08-11-2022  10:19 pm   •   PDX and SEA Weather
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NORTHWEST NEWS

Lottery Misses Mark on Minorities’ Fair Share

The Oregon Lottery’s most recent advertising slogan is “Together, we do good things”. But when we look at where the profits are coming from and where any potential benefit from lottery profits flow to, is this really true? 

Court Sides With Governor Kate Brown Over Early Prison Releases

Two attorneys took particular issue with Brown’s decision to allow 73 people convicted of murder, assault, rape and manslaughter while they were younger than 18 to apply for early release.

Ballot Measure to Overhaul City Government Promises Minority Representation While Facing Controversy

The Portland Charter Commission aims to bring city in line with how other major U.S. cities do local governance. 

White Woman Calls Police on Black Man Standing at His Home

“If you guys have a lease, I’d just like to see the lease,”

NEWS BRIEFS

Jefferson Alumni Invites Community to Block Party

This inaugural event is open to the public and will have tons of entertainment in tow, including a live DJ and music, a rib contest,...

Oregon Approved to Issue an Additional $46 Million in Pandemic EBT Food Assistance to 80,000 Young Children

The additional food benefits will be issued to families’ existing EBT cards in Fall 2022, with the exact dates yet to be...

Free Vaccination Events Provide Required Back-to-School Immunizations

On or before the first day of instruction, all K-12 students in Washington state must be up to date on vaccinations required for...

Merkley, Colleagues Continue Push for Robust Federal Response to Monkeypox Public Health Emergency

“As the country continues to navigate the [monkeypox public health emergency], the United States public health system remains on the...

Washington Ferries to Get $38 Million to Improve Services

Out of the 35 states and three territories receiving federal money for ferries, Washington will get the biggest allocation ...

Cops: Oregon crime ring moved M in catalytic converters

PORTLAND, Ore. (AP) — Police in suburban Portland, Oregon, said Thursday they arrested a crime ring leader responsible for trafficking more than 44,000 catalytic converters stolen from vehicles on the West Coast since 2021. Detectives said they identified Brennan Doyle, 32, as the...

Seattle hospital to refuse some patients due to capacity

SEATTLE (AP) — Harborview Medical Center in Seattle will temporarily stop accepting less acute patients and will divert them to other health care systems as capacity challenges worsen, according to the hospital’s CEO. “All hospital systems (are) very much over capacity with very...

OPINION

No One Ever Told You About Black August?

Black America lives in a series of deserts. Many of us live in food deserts, financial deserts, employment deserts, and most of us live in information deserts. ...

Betsy Johnson Fails to Condemn Confederate Flags at Her Rally

The majority of Oregonians, including our rural communities, value inclusion and unity, not racism and bigotry. ...

Monkeypox, Covid, and Your Vote

We must start a voter registration drive right here where we live. This effort must become as important to us as putting food on the table and a roof over our heads. ...

Speaking of Reparations

To many Americans, “reparations” is a dirty word when applied to Black folks. ...

AFRICAN AMERICANS IN THE NEWS

Cuomo: Taxpayers should pay sexual harassment legal bills

NEW YORK (AP) — Former New York Gov. Andrew Cuomo wants taxpayers to foot his legal bills as he defends himself against a workplace sexual harassment claim — and he's suing the state's attorney general over it. Cuomo filed the suit against Attorney General Letitia James on...

Judge sends Wisconsin man to institution in hate crime crash

FOND DU LAC, Wis. (AP) — A Wisconsin judge committed a man accused of targeting a motorcyclist in a fatal crash because of the victim's race to life in a mental institution Thursday. Daniel Navarro, a 27-year-old Mexican American from Fond du Lac, was convicted Wednesday of...

ReAwaken Tour host says he feels harassed by NY prosecutor

BATAVIA, N.Y. (AP) — A Christian pastor in western New York said he felt intimidated and harassed after the state's attorney general, a Democrat, sent a letter saying she believed a planned far-right political event at his church this week could lead to racial violence. In the...

ENTERTAINMENT

Mary Gauthier uses songwriting to help people through trauma

NEW YORK (AP) — Having used songwriting to navigate her own trauma, Mary Gauthier is putting those skills to work helping others do the same. The Nashville-based musician has collaborated with war veterans to write about what they've been through, even producing a disc of the music,...

Novel inspired by Shirley Jackson classic expected in 2023

NEW YORK (AP) — The family of the late Shirley Jackson has authorized a novel inspired by her classic “The Haunting of Hill House.” Elizabeth Hand's "A Haunting on the Hill” is scheduled to come out in fall 2023. It’s the first time Jackson’s estate has approved an...

Metallica, Mariah Carey headline Global Citizen NYC concert

NEW YORK (AP) — Metallica, Mariah Carey and The Jonas Brothers will headline a free concert in New York’s Central Park next month marking the 10th anniversary of the Global Citizen Festival organized by the international nonprofit fighting extreme poverty. The Sept. 24 event will...

U.S. & WORLD NEWS

Cause sought for Indiana house explosion that killed 3

EVANSVILLE, Ind. (AP) — Authorities worked Thursday to determine the cause of a house explosion in a southern...

'Disturbing': Experts troubled by Canada’s euthanasia laws

TORONTO (AP) — Alan Nichols had a history of depression and other medical issues, but none were...

Groups get creative to help Alaska voters with ranked voting

JUNEAU, Alaska (AP) — Drag performers shimmied up and down a walkway between café tables, as enthusiastic...

UN demands end to military activity at Ukraine nuke plant

UNITED NATIONS (AP) — The U.N. nuclear chief warned Thursday that “very alarming” military activity at...

Greece asks Turkey to help migrants reported stuck on islet

THESSALONIKI, Greece (AP) — Greece on Thursday asked neighboring Turkey to help about 40 migrants, some urgently...

Initial dives in collapsed Mexican mine unsuccessful

MEXICO CITY (AP) — Rescue divers' first attempts to reach 10 miners trapped inside a flooded coal mine since...

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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