Epidural Steroid Injections / APDU’s Warning Letter to Pfizer

Dr. Hooman Noorchashm of the American Patient Defense Union (APDU) recently sent a strong letter to Mr. Doug Lankler, the Executive Vice President and General Counsel for Pfizer Global in NYC. Alarmed by increased reports of severe medical events caused by the off-label epidural administration of Pfizer’s steroid, Depo-Medrol®, the APDU decided to step into the debate. (Note: Epidural Steroid Injections or ESI’s are NOT FDA approved nor are they approved anywhere on the planet due to reports of severe adverse events, including death.) Here I read Dr. Noorchashm’s letter where he not only requests that Pfizer’s risk-managers move swiftly to issue a warning to all practitioners that set the standards of care for spinal-related pain management, he strongly encourages Pfizer to try once again to force the FDA to place an absolute “Contraindication (ban) for the off-label epidural administration of Depo-Medrol” in the United States. It should be noted that back in 2013 Pfizer Inc. did send an amended label request to all global Health Authorities with major changes to the Warnings & Contraindication Sections for Depo-Medrol, including a new specific “Contraindication for Epidural Administration” at all levels of the spine. Many nations have complied without protest. Among them are New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending. Unfortunately the United States’ FDA is not among them. Why not? Aren’t we Americans worthy of the same protections? Even though Pfizer submitted their label change request 6 years ago to all Global Health Authorities, the FDA repeatedly refused to accept these changes because only they hold the CORE Data-Sheet (CDS) for the steroid, nowhere else. Therefore if Pfizer’s New Warnings were enacted into the US-FDA’s CDS for Depo-Medrol, they would then filter down to all versions of the drug (whether they be generic or compounded formulations, etc.). That would have ended the off-licensed, unsafe but lucrative practice of Epidural Steroid Injections using Depo-Medrol (Methylprednisolone Acetate) all over the world. Pfizer’s request in 2013 to initiate these very important safety warnings were met with strong oppositional forces from interventional pain management societies in the USA (we prefer to call them Injection-Mills). The powerful and lucrative ESI INDU$TRY have many friends embedded within the government. This conflict of interest tilted the FDA’s prime directive to prevent harm in favor of keeping them and “Wall Street” happy. ESI therapies are not as efficacious as advertised, carry severe risks and therefore are not FDA approved. Despite this, it appears the agency deliberately played down the seriousness of these off-licensed injections with Pfizer’s blessings. So what game are they playing with our health? Need proof of their game? Back in 2014 an FDA advisory panel of medical experts voted 15 to 7 to “Contraindicate (ban) CESI’s” after three days of testimony and yet the FDA ignored their recommendation and said “no”. The decision was therefore rejected by the FDA without any real explanation other than their fear of disturbing a lucrative industry and their Wall $treet investors. I can honestly say that the patient community I represent owes Dr. Noorchashm a debt of gratitude for his tireless efforts against the increased use of Pfizer’s Depo-Medrol for epidural administration despite its poor safety and efficacy records. The slaughter will sadly continue until Pfizer demands the FDA to do the right thing, adding an “ESI Contraindication” and a “NOT FOR Epidural Administration” Black Boxed Warning to the CORE Data-Sheet in the USA. Link to Pfizer’s 2014 Tracking Changes for Depo-Medol: https://jmp.sh/ooWuGCw Link to Pfizer’s Completed Global DataSheet for Depo-Medrol. (Only New Zealand, Australia, Canada, France, Italy, Switzerland, Russia with 12 more pending accepted Pfizer’s urgent update. Unfortunately the United States’ FDA rejected their request fearing stock market reaction: https://jmp.sh/uxCiBGK Link to APDU’s Warning Letter to Pfizer: https://medium.com/@patientdefenseuni… PLEASE FILE A MED-WATCH VOLUNTARY ADVERSE EVENT REPORT WITH THE FDA if you believe that you or a loved one may have been harmed by an ESI… Please file a FDA MedWatch Report. Use Form 3500B Link: https://www.accessdata.fda.gov/script… Thank you for watching! Dennis J. Capolongo Director / EDNC TheEDNC@verizon.net

Canada Healthcare : over 300 patients in the province died waiting for surgery from 2015 to 2016 because of a shortage of anesthesiologists

Sally Pipes dispels myths surrounding single-payer health care proposals

https://www.foxnews.com/opinion/sally-pipes-sanders-warren-want-medicare-for-all-like-canada-but-canadian-health-care-is-awful

Health care

Democratic presidential candidates Sens. Bernie Sanders and Elizabeth Warren want you to believe Canada’s health care system is a dream come true. And they want to make the dream even better with their “Medicare-for-all” plans. Don’t believe them.

In truth, Canada’s system of socialized medicine is actually a nightmare. It has left hospitals overcrowded, understaffed and unable to treat some patients. Americans would face the same dismal reality if Canadian-style “Medicare-for-all” takes root here.

Canada’s health care system is the model for the “Medicare-for-all” plan that both Sanders, I-Vt., and Warren, D-Mass., embrace.

expert discusses the Affordable Care Act, rising prescription drug costs and the Trump administration’s plans for health care reform.

North of the border, all residents have taxpayer-funded, comprehensive health coverage. In theory, they can walk into any hospital or doctor’s office and get the care they need, without a co-pay or deductible.

More from Opinion

Sanders and Warren would one-up Canada by providing all Americans with free prescription drugs, free long-term care, free dental care, free vision care, and free care for people with hearing problems.

Who could possibly object to all that free care?

Well, politicians in Canada object. They say even their country can’t do what Sanders and Warren want because all this free care would cost too much and cause other problems.

But for Sanders and Warren, money is no object. They can just raise taxes as higher and higher and higher.

And the huge tax increases needed to fund “Medicare-for all” would hit us all – there aren’t enough millionaires and billionaires to foot the bill.

It’s true that everyone in Canada has health coverage. But that coverage doesn’t always secure care. According to the Fraser Institute, a Canadian think tank, patients waited a median of nearly 20 weeks to receive specialist treatment after referral by a general practitioner in 2018. That’s more than double the wait patients faced 25 years ago.

In Nova Scotia, patients faced a median total wait time of 34 weeks. More than 6 percent of the province’s population was waiting for treatment in 2018.

Waiting for care is perhaps better than not being able to seek it at all. The hospital emergency department in Annapolis Royal in Nova Scotia recently announced that it would simply close on Tuesdays and Thursdays. There aren’t enough doctors available to staff the facility.

Canadians can’t escape waits like these unless they leave the country and pay out of pocket for health care abroad. Private health insurance is illegal in Canada.

Private clinics in Canada are not allowed to charge patients for “medically necessary” services that the country’s single-payer plan covers. And the government has deemed just about every conceivable service “medically necessary.”

For the past decade, Dr. Brian Day, an orthopedic surgeon who runs the private Cambie Surgery Centre in British Columbia, has tried to offer Canadians a way out of the waits by expanding patient access to private clinics. He’s been battling his home province in court for a decade to essentially grant patients the ability to pay providers directly for speedier care.

During closing arguments in Day’s trial before the British Columbia Supreme Court at the end of November, Dr. Roland Orfaly of the British Columbia Anesthesiologists’ Society testified that over 300 patients in the province died waiting for surgery from 2015 to 2016 because of a shortage of anesthesiologists. And that was in just one of the province’s five regional health authorities!

Shortages of crucial medical personnel and equipment are common throughout Canada. The country has fewer than three doctors for every 1,000 residents. That puts it 26th among 28 countries with universal health coverage schemes. If current trends continue, the country will be short 60,000 full-time nurses in just three years.

In 2018, Canada had less than 16 CT scanners for every million people. The United States, by comparison, had nearly 45 per million.

These shortages, combined with long waits, can lead to incredible suffering.

In 2017, one British Columbia woman who was struggling to breathe sought treatment in an overcrowded emergency room. She was given a shot of morphine and sent home. She died two days later.

That same year, a Halifax, Nova Scotia, man dying of pancreatic cancer was left in a cold hallway for six hours when doctors couldn’t find him a bed. Yes, people must sometimes be treated on hallway floors because of severe overcrowding.

In fact, some Canadian hospital emergency rooms look like they belong in poverty-stricken Third World countries.
WBUR Radio, Boston’s NPR station, documented these terrible conditions in a story about a hospital in Nova Scotia earlier this month.

Americans who find the promise of free health care difficult to resist would do well to take a hard look north.

Sure, “Medicare-for-all” as pitched by Sanders and Warren sounds good. But the reality is far from what these two far-left candidates are promising. Like a drug that helps you in one way but causes even more serious problems, “Medicare-for-all” has dangerous side effects that can be hazardous to your health.

CLICK HERE FOR MORE BY SALLY PIPES  

Evernote complies with DEA

Evernote complies with DEA

https://dlike.io/post/@arunava/evernote-complies-with-dea

I don’t know if i should categorise this under Tech but anyways let’s mobe on with it. It seems Evernote which is a Note Taking App and very useful if I may add recently gave data on an User of theirs to the DEA. Now it has been notified that the user was allegedly a Dark Web Drug Dealer so that sounds good in a way but since it was only alleged this does leave a sour taste in my mouth.

The DEA did get warrants to do so but still Evernote should have resisted a little as the next one could be anyone else. This does serve as a breach of privacy as many people do keep important stuff on that App and after this news came out a lot of users are already jumping ship as they are looking for better Privacy options.

 

all sunshine…. lollipops…. & roses…key stakeholders focused on (pain) policy solutions

I’m so energized by two meetings in DC this week with key stakeholders focused on policy solutions that promote individualized, multimodal, comprehensive, person-centered, integrative pain care. Some takeaways – our voices do change policies; earlier access to treatment is key; we must implement HHS best practices pain management task force report recommendations; increasing awareness/education about what comprehensive pain care looks like is of highest priority. All these efforts – and so many more – make a difference together. No shortage of good work to do. patientaccess afbpm voicessummit aacipm acute chronicpain @AACIPM Kate Nicholson Dania Palanker Cindy Steinberg Jianguo Cheng MD, PhD, FIPP John Prunskis Vanila M. Singh MD

Maybe it is just me… but looking at the sign from this “solution summit” and looking at the “fine print”  VOICES FOR NON-OPIATE CHOICES

POLICIES TO ADDRESS ACUTE PAIN AND OPIATE ADDICTION IN AMERICA

It appears that this “summit” with all these “important people” are apparently trying to validate – the false belief – that all opiate prescribing leads to ADDICTION.

I wasn’t at this summit… but… nothing posted about it – that I read – mentioned any treatment of chronic pain.  There is no mention of anyone representing the DEA nor the CDC, but I get the gist that of the meeting was in line with the DEA’s and other entities misapplying of the CDC’s 2016 opiate dosing guidelines. Color we skeptical in how the results of this summit could benefit the chronic pain community

 

Epidurals Are DANGEROUS! Here’s My True Story From Experience – Dr Mandell

This is my own personal experience regarding the Dangers of Epidural Injections.  Epidural Steroid Injections are Dangerous for Neck & Back Pain Relief

Here is a post from just YESTERDAY — WORSE CASE — of having a ESI !! Epidural Steroid Injections / R.I.P. Dearest Jimmy / FDA-AADPAC

There is a lot of $$ change hands giving pts ESI’s and if the pain clinic is not giving the pt oral opiates… then the pain clinic practitioner has little concern about the DEA’s oversight of their practice… since no controlled substances are used in ESI’s.

More Than 80,000 Spinal Cord Stimulator Injury Reports Filed With FDA | NBC Nightly News

Some 60,000 spinal cord stimulators are surgically implanted every year. They send a mild electrical current to the spinal cord to relieve chronic pain. An NBC News investigation in partnership with the Associated Press found tens of thousands of injury reports had been filed with the FDA.

Is this an example of who is going to run our country in the future ?

 

16yr old vs. can opener

Epidural Steroid Injections / R.I.P. Dearest Jimmy / FDA-AADPAC

Epidural Steroid Injections / R.I.P. Dearest Jimmy / FDA-AADPAC

  It is claimed that there are 10 million of these ESI’s are given annually.  Both the FDA and the manufacturer of Methylprednisolone DO NOT RECOMMEND that this medication being administered as a ESI.

It is also claimed that abt 5% of pts getting these ESI’s will incur adhesive arachnoiditis   .. which is an INCURABLE, VERY PAINFUL HEALTH CONDITION and it is caused by the needle/syringe is inserted ONE MM TOO FAR..

Anything injected into the spinal fluid must not only be sterile and pyrogen free – as all injectable medications must be… it must also be PRESERVATIVE FREE and a SOLUTION…  methylprednisolone and that whole category of meds contain preservatives and is a SUSPENSION.

In the recent past CMS ( Medicare & Medicaid) was discussing/proposing to INCREASE what practitioners were paid for performing these ESI’s. I do not know if they ever finalized this propose increase.  They want to ENCOURAGE practitioners to provide more of these ESI’s.

“Non-Opioids Prevent Addiction In the Nation Act” or the “NOPAIN Act” H. R. 5172

Rep. Sewell, Terri A. [D-AL-7]

Rep. McKinley, David B. [R-WV-1]

Rep. Brindisi, Anthony [D-NY-22]

https://www.congress.gov/bill/116th-congress/house-bill/5172/text?r=1&s=1

To amend title XVIII of the Social Security Act to combat the opioid crisis by promoting access to non-opioid treatments in the hospital outpatient setting.

This Act may be cited as the “Non-Opioids Prevent Addiction In the Nation Act” or the “NOPAIN Act”.

November 19, 2019

Ms. Sewell of Alabama (for herself, Mr. McKinley, and Mr. Brindisi) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned

is this the destination for chronic pain pts… because of less opiates being prescribed ?

December 25th, 2019, will be my start date for the VSED program, since my family is coming here from Texas on the 24th to be by my side for my passing. I want to thank everyone for their support.

For those who aren’t too busy, I wish to invite everyone to a live FB feed celebration of my life, that I will be hosting with my family, on Christmas evening.

Wow. While this all couldn’t be happening fast enough, this is still all just way too soon in my book. But, it’s either now, with family & loved ones, or alone, and I’m not giving this disease that. I’ll be making my own final decisions, ones that CRPS won’t be allowed to decide for me.

 

This was a post on FB by a 52 y/o divorced male suffering with CRPS.  CRPS is commonly referred to as the “suicide disease”.. because of its unrelenting high intensity of pain.  Could this pt going down this path is a direct/indirect action of the CDC/DOJ/DEA and their self-serving war on drugs?
The VSED program is basically a personal decision to die by stopping all intake of hydration or food. This chronic pain pts is having to go down their path because the state in which he lives does not have a death with dignity law.

Voluntary Stopping of Eating and Drinking (VSED)

To voluntarily stop eating and drinking means to refuse all food and liquids, including those taken through a feeding tube, with the understanding that doing so will hasten death. This is an option for people with terminal or life-limiting diseases who feel that with VSED their dying will not be prolonged. One of the advantages of this decision is that you may change your mind at any time and resume eating and drinking.

The US Supreme Court has affirmed the right of a competent individual to refuse medical therapies and this includes food and fluids. This choice is also commonly accepted in the medical community.