Gay Lavender Mafia in the Catholic Church?

(August 29, 2018)  Is there a gay lavender mafia in the Catholic church?  According to a priest who has seen the culture from inside the church for several decades, the answer is an unequivocal “Yes.”  Sadly, the Church has even manipulated or blackmailed priests who have attempted to blow the whistle on the church’s homosexual / pedophile problems.  That’s the conclusion reluctantly reached by several honorable priests, including Father Edwin Palka.

Related: McCarrick tip of the Iceberg, Polish Priest  warns

Evil Homosexual Bishops  

Father Palka wrote earlier this month in the bulletin of The Epiphany of our Lord Catholic Church  that “evil” homosexual bishops set out to “punish, humiliate and blackmail” decent, God-fearing priests who threaten to blow the whistle on the gay “mafia” within the Roman Catholic church.  You can read Father Palka’s own words here,which he used in trying to answer one of his own parishioner’s queries over the church’s pedophile problem:  Why don’t Priests blow the Whistle?

Gay Lavender Mafia within Catholic Church

Father Palka blows the whistle on the horrendous damage done by what he calls the gay “Lavender Mafia” within the church.  Father Palka helps shed light on why the sexual abuse crisis within the U.S. church has raged unchecked for decades, as was shown in the recent grand jury report from Pennsylvania.

Pastor of the Tampa, Fla. parish, Father Palka wrote:  “Many people still don’t (I believe most priests still don’t) understand just how evil the active homosexual or homosexual activist… priests and bishops are.”

He continued:  “Not understanding the extent of their depravity and wrongly thinking that they are simply ‘normal’ men who just struggle with their sexual desires and sometimes might fail to remain chaste but are really, truly repentant when it happens and strive to ‘confess my sins, do penance and amend my life, amen’, they cannot possibly grasp the hellish depths to which… [homosexual activist]… clergy will go to persecute, lambaste, punish, humiliate and blackmail anyone who stands in their way or threatens their way of life.”

Father Palka’s speaking out to answer his own parishioner was partly a result of the shocking grand jury report on pedophile priests released from Pennsylvania this month.  The jury determined that a culture of corruption deep within the church hierarchy has pointedly protected pedophile priests for decades.

How else can one explain the church’s decades-long problem of allowing pedophile priests to abuse young children, 80% of whom have been boys?  How else can one explain the steady promotions which have elevated the worst of the worst – like Cardinal McCarrick – into the highest upper echelon positions in the Catholic church?  How else can one explain the cathedral  mural commissioned by an infamous archbishop in 2007 that suggests a homosexual orgy which includes naked children?

The Catholic church has, for too many years, been able to flaunt its homosexual pedophile priests right in the faces of its parishioners.  So brazen have the upper reaches of the church hierarchy been that they now feel emboldened to simply paint perverted pictures right on the walls of a cathedral, right in front of God and everybody.

Perhaps nothing so clearly shows church elders’ disdain for their own parishioners and all things holy as Archbishop Paglia’s homoerotic mural.  We dare anyone to examine this “Art” Paglia commissioned in 2007, and not come to the same conclusions of world-renowned art critic Maureen Mullarkey.  The truth hides in plain sight in Archbishop Paglia’s world.

Related: Archbishop defends x-rated mural as evangelizing tool

Archbishop Paglia’s Malicious Mural

An International Association of Art Critics member, Ms. Mullarkey wrote in March 2018 that Paglia’s mural was a “true scandal” for the Church.  She called the mural an “out-and-proud” display that reveals not only a “creep,” but a much deeper problem within the Vatican under Francis’ leadership.

“Paglia’s narcissism — the urge to flaunt his liberation from the moral considerations he is pledged to honor — is stunning,” Ms. Mullarkey wrote.  “It is a finger in the eye of congregants who trust in a priest’s fidelity to his vows.  To place it in a public house of worship is treachery.  It is also a declaration of Paglia’s own trust in his immunity from reprimand.”

Ms. Mullarkey wrote that the painting forces congregants to “peep through a keyhole at [Paglia’s] sexual inclinations — and suggested behavior.” (Paglia) disdains his own flock,”she wrote.  “He is taunting them. There is malice in that.”

She added: “The true scandal here is the basis — which goes unmentioned — of Paglia’s confidence that he could broadcast his sexuality on a cathedral wall without fear of censure.”

It is the kind of thing which a good attorney might like to enter into evidence in a priest abuse lawsuit against the church over its harboring, protecting, and even promoting pedophile priests.

It’s instructive to consider Paglia’s punishment for flaunting his deviant art, which was paid for in part by the very parishioners who were subjected to it.  In 2012, he was promoted to archbishop and appointed president of the Pontifical Council for the Family.

Under the direction of Paglia, in 2016 the Pontifical Council for the Family issued a new sex-ed program that includes lascivious and pornographic images so disturbing that one psychologist suggested Paglia be evaluated by a review board in accordance with norms of the Dallas Charter, which are designed to protect children from sexual abuse.

A psychiatrist, Dr. Richard Fitzgibbons, a consultant to the Congregation for the Clergy at the Vatican, said his immediate professional reaction was that, “[T]his obscene or pornographic approach abuses youth psychologically and spiritually.  (As) a professional who has treated both priest perpetrators and the victims of the abuse crisis in the Church, what I found particularly troubling was that the pornographic images in this program are similar to those used by adult sexual predators of adolescents.”

That’s more evidence hiding in plain sight of church elders’ attitudes toward pedophilia, and of a systemic problem in the church itself, at the highest levels, that both encourages and rewards unspeakable depravity.

LBGT Politics obscure Criminal Behavior

Meanwhile, some of the LBGT community, which has a very strong political presence in the church, has become inflamed as the pedophile priest stories have been used by some to help promote the King James’ Bible stories that homosexuality is a sin.   But this isn’t about the sin of homosexuality, which we can argue about all we want but cannot legislate.  We cannot legislate human behavioral choices between consenting adults.  We can, and have, legislated behavior between adults and children.  This issue concerns a crime.   Pedophilia is a crime, against both Man and God, and offending priests who violate the trust of their parishioners must be held accountable.

The Church needs to be held accountable

Since church elders have shown themselves to be abject failures in ferreting out and dismissing beastly priests who abuse young children, law firms must be employed to hold these priests and the church accountable.  The church needs to be held accountable.  If you have been abused by a priest, click here for a free confidential legal consultation regarding a potential lawsuit.

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The Catholic Church’s Child Sex Abuse Problem

(August 24, 2018)  A grand jury report issued in Pennsylvania last week has brought the Catholic church’s long-running pedophilia problem back into the public eye. It is a problem that has sadly festered for decades, likely for centuries.  After a two-year investigation in Pennsylvania, the grand jury found that some 300 priests had molested at least 1,000 children, and likely thousands more, dating back to the 1940s.  That’s when the church first began keeping records on pedophile priests.

10,000 Children Report Priest Abuse

The Pennsylvania grand jury report issued this month comes 14 years after the Catholic church itself commissioned what became its own shocking news release back in 2004.   The church then found that more than 4,000 US Roman Catholic priests had faced sexual abuse allegations since the 1950s.  Those sex abuse cases involved more than 10,000 children, most of them young boys.

Related:  Pennsylvania Priest Abuse Lawsuit

What is the church doing to address its Pedophile Priest Problem?

Many victims of priest abuse and priest-abuse-victims’ advocates have, for decades, criticized the church’s criminal lack of leadership in addressing the problem.  In too many actual cases, church leaders, including the pope, have either ignored the problem, or else they have enabled abuser priests to continue unchecked in their positions of power.

Priest Abuse Lawsuits

Evidence discovered in priest abuse lawsuits has found that many pedophile priests have been moved from one parish to another, often without any rehabilitation or proper supervision, legal or otherwise.  In many of those cases, church elders pointedly failed to inform the offending priest’s newly-assigned parishioners that they’d been given an accused pedophile priest.  In many of those cases, the priest was found to abuse children at his new parish just as he had in the last which had driven him out.

The Pennsylvania pedophile priest report also noted that when local law enforcement was called in to report a sex abuser priest – because pedophilia is a crime – the local police often gave the priest a free pass in “deference” to the church.

The Pope – Words sans Action

The current Pope, Francis, has done what virtually all of his predecessors have done, talk tough about taking responsibility for sex abuse and ferreting out offending priests; but his actions, or lack thereof, and his reactions before and after the Pennsylvania report overshadow his words.

Pope Francis had even gone so far as to denounce accusers who had been deemed entirely credible in telling their sad tales of abuse at the hands of a priest.  In Chile, the pope’s criticism of a credible victim’s veracity recently led to his apologizing to priest sex-abuse victims not only for their abuse at the hands of a priest, but for the pope’s own heaping of scorn upon their personal accounts of that horrific abuse.   In many cases, so many abused people came forward with similar stories about the same priests that it was simply impossible for the pope, or anybody else, to discount their credibility.

NPR: Pope apologizes for mis-handling Chile Sex-abuse Sscandal

Mainstream slow to Reveal Truth

The mainstream media first began to acknowledge child molestation by priests in the 1980s, in the US and Canada, at least 30 years after the first victims’ stories began coming out in the 1950s.

By the 1990s, stories came out in Argentina, Australia, and elsewhere.  In 1995, the Archbishop of Vienna, Austria, stepped down after sexual abuse allegations rocked the Church there. Widespread priest abuse stories also began hitting the newsstands in Ireland at that time. By the early 2000s, the beasty priest genie was out of the bottle all over the world.

The Boston Globe newspaper (as seen in the 2015 film: Spotlight) exposed widespread abuse.  The Globe detailed how pedophile priests were shuffled around by Church leaders instead of being punished.  The story inspired priest-abused people across the US and the world to tell their  stories.

Endemic Church Sex Abuse

In 2009, a report found that sexual and psychological abuse was “endemic” in Catholic-run industrial schools and orphanages in Ireland for most of the 20th Century.

In 2017, a five-year Australian inquiry found “tens of thousands of children” were sexually abused in Australian institutions over decades, including churches, schools, and sports clubs.

In 2018, a former Vatican representative received a five-year prison sentence for child pornography crimes.  In addition, Australian Archbishop Philip Wilson resigned in 2018 after being convicted of concealing the child sex abuse crimes of another priest. In Chile this year, 34 Roman Catholic bishops offered to resign in the wake of a child sex scandal and cover-up.

The Catholic Church’s Child Sex Abuse Problem

NPR reports that under Pope Francis, a special panel has been set up to deal with the priest abuse issue, but it has faced setbacks, including high-level resignations.  In 2017, an Irish survivor of  priest abuse, Marie Collins, left the group, citing “stumbling blocks and hindrances”.

Sadly, that sounds like business as usual for the Catholic church and how it tackles (or fails to tackle) its long-running pedophile priest problem.

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Monsanto Faces 8,000 Roundup Suits

(August 24, 2018)  Monsanto faces more than 8,000 lawsuits over Roundup links to cancer, the head of Bayer announced yesterday.  Part of the IG Farben company convicted of helping Nazis commit war crimes, Bayer acquired Monsanto this summer in a $62 billion-dollar deal.  That marriage merges two companies which have made their fortunes largely by making and selling deadly chemicals.

Roundup Cancer Verdict: $289 Million

Roundup cancer litigation exploded in the public eye this month after Monsanto was hit with a $289 million jury verdict in California state court following a month-long trial.  Plaintiff DeWayne Johnson sprayed Roundup and Ranger Pro on California school properties. He is now dying of non-Hodgkin’s lymphoma, which his lawsuit said was caused by his exposure to Monsanto’s Roundup and Ranger Pro.

World Health Organization: Roundup a Probable Carcinogen

Roundup lawsuits were spurred largely by a 2015 pronouncement from the World Health Organization that glyphosate – the only active ingredient named in Roundup, Ranger Pro, and other popular Monsanto poisons – was a probable human carcinogen.  Since that time, Monsanto has been shown in court documents  to have waged a worldwide PR campaign to discredit the WHO and any scientists or anyone else who dares suggest that glyphosate is carcinogenic.

Monsanto claims Hundreds of Studies show Roundup Safe

Monsanto claims incessantly that hundreds of studies have proven Roundup safe.  The problem is that virtually all of those “studies” were done by people on Monsanto’s payroll or by others financially beholden to the chemical giant from Missouri.  By contrast, the WHO refused to consider Monsanto’s own vested interest studies; the WHO considered only studies which were independent of Monsanto or its minions.

Monsanto EPA Collusion impugns EPA

Monsanto also endlessly repeats that the U.S. EPA has found glyphosate to be non-carcinogenic. The problem for Monsanto with that argument is that internal documents have shown some EPA officials either helping Monsanto or colluding with the company to delay or derail legitimate Roundup cancer studies.  The judge in the California trial allowed the jury to see some of that evidence which impugns Monsanto’s attempt to hide behind any EPA pronouncements.

Can Bayer erase the Monsanto Name from History?

Given the Monsanto moniker’s PR problem which Roundup lawsuits have brought to the forefront of the waking public’s mind, Bayer also hopes the acquisition will help erase the Monsanto name from the history books. Since most of Bayer’s crimes against humanity are further in the past than Monsanto’s, that ploy may work, eventually, given the enormously short attention span of most people today.

Bayer knows something about helping erase history; it knows something about helping erase people from history.  Bayer helped IG Farben erase the lives of millions of people enslaved in WWII concentration camps.  Bayer’s real history is no “conspiracy theory,” and neither is Monsanto’s.

Related:  10 Dirty Secrets you probably didn’t know about Bayer

Bayer CEO Werner Baumann

Meanwhile, Bayer CEO Werner Baumann told investors in a conference call that the 8,000 cases filed against Monsanto over glyphosate “is not indicative of the merits of the plaintiffs’ cases.”

Werner Baumann said Bayer/ Monsanto will vigorously defend against the lawsuits.  He also said the company plans to ask the judge who oversaw the trial of DeWayne “Lee” Johnson to overturn the verdict. If that doesn’t work, the company will appeal the verdict to appellate courts.

Mr. Baumann also repeated Monsanto’s endless argument that glyphosate safety is backed by hundreds of studies over decades.

The California state jury also found in the first and thus far only Roundup cancer trial that  Monsanto failed to adequately warn customers of risks associated with Roundup and its even stronger Ranger Pro products.   The jury also found that Monsanto acted with malice or oppression, and awarded punitive damages.

Monsanto Faces 8,000 Roundup Suits

CEO Baumann also said that another lawsuit alleging Roundup’s active ingredient glyphosate causes cancer is set for trial in St. Louis this October.

Federal Court Cases
While most of the 8,000 cases against Monsanto for Roundup are pending in state courts, some 400 glyphosate cases are pending in a federal multidistrict litigation court set up in California.

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Mosanto hit by $289 Million Verdict in First Roundup Trial

(August 10, 2018)  Monsanto was hit by a $289 million verdict in the first Roundup trial yesterday.  A jury deliberated for nearly three days before awarding a former California groundskeeper the decision in the landmark trial.

Plaintiff Dewayne Johnson sued Monsanto in 2016.  He claimed Monsanto knew of health risks linked with Roundup and its even stronger Ranger Pro products since the 1990s.  That’s when studies began showing a correlation between Monsanto’s flagship product and lymphoma. Monsanto, however, downplayed the risks,  the lawsuit petition charges.  Monsanto also failed to put a warning label on its cancer-causing products.  Monsanto failed to warn Mr. Johnson, ruled the jury.  He thought it safe to use Roundup and Ranger Pro while he worked as a groundskeeper for a San Francisco Bay Area school district.

Mr. Johnson took the stand toward the end of the month-long trial.  He recalled being told during an optional pesticide training program that Ranger Pro was “safe enough to drink.”  Shortly afterwards, he said that a spray machine malfunction drenched him in the poison, despite his taking extra safety precautions in wearing a Tyvek bodysuit over his uniform.

After he was drenched, he noticed a nodule on the back of his leg, behind his knee. Other nodules quickly spread to his arms, legs, chest, face, hands.  Mr. Johnson was eventually diagnosed with non-Hodgkin lymphoma.  But he continued spraying Monsanto’s poisons anyway.  He didn’t know if the Ranger Pro had caused his cancer, and he didn’t want to lose his job.  An additional accident covered his back in the poison.

Mosanto hit by $289 Million Verdict in First Roundup Trial

Three different plaintiff’s experts testified earlier that Monsanto’s Roundup causes non-Hodgkin’s lymphoma, or that Monsanto misrepresented the safety of the products used by Mr. Johnson.

Toxicologist Dr. William Sawyer testified to the 16-member jury that 10 percent of Roundup’s only named active ingredient – glyphosate — can be absorbed through human skin, more than 10 times the amount Monsanto claims can be absorbed when one is using Roundup or Ranger Pro.  Monsanto claims users absorb less than 1 percent.

Another plaintiff’s expert, Dr. Chadi Nabhan — an oncologist and former medical director of the University of Chicago’s cancer center — testified that Monsanto’s products caused Mr. Johnson’s non-Hodgkin’s lymphoma.

Dr. Chadi Nabhan told the jury that he had reviewed epidemiological studies and found that glyphosate can cause non-Hodgkin’s lymphoma.  After reading thousands of pages of Mr. Johnson’s medical records and examining him, Dr. Nabhan said glyphosate was likely to blame for his cancer.  Dr.Nabhan discussed risk factors associated with cancer, including age, race, the patient’s immune system, viruses, and work history. He said the only risk factors that raised a red flag were Mr. Johnson’s race — because his subtype of non-Hodgkin lymphoma, mycosis fungoides, is more prevalent in black patients  — and his glyphosate exposure on the job.

“There was exposure to an agent that has been determined [to be] a human carcinogen,” Dr. Nabhan testified.  “So nobody could logically exclude this as a substantial factor.”

Experts for Monsanto testified that hundreds of studies showed glyphosate was safe.  Plaintiffs countered that all of those studies were done by Monsanto employees, or else they were paid for by Monsanto, or they were studies that were of too short a duration to be definitive, or else their sample sizes were too small.

Monsanto experts also attacked the WHO, as Monsanto secretly did in the press and blogosphere across the world, for pronouncing glyphosate a probable carcinogen.  Monsanto’s lawyers and experts pointed out that the EPA and the European equivalent of the U.S. EPA had found glyphosate safe.

But in a glimpse behind the regulatory curtain, the jury also heard testimony concerning how a former EPA official, Jess Rowland, worked secretly at the behest of Monsanto to help kill a study over the safety of glyphosate.  Mr. Johnson’s lawyers also pointed out that the WHO looked only at independent studies not paid for by Monsanto in arriving at their conclusion that glyphosate was a probable carcinogen.

Monsanto vowed to appeal the verdict.

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Women’s Pelvic Mesh Use Suspended in England

(August 9, 2018)transvaginal mesh Women’s pelvic mesh use was suspended in England last month pending government review.  English regulators suspended the surgical use of transvaginal mesh after listening to mesh-related horror stories from several women.  The politicians listened as dozens of women detailed stories of how the mesh has caused them excruciating misery and endless pain.

Related:   Transvaginal Mesh Lawsuit

The suspension means surgical mesh meant to treat stress urinary incontinence is not to be used again in England until the mesh meets five strict conditions which thousands of mesh-injured women campaigned to demand.  Many of the women belong to a group of 6,100 people called ‘Sling the Mesh.’  Members have called attention to problems with both women’s pelvic mesh, hernia mesh, as well as rectopexy mesh, used to treat rectal prolapse.

Sling the Mesh

“This is incredible news,” said ‘Sling the Mesh’  founder Kath Sansom.  “It is a testament to people power.  Our members have written, emailed, attended Parliament and lobbied to get this result, and I am delighted.”

The government review of mesh is scheduled to conclude in March 2019.  It will determine if the suspension of the plastic mesh used in people will become permanent.

Ms. Sansom brought the anti-mesh campaigners to Parliament, which led to an internal investigation by the National Health Services, as well as debates in the House of Commons.  That action led to more public awareness of the severe complications surgical mesh can cause.  In the U.S., widespread use of transvaginal mesh has led to a virtual catastrophe, with more than 100,000 women filing lawsuits at one time over plastic mesh complications.

In February 2018, the government announced a review of surgical mesh.  Regulators planned to meet face-to-face with citizens around the UK.  Health and Social Care Secretary Jeremy Hunt said the government’s final recommendation should be publicized next March.

Baroness Julia Cumberlege led the mesh review.  Medical Mesh News Desk reported that she was so moved by the stories she heard that she suggested  an immediate suspension in the use of surgical mesh for stress urinary incontinence (SUI).  Ms. Cumberlege believes rectopexy mesh for rectal prolapse should also be suspended.

Human Suffering outweighs Benefits of Mesh

“We strongly believe mesh must not be used to treat women with SUI until we can manage the risk of complications much more effectively,”  Ms. Cumberlege told the Daily Mail.  “ We have not seen evidence on the benefits of mesh that outweighs the severity of human suffering caused by mesh complications.  I have been appalled at the seriousness and scale of the tragic stories we have heard from women and their families.”

Baroness Julia Cumberlege

“We had to act now,” said Ms. Cumberlege.  “My team and I are in no doubt that this pause is necessary. We must stop exposing women to the risk of life-changing and life-threatening injuries.”

Five Conditions Must Be Met

There’s no ban for now, but a “halt” to procedures pending five conditions:

  1. Surgeons may perform an SUI operation only if they receive proper training and regularly perform surgeries.
  2. Surgeons must report every procedure to a national database.
  3. A surgeries registry will be maintained to note the type of procedure and the woman involved.
  4. Complication reports to the MRHA must be linked to the register.
  5. Specialized centers must be identified and accredited to deal with complications and removals.

As in the U.S., mesh proponents claimed that only prolapse surgeries should be banned.  Health regulators, however, acknowledge that three-quarters of pelvic mesh surgeries are done to treat SUI, and they account for most of the horror stories.

An estimated 130,000 UK patients have had an SUI or POP procedure in the past decade.  Complication rates have been found up to 42%, with 30% reporting a lost or reduced sex life, and urinary infections reported at 22%, with bladder perforation in 31 percent of cases.

Women across the globe have complained of pelvic mesh complications.  Mesh-injured women  in Scotland have also addressed their government directly and achieved a suspension on the mesh used for SUI.   That suspension came in 2014 after a consistent talking campaign as well as extensive media coverage from an enterprising reporter, Marion Scott.

New Zealand also suspended mesh use for pelvic organ prolapse (POP) as well as incontinence, while Australia suspended mesh use for POP.  Hundreds of Australian women have filed lawsuits against Ethicon over its mesh implants.

Sling the Mesh Reaction

Ms. Sansom, who is also a CambsTimes reporter, said, “I think the really positive thing about the suspension is the government is finally listening to us and realizing just how awful it is when these mesh implants go wrong.”

She noted the government is not suspending the use of mesh for rectal prolapse, which Ms. Cumberlege also called for.  Ms. Sansom also noted the same plastic is used for hernia repairs and they are starting to get the same complications, pain loss of sex life, autoimmune conditions.

British Urogynaecology (BSUG) Disagrees with Mesh Suspension

The British Society of Urogynaecology (BSUG) strongly disagrees with the decision to suspend the use of surgical mesh for stress urinary incontinence recommended by the All Party Parliamentary Group (APPG).

The government’s decision is not based on any scientific logic or thinking, claim BSUG  members. The statement is signed by Professor Jonathan Duckett chairman of the BSUG.

Kath Sansom:  BSUG Deluded

Kath Sansom tells MND that the BSUG group is “Absolutely deluded, defensive, sounds very angry, totally not supportive to women and peddling the tired old myth that this is the most trialed procedure out there.  These are the aggressive urogyn surgeons.  It is very clear they have put a lot of pressure on Govt following Baroness C’s call to “pause.”

Government Trials Flawed

Ms. Sansom believes the government trials that are underway are flawed for several reasons:

  1. Most trials are not randomized, but simply mesh vs. mesh; there’s no control group.
  2. Most trials are short term, roughly two years, shy of when most problems start.
  3. Tiny cohorts: One study of 90 women drops to 58 after 17 yrs., a drop of 22%. Even a 5% drop adds significant bias to a study.
  4. Poor quality of life (QoL) studies fail to look at new onset of chronic pain, nerve damage, urinary infections, loss sex life, etc.
  5. Most QoL questions are based on the SUI pad test. Ludicrous!
  6. Many trials authors have conflicts of interest. In the Pt. 3 trial above, two authors were paid by Ethicon, which makes the mesh slings being “tested.”
  7. Many trials come up with damning statistics and then ignore them. One by Brubaker et al shows a 42% risk, but the abstract/conclusion claims it is only short term and says mesh is an effective treatment option. (Ludicrous!) Busy doctors don’t take the time to read through every report so they believe the hype.

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IVC Filters Need Randomized Controlled Trials

Medscape Cook Blood Clot Filter Lawsuitscommentary published August 7, 2018 declares that IVC filters need randomized controlled trials (RCTs).  Authored by Vinay K. Prasad, MD MPH – a hematologist-oncologist – the opinion piece explains exactly what RCTs are and why we need them for IVC filters and other medical devices.

Dr. Prasad penned the piece after reading a Twitter debate over whether we should run an RCT of the inferior vena cava (IVC) filter for patients with a venous thromboembolism (VTE) and a contraindication to anticoagulation.  Like so many runaway Twitter debates and diatribes, it was apparently fraught with ill-informed people flinging knee-jerk opinions before even clarifying the terms which made them butt heads.

The associate professor of medicine at Oregon Health and Science University explained that there are two basic prerequisites for a product requiring a randomized control trial.

First, he explained, randomized controlled trials are for interventions that are thought, or hoped, to offer benefits.  He contrasted them with devices or inventions which we know need no control group for comparison.  He offered examples such as smoking, drinking battery acid, falling off a bicycle, or getting kicked by a horse.  We don’t need a control group of people who don’t smoke, drink acid, fall off a bike, or get kicked in the head to know those things are bad. By contrast, we run randomized trials when we don’t know whether or not an invention, like an IVC filter, leaves us better off by using it than if we had avoided using it.

Second, Dr. Prasad points out, randomized trials are run for interventions that, at best, offer modest to medium benefits.  Again by contrast, if we know a light switch is beneficial, then we don’t ask or run RCTs.  Or if jumping from a plane with a parachute saves us vs. not using a chute, then we don’t need an RCT to test parachute vs. non-parachute jumpings.

RCTs in Medicine

To run or not to run an RCT gets most controversial when we consider medicine and medical devices.  RCTs are mentioned so often in medicine, explains Dr. Prasad, because “medicine lives in the ‘RCT zone.’”  Dr. Prasad explains, “Most of what we do involves offering interventions thought to benefit our patients, and most of what we offer confers a modest benefit, at best.”

Here’s where it gets interesting, and troubling.  The evidence shows that most medical practices are not beneficial for mortality.

1 in 80,000 Medical Practices Benefit Mortality

Dr. Prasad wrote:  “Data support the idea that medical treatments rarely have large benefits. Researchers studied every medical practice in the Cochrane database and found that only 1 in 80,000 practices had a very large, consistent benefit on all-cause mortality.”  Extracorporeal membrane oxygenation (ECMO) for neonates was the only one in 80,000 practices that showed a benefit for mortality!

Meanwhile, doctors have for years touted a list of practices with overwhelming benefit but lacking RCTs; that list includes just a few hundred items. That woeful number starkly contrasts with the hundreds of thousands of interventions and practices performed in biomedicine.

However, says Dr. Prasad, that doesn’t stop experts from pretending their “pet intervention” is an indispensable parachute and touting it as such.  The IVC filter is one such medical invention touted as a parachute, though no studies have proven that it is, or has ever been anything of the sort.

Dr. Prasad points to a recent paper in JAMA Network Open, in which Turner and colleagues found the IVC filter associated with an increased risk for death when used in patients with venous thromboembolism and a contraindication to anticoagulation.  That is especially troubling because that is the one group for which guidelines consistently recommend IVC filter use.

After adjusting for a common problem in observational data called immortal time, the authors found IVC filters associated with increased mortality (hazard ratio, 1.18; 95% CI, 1.13-1.22; P < .001). Dr. Prasad acknowledges that this study has limitations like all observational studies, but says we don’t have RCTs to guide us on this question.

Three randomized trials of IVC filter placement to date have included at least 100 participants, and none show a mortality benefit, even with extended follow-up. Curiously, all trials excluded patients with a contraindication to anticoagulation, which is again the only group which guidelines consistently recommend use IVC filters.   Additionally, said Dr.Prasad, “[O]ne of the three trials used an odd methodology that screened patients for symptoms of pulmonary embolism (not letting clots present on their own). 

Studies Show No Benefit for IVC Filters in Any Setting

“[T]he available evidence base for IVC filters is lousy,” declares Dr. Prasad.  “All observational studies have limitations—in this case, the patients who got filters may be different from those who did not; and these differences, and not the filter itself, may be responsible for any findings—and we may not be able to adjust for all of these factors. Moreover, all of the relevant RCTs are small and limited, and none show a clear benefit for filters in any setting. And there are no studies in the setting of contraindication to anticoagulation—a common reason why filters are placed.”

IVC Filters Need Randomized Controlled Trials

RCTs are needed for IVC filters because we only hope, but do not know, whether they benefit people.  IVC filters are costly, invasive, and harmful; and they’ve now been shown to offer no mortality benefit to the only group of people for which they are consistently recommended by common medical practice.

Something is terribly wrong with a system that allows a product to be implanted by the hundreds of thousands into people with no evidence of benefit.  Consequently, problems with IVC filters have led to IVC filter lawsuits being filed all across the country.

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Judge Sanctions Ford in Rollover Case

(August 4, 2018)  A state court judge sanctioned the Ford Motor Company in a rollover case in Georgia last month.  The Gwinnett County State Court judge in tiny Lawrenceville (Pop. 30,782) forbid the auto giant from challenging its fault in a wrongful death rollover lawsuit.  The judge levied several sanctions against Ford for conduct which he said forced a mistrial in an F-250 pickup rollover case in his court.

Related:  Ford loses Trademark Case against Texas Printer

The case involves two people who were killed when a 2002 Ford Super Duty F-250 Crew Cab pickup rolled over after a tire blowout.

Ford Caused Mistrial

“Ford intentionally, and after several warnings and admonitions, elicited testimony that forced this Court to declare a mistrial,” declared Judge Shawn Bratton.  He then sanctioned Ford for trial conduct over the 2014 truck crash deaths of Melvin and Voncile Hill.

The judge said, “Plainly, Ford willfully caused a mistrial in this case, in bad faith, and issue preclusion sanctions are appropriate.”

Judge Bratton’s order came in response to plaintiffs’ request for sanctions.  It bars Ford from challenging its liability as to design defect and failure to warn claims. Further, it sets up a trial focused on damages, which includes potential punitive damages against Ford.

The sanctions came three months after Judge Bratton declared a mistrial in proceedings over the rollover which killed the Hills as they drove along SR 49 in Americus, Georgia. During the April 2018 trial, the Hills’ family survivors claimed there was a dangerously weak roof in the couple’s 2002 Ford Super Duty F-250 Crew Cab pickup.

As he issued the sanctions, Judge Bratton said a Ford attorney, Huie’s Alan Thomas, willfully violated repeated court directives when he asked defense expert Dr. Thomas McNish to give his opinion on Melvin Hill’s cause of death.

Judge Bratton wrote: “The Court instructed Ford’s counsel, Alan Thomas, to explain to McNish, before his testimony began, that he would not be allowed to give specific cause of death opinions.  In clear disregard of the Court’s ruling, Mr. Thomas asked Dr. McNish whether he agreed with Plaintiffs’ expert’s opinion as to the cause of Mr. Hill’s death. Dr. McNish then opined, before the jury, the very testimony that the court prohibited — i.e. his opinion as to the cause of Mr. Hill’s death.”

Judge Bratton also noted in his sanctions ruling that Ford’s legal team violated earlier orders barring them from questioning the Hills’ seatbelt use or arguing any fault on the Hills’ part.

The judge said that Ford “deliberately injected the seatbelt use, as relevant, at least twice, before the jury,” and referred to a post-mortem toxicology report on Melvin Hill, “intimating that the results showed that Mr. Hill had alcohol in his blood.”

No Alcohol in Decedent’s Blood

Judge Bratton added:  “This example of Ford’s willful disregard of the Court’s orders in limine was particularly troubling, because the toxicology report showed that alcohol was not present in Mr. Hill’s blood.”

The judge also ordered Ford to pay more than $10,000 in jury-related costs, and he required Mr. Thomas to show why he should not be held in contempt of court. The order did, however, reserve ruling on plaintiffs’ motion for attorney fees.

170 Ford F-250 Rollover Cases

One of the Hills’ attorney in the case said that he has never seen anything like Ford’s courtroom misconduct in his 41 years of trying some 200 cases.

Shortly after the mistrial, Ford unsuccessfully requested that Judge Bratton recuse himself from the case, while the Hills’ plaintiffs sought sanctions.

The Hills attorney said in an email to Courtroom View Network:  “There was no doubt that the rollover was ‘foreseeable.’ Ford admitted that, and also admitted it had been sued some 170 times when this same truck rolled over causing roof crush and deaths or injuries.  (There) was no doubt that the roof on these trucks is defective and dangerous.  Ford’s own conduct admits that.  Ford had a team of Ford engineers design a far stronger roof for this same truck back in 2004, because Ford knew this roof was too weak.”

Judge Sanctions Ford in Rollover Case

Ford promised to challenge the decision. “Unfortunately, this is the latest in a string of orders that defy the evidence and the record in this case,” Ford’s statement read. “Ford will pursue appellate review.”

The case is Hill v. Ford, 16-C-04179-S2.

Ford has faced several lawsuits over weak roofs in its F-250 and F-150 pickup trucks. The lawsuits typically charge that the weight of the frame and body in the Ford pickups is too much for the roof to bear in a rollover crash.  Roof crush results, and many people have been killed or maimed in such accidents.

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Physiomesh Hernia Repair Problems

Physiomesh used for hernia repair has caused serious problems for many people.  As a direct result, Johnson & Johnson subsidiary Ethicon removed Physiomesh from the market in 2017. Complications from Physiomesh include hernia recurrence, mesh folding, bunching up, adhering to body organs, failing to integrate, causing pain, inflammatory reactions, and more. These problems have led to Physiomesh lawsuits.

What is Physiomesh?

Physiomesh Flexible Composite Mesh is a partially absorbable surgical mesh used for hernia repair.  The mesh is made from polypropylene, a plastic, set between two synthetic film layers.  Over time, a body absorbs the coating on the laminated layers, a controversial process that can lead to different bodily injuries.

FDA Clearance via 510(k)

The U.S. FDA cleared Physiomesh in 2010 under the auspices of its 510(k) program. By this path, Ethicon had only to claim the mesh was “substantially similar” to products already on the market. This truncated  path to market saved Johnson & Johnson and Ethicon lots of money and time, but it also leaves the maker of Physiomesh subject to liability for problems caused by the device.  By contrast, medical devices approved through the FDA’s regular Premarket Approval Process (PMA) are typically exempt from liability when they hurt people.  Makers of those devices were made exempt from liability via the U.S. government’s gift to corporations known as the Medical Device Amendments of 1976.

Related:  Physiomesh Lawsuit

Physiomesh Hernia Repair with Laparoscopic Surgery

The Physiomesh version removed from the market was for laparoscopic surgery, a minimally-invasive technique.   A surgeon makes several small incisions through which surgical tools are inserted. The surgeon then uses the tools to implant and secure (in theory, at least) the mesh in place around the hernia.

Foreign Body Reaction

Like many plastic meshes, Physiomesh depends on the human body’s own defense mechanism to attack and destroy foreign bodies in order to “mesh” with the patient’s body.  Therein lies both the genius and the idiocy of implanting plastic mesh in the human body.  Ethicon designed Physiomesh with a coating to prevent adhesions.  In theory, the body absorbs the coating over several weeks and stops absorbing where it “should” to strengthen the hernia-weakened tissue. However, the human body doesn’t always stop absorbing when and where it “should,” and the mesh doesn’t always strengthen repairs.  Sometimes it meshes uncontrollably and adheres to body organs, wreaking dangerous havoc.

Physiomesh Complications

The most common Physiomesh complication appears to be hernia recurrence, when the hernia comes back after the mesh implant surgery.

A Polish Hernia Study Group ran a clinical trial on Physiomesh in 2015, which included included Physiomesh Flexible Composite Mesh for laparoscopic surgery. The Polish group halted the trial for ethical reasons when researchers noted a high rate of hernia recurrences.

Ethicon removed the Physiomesh laparoscopic model from the market, but doctors and patients reported even more complications to the FDA.

Physiomesh Complications Reported to the FDA  

  • Hernia recurrence
  • Mesh folding, bunching up
  • Adherence to organs
  • Integration failure
  • Pain
  • Inflammatory reactions

Physiomesh Recalls and Market Withdrawals

Ethicon pulled all units of Physiomesh for laparoscopic surgery from the global market in May 2016, then sent out an Urgent Field Safety Notice. The notice explained why Ethicon ordered the market withdrawal. The notice also affected Ethicon Laparoscopic Hernia Kits. Ethicon wrote:

“The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”

Ethicon later discontinued laparoscopic versions of Physiomesh.

FDA Actions re: Physiomesh

The FDA began receiving reports of Physiomesh failures shortly after the 510(k) clearance. Those reports detailed recurring hernias, adhesions, infections, and other problems.

Physiomesh Lawsuits

A federal panel combined the first 16 Physiomesh lawsuits in June 2017. Hundreds of people have since sued Ethicon over Physuiomesh.

Physiomesh Litigation

A federal court in the Northern District of Georgia oversees Physiomesh lawsuits.  The presiding judge set the first trial date for Sept. 16, 2019. There were 1,279 Physiomesh lawsuits pending as of July 2018.

Physiomesh lawsuits accuse Ethicon of failing to warn people of Physiomesh risks. The suits also accuse Ethicon of negligence and putting a defective product on the market.

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Bayer Can’t Keep Essure Cases in Fed. Court

(July 25, 2018)  Bayer can’t keep Essure cases in federal court, said a Pennsylvania federal judge on Monday.  The judge ordered 16 consolidated Essure lawsuits back to state court.  The cases were brought by women who allege they were hurt by Bayer’s Essure birth control / sterilization device.  The judge found Bayer had failed to establish federal jurisdiction over the lawsuits.  The Big Pharma giant – now trying to buy the much-despised Monsanto juggernaut – had filed a petition in an attempt to keep the Essure cases in federal court.

In his ruling against Bayer, U.S. District Judge John R. Padova cited a piece of the U.S. Supreme Court’s controversial Riegel v. Medtronic decision.  The judge said that ruling made clear that Congress intended the state courts to resolve cases like those of the women suing Bayer over Essure.  The women’s suits claim Bayer AG violated state laws that parallel federal requirements for medical devices. According to the high court’s Riegel opinion, under the 1976 Medical Device Amendments Act — which regulates medical devices for safety and effectiveness — state claims in medical device cases are barred only if they seek to impose non-federal requirements.

Judge Padova said, “[U]nder the congressionally-designed scheme, the MDA permits individuals to bring state law causes of action alleging violations of duties that parallel the federal requirements. (It) would be entirely inconsistent with this structure to conclude that Congress intended all such state law causes of action to be brought in federal court.”

The judge’s using Riegel v. Medtonic to rule against a corporation’s wishes is more than a little ironic; the Riegel ruling by the nation’s highest court virtually erased liability for most medical device makers, if their device had been approved by the FDA.  In a scheme known as “preemption,” Medtronic had argued – in a nutshell – that it was impossible to fulfill both state and federal obligations regarding a warning label. It was a specious argument at best, but it was enough to give a majority of the U.S. Supreme Court cover to back corporate immunity at the expense of injured U.S. citizens.

Judge Padova’s ruling in this case recalls Macbeth’s hesitation in pondering the murder of Duncan.  He wisely worries, “That we but teach bloody instructions, which, being taught, return to plague the inventor.”  Thus Riegel v. Medtonic has returned to plague the inventors, corporations angling for total immunity from liability.

Judge Padova sent the 16 Essure lawsuits back to the Court of Common Pleas of Philadelphia County, where they had first been filed.

Bayer Halts Essure Sales
Bayer’s Essure birth control — or sterilization — device is a medical coil placed in a woman’s fallopian tubes to prevent pregnancy. On July 20, 2018, Bayer said it had decided to stop selling or distributing Essure in the U.S. by the end of the year. The company said in a statement that it had concluded its Essure business was no longer sustainable after years of declining U.S. sales, though Bayer was quick to note that it still stood by the safety and efficacy of Essure.

In April 2018, the FDA required an unusual limitation on Essure sales.  The agency said Essure can be used only if patients are directly informed of its potentially serious side effects.  Essure’s most serious risks – including perforation of the uterus or fallopian tubes – are listed on a black box warning which has appeared on Essure’s label since 2016.

The 16 women in these cases claim Essure migrates from the fallopian tubes and then breaks into pieces. The claimants allege that they’ve suffered severe and permanent injuries.

The women also charge that Bayer negligently trained doctors to implant the Essure device.  They claim Bayer failed to tell the FDA about Essure’s adverse event reports, and failed to include them in the company’s own risk analysis.

Bayer Can’t Keep Essure Cases in Fed. Court
The judge also rejected Bayer’s argument that the cases present substantial disputes of federal law.  He said Bayer didn’t elaborate on what those would be.

Judge Padova said, “Moreover, it has not established that the resolution of any dispute would have ramifications in federal cases outside of the Essure context or is otherwise important to the ‘federal system as a whole.   (We) conclude that Bayer has failed to identify any federal issue that holds significance for anyone other than the parties.”

The case is McLaughlin v. Bayer Essure Inc. et al., case number 2:14-cv-07315, in the U.S. District Court for the Eastern District of Pennsylvania.

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Cell Phone Cancer Link? Maybe.

Is there a Cell Phone Radiation Lawsuitcell phone cancer link?  The answer is, “Maybe.”  That’s the latest conclusion from a study on rats unfortunate enough to be recruited for it.  Most of the rest of us have also been recruited for quite some time, though many of us might not yet know it.

Related:  NBC News raises question to discount it

Brain tumors are typically slow growing.  They can take 20-30 years to develop, which is roughly the time most of us have been living with cell phones stuck to our heads.  Maybe we’re made of wood and no amount of radiation from the phones can hurt us.  Or maybe we should note that we are not made of wood, that radiation is real, and that we don’t know as much about it as we think we do, or as much as the people who call themselves scientists think they do.

Malignant Schwannomas

In Spring 2018, the National Toxicology Program (part of NIH) drafted a report on two long-running studies regarding cell phone radiation’s health effects. The researchers found exposure to high levels of radiofrequency radiation linked with a slight increase in the incidence of malignant schwannomas.  That is a rare type of tumor in nerve tissues near the hearts of male rats.

Researchers also found a radiation link with damage to heart tissue in both girl and boy rats. Mice had no similar effects.  Both mammal species’ entire bodies were exposed to high levels of radio frequency radiation nine hours per day for up to two years. (Keep in mind, that is a comparatively tiny amount of time exposed considering the radiation most of us have been exposed to daily for decades now.  But you do the math, extrapolate, compare, and see what you think. Don’t forget to factor in so-called Smart meters and “Smart” appliances, cell phone towers, Wifi — some or all of which radiate most of us almost constantly — and  the rest of the radiation soup we’ve lived in for years.)

In May 2018, a panel of peer reviewers met for three days to discuss the rat and mice studies and determine conclusions.  The reviewers voted to increase the level of confidence in their findings.  They concluded there was a clear link between the radio frequency radiation exposure and the male rat heart tissue tumors. The National Toxicology Program must now decide whether to accept the panel’s recommendation before the final report is released.   (Cue the telecom industry lobbyists to discount any “negative” health conclusions of this study, or see NBC News above do it for them.)

The studies, the “experts” say, are far from conclusive. The studies have yet to be peer-reviewed,  but some of the findings are scary enough to warrant public discussion (if only the public could be made to discuss its failing health, beyond being forced to buy “health” insurance).

Two previous papers on the studies noted that “studies published to date have not demonstrated consistently increased incidences of tumors at any site associated with exposure to cell phone RFR [radio frequency radiation] in rats or mice.”  But the researchers felt that “based on the designs of the existing studies, it is difficult to definitively conclude that these negative results clearly indicate that cell phone RFR is not carcinogenic.”

So because no clear conclusion can be drawn that proves cell phones cause cancer, we are told not to worry.  Clearly, we will need many dead of brain tumors in the exact same area of the head before we will see “the experts” venture to draw any conclusion regarding the safety of cell phones.

This study does, nonetheless, raise the instinctual fears many of us have that holding radiation-emitting devices to our heads that heat them and alter our natural frequencies may not be healthy.

Devil in the Details

The studies exposed mice and rats to both 900 MHz and 1900 Mhz wavelength radio waves (each frequency being its own experiment) for about 9 hours per day.  The mad scientists torturing the rodents varied the strengths from 1 to 10 watts per kilogram. For comparison, the general limit the FCC imposes for exposure is 0.08 W/kg.  The absolute maximum allowed, for the extremities of people with occupational exposures, is 20 W/kg for no longer than 6 minutes. So the poor mice were being pretty severely blasted, perhaps to get at the truth of radiation; or perhaps to later say that people are not so severely blasted, so nobody can use this experiment as any sort of relevant comparison to human exposure. (We report, you decide).

In addition, it is worth noting that a recent investigation of cell phones has found that most are emitting dangerously high levels of radiation far beyond what their makers say they emit and far beyond the FCC limits for radiation exposure. (See that Natural News story here.)

NTP senior scientist John Bucher explained away the findings in just that fashion in a news release that accompanied the papers.  “The levels and duration of exposure to RFR were much greater than what people experience with even the highest level of cell phone use, and exposed the rodents’ whole bodies,” said Mr. Bucher.  “So, these findings should not be directly extrapolated to human cell phone usage.”

Mouse Tumors Match People Tumors

But in the next breath, Mr. Bucher also showed some comparison could be made with humans. “We note, however,” said he, “that the tumors we saw in these studies are similar to tumors previously reported in some studies of frequent cell phone users.”

As with most of these studies which try to use rat results to duplicate the experiences of human beings, no definite conclusions can be drawn, and the researchers recommend further testing. That testing is ongoing, of course, in the millions of humans living with radiation-producing cell phones closely tethered to their bodies and brains.

Cell Cancer Lawsuit

Our law firm is investigating possible links between cell phone radiation and brain cancer.  Call us for a free legal consultation if you or someone you love has been diagnosed with brain cancer following heavy cell phone use.

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