02-07-2023  12:16 am   •   PDX and SEA Weather
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NORTHWEST NEWS

Arrest Made in Stolen Yacht Rescue, 'Goonies' Fish Incident

Oregon police called it a series of “really odd” events along the Pacific Northwest coast spanning 48 hours that concluded Friday night with the arrest of a Canadian man.

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.

NEWS BRIEFS

Allen Temple C.M.E. Church Announces Annual Unsung Heroes & Heroines Award Luncheon

The purpose of the award is to acknowledge and honor individuals and/or organizations who are unsung heroes/heroines who make a...

Bonamici Invites Portland Community College President to 2023 State of the Union

PCC recently received 0K to advance semiconductor, advanced manufacturing training ...

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...

1 missing, 2 rescued from crab boat off Washington coast

RAYMOND, Wash. (AP) — A crew member remains missing and two others were rescued from crab boat that sank near Willapa Bay in southwest Washington on Sunday evening, according to the Coast Guard. The Coast Guard on Twitter posted a video and said a helicopter crew from Astoria,...

Proposed bill would pay incarcerated workers minimum wage

OLYMPIA, Wash. (AP) — A Washington state lawmaker who has spent time in prison wants the state to pay incarcerated workers minimum wage for doing their jobs. State Rep. Tarra Simmons, D-Bremerton, is sponsoring House Bill 1024, called the “Real Labor, Real Wages Act,” to raise...

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

Arkansas Gov. Sanders to offer State of the Union rebuttal

LITTLE ROCK, Ark. (AP) — Arkansas Gov. Sarah Huckabee Sanders, once a White House press secretary for President Donald Trump, is set to return to the national stage when she delivers the GOP response to President Joe Biden’s State of the Union address. Sanders, 40, is giving the...

State of the Union? Congress doesn't fully reflect diversity

WASHINGTON (AP) — When lawmakers gather for President Joe Biden's State of the Union address, the Republican side of the aisle will look slightly different than it did a few years ago. Rather than row after row of white men in suits, the House Republican majority increasingly has...

Missouri governor denies clemency for man facing execution

ST. LOUIS (AP) — Missouri Gov. Mike Parson said Monday he will not grant clemency and halt the execution of Raheem Taylor, who faces lethal injection for the deaths of his girlfriend and her three children. Taylor, 58, is scheduled to be put to death Tuesday evening at the state...

ENTERTAINMENT

List of Grammy winners in top categories

LOS ANGELES (AP) — Winners Sunday in the top categories at the 65th Grammy Awards: — Album of the year: “Harry’s House,” Harry Styles — Record of the year: “About Damn Time,” Lizzo — Song of the year (songwriter’s award): “Just Like...

Viola Davis' Grammy win for audiobook makes her an EGOT

LOS ANGELES (AP) — Viola Davis has achieved EGOT status. The actor won a Grammy Award Sunday for best audio book, narration, and storytelling recording for her memoir “Finding Me.” “I just EGOT!” she shouted from the stage as she accepted the trophy, using the...

Grammys 2023 live updates: Latest news from red carpet, show

LOS ANGELES (AP) — Follow along for real-time, on-the-carpet and behind-the-scenes updates on the 2023 Grammy Awards from The Associated Press. Live updates — any times Pacific — are brought to you by AP journalists at the show in Los Angeles and around the country. ___ ...

U.S. & WORLD NEWS

The Grammys ended in controversy, again. Here’s what to know

NEW YORK (AP) — A night in music brimming with shocking upsets, historic wins, tributes for artists like the...

What to Watch: New political vibes this State of the Union

WASHINGTON (AP) — Look for new faces and fresh political dynamics as President Joe Biden delivers this year's...

Lucky player in Washington wins 7 million Powerball prize

DES MOINES, Iowa (AP) — Someone in Washington state overcame steep odds Monday night to win an estimated 7...

EU Parliament planning for possible Zelenksyy visit in days

BRUSSELS (AP) — The European Union's legislature was preparing plans Monday to host Volodymyr Zelenskyy should...

India's aircraft carriers key to Indo-Pacific strategy

NEW DELHI (AP) — India is preparing to relaunch its INS Vikramaditya aircraft carrier after a major refit, a...

Hong Kong transgender men win appeal over status change

HONG KONG (AP) — Hong Kong’s top court ruled Monday that full sex reassignment surgery should not be a...

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.