02-05-2023  4:53 pm   •   PDX and SEA Weather
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NORTHWEST NEWS

Portland Cop Fired for Leaking False Allegations Against City Commissioner Reinstated

Mayor Ted Wheeler fired Brian Hunzeker after he leaked a false complaint saying city Commissioner Jo Ann Hardesty had been involved in a hit-and-run crash.

Hundreds of Portland City Workers on Strike for Better Pay

Workers represented by the union Laborers’ Local 483 have been without a contract since June. Negotiations over a new four-year deal broke down in December

Washington State Gov. Inslee Tests Positive for COVID-19

He plans to continue working. Trudi Inslee, the first spouse, has tested negative.

Oregon BIPOC Caucus Calls for Action to Support Victims of Gun Violence

The Legislative Black, Indigenous, People of Color (BIPOC) Caucus has released the following statement in response to the tragedy at Half Moon Bay, CA that left seven dead and one person wounded, all of whom were people of color

NEWS BRIEFS

Market Features Work of Local Black-Owned Businesses for Black History Month

MESO Makers Market in Portland to feature the work of 40 local, Black-owned small businesses to celebrate Black History Month in...

The Seattle Public Library's Homework Help Program Expands to Eight Locations and Increases Hours

Homework Help, The Seattle Public Library’s free after school tutoring service, will add two locations and increase hours in...

County Seeks Community Needs Survey Responses From Residents

Clark County Community Services is asking residents who are low-income to complete a survey to help determine what resources and...

"Meet Me at Higo" Opens in the Level 8 Gallery of The Seattle Public Library's Central Library

The traveling exhibit from the Wing Luke Museum tells a fascinating community and family history about Seattle’s Japantown ...

NAACP Portland Calls for Justice With Community Prayer Vigil

Community leaders will hold a prayer vigil Tuesday, Jan. 31 at noon, to reflect on the tragic brutality that led to the death of Tyre...

US states take control of abortion debate with funding focus

LAWRENCE, Kan. (AP) — Though the Insight Women’s Center sits at the epicenter of a reinvigorated battle in the nation’s culture wars, the only hint of its faith-based mission to dissuade people from getting abortions is the jazzy, piano rendition of “Jesus Loves Me” playing in a waiting...

Arrest made in stolen yacht rescue, 'Goonies' fish incident

SEATTLE (AP) — A stolen yacht. A dramatic Coast Guard rescue. A dead fish. And the famed home featured in the classic 1985 film “The Goonies.” Combined, Oregon police called it a series of “really odd” events along the Pacific Northwest coast spanning 48 hours that concluded...

Jones scores 18, Southern Illinois tops Missouri State 73-53

CARBONDALE, Ill. (AP) — Lance Jones' 18 points helped Southern Illinois defeat Missouri State 73-53 on Sunday. Jones also added four steals for the Salukis (18-7, 10-4 Missouri Valley Conference). Troy D'Amico shot 5 of 6 from the field and 4 for 4 from the line to add 15 points....

DeVries and Drake earn 85-82 2OT win over Valparaiso

VALPARAISO, Ind. (AP) — Tucker DeVries scored a career-high 32 points and grabbed 11 rebounds and Drake beat Valparaiso 85-82 in double overtime on Saturday night. Roman Penn scored 16 points and added 12 rebounds and six assists for the Bulldogs (19-6, 10-4 Missouri Valley...

OPINION

Updates That May Affect Your Tax Season

The IRS released a statement that taxpayers should brace themselves for small tax refunds due to no economic impact payments ...

Unaffordable Rental Costs Now Plague 44 Million People in Every State Economic Inequality Places Most Risk of Eviction on Blacks and the Poor

For the first time in more than two decades of research, every state now has renters who are nearing a financial breaking point in housing affordability. ...

The Beating and Murder of Mr. Tyre Nichols, A Black Man

Time to Abolish the Criminal Injustice System ...

It's Time to Irrigate the Fallow Ground of Minority Media Ownership

In 2023, one aspect of civil rights and racial justice that barely remains addressed is racial inclusion in media ownership. ...

AFRICAN AMERICANS IN THE NEWS

DeSantis eyes 2024 from afar as GOP rivals move toward runs

DES MOINES, Iowa (AP) — Florida Gov. Ron DeSantis may be months away from publicly declaring his presidential intentions, but his potential rivals aren't holding back. No fewer than a half dozen Republicans eyeing the White House have begun actively courting top political operatives...

At Nichols' funeral, Black America's grief on public display

MEMPHIS, Tenn. (AP) — The sound of the djembe drums started as a low tremble and grew more distinct as the musicians drew closer to the hundreds gathered inside the Memphis church. “We love you, Tyre,” the drummers chanted, referring to Tyre Nichols, a 29-year-old Black man...

Arkansas Gov. Sanders to give GOP response to Biden address

WASHINGTON (AP) — Arkansas Gov. Sarah Huckabee Sanders will deliver the Republican address to the nation in response to President Joe Biden's State of the Union speech next week as the GOP seeks to show it's creating a new generation of leaders. House Speaker Kevin McCarthy and...

ENTERTAINMENT

Boyhood collides with masculinity in Oscar-nominated 'Close'

NEW YORK (AP) — When Lukas Dhont was 12, a camera was thrust into his hands. For Dhont, who would come out as gay as a young adult, the camera was an escape from the strains and stereotypes he was beginning to feel pushed on him. “I needed this other reality in which I could...

Why is R&B music more explicit than ever? It’s complicated.

NEW YORK (AP) — Tank was nervous after sending his manager a preview of “When We” — he’d never released a song that explicit. “He’s like, ‘You’re crazy, but it’s jammin'!’” the R&B singer recalled. “It ended up being my biggest record ever.” Released in...

Gordy, Robinson honored at reunion of Motown stars

LOS ANGELES (AP) — The Temptations, the Isley Brothers and the Four Tops turned back time, singing and dancing as if in their prime at a reunion of Motown stars. The occasion was to honor Motown Records founder Berry Gordy and singer-songwriter Smokey Robinson for their musical...

U.S. & WORLD NEWS

Biden's State of the Union to tout policy wins on economy

WASHINGTON (AP) — President Joe Biden will use his second State of the Union address on Tuesday to remind...

Northeast temperatures soar a day after bone-numbing cold

Temperatures in many areas of the Northeast U.S. climbed to the mid-40s Fahrenheit on Sunday, a day after the...

AP source: Kyrie Irving going to the Dallas Mavericks

DALLAS (AP) — Kyrie Irving is getting his wish. He’s getting traded. And Luka Doncic is getting...

How will EU ban and West's price cap on Russian diesel work?

FRANKFURT, Germany (AP) — The European Union is taking another big step toward cutting its energy ties with...

Former Israeli PM: Putin promised not to kill Zelenskyy

TEL AVIV, Israel (AP) — A former Israeli prime minister who served briefly as a mediator at the start of...

Chile wildfires spread amid heat wave as death toll rises

SANTIAGO, Chile (AP) — Chile extended an emergency declaration to yet another region on Saturday as firefighters...

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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MLK Breakfast 2023

Photos from The Skanner Foundation's 37th Annual Martin Luther King, Jr. Breakfast.