12-10-2019  4:58 pm   •   PDX Weather    •   SEA weather  
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NORTHWEST NEWS

San Francisco Aims to Rein in Tests of Tech Ideas on Streets

Entrepreneurs would not be allowed to test their products in San Francisco's public space unless the tech in question is declared a "net public good."

Portland-area Residents May Vote on Funding for Homeless

There may be a measure on the November 2020 ballot to fund likely hundreds of millions of dollars for increased social services

Black Food Professionals See Opportunities to “Scale Up” in School Cafeterias and on Store Shelves

Two Portland women are addressing disparities in the local food scene with Ethiopian and Haitian flavors, ingredients

Portland Fire Chief Sara Boone Climbing Historic Ladders

In 1995, Boone was the first African American woman hired by Portland Fire & Rescue; this year she became its first African American Chief

NEWS BRIEFS

EPA Approves Funding for Oregon and Washington to Improve Drinking Water, Wastewater Infrastructure

States estimate $190 million for wastewater, $35 million for drinking water projects in Oregon, and $120 million for...

Conservation Breakthrough for Endangered Butterfly

The Oregon Zoo's breeding success provides new hope in an effort to save Oregon silverspots ...

Meet 80 Local Authors at OHS 52nd Holiday Cheer Book Sale and Signing

This free Oregon Historical Society event will be held this Sunday, December 8 from 12 p.m. – 4 p.m. ...

Need for Blood Doesn’t Stop for Holidays – Donors Needed

Those who come to give through Dec. 18 will receive a Amazon.com Gift Card ...

North Carolina Court Decision Upholds Removal of Confederate Monument

Lawyers argued that the monument was installed at the end of Reconstruction to further the false “Lost Cause” narrative,...

Man gets jail, probation for strangling 85-year-old mom

PORTLAND, Ore. (AP) — A Portland man who violated a no-contact order and strangled his 85-year-old mother has been sentenced to six months in jail and two years of probation. The Multnomah County District Attorney's Office said 57-year-old James Keith was sentenced Tuesday. Keith assaulted...

M lawsuit claims meningococcal diagnosis delayed

PORTLAND, Ore. (AP) — An Oregon State University student who visited Portland-area medical providers amid a 2017 meningococcal outbreak at her Corvallis campus — but was not immediately diagnosed with the disease — has sued for million.The Oregonian/OregonLive reports then...

New Missouri coach Eli Drinkwitz predicts success

COLUMBIA, Mo. (AP) — Eli Drinkwitz was saying all the right things after being introduced as the new football coach at Missouri, laying out his vision for the once-proud program with unwavering confidence and bold proclamations.Then the former Appalachian State coach made a minor...

LSU's Burrow, Auburn's Brown named AP SEC players of year

LSU quarterback Joe Burrow is a unanimous selection as the offensive player of the year on The Associated Press All-Southeastern Conference football team.The top-ranked Tigers also have the SEC’s coach of the year in Ed Orgeron and the newcomer of the year in freshman cornerback Derek...

OPINION

Will You Answer the Call for Moral Revival?

In embracing and expanding the legacy of Dr. Martin Luther King, Jr., Revs. Barber and Theoharis have asked Presidential candidates to consider a debate that focuses exclusively on poverty ...

What I’m Thankful For This Season

Ray Curry gives thanks for a human right that shaped our country throughout the 20th century and that made Thanksgiving possible for so many Americans who, like him, didn’t get here by way of the Mayflower ...

Congressional Black Caucus Members Visit U.S.-Mexico Border: “Mistreatment of Black Immigrants is Another ‘Stain on America’”

Members said they witnessed first-hand the deplorable treatment and plight of Black immigrants ...

Portland, I'm Ready

Last month I had the privilege to stand with hundreds of supporters and announce my intention to run for re-election ...

AFRICAN AMERICANS IN THE NEWS

Trump to sign order targeting anti-Semitism at colleges

WASHINGTON (AP) — President Donald Trump will sign an executive order on Wednesday targeting antisemitism on college campuses, the White House said.The order, which is likely to draw criticism from free speech advocates, will broaden the federal government's definition of antisemitism and...

In South Carolina, Steyer investing in black voters

COLUMBIA, S.C. (AP) — In the waning weeks before South Carolina's presidential primary, Democrat Tom Steyer is renewing his focus on the black voters who play a pivotal role in the first-in-the-South state, rolling out a proposal to improve historically black colleges and institutions.The...

Multistate voter database suspended in lawsuit settlement

WICHITA, Kan. (AP) — A much-criticized database that checks whether voters are registered in multiple states has been suspended “for the foreseeable future” until security safeguards are put in place as part of a settlement of a federal lawsuit, a civil rights group said...

ENTERTAINMENT

Netflix says more than 26M watched 'The Irishman' in 7 days

NEW YORK (AP) — Netflix says that 26.4 million households worldwide watched “The Irishman” in its first week of streaming. That figure includes those who watched at least 70% of Martin Scorsese's 3 1/2 hour crime epic. Netflix selectively announces viewership for its films and...

NFL, NCAA football fuel Fox TV's win of the prime-time week

LOS ANGELES (AP) — Fueled by both college and pro football, Fox won a rare title as champ of the broadcast week among networks. Fox's Thursday night NFL airing of the Dallas Cowboys and Chicago Bears was the week's top show of any kind with 18.23 million viewers, and its broadcast of the Big...

The Associated Press picks the top moments on TV from 2019

NEW YORK (AP) — Many have noticed how fragmented our TV viewing is, with multiple competing streaming services and dozens of channels pulling us in different directions. But the year also saw some jaw-dropping moments that found huge audiences, whether it was a royal interview or a viral...

U.S. & WORLD NEWS

Adam Sandler on plunging into the Safdies' 'Uncut Gems'

TORONTO (AP) — Adam Sandler was waiting to be thrown into a midtown fountain on Sixth Avenue for a scene in...

Newspaper criticizes film's take on Olympic bombing coverage

ATLANTA (AP) — After a bomb exploded in a downtown Atlanta park midway through the 1996 Olympics, a...

Thousands rally around Holocaust survivor in Milan

MILAN (AP) — A Holocaust survivor who has been put under police protection due to anti-Semitic threats was...

In Mexico, effeminate Zapata painting draws fury

MEXICO CITY (AP) — A painting showing Mexican Revolution hero Emiliano Zapata nude and in an effeminate...

Parisians dodge strikes by logging on to share rides, bikes

ARGENTEUIL, France (AP) — Adrien Lachevre and Nailat Msoili live a few kilometers (miles) apart in Paris'...

Thousands rally around Holocaust survivor in Milan

MILAN (AP) — A Holocaust survivor who has been put under police protection due to anti-Semitic threats was...

McMenamins
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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