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

Posted on June 15, 2019 by Pharmaciststeve

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Mexican poppy production INCREASED 300% this decade

Posted on June 15, 2019 by Pharmaciststeve

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.”

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The VA Killed Me Russell Ervin Video

Posted on June 14, 2019 by Pharmaciststeve

https://youtu.be/IMFVov8dtL8

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

Posted on June 14, 2019 by Pharmaciststeve

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.

 

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FDA Advisors on Opioid Dosing Limits: We Dunno

Posted on June 14, 2019 by Pharmaciststeve

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 ?

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Do You Experience Chronic Pain? – survey link on post

Posted on June 14, 2019 by Pharmaciststeve

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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‘He’s Never Treated Chronic Pain Patients’: Protesters At Opioid Trial On State’s Expert Witness

Posted on June 12, 2019 by Pharmaciststeve

https://www.news9.com/story/40642679/hes-never-treated-chronic-pain-patients-protesters-at-opioid-trial-on-states-expert-witness

‘He’s Never Treated Chronic Pain Patients’: Protesters At Opioid Trial On State’s Expert Witness

CLEVELAND COUNTY, Oklahoma – The state’s trail against Johnson & Johnson’s pharmaceutical manufacture entered into day 12 Wednesday afternoon. 

A small group of protesters gathered outside the Cleveland County Courthouse as arguments resumed. Protesters voiced concern with the state’s expert witness on the stand, Dr. Andrew Kolodny.

“The state’s expert witness is one of the most-cruel human beings. His attitude is so egregious,” Donna Hill said.  

“He’s never treated chronic pain patients,” Protester Tracy Kennedy said. “He’s treated people with addiction, but not with chronic pain. So, we are out here to let them know we don’t agree with that.”

In a statement to News 9, a spokesman for the state says, “his background speaks for itself.”

Kolodny is a senior scientist at Brandeis University. According to the university’s website, Kolodny previously served as Chief Medical Officer for an addiction treatment agency. It lists his current position as Co-Director of opioid policy research at the university.

Many at the rally say they rely on opioids to cope with pain to perform daily functions.

Don’t control what we can do and what we can’t do, Elisha Grove said. “Understand that we have pain, some of us look like we don’t have pain, but we do.”

The state’s attorneys have said they understand there are people who need these medications and this trial is not about them.

“We matter. We are chronic pain patients,” Kennedy said. “We have conditions that can’t be seen. But we need our opioids.”

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Gov. Walz: Special session possible if lawmakers make emergency insulin deal

Posted on June 12, 2019 by Pharmaciststeve

http://www.fox9.com/news/gov-walz-special-session-possible-if-lawmakers-make-emergency-insulin-deal

ST. PAUL, Minn. (FOX 9) – Gov. Tim Walz continued his push for an emergency insulin bill Wednesday, holding a roundtable discussion to hear from people with diabetes who rely on the medication.

Walz told the roundtable that he is willing to call a special session if lawmakers can agree on a bipartisan bill. Lt. Gov. Peggy Flanagan joined the Governor, insulin advocates and medical professionals during the roundtable.

“No one should be forced to go without lifesaving drugs, especially something as common and as necessary as insulin,” said Governor Walz. “This is an urgent and important conversation to continue beyond today, and I am committed to elevating the stories of Minnesotans with diabetes and the struggles they face in getting necessary care.”

The House passed its version of the bill during the session, but the Senate ran out of time. 

Making insulin affordable was one of the priorities that was left on the cutting room floor as lawmakers scrambled to agree on spending priorities this spring.

Still, many of them are committed to making emergency insulin available.

Lawmakers have asked the Governor to call another special session to pass the Alec Smith Emergency Insulin Bill, named after the young man who died trying to ration his insulin due to the high costs.

“The cost of insulin and other lifesaving drugs has skyrocketed, putting the lives of Minnesotans on the line,” said Lieutenant Governor Flanagan. “For too long, people have had to choose between their health and their housing, their food, or other necessities, with devastating consequences. We must work together to find a solution to this crisis.”

“My younger brother was diagnosed in 1996, I was diagnosed in 1999. Back then, a vial, this vial of insulin, would cost around $16 to 20 dollars. The vial of insulin has not changed, there’s nothing new that has come out. But now, twenty years later, this vial of insulin is anywhere from $300 dollars to $400 dollars,” said Quinn Nystrom, Chapter Leader of Minnesota Insulin for All. “This is my life support. This is not an optional medication. This is not Tylenol. This is not ‘I can do this every other day.’ That’s not an option for people with diabetes. That’s something we need to be very clear on here. If I don’t have this, I’m dead.”

The bill would allow diabetics with little or no health insurance to get an emergency supply on insulin for free. The medication would be paid for by a fee on drug companies.  

“Part of how we got into this mess is the whole rebate system. The drug company sells their drug, insulin in this case, to a distributor who then sends it to the pharmacy,” said Dr. David Tridgell, an endocrinologist with Park Nicollet Clinic. “But what’s happened is in part, in order to get drugs covered by a certain formulary, the drug company pays a rebate and so if you want to get your insulin paid for, people having been raising, and raising, and raising the list price because then the for-profit insurance companies and PBMs, then they get a rebate.”

Roundtable participants included Nystrom, Dr. Tridgell, Executive Director of the Minnesota Board of Pharmacy Cody Wiberg, RN and diabetes educator Marcia Meier, insulin advocates Lija Greenseid and Abigail Hansmeyer, and James Holt and Nicole Smith-Holt, insulin advocates and parents of Alec Smith, a 26-year old Minnesotan who died in 2017 because he could not afford the insulin necessary to treat his diabetes.

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For those we know of and so many more we don’t…

Posted on June 12, 2019 by Pharmaciststeve

For those we know of and so many more we don’t…

In Loving Memory but Not Forgotten

Veterans

Hosking, Rory G. – 50, US Army – Feb. 9, 2019

Watts, John – 58 – Air Force – June 26, 2018

Cole, Lee – 38 – US Army – April 23, 2018

Baroda, Jesse Schmaltz , 31 -USMC, Oct 23, 2017

Ingram III, Charles Richard 51 – US Navy – Mar 2016

Kaisen, Peter – 76 – US Navy – July 25, 2014

Keller, Kevin – 52 – US Navy – July 30, 2014

Lawrence, Jay – US Navy – March 2017

Murphy, Thomas – Veteran – May 2015

Patterson, Travis “Patt” 26 – US Army Jan 27, 2017

Somers, Daniel – 30 – US Army – June 10, 2013

Spece, Brian – 54 – US Marine – May 3, 2017

Tombs, John – US Army – November 2016

Trunzo, Ryan US Army – 2012

Williams, Zack US Army – 2012

 

Civilian Losses

Anderson, Dawn, 52 – Indiana – Civilian – March 2019

Anderson, Larry – Civilian – June 2017

Howard, Carla – Tennessee – March 2019

Bales, Debra 52 – Civilian – Jan 10, 2018

Beyer, Donald Alan – 47 – Civilian – May, 8, 2016

Bloem, Michelle – Civilian – January 29, 2017

Christman, John – Civilian – August 2016

Cochran, Jennifer Marie, 34, – Civilian – December 22, 2016

Coggins, Warren Earl, 63, – Civilian – 2018

Goddard, Katherine 52 – Civilian – June 30, 2017

Graham, Bruce – 62 – Civilian – Jan 20, 2015

Hale, Doug – 53 – Civilian- Oct 11, 2016

Hamilton, Harold – 96 – Nov 2010

Hartsgrove, Daniel P – 62 – Civilian – May 19, 2017

Jonsson, Sonja Mae – Civilian – Aug 25, 2016

Kershaw, Sarah  – 49 – Civilian- Feb  23, 2016

Kimberly, Allison – 31 – Civilian- June 2017

Kuykendall, Phillip – 63 – Civilian – Dec. 29, 2016

Lichtenberg, Steven – 32 – Civilian, May, 2005

Little, Sherri – 53 – Civilian – July 7, 2015

Markel, Robert – 56 – June 2016

McGuire, Mercedes – 25 – Civilian – August 4, 2017

Paddock, Karon 43 – Civilian – Au 7, 2013

Peck, Denny – 58 – Civilian – Sept 17, 2016

Peterson, Michael Jay Civilian – Nov 22, 2005

Reid, Marsha 59 – Civilian – Nov 2, 2016

Simpson, Jessica – 28 – Civilian – July 17, 2017

Trickle, Richard “Dick”- Civilian- May 16, 2013

Unruh, Amanda – Civilian – January 14, 2018

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allegedly suspicious orders: not defined… just an opinion ?

Posted on June 12, 2019 by Pharmaciststeve

Morris & Dickson Settle for $22 Million for Failing to Report (allegedly) Suspicious Opioid Orders

https://www.drugtopics.com/latest/morris-dickson-settle-22-million-failing-report-suspicious-opioid-orders

Morris & Dickson Company, LLC, will pay the United States $22 million in civil penalties to settle charges that it violated controlled substance laws by “failing to report suspicious orders of hydrocodone and oxycodone.”

The settlement agreement is the latest in legal and policy actions to combat the opioid epidemic. 

U.S. Attorney David C. Joseph said in a prepared statement, “The fight against opioid abuse in among our nation’s most pressing law enforcement and public health initiatives. Opioids are now the leading cause of accidental death in the United States—killing approximately 130 Americans every day.”

As part of the agreement, Morris & Dickson agreed to invest millions in upgrades to its compliance program. The settlement followed a DEA Office of Diversion Control investigation, according to the U.S. Attorney’s Office. DEA diversion agents have identified more than 12,000 “allegedly suspicious retail pharmacy orders.”

DEA Special Agent in Charge Brad L. Byerley adds, “The settlement with Morris & Dickson demonstrates the resolve by DEA to use all available tools to address this crisis at every level and reduce the availability of highly addictive, dangerous drugs.”

Morris & Dickson is the largest privately-owned wholesale pharmaceutical distributor in the United States with revenues estimated at $4 billion in 2018.

In a prepared statement, Morris & Dickson says, “We reached this settlement so that we can focus on continuing to dependably deliver life-saving medications to hospitals, pharmacies and healthcare facilities. Despite working in a highly regulated industry for 178 years, our company has never before received a significant fine, citation, or penalty.” The company adds, “We share the goal of preventing diversion of controlled substances with the DEA and stand ready to work with it to meet these shared goals.”

Notice how they blur the lines between legal and illegal opiates and OD’s …  Opioids are now the leading cause of accidental death in the United States—killing approximately 130 Americans every day.”

Notice that they claim – as fact – that opiates are highly addictive… when anyone with three brain cells holding hands..knows that they are POTENTIALLY ADDICTING.  if they were in fact HIGHLY ADDICTING.. why is only 0.6% of chronic pain pts prescribed opiates.. demonstrates drug seeking/addictive behaviors ?

“The settlement with Morris & Dickson demonstrates the resolve by DEA to use all available tools to address this crisis at every level and reduce the availability of highly addictive, dangerous drugs.”

If the DEA is… using all available tools to address this crisis at every level and reduce the availability of highly addictive, dangerous drugs.” Their toolbox MUST BE AWFUL SMALL… since our streets are being flooded with Illegal Fentanyl from China and Mexico and  Methamphetamine and Cocaine are also on a dramatic upswing.

 

 

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