Hope you had a great weekend. This is from Saturday night, Isaiah's THE WORLD TODAY JUST NUTS "THE PEW stinks"
Ms. Wersching’s publicist told the AP that Wersching died of cancer early Sunday in Los Angeles. It was not immediately clear what type of cancer she had. Deadline reported that cancer was diagnosed in 2020.
Ms. Wersching’s husband, Stephen Full, confirmed her death in a statement to Deadline. “There is a cavernous hole in the soul of this family today,” he said. “But she left us the tools to fill it. She found wonder in the simplest moment. She didn’t require music to dance. She taught us not to wait for adventure to find you. ‘Go find it. It’s everywhere.’ And find it we shall.”
Tributes to Ms. Wersching flooded social media late Sunday. “We just lost a beautiful artist and human being. My heart is shattered,” tweeted Neil Druckmann, the creator of “The Last of Us” and co-president of the video game developer Naughty Dog.
Illegal marketing of gabapentin for off-label uses
In 1993, the Food and Drug Administration (FDA) approved gabapentin only for treatment of seizures. Warner–Lambert, which merged with Pfizer in 2000, used continuing medical education and medical research, sponsored articles about the drug for the medical literature, and alleged suppression of unfavorable study results, to promote gabapentin. Within five years, the drug was being widely used for off-label uses such as treatment of pain and psychiatric conditions. Warner–Lambert admitted to violating FDA regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses. In 2004, the company paid $430 million in one of the largest settlements to resolve criminal and civil health care liability charges. It was the first off-label promotion case successfully brought under the False Claims Act. A Cochrane review concluded that gabapentin is ineffective in migraine prophylaxis. The American Academy of Neurology rates it as having unproven efficacy, while the Canadian Headache Society and the European Federation of Neurological Societies rate its use as being supported by moderate and low-quality evidence.
Illegal marketing of Bextra
In September 2009, Pfizer pleaded guilty to the illegal marketing of arthritis drug valdecoxib (Bextra) and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. Pfizer promoted the sale of the drug for several uses and dosages that the Food and Drug Administration specifically declined to approve due to safety concerns. The drug was pulled from the market in 2005. It was Pfizer's fourth such settlement in a decade. The payment included $1.195 billion in criminal penalties for felony violations of the Federal Food, Drug, and Cosmetic Act, and $1.0 billion to settle allegations it had illegally promoted the drugs for uses that were not approved by the Food and Drug Administration (FDA) leading to violations under the False Claims Act as reimbursements were requested from Federal and State programs. The criminal fine was the largest ever assessed in the United States to date. Pfizer entered a corporate integrity agreement with the Office of Inspector General that required it to make substantial structural reforms within the company, and publish to its website its post approval commitments and a searchable database of all payments to physicians made by the company.
Termination of Peter Rost
Peter Rost was vice president in charge of the endocrinology division at Pharmacia before its acquisition by Pfizer. During that time he raised concerns internally about kickbacks and off-label marketing of Genotropin, Pharmacia's human growth hormone drug. Pfizer reported the Pharmacia marketing practices to the FDA and Department of Justice; Rost was unaware of this and filed an FCA lawsuit against Pfizer. Pfizer kept him employed, but isolated him until the FCA suit was unsealed in 2005. The Justice Department declined to intervene, and Pfizer fired him, and he filed a wrongful termination suit against Pfizer. Pfizer won a summary dismissal of the case, with the court ruling that the evidence showed Pfizer had decided to fire Rost prior to learning of his whistleblower activities.
Illegal marketing of Rapamune
A "whistleblower suit" was filed in 2005 against Wyeth, which was acquired by Pfizer in 2009, alleging that the company illegally marketed sirolimus (Rapamune) for off-label uses, targeted specific doctors and medical facilities to increase sales of Rapamune, tried to get transplant patients to change from their transplant drugs to Rapamune, and specifically targeted African-Americans. According to the whistleblowers, Wyeth also provided doctors and hospitals that prescribed the drug with kickbacks such as grants, donations, and other money. In 2013, the company pleaded guilty to criminal mis-branding violations under the Federal Food, Drug, and Cosmetic Act. By August 2014, it had paid $491 million in civil and criminal penalties related to Rapamune.
In June 2010, health insurance network Blue Cross Blue Shield (BCBS) filed a lawsuit against Pfizer for allegedly illegally marketing drugs Bextra, Geodon and Lyrica. BCBS alleged that Pfizer used kickbacks and wrongly persuaded doctors to prescribe the drugs. According to the lawsuit, Pfizer handed out 'misleading' materials on off-label uses, sent over 5,000 doctors on trips to the Caribbean or around the United States, and paid them $2,000 honoraria in return for listening to lectures about Bextra. Despite Pfizer's claims that "the company's intent was pure" in fostering a legal exchange of information among doctors, an internal marketing plan revealed that Pfizer intended to train physicians "to serve as public relations spokespeople." The case was settled in 2014 for $325 million. Fearing that Pfizer is "too big to fail" and that prosecuting the company would result in disruptions to Medicare and Medicaid, federal prosecutors instead charged a subsidiary of a subsidiary of a subsidiary of Pfizer, which is "nothing more than a shell company whose only function is to plead guilty."
Removal of ads after unflattering article
According to Harper's Magazine publisher John R. MacArthur, Pfizer withdrew "between $400,000 and a million dollars" worth of ads from Harper's Magazine following an unflattering article on depression medication.
Quigley Company asbestos
The Quigley Company, which sold asbestos-containing insulation products until the early 1970s, was acquired by Pfizer in 1968. In June 2013, asbestos victims and Pfizer negotiated a settlement that required Pfizer to pay a total of $964 million: $430 million to 80% of existing plaintiffs and place an additional $535 million into a settlement trust that will compensate future plaintiffs as well as the remaining 20% of plaintiffs with claims against Pfizer and Quigley. Of that $535 million, $405 million is in a 40-year note from Pfizer, while $100 million is from insurance policies.
Shiley defective heart valves
Pfizer purchased Shiley in 1979, at the onset of its Convexo-Concave valve ordeal, involving the Bjork–Shiley valve. Approximately 500 people died when defective heart valves fractured and, in 1994, Pfizer agreed to pay $10.75 million to settle claims by the United States Department of Justice that the company lied to get approval for the valves.
Firing of employee that filed suit
A federal lawsuit was filed by a scientist claiming she got an infection by a genetically modified lentivirus while working for Pfizer, resulting in intermittent paralysis. A judge dismissed the case citing a lack of evidence that the illness was caused by the virus but the jury ruled that by firing the employee, Pfizer violated laws protecting freedom of speech and whistleblowers and awarded her $1.37 million.
Celebrex intellectual property
Brigham Young University (BYU) said a professor of chemistry, Dr. Daniel L. Simmons, discovered an enzyme in the 1990s that led towards development of Celebrex. BYU was originally seeking a 15% royalty on sales, equating to $9.7 billion. A research agreement had been made between BYU and Monsanto, whose pharmaceutical business was later acquired by Pfizer, to develop a better aspirin. The enzyme Dr. Simmons claims to have discovered would induce pain and inflammation while causing gastrointestinal problems and Celebrex is used to reduce those issues. A six-year battle ensued because BYU claimed that Pfizer did not give Dr. Simmons credit or compensation, while Pfizer claimed that it had met all obligations regarding the Monsanto agreement. In May 2012, Pfizer settled the allegations, agreeing to pay $450 million.
Nigeria Trovafloxacin lawsuit
In 1996, an outbreak of measles, cholera, and bacterial meningitis occurred in Nigeria. Pfizer representatives and personnel from a contract research organization (CRO) traveled to Kano to set up a clinical trial and administer an experimental antibiotic, trovafloxacin, to approximately 200 children. Local Kano officials reported that more than fifty children died in the experiment, while many others developed mental and physical deformities. The nature and frequency of both fatalities and other adverse outcomes were similar to those historically found among pediatric patients treated for meningitis in sub-Saharan Africa. In 2001, families of the children, as well as the governments of Kano and Nigeria, filed lawsuits regarding the treatment. According to Democracy Now!, "[r]esearchers did not obtain signed consent forms, and medical personnel said Pfizer did not tell parents their children were getting the experimental drug." The lawsuits also accused Pfizer of using the outbreak to perform unapproved human testing, as well as allegedly under-dosing a control group being treated with traditional antibiotics in order to skew the results of the trial in favor of Trovan. Nigerian medical personnel as well as at least one Pfizer physician said the trial was conducted without regulatory approval.
In 2007, Pfizer published a Statement of Defense letter. The letter stated that the drug's oral form was safer and easier to administer, that Trovan had been used safely in more than five thousand Americans prior to the Nigerian trial, that mortality in the patients treated by Pfizer was lower than that observed historically in African meningitis epidemics, and that no unusual side effects, unrelated to meningitis, were observed after four weeks.
In June 2010, the US Supreme Court rejected Pfizer's appeal against a ruling allowing lawsuits by the Nigerian families to proceed.
In December 2010, a United States diplomatic cables leak was released by WikiLeaks indicating that Pfizer hired investigators to find evidence of corruption against Nigerian attorney general Aondoakaa to persuade him to drop legal action. The Washington Post reporter Joe Stephens, who helped break the story in 2000, called these actions "dangerously close to blackmail". In response, the company released a press statement describing the allegations as "preposterous" and saying that it acted in good faith. Aondoakka, who had allegedly demanded bribes from Pfizer in return for a settlement of the case, was declared unfit for office and had his U.S. visa revoked in association with corruption charges in 2010.
The lawsuits were eventually settled out of court. Pfizer committed to paying US$35 million "to compensate the families of children in the study", another US$30 million to "support healthcare initiatives in Kano", and 10 million to cover legal costs. Payouts began in 2011.
In July 2022, UK antitrust authorities fined Pfizer £63 million for unfairly high priced drug that aids in controlling epileptic seizures. The Competition and Markets Authority stated that the company took advantage of loopholes by de-branding epilepsy drug Epanutin, by doing so the price of Epanutin's price was not regulated to the same standards the company are used to and therefore the price of the drug was raised. It was stated that over a four-year period, Pfizer had billed Epanutin for around 780% and 1,600% higher than its standard price.
Allegations of patent infringement on mRNA technology
In August 2022, Moderna announced that it will sue Pfizer and its partner BioNTech for infringing their patent on the mRNA technology.
Since 2000, the company has implemented more than 4,000 greenhouse gas reduction projects.
In 2012, the company was named to the Carbon Disclosure Project's Carbon Leadership Index in recognition of its efforts to reduce greenhouse gas emissions.
Pfizer has inherited Wyeth's liabilities in the American Cyanamid site in Bridgewater Township, New Jersey, a highly toxic EPA Superfund site. Pfizer has since attempted to remediate this land in order to clean and develop it for future profits and potential public uses. The Sierra Club and the Edison Wetlands Association have opposed the cleanup plan, arguing that the area is subject to flooding, which could cause pollutants to leach. The EPA considers the plan the most reasonable from considerations of safety and cost-effectiveness, arguing that an alternative plan involving trucking contaminated soil off site could expose cleanup workers. The EPA's position is backed by the environmental watchdog group CRISIS.
In June 2002, a chemical explosion at the Groton plant injured 7 people and caused the evacuation of more than 100 homes in the surrounding area.
Here's C.I.'s "Iraq snapshot:"
Monday, January 30, 2023.
History is the life that has been lived and information is not static, we learn new things about the past all the time. Starting with news of discoveries in Iraq, Michele W. Berger (PENN TODAY) reports:
When Holly Pittman and colleagues from the University of Pennsylvania and University of Pisa returned to Lagash in the fall of 2022 for a fourth season, they knew they’d find more than ceramic fragments and another kiln. With high-tech tools in hand, the team precisely located trenches to excavate a variety of features of a non-elite urban neighborhood from one of southwest Asia’s earliest cities.
What surprised the researchers most was the large “tavern” they uncovered, complete with benches, a type of clay refrigerator called a “zeer,” an oven, and the remains of storage vessels, many of which still contained food. “It’s a public eating space dating to somewhere around 2700 BCE,” says Pittman, a professor in Penn’s History of Art department, curator of the Penn Museum’s Near East Section, and the Lagash project director. “It’s partially open air, partially kitchen area.”
The find provides another glimpse into the lives of everyday people who dwelled some 5,000 years ago in this part of the world, an area Penn researchers have studied since the 1930s when the Penn Museum teamed up with Leonard Woolley and the British Museum to excavate the important archaeological site of Ur about 30 miles to the southwest. In 2019, the latest round of Lagash excavations began, and despite a short pandemic-necessitated pause, the project has real momentum, with four field seasons now complete.
To excavate most effectively, the researchers are employing cutting-edge methodologies, including drone photography and thermal imaging; magnetometry, which captures the magnetic intensity of buried features; and micro-stratigraphic sampling, a surgically precise type of excavation. To understand the city’s environmental context, they’ve also extracted sediment cores that reflect millennia of ecological development.
“At more than 450 hectares, Lagash was one of the largest sites in southern Iraq during the 3rd millennium,” Pittman says. “The site was of major political, economic, and religious importance. However, we also think that Lagash was a significant population center that had ready access to fertile land and people dedicated to intensive craft production. In that way the city might have been something like Trenton, as in ‘Trenton makes, the world takes,’ a capital city but also an important industrial one.”
The past expands our knowledge of the present -- unless you're an anti-LGBTQ+ lawmaker in Florida -- and helps us appreciate accomplishments of those who came before. Of the latest discovery, Mihai Andrei (ZME SCIENCE) adds:
Some 5,000 years ago, the city of Lagash was one of the best places you could be in the world. Close to the junction between the Tigris and the Euphrates, it evolved and developed in an area we now consider a cradle of civilization. But many of its mysteries are now covered by the shroud of time. Holly Pittman from the University of Pennsylvania is one of the researchers working to uncover that shroud.
Lagash is one of the largest archaeological sites in the region, measuring roughly 3.5 kilometers north to south and 1.5 kilometers east to west. Previous surveys found that Lagash was a bit like Venice — it developed on four marsh islands, some of which were gated. Subsequent archaeological digs have resulted in the discovery of urban neighborhoods, tens of thousands of pottery sherds, and much more.
[. . .]
But perhaps the most intriguing find was a large “tavern”. The building featured benches, an oven, and a type of clay refrigerator called a “zeer.” The zeer used an external clay layer lined with wet sand that contained an inner clay container within which the food or drinks were placed. The evaporation of the outer liquid draws heat from the inner pot and keeps the container cool while only requiring a source of water.
According to a 2022 article in Ancient Origins , the city of Lagash, known today as Tell al-Hiba, was located in ancient Mesopotamia, and is believed to have been established between 4,900 and 4,600 years ago and abandoned 3,600 years ago. This makes it one of southwest Asia’s earliest cities.
It has now been more than 40 years since excavations started in Lagash, a city of marsh islands . The latest round of excavations began in 2019, and despite pandemic-induced interruptions, has completed four intense seasons.
In other news, the PRESS TRUST of INDIA notes:
The dreaded terror outfit Islamic State of Iraq and Levant in South-East Asia (ISIL-SEA) has been designated as a global terrorist organisation by the United Nations Security Council.
The Security Council's 1267 Islamic State in Iraq and the Levant and Al-Qaida Sanctions Committee added the Islamic State in Iraq and the Levant in South-East Asia to its list of designated entities last week, subjecting it to assets freeze, travel ban and arms embargo.
The outfit, also known as Islamic State East Asia Division and Dawlatul Islamiyah Waliyatul Mashriq, was, according to the UN website, formed in June 2016 “upon announcement by now-deceased Isnilon Hapilon” and is associated with Islamic State in Iraq and Levant, listed as Al-Qaida in Iraq. Hapilon was the leader of Abu Sayyaf, a group affiliated with ISIL, and was killed in 2017.
I guess we could have led into that topic by saying, "Staying with ancient history . . ." Seven years? It took seven years for them to make that designation? Amr Salem (IRAQI NEWS) notes that the UN has a new post in Iraq:
The United Nations Under-Secretary-General for Political and Peacebuilding Affairs, Rosemary DiCarlo, said that the Secretary-General of the United Nations decided to create a new position in Iraq, which is the advisor on climate change and security, the Iraqi News Agency (INA) reported.
The announcement of the new decision took place after the Iraqi President, Abdul Latif Rashid, received DiCarlo, in Baghdad, in the presence of the Special Representative of the Secretary-General of the United Nations in Iraq, Jeanine Hennis-Plasschaert, according to a press statement issued by the Iraqi Presidency.
DiCarlo stressed that the United Nations is keen to help Iraq face the challenges of climate change, and emphasized the United Nations readiness to cooperate to reduce the risks of drought and water scarcity.
As climate change damages Iraq, Gaith Abdul-Ahad (GUARDIAN) reports:
Small gangs of buffaloes sat submerged in green and muddy waters. Their back ridges rose over the surface like a chain of black islets, spanning the Toos River, a tributary of the Tigris that flows into the Huwaiza marshes in southern Iraq.
With their melancholic eyes, they gazed with defiance at an approaching boat, refusing to budge. Only when the boatman shrieked “heyy, heyy, heyy” did one or two reluctantly raise their haunches. Towering over the boat, they moved a few steps away, giving the boatmen barely enough space to steer between a cluster of large, curved horns.
On the right bank of the river stood a cultural centre built in the traditional style of southern Iraq, with tall arches made of thick bundles of reed tied together. It catered to a large number of Iraqi tourists and a handful of foreigners who have flocked to visit the marshland region since it was named a Unesco world heritage site in 2016.
A couple of hundred metres past the cultural centre, however, the engine of the boat sputtered, and its bottom scrapped against the mud as the river dwindled into a shallow swamp, where small herons and grebes stood in water barely reaching halfway up their stick-like legs.
The foliage on the two banks also disappeared, revealing a devastating scene: what two years earlier was a great expanse of blue water, a lagoon teeming with wildlife, fish, and home to large herds of water buffaloes, had turned into a flat desert where a few thorny shrubs sprouted.
Under the scorching sun, the hot wind kicked tumbleweed across parched yellow earth, scarred with deep cracks and crumbling into thin dust under the feet. Rising above the ground were mounds of dead reed beds upon which the marsh dwellers had built their homes. A few relics of their former life lay scattered around: broken plastic buckets, some rusting metal pipe, and a kettle.
The Iraqi government is still refusing to seriously address climate change -- even as the impact is evident. Instead, they spend their time with nonsense like taking offense at criticism. For example, the Iraqi courts have always concerned themselves with the actions of others -- even when it meant violating the law. They're now violating the Constitution. RUDAW reports:
A court in Baghdad on Sunday issued a summons order for the second
deputy speaker of the Iraqi parliament, Shakhawan Abdullah, following a
statement he made criticizing the decision from Iraq’s top court to not
pay the Kurdistan Region’s financial entitlements.
The Iraqi Federal Supreme Court on Wednesday ruled against the payment of the Kurdistan Region’s financial entitlements by Baghdad, claiming it violates the 2021 Iraqi Budget Law.
The decision was criticized by top Kurdish officials, including Abdullah, who accused “a party within the Running the State coalition” of directing the Federal Court to issue the recent decision against the Kurdistan Region, ordering the court to deem the Region’s oil and gas law “unconstitutional” last year, and being responsible for the fluctuation of the Iraqi dinar’s exchange rate with foreign currencies in recent months.
“Rest assured that there will be an end to the overstepping by the Federal Court,” said Abdullah in his statement.
The Iraqi Federal Supreme Court on Sunday said that Abdullah was being summoned for his “infringement of the judiciary authority’s independence, and his interference in the work of the Federal Supreme Court, his transgression of it, and the violation of the sanctity of its decisions contrary to the constitution and the law.”
Oh, they don't like what a member of Parliament said about them. Boo hoo. They might try referring to the Iraqi Constitution, maybe start with Section 2, Article 36: "The state guarnees in a way that does not violate public order and morality: a) Freedom of expression, through all means. b) Freedom of press, printing advertising, media and publication. c) Freedom of assembly and peaceful demonstration. This shall be regulated by law." They could also check out Section Two of Article 38 as well.
They're in violation.
Iraq’s Prime Minister Mohammed Shia’ al-Sudani on Sunday appointed Nima
al-Yasiri as his advisor on constitutional affairs, in a step towards
amending constitutional articles that hindered the formation of a new
government in the country for over a year.
The newly appointed advisor will hold meetings with executive and legislative officials, in order to “chart the roadmap for making the required constitutional amendments,” according to a statement from Sudani’s office.
The statement from the premier added that the step is part of the new government’s ministerial program which was approved by the Iraqi parliament in October, in an effort to prevent the recurrence of political deadlocks, similar to the one that plagued the country following the 2021 parliamentary elections.
I don't understand. Why go to all the trouble? Why not just ignore the Constitution the way the Court does?
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