FDA Funds Study of Therapies for Pain, Addiction, Sedation

https://www.urmc.rochester.edu/research/blog/October-1/FDA-Funds-Study-of-Therapies-for-Pain-Addiction-Se.aspx

A team led by Robert H. Dworkin, Ph.D., professor in the department of Anesthesiology has been awarded five years of funding from the FDA for up to $4 million to speed the discovery and development of analgesic, anesthetic, addiction and peripheral neuropathy treatments for patients. The award continues the work of the ACTTION public-private partnership, which was initiated by the FDA, Dworkin and Dennis Turk, Ph.D., from the University of Washington in 2010. 

ACTTION, which stands for Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, studies different approaches to improve the methods used to evaluate and approve safe and effective treatments for patients who have few or no options. The work is greatly needed: in the last decade, very few truly new therapies have been approved by the FDA for acute or chronic pain. In addition, individuals with diabetic peripheral neuropathy or chemotherapy-induced peripheral neuropathy have no disease-modifying treatment options. The few existing treatments in addiction medicine lack strong safety and efficacy profiles, and though adequate sedation approaches exist, many are old and companies are unsure of the best way to test new methods.  

The ACTTION team’s focus will be the assessment of outcome measures and clinical trial designs. One major undertaking is making the pain scale, which patients use to rate their pain from 0 to 10, more “user friendly” so that patients’ responses more accurately and consistently reflect their pain experience. An improved pain scale will allow researchers to better gauge the efficacy of new treatments. Another is defining “success” in clinical trials of treatments for stimulant addiction: is a therapy considered successful if a patient addicted to cocaine becomes abstinent, or reduces cocaine use by 50 percent? These and many other questions will be addressed through extensive data review, carefully designed studies and consensus meetings.

ACTTION involves the collaboration of public and private organizations, including professional societies, patient advocacy groups, industry and government. The group recently published its sixtieth journal article. In addition to Dworkin, Denham S. Ward, M.D., Ph.D., professor emeritus and past chair of the Department of Anesthesiology and Jennifer Gewandter, Ph.D. and Shannon Smith, Ph.D., both assistant professors of Anesthesiology, participate in ACTTION.

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The CDC SPIDER bites! CDC Whistleblowers Team Up and Demand “House Cleaning” and Lend Credence to Increasingly Critical Views of Authority Structures

globalfreedommovement.org/the-biggest-medical-whistleblower-event-in-history-just-happened/

While the mainstream media and medical/Big Pharma spokespeople were doing their best to ignore the raging conflagration that is the VAXXED phenomenon and pretend it isn’t happening, another major blow was just struck against the entrenched liars in politics claiming across-the-board “safety” and “zero risk” of vaccines (see: Victorian Health Minister Jill Hennessy). CDC whistleblower/confessor William Thompson – the primary subject of the VAXXED documentary – appears to have triggered somewhat of a whistleblower avalanche following his explosive confession that he and his superiors literally binned (yes, threw in the trash) hard evidence linking vaccines to autism, thus vindicating the work of numerous scientists around the world who have detected such causal connections.

This most recent blow against such malfeasance and criminal conspiracy consists of a letter addressed to Chief of Staff Carmen Villa at the CDC and signed off on by a group of at least a dozen disenchanted/fed up CDC scientists identifying themselves as SPIDER (CDC Scientists Preserving Integrity, Diligence and Ethics in Research).

CDC SPIDER constitutes the biggest whistleblower event we’ve ever seen, bigger even than Thompson’s disturbing and compelling confession of conspiracy and coverup at the highest levels. The latest bombshell reveals (read: confirms once more) that the corruption and complicity are not anomalies, but entrenched systemic problems.

SPIDER’s August 29, 2016 plaintive demand opens with this extremely revealing paragraph (emphasis added):

We are a group of scientists at CDC that are very concerned about the current state of ethics at our agency.  It appears that our mission is being influenced and shaped by outside parties and rogue interests. It seems that our mission and Congressional intent for our agency is being circumvented by some of our leaders.  What concerns us most, is that it is becoming the norm and not the rare exception.  Some senior management officials at CDC are clearly aware and even condone these behaviors.  Others see it and turn the other way.  Some staff are intimidated and pressed to do things they know are not right.  We have representatives from across the agency that witness this unacceptable behavior.  It occurs at all levels and in all of our respective units…We are asking that you do your part to help clean up this house!

Let’s decode some key phrases:

• “Outside parties and rogue interests.” =  Big Pharma and general corporate whores with connections to (or jobs in) these key agencies (CDC, AMA, etc.). It’s well known that there is a revolving door between massive pharmaceutical corporations and government agencies, such that “outside parties” tend to become “internal parties” and vice versa. The governmental arena has been thoroughly infiltrated by these “rogue interests,” to the extent that such interests control policy creation itself.
• “…becoming the norm and not the rare exception.” – Well, let’s be real: this problem became normative a long time ago. Their statement shows that ALL authoritative claims around health/medical issues/medical interventions made by authorities such as the CDC or AMA should be viewed with suspicion and investigated thoroughly instead of taken prima facie (at face value). In other words, CDC and other such government agencies lie… a lot.
• “Some senior management officials…even condone these behaviors.” – Because they are paid handsomely to sell humanity out to the highest bidder, whether Big Pharma, Coke, or what have you. Senior management condoning this activity creates a top-down systemic problem that poisons the entire barrel, so to speak. A strained climate of pressure to “go along to get along” ensues. The public’s suspicion of such agencies is thus well justified.
• “It occurs at all levels and in all of our respective units.” I.e., no part of the CDC apparatus remains untainted by this repugnant corruption (See: William Thompson’s confession). It is all-pervasive and, frankly, we have no reason at all to believe this problem is restricted – as if by magic – to just the CDC. Parallel government agencies with similar or related functions are just as compromised. Truth is a minor concern (or even just plain problematical) for these corrupt elements whose primary interest appears largely to be lining their pockets with a lot of cash.

The SPIDER letter also outlines some other issues, including data manipulation by the National Center for Chronic Disease Prevention and Health Promotion in the Wise Woman Program in order to present misleading results to Congress (“to make the results look better than they were.”) As they said, “definitions were changed and data ‘cooked’” – now where have we heard about definitions being changed before? Ah, yes, POLIO (but that’s another scandal for another day).

SPIDER added:

An “internal review” that involved staff across CDC occurred and its findings were essentially suppressed so media and/or Congressional staff would not become aware of the problems.

SPIDER also singled out Drs. Barbara Bowman and Michael Pratt for their “irregular (if not questionable) relationships with Coca­Cola and ILSI representatives.  Neither of these relationships were necessary (or appropriate) to uphold our mission.  Neither organization added any value to the good work and science already underway at CDC…It appears to us that something very strange is going on with Dr. Pratt…His behavior and that of management surrounding this is very troubling.”

Carey Gillam reported on the notorious Bowman and dubious Pratt (whose surname seems apt):

It’s all merely the tip of a corrupt and fetid iceberg, folks.

Finally, the CDC SPIDER letter closes with:

Why has the CDC OD turned a blind eye to these things.  The lack of respect for science and scientists that support CDC’s legacy is astonishing. Please do the right thing.
Please be an agent of change.
Respectfully,
CDC Spider
(CDC Scientists Preserving Integrity, Diligence and Ethics in Research)

Remember, fellow change agents: it is agencies such as the CDC, AMA, TGA, etc. that are orchestrating the war on natural/”complementary” medicine. It is these outlets that are enacting Big Pharma’s modern day Inquisition against natural healing and demonizing those modalities and their practitioners at every opportunity, employing the lap dog mainstream media to great effect. Simultaneously they engineer a cult-like mentality in the public at large, touting the unquestionable “benefits” of various mainstream interventions while aggressively discouraging any free thinking or critical analysis. Anyone who points out the well documented risks or harms resulting from said “wonderful” interventions is mocked and ostracised in the most juvenile form of groupthink imaginable. Welcome to 1984, 2016 style.

Beware the players with the deepest pockets – they have the motive and the means for distorting collective reality and convincing millions of us that black is white and 2 + 2 = 5.

I’m pretty sure that 2 + 2 = 4, even when it’s not “PC,” and even when our government agencies and ministers insist the answer is “5.”

Not to worry – there are legal means of dealing with their mendacity and complicity.

The truth will out.

About the Author

Co-founder of Global Freedom Movement and host of GFM Media, Brendan D. Murphy is a leading Australian author, researcher, activist, and musician. His acclaimed non-fiction epic The Grand Illusion: A Synthesis of Science & Spirituality – Book 1 is available here. Come and get your mind blown and DNA/kundalini activated at www.brendandmurphy.net
“Brendan is the Chomsky of the Spiritual movement.” – Alistair Larmour, medical intuitive
“Every person in the field of ‘paranormal’ psychology or related topics should have this book as a major reference.” – Dr. Buryl Payne
“A masterpiece…The Grand Illusion is mind-blowing.” – Sol Luckman, author of Potentiate Your DNA.
“You’ve written the best synthesis of modern science and esoteric science that I’ve seen in 40 years…Brilliant!” – Michael K. Wade

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Apparently some people believe that I am VERY PRO-TRUMP… when I am really VERY ANTI-CLINTON… but I looked at this post that was done two weeks ago and only TWELVE people viewed it. If you think that having another ATTORNEY in the White House – that will be supportive of the legal system/DEA –  and most likely keep the current AG, head of DEA and Surgeon General and continue the path that Obama has created and your pain management and quality of life will get better and not worse.. then vote for going down that path…  It is obvious to me that “the establishment” will do just about anything – legal/illegal – to keep “the establishment” in power… political party really doesn’t matter to them. All we have to do is look back a couple of decades to see how this has worked out for most of us.

There is a difference between anti-Clinton and pro-Trump

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The Third-Leading Cause Of Death Is Preventable, But Candidates Don’t Mention It

http://www.forbes.com/sites/leahbinder/2016/10/26/the-third-leading-cause-of-death-is-preventable-but-candidates-dont-mention-it/#6626222f530e

Leah Binder ,  

Contributor

Opinions expressed by Forbes Contributors are their own.

 It is more likely to kill you than terrorism. It has profoundly impacted virtually every American family. So this election year, why aren’t politicians at all levels of government talking about the third-leading cause of death in America—preventable errors in healthcare?

The statistics are staggering: more than 500 patients per day are killed by errors, accidents and infections in hospitals alone. Medical errors kill more people annually than breast cancer, AIDS or drug overdoses. One in four Medicare beneficiaries admitted to a hospital suffers some form of preventable harm during their stay. And yet, it’s nowhere to be found in those stump speeches.

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There are a few reasons for the silence. First is all about the illogical way Americans pay for health care. With the traditional “fee for service” model, we pay for procedures and tests—not outcomes. It means we also pay for medical mistakes. If you got the wrong medication in post-op, chances are no doctor or nurse will tell you about it. But it will show up on your bill, alongside the charges for any other intervention required to treat your adverse reaction. Considering that deciphering these bills is akin to reading hieroglyphics, many of us are victims of medical mistakes without even realizing it.

Another reason we may not hear much about it is that our political candidates are not eager to annoy deep-pocketed supporters. Last year, the healthcare and pharmaceutical sector was the top lobbying industry in Washington, spending $240 million—twice as much as Big Oil. At the local level, hospitals are often one of the largest employers in a community, a pillar of almost every congressional district. While many healthcare leaders are outspoken and bold proponents of change, some are embarrassed by the errors and would prefer their politicians not dwell on it.

Just this summer, CMS faced enormous backlash after announcing its intention to issue five-star ratings for hospital safety and quality, based on over 60 tested and validated measures. (My organization also assigns grades to hospitals based on data from CMS and our own annual hospital survey). Congress tried to suppress the release of the CMS star ratings, at the urging of the hospital lobby, which argued the measures weren’t perfect and the methodology wasn’t fair. (Fortunately, it didn’t prevail and the ratings were released, albeit a few months behind schedule.)

Finally, how to measure healthcare performance—what data to collect and how to share it—can be as controversial as the current election itself. Most healthcare leaders agree we need measure quality to ensure accountability and improvement, but the agreement stops there. Many leading researchers and organizations like the National Quality Forum, which reviews and validates quality metrics, have helped guide us toward resolving some of these controversies, but the debate rages on.

Curiously, experts even disagree over how to measure the death toll from medical errors. Earlier this year the reputable BMJ released a study showing that medical errors are the third-leading cause of death in the U.S. But some researchers pushed back, citing concerns about the study’s definition of medical error. This led to a distracting and disheartening series of arguments in the medical literature about which errors outright kill patients and which merely hasten a patient’s inevitable decline. Can’t we agree that even one preventable patient death is one too many? And everyone agrees that at a minimum the death toll is in the thousands.

The good news that candidates should embrace is that this problem can be solved, and it’s not expensive to do so. The administrations of Presidents Bush and Obama made substantial moves to shift Medicare away from the bloated fee-for-service model. Many employers and other purchasers of health benefits have taken similarly bold steps. A good number of hospitals and health systems have dramatically improved their safety records by making patient well-being a top priority. That means they enforce rules about hand hygiene or surgical checklists, and follow known best practices for protecting their patients. As a result of this progress, deaths and injuries from infections and errors are down, particularly in high-performing health systems. But too many Americans remain at serious risk.

Solving this requires putting a priority on patients. Elected officials, health systems and business leaders showed us results by embracing that priority. Now it’s time for our candidates to do the same.

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https://youtu.be/4lMp_363B2c

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Medical marijuana legal in Ohio, but patients still can’t get it

http://www.dispatch.com/content/stories/local/2016/10/26/medicine-medical-marijuana-legal-but-patients-still-cant-get-it.html

Can you legally buy medical marijuana in Ohio?

If so, can you get it from a licensed medical marijuana dispensary, family member or friend, drug dealer or grow it yourself?

You would think the answers to these questions would be simple and straightforward under the letter of the law. Not so much.

Technically, medical marijuana has been legal in Ohio since a new law, House Bill 523, took effect Sept. 8.

But as of yet — and probably not until 2018 — patients in Ohio cannot legally buy marijuana for medical purposes.

Before that happens, the complicated, time-consuming job of drafting rules, policies, certifications, licenses and many other things must be completed. Rules don’t have to be in place, by law, until next year. Only after rules go through two state oversight agencies can cultivators begin growing marijuana crops, with processing, lab testing and sales through licensed dispensaries to follow.

That begs the question: Is it legal now?

The best answer to that came last week from the State Medical Board. Even then, it wasn’t a very good answer.

Advocates have pressed the board to allow physicians to utilize an “affirmative defense” clause in the statue, essentially offering legal protection against prosecution if physicians recommend medical marijuana for a patient prior to it being available here.

Robert Giacalone, a medical board member, said the agency “is in no way prohibiting the recommendation of medical marijuana now that HB523 is effective.” But he added there is “ conflicting language” in the law because of a provision prohibiting physicians from recommending marijuana until Ohio rules are written and the product is grown and sold in the state.

“If any physician wishes to recommend medical marijuana before the rules are in place, we strongly recommend that they contact a private attorney,” Giaclone said at a board meeting last Wednesday.

Rob Ryan, head of Ohio Patient Network, an advocacy group, said, “There is no doubt in my mind that people with qualifying conditions should be able to get medical marijuana in Ohio.”

Ryan said he knows some physicians are recommending marijuana but, like patients, they are being very cautious.

Asked where patients can get marijuana if they have a physician’s recommendation, Ryan said, “it might be growing in your backyard or basement, from a family member or friend, or a dealer as a last resort. I’d be very careful going out of state.”

Attorney General Mike DeWine’s office, which advises the medical board, concludes it would be “ very difficult” to legally obtain marijuana in Ohio at this time.

“Everybody knows there’s significant lead time built into this statute,” DeWine spokesman Dan Tierney said. “We don’t have the specific rules in place at the medical board or the pharmacy board.”

Ohio will not permit smoking marijuana for medical purposes. Alternatives are vaping, oils, patches and edibles.

Officials with the Ohio Commerce Department, which will oversee and license cultivators, processors and testing labs, and the Ohio Board of Pharmacy, which is in charge of dispensaries and a patient registry, said they are working on draft rules to be released later this year.

The rules will have to be reviewed by the Common Sense Initiative panel, which looks at the impact of government regulation on business, and the Joint Committee on Agency Rule Review, a legislative body that considers rules enacted by state agencies.

Another potential hurdle being put up by dozens of communities statewide are moratoriums on medical marijuana dispensaries. The moratoriums range from six months in New Albany, Pickerington, Springfield and 40 other cities to 18 months in Bexley, and a permanent ban in Hamilton in Butler County.

The delays and moratoriums are seen as chipping away at the law by Savannah Smith of the Ohio Rights Group, an advocacy organization.

“It’s extremely frustrating,” Smith said. “The sick, dying and disabled of Ohio are our most vulnerable. They are medical refugees.

“We had hoped this law would provide some real relief for the population that we’ve been fighting for for years.”

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Drug maker thwarted plan to limit OxyContin prescriptions at dawn of opioid epidemic

www.statnews.com/2016/10/26/oxycontin-maker-thwarted-limits/

ELCH, W.Va. — The warning signs of what would become a deadly opioid epidemic emerged in early 2001. That’s when officials of the state employee health plan in West Virginia noticed a surge in deaths attributed to oxycodone, the active ingredient in the painkiller OxyContin.

They quickly decided to do something about it: OxyContin prescriptions would require prior authorization. It was a way to ensure that only people who genuinely needed the painkiller could get it and that people abusing opioids could not.

But an investigation by STAT has found that Purdue Pharma, the manufacturer of OxyContin, thwarted the state’s plan by paying a middleman, known as a pharmacy benefits manager, to prevent insurers from limiting prescriptions of  the drug.

The financial quid pro quo between the painkiller maker and the pharmacy benefits manager, Merck Medco, came to light in West Virginia court records unsealed by a state judge at the request of STAT, and in interviews with people familiar with the arrangement.

“We were screaming at the wall,” said Tom Susman, who headed the state’s public employee insurance agency in the early 2000s and led the push to limit OxyContin prescribing in West Virginia.

“We saw it coming,” he said of the opioid epidemic, which today causes 28,000 overdose deaths a year in the United States. “Now to see the aftermath is the most frustrating thing I have ever seen.”

Overprescribing of OxyContin and other opioid painkillers is blamed for helping to plant the seeds for the current opioid crisis. West Virginia has been hit harder than any other state: It suffers the highest per capita drug overdose death rate in the country — more than double the national average. It also has one of the highest rates of painkiller prescribing.

In McDowell County, where the court records from a state lawsuit against Purdue were unsealed, the local sheriff said prescription pill abuse is so rampant that the county plans to file a new lawsuit against painkiller makers.

The strategy to pay Merck Medco extended to other big pharmacy benefit managers and to many other states, according to a former Purdue official responsible for ensuring favorable treatment for OxyContin. The payments were in the form of “rebates” paid by Purdue to the companies. In return, the pharmacy benefit managers agreed to make the drug available without prior authorization and with low copayments.

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AT&T earns millions selling call data to law enforcement without court order

http://www.phonearena.com/news/AT-T-earns-millions-selling-call-data-to-law-enforcement-without-court-order_id87067

When it comes to call info sweeps, nothing beats the NSA, one might think, but they would be wrong. Back in 2013, the New York Times discovered that the DEA – you know, the department in charge of the “war on drugs” – appears to have logged billions of AT&T call records, in fact a 26-year amount, and counting. Dubbed Project Hemisphere, the undertaking lifted off in 2007, and has apparently never looked back.

We are talking here about actual AT&T personnel sitting in DEA’s offices, helping with the data collection and assisting with, say, tracking those “burner” phones drug dealers use, says the Sunday Times. The report was based on a 27-slide PowerPoint presentation by the DEA, meant for law enforcement officials. The government is apparently chipping in for the expenses connected with all that snooping that goes back to phone records from 1987, and includes every call that has ever passed through the AT&T network, including from other carriers.

This is a pretty dangerous precedent, and AT&T has the incentive to keep the scheme going. After all, municipalities are paying well for using Hemisphere, from $100 thousand to more than a million a year, so why ruin a good thing with extra privacy precautions. The money then get reimbursed through that same police militarization program that supplies Iraq insurgency level equipment to local police departments, so ultimately it’s the taxpayer covering the costs on their own court order-less snooping.

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