12-02-2021  7:29 am   •   PDX and SEA Weather
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NORTHWEST NEWS

Sen. Manning on the Year Ahead and the Year That Was

Prominent BIPOC Caucus member concerned with gun regulation, access to Covid-19 testing

Dozens of Oregon Workers Fired for Not Getting COVID Shot

Officials in Oregon say at least 99 state workers have been fired for failing to get vaccinated against COVID-19.

Attorney General Rosenblum Says She Won’t Run for Governor

Attorney General Ellen Rosenblum on Monday put to rest rumors and officially said she will not enter Oregon’s crowded race for governor.

Portland’s Black Population Grew in the Last Decade, but That’s Not the Whole Story

The Black population in North and Northeast Portland declined by 13.5% over the last 10 years as more than 3,000 Black residents moved away, new numbers from the 2020 census show.

NEWS BRIEFS

Oregon's Cannabis Industry Could Be More Vulnerable Than Ever

Portland is the first in the country to allocate cannabis tax revenue to relieve the industry's impacts of...

Open Enrollment Deadline Is Dec. 15 for Health Insurance Coverage Starting Jan. 1, 2022

Help applying and financial assistance is available through the Oregon Health Insurance Marketplace ...

Commissioners From Three Counties Select Lawrence-Spence to Fill Senate District 18 Vacancy

District 18 includes portions of west Portland and Tigard. ...

Congressional Black Caucus Issues a Statement on the Passing of Former Congresswoman Carrie P. Meek

Meek, the first Black person to represent Florida in Congress since the post-Civil War Reconstruction, died Sunday, Nov. 28 at her...

Vsp Global Partners With Black EyeCare Perspective to Eliminate Inequities and Increase Representation of People of Color in the Eye Care Industry

Partnership includes scholarships, leadership development, and outreach to prospective optometrists ...

Yakama Nation approves school district use of Warrior image

YAKIMA, Wash. (AP) — Yakama Nation officials said this week they will allow a rural school district in central Washington to continue the use of the Wahluke Warrior image while a plan for respectful usage is developed. The Yakima Herald-Republic reports the Wahluke School...

Christmas tree buyers face reduced supplies, higher prices

ALAMEDA, Calif. (AP) — Even Christmas trees aren’t immune to the pandemic-induced shortages and inflation plaguing the economy. Extreme weather and supply chain disruptions have reduced supplies of both real and artificial trees this season. American shoppers should expect...

No. 25 Arkansas beats Missouri, caps best season since 2011

FAYETTEVILLE, Ark. (AP) — Sam Pittman grinned for almost the entirety of his postgame press conference Friday night. The Arkansas coach and his team had done something no others ever had. The No. 25 Razorbacks capped their regular season with a 34-17 victory over Missouri,...

Mizzou's Drinkwitz returning to Arkansas for rivalry game

FAYETTEVILLE, Ark. (AP) — Just 45 miles of interstate highway separate Eli Drinkwitz from where he started and where he is now as Missouri's head football coach. Raised in the small Arkansas town of Alma, Drinkwitz will come full circle Friday when his Tigers visit No. 25...

OPINION

State is Painting Lipstick on Its One-of-a-kind, Long-term-care Law

Starting in January, the unpopular law imposes a stiff new tax of 58 cents per 0 earned for every worker in the state ...

Giving Thanks

Just by being alive we can be sure of having moments of sadness as well as happiness. When you’re active in politics, you experience both wins and losses. Sometimes it can be hard to feel grateful. ...

Acting on Climate will Require an Emphasis on Environmental Justice

Climate change affects us all, but its effects aren’t distributed equally. ...

Small Businesses Cannot Survive With Current Level of Postal Service

At The Skanner News office we received an important piece of correspondence that was postmarked June 12, 2021, and delivered to us on November 4, 2021. ...

AFRICAN AMERICANS IN THE NEWS

Florida law school creates Ben Crump social justice center

A law school in South Florida will announce on Thursday the creation of a social justice center named after Ben Crump, the Black civil rights attorney who has gained national notoriety representing victims of police brutality and vigilante violence. The Benjamin L. Crump Center...

AP source: Notre Dame set to promote Freeman to head coach

Notre Dame is working on a deal to promote defensive coordinator Marcus Freeman to head coach to replace Brian Kelly, a person with knowledge of the situation told The Associated Press on Wednesday night. The person spoke on condition of anonymity because nothing had been...

Biden says HIV/AIDS strategy needs to confront inequity

WASHINGTON (AP) — President Joe Biden on Wednesday unveiled his new HIV/AIDS strategy to end the more than 40-year-old epidemic, calling for a renewed focus on vulnerable Americans — including gay and bisexual Black and Latino men, who his administration says are too often stigmatized even as...

ENTERTAINMENT

Baldwin to ABC about shooting: 'I didn't pull the trigger'

NEW YORK (AP) — Alec Baldwin told ABC's George Stephanopoulos in an interview airing Thursday that he did not pull the trigger on a prop gun he was holding on a New Mexico film set when it went off, killing a cinematographer. “I didn't pull the trigger,” Baldwin said. “I...

Dystopia, 'she-cession,' TikTok dances: We're over you, 2021

NEW YORK (AP) — The pandemic, politics, pervasive anxiety over the climate and the economy. Did 2021 leave us any time to ponder anything else? As we limp our way into a new year, there are a few more things we'd like to leave behind, from pop culture's obsession with all things apocalyptic to...

Smollett defense set to cross-examine star state witness

CHICAGO (AP) — Jussie Smollett’s legal team Thursday will seek to dent the credibility of a star state witness who the day before testified about how he said the former “Empire” actor recruited him and his brother to stage a racist, homophobic attack on Smollett. But...

U.S. & WORLD NEWS

Live updates: Company says drug seems effective with omicron

WASHINGTON — GlaxoSmithKline says its COVID-19 antibody drug appears to be effective against the omicron variant...

EXPLAINER: Why was Michigan suspect charged with terrorism?

LANSING, Mich. (AP) — Michigan prosecutors on Wednesday charged a teen with terrorism in a deadly mass shooting...

US warns Russia as Kremlin talks about war threat in Ukraine

MOSCOW (AP) — The Kremlin voiced concern Thursday about a possible escalation of fighting in a separatist...

AP PHOTOS: Drama festival puts spotlight on Romanian inmates

BUCHAREST, Romania (AP) — Performing on the main stage of the Nottara Theatre in downtown Bucharest is a dream...

Paris archbishop who had 'ambiguous' relationship resigns

PARIS (AP) — Pope Francis has accepted the resignation of the archbishop of Paris after he admitted to an...

US defense chief slams China's drive for hypersonic weapons

SEOUL, South Korea (AP) — America's defense chief rebuked China on Thursday, vowing to confront its potential...

Linda A. Johnson AP Business Writer

TRENTON, N.J. (AP) -- Federal inspectors say the contract manufacturer for Johnson & Johnson's cancer drug Doxil hasn't been maintaining equipment or promptly investigating defective product batches and other serious problems at its Bedford, Ohio, factory.

The latest Food and Drug Administration inspection report details lax quality control, failure to follow standard procedures and even lack of follow-up about a container of urine found in the Ben Venue Laboratories Inc. facility, which makes sterile medicines.

Doxil is one of a record 251 medications reported unavailable or in short supply in the U.S. this year, most of them injected drugs crucial for hospital operations. The crisis, blamed on at least 15 deaths, is disrupting patient care and clinical testing of new drugs being compared to or combined with older drugs in short supply.

Ben Venue is the sole supplier for Doxil, which has been in short supply since early summer and is no longer available for new patients.

First approved in 1995, Doxil is used to treat ovarian cancer, the bone cancer multiple myeloma and an HIV-related cancer called Kaposi's sarcoma. Currently, only 2,000 U.S. patients are getting it, and another 2,240 are on a waiting list, according to New Brunswick, N.J.-based J&J.

Ben Venue, part of German drugmaker Boehringer Ingelheim, said three weeks ago that it was temporarily halting manufacture and distribution of all products made at the Bedford plant. It cited an internal review indicating that routine preventive maintenance and tests to ensure manufacturing equipment is operating properly "did not occur at the specified time interval and is overdue."

Ben Venue spokesman Jason Kurtz said Thursday in an e-mailed response to The AP that the company is "working diligently to assess and implement the appropriate corrective actions to address the observations of the FDA investigators."

"Our highest priority is the delivery of safe and effective products to patients," he wrote. "We are continuing to work closely with the FDA with the goal of bringing the products we make back to patients as quickly as possible."

The inspection report posted this week on the FDA's website, covering visits to the factory from Nov. 7 through Dec. 2, details numerous deficiencies not promptly resolved or reported to plant managers. Some problems labeled as "critical" by the factory's quality unit were downgraded to "major" without justification, and the plant's vice presidents for operations and quality were unaware of them when the FDA inspectors asked about them.

The report notes:

-An investigation was opened on Sept. 19 on a 10-gallon can, found in a storage area, that contained a liquid that testing later indicated was urine. Follow-up was "past-due" at the time of the FDA inspectors' visits. Kurtz wrote Thursday that the container of liquid "consistent with urine" was reported to local police and the investigation remains open.

--Monitoring of air samples in manufacturing areas identified microbial contaminants, but Ben Venue did not identify their sources.

-The company doesn't have data showing its "manufacturing process consistently produces product meeting an acceptable level of sterility assurance."

-As of four weeks ago, there were "approximately 107 required preventive maintenance activities" at least 30 days past their scheduled due date.

-Quality-control staff lacked the training, technical expertise and oversight to perform their duties.

Johnson & Johnson spokeswoman Lisa Vaga said J&J does not know when Ben Venue will again be able to ship Doxil, but it has been working on finding additional suppliers since the summer and has found an alternate. The transition will require "an extended period," she said.

Ben Venue announced on Aug. 18 that it would be transitioning out of contract manufacturing over the next several years. That decision followed a May report by FDA inspectors at the same factory stating that, despite complaints dating back to August 2006, the company still had not identified the cause of metal particles contaminating two products that had been distributed. The names of the products were blacked out in the report.

Johnson & Johnson warned doctors on June 21 that it anticipated a shortage of Doxil, which has no generic alternatives. In August, it started a rationing system to allocate Doxil as supplies became available to patients who had started treatment.

As the drug shortages have mounted, President Obama on Oct. 31 ordered the FDA to take several steps to resolve and prevent shortages. The FDA and several members of Congress have been holding hearings since September to identify reasons for and possible solutions to the shortages.

The causes include manufacturing deficiencies leading to production shutdowns, companies ending production of some drugs with tiny profit margins, consolidation in the generic drug industry and limited supplies of some ingredients.

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