97% of Congress voted for this law designed to DENY CHRONIC PAIN PTS APPROPRIATE THERAPY

Posted on October 25, 2019 by Pharmaciststeve
10/03/2018 Senate Senate agreed to the House amendment to the Senate amendment to H.R. 6. by Yea-Nay Vote. 98 – 1. Record Vote Number: 221.
09/17/2018 Senate Passed Senate with an amendment by Yea-Nay Vote. 99 – 1. Record Vote Number: 210.
06/22/2018-12:03pm House On passage Passed by the Yeas and Nays: 396 – 14 (Roll no. 288). (text: CR H5522-5560)

https://www.congress.gov/bill/115th-congress/house-bill/6/all-actions?overview=closed&q=%7B%22roll-call-vote%22%3A%22all%22%7D

DEA Channels Stalin: ‘Suspicious Orders’ of Opioids? Just Say Nyet

https://www.acsh.org/news/2019/10/25/dea-channels-stalin-suspicious-orders-opioids-just-say-nyet-14356

Here are five things we really don’t need:

  1. Further restrictions on prescription opioid drugs. They have been a disaster by any measure. (1)
  2. More power for the DEA to misuse.
  3. Forcing doctors and other healthcare providers to effectively become another arm of law enforcement.
  4. Further erosion of our rights to a personal and private relationship with our doctors.
  5. A bunch of chuckleheads who passed a law making all of this possible.

Unfortunately, as of October 23rd, we got all five. There is some scary stuff going on. One of the physicians who I collaborate with gave me an early heads up about an atrocity that just became reality thanks to a misguided and misnamed law. The atrocity is called Suspicious Orders Report System (SORS), and if this conjures up memories of Stalinist Russia, where everyone was spying on everyone else, you’re not alone.

Original image: Asia News

SORS came into being thanks to a new law called Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment For Patients And Communities Act, aka, Public Law 115-271 115thCongress. The law was introduced in 2018 by Representative Greg Walden (R-OR). It can’t be the least bit surprising that this dangerous law originated in Oregon (2).

In case you haven’t noticed, the acronym for the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment For Patients And Communities Act is the SUPPORT Act. I really hate to use Stalin and Orwell in the same article (so trite) but it is unavoidable here.

SUPPORT????? Are they kidding? It is anything but, something that will quickly become obvious in a moment.

Earlier this week I wrote about a report in Public Health Reports, the official journal of the Office of the Surgeon General), (2) which concluded in no uncertain terms that prescription opioids play only a very minor role in overdose deaths in the US – something that has been obvious for quite some time.

So, perhaps this country will finally come to its senses, right? 

No. Quite the opposite.

Here’s what Greg Walden and his comrades buddies came up with. It’s horrifying.

  • Distributor
  • Manufacturer
  • Importer
  • Pharmacy
  • Hospital/Clinic
  • Teaching Institution
  • Practitioner
  • Mid-Level Practitioner
  • Mid-Level Practitioner-Ambulance Service
  • Researcher
  • Analytical Lab
  • Narcotic Treatment Program (NTP)

In other words, anyone who might get within one zip code of a Vicodin pill will be required to report any of the following “suspicious acts” to the SORS Gestapo, where it will go into a database.

“The SUPPORT Act states the term “suspicious order” may include, but is not limited to”:

  • An order of a controlled substance of unusual size
  • An order of a controlled substance deviating substantially from a normal pattern
  • Orders of controlled substances of unusual frequency

When the physician, who wisely wishes to remain anonymous, wrote to me he/she also included some comments along with his/her email (emphasis mine).

The DEA has launched a new program as part of the initiative to discourage legitimate prescription of opioid analgesics.

The Suspicious Orders Report System (SORS) is a new online centralized database required by the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. Pharmacies, hospitals, clinics, doctors and even EMS workers are now required to report a “suspicious order” to the centralized database established by DEA (SORS Online).

A “suspicious order” may include, but is not limited to: an order of a controlled substance of unusual size; an order of a controlled substance deviating substantially from a normal pattern, and; orders of controlled substances of unusual frequency constitutes compliance with the reporting requirement under 21 U.S.C. 832(a)(3).

Doctors beware, Big Brother DEA is watching you.

Anonymous, October 23, 2019

My take? The DEA has failed miserably in keeping illicit fentanyl and its analogs out of this country (3) so the agency, like lawmakers, has doubled down on pills, even as more and more evidence emerges that pills are not only not the primary (or even close) culprit in causing overdose deaths, but there is a real inverse relationship between the number of prescriptions and overdoses, something I have written about numerous times in the past. 

So, pain patients, already suffering mightily because they can no longer get the medications they need, will suffer more. Doctors, who are already being targeted by law enforcement agencies for trying to do their jobs properly will face additional pressure to not prescribe painkilling medications. And addicts, who have been dying in increasing numbers as pills become harder to come by, will be sitting ducks for street fentanyl. OD deaths will continue to rise and probably even more so because the people who really need help and support will instead get SUPPORT.

There isn’t much more to say.

NOTES:

(1) See Gee, Pain Pills Are Not Killers. And The Sun Rises In The East. Who Knew?

(2) Oregon is arguably the cruelest state in the nation for pain patients. See Shades Of Tuskegee – Oregon’s Monstrous Experiments On Poor Pain Patients

(3) To be fair, keeping illicit fentanyl out of the US is just about impossible. It is easy to make and transport, hard to detect, and you don’t need a lot of it because of its potency. I have to cut DEA a break here. But to project success by going after pills, something that is rather easy to do is wrong on every level. If X punches you in the face you don’t hit Y.

About a year ago 97% of voting members (25 members of the House did not vote) voted in favor of this particular law. Anyone believes that the member of the House or Senate with a particular political  letter behind their name  <D> or <R> will help those legit chronic pain pts get their medically necessary treatments…  This  115th Congress has been EXTREMELY PARTISAN  since they were swore into office… with seemingly the exception of this particular bill… where it was passed with a nearly unanimous vote in favor of denying chronic pain pts their medically necessary therapy.

Since the vast majority of chronic painers are on Medicare or Medicaid… is this Congress’ backdoor approach to help extend the “viable life” of the various “trust funds” that pay for SS, Medicare & Medicaid ?

Who thinks that SUICIDES within the chronic pain community are going to increase exponentially ?

Is it finally time for the chronic pain community to establish a legal defense fund ?  10% of the estimated 100 million chronic pain community started donating $10/month to a non-profit legal defense fund…  Imagine at the end of the first month the defense fund could be sitting on TEN MILLION DOLLARS

and it will have law firms, PR firms, and Lobbying firms beating a path to its door… WANTING TO HELP !

If you are a chronic pain pt… have you yet have the sense that you now – or soon will have – a TARGET ON YOUR BACK ?   The state AG’s are going after $$  from anyone that “touches a opiate” Certain people who claim to be “experts” are testifying at these hearings … getting paid $600 +/hr   Form DEA employees are going after $$ to help legal firm go after $$$

‘Business decision’: Former DEA official works for opioid lawyers but set standards for how many pills were made

They are looking to put dollars in their pockets and will never SHARE YOUR PAIN and may end up causing your pain to become UNTREATED and how many within the community that can say that they will NEVER COMMIT SUICIDE BECAUSE OF THEIR UNTREATED PAIN ?  Even if you don’t commit suicide… your untreated pain could cause your other co-morbidity issues to worse and you end up dying of “natural causes”  Just look at this chart …

 

 

Filed under: General Problems | 25 Comments »

DEA: diversion of prescription opioids into the black market is now a rare event

Posted on October 24, 2019 by Pharmaciststeve

DEA Is About to Demonstrate “How Little They Know About What They Imagine They Can Design”

https://www.cato.org/blog/dea-about-demonstrate-how-little-they-know-about-what-they-imagine-they-can-design

Last month the Drug Enforcement Administration, tasked with setting quotas for opioid production in the U.S, announced a proposal to reduce production levels another 10 percent, having already reduced production by 25 percent in 2017 and an additional 20 percent in 2018. This would bring down production levels to 53 percent of 2016 levels. Yesterday the DEA released a proposal to develop “use-specific” quotas. The DEA press release explains this as follows:

Today’s proposal amends the manner in which DEA grants quotas to manufacturers for maintaining inventories…The proposal also introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers. These use-specific quotas include quantities of controlled substances for use in commercial sales, product development, packaging/repackaging and labeling/relabeling, or replacement for quantities destroyed.

The rationale behind the production quotas is to reduce the amount of prescription opioids that can be diverted into the black market for non-medical use. But last month’s DEA quota proposal stated (Federal Register page 48172):

As a result of considering the extent of diversion, DEA notes that the quantity of FDA-approved drug products that correlate to controlled substances in 2018 represents less than one percent of the total quantity of controlled substances distributed to retail purchasers.

Therefore, it appears that diversion of prescription opioids into the black market is now a rare event. An obvious question then is why tighten quotas even further? Is the DEA on a mission to reduce or eliminate the use of opioids based upon this law enforcement agency’s belief that it knows best how health care practitioners should engage in pain management?

As I have pointed out many times, there is no correlation between per capita prescription opioid volume and misuse or opioid use disorder in persons age 12 and up. And opioid-related overdose rates soared while prescription volume plunged. In 2017, illicit fentanyl and heroin were involved in 75 percent of opioid-related overdose deaths, and 68 percent of all opioid-related overdoses were “polydrug,” i.e., involved multiple other drugs, including alcohol, cocaine, heroin, fentanyl, benzodiazepines, and barbiturates. In fact, less than 10 percent of opioid-related overdose deaths in 2017 were from prescription opioids that didn’t involve other drugs.

The DEA’s presumption to know just how many prescription opioids of all classifications and in all situations will be needed in the coming year for a nation of 325 million people is a great example of what FA Hayek called the “fatal conceit.” DEA prescription opioid quotas have already been tied to an acute shortage of injectable opioids that afflicted hospitals across the country in 2018.

Aside from that, these additional quotas will do nothing to stem the deaths from illicit fentanyl and heroin that comprise the overwhelming majority of opioid-related overdose fatalities.

Filed under: General Problems | 4 Comments »

Hospital Acquired Infections: BODY COUNT … up to 100,000/yr – BUT NO CRISIS HERE

Posted on October 24, 2019 by Pharmaciststeve

New technologies have potential to prevent HAIs

https://www.healio.com/infectious-disease/nosocomial-infections/news/print/infectious-disease-news/%7B521b9799-cd2c-4872-b444-b34ced54ee6b%7D/new-technologies-have-potential-to-prevent-hais

Curtis J. Donskey, MD, and colleagues at the Louis Stokes Cleveland VA Medical Center had a novel idea to prevent some infections in their facility.

During influenza season, patients entering the hospital coughing and sneezing can use one of the many available touchscreens to check in.

“Dozens of people in the course of the day will be touching the same screen and they are very seldom practicing hand hygiene after doing that. And what we asked is if we could come up with some automated way to decontaminate the screens with each use — that could be a useful technology,” Donskey, an infectious disease physician at the hospital and professor of medicine at Case Western Reserve University, told Infectious Disease News.

The idea inspired the creation of an automated device that uses ultraviolet C light as a disinfectant to clean the touchscreens. A prototype of the device was designed by a scientist and then tested by Donskey. In his experiments, Donskey found that the UV-C device, which was designed to automatically scan the touchscreen after patient use, reduced the transmission of viruses from contaminated screens to fingertips in simulations.

Curtis J. Donskey

The UV-C touchscreen cleaner is just one of many new technologies that have been developed and tested recently to prevent health care-associated infections (HAIs).

‘One jumbo jet’s worth of people’

Although the prevalence of HAIs in hospital patients in the United States decreased from 4% in 2011 to 3.2% in 2015, they remain a significant issue for patients and health care facilities.

Each year, about 2 million Americans contract an HAI and between 75,000 and 100,000 die from one, Michael G. Schmidt, PhD, professor of microbiology and immunology at the Medical University of South Carolina, told Infectious Disease News. Broken down, that means almost 300 Americans may die every day from an HAI.

“If one plane, a jumbo jet, crashed each day in the United States, would anybody fly? The answer is no. That is precisely the number of U.S. citizens who die each day from a health care-associated infection. One jumbo jet’s worth of people,” Schmidt said.

Additionally, he noted the large financial burden, observing that HAIs may cost taxpayers an estimated $150 billion per year, according to a study published in the Journal of Medical Economics.

“Imagine what we could do if we just cut that rate by 10%,” Schmidt said. “What could we do with $15 billion?

New technologies

Different types of technologies aimed at decreasing the risk for HAIs have emerged in recent years, Hilary M. Babcock, MD, MPH, president of the Society for Healthcare Epidemiology of America and professor of medicine at Washington University School of Medicine, told Infectious Disease News.

“These technologies definitely have the potential to transform care for our patients,” she said.

Hilary M. Babcock

Many of the newer technologies use environmental decontamination to prevent the transmission of pathogens, Donskey said. Efforts have focused on developing novel disinfectants and delivery methods, no-touch devices and antimicrobial surfaces.

Bleach and quaternary ammonium disinfectants are the standard cleaning products used in hospitals. However, quaternary ammonium does not inhibit Clostridioides difficile, and bleach — while effective — can damage surfaces and irritate some patients, according to Donskey. Peracetic acid-based disinfectants have been developed as a modified solution and have been found to be effective at destroying spores and less harmful to surfaces, he said.

Because wiping down surfaces mechanically is not efficient for disinfecting irregular surfaces or an entire room, new delivery methods have been investigated, Donskey said. For example, electrostatic spraying devices might allow for more rapid and effective decontamination, he said.

Moreover, no-touch technologies are gaining traction, the most common of which are UV devices, according to Donskey. Many different UV devices have been created to decontaminate patient rooms and equipment, such as CT tables, tablets, keyboards and stethoscopes, and have demonstrated efficacy in reducing pathogens. One study published in The Lancet showed that adding UV-C light to standard terminal cleaning strategies reduced the likelihood that patients would acquire the same infection as the previous patient by 30%.

Antimicrobial surfaces also have been shown to be useful in helping rid hospital rooms of pathogens, Schmidt said. One study demonstrated that placing copper surfaces on significant touch points in the patient care environment decreased the rate of HAIs by 58%, he noted.

Many more technologies have demonstrated the ability to prevent the spread of pathogens, including novel sink drain covers, electronic hand hygiene monitors — including voice-based monitors that remind clinicians to sanitize their hands — antimicrobial catheters and antimicrobial textiles, such as surgical scrubs, hospital curtains and bed linens.

“All of these technologies are intended to prevent a wide range of infections, from common bacterial pathogens, such as C. difficile and MRSA, to fungal infections, such as Candida auris, that may be associated with contaminated surfaces,” Donskey said.

Implementation within hospitals

The move to implement new technologies in hospitals has been gradual, but more and more facilities are using them, especially UV room decontamination devices, Donskey said. In fact, a survey of health care facilities in the U.S. and 11 other countries showed that, in 2018, 37% of facilities reported using UV light for environmental cleaning.

Babcock said most infection preventionists are aware of the new technologies. The companies that manufacture them will often exhibit them at hospitals and conferences. Hospitals will consider the devices and their claims for prevention and purchase them if they are well suited for their specific needs, she said.

“One of the challenges for a lot of these technologies is to show a direct link between the use of that device and an actual decrease in infections in patients. A lot of these kinds of technologies clearly do decrease the amount of bacteria on a surface, but it can be difficult to prove that using this kind of device or technology can actually decrease infections in patients,” Babcock said.

Plus, not every hospital is in need of these types of new technologies.

“If a hospital has already done a lot of work with preventing infections after surgery then maybe they don’t need a special dressing to prevent this problem in their patients,” Babcock said.

Whether the new technologies have a significant benefit compared with emphasizing standard infection control measures is also up for debate, Donskey said. A great deal of effort goes into introducing any new technology into a hospital. Costs go up, and training health care workers to use them can be time consuming, he said. Hospitals may see a comparable reduction in infections by investing the same amount of time in improving standard infection control strategies than they would in implementing a new technology, he noted.

Regardless, the No. 1 thing that physicians and patients can do to prevent HAIs is wash their hands whenever they go in and out of a hospital room, Schmidt said.

“Simple things like practicing good hand hygiene make all the difference in the world at reducing the rate,” he said.

Infection prevention mostly relies on health care providers doing things correctly while providing care to patients, Babcock said.

“HAIs kill more people than HIV and breast cancer combined,” Schmidt said. “If we had tools like UV light, copper and hand hygiene monitors to alleviate breast cancer and HIV, we’d be out there cornering the market to end those diseases.” – by Alaina Tedesco

Filed under: General Problems | 1 Comment »

asked to share: Medical Board Corruption is violating Your Constitutional Rights!

Posted on October 24, 2019 by Pharmaciststeve

Medical Board Corruption is violating Your Constitutional Rights!

https://www.change.org/p/dr-arnold-feldman-medical-board-corruption-is-violating-your-constitutional-rights

Feldman v Federation
                                               Patient Petition

              For Patients and their families, friends and loved ones
 
 
We, the undersigned, submit this petition in support of the above lawsuit, filed by Drs. Feldman and Kaul. We are the patients, the people without whom the American healthcare system would not exist, and the people for whom the system was intended to serve. We all suffer from chronic debilitating pain, that has had devastating and tragic consequences on our lives, and those of our fathers, mothers, brothers, sisters and children. We, the voting public, the people of this country, have been forgotten by the politicians, the insurances companies and healthcare corporations, who have raped our healthcare system for profit, mercilessly and behind their faceless corporations, have, through their predatory pricing deprived us of life saving care. We are dying and no one cares, except our doctors, healers like Drs. Feldman and Kaul.
 
Within at least the last five years, our access to life saving treatment has been either severely reduced or completely eliminated. This is a direct consequence of rampant corruption within state medical boards and reckless, evidentially unsupported policies propagated by politically motivated state and federal bureaucrats. These agencies and the people who work within them do not care for our welfare, our lives and the unrelenting pain in which we now live, because of their own selfish economic and political agendas. We wake in pain, we live in pain, and when we can actually go to sleep, we know that our relief will be short lived. Many of us think about suicide every day. At least in death we will have relief from the excruciating agony that now plagues our existence, because corrupt medical boards have taken away the licenses of our doctors, and deprived us of care. For some of us, our doctors have been sent to jail for life, for simply doing their job, that of healing our pain. We are shocked, saddened and find it hard to believe we live in America, the supposed land  of the free and the brave. Well those brave enough to treat our complicated and debilitating pain have been mercilessly thrown into concrete cages, had their careers destroyed and left to rot, while we, and there are now many of us, have been abandoned by the profiteers and opportunists who now run our healthcare system. At the center of this cesspool of corruption are the state medical boards, who claim to “protect the public”. This is a massive lie.
 
These agencies abuse their power, unregulated, unsupervised and existing not to help the public, but to exploit and profit from the public, us. They use us as their excuse, their cover, to perpetrate their crimes against humanity. Their crimes contribute to the epidemic of physician suicides in the United States, reported as four hundred a year, although the number is likely much higher, and they kill patients, by taking away our doctors, jailing our doctors and causing them to commit suicide. Corrupt medical boards have permitted corrupt insurance companies, pharmaceutical companies and healthcare corporations to financially rape the American public, dictate local healthcare policy, and revoke the licenses of our doctors in the most cruel and arbitrary manner, with no regard for due process or the law. All of these events have caused us and our families immense suffering, and for too long we have suffered in silence, hoping that eventually sense would prevail, that our doctors would start to take care of us once again, without fear of jail or license revocation. We now see that hope in the lawsuit that Drs. Feldman and Kaul are about to file. We see two dedicated, courageous and committed men, whose fight is a righteous one, one for the people, for us, the American people, the people who pay taxes, who vote and who power, we are convinced, will cause Drs. Feldman and Kaul to prevail in their landmark case to end medical board corruption.
 
We will be victorious in our fight for justice.

Filed under: General Problems | 4 Comments »

Study: Chocolate chip cookies as addictive as cocaine

Posted on October 23, 2019 by Pharmaciststeve

chocolate chip cookies_1536090725178.jpg.jpgStudy: Chocolate chip cookies as addictive as cocaine

https://www.wowktv.com/news/u-s-world/study-chocolate-chip-cookies-as-addictive-as-cocaine/

BORDEAUX, France (WIAT) — Having a hard time staying away from the cookie jar? According to the smart cookies behind a recent study, there’s a reason you can’t deny your sugar cravings.

Researchers at the University of Bordeaux say the combination of ingredients in a traditional chocolate chip cookie trigger the same addictive response in your brain as cocaine or marijuana.

“Overall, this research has revealed that sugar and sweet reward can not only substitute to addictive drugs, like cocaine but can even be more rewarding and attractive,” the study’s abstract posits.

Like your cookies with a dash of salt? Your brain does too. Salt consumption activates the brain’s reward centers, compounding the already addictive effects of these chocolaty treats.

So the next time your cookie cravings compel you to act against your better judgment, don’t beat yourself up about it. It’s basically a natural human response, the study shows.

Chocolate chip cookies account for about a fifth of the global cookie market, which is expected to become a $38 billion industry by 2022.

Filed under: General Problems | 2 Comments »

Last-ditch opioid settlement in Ohio could open door for much larger deal

Posted on October 22, 2019 by Pharmaciststeve

Last-ditch opioid settlement in Ohio could open door for much larger deal

https://www.washingtonpost.com/health/ohio-counties-drug-firms-reach-260m-settlement-averting-trial/2019/10/21/c9ac1dd4-f39f-11e9-ad8b-85e2aa00b5ce_story.html

CLEVELAND — Two Ohio counties and four drug companies settled a landmark lawsuit over responsibility for the opioid epidemic Monday in a deal that could help push the parties toward a wide-ranging agreement on more than 2,400 similar claims filed across the country.

The $260 million settlement, reached just hours before opening arguments were scheduled to begin in the first federal lawsuit of the opioid era, will give Cuyahoga and Summit counties badly needed cash and anti-addiction medication. Those will be provided by mammoth opioid distributors McKesson Corp., AmerisourceBergen and Cardinal Health, and drug manufacturer Teva Pharmaceuticals, four of the defendants in the first case.

But the agreement also may help guide the next round of negotiating as drug companies and governments that have sued them continue efforts to resolve the remaining legal actions all at once. “Hopefully it’s a first step. We learned a lot. I think the defendants learned a lot” as the case moved toward trial, said Joseph F. Rice, one of the lead attorneys for the cities and counties whose cases have been consolidated into one “multidistrict litigation” in the federal courthouse here.

“And I believe there are a lot of corporations involved in the opioid crisis . . . that recognize that it’s time for them to contact us, and let’s see if we can put everybody together and get a global settlement.”

Two Ohio counties settled on Oct. 21 with four drug companies before the start of a landmark federal trial over who is responsible for the opioid epidemic. (Luis Velarde/The Washington Post)

The Ohio deal ratchets up the pressure on plaintiffs and drug companies to reach a global settlement or, some argue, to cut their own deals sooner. If the hundreds of lawsuits filed by cities, counties, Native American tribes and others continue to be settled individually, the first jurisdictions are likely to get larger payouts, attorneys said.

“This is a national crisis that demands a national solution,” said North Carolina Attorney General Josh Stein said on a conference call Monday afternoon. “The trial date has now been resolved. It’s in the past. And we can focus on coming up with what is going to do the best for our people.”

But finding such a solution is posing challenges amid the tensions between the mostly private lawyers representing local governments and the elected state attorneys general, as well as between states devastated by the opioid crisis and those less affected.

‘Why can’t I have the medicine I need?’: A painful new reality for patients who rely on opioids
Hank Skinner uses a fentanyl patch to treat his chronic pain. Now his doctor is lowering the dose – a new reality for millions relying on high doses of opioids. (Video: Dalton Bennett/Photo: Salwan Georges/The Washington Post)

In a moment of high drama Monday, U.S. District Judge Dan Aaron Polster, who has pushed for that global settlement for nearly two years, took his seat at the bench at 9:01 a.m. and announced the two-county Ohio settlement, which had leaked to the media before he spoke.

“I hope very productive discussions continue and we don’t lose the momentum that was created,” Polster said.

Hours later, a bipartisan group of state attorneys general said they had reached a $48 billion agreement in principle with the same four companies and Johnson & Johnson for a much larger nationwide deal.

They said they would press cities and counties to back the global settlement — $22 billion in cash paid out over 18 years, and $26 billion in anti-addiction and drug treatment medication.

But that proposal is nearly the same one lawyers for the cities and counties rejected after 10 hours of bargaining Friday, and the lawyers were quick to say Monday that the sum is too small and the payout period much too long.

“They can keep repeating the same offer, but that doesn’t mean it’s going to happen, because it’s not,” said Paul J. Hanly Jr., another attorney for the cities and towns. “A majority of the towns and cities are opposed to this, and they are not going to accept it.”

Democrats Stein of North Carolina and Josh Shapiro of Pennsylvania have been leading the negotiations for a proposed $48 billion national settlement, along with Republican attorneys general Herbert H. Slatery III of Tennessee and Ken Paxton of Texas.

In a conference call with reporters Monday, the four acknowledged the difficulty of persuading the cities and counties — as well as other attorneys general — to go along.

Asked on the call how many of their state counterparts were on board, the attorneys general declined to provide a number.

One proposal under discussion is to create a large national trust fund with rules under which cities, counties, states and others could apply for the money, said an attorney who spoke on the condition of anonymity because the idea is in its early stages. Polster or his designee might be tapped to control the fund, said the attorney.

More than 200,000 people have died of overdoses of prescription narcotics in the past two decades, and another 200,000 have succumbed to overdoses of heroin and illegal fentanyl, which is now the main driver of the worst drug crisis in U.S. history.

In August, an Oklahoma judge found health care giant Johnson & Johnson liable for fueling the opioid epidemic in the first state court trial of its kind and ordered the company to pay $572 million. Johnson & Johnson has appealed that decision.

Polster selected the two Ohio counties in Monday’s trial as a “bellwether” case, one designed to determine, via a jury verdict, how other plaintiffs might fare. A trial could have cost the companies more than $8 billion if the counties were awarded all the money they were seeking.

In settling the case, however, the companies admitted no wrongdoing.

Greg McNeil, whose son became addicted to pain pills and died of a heroin overdose in 2015, said outside Polster’s 18th-floor courtroom that families would have liked an apology from the companies.

“A settlement with an admission of wrongdoing would have begun to bring closure for families who have lost loved ones to the opioid epidemic,” he said. “Sadly, that didn’t happen.”

Plaintiffs’ attorneys said this and previous settlements were tantamount to an admission of culpability. “They paid over $323 million to these two counties,” when previous settlements by Johnson & Johnson, Mallinckrodt Pharmaceuticals and other drug companies are included, Rice said. “One might say that’s a pretty good admission.”

Ilene Shapiro, county executive for Summit County, said the counties had sent a message to the drug industry.

“We started this originally to stop the [drug companies’] behaviors — to hold these folks accountable,” she said. “Enough is enough. We’ve got people dying on our streets.”

The three wholesale distributors released a joint statement saying that “while the companies strongly dispute the allegations made by the two counties, they believe settling the bellwether trial is an important steppingstone to achieving a global resolution and delivering meaningful relief.

“The companies expect settlement funds to be used in support of initiatives to combat the opioid epidemic, including treatment, rehabilitation, mental health and other important efforts.”

Walgreens, a fifth defendant, did not take part in the settlement. Its trial was postponed until early next year, when it may be joined by other companies that were dropped from the first trial by mutual consent.

The company issued a statement saying that the allegations against it were very different from those against the others companies. “We never manufactured, marketed or wholesaled prescription opioid medications,” the statement said. “Our pharmacists have always been committed to serving patients in the communities where they live and work.”

A sixth defendant, Henry Schein Medical, which distributed a tiny amount of opioids in Summit County and was sued only by that jurisdiction, said it had also reached a deal. Under the plan, the company will donate $1 million to establish an educational foundation in Summit County that will develop best practices for the proper use of prescription opioids and will pay $250,000 of Summit County’s legal expenses.

The two-county Ohio settlement follows the collapse of an extraordinary effort Friday to reach a deal covering all the cases. Polster had summoned the chief executives of the distributors and representatives of the other two companies to his courtroom.

Also called were the plaintiffs’ lawyers and the four attorneys general who represented dozens of states that have been negotiating separately with the drug companies.

Polster shuttled among the parties, trying to find common ground. But after about 10 hours of talks, the parties were still far apart.

Negotiations continued over the weekend between the two Ohio counties and the drug companies, Hanly said. As of late Saturday, the distributors were offering $90 million, and the counties were holding out for $250 million. For the plaintiffs, he said, $200 million was an important target. Eventually, he said, the distributors raised their offer to $215 million, and the plaintiffs accepted.

They claim in this article that FOUR DRUG COMPANIES made a settlement… of the four companies that made the settlement, THREE WERE WHOLESALER and one was a generic pharma manufacturer. None of the companies in this settlement has direct access to pt information. Generally speaking a generic manufacturer does not even have a detail/marketing staff seeing doctors and neither does drug wholesalers.

A entity that seems to get a PASS in all of this is the DEA … they are the ones who maintain the ARCOS database https://www.deadiversion.usdoj.gov/arcos/index.html .. so for all of these years that these four entities were supposedly selling all of these opiate doses… the DEA was not looking at the database that they were maintaining on these very same medications ?  OR.. they were looking and chose to turn a blind eye to what was going on ?

Does it seem strange that the DEA is part of our judicial system and these dollar settlements are going to other parts of the judicial system – all the law firms that have taken these cases on a contingencies basis – they get a PER-CENT of the proceeds and the rest of the $$$ goes to cities/counties/states and it has been reported that many/some of these agreements are written that those bureaucracies getting these $$$ may or may not have to put it to the use that they were claiming that the bureaucracies were harmed by the actions of these defendants.

This is the same thing that happened with the monies from the billions being distributed from the large tobacco settlement – that was to be paid out annually – from about 20 yrs ago and that money will dry up in a few years…  It would appear that this opiate crisis is the bureaucracies new “golden goose”

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Gee, Pain Pills Are Not Killers. And the Sun Rises in the East. Who Knew?

Posted on October 22, 2019 by Pharmaciststeve

Gee, Pain Pills Are Not Killers. And the Sun Rises in the East. Who Knew?

https://www.acsh.org/news/2019/10/21/gee-pain-pills-are-not-killers-and-sun-rises-east-who-knew-14349

Anyone see a trend? Source: FDA, Pain News

In 2016 I testified at an FDA hearing about the “opioid crisis,” which was starting to make its way into the news in a big way. I was the last of 15 speakers, which included, among others, addiction specialists, physicians, patient advocates and parents whose children had died from drug overdoses. 

The word “fentanyl” was not mentioned even once until I spoke, when I predicted that it, which I referred to as the “devil in the room,” was the real threat. Some people looked at me as if I had sprouted moose antlers. I could almost hear them thinking “what is this guy talking about?” Despite the fact that fentanyl had just begun to pour into the US two years earlier the hundreds of people in the room seemed to be oblivious to what was really going on.

J. Bloom, Presentation to the FDA Science Board, White Oak MD, March 4th, 2016. In 2010 Purdue Pharma launched a new formulation OxyContin that was difficult to abuse. Heroin use (and death rates) took off immediately as addicts switched to street heroin, which is far more dangerous than any pill, this the surge in deaths. Fentanyl, which is more powerful, cheaper, and easier to transport, began to replace heroin soon after it entered the US three years later. 

Despite rhetoric from the oblivious media and opportunistic politicians, and distorted propaganda from shady groups like Physicians for Responsible Opioid Prescribing, what was really going on was perfectly obvious. I spent the next 3+ years banging my head against the periodic table on the wall, trying to bring home the message that we were fighting the wrong battle; injectables, not pills, were the primary cause of the soaring rate of lethal opioid overdoses and the more that the pills were restricted the more deaths would occur.
 

Yet, it wasn’t until 2018 when a study confirmed what was already obvious five years earlier (See ‘Study Links Rising Heroin Deaths To 2010 OxyContin Reformulation.Duh.’). The crackdown on prescribing (1) opioid analgesics was not only associated with a spike in overdose deaths, but it also caused it. 

A recent report in Public Health Reports further drives home the point that I made in 2016. “The Contribution of Prescribed and Illicit Opioids to Fatal Overdoses in Massachusetts, 2013-2015” clearly identifies fentanyl as the drug responsible for tens of thousands of people dying each year. It clarifies something that should have needed no clarifying in the first place (Figure 1). 

Figure 1. (Top) Overdose deaths from all opioids rose by about 30,000 between 2013-2017, virtually all of the increase (Bottom) due to fentanyl (yellow line) and heroin (green line). Deaths from prescription analgesics (blue line) remained stable during this same time. Source: National Institute on Drug Abuse. 

Anyone who has been following the real story (2) shouldn’t be the least bit surprised surprised about any of the following:

Of the 2916 people who died in Massachusetts between 2013-2015 (and had complete toxicology reports): 

  • 1789 (61%) had heroin detected.
  • 1322 (45%) had fentanyl detected.
  • Of the 491 (17%) people who died (and had an active prescription for an opioid on the day that they died), the prescription drugs were detected only 1.3% of the time.
  • In other words, almost without exception, legally prescribed pills did not kill the patients that they were intended to treat. So much for the injury-pain-addiction-overdose theory. It was stupid in the first place.

If this isn’t convincing enough, try Figure 2.

Figure 2. The bottom graph from Figure 1, when blown up, reveals that the article in Public Health Reports is examining the tip of an iceberg. Although fentanyl was already one of the two “killer opioids” between 2013-15 its impact was only beginning to be felt. During 2015-17 – the two years after the report – fentanyl deaths skyrocketed.

So, it would not be unreasonable for one to conclude that after 2017 fentanyl (3) was responsible for almost all opioid deaths in Massachusetts and prescription narcotics virtually none. One would be correct (Figure 3).

Figure 3. In mid-2014 (Massachusetts) prescription opioids (turquoise arrow) were present in more than 35% of tox samples. By 1Q 2019 that number had dropped to about 10%. Conversely, fentanyl was present in about 25% of samples in mid-2014 but by 1Q 2019 it was present in nearly all samples. Source: Massachusetts Department of Health.

TAKE HOME MESSAGES:

  • Fentanyl gained a foothold in the US beginning in 2013 because there was a booming heroin market.
  • Overdose deaths from all opioids rose steadily in Massachusetts between 2013-15, with fentanyl being a major factor.
  • Even during this time, when fentanyl use was just beginning to take root in the US, legally prescribed prescription opioid narcotics were responsible for only a minor percentage of total opioid deaths.
  • In Massachusetts between 2013-15 fentanyl was detected in about half of the people who died.
  • By 1Q 2019 that number was >90%.
  • It is virtually certain that when the 2013-15 numbers are updated to include 2017-19, the deaths from legally prescribed narcotics will be negligible.
  • It is also a virtual certainty that almost all deaths will be due to fentanyl.
  • By all means, let’s keep suing opioid makers, restricting their manufacture and prescription. But don’t expect this to change. Except maybe for the worse:

Source: (Top) Pain News Network/DA. (Bottom) National Institute on Drug Abuse

Keep your eyes on the orange box. Do you see any relationship between fewer prescriptions and more deaths?

Just asking. 

NOTES:

(1) The crackdown is spreading. Now the DEA wants to dictate how much of which drug can be manufactured. Does this sound like a good idea? Didn’t think so.

(2) My articles during this time have been compiled and categorized (See Analyzing The Opioid Crisis: 65 Articles By Dr. Josh Bloom).

(3) When I write “fentanyl” it does not mean pharmaceutical fentanyl, which is sold for severe pain in patches, candy, nasal sprays… in very small doses, typically a fraction of a milligram. I mean pounds/tons of illicit fentanyl and its analogs manufactured (mostly) in China. Pharmaceutical fentanyl is not a significant contributor to the carnage that is going on.

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DEA on adjusting quotas for opioids

Posted on October 22, 2019 by Pharmaciststeve

DEA on adjusting quotas for opioids

In our series, Issues that Matter, we are focusing on the opioid crisis. According to the CDC, almost 400,000 Americans died from prescription and illicit opioid overdoses between 1999 and 2017. In 2017, more than 2.1 million Americans were addicted to opioids. This Saturday, the Drug Enforcement Administration is hosting National Prescription Drug Take Back Day, where you can turn in your unused and unwanted medications, no questions asked. Acting DEA Administrator Uttam Dhillon joins “CBS This Morning” to discuss the initiative.

These people are so CLUELESS and what is bad is that apparently they don’t have a clue that they are CLUELESS… they are stating that it is “harmful for the environment” to flush unused meds down the toilet…

When a person takes a dose of a medication… it doesn’t magically “disappears” … it is metabolized in the body and some metabolites from the medication is excreted in the pt’s urine or feces… and guess where those go… 

People dumping excessive medication that is not taken … will not begin to move the needle on the parts per million or billion that is able to be measured in the water table or ground.

I wonder how the DEA determines the “correct amount” of opiates for all the 100 million chronic pain pts ?

 

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SUICIDE: who you gonna call ?

Posted on October 22, 2019 by Pharmaciststeve

Until a few years ago … suicide was considered a CRIME… now we have some 6 states that have laws that makes “death with dignity” condones certain suicides within the guidelines that the state consider acceptable and reportedly a large number of states are considering passing same/similar laws.

It is still ILLEGAL to assist and/or encourage suicide.. in fact a young woman https://www.womenshealthmag.com/life/a28326092/michelle-carter-sentence-texting-suicide-case/

got a 30 month sentence for INVOLUNTARY MANSLAUGHTER for encouraging her boyfriend to commit suicide – mostly via text messages.

prescribers, pharmacists, nurses are considered “learned professionals” and should be full aware of the consequences of denying, withholding or reducing a pt’s medication for chronic conditions – especially subjective diseases such as chronic pain, anxiety, depression or other mental health issues.

Could it be that all opiate OD deaths have been classified as “accidental overdose” because would our judicial system would have to investigate a suicide and spend money on the investigation and maybe be forced to charge someone with assisting the suicide ?  But it also serves the DEA’s agenda that we have a opiate crisis that is being fueled by Rx opiates.

We know that there are abt ONE MILLION attempted suicide EVERY YEAR and that abt 50,000/yr deaths from suicide.. what we don’t know is how many of those deaths or attempts are because chronic pain pts or other pts dealing with subjective diseases are being denied their medically necessary medication.  We also don’t know how many of those deaths are because those serious/dedicated substance abusers are just “sick & tired” of dealing with being “dope sick” and suffering thru going thru withdrawal and just has decided to “end it all”… and their death is not really a accident.

We have also heard of chronic pain pts leaving suicide notes that seem to “disappear” after the fact… Who would make a suicide note disappear… the relatives because they are ashamed that their relative committed suicide, because suicide would cause any/all life insurance policies to become null/void or back to the agenda of the DEA and every “body” they can count… helps their agenda of the opiate crisis.

What would happen if the person who has committed suicide, has sent out a “suicide video” or sent a registered letter to the local prosecuting attorney accusing their prescriber, pharmacist, insurance/PBM company or the company that any of these healthcare professionals work for that have established policies that caused the pt to be denied their necessary medication.

Why is it that we seldom – if ever – hear from a family member of a chronic pain pt who has committed suicide .. like we hear from family members of those who OD from a claimed opiate OD… saying… “we never want another family to go thru what we did… losing a family member to a opiate OD…”  More likely one will hear from a chronic pain pt’s family after a suicide …” he/she is now at peace and out of pain “… and they get back to living their lives…

BUT… how does someone who is planning on a suicide and sends a certified “suicide letter” to the local prosecutor… who is going to get the return post card that it was signed for ? Would a prosecutor even consider taking action against the professionals or corporation that contributed to the suicide ? Could any of those entities be accused or charged with assisting suicide, involuntary manslaughter or some other law that they could legally charged with breaking and contributing to a person’s death ?

I doubt if FB, twitter,  youtube or any other media outlet would allow a “suicide video” to be published or if published it would probably be quickly taken down.

Could/should the pt entrust a copy of the letter or video with another chronic pain pt friend… to send it to the media.. if the local prosecutor fails to take action ?

Probably the only place that such a letter or video could be published without immediate repercussion is with a chronic pain advocate that has their own website domain and no one that would have any authority to force it to be taken down.

 

 

 

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How the DEA is cracking down on resurgence of meth

Posted on October 21, 2019 by Pharmaciststeve

How the DEA is cracking down on resurgence of meth

https://www.10tv.com/article/how-dea-cracking-down-resurgence-meth-2019-oct

Opioids aren’t the only drugs causing major problems in our area. ​Methamphetamines are making a big come-back.

The number of arrests for methamphetamines has grown 5 times in the Southern District of Ohio just since 2014.

“There is no shortage of work,” said Mauricio Jimenez, Assistant Special Agent in Charge for the Drug Enforcement Administration.

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On Sunday, there were 5 opioid overdose deaths in Franklin County.

“This area was once hit hard with fentanyl and opioids, and now it’s starting to move towards meth. There’s a certain element of violence,” Jimenez explained.

Opioids aren’t Mauricio Jimenez’s biggest concern.

“We’ve seen a switch from people who were addicted to heroin or fentanyl to methamphetamine because meth they know won’t kill them like fentanyl would,” Jimenez said.

Jimenez explained methamphetamines are now rampant in southern and central Ohio.

“Now we are seeing street-level distributors with ounces of meth in their pockets because it is readily available and cheap,” Jimenez said.

DEA arrests for methamphetamines in our area have jumped from 17 in 2015 to 86 in 2019.

“The quality of meth today is completely different than what we saw 20 years ago. It’s about as pure as pure gets,” Jimenez explained.

Jimenez says most of it is coming from the southwest and Mexico. He adds, the DEA is teaming up with local departments to nab as much of the drugs as they can before it hits the streets in our area.

“I don’t think we are ever going to see the days where this is completely done,” Jimenez said.

 

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