AK has a STRONG OPINION – about opiate crisis – not based on FACTS ?

https://kfor.com/2019/06/13/defense-questions-key-witness-for-state-in-opioid-trial/

NORMAN, Okla. — A key witness in the ongoing trial against the nation’s largest drugmaker described the company as the “kingpin” in the state’s opioid crisis.

Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University, testified Thursday he believed Johnson & Johnson was a “major cause” of the epidemic. The company is being sued by the state of Oklahoma, accused of fueling the opioid epidemic through deceptive marketing and downplaying the risks of addiction.

“In 2007, when Purdue Pharma was convicted criminally of claiming that OxyContin was less addictive because of its extended release formulation, Johnson & Johnson continued to sell opium and oxycodone to Purdue Pharma and continued to do exactly what Purdue Pharma was convicted criminally of doing,” Kolodny said. “It was Johnson & Johnson’s opium that flooded into the United States.”

He added the company then continued to promote their own products as having “lower abuse potential.”

Kolodny first took the stand on Tuesday after the state presented him as an expert witness, but defense attorneys objected to him being considered an expert on the subject. They argued Kolodny was not qualified to testify on the cause of the epidemic because his research primarily relies on correlation, not causation.

“Those are different things,” attorney Michael Yoder stated.

On Thursday, the defense continued to build their argument that Kolodny has not provided any evidence showing addiction or deaths in Oklahoma were actually caused by a doctor misled into prescribing their drugs.

Yoder: “You have some strongly held personal opinions. I’m not asking what they are right now. I’m just asking you if you agree that there are strongly held opinions.”

Dr. Kolodny: “Yes, I would imagine I would have some strongly held opinions.”

The trial continues on Friday.

Don’t Punish Pain Rally Montage

When local officers work with federal agents on joint task forces, they are prohibited from wearing body cameras

In this image, the Atlanta police chief speaks into a microphone from behind a podium.

Local police increasingly clash with federal law enforcement on body cameras

https://www.axios.com/local-police-federal-agents-body-cameras-e798279c-aecb-4303-84ef-cf46dbd2f320.html

Local police are increasing their use of body cameras, which often puts them at odds with the federal agents they work with — who “never wear body cameras,” the Washington Post reports.

The big picture: A 2018 Justice Department survey found that 47% general-purpose law enforcement agencies had acquired body cameras by 2016. 80% of the largest local police departments, which employ 500 or more full-time sworn officers, had acquired body cameras by that time.

What’s happening: Local police departments tell the Post the DOJ “has helped fund and train local police departments in body-camera use while ignoring federal use.” When local officers work with federal agents on joint task forces, they are prohibited from wearing body cameras.

What they’re saying:

  • “I believe they have an obligation to join us in 21st-century policing,” Todd Axtell, the St. Paul, Minnesota police chief, told the Post about federal agencies.“This is what they’ve been preaching. It’s ironic they aren’t complying with what they preach to be so important in policing.”
  • The Justice Department’s lack of camera use is due to “safety and security concerns, such as protecting sensitive or tactical methods used in arresting violent fugitives or conducting covert investigations,” a DOJ official told the Post.
  • “If you’re policing and you’re policing properly,” Atlanta Police Chief Erika Shields told the Post, “you have nothing to fear” from wearing a body camera.

What to watch: Shields pulled Atlanta’s officers from federal joint task forces with the DEA, the FBI and others after federal agents refused to wear body cameras — and chiefs in Houston and Austin are considering the same if a compromise isn’t reached with federal agencies.

Go deeper: The police technology revolution no one is hearing about

 

Chronic Pain Patients To “Assemble” at the CDC on June 21st

Chronic Pain Patients To “Assemble” at the CDC on June 21st

Chronic Pain Patients To “Assemble” at the CDC on June 21st

www.nationalpainreport.com/chronic-pain-patients-to-assemble-at-the-cdc-on-june-21st-8840092.html

An Indianapolis woman is leading a group of chronic pain patient for a two-hour event in front of the Centers for Disease Control Office in Atlanta on Friday June 21st.

Johnna Magers says that patients—some of whom who will be in wheelchairs– from Texas, Indiana, Kentucky and Colorado are already planning to go.

The group is called Chronic Pain Warriors Unite for Our Right to Pain Management.

The idea she said is “we want to educate the CDC” about the impact its Guideline for Opioid Prescribing for Chronic Pain has had on patients.

In April, CDC issued a statement that stated that some policies, practices attributed to the Guideline are inconsistent with its recommendations. Here’s the media statement.

But for many pain patients that moderation was too little too late.

Magers has been promoting the event thanks to number of Facebook pain groups and others and says there’s understandably lots of enthusiasm for the getting more visibility for the chronic pain patient point of view.

The Facebook page for the event is CDC Protest for Pain Patients. As the Facebook page says, “We will have an assembly peacefully to show our dissatisfaction of the CDC 2016 guidelines that have affected millions of lives.”

In addition, she has what she described as a 40-page list of chronic pain patients who have taken their lives in the last several years and will have some cut-outs to commemorate them in their line of protestors in Atlanta Saturday.

Magers is a 50-year old woman who has battled chronic pain for 15 years—at times the pain was so debilitating she could barely work. “I know that I’m going to need pain medicine for the rest of my life.”

The group—which has already secured an assembly permit–will gather at Clifton Road and CDC Parkway in Atlanta. The event will also be live streamed on social media.

Magers wanted to give credit to a number of groups that have been supporting this effort including Pain is Pain, Chronic Pain Voices, CCP News Source, Chronic Pain Support-Pain Doctor.com, International Support Fibromyalgia Network, Adele Faba Foundation for CRPS/PAIN, Refugees of the Opioid Crisis, Don’t Punish Pain Rally Organization, Chronic Pain Patients Lives Matter, United in Pain, Pain in the USA, Pain Patients United Community, Chronic Pain Management Forum, The National Pain Report, PAW Pain Advocate Warriors, Richard A. “Red” Lawhern Ph.D., Steve Ariens P.D.R.Ph., Leah Houston, M.D., and Arnold Feldman, M.D.

Magers is looking for more people. If you want to find out more about the event or contact her directly, email her chronicpainpatients@gmail.com or visit their Facebook page

UPDATED: As seen on the web 06/10/2019 – share with all

Mexican poppy production INCREASED 300% this decade

Mexico’s poppy and heroin production down slightly but still at record highs

https://mexiconewsdaily.com/news/poppy-and-heroin-production-remain-at-record-highs/

Poppy cultivation and heroin production remain at record-high levels in Mexico, according to the United States government.

The Office of National Drug Control Policy (ONDCP) said in a statement yesterday that an annual U.S. government estimate found that the area of land dedicated to poppy cultivation decreased by 5% from 44,100 hectares in 2017 to 41,800 hectares last year.

But the size of the area was the second highest recorded this decade and 298% above the low of 10,500 hectares estimated in 2012.

The ONDCP said that the potential for pure heroin production declined by 4% from 111 tonnes in 2017 to 106 tonnes last year. They were the only years in the last decade in which heroin production estimates have exceeded 100 tonnes.

Production last year was 31% higher than in 2016 and 308% above the lowest level estimated this decade – 26 tonnes in both 2012 and 2013.

Mexico continues to be the primary supplier of heroin to the United States, the ONDCP said, explaining that 91% of heroin seized by the Drug Enforcement Administration (DEA) in 2017 was determined to have originated in Mexico.

Six Mexican criminal organizations – the Jalisco New Generation, Sinaloa, Juárez, Gulf, Los Zetas and Beltrán Leyva cartels – have the greatest drug trafficking impact on the United States, according to the DEA.

“Poppy cultivation and heroin production in Mexico continue to threaten the United States,” the ONDCP said.

In 2017, the Centers for Disease Control and Prevention reported that 47,600 Americans died from overdoses involving opioids and that 15,482 of those deaths involved heroin.

“President Donald J. Trump is focused on stopping the trafficking of heroin and other dangerous drugs coming from Mexico.  He declared a national emergency on our southern border in part to ensure the safety of the American people from these deadly drugs,” the ONDCP said.

According to the Mexican government, cartels also ship fentanyl to the United States from 13 states.

The rising demand for the powerful synthetic opioid among U.S. drug users has been identified as the cause of plummeting opium gum prices in Mexico.

United States Secretary of State Mike Pompeo told senators Tuesday that during the migration tariff negotiations between U.S. and Mexican authorities last week there were also discussions about measures to stop the production and transit of illicit drugs.

“The joint declaration we signed was mostly focused on migration, but a good deal of the conversation was . . . about the traffickers’ desire to move whatever product will bring a market price that causes them to have an incentive to continue to do the things that disrupt so many lives here in the United States,” he said.

“We’ll try and take down these criminal enterprises between all of the elements of the U.S. government. We’ve donated equipment to the Mexican law enforcement, security forces; we’ve trained their officers to eradicate poppy and interdict drugs; we’ve provided them sniffing dogs. And yet, as you can see from the data today, many challenges remain.”

The VA Killed Me Russell Ervin Video

head of Suboxone mafia: testified at J&J opiate crisis trial

Opioid epidemic expert testifies drug companies used front groups

https://oklahoman.com/article/5633797/opioid-epidemic-expert-testifies-drug-companies-used-front-groups

NORMAN — Johnson & Johnson and other opioid manufacturers used a “web” of front groups and paid physicians to push for more liberal prescribing of opioids, an expert witness on the nation’s opioid epidemic testified Wednesday.

Helping orchestrate the campaign was a group called the Pain Care Forum, said New York City psychiatrist Andrew Kolodny.

Kolodny referred to the group as the “opioid mafia” and described it as a collaboration of officials from Johnson & Johnson, Purdue Pharma LP and other opioid manufacturers and advocacy groups.

Drug manufacturers and front groups that were part of that group continued their marketing push even after opioid deaths had skyrocketed and it had become obvious that the overprescription of opioids was causing a public health crisis, he testified.

“They were going to do everything they could to block cautious opioid prescribing,” Kolodny said.

Kolodny spent all afternoon on the witness stand Wednesday during Day 12 of what is expected to be a two-month Cleveland County District Court trial in a case where Johnson & Johnson and its subsidiaries have been accused of creating a multibillion dollar public nuisance.

The companies are accused of helping cause an opioid epidemic that led to thousands of Oklahoma opioid deaths and addictions through false or misleading marketing efforts that understated the risks of addiction and overdose death associated with opioids, while overstating their benefits.

Kolodny testified that two advocacy groups, the American Pain Society and American Academy of Pain Management, touched off the nation’s opioid crisis in 1996 when they published a paper that promoted the idea that “pain is often managed inadequately despite the ready availability of safe and effective treatments.”

That paper “blew a hole” through the dam of conservative prescribing practices that physicians had followed with opioids for more than a century, Kolodny said.

Kolodny testified that opioid manufacturers have funded many “front groups” over the years that have masqueraded as grassroots organizations that support more liberal prescribing of opioids to treat pain.

He identified the American Pain Foundation as one such organization and talked about a chart that showed it had received more than $5 million from pharmaceutical companies, including $635,000 from Johnson & Johnson.

Kolodny cited numerous examples of messages put out by various advocacy groups and opioid manufacturers that have claimed untreated pain is a major problem in the United States.

Over the years, various groups have contended that anywhere from 34 million to 116 million Americans suffer from untreated pain, but there is no objective data to support any of those numbers, he said.

 

FDA Advisors on Opioid Dosing Limits: We Dunno

FDA Advisors on Opioid Dosing Limits: We Dunno

Too little data to go on, members say

https://www.medpagetoday.com/publichealthpolicy/opioids/80451

If FDA panelists reached one consensus at the end of a two-day meeting this week, it was that there’s not enough information to know just what regulatory action — if any — the agency should take about higher-dose opioids for outpatients with constant or chronic pain.

“We need much better-quality data to help inform us,” summed up panelist Sean Mackey, MD, PhD, of the Stanford School of Medicine.

Questions about the needs of chronic pain patients and the role opioids play in their lives remain unanswered, members of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesia Drug Products Advisory Committee said. “To get at those uncertainties we need better, high-quality data in real-world patients,” Mackey stated. “This is an incredibly vulnerable patient population.”

The FDA held the public meeting Tuesday and Wednesday to discuss the risks and benefits of strong opioid doses — defined loosely as 90 morphine milligram equivalents per day or more — and whether the agency should consider action to reduce access to high-strength products. Just what that action might be was unclear: “We’re talking about the impact of any possible action you think we should or shouldn’t do,” an FDA official told the committee. “Nothing’s on or off the table.”

The meeting was announced in April, just weeks after the advocacy group Public Citizen called for a moratorium on new opioid drug approvals until a new regulatory framework, such as the one proposed in a 2017 National Academies of Science, Engineering, and Medicine report, is developed.

It also came on the heels of a Risk Evaluation and Mitigation Strategy (REMS) launched in September for immediate-release opioids, expanding the FDA’s REMS for extended-release and long-acting opioids for outpatients established in 2012.

Some groups have asked the FDA to withdraw the approval of higher dosage strength oral and transmucosal opioid analgesics due to safety concerns, said Judy Staffa, PhD, RPh, associate director for the Public Health Initiatives Office of Surveillance and Epidemiology at the FDA’s Center for Drug Evaluation and Research (CDER), in introductory remarks.

“Higher dosage strength products may be more harmful in cases of accidental exposure and overdose, and may also be more sought out for misuse and abuse,” she noted. In recent years, federal, local, state, and payer efforts have evolved to encourage more judicious prescribing of opioid analgesics, she said: “It is in this complex and changing environment that we need to consider potential regulatory actions that would impact the availability of higher dosage strength products to vary degrees, depending on the action taken.”

But without more data, the value or harm of new FDA action is unclear, panelists said. “We don’t know what would happen with misuse and abuse and what would happen with public health,” acknowledged Moon Hee V. Choi, PharmD, of CDER’s Division of Advisory Committee and Consultancy Management. And many committee members voiced concerns that any action to limit high opioid doses could destabilize pain patients and lead to lower quality of life and suicidality.

“I see a lot of risks associated with that, for patients particularly,” said panelist Joseph O’Brien, president of the National Scoliosis Foundation in Stoughton, Massachusetts. “Probably the best example of that is the misuse and misunderstanding of the CDC guidelines.”

“We have now shifted the opioid epidemic to a patient-care crisis,” O’Brien stated. “There is now more feedback from patients and concern and alarm that they’re not getting what they need.”

Others at the meeting, including guest speaker Adriane Fugh-Berman, MD, of the Georgetown University PharmedOUT project, called for high-dose opioids to be removed from the market completely.

“I can’t think of another self-administered class of medications where doubling a dose has potentially lethal consequences,” Fugh-Berman told the advisory committee. “A handful of pills is a visual reminder that you’re taking a lot of medicine, and that’s a good thing.”

But taking a handful of opioids opens up greater risks for patients who aren’t sure how many they have taken in a day and poses hardships for those who have difficulties swallowing, some panelists argued. It also makes it difficult to spot whether others are diverting pills for their own use.

Clearer education about high-strength opioids and proper disposal is needed, most panelists urged. Using specialists to follow patients with high-dose prescriptions more closely also could minimize patient risks — and that doesn’t necessarily mean physicians, pointed out panelist William Becker, MD, of Yale School of Medicine. “Consider a model like a Coumadin clinic, where pharmacists do the requisite monitoring and make decisions on dose titrations,” he said. “This is the kind of distributed model that might work to help preserve access, yet ratchet up the amount of appropriate monitoring and specialization that will increase safety.”

To encourage further discussion, the FDA has established a docket for public comment about this issue, which remains open until June 30. To date, more than 1,000 comments have been registered.

The agency will not issue a final determination until input from the advisory committee process has been considered and all reviews have been finalized. That determination may be affected by issues not discussed at the advisory committee meeting.

If the FDA can’t/won’t make opiate dosing recommendations because  there’s not enough information to know just what regulatory action — if any — the agency should take about higher-dose opioids for outpatients with constant or chronic pain.

One has to ask… what sort of data does the DEA and CDC have to come to rather specific limits on opiate dosing and/or what combination of meds have NO VALID MEDICAL USE ?

Could it be that the DEA is just coming up with OPINIONS to try to justify their activities ?

Do You Experience Chronic Pain? – survey link on post

Do You Experience Chronic Pain?Do You Experience Chronic Pain?

https://www.healthywomen.org/content/article/do-you-experience-chronic-pain

HealthyWomen is studying how chronic pain impacts women’s lives. Please take a moment to share your experience with us. Results will be gathered anonymously and shared with researchers, clinicians and patients at HealthyWomen’s Chronic Pain Summit at the Turf Valley Resort in Ellicott City, MD. Click here to learn more about the summit.

Survey on the link above

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