go. You’ll see in the indictment. In my line of hobby work (political blogging), I’ve seen this over and over and over again. An alphabet agency gets you in its sights and just will not quit.

And why would they quit? No skin off their teeth and gives them something to do. State agencies are bad enough, but the feds… the feds are especially lawless. There is no accountability in a federal agency, they break their own rules as a matter of course.

I have a little inside info on why this persecution is taking place plus a couple of questions. “Inside info” because I’m involved in food and health freedom, so aware of persecution of other farmers around the country.

The first thing of note is that, when it comes to powerful well-funded federal agencies looking to set precedent, the Amish have a special target on their backs. Why? Because they generally don’t use lawyers which makes them easy prey. They don’t use lawyers because the Amish are self-sufficient, they know their constitutional rights and they are a peaceful community. They don’t fight back (unless lives are at stake).

The FDA is also after an enormously successful Amish farm in PA, Miller’s Organic Farm. Like Sam, the Millers have established a private club whereby only members can purchase products. As a member of Miller’s Organic Farm, I can order anything I want, including raw milk, that can be shipped to me anywhere in the country. (Read up on the Miller’s case here.)

The FDA hates private membership clubs because club sales and products are NOT subject to FDA rules and regulations! Private memberships are protected under the Constitution’s contract clause. I can contract with anyone I want, sell them anything I made or produced, and the state may not interfere. The state, of course, hates this kind of freedom and will do anything it can to pierce that veil. Including bankrupting businesses and jailing a peaceful farmer for the rest of his life.

The FDA also seems to have a special soft spot for bloodroot salves. They’ve been persecuting makers of bloodroot salves for decades, starting with Greg Caton, jailing him twice and driving him from the country. A quick search brought up this company as well.

Two questions:

  1. Why was Sam kept handcuffed during the hearing on Friday. Was he a flight risk or a danger to anyone? IMO, the gov was attempting to show Sam who’s the boss. Newsflash: the gov is not Sam’s boss.
  2. Why did the FDA wait so long to formally charge Sam? Most of his alleged crimes (Counts 1-11) took place between 9/2013 and 1/2014 with the M.M. situation (Count 12) in 12/2014. If Sam is so dangerous that he needs to be jailed for life… why did they wait for years to charge him?

Here comes the Girod indictment.

This is pretty long but a lot the counts are basically repeats with different dates. The gov likes to pad the bill so the defendant will take a plea.

Remember, folks, we are talking about a Chickweed Salve here along with two other equally benign, non-drug products that are for sale all over the world, that I and my friends have used with no ill-effects (in fact, to good effect). Is the purpose of this prosecution to protect the public or to punish those citizens who don’t kneel at the pointy end of a bureaucrat’s pen (and, in this case, firearm)?

The FDA vs Kentucky Amish Farmer Samuel A. Girod

PLEASE CONTINUE READING HERE!

“Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.”


Drug-makers stand to benefit from act

By Staff Reports

1/6/17 8:19 PM

Will patients benefit from the passage of the 21st Century Cures Act? After listening to politicians and reading the headlines, most people might think it’s the best thing ever to come along for patients.

“A new day for medical research is on the horizon,” proclaimed Rep. Fred Upton, the outgoing chairman of the House Energy and Commerce Committee which had just won a major victory last week. “The House and the Senate have passed this bipartisan legislation which will ensure our health system can keep pace with incredible advances in science and technology,” Upton said in the GOP’s weekly radio address. “We needed to do better. And with 21st Century Cures, we will.”

Media headlines mirrored Upton’s victory declaration. Headlines like this from the Wall Street Journal, “House Passes Health Bill to Speed Drug Approvals, Boost Biomedical Research” seemed to say it all: faster drug approvals, more money for research, less pesky regulation.

Or was there more to the story? Not everyone thinks the Cures Act will be wonderful for patients. But their voices were drowned out in the slick public relations campaign Upton’s committee waged over the past few years using some 200 or so patient advocacy organizations to push for the bill. Most of those groups have strong ties to the drug and medical device industry.

A recent study by Dr. Vinay Prasad, an oncologist at Oregon Health Sciences University, found that three-quarters of 68 cancer advocacy groups he studied disclosed sponsorship from pharmaceutical companies. Some groups received money from as many as 16 or 17.

Prasad told me, “Ten years from now, someone with a cancer diagnosis will be worse off with this bill. People will be exposed to more things that don’t work.” Prasad and others say the Cures Act actually lowers the regulatory standards for drugs and devices. It’s a step backward for patients.

In a nutshell the Act turns current regulatory practice on its head.

Randomized trials, the gold standard for medical research, may disappear if a drug company wants to sell a medicine for a different condition than the one it’s already approved for. Instead it can use “real world evidence” to show the drug also works for a new indication. Such “evidence” could be observational studies, which are less reliable than randomized trials, but are cheaper and take less time.

The FDA can use patient experience to inform its regulatory decisions — information about the impact of a disease or related therapy on patients’ lives. The data can come from patients, family members, caregivers, patient advocacy organizations, disease research foundations and drug manufacturers.

The agency can approve new drugs on the basis of data summaries rather than requiring the FDA to independently analyze study results for a new drug indication. Drug makers would have to submit all their data, but the FDA would not have to review it.

And although the bill authorizes billions for new medical research at the National Institutes of Health (NIH), the funding is not guaranteed, and the NIH would have to fight Congress for the money.

The Cures Act is the culmination of a 20-year effort by the drug industry and Beltway think tanks to loosen standards and permit new uses for drugs already approved in order to expand their markets. It can be traced back to the 1997 FDA Modernization Act, which was then — as the Cures Act is now — sold on the promise of getting cures to market faster. The 1997 law loosened regulatory standards and reduced the number of clinical trials needed for drug approval.

Are the changes brought about by the earlier law a harbinger of what’s to come?

The reporting by John Fauber and his colleagues at the Milwaukee Journal Sentinel offers a cautionary tale. In the past few years the paper has reported how drug and device makers have spent huge sums of money to sell drugs for conditions that were once thought to be part of everyday life.

The reporters found that drug companies turned conditions such as overactive bladder, adult ADHD and premenstrual dysphoric disorder into medically treatable ailments. They reported that the latter was not even recognized as a mental disorder until 13 years after the first drug treatments were on the market. “Drugs used to treat the various medicalized conditions don’t work that well and often have side effects that are nearly as common as the benefit,” Fauber told me.

Are we turning the calendar back to 1933 when a book called “100,000,000 Guinea Pigs” was published exposing the dangers of patent medicines? Federal oversight of drugs was pretty lax then, and patients died. It’s obvious drug makers will benefit from looser regulation. It remains to be seen whether patients will, too.

Trudy Lieberman, a journalist for more than 40 years, is a contributing editor to the Columbia Journalism Review, where she blogs about health care and retirement at cjr.org. She can be reached at trudy.lieberman@gmail.com. This column was distributed by The Rural Health News Service.

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The Stakes Are High As DEA Reconsiders Waging War On The Herb Kratom


11/30/2016 04:03 am ET

Those who use and study the plant say an outright ban could do serious harm.

Seven weeks after the U.S. Drug Enforcement Administration officially withdrew its plan to ban kratom, the federal government is once again set to decide the fate of the herb and the people who rely on it for pain relief and other treatment.

The DEA had initially planned to use its emergency scheduling power to push through the ban without input from the public, despite concerns from lawmakers and scientists ― as well as kratom users ― that the move would do more harm than good. In October, however, the DEA opened a public comment period allowing individuals to weigh in on the agency’s decision to place mitragynine and 7-hydroxymitragynine, two active compounds in kratom, in Schedule I. Substances in this category include heroin and LSD and are considered to have no known medical benefit and a high potential for abuse.

With the comment period set to close on Thursday, the DEA will now have to take into account the nearly 9,000 submissions from people who wanted to voice their opinions about this proposed expansion of the war on drugs.

But kratom isn’t in the clear yet. The DEA is currently awaiting the results of a U.S. Food and Drug Administration analysis on the potential harms and health benefits of the herb, which will determine if kratom truly poses an “imminent hazard to the public safety,” as the agency initially claimed in August.

The DEA doesn’t know when it will get the results of the FDA’s review, Russell Baer, a spokesperson for the agency, told The Huffington Post.

“We’ve asked the FDA to expedite their analysis, but they’ve not given us any indication as to when that may be done, other than as soon as practical,” said Baer. “They’re involved in an exhaustive scientific review and evaluation, so these things do take time.”

Although Baer said he expects the DEA to wait for the FDA’s analysis before deciding on an appropriate schedule for kratom ― or whether it should be scheduled at all ― he noted that the agency could still proceed with emergency scheduling even in the absence of more concrete scientific evidence.

The DEA’s next steps will have huge implications for people like Joshua Levy. In the video above, Levy explains that he turned to kratom after struggling with dependence on the opioid painkillers he’d been prescribed following a hit-and-run accident. Like many kratom users, he says the herb gave him back the life that had been taken from him by addiction and other side-effects of narcotic painkillers.

“Since I started taking kratom, since I had gotten off of the pain pills, my life has basically opened up dramatically,” Levy told HuffPost. “I got a new job. I’m building a friendship up with my sister that I haven’t had in a long time. I’m not lazy anymore. I don’t want to isolate myself. I want to go out, I want to be out of the house.”

The kratom community is full of success stories like Levy’s. But together, they form only anecdotal evidence of the herb’s benefits, which is not enough to support a more official confirmation of its medicinal value.

Experts like Andrew Kruegel, an associate research scientist at Columbia University, hope the DEA will allow kratom to remain legal so they can keep working to unlock the herb’s potential.

Kruegel’s studies have shown that kratom can be used to alleviate mild pain, and that the plant’s negative side effects are relatively minor.

“As a scientist, I try to be as objective as possible and not overstate the promise of kratom,” said Kruegel. “We just don’t know that much about the plant yet.”

But Kruegel also has bigger hopes for kratom, which he believes can be used to aid in the development of safer alternatives to the prescription opioids that claimed more than 18,000 lives in the U.S. in 2014 due to overdose.

“Of course, if it’s in Schedule I, historically that greatly limits the ability to do research on it,” he said.

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An effort to get ecstasy FDA-approved is entering a key final test


Ecstasy tablets

After veteran Tony Macie came back from Iraq in 2007, he learned he had post-traumatic stress disorder.

Macie went to the VA “on and off” and tried the standard therapy.

“And then I kind of just fell off the radar, secluded, and did my own thing and got really dependent on a lot of the meds,” Macie explains in a video by the Multidisciplinary Association for Psychedelic Studies.

The retired sergeant then became part of a clinical trial organized by MAPS that was testing an unusual substance in an attempt to heal people who hadn’t responded to traditional therapies for PTSD.

That substance, MDMA, commonly referred to as “Molly,” is the pure form of something commonly thought of as an illegal party drug — ecstasy. (Most nonresearch substances that are sold as ecstasy or Molly are not actually pure MDMA and can be significantly more dangerous.) The trial pairs MDMA with psychotherapy.

“One of the first things I said when it kicked in was, ‘This is what I’ve been looking for,'” Macie says in the video. “I reconnected with myself and did a lot of internal work, and afterwards it was like a huge weight was lifted off my shoulders.”

The trial Macie was involved in and other Phase 2 clinical studies conducted by MAPS have been so effective that the Food and Drug Administration on Tuesday agreed to allow large-scale Phase 3 clinical trials — the third and final in the three sets of human trials required before the FDA will consider a new drug for approval — to go forward, according to a report in The New York Times.

If those trials continue to show that MDMA effectively treats PTSD, ecstasy could enter clinical use as soon as 2021, fitting the timeline that MAPS has been working toward for some time now.

And so far, MDMA has consistently been very effective.

One of the early studies conducted by MAPS showed that 83% of the study participants no longer showed signs of PTSD two months after treatment, and long-term follow-ups conducted an average of four years later showed that most of those benefits stuck. That was a proof-of-concept study, with just 20 participants, all of whom had psychotherapy as well. (Twelve were given MDMA, and eight were given a placebo; 25% of those on the placebo improved, too.)

Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials, which MAPS announced were coming to an end last March. These trials consisted of at least eight studies that Brad Burge, the director of communications for MAPS, recently told Inverse treated 136 people using MDMA-assisted psychotherapy for PTSD.

Those trials dealt with patients who were struggling with PTSD from a variety of sources. They included military veterans, people who had been sexually assaulted, firefighters, and police officers, all who had not responded to traditional treatments.

The data released from those studies so far is very promising, with a large percentage of patients not showing any signs of PTSD more than a year after completing the therapy.

“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all,” Dr. Michael Mithoefer, a psychiatrist involved in the research, told The Times.

The final tests will involve hundreds of people and must be conducted before the FDA decides to approve a new medication. MAPS has applied for “breakthrough” therapy status, which could speed up the approval process.

“Phase 3 starts around 2017, and it will take four to five years to finish,” Burge has previously said. “So that will put it at early 2021 for FDA approval.”

MAPS is mostly raising money itself to fund what it describes as a roughly $20 million plan to complete these trials, which are largely not of interest to pharmaceutical companies since the patent on MDMA has expired. That will mean significant fundraising is required.

Last year the organization reported $9.1 million in assets, more than $5 million of which was a bequest from a longtime board member that has been earmarked specifically for those Phase 3 trials. In fiscal-year 2015, MAPS raised a combined $2.99 million from 2,500 donors. It said in its most recent annual report that “substantially increasing our donor base” would be necessary to move forward with Phase 3 trials.

It’s only after those trials wrap up that we’ll know for sure whether using MDMA to treat PTSD is safe and effective. MAPS calls making that happen its “top priority.”

The group is also conducting research testing the efficacy of MDMA-assisted therapy to treat social anxiety in autistic adults and to treat anxiety associated with life-threatening illnesses like cancer.

“It’s a really interesting and a very powerful new approach,” Thomas Insel, a former director of the National Institute of Mental Health, told the San Francisco Chronicle. “It’s not just taking MDMA. It’s taking it in the context of a treatment that involves improved insight and increased skills and using this in the broader context of psychotherapy.”

As Macie says in the MAPS video, “this tool, it may not be the end all, but it [could] be a tool that can help a lot of people drastically.”

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House passes medical cures bill


By Peter Sullivan – 11/30/16 06:40 PM EST

House passes medical cures bill

The House on Wednesday passed a medical innovation bill aimed at curing diseases, with the measure securing bipartisan support after months of negotiations.
The legislation, known as the 21st Century Cures Act, passed 392-26. It seeks to speed up the Food and Drug Administration’s approval of new drugs while investing new money in medical research. 

The package also includes a range of other healthcare priorities, including $1 billion over two years to fight the epidemic of opioid addiction and $1.8 billion for Vice President Biden’s cancer “moonshot.”
The opioid money releases some pressure from a long-running dispute between the parties. Congress passed a bipartisan opioid bill before the election, but Democrats criticized that measure for lacking funding.
The cures legislation also includes a mental health portion that seeks to reorganize and improve accountability for government mental health programs.
Republicans have portrayed the mental health bill, sponsored by Rep. Tim Murphy (R-Pa.), as their response to mass shootings, though that messaging has been emphasized less now that it is part of a larger package.

Democrats agree reforms are needed in mental health, though they note that the bill lacks funding. They say the bigger policy response to mass shootings should be gun control.
House leaders are hoping that the bipartisan vote Wednesday puts pressure on the Senate, which is expected to take up the cures bill sometime before leaving town next month.
The bill faces a bumpier path in the upper chamber, where Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.) have blasted it as a giveaway to pharmaceutical companies.
Still, enough Democrats are expected to support the measure to get it across the finish line.

“This bill, which expedites the approval of drugs and devices, includes literally billions of dollars in additional spending for health research so that we can find the cures and the answers to what patients are demanding today,” said House Energy and Commerce Chairman Fred Upton (R-Mich.), the measure’s main sponsor. 

The White House gave the measure a boost on Tuesday night by announcing that it “strongly” supports passage, pointing in particular to the opioid funding and the funding for the cancer moonshot.
The liberal detractors note that the new research funding, which is helping to bring some Democrats on board, is not mandatory funding, meaning it is not guaranteed.

Still, the $4.8 billion over 10 years is set aside in a separate fund and not subject to the usual budget caps.

Sanders and Warren have denounced the bill as helping out pharmaceutical companies, in part by lowering the FDA’s regulations for approving their new drugs, while doing nothing to deal with the hot-button issue of high drug prices.

Some consumer groups have also criticized the measure, fearing that in speeding up the FDA’s approval process, it would lower safety standards.
The measure allows for ideas like sometimes using “real world evidence,” rather than more rigorous and time-consuming clinical trials, in drug approvals.
Rep. Frank Pallone (D-N.J.), a lead negotiator on the bill in the House, rejected criticisms of the FDA changes.

“It’s just a way of trying to address these cures in a more effective way, the way the public has asked for, without sacrificing any safety,” Pallone said.

The mental health portion of the legislation establishes a new assistant secretary for mental health in the Department of Health and Human Services as well as a chief medical officer. Murphy argues that these positions will bring more accountability and medical knowledge to the Substance Abuse and Mental Health Services Administration, an agency he has criticized as ineffective.
The bill also authorizes grants for areas like suicide prevention.

The mental health measure is significantly scaled down from the more sweeping version originally proposed by Murphy, though. It does not lift restrictions on Medicaid paying for care at mental health facilities, which would have cost billions of dollars.

The measure also includes elements from a companion mental health bill in the Senate from Sens. Chris Murphy (D-Conn.) and Bill Cassidy (R-La.).
Both the Cures and mental health portions of the bill come after more than a year of bipartisan negotiations.

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The DEA is withdrawing a proposal to ban another plant after the Internet got really mad


By Christopher Ingraham October 12 at 10:42 AM

The Drug Enforcement Administration is reversing a widely criticized decision that would have banned the use of kratom, a plant that researchers say could help mitigate the effects of the opioid epidemic.

Citing the public outcry and a need to obtain more research, the DEA is withdrawing its notice of intent to ban the drug, according to a preliminary document that will be posted to the Federal Register Thursday.

The move is “shocking,” according to John Hudak, who studies drug policy at the Brookings Institution. “The DEA is not one to second-guess itself, no matter what the facts are.”

The DEA had announced in August that it planned to place kratom in schedule 1 of the Controlled Substances Act, the most restrictive regulatory category, as soon as Sept. 30. But since announcing their intent to ban kratom, the “DEA has received numerous comments from members of the public challenging the scheduling action,” acting administrator Chuck Rosenberg wrote in the notice, “and requesting that the agency consider those comments and accompanying information before taking further action.”

A spokesman for the Drug Enforcement Administration did not immediately respond to requests for comment.

[What it’s like to be high on kratom, according to the people who use it]

Kratom is a plant from southeast Asia that’s related to coffee. It contains a number of chemical compounds that produce effects similar to opiates when ingested.

People who take it have have said kratom helped them overcome addiction to opiates or alcohol and treat otherwise intractable pain. Researchers say that their work with kratom could eventually lead to the development of nonaddictive alternatives to powerful opiate painkillers. Placing kratom in schedule 1 would cripple researchers ability to study the drug, they say.

U.S. lawmakers were among the groups expressing their displeasure with the DEA’s intent to ban kratom. A group of 51 U.S. representatives wrote to the DEA saying that the DEA’s move “threatens the transparency of the scheduling process and its responsiveness to the input of both citizens and the scientific community.”

Another group of nine senators said the DEA’s “use of this emergency authority for a natural substance is unprecedented,” and urged the administration to reconsider.

The DEA will now open up a period for public comment until Dec. 1 of this year. It is also asking the FDA to expedite a “scientific and medical evaluation and scheduling recommendation” for the active chemical compounds in kratom.

At the close of the comment period, a number of things could happen. The DEA could decide to permanently place the plant in a schedule of the Controlled Substances Act, which would require an additional period for lawmakers and the public to weigh in. It could also decide to temporarily schedule kratom, which would not require any additional comment.

It could also decide to leave kratom unregulated.

[Police arrest more people for marijuana use than for all violent crimes — combined]

Advocates for kratom use, who say the plant has helped them treat pain and stop taking more powerful and deadly opiate painkillers said they are elated.

“I am in tears,” Susan Ash of the American Kratom Association said in an email. “Our voices are being heard, but we still have a long road ahead of us.

Lawmakers who criticized the initial announcement to ban kratom are also pleased. “Concerned citizens across the country have made it clear, they want the DEA to listen to the science when it comes to the potentially life-saving properties of kratom,” said Mark Pocan (D.-Wis.) in an email.

Researchers are welcoming the move, but they point out that the future of their work with the plant is an uncertain one.

“It’s certainly a positive development,” said Andrew Kruegel of Columbia University in an email. Kruegel is one of the researchers working to develop next-generation painkillers based on compounds contained in kratom.

Kruegel says that the FDA’s evaluation of the drug will carry a lot of weight in the DEA’s decision. But the kind of rigorous, controlled trials that the FDA typically refers to in situations like this simply don’t exist for kratom.

“Unfortunately, in the United States I don’t think we have a good regulatory framework for handling this situation or taking perhaps more reasonable middle paths” between banning the drug outright or keeping it unregulated, Kruegel says.

Still, he says, “the FDA is a scientific agency rather than a law enforcement agency, so I am encouraged that they will now be having more serious input on this important policy decision.”

Marc Swogger, a clinical psychologist at the University of Rochester Medical Center who has published research on kratom use and earlier called the decision to ban the plant “insane,” said in an email that “I’m happy to see this. It is a step in the right direction and a credit to people who have spoken out against scheduling this plant.”

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Kratom Advocates Sip Tea and Seethe at White House Rally Against DEA Ban


One user plans to move to Canada. Another plans to quit. Many more don’t know what to do.

By Steven Nelson | Staff Writer Sept. 13, 2016, at 6:20 p.m.

Several protest attendees brought their own bottle of kratom tea Tuesday to the White House. Those who did not were offered a Solo cup.

Several protest attendees brought their own bottle of kratom tea Tuesday to the White House. Those who did not were offered a Solo cup. Steven Nelson for USN&WR

Hundreds of passionate protesters gathered Tuesday near the White House to demand that the popular plant product kratom remain legal. It was jointly a business industry conference, a tea party and a desperate consumer lobbying effort — but the clear-eyed crowd appears to have little chance of near-term victory.

A comprehensive U.S. ban likely will take effect on Sept. 30, just a month after the Drug Enforcement Administration surprised users by saying it would invoke emergency powers to make leaves from the tree grown in Southeast Asia illegal by labeling two main constituents Schedule I substances.

In the face of long odds and silence from Capitol Hill, the event called by the American Kratom Association sought to pressure officials to reconsider while laying the groundwork for what may become a protracted re-legalization campaign.

A large jug of brewed kratom sat in the middle of Pennsylvania Avenue, with red Solo cups offered to anyone who wanted some. At least one reporter sipped the brew, which tasted like astringent green tea. Another journalist took a pill offered as a free sample by a businessman.

Kratom users who attended the rally said it’s wrong for them to lose legal access to what they say is an effective treatment for pain, addiction, depression and other conditions.

Though many said they were angry, chant-leaders asked the crowd of a couple hundred to stay on message and favored reason over rage, which often is a leading emotion at White House protests staged by marijuana reform advocates who say decades in Schedule I has stalled medical cannabis research amid millions of arrests.

“I’m usually very quiet but felt the need to come out and speak,” says Veronika Bamford-Conners, a kratom-selling store owner from Sullivan, Maine, where, she says, most of her customers are older than 55.

“If they don’t have insurance and can’t afford medications, they find a cheaper alternative in kratom,” she says, though some seem to prefer relief from the leaf to painkillers, such as a 73-year-old man who she says called her weeping “because pharmaceuticals were killing him” before.

Chants at the rally advertised the death toll from accidental overdoses of opioids – more than 28,000 in 2014 alone, including legal painkillers and illegal drugs like heroin – with the low or nonexistent U.S. toll from kratom.

The DEA says it believes 15 deaths were caused by kratom, though American Kratom Association founder Susan Ash says the group hired a toxicologist who concluded each case could be attributed to other drugs.

Many kratom users say the plant has helped them abstain from substances they formerly were addicted to, often heroin or prescription painkillers.

“Kratom saved me, I was a bad heroin addict,” says David Allen, who traveled from Chapel Hill, North Carolina. “It keeps cravings away and helped me not drink. I came because I don’t want to lose my medicine.”

Allen says that although the DEA – and even some former kratom users – say the drug can lead to dependence, it’s nothing like the grasp of opioids. He says he believe it’s about as abusable as coffee, which comes from a related plant, and that like coffee withdrawal, ending kratom can cause minor headaches.

Brad Miller, a physics teacher at Spotsylvania High School in Virginia, says he drinks small amounts of kratom tea between three and five times a day to treat arthritis in his knees. He says the effects are “very mild” and “just enough to take the edge off so I can get through my day standing.”

Miller says prescribed painkillers from his rheumatologist were too strong and that unlike opioids he hasn’t developed an addiction to kratom. He says he went on a weeklong camping trip and – unlike the experiences of some users – felt no withdrawal symptoms.

“I didn’t have withdrawal symptoms, but I did have arthritis pain,” he says. “I’d be surprised if anyone has experienced strong withdrawal symptoms.”

Though Miller and others at the event said they aren’t sure what they will do at the end of the month, Heather Hawkins says she’s made up her mind to move to Canada, where kratom remains legal.

Hawkins, a journalist with northern Florida’s Pensacola News-Journal and owner of the Kratom Literacy Project, says she has an incurable bladder disease and is eyeing Vancouver after already moved to the Sunshine State from Alabama in reaction to a local kratom ban.

Talk about moving abroad often is spouted unseriously by political partisans around election time, but Hawkins says she’s completely serious after living in a painkiller-induced haze that left her depressed and unable to get out of bed.

“I’m not going to stay here [if the ban takes effect] because I’m not going back to that life,” she says.

Hawkins says she’s in addiction recovery from cocaine, which she says she used as self-medication to give her the energy to power through her pain and despair, and that if she regarded kratom as a drug she would not take it.

Though kratom is widely known for claims that it can help keep opioid addicts clean, it’s also credited with sapping desire for other substances.

Jeremy Haley, owner of Colorado’s Rocky Mountain Kratom, says he began using kratom in 2012 after a drunk driving arrest, and that it has helped veer him away from his alcoholism, which runs in the family.

Although the ban hasn’t yet taken effect, Haley says local officials have shut down his shop for what he views as dubious reasons, making him unable to sell the remaining inventory – the latest in what he says has been a constant regulatory headache that featured him asking Yelp reviewers to delete positive reviews to placate federal officials who wanted proof he was not marketing kratom for human consumption.

Haley plans to open a totally legal apothecary shop if the ban takes effect.

CONTINUE READING…



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The DEA is looking for candidates to grow marijuana for research – but will it find any takers?


Wanted: Someone to grow marijuana for the federal government. Benefits: A contract likely worth millions and the chance to enable medical research. Requirements: Ability to deal with the costs and regulations that come with growing an illegal drug for the federal government.

For more than four decades, the University of Mississippi has had an exclusive license with the government to grow marijuana for federally sanctioned research. But this month, the Drug Enforcement Administration announced it would grant permission to other growers — an effort, it said, to expand the supply and variety of marijuana available for research.

So has the change set off a gold rush to grow the green? Not exactly.

STAT contacted almost a dozen agricultural schools, including those with industrial hemp programs, to gauge their eagerness to grow marijuana for the government.

Not interested, said Cornell University, the University of Kentucky, and Virginia Tech. Ditto, said Michigan State University, the University of Vermont, and Western Kentucky University.

No plans, said University of California, Davis, and University of Nebraska, Lincoln. Same with Colorado State University, Oregon State University, and Purdue University.

“We are very boring that way,” Janna Beckerman, a plant pathologist who researches hemp at Purdue, wrote in an email.

Some interested groups could be keeping their plans under wraps. And other possible candidates may be trying to get a better sense of what the DEA wants. But any reluctance might stem from more than being boring.

More on this…

To register with the agency, applicants will need to show that they will have security measures in place to protect the marijuana and be willing to comply with a host of other requirements. And depending on the scale of the operation, prospective growers will likely have to make significant investments to get it up and running.

Bob Morgan, an attorney at Much Shelist who formerly led the Illinois medical marijuana program, said that facilities in states that have strict regulations on medical marijuana growers are probably looking at multimillion-dollar expenditures for construction alone.

“I think everybody is just thinking about how to approach this,” said Dr. Igor Grant, director of the Center for Medicinal Cannabis Research at the University of California, San Diego. “What will it really take to get one of these DEA licenses?”

Grant said he would consider talking with other universities and agencies in California to see if it was worth the effort to get a cultivation operation in the state, but beyond that had not heard of groups intending to apply.

One researcher in the running is Lyle Craker, who studies medicinal plants at the University of Massachusetts, Amherst, and has tried in the past to get approval to grow marijuana. He did not reply to an email requesting comment, but a spokesman for a group called the Multidisciplinary Association for Psychedelic Studies — which sponsors related research — said it is supporting Craker’s efforts to get a license, as it has in the past.

Other possible applicants include independent growers who operate in states where medical and recreational marijuana is legal. Some cultivators have an expertise in running a large-scale marijuana facility — with state-of-the-art practices and security measures and experience dealing with state regulators — that in theory might appeal to federal authorities.

But the fact is, their existence contravenes federal law.

In a memo announcing the policy change, acting DEA Administrator Chuck Rosenberg said that it would consider whether applicants have “engaged in illegal activity involving controlled substances … regardless of whether such activity is permissible under state law.” While that doesn’t disqualify current cultivators, policy experts and people in the industry say the DEA won’t look highly upon them.

“They made it very clear that if you have been in violation of the [Controlled Substances Act], that would be weighted heavily against you,” said Rachel Gillette, an attorney at Greenspoon Marder in Colorado who represents marijuana businesses.

That might not stop people from trying, though.

Charlie Bachtell is the CEO and founder of Cresco Labs, which grows medical marijuana at three sites in Illinois. Bachtell said he is considering applying to the DEA because he wants to support research that could show marijuana has medical benefits.

“The future of this industry definitely starts with research,” Bachtell said. “The opportunity to help progress the acceptance, the elevation, and the professionalism of the medical cannabis industry really starts with research.”

The DEA’s policy change also opened the door to a new group of candidates: drug makers. While the Mississippi marijuana is funneled to academic research, Rosenberg wrote that marijuana can now be grown “for strictly commercial endeavors … aimed at drug product development.”

GW Pharmaceuticals, a company that is developing a drug for epilepsy from a component of marijuana called cannabidiol, said it has not made a decision about a growing facility in the United States, but remained vague enough to suggest possible interest. The company makes the drug, Epidiolex, in the United Kingdom, where it is based.

“We are exploring additional growing facilities in places around the world,” the company said in a statement.

The DEA’s application process is open, but the agency has set no deadline to select growers. The agency has indicated it wants just enough marijuana to be produced so research demands are met, but not more than that.

“It could be that two years from now, we still only have one registrant,” said Alex Kreit, an expert on marijuana law at Thomas Jefferson School of Law.

Even if cultivators gets licenses, they will confront a chicken-and-egg quandary: If they get special approval to grow marijuana, where do they get the supply they need to start it?

They could obtain marijuana from the University of Mississippi, but that would defeat the purpose of trying to expand the genetic variety of plants available. Or they could get seeds and plants from another country, such as Canada or Israel, with the proper permits.

An existing grower could also surrender some marijuana to law enforcement, which could then hand it over to a newly registered grower.

For its part, a spokesman wrote in an email that that the DEA “would require manufacturers to obtain their seeds from a lawful source, and the DEA would assist the new manufacturers in this regard.”

CONTINUE READING…

Marijuana studies

Craker is known for proposing that medical grade marijuana be available for scientific studies into its possible health benefits. Since the marijuana available for studies is too weak for any kind of medical study, he proposed that medical grade marijuanna be made available for research purposes. He has been named in many newspapers on this subject. The federal government refuses to give him a license to grow medical grade marijuana. On April 29, 2009, Senators Edward M. Kennedy and John F. Kerry wrote a letter to the Honorable David W. Ogden urging the Deputy Attorney General to delay a final decision on the application by Lyle E. Craker of the University of Massachusetts Amherst to produce research-grade marijuana for use in federally approved clinical trials[3][2][4][5]

FDA News Release: Kratom seized in California by US Marshals Service


Mitragyna_speciosa111

 

For Immediate Release

August 4, 2016

Release

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom Therapy, and are worth approximately $150,000.

The U.S. Department of Justice filed the complaint, on behalf of the FDA, in the U.S. District Court for the Central District of California, alleging that the seized kratom products are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

“The FDA will continue to take aggressive enforcement action to safeguard the public from harmful drug products illegally marketed as treatments for which they have not been studied or approved,” said Melinda Plaisier, the FDA’s associate commissioner for regulatory affairs.

The FDA is warning consumers not to use any products labeled as containing the botanical substance kratom. Mitragyna speciosa, commonly known as kratom, grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Serious concerns exist regarding the toxicity of kratom in multiple organ systems. Consumption of kratom can lead to a number of health impacts including, respiratory depression, vomiting, nervousness, weight loss and constipation. Kratom has been indicated to have both narcotic and stimulant-like effects and withdrawal symptoms may include hostility, aggression, excessive tearing, aching of muscles and bones and jerky limb movements.

In January 2016, the FDA inspected the Grover Beach facility and also found that Nature Therapeutics’ website and social media sites included claims establishing that the company’s Kratom Therapy products are drugs because they are intended for use in the cure, mitigation, or treatment of various diseases. The FDA has not approved Nature Therapeutics’ products for any use. In addition, the complaint alleged that Nature Therapeutics’ products are also misbranded drugs because their labeling fails to provide adequate directions for use. The California Department of Public Health embargoed the products on behalf of the FDA.

In February 2014, the FDA issued an import alert regarding imported dietary supplements and bulk dietary ingredients that are, or contain, kratom without physical examination.

Health care professionals and consumers should report any adverse events related to products containing kratom to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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SOURCE

 

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