https://youtu.be/IMFVov8dtL8
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https://youtu.be/IMFVov8dtL8
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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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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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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.
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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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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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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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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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Pharmacists are obviously key players in prescribing medications. Now, as medication-related harm impacts aging populations, these same pharmacists are being called to take on an equally crucial role in the deprescribing process.
Deprescribing — the planned and supervised identification and reduction or discontinuation of unnecessary, inappropriate or ineffective medications — is a collaborative process that involves weighing the benefits and harms of medications in the context of a patient’s care goals, current level of functioning, life expectancy, values, and preferences, explains Stephanie Swanson, Pharm.D., in an article published by Pharmacy Press at the University of Minnesota College of Pharmacy.
Deprescribing is a viable route to consider for patients who are suffering from a number of maladies, including polypharmacy, adverse drug reactions, ineffective treatment, falls, or when the goals of treatment have changed, note medical researchers from the Centre for Education and Research on Ageing at the University of Sydney.
“If patients are slowly weaned off their medicines, withdrawal and rebound syndromes are usually not serious. A cautious approach to deprescribing includes two principles — stop one drug at a time and wean doses slowly over weeks and months,” they emphasize.
Polypharmacy was named one of three key action areas in the World Health Organization’s third Global Patient Safety Challenge: Medication Without Harm, set up to tackle avoidable medication errors — a leading cause of avoidable harm and injury in healthcare systems around the world, estimated to cost $42 billion annually.
“Polypharmacy is common among older adults due to a high prevalence of chronic conditions that often require multiple medications for optimal management,” explain authors of an article in Physician Review. “It often results from prescribing cascades, which occur when an adverse drug effect is misinterpreted as a new medical problem, leading to the prescribing of more medication to treat the initial drug-induced symptom.”
Carefully evaluating every medication when caring for older adults is critical in avoiding patient harm and reducing polypharmacy, advises Michelle Tran, Pharm.D., in another article published by Pharmacy Press at the University of Minnesota College of Pharmacy.
Extreme caution needs to be exercised when using American Geriatrics Society Beers criteria and the STOPP/START criteria medications in the older population.
As Tran emphasizes, “In these instances, the risks need to be heavily weighed against the benefits of starting these medications.”
In addition to polypharmacy and inappropriate medications, the elderly population is susceptible to medicine-related harm due to physiological changes related to aging that affect metabolism, elimination and drug distribution, according to Tran.
Falls, another serious public health concern for older people, can be reduced through deprescribing. According to a 2010 Clinical Geriatric Medicine review, polypharmacy and drugs acting on the central nervous system are important risk factors for falls, increasing the risk by around 50%. A randomized, controlled clinical trial showed that falls were reduced by 66% following the gradual withdrawal of psychotropic drugs coupled with a home-based exercise program.
“A feasibility study to reduce polypharmacy in people over 70 years of age suggested that over half of their medicines could be discontinued. Overall there was improvement in cognition and the patients’ global health and only 2% of the drugs needed to be restarted because the original indication re-emerged,” share the University of Sydney authors.
Simplification of drug regimens has the added benefit for individuals trying to keep track of several different medications, making adherence easier while reducing dosage and related errors on the part of the patient.
“Pharmacists can be key players on the healthcare team to aid in effectively deprescribing unnecessary and unsafe medications in the older adult population,” writes Michelle Tran, Pharm.D.
In a 2018 randomized trial of patients over 65 years who were prescribed 1 of 4 Beers criteria medications and recruited from 69 community pharmacies in Quebec, pharmacists provided educational deprescribing brochures to an intervention group of 241 patients and sent evidence-based pharmaceutical recommendations on deprescribing to their corresponding physicians.
After six months, 43% of these patients no longer filled prescriptions for inappropriate medication as compared to 12% in the control group, which was provided usual care.
These results demonstrate the potential for community pharmacists to successfully intervene and advocate for the discontinuation of potentially harmful medications — positively impacting patient safety.
“Transitions of care programs may be more effective if they utilize pharmacists to help deprescribe potentially harmful drugs from hospital admission and improve patients’ understanding of medications,” concludes Tran. “Along with pharmacist-led interventions and pharmacist-to-physician communication, directly involving patients in decision-making processes to deprescribe further empowers the patients to be able to make these changes with their healthcare team.”
In Canada, hospitalization of people over 65 years of age due to medicine-related harm is five times greater that of younger people. To address this pressing issue, a concerned group of healthcare professionals, patient advocates, policymakers and researchers formed the Canadian Deprescribing Network (CaDeN) in 2015.
In only four years, significant progress has been made in empowering patients and raising awareness among policymakers, shares Director Cara Tannenbaum, geriatrician and researcher in the above-mentioned study out of Quebec.
“Medicines safety and deprescribing are now on the radar of Canadian community organizations, the government, patients and healthcare providers,” notes Tannenbaum in a recent Pharmaceutical Journal blog. “There has also been increased interest in traditional and social media, with appropriate medicine use now at the forefront of public health concerns. Older people are having meaningful conversations with their health providers.”
At the crux of their campaign is empowering patients with accurate, credible information largely through webinars, online quizzes and brochures about specific inappropriate prescriptions. All these materials are provided for free and many are available in different languages. Extensive resources for pharmacists and other healthcare providers as well as patients are available at deprescribing.org.
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While many spring break goers try to avoid the fuzz on their wild and crazy excursions during college, one attendee apparently was paid by the Drug Enforcement Administration while on his trip in what the Department of Justice’s Office of the Inspector General (OIG) says was a colossal waste and misuse of funding. How did the kid secure this tax dollar paid vacation? His dad, a DEA agent at the time, gave him a bogus contract upwards of thousands of dollars, reports Law and Crime.
According to Jerry Lambe, the OIG “initiated its investigation after receiving reports that the senior DEA official had hired his son, his former DEA colleagues, and the spouse of a former DEA colleague, as contractors for the administration.”
The full report released on Monday reveals that the senior DEA agent wrongfully gave his son and others in his sphere hundreds of thousands of dollars. It also stated that the “official took actions to try to expedite the security vetting for his son and also enabled his son to submit contractor work invoices while on collegiate spring break and before graduating college. ”
Here are more details:
Via OIG:
“The OIG substantiated the allegation that the senior DEA official 1) took actions to have the DEA’s contractor hire his son and to have his son work as a DEA contractor in his chain of command by, among other things, signing two DEA forms in 2017, authorizing a total of $340,280 in spending, including a raise, specifically for his son’s contractor position; and 2) took actions in contravention of appropriate procedures to hire two former DEA colleagues as contractors in his chain of command, including the spouse of a retired former colleague. The OIG also found that the senior DEA official took actions to appoint his son as a volunteer student intern before he graduated from college.
Furthermore, none of the parties the agent gave contracts to were qualified for their supposed positions. In conclusion, the OIG found that “the senior official violated DEA Standards of Conduct and potentially violated criminal statutes by making false entries about attending alcohol counseling on a Questionnaire of National Security Position,” according to Crime and Law.
But still, even with this investigation, the DOJ refused to criminally prosecute the agent but the feds. insisted that the now-retired agent will be barred from federal employment should he try to come out of retirement.
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