Judge Tosses Drug Company’s Libel Lawsuit Against Medical Society

— “Pharmaceutical companies are not free to intimidate the scientific process,” says ASA President

https://www.medpagetoday.com/special-reports/exclusives/97077

A federal court in New Jersey has dismissed a pharmaceutical company’s lawsuit against a medical society, its flagship journal editor, and contributing authors that claimed articles it published were libelous and damaging to the reputation of the company’s pain drug.

U.S. District Court Judge Madeline Cox Arleo ruled that statements made in articles in the American Society of Anesthesiologists (ASA) journal Anesthesiology about Pacira’s pain drug Exparel (bupivacaine) were scientific opinions that by their nature can’t constitute defamation.

“The peer-review process — not a courtroom — thus provides the best mechanism for resolving scientific uncertainties,” Arleo wrote in her opinion.

Pacira filed the suit in April 2021 against the ASA, the editor-in-chief of Anesthesiology, and 11 contributing authors, alleging that three articles about Exparel published in the February 2021 issue of the journal, along with a related podcast and continuing medical education (CME) program, created a false impression that Exparel was not an effective analgesic. Thus, the company sought retractions of the papers, in addition to unspecified damages.

Pacira’s two key allegations were that the articles were “scientifically unsound,” and that the journal failed to disclose that certain authors received payments from its competitors.

ASA President Randall Clark, MD, told MedPage Today that the judge ruled that the payments were minimal and unlikely to affect an author’s judgment.

The other allegation focused on whether the methodology used in the studies was accurate and whether studies were excluded improperly, Clark said.

“The judge clearly stated that’s a discussion for scientists to debate during the peer review process and then after publication, in either the refutation of an article through a subsequent study, or solidifying the finding by separate studies finding the same thing,” Clark told MedPage Today.

“This decision from the federal court makes clear that pharmaceutical companies are not free to intimidate the scientific process by filing lawsuits,” he said in a statement published by the ASA.

“The essence of scientific progress is conducting scientific studies, [followed by] the publication of those studies … for making it available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design,” Clark told MedPage Today. “That’s how we make medical progress. … There was a significant threat to that system of medical progress by this lawsuit. So we’re very pleased that the judge found in our favor.”

Tony Molloy, chief legal and compliance officer for Pacira, said in an emailed statement that the papers’ conclusions remain “severely flawed, plagued by personal biases and the intentional use of widely rejected analytical methods.”

“The Court reached a blanket conclusion that, even when ‘methodologically flawed,’ absent fraudulent data, a court cannot determine if a statement in a scientific journal is true or false,” Molloy said in the statement. “Pacira remains confident that continued scrutiny will only further demonstrate the falsity of Anesthesiology’s publications.”

When asked whether the company would appeal the decision, a spokesperson said via email that Pacira is “currently reviewing all of their options.”

Exparel, an extended-release bupivacaine, is a local anesthetic given at the time of surgery to control pain and reduce or eliminate use of opioids afterwards. It was first approved by the FDA in 2011 to treat postoperative pain, and then earned a subsequent indication in 2018 for brachial plexus nerve block, as well as a pediatric indication in early 2021.

Exparel is Pacira’s main product and accounted for about 96% of the company’s total revenues in 2019 and 2020, according to the original complaint.

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British Medical Journal Blows Lid On Pfizer and Facebook

https://peckford42.wordpress.com/2021/12/22/british-medical-journal-blows-lid-on-pfizer-and-facebook/

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Open letter from The BMJ to Mark Zuckerberg

Dear Mark Zuckerberg,

We are Fiona Godlee and Kamran Abbasi, editors of The BMJ, one of the world’s oldest and most influential general medical journals. We are writing to raise serious concerns about the “fact checking” being undertaken by third party providers on behalf of Facebook/Meta.

In September, a former employee of Ventavia, a contract research company helping carry out the main Pfizer covid-19 vaccine trial, began providing The BMJ with dozens of internal company documents, photos, audio recordings, and emails. These materials revealed a host of poor clinical trial research practices occurring at Ventavia that could impact data integrity and patient safety. We also discovered that, despite receiving a direct complaint about these problems over a year ago, the FDA did not inspect Ventavia’s trial sites.

The BMJ commissioned an investigative reporter to write up the story for our journal. The article was published on 2 November, following legal review, external peer review and subject to The BMJ’s usual high level editorial oversight and review.[1]

But from November 10, readers began reporting a variety of problems when trying to share our article. Some reported being unable to share it. Many others reported having their posts flagged with a warning about “Missing context … Independent fact-checkers say this information could mislead people.” Those trying to post the article were informed by Facebook that people who repeatedly share “false information” might have their posts moved lower in Facebook’s News Feed. Group administrators where the article was shared received messages from Facebook informing them that such posts were “partly false.”

Readers were directed to a “fact check” performed by a Facebook contractor named Lead Stories.[2]

We find the “fact check” performed by Lead Stories to be inaccurate, incompetent and irresponsible.

— It fails to provide any assertions of fact that The BMJ article got wrong

— It has a nonsensical title: “Fact Check: The British Medical Journal Did NOT Reveal Disqualifying And Ignored Reports Of Flaws In Pfizer COVID-19 Vaccine Trials”

— The first paragraph inaccurately labels The BMJ a “news blog”

— It contains a screenshot of our article with a stamp over it stating “Flaws Reviewed,” despite the Lead Stories article not identifying anything false or untrue in The BMJ article

— It published the story on its website under a URL that contains the phrase “hoax-alert” 

We have contacted Lead Stories, but they refuse to change anything about their article or actions that have led to Facebook flagging our article.

We have also contacted Facebook directly, requesting immediate removal of the “fact checking” label and any link to the Lead Stories article, thereby allowing our readers to freely share the article on your platform.

There is also a wider concern that we wish to raise. We are aware that The BMJ is not the only high quality information provider to have been affected by the incompetence of Meta’s fact checking regime. To give one other example, we would highlight the treatment by Instagram (also owned by Meta) of Cochrane, the international provider of high quality systematic reviews of the medical evidence.[3] Rather than investing a proportion of Meta’s substantial profits to help ensure the accuracy of medical information shared through social media, you have apparently delegated responsibility to people incompetent in carrying out this crucial task. Fact checking has been a staple of good journalism for decades. What has happened in this instance should be of concern to anyone who values and relies on sources such as The BMJ. 

We hope you will act swiftly: specifically to correct the error relating to The BMJ’s article and to review the processes that led to the error; and generally to reconsider your investment in and approach to fact checking overall. 

Best wishes,

Fiona Godlee, editor in chief
Kamran Abbasi, incoming editor in chief
The BMJ

Competing interests:
As current and incoming editors in chief, we are responsible for everything The BMJ contains. 

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Harmful effects of UNTREATED PAIN

I can’t count the number of times that I have heard from chronic pain pts that their prescriber is reducing their dose or eliminating their dose all together. Or the prescriber tells the pt that they must or must not do something because it is “the law ” when in fact it is now the policy of their practice or the healthcare system that they work for… has nothing to do any law.

Here is a chart that list the extensive effects that under/untreated pain has on various bodily functions and/or the pt’s comorbidity issues and this chart was composed almost TEN YEARS AGO… so it is not something that is new and most healthcare professionals should be aware of the issue that it contains.

When a pt gets this sort of edict of their medications are being reduced.  Their time to act to get things rectified could be a rather short window of opportunity. The pt should not say anything when given this edict, but should contact an attorney, probably one that deals with civil rights & discrimination.  If the prescriber is not reducing the pt’s other medications but just focusing on controls.

If I was a pt in this position, on my way out of the office, I would ask for a printout of the prescriber’s clinical notes for this visit.  In healthcare there is this saying, “if it is not documented… it didn’t happen”. If the only documentation that shows is the reducing of the dose – without any clinical reason – or – just claims they are following cdc guidelines… or no reason at all because they are following some corporate edict that they have been told not to disclose.

I would also suggest that the pt start taking daily blood pressure readings and record them…  Elevated blood pressure is one of the first visible side effects of the reduction of pain meds and the adjacent chart demonstrates what those adverse side effects are of HIGH BLOOD PRESSURE – which is also known as “THE SILENT KILLER”. If the pt dies of high blood pressure, their death certificate will probably be labeled as “natural causes” and the prescriber will get off with causing the pt’s premature death.

I am not an attorney and I may be way off base but what I am suggesting is a relative inexpensive initial step – a couple of hundred dollars.

This letter may end up being sent to a prescriber/healthcare corporation, pharmacy/pharmacist, insurance company, PBM.

My idea is just a letter to put those entities ON NOTICE that if the pt is harmed/dies from a reduction/elimination of controlled meds – especially they are intentional thrown into a cold turkey withdrawal. That there could be consequences for their actions.

If the entity claims that there are no studies that shows that opiates are beneficial to pts for long term use… here is a TEN YEAR study from the early 2000’s that documents otherwise

Opioid Treatment 10-year Longevity Survey Final Report

If the entity is just claiming that they are following the “law” in regards to max MME’s/day…

Here is a MME conversion program that I use for reference

https://globalrph.com/medcalcs/opioid-pain-management-converter-advanced/

and here is footnotes from the same prgm all MME conversion programs will have same/similar footnotes, basically these footnotes suggests that on a “good day” these MME conversion programs are JUNK SCIENCE.

• Published equianalgesic ratios are considered crude estimates at best and therefore it is imperative that careful consideration is given to individualizing the dose of the selected opioid. Dosage titration of the new opioid should be completed slowly and with frequent monitoring. 
• Conversion ratios in many equianalgesic dosing tables do not apply to repeated doses of opioids.
• The amount of residual drug in the patient’s system must be accounted for. Example: fentanyl will continue to be released from the skin 12 to 36 hours after removal of the patch. Residual effects from discontinued long-acting formulations should also be assessed before converting a patient to a new opioid.

If the entity states that 90 MME/day is the CDC guidelines and/or “it is the law”… here is quotes from the CDC 2016 opiate dosing guidelines:

https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

“The guideline is intended to ensure that clinicians and patients consider safer and more effective treatment, improve patient outcomes such as reduced pain and improved function.”

“Clinicians should consider the circumstances and unique needs of each patient when providing care.”

“Clinical decision making should be based on a relationship between the clinician and patient, and an understanding of the patient’s clinical situation, functioning, and life context.”

“This guideline provides recommendations for primary care clinicians who are prescribing opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.”

Then if the entity has not taken into consideration the pt’s CYP-450 opiate metabolism status, then all of the pt’s health issues has not been considered.

Here is a article about CYP-450 opiate metabolism rates .. this is just one of many articles available

https://www.practicalpainmanagement.com/treatments/pharmacological/opioids/making-practical-sense-cytochrome-p450

Here is a newer and more comprehensive DNA testing:  Pharmacogenomics: What does it mean for your health?

In sending this letter to these various entities, the attorney should consider a statement that being discharged from the practice will be consider a act of retaliation and/or pt abandonment and may result in further legal action against the entity.

If Epidural Spinal Injections (ESI)   are involved and the entity is mandating that the pt is required to get oral opiates they MUST SUBMIT to having ESI done.

Here is just one of many articles about the FDA’s  https://livelovefruit.com/dangers-epidural-steroid-injections/      FDA Warns About Dangers of Epidural Steroid Injections for Back Pain

The side effects of epidural steroid injections are so severe that the FDA ruled that all injectable steroid must carry an updated warning that includes the above risks, as well as “arachnoiditis, bowel/bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizure, [and] sensory disturbances (6).”

The FDA’s website also warns that “the effectiveness and safety of injection of corticosteroids into the epidural space of the spine have not been established, and FDA has not approved corticosteroids for this use (7).” This is largely due to the fact that research into the risks of epidural steroid injections is still being conducted. Approved or not, Dennis Capolongo of the ENDC, a ground that has campaigned against epidural steroid injections for years, believes that warning labels need to be stronger, and more visible – not just confined to the small print.

Then there is the issue of if the entity states that “no ESI’s … no oral opiates” … there is a portion of the Sherman Antitrust Act called TYING COMMERCE

https://en.wikipedia.org/wiki/Tying_(commerce)

This law basically states that it is illegal for a vendor to force a customer to purchase something that they don’t want in order to purchase something that they do want.

If the pt gets little or no benefit from these ESI’s then there is the question of Medicare/Medicaid law on inducement to cause a pt to cause Medicare/Medicaid to be charged for services that are not medically necessary https://benkofflaw.com/practice-areas/federal-and-state-anti-kickback-and-inducement-laws/

Then there is possibly the final “notice” to the entity… if the pt becomes incapacitate, dies or commits suicide then there is a possible legal recourse by the spouse and children 

Compensating The Spouse and Family of The Injured: Loss of Consortium Claims

This is probably the last thing that the entity will ever consider … being sued by the spouse and/or children of the pt.

Here is lawsuits settled last year for prescriber induced suicides  https://www.wdrb.com/news/7-million-awarded-to-family-of-man-who-killed-himself-after-pain-medication-denied/article_92db6b14-09c0-11ec-b39b-7b711a46b1c7.html

https://www.13wmaz.com/article/news/local/deposition-reveals-va-doctor-reduced-veterans-drug-medicine-mistakenly-4/93-2d9dc181-1f28-4bcc-9d5a-a2e7a4b74b72

A good law firm may see that a single letter to one set of healthcare entities have the distinct possibility of turning into a large class action lawsuit, since it is unlikely that the healthcare entity is doing this to just one or even a handful of pts, but more likely all similar pts in the practice or when it comes to large healthcare corporations, chain pharmacies, insurance/PBM companies could be applying this to thousands and/or tens of thousands  pts.

What I am suggesting is what prosecuting attorneys do to criminals… they “over charge” with the hopes that they will end up pleading guilty to one-two charges and/or if they go to trial… they will get a guilty verdict on one or two charges.

Any pt that attempts to talk to a law firm about being poorly treated for total denial of care… don’t talk to them about malpractice or let them go down that path… many states have caps on award for malpractice and each side hires a “expert” that will testify that who hired them was doing the correct thing… because of the award caps, most law firms will not even cover their expenses – if the take the case on a contingency basis – even if they win.

The look for a large number of people in a class action against a entity with deep pockets. IMO, sending the offending healthcare entity a letter of notice of the potential harm that could happen to a pt.. then they have been harmed and things may move from malpractice to known intent…  Intentionally and knowingly throwing a chronic pain pts – particularly a intractable chronic pain pts into cold turkey withdrawal and the pt ends up with a heart attack, failing kidneys, stroke, suicide or death… the $$$ damages should be greatly increased and if their is a spouse and children left behind or required to care for a loved one who is no longer self reliant and has to be cared for… that is financial damages…

 

 

 

 

 

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Spinal Cord Stimulators

An Analysis of the Adverse Events Reported to the Australian Therapeutic Goods Administration

https://journals.lww.com/journalpatientsafety/abstract/9000/spinal_cord_stimulators__an_analysis_of_the.98907.aspx

Abstract

Background

Spinal cord stimulators are used to treat intractable pain. Placebo-controlled trials of spinal cord stimulators typically involve short-term treatment and follow-up, so long-term safety and efficacy are unclear.

Aim

The aim of the study was to describe the adverse events relating to spinal cord stimulators reported to the Therapeutic Goods Administration of Australia between July 2012 and January 2019.

Methods

Adverse events were coded by seriousness, severity, body system affected, type of event, action taken, and attribution of fault. Data on the number of stimulators implanted and removed were sourced from the Admitted Patient Care Minimum Data Set.

Results

Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%). Device malfunction was the most common event (56.5%). The most common action taken in response to an adverse event was surgical intervention with or without antibiotics (80%). The ratio of removals to implants was 4 per every 10 implanted.

Conclusions

Spinal cords stimulators have the potential for serious harm, and each year in Australia, many are removed. In view of the low certainty evidence of their long-term safety and effectiveness, our results raise questions about their role in providing long-term management of intractable pain.

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I have been trying to advocate for the chronic pain community for abt 10 yrs.. The community seems to either be functioning under Eistein’s definition of insanity or a very bad “ground hog day” scenario

There has been too many years between now and Biochemistry class for me.
Today, I tend to rely on observations and my common sense to see things that seem abnormal.
I see chronic pain pts making statements that when they have had their pain meds involuntarily/forced reduction that their blood pressure goes into what I would call “stroke territory” – many north of 200/100.
Pts state that they may be taking up to 4 different categories of BP meds and their blood pressure doesn’t change little or none at all.
Apparently some practitioners just ignore their elevated BP, and can’t see – or don’t want to see the relationship between cutting the pt’s opiates and elevated BP.
Even those pts being put on up to 4 different categories of BP meds, their pressure will not return to what is considered acceptable 135/85 range.
Apparently, there is some physiological process effecting their blood pressure that is totally separate and distinct from what all of those different categories of BP meds have been targeted by clinical trials in controlling hypertension.
Since most opiates are generic, and there seems to be a near mass hysteria over the fear of addiction. There is probably little chance of some pharma to look at this issue.
My common sense suggests that there has to be one or more measurable components of our blood or urine that is raised or lowered and would indicate that the pt’s intensity of pain is elevated, maybe even capable of indicating just how high/intense it is.

Just look at line one on this chart on the effects to the human body from under/untreated pain. many/most of those items involved with the Endocrine system should be able to be measures with a simple blood or urine test. It is – or should be – common knowledge that any pts dealing with under/untreated pain for an extended period of time will end up with Addison’s disease – basically the adrenal glands have “quit/failed” while trying to compensate for the body’s stress and Addison is a disease that should not be ignored and not treated.

Hypertension from under/untreated pain is very common – ideal target for BP is 135/85 – but often pts who have had their opiate meds involuntarily reduced/eliminated will have a hypertensive crisis – with pressure often times north of 200/100 and that is STROKE TERRITORY.

What is even worse is – pts have told me that their practitioners will either ignore their hypertensive crisis and/or put them on as many as 4 different categories of blood pressure meds – and often their blood pressure will be reduced little to none.  There must be a whole separate physiological body function separate and distinct from what the blood pressure meds that we now have addresses.

Several years ago, Medicare/HHS/CMS started a program to monitor pt’s compliance with medications for blood pressure, diabetes, cholesterol.  They put the Medicare Advantage & Part D providers in charge of enforcing this program. Here is how it apparently works… the practitioner writes a Rx for pt to treat one or more of those medications…  Those insurance prgms start tracking the pt, the pharmacy and the practitioner … if the pt doesn’t refill the prescribed medications on a timely basis – based on the last fill/refill date submitted to the insurance program –  the insurance program will send out notices to the pt, pharmacy, practitioner – that the pt is NOT IN COMPLIANCE… the pharmacy and practitioner can get “financially dinged ” if more than a certain percent of their pts are no in  compliance.  

The ELEPHANT IN THE ROOM is that the insurance providers are apparently working under the belief that the pt’s lab values for those three disease states are being kept within “normal range”… In the case of under/untreated pain pts… taking 4 different blood pressure meds but their BP is still in “stroke range”.  As far as Medicare/HHS/CMS is concerned … all the “i’s” are being dotted and “t’s are being crossed, but the original intent of this program – lowering cost to medicare because the pt is being compliant with their medications is either a mirage or an illusion.

I have no idea how large this subset of chronic pain pts with hypertension, who have had their pain meds involuntarily/forced reduction or eliminated, and whose blood pressure in above recommended levels – especially those who are being prescribed- and regularly taking – blood pressure meds – that are not lowering their BP… HHS/CMS/Medicare is working under the false pretense that the practitioner has got the pt’s BP under control…

Perhaps this is a issue that is better about talking to your member of Congress about…  Congress or HHS put this program together to help Medicare folks to  optimize their QOL and OF COURSE – to save Medicare money !  After all, high blood pressure has always been referred to a the “SILENT KILLER”.  With that subset of chronic pain pts there can be a lot of other compromising QOL issues that high pressure will compromise – and cost Medicare MORE MONEY – before it kills you.

This chart pretty simply explains the potential adverse health consequences to a pt with long term high blood pressure.  A stroke may not kill you … could make you bed confined, could make you a paraplegic and in a wheelchair, heart attack doesn’t have to kill you, can cause a lot of different disabilities and if you are on Medicare you are “too old” for a heart transplant.

Kidney damage and you will end up on dialysis and again if you are on Medicare, you are “too old” for a transplant

How would losing your eye sight affect your day to day living and QOL ?

And who is going to pay for all of these medical services that you need ? Medicare will only pay for so many days in a nursing home and then you will be liable until you only have $2000.00 and a car and if you have a house.. they may sell it for you to keep paying your nursing home costs and then you will get on Medicaid…. and the care that you received will be dictated by Medicaid

This is just one example of how good intentions by Congress, HHS. CMS, Medicare could be costing our healthcare system unnecessary costs and costing pts unnecessarily having their QOL compromised because all those involved are only looking at part of a pt’s health issues.  It is also pathetic, that there could be all sorts of pt’s data points (lab tests) in Electronic Medical Records (EMR) that could verify and document a chronic pain pt’s intensity of pain.

Because NO ONE IS LOOKING at the data that is right under their noses !

 

 

 

 

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I am no attorney but in my short research,  suggest that:

“In God we trust; all others cash.” -GoFundMe says they will “send all remaining funds- abt 10 million – to credible and established charities – of GoFundMe choice – verified by GoFundMe.

 

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Meta Platforms (FB) shares are trading (26%) lower after the company reported worse-than-expected Q4 EPS results and issued guidance.

SUCKERBBERG is not going to get any sympathy from me… after his “opinionated ” FACT CHECKERS  – took a untold number of complaints from Richard Mark and his harem/tribe of minions falsely reported my blog as a SPAMMER.  With SUCKERBERG’S estimated net worth he may have LOST some TWENTY FOUR BILLION in net worth.

Maybe SUCKERBERG saw this coming, since he changed FAKE BOOK’S name to META and is taking the company in an entirely new direction… and dropped his attempt in creating his own cryptocurrency (DIEM) https://www.businessinsider.in/cryptocurrency/news/mark-zuckerbergs-controversial-crypto-project-diem-is-looking-to-repay-investors-by-selling-its-assets-report-says/articleshow/89138561.cms

Be the end of the day (02/03/2022) META (FB) company LOST 250 BILLION in value !

 

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