Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

https://www.regulations.gov/document?D=FDA-2019-N-1646-0001

Dates

The meeting will be held on June 11, 2019, from 8 a.m. to 5 p.m. and June 12, 2019, from 8 a.m. to 5 p.m.

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CVS Introduces Limit on Glucose Strips

www.nbcnewyork.com/on-air/as-seen-on/CVS-Introduces-Limit-on-Glucose-Strips_New-York-509231382.html

According to this report… CVS has decided to only allow 3 glucose test strips for Insulin dependent pts and it is being billed to Medicare Part B. Even though Medicare Part B will reimburse for 4 tests strips a day.

According to this article, the news reporter reached out to CVS and their response was that they suggested that this pt get her glucose test strips at another pharmacy.

I would hope that this woman takes ALL OF HER PRESCRIPTIONS TO ANOTHER PHARMACY and hopes that her doctor suggests to all of her pts that they find another pharmacy to take care of their medication needs.

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PRESS RELEASE from Nealy Tynes, President, International OPERATION PAIN RELIEF

www.nationalpainreport.com/press-release-from-nealy-tynes-president-international-operation-pain-relief-8839697.html

PRESS RELEASE
4-28-19

In 2010 the Department of Defense told us there were 18 vets of foreign wars dying by suicide everyday in Washington state.  That is approximately 6,570 per year.

Now, it’s 2019 and the suicide rate is increasing dramatically in Washington state each day, not only by the vets of foreign wars, but include cancer patients, fibromyalgia patients, RSD/CRPS patients, etc., who are all untreated for their pain.

Washington state was considered the first “Pilot Project” state in America, back in 2010.  Now there are 6 pilot project states in the union.

Whatever passed in Washington state, passed nationwide.  Blame ESHB 2876, sponsored and written by Jim Moeller (House Rep), in 2010.

I read it.  There were no facts, or findings of law in Jim’s Bill.  It was simply hearsay, and a story.  No proof of what he wrote was backed up by any documentation.

ESHB 2876 was about a story of children getting into their parents medicine cabinets, finding pill bottles, overdosing, while their parents were not at home.

And, that my friends, became law.  It was merely a story.

I interviewed each of the House of Representatives in the Washington state, Olympia, legislators’ offices.  Each and everyone of them had a ‘boiler plate’ answer to me.  They said:  “I was told to not read it, and to not research it, but to sign it and send it up the governor’s office.”  Governor Christine Gregoire then passed it into law.

I found out later, during my investigation, that the FDA pressured the legislators into signing ESHB 2876.

I confronted the FDA, and told them they have no jurisdiction over our Washington state legislators, and they need to get the hell out of our state, and don’t ever come back.

In the meantime, the doctors started leaving our state in droves.  There were none to be found who would take chronic pain patients, and the suicide rate climbed even further.

I was sad.  I was angry.  I was in shock.  I felt helpless.

But, God had a plan for me, and I kept advocating anyway, to the best of my ability.

Then I became empowered by FACEBOOK.  A whole new world opened up for me, and now I am on fire, and grateful.

Please share this PRESS RELEASE.

Signed, Nealy Tynes
President, International OPERATION PAIN RELIEF
Email:  opr.1@juno.com

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Oregon Pain Action Group

Published on Apr 3, 2019

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Express Scripts won’t cover Eli Lilly’s new generic insulin

https://www.axios.com/express-scripts-wont-cover-eli-lilly-insulin-lispro-37c347da-9383-425c-b3f2-8af755f7a1ae.html

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What Is Your State Doing About Pain?

www.nationalpainreport.com/what-is-your-state-doing-about-pain-8839662.html

The Federation of State Medical Boards is meeting in Fort Worth, Texas this weekend—and the “opioid” crisis is on the agenda.

“The State Medical Boards must lead the effort on regulation of the opioid crisis. The DEA and other federal agencies must work with the Medical Boards to avoid confusion with physicians legitimately taking care of their patients.”

Sherif Zaafran, MD, tweeted out his comments made as the Federation meeting got underway.

Dr. Zaafran is the head of the Texas Medical Board and a member of the HHS Pain Management Best Practices Inter-Agency Task Force and a very important voice

Saturday, he will also moderate a discussion of nationally recognized leaders who will “discuss new steps in the effort to address the nation’s opioid crisis. Included on that panel is Vanila M. Singh, MD, MACM, who is the chair of the Pain Management Task Force that calls for patient-centered approach to improve treatment of pain.

That Task Force Draft Report received some 6,000 public comments and the HHS group will gather again in May to adopt it.

“The action is at the state level,” said Terri Lewis, Ph.D. “Pain patients and physicians need to ask their state medical boards, what are you doing now?”

Just this month, two federal agencies eased some previous guidance on opioid prescribing.

The Centers for Disease Control and Prevention said many physicians have misapplied the 2016 guideline that resulted in a serious reduction on opioid prescribing.  The CDC tacitly acknowledged many physicians’ responses to the opioid crisis went too far.

Earlier this month, the FDA issued a safety announcement that it said “identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.”

These agencies have been receiving blowback—and plenty of it—from medical professionals who believe that the reaction to the “opioid crisis” tilted dangerously toward those who become addicted from opioids versus the million of chronic pain patients who were adversely affected by the physicians, insurers and state regulators reaction.

Here’s one of the National Pain Report stories on it.

The question now is what will the state medical boards do with this new information?

The answers may begin to come this weekend in Texas.

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FDA issues the rules all other agencies must follow. No agency outranks FDA

AMA welcomes CDC’s revised view on opioids guidelines

After posting these last night and pulling the title of the posts from the article itself…  I started reviewing the “whole game” that is being played out between the DOJ/DEA, FDA, CDC  and countless other agencies and healthcare corporations and provider that are struggling with the CDC guideline.

I have stated many times before, that the one agency that is completely silent and/or missing from the conversations is the DEA .

In all of this, what has not been revised is the Controlled Substance Act (1970)  (CSA) and it appears that the DEA’s authority in using the CSA apparently remains UNCHANGED.

This is how the DEA could keep screwing with the chronic pain community:

• The DEA controls the licenses of those who produce, prescribe or dispense controlled meds.
•  The Pharmas:  the DEA still can raise/lower the annual production quotas that each pharma is allowed to produce each year. Opiate Rxs peaked in 2012 and end the ensuing years, the DEA has already decreased production quotas have been DECREASED abt 50% of what was allowed in 2012.
• Wholesalers: the BIG THREE (Amerisource, McKesson, Cardinal controls about 80%+ of the medication market in the USA. Walgreens owns part of Amerisouce – not sure if it is a minority or majority interest. Cardinal is the primary wholesaler for CVS and Mc Kesson is the primary wholesaler for Rite Aid. The wholesaler Rochester Drug Cooperative, Inc – that was recently fined by the DEA for failing to report suspicious large pharmacy orders… it was reported that they are a “major wholesaler”, but they are really part of the “secondary wholesaler market” and are really “small potatoes” in the overall wholesaler market place.  In Jan 2017, Mc Kesson paid 150 million fine ( https://www.justice.gov/opa/pr/mckesson-agrees-pay-record-150-million-settlement-failure-report-suspicious-orders ) for the same violation that Rochester Drug Cooperative, Inc was accused of and at least one of Rochester’s exec is facing 10 yrs in jail.  DEA licenses wholesalers and can fabricate charges against wholesalers, fine the crap out of them and suspend the DEA licensed to one or more distribution centers.
• Prescribers:  We have seen the DEA fabricate charges and raid prescribers offices, close their practice down, use civil asset seizure laws to confiscate all their assets and put them in the DEA’S coffer.  We have also seen the DEA use nothing but the number of Rxs and/or doses to justify a raid on a practice.
• Pharmacies: Pharmacies are licensed by the DEA, Pharmacists do not have a DEA license.  CVS was recently fined 535 million because the DEA claimed that several stores filled a total of 39 bogus C-II Rxs  https://patch.com/rhode-island/woonsocket/cvs-fined-535-000-filling-fake-opioid-prescriptions
• Pharmacy & Medical licensing boards:  These boards usually “play along” with the DEA in fining or “busting” providers.  The Medical board is mostly staffed with DEA licensed prescribers and Pharmacy boards are mostly staffed with non-practicing corporate Pharmacists – whose chains that they work for does have DEA licenses in their pharmacies.
• Then there is that part of the controlled substance act “Corresponding Responsibility”  ( https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm ) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.  Because the DEA’s statutory authority only concerns the diversion of controlled substances for illegitimate uses.. they have no authority – and thus doesn’t have to care – if valid prescription does not get filled and the valid medical need of a pt is met.

So with this revision of the CDC guidelines and the FDA getting on board, the authority and the actions of the DEA against all DEA license holders and chronic pain pts could remain unchanged.

We know that the DEA abt 4 yrs ago “forced” all of the drug wholesalers to RATION controlled substances to pharmacies which is a violation of the Interstate commerce law ( https://www.britannica.com/topic/interstate-commerce-United-States-law ) but when the entity (DOJ) that is suppose to be enforcing this law is the same entity that is causing the law to be violated… who do you turn to ?

You can ask the same question about the Americans with Disability Act and the discrimination against chronic pain pts when they are denied acceptance into a practice, a Rx filled at a pharmacy or some other issue ?

Hypothetical:  FDA/CDC and other oversight agencies implement policies and procedures that legit chronic pain pts are entitled to getting adequate pain therapy, but the DEA has continued to lower the pharma’s annual quota… wholesalers don’t have to forcibly ration controls to pharmacies …there will not be enough production to cover all the needs of acute and chronic pain pts.

Previously, I have been told that some pharmacies made sure that their “regular pts” got their pain meds and others fill controlled meds on a first come … first serve basis… when they ran out of a particular med towards the end of the month… everyone of their regular pts are just OUT OF LUCK ?

We all hear routinely, that the illicit use/abuse of controlled substances has DESTROYED families, but no one talks about how the CDC opiate dosing guidelines and their implementation has destroyed families as chronic pain pts have had their pain management therapy reduced or totally taken away.  

Let’s hope that the changes that are coming out from the CDC and FDA do not end up doing more damage than the original launch of the CDC opiates dosing guidelines has caused over the past three years because of the DEA, DOJ and our politicians being entrenched in believing that opiate prescribing to treat chronic pain is the gateway to people using/abuse illicit drugs and ODing.

They are using laws and breaking laws to deny pain pts their necessary medications… and IMO… the chronic pain community is never going to get justice and their needed medications unless they get their dollars together into a legal defense fund to level the playing field by engaging law firms or lobbyists to help us do that.

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CDC Officially Begins Issuing Corrections to Opioid “Guidelines”

Guideline Corrections Issued Three Years after Catastrophic Damage Wrought on Chronic Disease Community

www.medium.com/@heatherzamm/cdc-officially-begins-issuing-corrections-to-opioid-guidelines-3d79b68993f5

The current narrative CDC is promulgating places the blame for the guideline fiasco, patient deaths, misery and force tapering on “physician misapplication”.

This is nothing more than artful deflection and political pandering at the highest levels.

Firstly, why would the CDC place a disclaimer on their work in the first place? Surely, if they were confident in their contracted work and guidance, there would be no need for a CYA.

Also, one needs to look no further than the DEA and their unhinged arresting of physicians, left and right, through PDMP (prescription drug program monitoring) targeting.

If physicians have “been allowed” all along (per what the CDC is now saying) to prescribe opioids at the amounts patients require to relieve their pain, then why is the DEA using the PDMP to target physicians who… prescribe any opioids?

In fact, isn’t the PDMP supposed to be an aid for doctors to keep drug addicts from working the system, not a tool for law enforcement (99.9% of whom are clueless about pharmacology and medicine, dosages) to use to target doctors in some kind of fantastical “pre-crime” Minority Report profiling system?

Social engineering has conditioned society at this point to view any person who needs or uses opioids in a negative, dim way. Therefore the CDC knows that they can wholesale push anything onto the public at this point and it will be believed by most, unquestioned.

Please start asking questions.

Don’t let these agencies attempt to talk their way, shame patients and doctors, and weasel around their extremely questionable actions and culpability.

It makes virtually no sense at all, the way this has all unfolded. Now it appears that it will be rugswept and hopefully no one with a credible reach will point it out to the public.

To illustrate how nonsensical the entire scenario has been and still is, think of it in this way:

Insurers are tired of paying out claims on texting and driving accidents. They want to reduce the numbers of teenagers even getting licenses in the first place. Stakeholders reach out to FCC.

In response, the FCC issues a broad guidance on driver’s licenses, across the country. All drivers license centers that test people for drivers licenses have a list of suggestions, 18 to be precise, of things that FCC thinks are pertinent to the fight against texting and driving.

These suggestions are not laws. They are not issued by Congress. However, the drivers license centers notice that if they don’t implement the suggestions, their funding is denied at the state level. Many of the centers have had to close in the wake of the suggestions. Some of the drivers license test implementers think the suggestions are unfair. These people have gotten visits from the government. They have been threatened with early retirement from government service or loss of their pension if they don’t go along with the suggestions from FCC. Whistleblowing does nothing. Whistleblowing only works if one can whistle blow to an agency that isn’t in on the scam… if they are all in, it does nothing but put a target on one’s back.

Others have pointed out that FCC has zero jurisdiction over drivers licenses. That is under the jurisdiction of the DMV.

Anyone who points this out finds themselves the target of attacks, personal and professional. The person finds their reputation is quickly destroyed in an insidious, relentless manner.

Soon the vast majority of the United States public believes that driver’s licenses are a very expensive and time consuming ordeal to obtain, versus what they used to be, a rite of passage for a teenager- something a parent would look forward to doing with their child as the age approached. People on social media view and attack others who speak out on this issue as non-conformist, elitist, or conspirators, as well as horrible parents for allowing their children to even drive, thanks to being socially engineered by government hired influencers.

The fact that a federal agency that had no invitation or business injecting themselves into rules and regulations of another agency is not even noted by anyone. It was worked out behind closed doors as usual.

The goal was obtained. Reducing the number of driver’s licenses being sought in the first place.

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Some of us has always wondered if the CDC really had any statutory authority to generate the opiate dosing guidelines since their primary statutory authority is to deal with contagious diseases.

Maybe they didn’t and that is why the then head of the CDC Thomas R. Frieden quickly made public statements that the guidelines did not bear the weight of law – they were just suggestions/guidelines.

A couple of nights ago, I going over a couple of pages from the CDC’s annual budget and there was a line item for dealing with HIV, HEP B & C.

One of the problems with substance abuse is the sharing of needles and likewise the sharing of any disease(s) that any of the previous people who had used the needle had.

A few years ago, the small southern Indiana Scott County had a “outbreak” of HIV, Hep B & C with about 200 people.  After all the dust settled, all of those pts .. 85% of the HIV, Hep B & C were DNA verified from the same source… strongly suggested a lot of “needle sharing” of the substance abusers in Scott County.

So who within or outside of the CDC got convinced the CDC that if they tried to address opiate use/abuse… a reduction in substance abuse would decrease and also would the prevalence of the CONTAGIOUS DISEASES of HIV, Hep  B & C.  Which they get money to address.

The war on drugs is a 81 billion/yr and primary function of all bureaucracies is to grow their budget and the number of people on the payroll, because in the political world those two things equate to POWER & INFLUENCE in that world.

There is nothing in our legislative system that guarantees that a bill that Congress passes and a President signs into law or a agency creates a new interpretation of an existing law/regulation.. that it is constitution. Until someone challenges the constitutionality of the law/interpretation in our court system… Those laws/interpretation can be applied/enforced until they are declared unconstitutional by our court system.  Of course, the only ones who win in challenging the constitutionality of a law/interpretation is the law firms.

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