SOS: FDA CONSIDERING REMOVAL OF HIGH DOSE OPIOIDS – this one is DIRE for ANYONE utilizing opioids.

Posted on February 28, 2018 by Pharmaciststeve

LAST DAY TO MAKE COMMENT

 

SOS: FDA CONSIDERING REMOVAL OF HIGH DOSE OPIOIDS – this one is DIRE for ANYONE utilizing opioids.

USE THIS LINK  https://www.regulations.gov/document?D=FDA-2017-P-5396-0001

PLEASE SHARE/Copy&Paste encouraged/please ask admins first before posting in other groups/FDA deadline Weds. 2/28/18

Andrew Kolodny and PROP has submitted a petition to the FDA that could threaten to limit your access to high dose opioid medications, regardless of your doctor’s prescriptions or your medical needs. The FDA is considering this petition which would remove ultra high dose (UDHU) opioids from the market. This is a very, very serious issue and 100% participation is needed before Wednesday, February 28th, 2018, to stop this from happening. The FDA already removed Opana ER, lets not let this happen to a medication YOU or your loved ones might need. Please remember, the FDA will toss if comments appear similar, so use this as a guide.

From: Valorie Hawk/Director/C-50/Coalition of 50 State Pain Advocacy Groups -Please join your state advocacy group and work alongside your neighbors at your state and local level. https://www.facebook.com/Coalition-of-State-Pain-Advocacy-…/

FDA RESPONSE

1.Check out the petition to the FDA here: http://www.supportprop.org/wp- content/uploads/2014/12/ Citizen-Petition-UHDU-Opioids- 8.30.17-final-signatures-2.pdf

2.Go to https://www.regulations.gov/ comment?D=FDA-2017-P-5396-0065 to comment

3. In the large text box, enter your comments about WHY you oppose this petition and why the FDA should as well. These are some points you could make. Please tailor them to your own situation – if you copy these exactly the FDA will NOT consider them.

A. I am a chronic pain patient with ___________ (diagnosis)

B. I rely upon opioid medications to: manage my incurable pain, allow for increased function, preserve my way of life, and remain productive. Please explain how benefits outweigh risks.

If you are taking high dosage or extended release opioids, please discuss how they control your pain better/longer than other options, please be brief, clear and concise – no caps. Things you may want to include:

* benefits outweigh risks, over 95% of legitimate pain patients
do not abuse
* explain how opioid medications help(ed) you and how for
long, especially if they are/were high dosage.
* discuss function – the things you are able to do (work,
chores, travel, enjoy life, sleep) with pain relief and what it is
like (or would be like) without it. Mention if you have had to
leave your job, lost your house, your family, car, etc. Share
if you have had increased BP/pulse or other adverse health
effects if your medications have been reduced/dropped.
* discuss the non-opioid medications you have tried (and
adverse reactions) –
* explain you do not get high/euphoria
* discuss all of the treatments you have tried – for example –
PT, OT, Aqua T, Chiropractic, Osteopathic, TENs, MENs,
mindfulness, yoga, CBT therapy, biofeedback, acupuncture,
acupressure, CBD, Kratom, etc., and how they failed to
‘heal’ you or lessen your pain.
* explain you have been a model, compliant patient, and if
you have a pain contract (include how often you have UAs,
pill counts, and if you have to use one pharmacy, avoid
alcohol, etc.). Mention that it’s unlikely your condition will
approve, and the effects of time and aging will make things
worse.
* Opioids and pain management were a last resort option.

D. I always secure my medications where they cannot be
stolen, never allow others to borrow and do NOT have
excess medication.

E. These proposed regulations are not supported by any
reliable science.

* the 90 MME cutoff that defines what medications are ultra-
high dose is arbitrary
* everyone genetically metabolizes medications differently
* the CDC guidelines were written outside the rules by non-
pain management physicians, some who may have
professionally or personally profited from the outcome
* none of the petitioners are qualified or Board Certified in pain
management
*cancer patients need these, as well

F. Not everyone can just “swallow more pills” – *some pain
patients have conditions (e.g. nausea, esophageal
spasms) that make swallowing difficult

G. If enacted, these policies could:

* force even more doctors away from treating pain
* force more patients onto Disability, Medicare and Medicaid
* create more demand for emergency room and social
services
* increase the rate of expensive and possibly dangerous
procedures
* increase the rate of suicides
* possibly put many more pills into circulation

3. Fill in the information at the end
4. You may choose to be anonymous or use your name
5. Do not write anything under the category “organization”
6. Choose SUBMIT. If you get a receipt, you have been
successful! It will take a few days to see your comment
posted.

AT LEAST 10,000 COMMENTS ARE NEEDED TO START BEING NOTICED. ASK EVERYONE YOU KNOW TO HELP. SHARE THIS POST EVERYWHERE

Filed under: General Problems | 4 Comments »

DEA’s role in two operations in Mexico that resulted in dozens, perhaps hundreds, of deaths

Posted on February 27, 2018 by Pharmaciststeve

Top Lawmakers Call for Investigation of DEA-Led Unit in Mexico

https://www.propublica.org/article/top-lawmakers-call-for-investigation-of-dea-led-unit-in-mexico

Democratic leaders in the House and the Senate cited ProPublica’s reporting into the DEA’s role in two operations in Mexico that resulted in dozens, perhaps hundreds, of deaths.

by Ginger Thompson

Powerful Democrats in both the House and Senate called Tuesday for an investigation into Drug Enforcement Administration-led operations in Mexico that played a role in triggering violent drug cartel attacks. These attacks left dozens, possibly hundreds, of people dead or missing, including many who had nothing to do with the drug trade.

The call was issued in a letter signed by ranking members of the committees that oversee America’s foreign law enforcement operations and draws heavily on two stories last year by ProPublica and National Geographic that documented the attacks and the DEA’s role. One story reconstructed a 2011 massacre by the Zetas cartel in the Mexican state of Coahuila. It revealed that the wave of killings was unleashed after sensitive information obtained during a DEA operation wound up in the hands of cartel leaders, who ordered a wave of retaliation against suspected traitors.

A second story investigated a 2010 cartel attack on a Holiday Inn in Monterrey, Mexico, and found that it, too, was linked to a DEA surveillance operation. Four hotel guests and a hotel clerk, none of whom were involved with the drug trade, were kidnapped and never seen again.

In both cases, the DEA never revealed its involvement or helped in the investigation of the slaughter of Mexican citizens. Until contacted by ProPublica, the family members of the victims never knew why their loved ones had been targeted.

Both operations involved a Mexican federal police unit that is specially trained and vetted by the DEA to work with U.S. law enforcement. ProPublica’s reporting found that despite that scrutiny, the Sensitive Investigative Unit had a record of leaking information to violent and powerful drug traffickers. The DEA, ProPublica found, had long been aware of this corruption and failed to address it, even when innocent lives were lost. The agency has similar units in 12 other countries.

“These operations raise serious questions about the practices of DEA-trained and funded SIU’s,” the congressional letter said, “and point to the need for greater accountability for these vetted units.”

The letter was signed by Sen. Patrick Leahy of Vermont, vice chairman of the Senate Appropriations Committee, who has long pursued accountability for the DEA’s operations abroad, as well as Sen. Dianne Feinstein of California, the ranking member of the Senate Judiciary Committee and one of the country’s leading authorities on national security matters, Rep. Eliot L. Engel, the ranking member of the House Foreign Affairs Committee, and Rep. Jerrold Nadler, the leading Democrat on the House Judiciary Committee. The two representatives are from New York, and their committees oversee the State and Justice departments.

The legislators asked the inspectors general at the Justice and State departments to investigate the attacks in Monterrey and Coahuila, as well as the DEA’s overall work with vetted units. They asked eight detailed questions about the two deadly incidents, including how information about the operations was leaked to the cartels and whether the DEA attempted to provide assistance to the families of those kidnapped or killed and whether the United States Ambassador to Mexico had been fully informed.

“In light of these incidents,” the letter said, “we believe that a thorough investigation into the practices of the DEA’s vetted units is essential.”

For two decades, the “Sensitive Investigative Unit Program” has been the DEA’s workaround method of battling drugs with foreign partners it doesn’t always trust. The agency sets up a unit under its supervision, choosing members from the host country’s police forces. Then it trains these foreign officers — often in the U.S. — polygraphs them, and, in some cases, works alongside them in the field.

Administrators at the agency have hailed them as the “bread and butter” of the DEA’s activities abroad.

In Mexico, however, the SIU has been plagued by corruption from the start. Since 2000, at least two supervisors have been assassinated after their identities and locations were leaked to drug traffickers by SIU members, according to allegations by current and former DEA agents who worked in Mexico. Earlier this year, another SIU supervisor, Ivan Reyes Arzate, flew to Chicago and surrendered to U.S. authorities, who charged him with collaborating with drug traffickers.

In interviews, current and former DEA agents who worked with the unit didn’t dispute the corruption within the Mexican unit’s ranks. Several agents said that part of “the game” of working in Mexico involves understanding that the vetted unit — and every other Mexican law enforcement agency — might leak to a specific cartel and reliably help pursue another. The trick, they said, was figuring out which cartel the vetted unit was helping, and then using the unit to pursue that cartel’s rivals.

When it works, the agents said, they bring down a cartel kingpin and garner headlines. But the investigations by ProPublica made clear that the game sometimes has tragic consequences, about which the DEA has remained largely silent.

Both Engel and Leahy have been seeking accountability for U.S. foreign law enforcement operations for years. Engel was among more than a dozen legislators who signed a letter to the Justice and State departments last year, expressing concern about the DEA’s role in the massacre in Coahuila. And Leahy was a driving force behind government efforts to investigate a botched DEA operation in Honduras in 2012 that left four unarmed people dead, and another four injured.

Earlier this year, Leahy sent a letter directly to the DEA’s Acting Administrator, Robert W. Patterson, to convey his concerns about ProPublica’s reports. The letter contained 22 questions about the DEA’s work with SIUs; questions that Leahy said warranted response, “given the reported history of corruption and misconduct by some members of the SIU.”

Filed under: General Problems | 1 Comment »

the appointment

Posted on February 27, 2018 by Pharmaciststeve

www.lingeringson.com/2018/02/03/the-appointment/

i hear his footsteps approach the exam room, my breath catches as thoughts race. my pulse quickens, i feel slightly sick…

memories flood past…playing with my children, grandchildren, babies chortling, making music with friends, farming…further back..giving birth, weddings, falling in love, childhood..

all accomplished with some level of pain, the last twenty years with proper treatment. happy and still productive, at sixty now i am in school, volunteering, advocating, caregiving, loving…or was. the change in my life has been head spinning these past few months.

he interrupts my thoughts as he enters. without making eye contact, he announces my medication will again be cut in half. i protest. i can’t spend more time in bed. i like to walk with my cane. to move. moving is important to be healthy.

i remind him i am a caregiver. my son cannot speak or move. who will care for him? for me? what have i done wrong?

he won’t risk his license for a patients function, he says. nothing personal. he shows me a printout. says i’m over a limit that never existed before. that someone, somewhere, says now they know the risk of addiction. after over twenty years of none. liars.

he never took his hand off the door handle. bastard. he grins. buffoon. it will be a transition, he says. fool. death is a transition, i reply, that doesn’t make it a desirable outcome. he quickly disappears, leaving a nurse to pick up the pieces, and hand me my sentence. coward.

as i leave, a protesting patient is escorted out by security. an old man asks what ‘non-opioid treatment’ means for his cancer pain. my chest feels tight.

outside, the addicted continue to die in record numbers. their pain is not physical. the escape they seek is not with any medication i am prescribed, yet this is somehow laid at my feet. the world has lost its collective mind.

Filed under: General Problems | 22 Comments »

Florida school shooting: Students to march on Washington

Posted on February 27, 2018 by Pharmaciststeve

http://www.bbc.com/news/world-us-canada-43105701

Young survivors of Wednesday’s school shooting in Florida have announced a national march on Washington to demand political action on gun control.

Student organisers told US media that they were determined to make Wednesday’s shooting a turning point in the national gun debate.

The attack, which left 17 students and staff members dead, was the deadliest US school shooting since 2012.

Yesterday protestors chanted “shame on you” to US lawmakers and the president.

Mr Trump said last year he would “never” infringe on the right to keep arms – a long-running and contested debate within the US.

In his first public comments on the gun control issue since the attack, Mr Trump blamed the Democrats for not passing legislation when they controlled Congress during the early years of Barack Obama’s administration.

What are the students’ plans?

Speaking on US television networks on Sunday morning, student survivors from Marjory Stoneman Douglas announced their March for Our Lives campaign.

They are planning to march on Washington on 24 March to demand that children and their families “become a priority” to US lawmakers. They want other protests to happen simultaneously in other cities on the same day.

“We are losing our lives while the adults are playing around,” Cameron Kasky, a survivor from the school said.

It is one of many student-led protests amassing support on social media in the wake of Wednesday’s attack.

Image copyright Reuters
Image caption The students from Parkland have demanded “never again” in response to the shooting

On Saturday students and their parents – as well as politicians – took part in an emotionally-charged rally in Fort Lauderdale, close to Parkland.

Arguably the most memorable moment came when high school student Emma Gonzalez took to the podium and attacked the US president and other politicians for accepting political donations from the National Rifle Association (NRA), a powerful gun rights lobby group.

“If the president wants to come up to me and tell me to my face that it was a terrible tragedy and… how nothing is going to be done about it, I’m going to happily ask him how much money he received from the National Rifle Association,” said Ms Gonzalez.

“It doesn’t matter because I already know. Thirty million dollars,” the 18-year-old said, referring to donations during Mr Trump’s presidential campaign.

 
Media captionInside the classroom: ‘We watched gunman shoot our friends’

“To every politician who is taking donations from the NRA – shame on you!” said Ms Gonzalez, who took cover on the floor of her secondary school’s auditorium during the attack.

According to the Center for Responsive Politics, the NRA spent $11.4m (£8.1m) supporting Mr Trump in the 2016 campaign, and $19.7m opposing Hillary Clinton.

What is Mr Trump’s stance on gun control?

The president’s views on gun control have shifted over time. In recent years, he has pledged to fiercely defend the Second Amendment to the US Constitution, which protects people’s right to keep and bear arms.

Last year, he told an NRA convention he would “never, ever infringe” on that right.

In a tweet late on Saturday, the Republican president accused the Democrats of not acting on gun legislation “when they had both the House & Senate during the Obama Administration.

“Because they didn’t want to, and now they just talk!” he wrote, referring to criticism from Democrats following Wednesday’s shooting.

Mr Trump – who on Friday met survivors of the attack – has also blamed the shooter’s mental health and the FBI’s failings.

The US news network CNN has invited Florida lawmakers and the president to attend a town hall event with survivors of the attack on Wednesday.

Saturday’s rally coincided with a gun show in Florida. Hundreds of people attended the event at the Dade County fairgrounds, despite calls to cancel it.

What do we know about the suspect?

Mr Cruz, 19, is a former student at the Marjory Stoneman Douglas High School.

He was reportedly investigated by local police and the Department of Children and Family Services in 2016 after posting evidence of self-harm on the Snapchat app, according to the latest US media reports.

Child services said he had planned to buy a gun, but authorities determined he was already receiving adequate support, the reports say.

The 5 January tip was not the only information the FBI received. In September, a Mississippi man reported to the law enforcement agency a disturbing comment left on a YouTube video under Mr Cruz’s name.

Florida Governor Rick Scott called for FBI director Christopher Wray to resign over the failures to act.

In a late tweet on Saturday, the President rebuked the organisation for their handling of tip-offs.

“Very sad that the FBI missed all of the many signals sent out by the Florida school shooter. This is not acceptable. They are spending too much time trying to prove Russian collusion with the Trump campaign.”

Listening to the interviews with politicians on the nightly news, doesn’t appear that all of the FACE to FACE meetings with our elected representatives will do little/nothing about getting things changed.

So it looks like these students are learning a very valuable lesson that if you can’t vote for them or donating money to their re-election campaign.. they are not going to listen to your concerns.

Is there little wonder why the lobbyists spend 9+ million/day to get the 535 members of Congress to see things the way that who the lobbyist is working for.

Sooner of later those in chronic pain community is going to figure it all out… you either raise a lot of money to hire lobbyists and/or file lawsuits or just VOTE THE BUMS OUT…

It would appear that 17 tombstones from innocent teenage victims … is not enough to register with those in Congress..

 

Filed under: General Problems | 2 Comments »

DOJ to Support Lawsuits Against Companies Selling Opioids

Posted on February 27, 2018 by Pharmaciststeve

https://www.usnews.com/news/business/articles/2018-02-27/doj-to-support-lawsuits-against-companies-selling-opioids

WASHINGTON (AP) —

The Justice Department said Tuesday it will support local officials in hundreds of lawsuits against manufacturers and distributors of powerful opioid painkillers that are fueling the nation’s drug abuse crisis.

The move is part of a broader effort to more aggressively target prescription drugmakers for their role in the epidemic, Attorney General Jeff Sessions said. The Justice Department will file a statement of interest in the multidistrict lawsuit, arguing the federal government has borne substantial costs as a result of the crisis that claimed more than 64,000 lives in 2016.

 The Trump administration has said it is focusing intensely on fighting drug addiction, but critics say its efforts fall short of what is needed. Trump signed off this month on a bipartisan budget deal to provide a record $6 billion over the next two years to fight opioids, but it’s not yet decided how that will be allocated.

The statement of interest was the latest move by the Justice Department, which has also sought to crack down on black market drug peddlers and doctors who negligently prescribe.

It could increase the role of the federal government in talks aimed at reaching a settlement between government entities, drugmakers, distributors and others. A federal judge in Cleveland is overseeing the talks as an attempt to resolve the case rather than hold a trial involving more than 370 plaintiffs, mostly county and local governments. The talks also include a group of about 40 states that are conducting a joint investigation of the crisis but which have not yet sued, as well as states that have sued in state courts.

Targets of the lawsuits include drugmakers such as Allergan, Johnson & Johnson, and Purdue Pharma, and the three large drug distribution companies, Amerisource Bergen, Cardinal Health and McKesson. Drug distributors and manufacturers named in these and other lawsuits have said they don’t believe litigation is the answer but have pledged to help solve the crisis.

Any settlement deal could include billions of dollars in payments that could be used for treatment programs, abuse prevention and to cover some of the costs incurred by government dealing with the crisis. A filing could also put the federal government in line to receive some of the payouts in a deal. But any settlement is not likely to cover the cost of the crisis. A White House report last year estimated the annual cost at about $500 billion, including deaths, health care, lost productivity and criminal justice costs.

“It’s a game-changer,” Ohio‘s attorney general Mike DeWine said of the Justice Department’s involvement. “It’s a real realization of what has been going on.”

The latest effort by the Justice Department targets powerful, but legal, prescription painkillers OxyContin and Vicodin, which have been widely blamed for ushering in the drug crisis. But prescribing of those drugs has been falling since 2011 due to policies by government, medical and law enforcement officials designed to reverse years of overprescribing.

The majority of opioid deaths now involve illegal drugs, especially the ultra-potent opioid fentanyl. Deaths tied to those fentanyl and related drugs doubled in 2016, to more than 19,000, dragging down Americans’ life expectancy for the second year in a row.

Guess who is going to get all the “gold” if these attorneys are going to be able to win these cases for SELLING A LEGAL PRODUCT ?  What product is next… Caffeine …. Sugar… Chocolate… Fast Food… Soda ?

Filed under: General Problems | 13 Comments »

Health care’s fundamental problem: Your doctor doesn’t work for you

Posted on February 27, 2018 by Pharmaciststeve

Health care’s fundamental problem: Your doctor doesn’t work for you

http://thehill.com/opinion/healthcare/375348-health-cares-fundamental-problem-your-doctor-doesnt-work-for-you

You seek us out when you’re sick, share with us the most intimate details of your life, and trust that our treatments will make you better.

There’s just one problem: Your doctor may not actually be working for you, the patient. 

Over the last three decades, as patients have seen their medical costs increase dramatically, the number of self-employed doctors has plummeted. Today, just a third of doctors are self-employed, as more doctors find independent practice difficult and seek the sense of security offered by large hospitals.

Once the backbone of America’s health care system, primary care physicians have been overtaken by medical middlemen that drive up costs and get between doctors and our patients. Every step of the way, the patient’s interests are subordinated to another customer. Doctors answer to their hospital employers. The hospitals are eager to please the insurance companies that decide whether to pay medical claims.
Throughout its history, the health insurance industry has paid lip service to controlling costs while actually driving them higher. At any time, your doctor’s years of training and knowledge of your unique condition can be vetoed by your insurance company. By overriding a doctor’s recommendation, a patient’s condition can deteriorate and lead to more costly procedures. 

Patients have little recourse to hold insurance companies accountable. In 2018, more half of all counties in the United States have just a single health insurance plan offered through the Affordable Care Act marketplace. More than 157 million Americans receive health care coverage through their employment, and these plans cater to employers’ wishes. Patients are left with fewer plan benefits and increased out-of-pocket costs. In fact, the most recent analysis of health care spending shows patients’ out-of-pocket spending increasing at the fastest rate in a decade.

Thankfully, Amazon’s recent announcement that it is partnering with Berkshire Hathaway and J.P. Morgan to bypass the health insurance industry could usher in a new era of consumer choice. Although few details have been announced, patients should be excited by Amazon’s notorious customer obsession and track record of market disruption. What would an Amazon customer-obsessed, disruptive health care system look like?

“Leaders start with the customer and work backwards,” Amazon explains of its core philosophy. “They work vigorously to earn and keep customer trust.”

Direct primary care — where your doctor works for you, not an insurance company — is the most logical option. Think back to the days of the town doctor making house calls.  

Direct practices offer home visits, answer calls 24-7, and personally manage patient’s hospital care. These physicians work directly for and are paid directly by their patients, which forces doctors to provide the best service. Under the conventional health insurance system, primary care physicians can be responsible for 2,000 to 3,000 patients per doctor. Concierge practices, in contrast, limit the number of patients to a few hundred in order to spend more time with each patient.

Direct primary care can help reduce health costs by addressing minor issues early on. Emergency room visits and urgent hospitalizations represent one of the greatest financial burdens in health care, both of which are reduced with direct practice. A 2012 study published in the American Journal of Managed Care found that personalized preventive care substantially lowered hospital utilization rates and reduced overall health care spending by an average of $2,551 per patient while reducing emergency room visits and urgent hospitalizations by 50-80 percent.

There are now tens of thousands of doctors caring for millions of patients, who have made the conscious decisions to get out from under the insurance system’s control. Most practices charge between $50 and $300 per month, an affordable price for many, but a barrier for others.

Until now, concierge medicine has struggled to gain widespread appeal. It’s understandably a tough sell for financially-strapped patients who can barely afford their sky-high insurance premiums. Enlightened employers, such as Amazon and Co., could disrupt the health care framework by adopting a system based on independent primary care physicians that work only for their patients. To serve their 3 million employees, Amazon, Berkshire Hathaway, and J.P. Morgan would need as few as 6,000 physicians, thereby showing a proof of concept for broader reform.  

When doctors work directly for patients, patients become empowered consumers in charge of their medical care. In other words, it returns to what most doctors used to do before the health insurance industry took over and changed the rules.

Dr. Thomas W. LaGrelius serves as president and chairman of The American College of Private Physicians. LaGrelius owns a concierge practice and is paid directly by and works directly for his patients.

Filed under: General Problems | 1 Comment »

Judge rules: only DEA/judicial system can decide if MJ has a valid medical use ?

Posted on February 27, 2018 by Pharmaciststeve

Judge tosses lawsuit challenging federal marijuana laws

http://www.startribune.com/judge-tosses-lawsuit-challenging-federal-marijuana-laws/475226443/

NEW YORK — A judge on Monday dismissed a lawsuit challenging federal laws criminalizing marijuana as unconstitutional, saying the five plaintiffs had failed to pursue changes in the drug’s legal status by first going through the Drug Enforcement Administration.

U.S. District Judge Alvin Hellerstein did not address the plaintiffs claim that marijuana has medical benefits, but said

the DEA has the authority to make that decision and not the courts.

The plaintiffs included former NFL player Marvin Washington, the co-founder of a company that sells hemp-based sports products, Army veteran Jose Belen, who said the horrors of the Iraq War left him with post-traumatic stress disorder, and two young children who use marijuana to treat medical conditions.

Michael Hiller, lead attorney for the plaintiffs, said they would appeal the decision.

“Resigning the plaintiffs to the petitioning administrative process is tantamount to a death sentence for those patients who need cannabis to live,” said Hiller, who had earlier argued that the administrative process takes an average of nine years.

In a statement, Belen called the ruling disappointing, “but just the beginning.”

“We are on the right side of history, and we will take this fight to the Supreme Court if necessary,” Belen said.

 

Hellerstein earlier had evinced sympathy for the plaintiffs’ claims that medical marijuana had helped them, but appeared to take the government’s argument seriously that the plaintiffs should petition the DEA.

The suit originally was filed in July as a growing number of states broke with the federal government and declared marijuana to be legal. Thirty have now legalized it in some fashion, including six for recreational use.

The lawsuit challenged the listing of marijuana as a Schedule I drug, a category that includes heroin and LSD. The federal government says drugs under that classification have no accepted medical use and cannot legally be prescribed.

The plaintiffs had asked the court for a permanent injunction preventing the government from enforcing the Controlled Substances Act as it pertains to cannabis.

Marijuana got its Schedule I designation as part of the ranking or “scheduling” of drugs under the 1970 act.

 

Government lawyers had argued there were logical reasons to classify marijuana as a dangerous drug under federal law.

A message seeking comment from the U.S. Attorney’s office was not immediately returned.

Who could have not seen this coming… typically Congress consists of 40% attorneys…  Who passed the Controlled Substance act and put the DEA in charge of enforcement … and the DEA is part of the judicial system… so a federal judge -part of the judicial system – ruled that the DEA should be the only entity to determine if Marijuana has any valid medical purpose.

Filed under: General Problems | 4 Comments »

Pharmacy benefits managers in crosshairs of latest opioid lawsuit

Posted on February 26, 2018 by Pharmaciststeve

http://www.benefitspro.com/2018/02/26/pharmacy-benefits-managers-in-crosshairs-of-latest

They’d been out of the fight over the widespread use and abuse of opioids, but that could be about to change. Pharmacy benefit managers are being targeted by a lawsuit filed by Webb County, in South Texas, charging that PBMs enabled the opioid crisis and profited from the sale of the drugs that fueled it, according to a lawyer who represents the county.

Stat News reports that not only does this suit, filed in January, target PBMs, but in being rolled over into a larger that aggregates claims from cities and states across the country, it could also open up PBMs across the country to potential settlements as well as court orders meant to change the way the drug industry operates.

PBMs, the financial middlemen that determine which drugs are available and how much they’ll cost patients out of pocket, provide little transparency on how they make those determinations. The Webb County lawsuit is thought by its attorneys to be the first in the country to name PBMs as defendants in a municipal opioid lawsuit. 

While some experts say that because PBMs aren’t publicly visible in their role, that could make it tough to prove liability for the overdose deaths and other consequences of the crisis.

Related: How can brokers help clients address the opioid epidemic?

“They are far more removed than manufacturers and distributors,” Jodi Avergun, a former chief of staff of the Drug Enforcement Administration and now a defense lawyer with Cadwalader, Wickersham & Taft, is quoted saying in the report. Avergun adds, “PBMs play a less significant role and one that’s harder to ascribe liability to under traditional tort principles.”

But that’s not the only expert opinion on the subject; other experts believe that legal discovery could be especially damaging for PBMs, since they hold records on the number of opioids dispensed in communities hit with huge increases in overdoses.

“It’s hard for these companies to [argue] that in certain locales the volume of pills was for a legitimate medical purpose,” Rebecca Haffajee, a professor of health management and policy at the University of Michigan School of Public Health, is quoted saying in the report. She adds, “The paper trail of prescriptions makes it more compelling, and those records should be disclosable.”

Joanne Cicala, a lawyer who represents Webb County, says in the report that PBMs enabled the opioid crisis and profited from the sale of the drugs that fueled it. She’s quoted saying, “We see them as an absolutely essential part of this scheme. They made sure these drugs were dispensed and they controlled their flow out into the communities.”

According to the report, the county’s suit includes claims against three PBMs that control most of the U.S. market: Express Scripts, CVS Health, and OptumRx. In addition, it names two smaller companies that also operate in South Texas, Prime Therapeutics and Navitus Health Solutions.

The suit also includes fraud, conspiracy, and racketeering charges against major drug manufacturers and wholesale distributors, which is common to many other complaints filed across the country. However, Webb County’s case stands out thanks to its legal claims and language directed at PBMs, entities the suit calls “the gatekeepers to the vast majority of opioid prescriptions filled in the United States.”

The PBMs aren’t going down without a fight, however. The report cites an e-mailed statement from Jennifer Luddy, a spokeswoman for Express Scripts, saying that the allegations in the case are without merit. “We plan to defend ourselves vigorously,” the statement says. In addition, CVS Health, Prime Therapeutics and Navitus Health Solutions all were quoted in the report saying that charges were baseless or defending their practices.

I have been talking about this for several months… I knew at some point that the PBM’s would be pursued for “damages” for paying for all those opiates that are part of the FABRICATED OPIATE CRISIS.

There are three major PBM’s that control some 80%+ of that market place

Then there are three major drug wholesalers that control some 80%+ of that market place

Then there are a handful of pharmas that control the high majority of the legal prescription opiate production

And all of these entities being sued have DEEP POCKETS

The PBM’s work – hired by – insurance companies and self-funded large employers whose insurance is self funded..  Where the “insurance company or PBM” is just a hired entity to pay out the employer’s money and adjudicate healthcare claims for the employer’s employees and family.  Reportedly, ERISA type programs are about 50% of  “health insurance” being provided to employees.  These companies rely on these insurance companies/PBM’s to establish protocols as to what services/medication should be paid for and recommend other limits.   Typically, the employer will accept the recommendations, because few have the internal expertise to manage this… this is why they hire these companies … they are the ones who are suppose to be experts in cost controls in this area.

Could we expect to see lawsuits by large ERISA companies towards their insurance/PBM administrators in the not so distance future.  Anthem is already suing Express Script over alleged not “sharing” rebates from the pharma ? https://www.washingtonpost.com/news/wonk/wp/2016/03/21/anthem-sues-express-scripts-over-prescription-drug-pricing

 

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#Kolodny: Suboxone, Vivitrol, Methadone FOR EVERYONE ?

Posted on February 25, 2018 by Pharmaciststeve

F.D.A. to Expand Medication-Assisted Therapy for Opioid Addicts

https://www.nytimes.com/2018/02/25/science/fda-medication-assisted-therapy.html

www.nytimes.com/2018/02/25/science/fda-medication-assisted-therapy.html

In an effort to encourage new treatments for opioid addiction, the Food and Drug Administration plans to begin permitting pharmaceutical companies to sell medications that help temper cravings, even if they don’t fully stop addiction.

The change is part of a wider effort to expand access to so-called medication-assisted treatment, or MAT. The agency will issue draft guidelines in the next few weeks. A senior agency official provided details of the proposal to The New York Times.

The new approach was signaled Saturday by the health and human services secretary, Alex M. Azar II, in remarks to the National Governors Association. Mr. Azar said the agency intended “to correct a misconception that patients must achieve total abstinence in order for MAT to be considered effective.”

While the Trump administration has generally supported medication-assisted treatment, Mr. Azar’s predecessor, Tom Price, was not completely on board with it. Mr. Price caused an uproar among treatment experts when he dismissed some medications that reduce cravings through synthetic opioids last spring as substituting one opioid for another. He subsequently walked back those comments, saying officials should be open to a broad range of treatment options.

Mr. Azar, who took office late last month, said he would work to reduce the stigma associated with addiction and addiction therapy, and would not treat it as a moral failing.

The opioid epidemic is considered the most unrelenting drug crisis in United States history. In 2016, roughly 64,000 people were killed by opioid-related overdoses, including from prescription painkillers and heroin.

Noting federal data showing that only one-third of specialty substance abuse treatment programs offer medication-assisted treatment, Mr. Azar said, “We want to raise that number — in fact, it will be nigh impossible to turn the tide on this epidemic without doing so.”

Mr. Azar’s comments echo those of the F.D.A. chief, Dr. Scott Gottlieb, who has made battling opioid abuse a priority for his agency. Dr. Gottlieb has moved to reduce opioid prescriptions by doctors and dentists and to promote more medication-assisted treatment, defined as drugs used to stabilize brain chemistry, reduce or block the euphoric effects of opioids, relieve physiological cravings, and normalize body functions.

The F.D.A. has approved three drugs for opioid treatment — buprenorphine (often known by the brand name Suboxone), methadone and naltrexone (known by the brand name Vivitrol) — and says they are safe and effective combined with counseling and other support. But the agency said it would soon publish two guidances, recommendations for drugmakers, on the issue.

One encourages the development of new, longer-acting formulations of existing drugs for opioid treatment. The other, which was described in detail to The Times, said new drugs would be eligible for approval that don’t end addiction but help with aspects of it, such as cravings, or overdoses, with the goal remaining complete abstinence.

“We will permit an endpoint that shows substantial reductions but does not require the patient to be totally clean at every visit if the measurements are fairly frequent,” a senior F.D.A. official said.

The official also said the F.D.A. was seeking medications that can help patients function better and can be helpful when used in combination with therapy and other social support, even if on their own the medications don’t completely end addiction. Under the new guidelines, patients and their families will have input in assessing how useful a drug is.

“You could envision different MATs where the different treatments are addressing different aspects of what underlies the addiction, and helping people lead productive lives free from addiction to opioids, even in situations where they still might require replacement therapy,” the official said.

Addiction experts were cautious in their praise of the plan, which should be released in March.

“The F.D.A. should keep companies focused on major clinical improvement for patients,” said Yngvild Olsen,medical director of the Institutes for Behavior Resources in Baltimore. “A more thoughtful approach to measuring meaningful clinical improvement could expand treatment options, but there is a danger; subjective outcomes that are neither here nor there could encourage the development of products of questionable value.”

And Dr. Andrew Kolodny, a director of opioid policy research at Brandeis University, said that the F.D.A. was smart to look for new treatments but that the biggest problem now in treatment wasn’t lack of effective medication, but lack of access.

“We already have an effective treatment that people aren’t getting access to,” he said. “The primary challenge is getting it to people.”

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They said YES…. before they said NO

Posted on February 25, 2018 by Pharmaciststeve

Hi Steve, I just read an article you wrote that gave me some hope. I don’t know where to begin, so I will try to make this as short as possible. I have been on opioids for a year( on ssdi for 6 ). Not that it matters but 17 knee surgeries. Torn rotator cuff etc.. I have a perfect cures record, same dr, same pharmacist etc.. due to the opioid crisis I started hating going to the pharmacy because you had to call in, ask for the medication, feel like a criminal etc…I decided to just go through my insurance mail order. First time I did it they denied me because it was through a “regular” dr. So, they spoke with him and adjusted the amount and said I needed to see a pain management dr. So, $400 later, I did exactly as they asked. BEFORE I sent in the prescription. I called to make sure everything ok. They asked for the pain management doctors DEA number, number of pills prescribed etc..They said everything was fine and I complied with their rules and regulations. Now they said they will not fill it again. I give up! I just got my teaching credential and was getting my knees done etc..but lo and behold I was offered a job immediately so I will wait till the summer. Don’t laugh, but I am a physical education teacher! I do not know what to do anymore. Oh, also the time they sent the last prescription, they sent it 3 weeks early and I called them begging them to let me return it so it would not ruin my cures report. They wouldn’t let me and I asked if they would write a letter saying they made the mistake. Needless to say they were of no help. I believe this is a violation of my civil right? Please help, I do not know what else to do. It is Express Scripts and I have spoke. With 12 different people and they cannot seem to tell me why because they say I am within their regulations. I can be reached at xxxxx@aol.com. Sorry for any typos,I have been grading papers all day!

 

This is just another good example why people should not deal with mail order… they could be hundreds or thousands of miles from you and you may not even know their name… all you  know is the name that they may give you.  They told their person what to do to get her prescriptions filled and then refused to fill her prescriptions.

They are able to “dodge” the fact that they are attempting to practice medicine by conning or persuading the pt’s prescriber to change the quantity… that way the licensed professional of the pt changed the prescription.

If prescribers would “stick to their guns” and not agree to change the prescription, then if the person on the other end of the phone call will either have to give in to what was written, change the quantity or refuse to fill the prescription. The latter two choices is either practicing medicine without a license or denial of care.

IF you have health insurance, that policy is a contract.. and they probably have published list of their providers on .. if they are only willing to collect premiums and not provide the services promised in the contract.. then some would consider that as FRAUD.

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