Time to Contact our Representatives about Samuel Girod


https://i0.wp.com/www.kyfreepress.com/wp-content/uploads/2017/05/girod-buggy-cropped.jpg

It’s time to start sending letters, emails, calls to the 8 elected representatives below (9 if you count Melania). Here’s the plan in two steps:

STEP 1: Have your letter and social media post handy in a text doc. You can copy and paste from the examples below or click here to download samples, then edit as you like.

STEP 2: Open each person’s website/social media, copy and paste your note, and send. Click here to jump to the addresses.

I tweeted, facebooked and emailed everyone in less than 20 minutes!

WHY

At the very least, our elected representatives must know that PLENTY of people care about an Amish KY farmer being railroaded into prison by an out of control federal agency.

Sam is 56, so even a paltry 20 years (of the 68 possible) could be a life sentence. And the feds might be able to take his farm if the judge makes the fine big enough.

All this over an innocent labeling infraction. Read the entire story here.

STEP 1: WHAT to Say

Examples below — it’s best to put in your own words so that every letter does not sound exactly the same. But if you don’t have time for that, copy and paste! Click here to download samples, then edit as you like.


TWEETS The following tweet is exactly the right # of characters. If you edit, make sure it’s no longer.

Did you know the FDA is jailing a KY Amish farmer for life over a label? He needs YOUR help now! #freeamishsam bit.ly/fda-sam


SHORT EMAIL or FACEBOOK POST

Did you know the FDA is jailing a KY Amish farmer for life over an innocent labeling infraction? He needs YOUR help now! Read the story at KyFreePress.com (bit.ly/fda-sam) Please let me know what you will do to keep this insanity from happening to other innocent Americans, and that you will do everything in your power to help secure a Presidential pardon for Samual Girod. We are ALL at risk! #freeamishsam #thefreedomcoalition


LONG EMAIL/LETTER

Dear ___________,

Ky Amish farmer Samuel Girod has been railroaded by the FDA into prison over an innocent labeling infraction on an all-natural salve that his family has made for 20 years with no complaints and no victims. He’s facing up to 68 years and $3M in fines.

Sam is currently in prison awaiting sentencing on June 30th, 2017. He is 56yo, has lived his whole life without electricity, the salve business has supported his family of 12 children and 25 grandchildren for 2 decades. Again, no complaints, no victims.

The FDA is the perfect example of a runaway federal bureaucracy making laws, then using them to bully innocent Americans. The FDA spent 16 years and hundreds of thousands of dollars to harass the Girods, destroying their quiet Amish farm life, then convicting Sam of the most outrageous charges!

What happened to Samuel Girod can happen to any small business owner in America. Details here: http://www.kyfreepress.com/2017/03/updated-sam-girod-v-fda/

We Americans are ALL at risk from the FDA and other over-reaching federal agencies! If you doubt that, check out thefreedomcoalition.com. There are literally thousands of innocent Americans in U.S. prisons for breaking a law made up out of thin air by an agency bureaucrat.

Please let me know what you will do to keep this insanity from happening to other innocent Americans.

Finally, and most importantly today, I am counting on you to resolve this outrageous injustice and do your part to secure a Presidential pardon for Samuel Girod.

#freeamishsam

Sincerely, (your name and title)

For Trump’s letter, make sure to ask for a presidential pardon directly: “…injustice and sign a Presidential pardon for Samuel Girod.”


STEP 2: WHO + Addresses

Be nice in your missives, please. We don’t know why politicians are silent, but they must have a reason. Let’s assume it’s valid. Keep in mind that Sam needs friends in high places. Let’s not alienate the very people who can help him.

TO EMAIL: Go to each website and use their form, all contact info below:

  • KY Congressman Thomas Massie — He’s at least been sympathetic to the issue. You can only email him if you live in his district. Mailing and phone are at the bottom of the page. Phone & Mail, Email | Facebook | Twitter

HOW Often?

Once a week. There are over 26,000 of us, that’s a big weekly voice! If we make contact only once, it will have minimal impact. We are aiming for BIG CONTACT so let’s do this weekly!!! Don’t worry, I’ll remind you.

Tips for Efficiency

Ain’t nobody got time for dis! Here’s how I made it as efficient as possible.

  1. Open your handy doc with your missives for easy copy and paste
  2. TWEETS — took me just 2 minutes to do them all! Open all the twitter pages at once (right click on each Twitter link above and “open link in new tab”). There is a “Tweet to Person” link under the profile pix (see Matt’s screenshot below). Click that, paste the tweet in the window, hit Tweet, close the tab, next. Tweet your representatives!
  3. FACEBOOK: either go to each person’s FB page (right click and open in a new tab) and make a comment on an existing post (any post, it doesn’t matter, pick one you like). OR do a post on YOUR timeline and “tag” everyone. All tags and instructions are on the word doc above. (I did a single post and tagged everyone, it took less than a minute!)
  4. EMAIL: Open all the email pages (right click and open in new tab), then copy and paste each letter one after the other. This part took me 13 minutes total.

For those of you who don’t live in Kentucky, you might take a few extra seconds and email your state reps. Tell them to “Rein in the federal agencies. Do not let this happen in our state!”


Please share your letters/tweets in the comments so others can see them and get ideas for their missives — thank you!!!
#freeamishsam #thefreedomcoalition

CONTINUE READING…

UPDATED: Sam Girod v FDA


Samuel Girod's all-natural herbal products

By Sally Oh on March 30, 2017 | Comments 4 | Affiliate Disclosure

First, please sign and share the petition here: bit.ly/freeamishsam.

Click here for more details and links to all court documents and the indictment.

Feel free to copy and repost on your blog, social media, or print and handout, use as a cover letter for a printed petition (click here to download petition). Since the Amish don’t use the internet, many of them don’t even know about Sam’s situation! Please share the printed petition, get their signatures, then email or mail to me here.

Samuel Girod [G as in Gee: gi-ROD] and his family have been making and selling three all-natural herbal products for nearly 20 years.

No one has ever been harmed by the products; the Girods have pages of testimonials and scores of repeat customers.

Similar products are currently made and sold online worldwide (including on Amazon) by other people using the same or similar basic ingredients. The recipes are online as well, you can make them in your kitchen.

In 2001, an FDA agent informed Sam that his product labels were making medical claims regarding healing certain conditions. At the time, Sam’s label said, ““[g]ood for all skin disorders. Skin cancer, cuts, burns, draws, and poison ivy.”

Sam had to change his label, removing the skin cancer claim specifically, or do very expensive testing proving the claims. Sam changed the label, removing any reference to skin cancer.

Sam did not receive any further communication from the FDA until 2012 when someone called the FDA and reported that a store in MO was selling Sam’s products and that medical claims were being made.

The “medical claims” were in fact customer testimonials contained in a brochure about Sam’s products! These testimonials are no different than Amazon reviews.

Then the FDA claimed to have found a MO customer who had been harmed by Sam’s bloodroot salve.

In early 2013, during the investigation on that claim, FDA agents went to Sam’s home and demanded a warrantless search. Wanting to be cooperative, Sam said OK on one condition: that no photographs were taken (the Amish are religiously opposed to photography). The agents said no problem, no photos.

Then they got on the property, whipped out their cameras and took photos of everything.

Several months later, the Girods went before a federal judge in MO re the medical claims and the person supposedly injured. Turns out, not only has this customer never been identified or produced, the bloodroot salve this customer used was not even Sam’s!!!

Yet that judge put an injunction on Sam’s products with three stipulations:

  1. none could be sold until all medical claims were removed (referring to the brochures);
  2. Sam’s bloodroot salve could never be sold again EVER (1); and
  3. Sam had to allow inspection of his property where the products were made FOR FIVE YEARS.

Sam complied with 1 and 2: he stopped selling the bloodroot salve and stopped using the brochures. He was not so compliant with the searches.

In late 2013, after the injunction, FDA agents came to do a second search. Sam informed them that nothing had changed since the first search 7 months earlier, and that, since they had lied and taken photos during the first search, they were not welcome to do a second.

Sam had a Bath County Sheriff’s deputy there who witnessed the entire event and told the agents to leave the property.

Unfortunately for Sam, he knows his constitutionally-guaranteed rights and he relied on them to make his next decisions.

These three product sales are how Sam’s family made their living. They had been denied this right via an arbitrary regulation made up by a federal agency with no true jurisdiction in the states — and with NO VICTIM.

So the Girods started selling their products again. Then, in 2014, Sam started a legal private membership club and sold his products to members via that framework. Perfectly legal.

Meanwhile, the FDA started criminal proceedings against Sam for disobeying the injunction (selling his products and refusing the search) plus two other very serious charges:

1. The FDA agents claimed that, when they came for the 2nd search, Sam and his family threatened them with physical violence. That is ludicrous enough on the face of it. Plus, the Sheriff’s deputy testified under oath that absolutely no threats were made, that, essentially, the FDA agents lied under oath.

2. The FDA also charged Sam with witness tampering. The witness who was supposedly tampered with? Read the eyewitness account of Mary Miller’s testimony, link below. (2)

The Trial 2.27.17

The Amish do not use lawyers as a rule and Sam did not. This is a decision made by the community, not just the accused. Apparently the Amish don’t trust lawyers. Imagine that.

Because he barely presented a defense against federal prosecutors for whom money and conscience are not problems, Sam was convicted on all counts. (3)

The judge ordered Sam to remain in jail until sentencing on 6/16/17. He’s been in jail since 2/27/17.

Had Sam had a good attorney, he would certainly have been acquitted on the most egregious counts (threatening federal agents and witness tampering). These charges were clearly manufactured solely to make Sam into a “real” criminal, with the FDA being the only victim.

The only other charges — selling “drugs” across state lines — were manufactured out of whole cloth as well. The FDA’s own tests proved that the products were not drugs, that they were made from all-natural ingredients!!! These charges should have been dismissed from the start.

Sam’s sentencing is 6/16 and he is looking at 68 years in prison. This is essentially a life sentence for charges stemming from an innocent labeling infraction!

Sam should not spend a minute in jail. Please sign and share our petition to President Trump for a presidential pardon: bit.ly/freeamishsam

Burning Questions

  • How does the FDA get away with determining what constitutes a “medical claim” anyway?
  • How are they able to define “drug” so broadly that a topical salve made from all edible ingredients becomes a “drug?”
  • Why are Amazon reviews ok but Sam’s customers’ testimonials a basis for criminal charges?
  • How is the FDA able to create criminal penalties for violation of arbitrary rules?
  • How does this kind of action against an Amish grandfather making salves from all-natural ingredients protect the public, particularly considering that every 19 minutes, someone dies from an FDA-approved pharmaceutical, an actual drug that has been tested and “proven safe”?
  • How will Sam’s incarceration for life make the American public any safer?
  • Considering that no one was harmed by his products, how has spending millions of dollars on Sam’s prosecution and 16 years of harassment made the world a better place?

A SOLUTION

There is a better way to handle this. Let us Americans make healing claims on our products with the disclaimer, “These claims have not been scientifically proven. Please use your internet and library to verify claims to your own satisfaction prior to use.”

Sam’s prosecution is a prime example of bureaucracy run amok, enforcement for enforcement’s sake to justify an agency’s existence. There are literally thousands of people in jail (4) for breaking agency regulations fabricated by the agencies! Their rules and regulations are as arbitrary and illegal as they can be, with the result of making us all criminals in our own homes.

Who exactly is being protected here?


Resources:


(1) In the indictment, bloodroot is repeatedly referred to as “dangerous” with no documentation whatsoever. Bloodroot is from a plant grown in North America, it’s perfectly legal and used by millions of people for centuries for healing purposes. Bloodroot products are sold all over the internet, including on Amazon.


(2) Mary Miller is the 2nd witness called: http://www.kyfreepress.com/2017/03/trial-fda-v-samuel-girod-day-2/


(3) Trial Day 1, Trial Day 2, Trial Day 3


(4) http://thefreedomcoalition.com

Sally Oh

Sally Oh

Sally Oh is a native Kentuckian, wife, mother, blogger, homesteader, chickenista, recovering REALTOR® and Functional Medicine Practitioner. A liberty activist and registered voter, that’s her falling down a rabbit hole.

CONTINUE READING…

This is the story of the FDA’s persecution of Samuel Girod.


 

 

By Sally Oh on March 1, 2017 | Comments 2 | Affiliate Disclosure

Here’s a video explaining the entire thing, transcript with links below.

Let’s be clear about a couple of pertinent facts:

1. The FDA made up arbitrary rules, then accused Sam of breaking those rules.

2. There are no victims. Samuel Girod has hurt no one.

3. FDA-approved pharmaceutical drugs kill 1 person every 19 minutes. Merck’s FDA-approved Vioxx killed over 68,000 people. Nobody in Big Pharma goes to jail. They pay out billions in fines (after making billions in profits.) No companies close, nobody goes to jail. Nobody. Even after killing and harming 100s of thousands of people.

4. Sam Girod and his products have hurt no one.

The Story of the FDA v Samuel Girod

Samuel Girod and his family have been making and selling 3 all-natural herbal products for nearly 20 years. In all those years, one woman had a bad reaction to a salve (which Sam made right and the woman was fine).

No one has ever been harmed by the products, the Girods have pages of testimonials and scores of repeat customers.

The 3 products are: Original Chickweed, a beeswax, essential oils and olive oil salve; Sine-Eze, a blend of essential oils; and To-Mor-Gone, an herbal bloodroot product in a base of beeswax and olive oil aka “black salve”.

All of these products are currently ALSO made and sold online worldwide (including on Amazon) by other people using these same basic ingredients. The recipes are online as well, you can make them in your kitchen.

HOW IT STARTED

Sixteen years ago, in 2001, an FDA agent visited Sam at his home in IN and informed Sam that he could not claim his products could help skin cancer. At that time, the chickweed salve label said: “[g]ood for all skin disorders. Skin cancer, cuts, burns, draws, and poison ivy.”

According to the FDA, when you make a medical claim about a product, that means the product is a “drug. Therefore you have to do years of testing, costing millions of dollars to prove the claim.

Sam had to change his label or do the testing.

So Sam changed the label, removing the reference to skin cancer.

He asked the agent to get back to him on what label would be acceptable to the FDA. The agent said she would within three weeks but she never did.

The label now said, “[g]ood for skin disorders. Dry skin, cuts, burns, draws, and poison ivy.” No skin cancer reference.

Between 2001 and 2004, Sam was visited several times by FDA agents. When he asked the agents what was acceptable on the label, none would give
an answer.

Sam did not receive any further communication from the FDA until 2012.

In Jan 2012, someone called the FDA and reported that a store in MO was selling Chickweed Healing Salve and that medical claims were being made.

The FDA confiscated the products from the store and opened #Case 4:12-cv-00362-GAF on Sam. You will find a link to the complaint and a link to Sam’s answer in the transcript below.

This is the complaint: http://bit.ly/27-on-120928-Girod-Amended-Complaint

This is Sam’s answer to the complaint: http://bit.ly/37-on-121228-Girod-Answer-Defenses


In fact, here are all the court documents on Sam’s entire case. There are two folders: the 1st is for the labeling, the 2nd is for the criminal indictment.


PLEASE FOLLOW THIS LINK TO THE FULL STORY!

CONTINUE READING AND TO VIDEO HERE!

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

Our mailing address is:

KyFreePress.com

312 Pine Crest Rd #117

Morehead, KY 40531

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.

CONTINUE READING…

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.

CONTINUE READING…

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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