The DEA is accepting comments on the rescheduling of Kratom into Schedule I until December 1st…The time to comment is NOW!

Due to be published in the “Federal Register” on August 31st, 2016 is the DEA’s “Intent to reschedule” the opioids mitragynine and 7-hydroxymitragynine  These are the “ingredients” of the plant Kratom and they are placing it into schedule I using the “temporary scheduling provisions” of the Controlled Substances ActLINK

 

Image result for kratom

 

Speak now or forever hold your peace!  You have been notified! 

The DEA reluctantly put on hold it’s intentions of placing Kratom into a Schedule I controlled substance category in August of 2016 after having such a backlash of individuals complaining about the proposed plans.  However, they are still contemplating that move and we only have until December 1st to make our comments through a website designed for us which states that this is …

“Your voice in Federal decision making” on the website of REGULATIONS.GOV.

An unknown number of people in the U.S. use Kratom daily to ease pain and withdrawal symptoms among other things.  It is a “plant” and it belongs to the “People”!  It is a part of our unalienable rights!

This is just the latest move by the DEA through the U.N. and “Agenda 21” to claim all of our rights to any substance that can possibly make the pharmaceutical companies more profitable in the future by denying access to this plant by the individual now.  In fact, a Patent application, dated 2009 exists already. 

United States Patent Application
20100209542

LINK

PLANT MATERIAL OR PLANT EXTRACT OF UNDETERMINED CONSTITUTION AS ACTIVE INGREDIENT (E.G., HERBAL REMEDY, HERBAL EXTRACT, POWDER, OIL, ETC.):  LINK

U.S. Classification
424/725, 514/285

STATEMENT OF GOVERNMENTAL SUPPORT [0001] This invention was made with government support awarded by: i) the National Institutes of Health (grant number NIH 022677); ii) the National Institute For Drug Abuse (grant numbers DA022677 and DA014929); and iii) the National Center for Research Resources (grant number P20RR021929). The government has certain rights in the invention.  LINK

Scientific American published an article “Should Kratom Use Be Legal?” in 2013, which features an interview with Edward Boyer, a professor of emergency medicine and director of medical toxicology at the University of Massachusetts Medical School, which is a very good article concerning Kratom.  It is a good source of information for those who are not familiar with Kratom.  Ironically enough, it is the University of Massachusetts Medical School which is the “Assignee” on the above patent.  In addition, the following Patents are noted in 2016:

Citing Patent
Filing date
Publication date
Applicant
Title

US9265458
Dec 4, 2012
Feb 23, 2016
Sync-Think, Inc.
Application of smooth pursuit cognitive testing paradigms to clinical drug development

US9380976
Mar 11, 2013
Jul 5, 2016
Sync-Think, Inc.
Optical neuroinformatics

 

Please take note of the “LEGAL EVENTS” that are at the bottom of the page at this LINK.

The “drug war” has taken enough of our plants and enough of our lives.  We cannot continue to let them regulate us out of every plant of food and medicine which were ever given to us as Our “inalienable rights” as Human Beings and laid out in Our Constitution.  I wrote an article concerning this in 2015, entitled, HOW THE UNITED NATIONS IS STEALING OUR “UNALIENABLE RIGHTS” TO GROW FOOD AND MEDICINE THROUGH THE U.N. CONVENTION ON NARCOTIC DRUGS AND AGENDA 21 (LINK), which explains much of how this is being accomplished by our Government(s).

Kentucky Senate Bill 136, in 2016, was defeated and did not take effect this year.  However, there are many other states in which it has been rescheduled to a I on a state level.  If we do not stop this from happening now, we will never be able to once it is Federally rescheduled.  So take a moment and make your opinion heard.  Use the Federal website to post your comment now!

#PlantsRights #EndProhibition #EndTheDrugWar

 

KRATOM

 

 

https://www.regulations.gov/document?D=DEA-2016-0015-0006

https://www.regulations.gov/document?D=DEA-2016-0015-0002

https://www.regulations.gov/docket?D=DEA-2016-0015

https://kentuckymarijuanaparty.com/2016/02/23/oppose-sb-136-banning-the-kratom-herb/

https://kentuckymarijuanaparty.com/2015/10/26/rights-and-freedoms-may-in-no-case-be-exercised-contrary-to-purposes-and-principles-of-the-united-nations-how-the-united-nations-is-stealing-our-unalienable-rights-to-grow/

http://www.americankratom.org/legal_status#_=_

https://www.scientificamerican.com/article/should-kratom-be-legal/

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20100209542.PGNR.

https://www.google.com/patents/US20100209542#legal-events

http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20100209542.PGNR.

https://www.google.com/patents/US20100209542

http://www.alternet.org/drugs/big-pharma-patents-kratom-alkaloids-real-reason-dea-banning-plant

 

sk

9 States to Vote Soon on Expanding Legal Access to Marijuana

SAN FRANCISCO — Sep 28, 2016, 2:35 AM ET

Marijuana National Vote

From California, with its counterculture heritage, to the fishing ports and mill towns of Maine, millions of Americans in nine states have a chance to vote Nov. 8 on expanding legal access to marijuana. Collectively, the ballot measures amount to the closest the U.S. has come to a national referendum on the drug.

Five states — Arizona, California, Maine, Massachusetts and Nevada — will consider legalizing the recreational use of pot. Three others — Florida, Arkansas and North Dakota — will decide whether to permit marijuana for medical purposes. Montana will weigh whether to ease restrictions on an existing medical marijuana law.

As the most populous state, with a reputation for trend-setting, California is attracting the most attention — and money — in an intensifying debate over Proposition 64.

Silicon Valley tycoons and deep-pocketed donors with connections to the legal medical marijuana industry are among the top financial backers of a pro-pot campaign that has raised almost $17 million. Opponents have raised slightly more than $2 million, including a $1.4 million contribution from retired Pennsylvania art professor Julie Schauer.

Advocates on both sides say passage in California would likely ignite legalization movements in other states, especially when the tax dollars start adding up. California’s nonpartisan Legislative Analyst’s Office estimated the state could collect up to $1 billion a year in marijuana taxes.

"As California goes, so goes the nation," said University of California, Berkeley political science professor Alan Ross.

If "yes" votes prevail across the country, about 75 million people accounting for more than 23 percent of the U.S. population would live in states where recreational pot is legal. The jurisdictions where that’s already the case — Alaska, Colorado, Oregon, Washington state and the District of Columbia — have about 18 million residents, or 5.6 percent of the population. Twenty-five states allow medical marijuana.

According to national polls, a solid majority of Americans support legalization. Gallup’s latest survey gauged support at 58 percent, up from 12 percent from when the question was first posed in 1969. Gallup says 13 percent of U.S. adults report using marijuana at present, nearly double the percentage who reported using pot in 2013.

California voters rejected an attempt to legalize recreational marijuana in 2010 after campaign leaders struggled to raise money and support for a four-page ballot measure hastily written by the owner of a small medicinal marijuana store.

This time, the 62-page ballot measure was crafted by political professionals and has the backing of many elected officials, including Lt. Gov. Gavin Newsom, who is running for governor in 2018. Current Gov. Jerry Brown says he’s close to announcing his position.

The measure would allow people 21 and older to legally possess up to an ounce of weed and grow six marijuana plants at home. Pot sales would be subject to various tax rates that would be deposited into the state’s Marijuana Tax Fund. Most of that money would be spent on substance-abuse education and treatment. Some would be used to repair environmental damage caused by illegal growers.

Opponents argue that the measure will do more harm than good by opening a marijuana market dominated by small farmers to corporate interests and encouraging children to use the drug through pot-laced sweets like gummy bears, cookies and brownies.

The proposal "favors the interests of wealthy corporations over the good of the everyday consumer, adopting policies that work against public health," said Kevin Sabet, co-founder of the California-based advocacy group Smart Approaches to Marijuana.

Napster founder and early Facebook investor Sean Parker has contributed more than $3 million to the legalization effort, which has also attracted sizable contributions from an organization backed by billionaire George Soros and another backed by Weedmaps, which rates pot stores throughout the state.

"It’s a huge deal and it’s long overdue," said Steven DeAngelo, owner of one of the nation’s largest medicinal marijuana dispensaries and a Proposition 64 supporter.

In most of the states with marijuana ballot measures, polls have shown the "yes" side leading. Sabet believes opponents of legalization would attract more support if they could narrow a large fundraising gap and spread their cautionary messages. He does not buy the other side’s argument that nationwide legalization will come sooner or later.

"Repeating that this is inevitable, and repeating they are so excited, is part of their narrative to makes folks like us feel helpless," he said.

Mason Tvert of the Marijuana Policy Project, a leading pro-legalization group, said his side has a chance to win in most of the nine states, but some losses will not derail the movement.

"Even if a measure doesn’t pass, support will grow," he said, citing failed ballot measures in Oregon and Colorado that preceded the victories for legalization.

"Most people believe marijuana should be legal. It’s a question of whether opponents do a good job of scaring them out of doing it now," Tvert added. "We might see people opt to wait a couple more years."

All five states voting on recreational marijuana have seen intense debate over the effect of legalization in the states that have already taken that step.

Opponents of the ballot measures make an array of claims, contending, for example, that Colorado’s legalization of pot has coincided with an increase in crime in Denver and fueled a jump in the number of traffic fatalities linked to marijuana use.

However, an analysis by three academic experts, published this month by the libertarian-leaning Cato Institute, asserted that the impact of legalization has been minimal.

"The data so far provide little support for the strong claims about legalization made by either opponents or supporters," the analysis said.

Harvard University economist Jeffrey Miron, one of the co-authors of the study, predicted Californians would approve Proposition 64, but he was less certain of the outcome in his home state of Massachusetts, where the Republican governor, Charlie Baker, and the Democratic mayor of Boston, Marty Walsh, have teamed up to oppose legalization.

Miron said it’s difficult to predict when legalization might get support in Congress or surge to approval in a majority of states.

"I’m not sure if this November will get us to the tipping point. It may be two or four more years," he said. "Certain things seem impossible, until all of a sudden they are possible, and they happen fast."

———

Crary reported from New York.

CONTINUE READING AND TO VIDEO!

The FDA Just Outlawed Hemp Oil

The FDA Just Outlawed Hemp Oil — The #1 Cancer Treatment in The World

 

VIA/Hemp oil extracts containing CBDs (cannibidiols) are such a threat to the pharmaceutical industry that the FDA is now invoking totally insane justifications for outlawing them.

FDA’s own website: “12. Can products that contain cannabidiol be sold as dietary supplements? A. No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition…”

The FDA has also started sending aggressive warning letters to CBD product marketers.

Cannabis Oil - Banned by FDA

CBDs are non-psychoactive compounds found naturally in hemp plants. They work so well as powerful natural medicine that people everywhere are realizing CBDs work better than pharmaceuticals for treating epilepsy, seizures, neurological disorders and other serious health conditions (including HIV infections).

So the FDA has just launched a massive regulatory assault against CBDs by invoking the most insane logic you’ve ever heard. Here’s how it goes:

1) CBDs work so well that drug companies are now investigating them to be approved by the FDA as medicines.

2) Because CBDs are being investigated by drug companies, the FDA has granted CBDs status as being “investigated as a new drug.”

In the FDA’s own language from their website:

“FDA CONSIDERS A SUBSTANCE TO BE ‘AUTHORIZED FOR INVESTIGATION AS A NEW DRUG’ IF IT IS THE SUBJECT OF AN INVESTIGATIONAL NEW DRUG APPLICATION (IND) THAT HAS GONE INTO EFFECT.”

3) Because CBDs work so well and have been authorized for drug investigations, the FDA now OUTLAWS them being sold as dietary supplements.

Per the FDA’s own website:

“FDA HAS CONCLUDED THAT CANNABIDIOL PRODUCTS ARE EXCLUDED FROM THE DIETARY SUPPLEMENT DEFINITION UNDER SECTION 201(FF)(3)(B)(II) OF THE FD&C ACT.

“UNDER THAT PROVISION, IF A SUBSTANCE (SUCH AS CANNABIDIOL) HAS BEEN AUTHORIZED FOR INVESTIGATION AS A NEW DRUG FOR WHICH SUBSTANTIAL CLINICAL INVESTIGATIONS HAVE BEEN INSTITUTED AND FOR WHICH THE EXISTENCE OF SUCH INVESTIGATIONS HAS BEEN MADE PUBLIC, THEN PRODUCTS CONTAINING THAT SUBSTANCE ARE OUTSIDE THE DEFINITION OF A DIETARY SUPPLEMENT.”

4) Now the FDA has begun sending warning letters to CBD makers, claiming they are in violation of FDA regulations because they are selling “adulterated products.”

Adulterated with what, exactly? CBDs, of course!

“THE DEBATE OVER HEMP CBD’S LEGAL STATUS CONTINUES AFTER FDA SENT EIGHT WARNING LETTERS TO MANUFACTURERS OF CBD DIETARY SUPPLEMENT AND FOOD PRODUCTS EARLIER THIS MONTH,” REPORTS NUTRITIONAL OUTLOOK.

“THE WARNING LETTERS CITE IMPERMISSIBLE HEALTH CLAIMS USED TO MARKET THE PRODUCTS, AS WELL AS CBD’S INVALID STATUS AS A DIETARY INGREDIENT DUE TO ITS PRESENCE IN TWO DRUG APPLICATIONS CURRENTLY UNDER CONSIDERATION.”

The FDA just criminalized one of the most miraculous healing medicines in the world by handing it over to Big Pharma

In other words, the FDA just handed Big Pharma an absolute monopoly over CBDs (hemp oil extract) by ridiculously claiming such natural products are “adulterated” with molecules (CBDs) that the FDA says might one day become a drug.

“Drugs,” according to the FDA, are substances that are proven to treat, prevent or cure a disease, and thus the FDA’s own logic admits that CBDs must be able to treat, prevent or cure diseases, otherwise they would be useless as “drugs”.

But when a dietary supplement company makes the same claim, they are hit with aggressive warning letters from the FDA, threatening to shut them down, confiscate their products and seek criminal prosecution of the company executives.

This is how the FDA can instantly criminalize any vitamin or plant extract

Do you see how this twisted, corrupt regulatory tactic can allow the FDA to instantly criminalize any dietary supplement, vitamin, herb or plant extract?

Vitamin D, for example, could be outlawed by the FDA announcing that it has granted “Investigational New Drug application (IND)” status to any drug company studying vitamin D.

Using this same corrupt, mafia-style tactic, the FDA could outlaw resveratrol or even vitamin C, denying Americans the right to access safe, affordable, natural substances that are routinely found in nature.

It’s time to end the FDA’s monopolization over natural plant molecules

If humanity is ever to achieve medical freedom, we must end the FDA’s outrageous medical monopolization of plant molecules such as CBDs.

By allowing this corrupt, criminally-run regulatory agency to criminalize every molecule found in nature, our nation’s lawmakers condemn us all to life in what can only be called medical totalitarianism under FDA tyranny.

Any time a healing substances is found in nature, the FDA can simply assert that such molecules are now in the process of being studied as drugs and are therefore illegal to sell as dietary supplements even though they were developed by Mother Nature, not drug companies.

This FDA tactic is nothing more than the FDA proclaiming intellectual monopolies over all molecules of interest found in nature.

It is Monsanto-like in its arrogance and wickedness, and it deprives the People of their right to access medicinal plants and healing substances that have existed in nature for countless thousands of years long before the FDA ever came into existence (1906).

If we do not stop this FDA, we are all doomed to living under a totalitarian regulatory regime that will systematically criminalize every healing molecule found in nature, from the curcuminoids in turmeric root to green tea catechins and even phycocyanins found in spirulina.

That this federal agency has now resorted to such tactics of medical totalitarianism and outright tyranny is proof that we need to strip the FDA of regulatory powers over natural dietary supplements and limit its domain to pharmaceutical drugs only.

Coincidentally, a Presidential election is upon us that threatens to shake up the entire establishment if the right person wins.

“Establishment” candidates on both sides of the aisle would simply continue the FDA war on natural molecules that’s now under way, but there is one candidate who has openly threatened to challenge the authority of federal regulators like the EPA and FDA.

FDA begins crackdown by targeting inaccurate label claims… but it won’t end there

The FDA has now declared war on CBDs and hemp oil extracts. Its first targets are those companies who have inaccurate label claims or are committing outright fraud in claiming CBD concentrations that don’t even exist in their products.

On this point, I must agree that inaccurate label claims deserve regulatory enforcement. The CBD industry is heavily populated with fraudulent sellers whose products often contain no CBDs at all.

“THE FDA HAS TURNED ITS BACK ON THE CANNABIS INDUSTRY, CLAIMING THAT CBD PRODUCTS CANNOT BE SOLD AS DIETARY SUPPLEMENTS,” REPORTSCANNA BUSINESS.

“COMPANIES AFFECTED BY THE LATEST CRACKDOWN INCLUDE CALI STORES, DOSE OF NATURE, GREEN GARDEN GOLD, HEALTHY HEMP OIL, MICHIGAN HERBAL REMEDIES, MORGUE JUICE, PAIN BOMB AND SANA TE PREMIUM OILS. ACCORDING TO THE FDA’S ANALYSIS, ALL PRODUCTS CONTAINED DIFFERENT AMOUNTS OF 9-THC, THCA, CBDA, CBN AND CBD THAN THEY HAD CLAIMED.”

The second target of the FDA is companies that made disease treatment claims that their CBD products might treat epilepsy, cancer or other conditions.

The FDA, of course, routinely attacks any dietary supplement maker that tells the truth about the medicinal benefits of their products.

According to the FDA, there is no such thing as any food, nutrient, herb or natural molecule that has any ability whatsoever to treat, prevent or cure any disease.

This position is, of course, patently absurd and stands in total violation of nutritional science, but it is the “big lie” the FDA must maintain in order to keep putting dietary supplement companies out of business.

Once the FDA finishes destroying all the companies with inaccurate labels and disease marketing claims, it will target all the honest suppliers of CBDs who are selling genuine, honest products that contain accurate CBD labels.

This is the real goal of the FDA: to threaten, intimidate and destroy the entire CBD industry and thereby protect the medical monopolies of drug companies that can’t wait to cash in on these amazing molecules that really do treat disease (otherwise, Big Pharma would have no interest in them).

This is how the FDA keeps the medical racket marching along

And so the great medical monopoly racket marches on, with the FDA giving a big “F-YOU” to the American people while handing lucrative medical monopolies to its greed-driven friends in the pharmaceutical industry.

Meanwhile, the American people are denied healing medicine that works at a fraction of the cost of overpriced pharmaceuticals.

Entrepreneurial companies that offer such hemp oil extracts containing CBDs — natural medicines that could help reduce human suffering while lowering health care costs nationwide — are threatened by the FDA with devastating enforcement actions that could land their executives in prison.

This is all part of the FDA’s war on natural medicine that systematically criminalizes molecules found in nature and the people who seek to make those molecules available to patients in need.

While disease suffering skyrockets across America and medical expenses push more and more families over the threshold of bankruptcy and destitution, isn’t it comforting to know that your federal government is doing everything in its power to deny you access to safe, affordable natural medicine while protecting the profits of the drug giants?

What can you do to oppose this medical tyranny by the FDA?

None of this is ever going to change, by the way, if we keep electing establishment politicians to the White House.

If you want to see real change in the legalization of hemp extract components such as CBDs, you’d better vote for someone who terrifies the establishment and threatens to tear it down.

At the same time, you need to support health freedom organizations like the Alliance for Natural Health, which is fighting to keep dietary supplements legal in America.

You should also watch this video animation that exposes the anti-dietary supplement bias of PBS Frontline, which recently ran a totally dishonest hit piece documentary attacking supplements.

There is a nationwide effort under way right now to criminalize ALL dietary supplements and force every plant extract, vitamin or food concentrate to be regulated by the FDA as if they were prescription drugs.

This would utterly wipe out the entire dietary supplements industry and plunge America into an era of runaway disease, suffering and death as people are denying access to the healing nutrients that are presently preventing disease (and even reversing serious disease in some cases).

Finally, share this story and join the Natural News email list (below) to stay informed on all this.

As the editor of Natural News, I am fighting for your right to access CBDs and hemp oil extracts, as they are amazing natural medicines that can treat, prevent and in some cases even help cure serious health conditions.

The FDA is anti science and anti human rights

We have a fundamental human right to access healing plants found in nature, and the FDA has systematically sought to destroy that right and criminalize those who seek to express it.

Access to Mother Nature’s healing molecules is a fundamental human right that exists above and beyond the Bill of Rights. It is a DIVINE right.

To reestablish our access to these rights, we need a political revolution in Washington that puts people in power who are ready and willing to dismantle the FDA and end its devastating monopolies over dietary supplements, medicinal herbs and natural molecules found in nature.

We need to legalize health freedom in America and set this nation on a new path of disease prevention and drastically reduced health care costs through access to affordable, natural medicines.

The only way to accomplish this is to end the FDA’s reign of tyranny over the dietary supplements industry.

We need a new health freedom revolution in America, and it starts at the ballot box. It’s time to start electing outsiders, not insiders… people who the terrify the Washington establishment because they know their insidious grip on regulatory power will be challenged.

If you want medical marijuana legalized, or if you want access to CBD oil as an affordable dietary supplement, it’s time to start voting for people the establishment is desperately trying to destroy.

Because it is only those people who have any real hope of achieving the kind of political and legislative goals that will end the FDA’s stranglehold on natural medicine in America.

CONTINUE READING…

The Complete History of Monsanto, “The World’s Most Evil Corporation”

By E Hanzai

Global Research, December 23, 2015

Waking Times 22 June 2014

Monsanto-2.0

First published by Waking Times and Global Research in May 2014

Of all the mega-corps running amok, Monsanto has consistently outperformed its rivals, earning the crown as “most evil corporation on Earth!” Not content to simply rest upon its throne of destruction, it remains focused on newer, more scientifically innovative ways to harm the planet and its people.

1901: The company is founded by John Francis Queeny, a member of the Knights of Malta, a thirty year pharmaceutical veteran married to Olga Mendez Monsanto, for which Monsanto Chemical Works is named. The company’s first product is chemical saccharin, sold to Coca-Cola as an artificial sweetener.

Even then, the government knew saccharin was poisonous and sued to stop its manufacture but lost in court, thus opening the Monsanto Pandora’s Box to begin poisoning the world through the soft drink.

toxiclove1920s: Monsanto expands into industrial chemicals and drugs, becoming the world’s largest maker of  aspirin, acetylsalicyclic acid, (toxic of course). This is also the time when things began to go horribly wrong for the planet in a hurry with the introduction of  their polychlorinated biphenyls (PCBs).

“PCBs were considered an industrial wonder chemical, an oil that wouldn’t burn, impervious to degradation and had almost limitless applications. Today PCBs are considered one of the gravest chemical threats on the planet. Widely used as lubricants, hydraulic fluids, cutting oils, waterproof coatings and liquid sealants, are potent carcinogens and have been implicated in reproductive, developmental and immune system disorders. The world’s center of PCB manufacturing was Monsanto’s plant on the outskirts of East St. Louis, Illinois, which has the highest rate of fetal death and immature births in the state.”(1)

Even though PCBs were eventually banned after fifty years for causing such devastation, it is still present in just about all animal and human blood and tissue cells across the globe. Documents introduced in court later showed Monsanto was fully aware of the deadly effects, but criminally hid them from the public to keep the PCB gravy-train going full speed!

1930s: Created its first hybrid seed corn and expands into detergents, soaps, industrial cleaning products, synthetic rubbers and plastics. Oh yes, all toxic of course!

1940s: They begin research on uranium to be used for the Manhattan Project’s first atomic bomb, which would later be dropped on Hiroshima and Nagasaki, killing hundreds of thousands of Japanese, Korean and US Military servicemen and poisoning millions more.

The company continues its unabated killing spree by creating pesticides for agriculture containing deadly dioxin, which poisons the food and water supplies. It was later discovered Monsanto failed to disclose that dioxin was used in a wide range of their products because doing so would force them to acknowledge that it had created an environmental Hell on Earth.

CONTINUE READING….

French drug trial disaster leaves one brain dead, five injured

PARIS | By Matthias Blamont

Fri Jan 15, 2016 11:30am EST

 

An ambulance is seen outside the Emergency Entrance at the CHU de Rennes hospital, in Rennes, France, where six people are in a serious condition after taking part in a medical trial for an unnamed European laboratory to test a new drug, France’s health ministry said January…Reuters/Stephane Mahe

One person has been left brain dead and five others are in serious condition after taking part in a clinical trial in France of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

The medicine involved works by targeting the body’s pain-controlling endocannabinoid system, which is also responsible for the human response to cannabis.

The ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication at a private facility that specializes in carrying out clinical trials.

 

The brain-dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.

The volunteers are all men aged 28 to 49, French Health Minister Marisol Touraine told a news conference. They started taking the drug on Jan 7. One person started feeling ill on Sunday and the other five afterwards.

In total, 90 people have taken part in the trial, taking some dosage of the drug, she said, adding that others took a placebo.

All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

A spokeswoman for the European Medicines Agency in London said it did not have full details of the case but was monitoring the situation.

Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care. One was described as looking like "the elephant man" after his head ballooned. Another lost his fingertips and toes.

"INHERENT RISK"

In the initial Phase I stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.

"Undertaking Phase 1 studies is highly specialist work," said Daniel Hawcutt, a lecturer in clinical pharmacology at Britain’s University of Liverpool.

Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale.

Europe has strict regulations governing the conduct of clinical trials, with Phase I tests subject to particular scrutiny. But Ben Whalley, a professor of neuropharmacology at the University of Reading, said these could only minimize risks, not abolish them.

"There is an inherent risk in exposing people to any new compound," he said.

The 2006 London trial led to the collapse of Germany’s TeGenero, the company developing a medicine known as TGN1412. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.

(Additional reporting by Ben Hirschler, John Irish, Noelle Mennella and Ingrid Melander; Editing by Michel Rose and Larry King)

CONTINUE READING…

A Way to Brew Morphine Raises Concerns Over Regulation

By DONALD G. McNEIL Jr.MAY 18, 2015

All over the world, the heavy heads of opium poppies are nodding gracefully in the wind — long stalks dressed in orange or white petals topped by a fright wig of stamens. They fill millions of acres in Afghanistan, Myanmar, Laos and elsewhere. Their payload — the milky opium juice carefully scraped off the seed pods — yields morphine, an excellent painkiller easily refined into heroin.

But very soon, perhaps within a year, the poppy will no longer be the only way to produce heroin’s raw ingredient. It will be possible for drug companies, or drug traffickers, to brew it in yeast genetically modified to turn sugar into morphine.

Almost all the essential steps had been worked out in the last seven years; a final missing one was published Monday in the journal Nature Chemical Biology.

“All the elements are in place, but the whole pathway needs to be integrated before a one-pot glucose-to-morphine stream is ready to roll,” said Kenneth A. Oye, a professor of engineering and political science at M.I.T.

Yeast cells on this Petri dish are producing the pigment betaxanthin, which researchers used to identify key enzymes in the production of benzylisoquinoline alkaloids, the metabolites in the poppy plant that could lead to morphine, antibiotics and other pharmaceutical agents. Credit William DeLoache/UC Berkeley

This rapid progress in synthetic biology has set off a debate about how — and whether — to regulate it. Dr. Oye and other experts said this week in a commentary in the journal Nature that drug-regulatory authorities were ill prepared to control a process that would benefit the heroin trade much more than the prescription painkiller industry. The world should take steps to head that off, they argue, by locking up the bioengineered yeast strains and restricting access to the DNA that would let drug cartels reproduce them.

Other biotech experts counter that raising the specter of fermenting heroin like beer, jokingly known among insiders as “Brewing Bad,” is alarmist and that Dr. Oye’s proposed solutions are overkill. Although making small amounts of morphine will soon be feasible, they say, the yeasts are so fragile and the fermentation process so delicate that it is not close to producing salable quantities of heroin. Restricting DNA stifles all research, they argue, and is destined to fail just as restrictions on precursor chemicals have failed to curb America’s crystal meth epidemic.

A spokesman for the Drug Enforcement Administration said his agency “does not perceive an imminent threat” because no modified yeast strain is commonly available yet. If that happens, he said, D.E.A. laboratories would be able to identify heroin made from it.

An F.B.I. agent who has been following the yeast strains since 2009 said he was glad that the debate was beginning before the technology was ready and before lawmakers moved to restrict it.

“We’ve learned that the top-down approach doesn’t work,” said Supervisory Special Agent Edward You, who said he coined the “Brewing Bad” term and had held workshops for biotech students and companies. “We want the people in the field to be the sentinels, to recognize when someone is trying to abuse or exploit their work and call the F.B.I.”

No scientific team has yet admitted having one strain capable of the entire sugar-to-morphine pathway, but several are trying, and the Stanford lab of Christina D. Smolke is a leader. She said she expected one to be published by next year.

No one in the field thought there should be no regulation, she said, but suggestions that home brewers would soon make heroin were “inflammatory” because fermenting manipulated yeasts “is a really special skill.” Implications of research like hers should be calmly discussed by experts, she said, and Dr. Oye’s commentary “was getting people to react in a very freaked-out way.”

Robert H. Carlson, the author of “Biology Is Technology,” said restrictions were doomed to fail just as Prohibition failed to stop the home brewing of alcohol.

“DNA synthesis is already a democratic, low-cost technology,” he said. “If you restrict access, you create a black market.”

What is considered one of the last important missing steps, a way to efficiently grow a morphine precursor, (S)-reticuline, in brewer’s yeast, Saccharomyces cerevisiae, was published in Nature Chemical Biology on Monday by scientists from the University of California, Berkeley, and Canada’s Concordia University.

Photo

Kenneth A. Oye, a professor of engineering and political science at the Massachusetts Institute of Technology, said that drug-regulatory authorities are ill-prepared to control a process that can create heroin’s raw ingredient. Credit Stuart Darsch

The leader of the Berkeley team, John E. Dueber, said it was not trying to make morphine but 2,500 other alkaloids for which reticuline is a precursor, some of which might become antibiotics or cancer drugs.

Nonetheless, he said, since he realized his research has implications for the making of morphine, he sent his draft paper to Dr. Oye, suggesting the debate become more public.

One crucial question is whether the technology is of more use to the pharmaceutical industry or drug cartels. Dr. Oye argues it is the latter.

Companies are always seeking painkillers that create less addictive euphorias or do not paralyze breathing muscles, and having a predictable process they could tweak would be useful, but they already have a cheap, steady supply of opium from India, Turkey and Australia, where poppies are grown legally by licensed farmers.

That chain will be hard to disrupt. Since the 1960s, when it was created to convince Turkey to crack down on heroin, the International Narcotics Control Board has set quotas. Thousands of small farmers, their bankers and equipment suppliers depend on the sales, and they have local political clout just as American corn farmers do.

Also, pharmaceutical companies can already synthesize opiates in their labs. Fentanyl, a painkiller 100 times as powerful as morphine, is synthetic, as is loperamide (Imodium), an antidiarrheal opiate.

Heroin sellers, by contrast, must smuggle raw materials out of lawless Afghanistan, Laos, Myanmar and Mexico. Their supply lines are disrupted when any local power — from the Taliban to the United States Army — cracks down. Brewing near their customers would save them many costs: farmers, guards, guns, planes, bribes and so on.

One frightening prospect Dr. Oye raised was how viciously drug cartels might react if Americans with bioengineering know-how started competing with them. Gunmen from Mexican drug gangs have taken control of many secret marijuana fields in American forests.

His commentary suggested several possible steps to prevent misuse of the technology. The yeasts could be locked in secure laboratories, worked on by screened employees. Sharing them with other scientists without government permission could be outlawed.

Their DNA could be put on a watch list, as sequences for anthrax and smallpox are, so any attempt to buy them from DNA supply houses would raise flags. Chemically silent DNA “watermarks” could be inserted so stolen yeasts could be traced. Or the strains could be made “wimpier and harder to grow,” Dr. Oye said, perhaps by making them require nutrients that were kept secret.

Agent You said he did not want to comment on Dr. Oye’s suggestions, but was glad a threat had been identified by scientists before it was a reality, adding, “If this occurred across the board, it would make the F.B.I.’s life a heck of a lot easier.”

A version of this article appears in print on May 19, 2015, on page D1 of the New York edition with the headline: Makings of a New Heroin. Order Reprints| Today’s Paper|Subscribe

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Make the FDA Advisory, Not Mandatory

You should control what medicines you use, not the FDA. The FDA should make advisory recommendations only. It should NOT have the power to mandate which drugs you can buy, and which you cannot.

  • If pharmaceutical companies value the FDA seal of approval, then they can pay the FDA to evaluate their drugs.
  • If consumers value FDA approval, then they can decide to only buy FDA approved drugs.

If the FDA’s seal of approval is really so valuable, then it does NOT need to be mandatory. No coercion is necessary. Instead, the FDA should be able to sell its services through voluntary means, just like Underwriter’s Laboratory does.

Consumers and doctors should be free to consult available science, and make their own decisions about which treatments to try.

All human beings are unique. Treatments that might be dangerous for one person, could be the only possible solution for another. There is zero chance that one-size-fits-all dictates can possibly account for the vastness of human variability. Patients and doctors must have the flexibility to deal with individual human uniqueness.

The FDA should serve, not rule.

Talking Points:

There are thousands of reasons why the FDA should lose its power to coerce you and your loved ones. Some of these reasons will be listed below, so that you can use them when writing to Congress, or when asking your friends to contact Congress on this issue . . .

The FDA gives consumers a false sense of security. Americans assume that the FDA is actually protecting them, but it is not. For instance . . .

The Union of Concerned Scientists surveyed 6,000 FDA scientists in 2006, and 1,000 of them responded with the following disturbing admissions:

  • 17% admitted that they had been "asked explicitly by FDA decision makers to provide incomplete, inaccurate, or misleading information to the public, regulated industry, media, or elected/senior government officials."
  • Less than half agreed that the FDA "routinely provides complete and accurate information to the public."
  • 47% admitted to being aware of instances "where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal, or modification of FDA determinations of actions."

The FDA is constantly attempting to expand its powers. The people in that agency are relentlessly pushing into areas that are NOT part of their mandate — even where there is NO problem that needs to be fixed.

For Example: The FDA has made repeated attempts to regulate vitamins and supplements, even though there is no evidence that these things present any danger. Quite the contrary — vitamins and supplements are a powerful example of how health outcomes can be improved, without FDA involvement. The website of the Life Extension Foundation is full of scientific citations to demonstrate this. For instance . . .

A review of 2009 information for "adverse events" reported to the national control center’s data system shows that, NO major adverse events or deaths were reported for . . .

  • Botanical supplements like St. John’s wort, ginseng, and Echinacea
  • Hormone supplements like DHEA, melatonin, and pregnenolone
  • Phytoestrogen supplements
  • The joint- and cartilage-support supplements glucosamine and chondroitin
  • Vitamins A and E, and only one adverse event each was reported for vitamin B6 and C

In total, 41 major adverse events were reported for the entire spectrum of supplements including botanicals, amino acids, and vitamins, and only one was a death.

In contrast, more than 7,000 major adverse events were reported for pharmaceutical drugs, including a total of 496 deaths. And based on previous studies, we know the overall death rate for physician prescribed drugs to be far higher.

The Downsize DC position is pro-choice. The FDA should serve, not rule.

Use the form at right to send your elected representatives a letter about this issue. It’s easy!

  • Your position will be counted by each Congressional office,
  • Will educate the Congressional staffer who reads it,
  • May be passed up the chain of command,
  • May receive a reply (many DC Downsizers get them). If you receive such a letter, please share it with us at [email protected].

 

Send a letter to Congress

We provide the first few words of the letter so that Congressional offices will see the most important point

right at the start, and so that no one can hijack our system for another purpose.

Here’s the part we provide . . .

Make the FDA advisory, not mandatory.

LINK

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Medical marijuana company developing drug to protect NFL players’ brains

  • February 12, 2015
  • OCGreenRelief
  • Health, Medical Marijuana, News

    With America in the midst of a pot revolution, companies are lining up to jump on the medical marijuana bandwagon. But 99 percent of them don’t have the exclusive license from the federal government to commercialize a medical marijuana patent currently held by the National Institutes of Health (NIH).

    The patent, called  “Cannabinoids as Antioxidants and Neuroprotectants,” was quietly filed in 2005 when scientists from the NIH found certain cannabis compounds had neuroprotectant properties, “for example, in limiting neurological damage following ischemic insults, such as stroke or trauma, or the treatment of neurological diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.”

    “I think the [NIH wanted] a public-private partnership … the government does a good job of using taxpayer dollars to foster research and development, and NIH is the largest laboratory of its kind in the world in terms of scientific research and development,” Dean Petkanas, CEO of KannaLife Sciences told FoxNews.com. “They don’t want to develop drugs, but they’d like private interest such as ours to step up to the plate and say ‘We’re gonna take some risk with you.’”

    In 2013, Petkanas’ New York-based company, which specializes in the research and development of plant-derived pharmacological products, obtained the license from the NIH’s Office of Technology Transfer to bring a marijuana-based neuroprotective drug to the market.

    “We’ve taken the preclinical approach so far to date on our first indication which is hepatic encephalopathy, which is a brain-liver disorder, where you do have neuronal degradation and degeneration, oxidative stress,” Petkanas said. “So we felt that we could look at that in parallel with chronic traumatic encephalopathy, (CTE) another brain-related disease, and see if neuroprotection would indeed be afforded across that panel.”

    CTE is a progressive degenerative disease of the brain found in athletes with a history of repetitive head trauma. The condition garnered national attention with a rash of suicides in retired National Football League (NFL) players who were suffering from symptoms similar to those seen in patients with Alzheimer’s, or other neurodegenerative diseases.

    To date, more than 4,500 retired players have filed suit against the NFL claiming that the league downplayed, dismissed and even covered up knowledge of the long-term neurological damage associated with repetitive concussions. The players acknowledge that while they expected some injury in playing the contact sport, they did not expect neurological damage fraught with symptoms usually experienced by aging dementia patients.

    Petkanas hopes his company’s research will pave the way for the development of cannabidiol-based (CBD) drugs to help protect the brains of contact sports athletes.

    CBD is one of at least 85 active cannabinoids found in cannabis that can be extracted from the plant for medical applications. In the United States, an orally administered liquid drug containing the compound was granted orphan status approval by the Food and Drug Administration (FDA)to treat a rare seizure disorder in children.

    “We’ve found in some clinical research that cannabidiol, CBD, acts as a neuroprotectant, so in the parlance of pharmaceutical sciences, we could be using that as a prophylaxis against repetitive concussive injury,” Petkanas said.

    To help raise awareness about the medicinal properties of CBD and its potential applications in the world of sports, KannaLife Sciences partnered with former NFL defensive lineman, Marvin Washington, who is part of the lawsuit against the league.

    “I’ve seen some of the effects of the concussions and CTE with guys that I played with in my era,” Washington told FoxNews.com. “My son is a collegiate football player and this is for the quality of life of guys that are retiring, this is for protection of the current players and future players in the NFL and college. This just doesn’t cover the former players — the things that are happening in our lab are gonna cover everybody that plays a contact sport. It’s gonna make the game safer.”

    Washington acknowledged the NFL’s efforts over the past couple of years, and said that the tide started to turn after studies of hall-of-famer Mike “Iron Mike” Webster’s brain revealed the extent of neurological damage many players, both retired and current, are facing.

    “They reconfigured the Head, Neck and Spine Committee, and now they have neurosurgeons and neuroscientists on there that are heading it, and they did this two years ago, so yes, the NFL is doing a good job the past couple years,” Washington said. “But they’re saying they need to follow the signs — we want them to lead the signs, because they’re the biggest fish in the water out there.”

    But even though NFL commissioner Roger Goodell said earlier this year that he would consider allowing the use of medical marijuana as a neuroprotectant if the science is there to back it up, the league has had a notoriously tough stance on pot.

    A recent review of the league’s drug policy sought to institute blood testing for human growth hormone, strengthen the punishment for DUI arrests and reclassify controlled substances, but maintained the strict rules on marijuana as evidenced when Cleveland Browns wide receiver Josh Gordon received a 16 game suspension after testing positive for the drug – a punishment many have criticized in comparison to Baltimore Ravens running back Ray Rice, who was initially suspended for only two games after his arrest for assaulting his then-fiancée.

    Washington argued that while the drug KannaLife Sciences is working to develop would cause a positive result on a drug test for an active player, CBD has no psychoactive effects. And, he added, research is piling up that shows the benefits – especially for football players – outweigh any negative stigma associated with marijuana.

    “Everybody calls football a contact sport – it’s a collision sport. And I know the story right now is domestic violence, but concussions and CTE … this is not going away, because the players are getting bigger and faster and stronger, and so they need something to protect the head,” Washington said. “This is something that players are not going to get high off of or anything like that because it has no psychoactive effects.”

    Petkanas said his company plans to file an investigational new drug application with the FDA in early 2015. But, he added, this is just the tip of the iceberg for medical marijuana.

    “We’re looking at a 15 to 20 year curve of really isolating some of these cannabinoids … and how they play a role in relieving stress in multiple diseases and disorders,” Petkanas said. “It interplays with our endocannabanoid system.”

    source;

    http://www.foxnews.com/health

     

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  • Surgeon General Says Yes to Science, Admits Weed Has Medical Benefits

    Vivek Murthy says marijuana is ‘helpful’ for certain medical conditions. Could this be the tide-turner for legalization?

    Surgeon General Vivek Murthy believes in science.

    As he answered questions Wednesday about the measles outbreak that is turning into the year’s first public health emergency, the 37-year-old doctor assured Americans that vaccines are safe and that government policy is informed by sound data and scientific consensus. When CBS This Morning host Gayle King pivoted to ask Murthy for his views on marijuana, the country’s youngest ever surgeon general gave an answer that was at once historic and entirely consistent with his scientific approach.

    “We have some preliminary data showing that for certain medical conditions and symptoms that marijuana can be helpful,” Murthy said. “We have to use that data to drive policy making.”

    While a first for a surgeon general, this was not actually a risky statement. Murthy’s belief is in line with the positions of the American College of Physicians (PDF), the American Academy of Pediatrics, the American Public Health Association, the American Nurses Association (PDF), the Leukemia & Lymphoma Society (PDF), The California Medical Association (PDF), Dr. Sanjay Gupta, countless less famous but equally sincere physicians, and laws in 23 states and the District of Washington that permit the use of marijuana for medical conditions including multiple sclerosis, glaucoma, epilepsy, and a host of cancer-related symptoms.

    But the statement also seemed to put the nation’s top health official in direct conflict with federal law. To the Department of Justice and its Drug Enforcement Agency, marijuana remains, along with heroin, a Schedule I narcotic, defined as “drugs with no currently accepted medical use.” Cocaine and crystal meth, on the other hand, are listed as Schedule II drugs, with “less abuse potential.”

    This absurd policy has been inexplicable for so long, that the nation’s highest officials have given up trying to defend it.

    “I don’t think it’s more dangerous than alcohol,” President Obama said to The New Yorker’s David Remnick about marijuana last year. Casual as his remark seemed, Obama rocked the drug reform movement. Just weeks after the president said what a sizable majority of Americans already agreed with, a group of 18 representatives from nine states took a stand on the issue and, in a gesture of bi-partisan consent, wrote a letter (PDF) that called on Obama to take executive action.

    “We were encouraged by your recent comments in your interview with David Remnick,” the name-dropping representatives wrote. “Classifying marijuana as Schedule I at the federal level perpetuates an unjust and irrational system. We request that you instruct Attorney General Holder to delist or classify marijuana in a more appropriate was, at the very least eliminating it from Schedule I or II.”

    This absurd policy has been inexplicable for so long, that the nation’s highest officials have given up trying to defend it.

    Nine months later, in his exit interview with Katie Couric, Holder passed the buck right back.

    “At the federal level marijuana is still classified in the same category as heroin,” Couric said. “In your view should that change?”

    “I think that’s certainly a question that we need to ask ourselves,” Holder said, “whether or not marijuana is as serious a drug as is heroin.” Couric nodded and as Holder weighed the pros and cons, she pressed him on decriminalization. That, he said, is “something for Congress to decide.”

    Congressional action might be Holder’s preference, but it is not actually mandated by the law.

    “Eric Holder could initiate that process today if he wanted to,” said Tom Angell, chairman of Marijuana Majority, a decriminalization advocacy group, and pointed out that the 1970 Controlled Substances Act gives the attorney general sweeping power to define and classify the full schedule of illegal drugs. At the same time, Angell said, “Congress could pass a bill to move marijuana from Schedule I to a lesser one, or make it unscheduled, like alcohol or tobacco.”

    But as public opinion on the issue passes the super majority mark, neither branch of government has made a move. “In essence, the Justice Department and Congress are both begging each other to fix federal marijuana laws,” wrote Christopher Ingraham at the Washington Post. An aide to Senator Rand Paul told The Daily Beast that the Kentucky lawmaker is considering a bill this year that would reschedule the drug. “It’s a work in progress,” the aide said, but couldn’t offer any specifics. 

    In his interview with Couric, Holder left open the possibility that his department could one day endorse rescheduling marijuana. Whatever is decided, Holder said the government should let science be the guide. “Use science as the basis for that determination,” he said.

    A Department of Justice spokesman said, “the Department supports research into potential medical uses of marijuana.” Surgeon General Murthy told the Daily Beast that “marijuana policy—and all public health policies—should be driven by science” and that “the Federal Government has and continues to fund research on possible health benefits of marijuana and its components.”

    The problem with this, said Angell, is how difficult it is even for academic institutions to gain government approval for such studies. The American Medical Association (AMA), one of the most conservative organizations on marijuana decriminalization, changed its long-held position on classification in 2009. Marijuana’s ongoing schedule I classification “limits the access to cannabinols for even research,” said Edward L. Langston, MD, an AMA Board of Trustees member. “It is very difficult,” he told American Medical News, to legally research the substance. A report by the AMA Council on Science and Public Health that same year found that, “bureaucratic hurdles apply to cannabis research that do not impede other drug investigations.”

    Evidence for the claim is not hard to find. At the University of Massachusetts, an agricultural professor has been trying for more than 15 years to gain approval to grow cannabis for research. In Kentucky, the DEA finally released a shipment of research-bound hemp seeds last May, but only after the state’s agricultural commissioner sued the agency in federal court.

    The medical community and public opinion has come a long way in the 20 years since Dr. Jocelyn Elders, Surgeon General under President Bill Clinton, took flak for defending decriminalization. But even as a new surgeon general calls for more science, Angell said the research opportunities won’t change until the laws do, and that politicians are lagging behind most Americans on the issue.

    “They don’t realize that a majority of Americans are ready for medical marijuana to be legalized,” he said. “They perceive it as dangerous when it is not.” 

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