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

Posted on March 29, 2021 by Pharmaciststeve

This promotes the video to a wider audience, thank you! ] Last November, Ms. Dawn Fickel was invited to address the FDA/AADPAC hearing on the safety and efficacy of epidural steroid injections. Her brother Jimmy was injected in 2013 with several simultaneous ESI’s using Pfizer’s Depo-Medrol (Methylprednisolone Acetate or MPA). The injections caused severe multiple adverse reactions that ultimately led to his death eight months later. Jimmy’s passing devastated his family and his friends. So please listen to Dawn’s heartfelt presentation in memory of her late brother to the FDA panel. May Jimmy’s spirit rest in peace, and may his memory echo the halls of the FDA forever. FDA Issues a MedWatch Drug Safety Alert on Epidural Steroid Injections (4/23/14) requiring strong label changes: FDA Link: http://www.fda.gov/Drugs/DrugSafety/u…​ Video Link: http://youtu.be/DKboChc6yt8?list=UUOU…​ News Update – Pfizer Global has asked the Health Authorities of the World to make major changes to the Warnings & Contraindication Sections of their steroid Depo-Medrol®. Many have already complied. Among them are New Zealand, Australia, Canada, France, Italy, Switzerland, etc, even Russia, with the strange exception of the United States. Lawsuits are pending to force the agency to comply with the Safety changes issued by the manufacturer. Stay tuned. Link: https://jmp.sh/uxCiBGK​ PLEASE FILE A MED-WATCH VOLUNTARY ADVERSE MEDICAL EVENT REPORT WITH THE FDA if you believe that either you or a loved one was harmed by an ESI… Here’s the Link to FDA’s form 3500B, fill it out completely to your best ability. Link: https://www.accessdata.fda.gov/script…​ Thank you for your time, Dennis J. Capolongo Director / EDNC End Depo-Now Campaign Washington, DC TheEDNC@verizon.net Closing Music Credit: “Secret Conversations” by The 126ers / YouTube Free-License Audio Library (Legal Disclaimer: All rights reserved ©2014/EDNC. Any and all duplication, (and/or posting) whether in full or in part is unlawful and prohibited. All video content & posted comments on this public forum are intended to express the investigative perspectives, impressions, findings and/or opinions of the host, the presenter as well as the viewer. It is not intended to be a substitute for professional medical advice for your individual case. Therefore please consult with your treating physician before making any medical decision. Follow only at your own personal discretion. Thank you.)

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Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: You can save lives for 26$

Posted on March 27, 2021 by Pharmaciststeve

Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: You can save lives for 26$

Narcan is being pushed on pain patients who have very little fear of overdosing and dying. you’re chances of dying on a prescription pain pill overdose are nearly zero, but if you are nervous, then we have a solution.

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FDA Sends 2 More Warning Letters to Companies Selling OTC CBD Products

Posted on March 26, 2021 by Pharmaciststeve

FDA Sends 2 More Warning Letters to Companies Selling OTC CBD Products

FDA Sends 2 More Warning Letters to Companies Selling OTC CBD Products (drugtopics.com)

The FDA has recently sent warning letters to Honest Globe Inc and BioLyte Laboratories LLC for selling products labeled as containing CBD in ways that violate federal law, according to the news release.1

Only 1 drug containing CBD has been approved by the FDA; therefore, the products from the 2 companies do not meet the requirements to be legally marketed without an approved new drug application (NDA). The agency cited that CBD has “known pharmacological effects on humans, with demonstrated risks.”

CBD cannot be legally marketed without an NDA regardless of whether the CBD is an active ingredient or inactive ingredient, according to current FDA requirements.

“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said Amy Abernethy, MD, PhD, FDA principal deputy commissioner in a news release.

“It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects,” Abernethy said.

Following an FDA inspection in January of BioLyte facilities, the agency reported myriad violations. For one, BioLyte’s OTC topical drug products were being shipped out without “adequate control testing,” according to the FDA investigator. “For example, identity and potency testing is not performed for the active ingredient in your Topical Pain Relief drug product (Menthol 4%) before release,” the letter to BioLyte asserted. Other violations include failing to conduct at least 1 test to verify the components of its drug product and failing to establish a written testing program to assess the stability and appropriate storage conditions for its product. 2

BioLyte has 15 days to submit a sizeable collection of information to the FDA, including, but not limited to, the following:

  • A list of chemical and microbiological specifications, including test methods, that will be used to analyze each batch of the product before being sold
  • Microbiological testing methods that are capable of recovering bioburden in the product and determining whether any microorganisms are objectionable in relation to the product’s intended use, route of administration, and patient population
  • A commitment to testing each batch of product using certified methods
  • A summary of all results from each batch of product testing
  • A comprehensive review of the company’s material system to confirm that all suppliers of components, containers, and closures are qualified, and the materials have appropriate expiration dates
  • A comprehensive assessment, corrective and preventative action plan to ensure that the program is adequate

The FDA letter to Honest Globe stated3 “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”

FDA investigators found these violations, among others:

  • Failure to establish an adequate quality control unit, where the responsibilities and procedures for the quality control unit are not in writing and not fully followed
  • Failure to prepare batch production and control records that clearly document each major step in the manufacture, processing, packing, or holding of the batch, for each batch of products
  • Failure to create written procedures for production and process control in a way that assures that the products have the identity, strength, quality, and purity they are represented to have.

Honest Globe must also mitigate these violations within 15 days of the letter by preparing detailed records, analyses, summaries, and data for its pain relief products.

“We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” Abernethy said. “Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products — prioritizing those that pose a risk to public health.”

 

References

  1. FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief. News Release. FDA; March 22, 2021. Accessed March 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief.
  2. Division of Pharmaceutical Quality Operations III. Warning Letter. FDA; March 18, 2021. Accessed March 23, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biolyte-laboratories-llc-603584-03182021.
  3. Division of Pharmaceutical Quality Operations IV. Warning Letter. FDA; March 15, 2021. Accessed March 23, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/honest-globe-inc-597177-03152021

 

 

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“Elder Abuse Claims” for Elder’s who have been cut off from pain medications for no medical reason by their Dr

Posted on March 24, 2021 by Pharmaciststeve
We are currently looking for people that have experience and or knowledge about filing “Elder Abuse Claims” for Elder’s who have been cut off from pain medications for no medical reason by their Dr.
At the National Pain Council we want to develop a team to help others file these complaints and to keep track of them.  If you would like to volunteer a couple to three hours per week please let us know!
Contact us at nationalpaincouncil@gmail.com with the subject line of “Elder Care”.
Thank You,
National Pain Council

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New Surgeon General : promised to use his role to turn the coronavirus pandemic around: no interest in war on drugs ?

Posted on March 23, 2021 by Pharmaciststeve

Senate votes to confirm Vivek Murthy as surgeon general

https://www.foxnews.com/politics/senate-votes-on-vivek-murthy-for-surgeon-general

The role for the nation’s top doctor was filled by the Senate Tuesday, after President Biden’s nominee, Vivek Murthy, was confirmed as the U.S. Surgeon General.

During Senate testimony late last month, he promised to use his role to turn the coronavirus pandemic around – a subject not only of national importance but one that has personally affected Murthy, who has lost several family members to the deadly virus.

“This is a moment of tremendous suffering for our nation. More than half a million people have lost their lives to COVID-19, including beloved members of my own family,” he told lawmakers.

Murthy had advanced through the Senate’s Committee on Health, Education, Labor on a bipartisan basis in a 16-6 vote last week.

Five Republicans including Lisa Murkowski of Alaska, Susan Collins of Maine, Mitt Romney of Utah, Bill Cassidy of Louisiana and Roger Marshall of Kansas, crossed party lines to support Murthy’s nomination as the “Nation’s Doctor.”

As surgeon general, he will play a critical role in shaping the public message surrounding the virus, which has infected more than 29.8 million in the U.S. and killed over 543,000 Americans.

“If confirmed as surgeon general, my highest priority will be to help end this pandemic, work I’ve been doing over the past year with state and local officials, schools and universities, businesses, health care providers, and others,” Murthy said in his February testimony.

Murthy is no stranger to the high-profile role, as he was confirmed as surgeon general under President Obama and served from 2014-2017. He also advised Biden on the coronavirus while on the campaign trail.

His nomination raised eyebrows after reports surfaced which showed Murthy made more than $2.5 million during the pandemic from advising companies like Netflix, Carnival Cruise Line and Airbnb on their coronavirus response, first reported the Washington Post.

But during his nomination hearing, he said his previous experience in consulting on the COVID-19 response, makes him an asset to the role.

“I have seen first-hand the importance of providing clear, science-based guidance to Americans on how to protect themselves and others. And I know how urgent it is that we communicate clearly about the safety and effectiveness of vaccines and get them to people as quickly as possible, particularly those in underserved rural communities and communities of color,” he told lawmakers.

“The most important job of a doctor is to help patients heal. And if confirmed, that will be my mission as Surgeon General – to do whatever I can to help heal our communities and our nation,” he added.

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Dr. Thomas Kline, MD, PhD: Medical Myths Revealed: What are red flags how do they affect your ability to get treatment with pain medicines

Posted on March 22, 2021 by Pharmaciststeve

What are red flags how do they affect your ability to get treatment with pain medicines

I was shocked when I went through and started to make a list of all the red flags. These are from the federal government, from hospital associations from pharmacy associations it’s a collection from multiple sources. Red flags are warnings to stop look and listen. they can be used to stop the treatment of pain patients as though they were rules. They are supposed to tell people to document why these red flags are not going to be a problem. But that’s not what’s happening. Pharmacies are being shut down for ignoring red flags, but there’s over 100 of them pretty hard to keep track

 

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Gretchen Whitmer may soon face Cuomo-like scrutiny over nursing homes, lawsuit plaintiffs say

Posted on March 21, 2021 by Pharmaciststeve

Gretchen Whitmer may soon face Cuomo-like scrutiny over nursing homes, lawsuit plaintiffs say

https://www.foxnews.com/politics/gretchen-whitmer-may-soon-face-cuomo-like-scrutiny-over-nursing-homes-lawsuit-plaintiffs-say

Michigan’s Democrat governor benefits from an exemption on disclosing data to the public, two critics say

The state of Michigan is facing a lawsuit whose plaintiffs are seeking information on Gov. Gretchen Whitmer’s coronavirus-related executive order regarding the state’s nursing home residents.

Whitmer could soon find herself under scrutiny similar to that faced by a fellow Democrat, New York Gov. Andrew Cuomo, the Michigan men taking the legal action against Whitmer say.

Plaintiffs Steve Delie and Charlie LeDuff outlined the purpose of their lawsuit in an article published Friday by USA Today. Delie is an official with the think tank Mackinac Center for Public Policy, while LeDuff is a Pulitzer Prize-winning journalist.

“It shouldn’t take a lawsuit to obtain this critical data,” the pair write. “Gov. Whitmer made the same policy choice as Gov. Cuomo, forcing contagious senior citizens into close proximity with other medically vulnerable people. In fact, her policy, a similar version of which is still in effect today, went even farther, forcing some non-senior patients into nursing homes, including a 20-year-old. Michigan citizens deserve to know why she did this, and whether our governor is telling the truth about the consequences.”

“Gov. Whitmer made the same policy choice as Gov. Cuomo, forcing contagious senior citizens into close proximity with other medically vulnerable people.”

— Steve Delie and Charlie LeDuff, suing to access Whitmer data

The writers say Whitmer issued her executive order April 15, 2020, just a few weeks after Cuomo issued his similar order in New York on March 25, 2020.

They go on to note the recent disclosures about the Cuomo administration’s alleged underreporting of deaths of New York’s nursing home patients as the coronavirus spread. New York patient numbers were underreported by more than 40% while the state’s deaths were underreported by more than 75%, they note, citing reporting by The Associated Press.

Delie and LeDuff argue that the New York public had a right to know accurate information about what was happening regarding nursing home patients but didn’t receive the data until after a five-month-long legal fight.

Whitmer’s unique legal exemption

They then note that under Michigan law, Whitmer has the advantage of being legally exempt from Freedom of Information laws.

“Thanks to this exemption, the governor [Whitmer] has no obligation to produce any records whatsoever, despite making decisions affecting the lives of every Michigander,” the authors write.

“The governor [Whitmer] has no obligation to produce any records whatsoever, despite making decisions affecting the lives of every Michigander.”

— Steve Delie and Charlie LeDuff, suing to access Whitmer data

They allege that Whitmer has used the shielding provided by the exemption to “act with impunity” – and was not required to provide the data on which she based her coronavirus policy decisions.

“This is unacceptable,” Delie and LeDuff write.

Aside from Whitmer, only the governor of Massachuetts has a similar exemption, The Detroit News reported.

Earlier this month, Michigan Attorney General Danna Nessel, a Democrat, declined a request by state Republicans to investigate Whitmer’s nursing home-related actions, saying a probe wasn’t needed “at this time.”

“I appreciate that you and your colleagues have policy disagreements with Gov. Whitmer’s response to COVID-19,” Nessel wrote in a letter dated March 15. “But an investigation by my office is not the mechanism to resolve those disagreements.”

Republicans have condemned the Michigan governor for allowing nursing home residents recovering from the virus to return to their nursing homes or gain admittance, alleging the move put other residents at risk.

Whitmer created 21 hubs in existing nursing homes that were intended to have room for isolation and specialty equipment for elderly groups discharged from the hospital, The Detroit News reported.

But state Republicans wanted separate isolation units designated for elderly populations recovering from COVID-19, in order to prevent other nursing home residents from contracting the virus.

Last week a New York City nursing home director told Fox News he viewed Cuomo’s nursing home orders to be “ridiculous,’ and complained to state health officials, saying, “We can’t be doing this.”

Cuomo is facing an investigation by the FBI and federal prosecutors in Brooklyn, N.Y., regarding his nursing home policies, The New York Times reported Friday.

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Navy vet shot himself after doc cut off opioid prescription, mom claims

Posted on March 20, 2021 by Pharmaciststeve

Gary PressleyNavy vet shot himself after doc cut off opioid prescription, mom claims

https://nypost.com/2020/03/14/navy-vet-shot-himself-after-doc-cut-off-opioid-prescription-mom-claims/

The mother of a decorated Navy vet who committed suicide in the parking lot of a VA Hospital last year is seeking $8.25 million from the beleaguered agency — alleging her son became suicidal when a VA-affiliated doc cut off his opioid prescription.

Gary Pressley, 28, shot himself outside the Carl Vinson VA Medical Center in Dublin, Georgia, on April 5, several months after his pain management specialist nixed his Hydrocodone supply over a payment dispute with the VA, according to the claim.

As a result, Pressley “experienced excruciating pain, the horrible side effects of withdrawal and lost all hope,” according to the wrongful death claim Rhonda Machelle Wilson filed last month.

Pressley joined the Navy in 2008 and was honorably discharged four years later, after a motorcycle accident left him disabled with a fractured hip, pelvis and chronic lower back pain, the claim says.

Pressley found relief through his pain management doctor, Ana Maria Platon. But she stopped treating him and other vets in early 2019, because the VA owed her “hundreds of thousands of dollars and purposefully failed to reimburse her,” the claim says.

Wilson also alleges that staff at the Carl Vinson Medical Center failed to look for Pressley after his sister, Lisa Johnson, informed a VA operator her suicidal brother was in the parking lot with a loaded gun.

His body was discovered three hours later inside his car with heavy metal music blaring on the radio and a note beside him that read, “This is what happens by punishing already suffering people muahahaha.” On the back it said “Thank you for the release,” the claim says.

A disturbing photo of his slouched and lifeless corpse included in the claim provided to The Post shows him in a blood-soaked collared shirt and sunglasses.

Platon and the VA did not respond to requests seeking comment

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It is a misconception that people turn to assisted suicide due to uncontrollable pain

Posted on March 17, 2021 by Pharmaciststeve

just what is needed is just another opinion from an ATTORNEY about suicides and chronic intractable pain… and how people dealing with intractable chronic pain – especially those not getting adequate pain management — WOULD NOT CONSIDER COMMITTING SUICIDE.  The article has no place to place a comment and there was no web link to reach out to the author.

And some “data” from Oregon 

Oregon data indicate that among the leading reasons people request lethal prescriptions are psychosocial factors such as perceived lessening of autonomy or feeling they are a burden.

Imagine that…. a person not receiving adequate pain management could in no way could “feel like a burden” to their family ?

Wasn’t it Oregon a couple of years ago that was proposing that Oregon Medicaid would no longer pay for any opiates for chronic pain pts ?

Opinion: It’s not end-of-of life care. It’s assisted suicide, and it needs to be stopped

https://www.courant.com/opinion/op-ed/hc-op-no-right-to-die-law-20210316-iubnvvaes5b65l2gjeo2h5xicm-story.html

It defies imagination that Connecticut is contemplating legalizing assisted suicide when COVID-19 deaths have exceeded 500,000 nationwide. The virus has laid bare the inequities and prejudices of our health system. Low-income people and people of color are dying at disproportionately high rates. Connecticut has the highest COVID-19 nursing home death rate in the Northeast. An appalling 91 out of every 100,000 nursing home residents in Connecticut have died. Early in the crisis, members of the Harvard Medical School Center for Bioethics wrote chillingly that “typical medical options may soon not be available to everyone.”

Yet, as concerned health care providers said, “Guidelines that evaluate patients by age or ‘comorbid conditions [that] impact survival’ or ‘underlying medical diseases that may hinder recovery’ implicitly rely on value judgments about these patients’ quality of life and deny these patients justice in our health care system.”

The Connecticut assisted suicide bill would let a doctor write lethal prescriptions for people deemed to have a life expectancy of less than six months if they so request, and would grant broad legal immunity to everyone involved in their deaths. Terminology about an “end-of-life option” or “aid in dying,” confusing assisted suicide with palliative care, or soaring rhetoric about choice and self-determination belies the fact that the only course of action facilitated is death.

There is a sharp distinction between a patient deciding when not to have life-prolonging treatment — which a patient has every right to do — and a doctor actively and knowingly prescribing lethal drugs to directly cause the patient’s death. As Dr. Joseph Marine, professor at Johns Hopkins University School of Medicine, has stated, assisted suicide “is not medical care. It has no basis in medical science or medical tradition. … The drug concoctions used to end patients’ lives … come from the euthanasia movement and not from the medical profession or medical research.”

It is a misconception that people turn to assisted suicide due to uncontrollable pain.

Oregon data indicate that among the leading reasons people request lethal prescriptions are psychosocial factors such as perceived lessening of autonomy or feeling they are a burden.

An “end of life option” law forecloses options in a very basic sense. It arbitrarily uses health status to exempt people from the suicide prevention services others receive (while discounting the possibility of errors in diagnosis and prognosis as well as the potential for support services to address the person’s concerns).

Assisted suicide sends the wrong message to people with disabilities. It is telling that in Washington state, one of few states that, like Oregon, has legalized assisted suicide, just 4 percent of the people who have used the act were given mental health evaluations.

Although the law proposed for Connecticut would mandate that a person receive “counseling” to determine mental status before obtaining lethal drugs, that is just to determine if there is “impaired judgment.” The law also allows for licensed clinical social workers, in addition to psychologists or psychiatrists, to do the mental health consultation. There is also no requirement that a person be evaluated just prior to taking these drugs. Mood and outlook can fluctuate radically based on physical factors like oxygen level as well as situational factors such as dread of being isolated in a nursing home because of the lack of in-home support.

Disinterested parties need not be present to ensure the drugs are self-administered and taken freely. The difficulties created by the pandemic have caused domestic abuse to skyrocket. There are bound to be at least some cases in which a person is steered or coerced into taking the pills by someone whose life might be emotionally, practically or financially easier if he died sooner rather than later.

In this grim time, a Boston University study has found that COVID-19-related stressors have caused one out of three adults to be depressed. The lead author wrote eloquently, “We would hope that these findings promote creating a society where a robust safety net exists.”

Legalizing assisted suicide would do the opposite. It would increase the shredding of the social fabric. Now is not the time for the state to enact this type of law. If we are honest about the inherent dangers, there will never be such a time.

Lisa Blumberg is a Hartford-area lawyer, writer and disability rights activist.

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I don’t know if this is true or not… just sharing

Posted on March 17, 2021 by Pharmaciststeve

when it was first announced that Pfizer & Moderna Covid-19 vaccinations were be approved with (EUA) emergency use authorization and the process of making these vaccines was a BRAND NEW PROCESS dealing with mRNA… I was skeptical, especially since Dr Fauci had been so adamant about the use of Hydroxychloroquine use in treating Covid-19. Hydroxychloroquine has been approved for human use for around 50 yrs… but Fauci was adamant about not using this medication because it had not been in a double blind clinical study for treating COVID-19…. these studies can take upwards of a decade. From what I had read, Hydroxychloroquine seem to show some success in combination with several other medications especially when pts were treated early in the disease process.

But, Fauci seemed to have jumped on and supported these vaccines from a never before used process and clinical trials of maybe just a couple of months.

Fauci seemed to try to put forward the image of “following the science”, but he was all over the map… don’t need a mask…. need one mask…. need two masks. He seemed to support cities/counties/states shutting down to all but very essential services, but here we are a year later and New York followed Fauci’s recommendations where states like FL did not and FL had fewer deaths per 100,000 than NY.

Personally/professionally I decided that we were going to wait until the J&J/Jansen vaccine got approval… because it is made using the same process that has been used for decades making the flu vaccine and it is a ONE AND DONE – SINGLE SHOT…. we got ours last Saturday.  By the end of the month, the two weeks it takes for antibodies to develop … we should be fully protected.

While the clinical studies of J&J/Jansen vaccine showed only a 65% effectiveness,  the clinical trials for this vaccine was much later than those for Moderna/Pfizer vaccines and the pts within the J&J/Jansen clinical trials had been exposed to the Brazilian and African COVID-19 mutations… which the other vaccines did not. BUT.. in the J&J/Jansen clinical trial… THERE WERE NO DEATHS within the clinical trials pts.

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