FDA: Pain Patients Dependent On Opioids Are Not Addicted

FDA: Pain Patients Dependent On Opioids Are Not Addicted

www.painnewsnetwork.org/stories/2019/2/6/fda-patients-dependent-on-opioids-are-not-addicted#.XJN0oMjDsMk.facebook=

The U.S. Food and Drug Administration has released new guidance to drug makers to streamline the development of buprenorphine products to treat opioid addiction. Commonly known by the brand name Suboxone, buprenorphine has long dominated the market for addiction treatment.

Of importance to pain patients is a statement about the guideline by FDA commissioner Scott Gottlieb, MD, that seeks to clarify the difference between opioid addiction and patients who need opioids for pain relief.

Gootlieb said there is still stigma and misunderstanding – even in the medical and addiction fields – about the difference between opioid addiction and dependence.

“Because of the biology of the human body, everyone who uses a meaningful dose of opioids for a modest length of time develops a physical dependence. This means that there are withdrawal symptoms after the use stops,” Gottlieb said. “A physical dependence to an opioid drug is very different than being addicted to such a medication.

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“Addiction requires the continued use of opioids despite harmful consequences on someone’s life. Addiction involves a psychological preoccupation to obtain and use opioids above and beyond a physical dependence. But someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

“Someone who is physically dependent on opioids as a result of the treatment of pain but who is not craving the drugs is not addicted.”

— Dr. Scott Gottlieb, FDA Commissioner

In recent years new and generic formulations of buprenorphine have been released in tablets, sublingual films, injections and implants, and the FDA is trying to promote the development of more of them.

The guidance released by the agency basically tells drug makers they may be able to submit new drug applications for buprenorphine products without conducting the safety and efficacy trials that are usually required for other medications.

“The guidance we’re finalizing today is one of the many steps we’re taking to help advance the development of new treatments for opioid use disorder, and promote novel formulations or delivery mechanisms of existing drugs to better tailor available medicines to individuals’ needs,” Gottlieb said. “Our goal is to advance the development of new and better ways of treating opioid use disorder to help more Americans access successful treatments.”

There are currently only three drugs approved by the FDA for medication-assisted treatment (MAT) – buprenorphine, methadone and naltrexone. Physicians wishing to prescribe buprenorphine to patients must have a special certification from the DEA and are limited in the number of patients they can treat.

Buprenorphine is an opioid that is also used to treat pain. When combined with naloxone, buprenorphine reduces cravings for opioids and lowers the risk of abuse.

Some addicts have discovered that buprenorphine can also be used to get high or to ease their withdrawal pain from heroin and other opioids. Buprenorphine is such a popular street drug that the National Forensic Laboratory Information System ranked buprenorphine as the third most diverted opioid medication in the U.S. in 2014. 

A patient’s opposition to the anti-opioid movement

A patient’s opposition to the anti-opioid movement

www.kevinmd.com/blog/2019/03/a-patients-opposition-to-the-anti-opioid-movement.html

I recently read an article — “California Doctors Alarmed As State Links Their Opioid Prescriptions to Deaths” — that infuriates and frightens me I’m furious that doctors are being persecuted for opioid prescriptions written years ago, and frightened that my doctor here in California may be pressured to stop prescribing them for my painful genetic disorder (Ehlers-Danlos).

Twenty-six states have already implemented arbitrary restrictions on our appropriately prescribed opioids, but the California medical board’s project is even more of a nightmare:

1. Comb through the state’s PDMP for the last three years to find links from people who recently died from an overdose of illegal drugs to a doctor who prescribed them opioids for any reason at any time during the last three years.

2. Then review the doctor’s records for this patient and, if the CA medical board doesn’t agree with some aspect of this long-ago prescription, threaten the doctor with future prosecution.

3. In the meantime, demand the doctor produce a “written summary of the care he had provided” (justification) due in only two weeks and fine him $1,000 each day he’s late with his report.

This certainly makes me better understand why doctors are so afraid to prescribe opioids, even when patients are suffering from incurable and painful conditions. I can’t imagine how I’d have reacted upon receiving such a career-threatening and legally intimidating letter while I was still working.

The idea of a “standard dose limit” for a medication like opioids is absurd. It’s like setting a standard cooking time for a roast without specifying the weight of the meat (amount of pain) or temperature of the oven (individual’s ability to metabolize opioids).

In its own guideline from 2013, the medical board advised that “for certain types of pain, opioids were the cornerstone of treatment and should be pursued vigorously.”

This is, of course, still the truth for intractable pain that cannot otherwise be relieved, like from sickle cell disease or my own connective tissue disorder.

I’ve heard from so many other pain patients these days that their doctors only initiated opioid therapy as a “last resort” after many non-opioid treatments were tried and failed and then just for patients for whose pain these medications are effective. Even so, opioids are usually only one of multiple pain management strategies a patient will use.

The CA medical board seems to suspect doctors of negligence if they didn’t perform a complete history, physical exam or repeated testing before each 30-day prescription, even when the same dose of the same pain medication has been prescribed for the same intractable pain condition for years.

This is no different than how so many other drugs are prescribed for ongoing conditions, like high blood pressure, high cholesterol, or depression. Especially when we’ve been seeing the same doctor for years, such repetitive documentation of the obvious and unchanging seems a waste of time.

Like most chronic conditions, chronic pain rarely improves and usually worsens with age. Once the pain has been investigated, sometimes diagnosed but often not, and the medically appropriate decision has been made to start opioid therapy, the necessary dose will rarely decrease and can be expected to continue forever.

That sounds crazy to people who don’t understand what a positive difference opioids can make for us, how they are literally life-saving for someone like me who faces a lifetime of unrelenting pain. For anyone else but the bureaucrats trawling through long-ago prescription records, the reasons for an ongoing opioid prescription should be obvious: unresolved pain.

The article quotes, “But it’s unclear if the overall effect of the project will be good for patients.”

No, it’s not unclear at all: forcing doctors to reduce the dose of opioids a patient is prescribed without a medical reason is always bad for patients. I can’t understand how mandated changes in medication regimes that are made against a doctor’s judgment can possibly be imagined to benefit patients.

The CDC’s opioid prescribing guideline is intended only for primary care physicians, not pain specialists, and for patients who haven’t already been taking them for years and decades, like I have. Yet, these caveats are ignored as anti-opioid advocates rush to make the guideline’s suggested opioid dose risk boundaries (at 50 and 90 MME) into absolute limits for every patient in every situation.

I don’t believe the current punitive policies were either unforeseeable or unintended when the CDC guideline authors chose to quantify that which is not quantifiable, namely chronic pain and its relief. Universally mandated dose limits ignore the complexity of patients, our genetics, body chemistry, mental state, and lifestyle, to focus only on a single number.

The amount of pain relief achieved by a specific opioid, at a specific dose, at a specific time, for a specific patient can vary by a factor of 10 or more: some need only 30 MME per day, others may need 300 and even up to 3,000 MME; I know pain patients at both extremes.

Even worse, these dose limits on pain relief are targeting the wrong substance and the wrong people. The government’s own data shows that the majority of “opioid” overdoses are from combinations of illicit street drugs, not from opioids prescribed to pain patients.

Trying to stem illicit opioid overdose deaths by mandating restrictions on opioids for patients in pain is only a cruel experiment fueled by ignorance and fear.

Angelika Byczkowski is a patient with Ehlers-Danlos syndrome who blogs at EDS Info.

Coalition of 50 states Pain Advocacy

From: TameraLynn Stewart
Sent: Thursday, March 21, 2019 12:20 AM
To: Steve Ariens
Subject: Federal health staffer gave us a plan!

 

Hi Steve! This is Tamera Stewart. As Valorie Hawk is stepping back to focus on her health and her family, I will be stepping into a more active roll. We have been given step by step instructions directly from an experienced Health Staffer for a Federal Rep that he believes will be our best chance to make a huge difference in the next 60 days, but we have to act fast! Here is step one, and I have the rest to put out over the weekend, but was wondering if you could help by sharing this also? This is what I am about to put on the page and into the groups.

A Congressman’s Health Staff gave us a plan to get our issue into the hands and minds of EVERY federal Representative and Senator in 5 weeks time, so here is Step1:

 

March 21 & March 22

 

Call the LOCAL office for your 3 congressmen (1 rep & 2 senators) and say something like:

 

My name is _____________ . I am a volunteer with the Coalition of 50 States Pain Advocacy Groups, and I am concerned about a renewed push to limit the abilities of our providers to prescribe pain medication to patients based on their individual need. This comes at a time when many unintended consequences of the CDC Guidelines for Responsible Opioid Prescribing are coming to light and some states are even rolling back their restrictive prescribing laws due to deaths and harms to patients.

I would like to meet with Congressman/woman or Senator _______________ when he/she is in the district/state next month while Congress is on their April break. It will likely be a small group of us from the district consisting of pain patients with varying conditions, care givers and/or advocates, and possibly medical professionals (possibly by skype or phone conference) if their schedule allows.

 

Then listen to what they have to say. If they ask you to email them with something formally requesting the meeting, no problem, we have that covered just get their email.  Some will ask that you meet with their field representative or liaison before the Congressman, and that is great; sometimes that is a better place to start anyway!

 

Basically follow their directions to set an appointment with SOMEONE! I personally have had good luck asking them if we can have 10-15 minutes before or after an already scheduled public event or townhall. Then you get to meet with them AND go to the event and really be seen and heard!!!

 

Main thing, if you have ANY questions, please PM me (Tamera Stewart) or the Facebook page (@c50advocacy) and ask! We will help find others in your area and have medical professionals ready to either meet with you or call/skype in to provide the professional side of it. The papers are ready, we have info that can be customized into a packet to fit your exact needs in minutes, including specific solutions that they can put into action! All you have to know is you and your story and be willing to work a little bit to prepare and then share!  THEY WILL MEET WITH YOU, BE CONFIDENT AND POLITE!

 

To find your federal Senators and Reps, and for step by step instructions, go to:

https://painadvocate.org/find-your-reps%2Fsenators

 

This could be a huge opportunity, we need EVERYONE to make these calls/requests to make sure they know how many of us are speaking out! to find your federal Senators and Reps, and for step by step instructions!

 

Unintended Consequences of Opioid Crackdown

Yesterday Kaiser Permanente signed my death warrant

I was left at an 8 due to a forced step down by Kaiser Permanente (due to the recs pre 2016.. Were those 2014? It’s hard for me to access memories anymore. The pain is too loud.) in Southern California. I had been at a daily pain level of 5-6 before the step down. Now, I am bedridden and have left the house once for anything but medical visits in four years. (We tried to go out for lunch on my birthday two years ago. It put me at a 9 for three days.) My pain controls my life. It is torture. And yes, I did file the motion to join California’s Starburst last month.

Yesterday Kaiser Permanente signed my death warrant.

They gave me a choice. I can either let them step me down or deal cold turkey with them stopping writing my pain prescriptions. I am barely holding on by a thread at an 8. Sooner or later at a pain level of 9, I will euthanize myself. I have started grieving my own death and prioritizing my books-to-be-read and movies-to-watch. Now I am waiting. I get to go until my next medication refill and then… Then.. Then I endure the painful horror as long as I can- and finally will love myself enough to let go via self euthanasia.

I promise, fellow pain sufferers, that I will not use opioids in my euthanasia. I will not be a statistic to use against you. The question is between an exit bag and helium or a severed carotid. (The exit bag is easier psychologically, but can be reversed-leaving brain damage. The severed carotid leaves you unconscious within 90 seconds, dead inside of five minutes and is absolutely sure, even if done in an emergency room. It is so screwed up that I had to research and learn that!) I promise I will send a snail- letter detailing my diagnosis (Fibromyalgia and Ehlers–Danlos syndrome), my attempts to control pain over the past 20 years, the horror of being stepped down, the torturous level of pain I have endured and my final exit to ABC, NBC, CBS and fox locally, in my state capital of Sacramento and Washington DC. I will also send it to my mayor, governor, state and federal representatives, the director of the CDC, the White House and to our president himself. I will post it on Facebook (who will probably delete it) and email it to Robert Rose. (I have already started it, as I am only sure of the next month.) I will do my best for those of you left. I will make sure everyone knows that I didn’t want to die, but was forced to it due to torturous pain after losing my pain control. I keep telling myself that I should be relieved. My suffering is almost over. Maybe I will even believe it by the end. I doubt it though. I don’t want to die,

This is NOT the first that I have heard from a Kaiser Permanente pt that they are being forced to reduce their opiate pain therapy until the pt is being forced to live/exist in a torturous level of pain.  This is the WORSE that I have seen come my from one of their pts. One has to wonder how many thousands of other Kaiser pts are in the same boat and/or have already committed suicide or died from “natural causes” because of their under/untreated pain. Below is a list of bodily functions that are adversely impacted by under/untreated pain.  Could pts that have had their pain meds reduced could end up dying from “natural causes” but in reality it is from under/untreated pain and the consequences of doing this.

I guess that the employee/prescribers working for Kaiser have abandoned their oath to “DO NOT HARM” for keeping their PAYCHECK going forward.

 

 

JUMPING TO CONCLUSIONS AT CVS ?

JUMPING TO CONCLUSIONS AT CVS ?

Image result for clipart jumping to conclusion

The Amount Of Meth Pouring Across The US Southern Border Is Skyrocketing

The Amount Of Meth Pouring Across The US Southern Border Is Skyrocketing

https://dailycaller.com/2019/03/18/meth-border-mexico-trump/

Law enforcement officials are confiscating substantially larger amounts of methamphetamine as Mexican drug cartels increasingly push the drug into U.S. markets.

A drug-tracking system from the Drug Enforcement Administration (DEA) indicates that a total of 347,807 law enforcement meth seizures were submitted to various labs across the country in 2017, according to a Wall Street Journal report. The number is a 118 percent hike from 2010 submissions.

U.S. meth-related deaths hit 6,762 in 2016, according to the Centers for Disease Control and Prevention. This is approximately 3.5 times the amount in 2011. While specific data beyond 2016 is not currently available, provisional data through July 2018 indicates that meth-related deaths are still climbing.

The flood of meth, a popular synthetic drug that is made in labs, has made it much more affordable for U.S. consumers and inflamed the drug overdose crisis currently plaguing the country.

“Everybody’s biggest fear is what’s it going to look like if meth hits us like fentanyl did,” Jon DeLena of DEA’s New England office said to the Wall Street Journal. Access to fentanyl, a dangerously potent synthetic opioid, has led to mass overdoses across the country. Many fear that the increased trafficking of meth could result in similar death rates.

DEA officials are blaming the situation on Mexican drug cartels, which are more aggressively pushing the drug into the U.S. interior as they attempt to rival South American-made cocaine. The synthetic stimulant is now becoming more prevalent in many regions — such as the U.S. Northeast — where meth was more-or-less scarce.

A member of the German Criminal Investigation Division (BKA) displays Crystal Methamphetamine (Crystal Meth) during a news conference at the BKA office in Wiesbaden November 13, 2014. Police found 4 kilograms of Crystal Meth and 2.9 tons of Chlorephedrine, a base substance to produce Crystal Meth, during a police raid in Leipzig on November 5 and November 8, 2014. REUTERS/Ralph Orlowski

A member of the German Criminal Investigation Division (BKA) displays Crystal Methamphetamine (Crystal Meth) during a news conference at the BKA office in Wiesbaden November 13, 2014. Police found 4 kilograms of Crystal Meth and 2.9 tons of Chlorephedrine, a base substance to produce Crystal Meth, during a police raid in Leipzig on November 5 and November 8, 2014. REUTERS/Ralph Orlowski

Meth production in the U.S. has generally declined in the past 10 years, but this trend has been offset with an increase in supply from Mexico.

“They’re flooding it through tunnels, they’re flooding it through ports of entry, they’re flooding it between ports of entry,” stated DEA Special Agent Doug Coleman.

News of meth’s rise follows President Donald Trump’s ongoing battle with Congress to secure the U.S.-Mexico border with a massive wall.

Congress allocated just over $1.37 billion to finance 55 miles of border wall in Texas following gridlock between Democratic and Republican lawmakers. Trump accepted that funding in February, but he then declared a national crisis. The president has since requested an additional $8.6. billion for wall construction. (RELATED: Trump To Close Immigration Offices In Other Countries To Save Money)

Trump vetoed a Congressional resolution that disapproved of his emergency declaration — the first veto of his presidency. However, a number of lawsuits are still seeking to block the declaration in court.

I’ve been a pharmacy tech for CVS for 8 years now.. “terminated”.. I haven’t been maintaining my full time status

From Joe:

“Thought I’d shoot a message your way. you can choose to do what you with with the info and I do not need to be anonymous. I’ve been a pharmacy tech for CVS for 8 years now (lead tech for 5) and recently been told I’m being let go. I started my own business about 2 years ago, and its finally taking off to the point where I wont even need CVS soon. But because I haven’t been maintaining my full time status (30hr+ per week) they cant just drop me down to part time, they have to “terminate” me and if I choose, can reapply for part time at a lower wage. This seems like a stab in the back from a company I gave my entire 20’s too. I still need the job because income from my business is sporadic at the moment, but my PIC told me realistically she can keep me on about another month before she thinks corporate is gonna make her give me the boot. 4 years ago this never would have been a thing and would have no problem dropping to part time. I’d encourage anyone thinking of leaving CVS to do so, or anyone thinking of applying, not to. it’s an evil company consumed by corporate greed”

 

I was informed the Mountain Home VAMC, Johnson City, TN is retaliating against my lawsuit by denying my State of Tennessee paperwork which can result in loss of more benefits

March 18, 2019, Wonderful Monday morning! Wonderful! I was able to speak to a dishonored Marine. I was informed the Mountain Home VAMC, Johnson City, TN is retaliating against my lawsuit by denying my State of Tennessee paperwork which can result in loss of more benefits, maybe even the small check I receive from being a teacher… Wonderful Monday morning. And yes, if it moves you to do so, please share to show how protected veterans are from retaliation from the Department of Veterans Affairs. Robert — Teufeulshunde

Senators Gillibrand And Gardner Announce Bipartisan Legislation To Combat Opioid Crisis By Limiting Prescriptions To Seven Days

Senators Gillibrand And Gardner Announce Bipartisan Legislation To Combat Opioid Crisis By Limiting Prescriptions To Seven Days

https://www.gillibrand.senate.gov/news/press/release/senators-gillibrand-and-gardner-announce-bipartisan-legislation-to-combat-opioid-crisis-by-limiting-prescriptions-to-seven-days

Legislation Would Help Combat Addiction and Abuse by Creating Tougher Law on Initial Opioid Prescriptions

Washington, DC – U.S. Senator Kirsten Gillibrand (D-NY) and U.S. Senator Cory Gardner (R-CO) today announced bipartisan legislation to combat the opioid crisis. The John S. McCain Opioid Addiction and Prevention Act would limit the supply of initial opioid prescriptions for acute pain to seven days. This bill is named after late-Senator John McCain, who was the Republican lead of this legislation last Congress.

According to the Centers for Disease Control and Prevention (CDC), there are nearly two million Americans misusing prescription opioids, and each day, 41 people die from an overdose related to these prescription painkillers. The CDC also found that in 2017, 68 percent of drug overdose deaths involved an opioid. This bill would create a seven-day prescription limit for opioids so that no more than a seven-day supply may be prescribed to a patient at one time for acute pain, such as a wisdom tooth removal or a broken bone. This would help restrict the excess supply of opioids and help minimize the risk of abuse.

“Too many families throughout New York and our country have suffered from the devastating consequences of the opioid epidemic. No community has been left untouched, and we need to be proactive when it comes to ending this crisis,” said Senator Gillibrand. “One of the root causes of opioid abuse is the over-prescription of these powerful and addictive drugs. I’m proud to join with Senator Gardner to introduce bipartisan legislation that limits the over-prescription of opioids. This would help our communities combat opioid addiction, and I urge my colleagues in Congress to pass this bill.”

“As I’ve met with Coloradans impacted by the opioid epidemic, the recurring story is clear. Oftentimes, the first over prescription spurs the devastating path of addiction,” said Senator Gardner. “Over prescriptions for pain management have allowed the opioid crisis to hit every corner of our communities, and this common sense legislation establishes the appropriate protections to help prevent addiction in the first place.” 

“The seven-day limit for initial acute-pain opioid prescriptions is consistent with pharmacists’ recommendations from the front-lines of care, their collaboration with law enforcement, and the needs of chronic pain sufferers. Six-in-10 Americans support this measure, with only two-in-10 indicating opposition, according to a January 2019 Morning Consult poll commissioned by NACDS. This bill will help prevent addiction and help prevent unused medications from falling into the wrong hands. Our support reflects pharmacies’ longstanding commitment to serve as part of the solution,” said NACDS (National Association of Chain Drug Stores) President & CEO Steven C. Anderson, IOM, CAE.

The John S. McCain Opioid Addiction and Prevention Act would help reduce the amount of excess opioids by requiring medical professionals, as a part of their Drug Enforcement Agency (DEA) registration, to certify that they will not prescribe an opioid as an initial treatment for acute pain in an amount that exceeds a seven-day supply. Medical professionals would also have to certify that they would not provide a refill. Under current federal law, a medical professional must register with the DEA in order to be allowed to prescribe a controlled substance in the United States. This registration must be renewed every three years.

This seven-day prescription limit would not apply to the treatment of chronic pain; pain being treated as part of cancer care, hospice care, or other end-of-life care; or pain treated as part of palliative care. This federal legislation is modeled after laws in several states. Currently, fifteen states, including New York, limit initial opioid prescriptions for acute pain.  

This was from Senator’s Gillibrand’s official government website… Apparently Senator Gillibrand – or whoever on her staff or Senator Gardner’s – or his staff doesn’t know the difference between the word PRESCRIPTION – a noun – and the word PRESCRIBING – verb.  Because you find this statement SEVERAL TIMES

One of the root causes of opioid abuse is the over-prescription of these powerful and addictive drugs

Here is another DECEPTIVE STATEMENT and this bill/law would deny pt that are continuing to experience pain after 7 days – NO ADDITIONAL OPIATE MEDS

Medical professionals would also have to certify that they would not provide a refill.

So a person who has a life altering event other than:  pain being treated as part of cancer care, hospice care, or other end-of-life care; or pain treated as part of palliative care. and ends up being a legit chronic pain pts… apparently – if this bill is passed – is just screwed in getting opiates to treat their chronic pain.  So is the ultimate goal of this bill/law is to prevent the disease of addiction/substance abuse as well as the disease of CHRONIC DISEASE from happening?

Here is another “little jewel” in this declaration:   41 people die from an overdose related to these prescription painkillers.  So exactly what does “related” to these prescription painkillers suppose to mean ?  Is this suppose to create a smoke and mirror scenario to hide the fact that the vast majority of opiate OD’s are from multiple substances including ILLEGAL FENTANYL ANALOG ?… and don’t forget that most/many include the DRUG — ALCOHOL ?

What does this say about their knowledge base of these two Senators, their staff, or whoever convinced them to support this bill ?

Don’t forget that there is no educational requirement nor experience to run/elected to a political office … this published statement and the related proposed bill from these two Senators might clearly demonstrate there could  be a definite need to review this issue.  AND one of these Senators has announced her intention to run for PRESIDENT ?