10-15-2019  8:56 am   •   PDX Weather    •   SEA weather  
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NORTHWEST NEWS

Hank Willis Thomas Exhibit Opens at Portland Art Museum

One of the most important conceptual artists of our time, his works examine the representation of race and the politics of visual culture

Grocery Workers Union Ratifies Contract with Stores

The United Food and Commercial Workers Union has agreed a three-year contract for stores in Oregon and Southwest Washington

PCC Weighing Community Input on Workforce Training Center, Affordable Housing in Cully

Portland Community College is compiling the results of door-to-door and online surveys

Lawsuit Filed Against Hilton Hotels in “Calling His Mother While Black” Discrimination Case

Jermaine Massey was ousted from the DoubleTree Hotel in Portland where he was a guest and forced to find lodging at around midnight

NEWS BRIEFS

Protesters Rally in Ashland to Demand 'Impeach Trump Now'

Activists are rallying in Ashland Sunday Oct, 13 to demand impeachment proceedings ...

Black Women Help Kick off Sustainable Building Week

The event will be held at Portland’s first and only “green building” owned and operated by African-American women ...

Voter Registration Deadline for the November Special Election is Oct. 15 

The Special Election in Multnomah County will be held on Nov. 5, 2019 ...

Franklin High School’s Mercedes Muñoz Named Oregon Teacher of the Year

In a letter of recommendation, Muñoz was referred to as “a force of nurture.” ...

Founder of Black Panther Challenge Creates Brand To Support Mental Health

The launch comes during Mental Health Awareness Week. The creators say they want people around the world to know that they aren’t...

West Nile virus case recorded in Crook County horse

PORTLAND, Ore. (AP) — State health officials say a case of West Nile virus has been confirmed in a horse east of Bend.The Oregonian/OregonLive reports West Nile virus was first recorded in Oregon in 2003, but this is the first case recorded in Crook County.The virus, which can spread in...

Jury: No criminal wrongdoing by police in fatal shooting

PORTLAND, Ore. (AP) — A Multnomah County grand jury has found no criminal wrongdoing by Portland police who fatally shot Lane Martin in the courtyard of a Portland apartment complex.The Oregonian/OregonLive reports the grand jury determined Monday the fatal shooting by officer Gary Doran was...

Bryant bounces back to lead Missouri over Mississippi

COLUMBIA, Mo. (AP) — Last week, when he heard a pop in his left knee after being hit low, Missouri quarterback Kelly Bryant briefly saw his college football career pass before his eyes. The injury wasn't as bad as it looked, and Bryant played like his old self in a 38-27 victory over...

Missouri out to stop Ole Miss ground game in SEC matchup

Ole Miss coach Matt Luke has watched every game Missouri has played this season, and he was no doubt excited by the way Wyoming ran wild against the Tigers in their season opener.It should have portended good things for the Rebels' own vaunted rushing attack.But the more Luke looked at the video,...

OPINION

“Hell No!” That Is My Message to Those Who Would Divide Us 

Upon release from the South African jail, Nelson Mandela told UAW Local 600 members “It is you who have made the United States of America a superpower, a leader of the world" ...

Rep. Janelle Bynum Issues Response to the Latest Statement from Clackamas Town Center

State legislator questions official response after daughter questioned for ‘loitering’ in parking lot ...

Why Would HUD Gut Its Own Disparate Impact Rule?

"You can’t expand housing rights by limiting civil protections. The ’D’ in HUD doesn’t stand for ‘Discrimination’" ...

Despite U.S. Open Loss, Serena Williams Is Still the Greatest of All Time

Serena Williams lost her bid for what would have been her sixth U.S. Open Singles title ...

AFRICAN AMERICANS IN THE NEWS

President of Bulgarian soccer resigns after fan racism, loss

SOFIA, Bulgaria (AP) — Criticized around Europe for the racist behavior of Bulgarian fans and under pressure from the country's prime minister following a run of poor results, the president of the country's soccer federation resigned on Tuesday.A few hours later, Bulgarian special police...

Money, hatred for the Kurds drives Turkey's Syrian fighters

BEIRUT (AP) — The Syrian fighters vowed to kill "pigs" and "infidels," paraded their Kurdish captives in front of cameras and, in one graphic video, fired several rounds into a man lying on the side of a highway with his hands bound behind his back.They are part of the self-styled Syrian...

The Latest: 0,000 bond set for ex-cop charged with murder

FORT WORTH, Texas (AP) — The Latest on the fatal police shooting of a black woman inside her own home in Fort Worth (all times local):8:25 p.m.A 0,000 bond has been set for a white former police officer jailed in the fatal shooting of a black woman inside the woman's Fort Worth home.Aaron...

ENTERTAINMENT

Author of 'Wreck This Journal' works on project for kids

NEW YORK (AP) — Author Keri Smith is bringing the wreckage to a new group of readers.The creator of the million-selling "Wreck This Journal" is working on "Wreck This Picture Book," an interactive project for ages 5-8. Dial Books for Young Readers announced Tuesday that the new book will...

Fashion's LaQuan Smith embraces that Champagne lifestyle

NEW YORK (AP) — LaQuan Smith is all about the Champagne lifestyle: bubbly, luxurious and, especially when it comes to the women's clothes he creates, sexy.The designer made his New York Fashion Week debut at 21 with a sleek and sassy collection he dubbed "Water Goddess." Ten years later, his...

Ex-inmate Cyntoia Brown-Long argues for redemption in memoir

NASHVILLE, Tenn. (AP) — Cyntoia Brown-Long, now 31 years old, knows as much about life in prison as she does about being free.At 16, she was arrested for robbing and killing a man she says picked her up for sex and later was sentenced to life in prison. But two months ago, Brown-Long walked...

U.S. & WORLD NEWS

AP Exclusive: Julie Andrews reflects on her Hollywood years

LOS ANGELES (AP) — Everyone is on their best behavior when Julie Andrews is around.It's early June in Los...

AP analysis: Most states lack laws protecting LGBT workers

Rumors started circulating around the fire station in Byron, Georgia, within a year after the medical treatments...

AP PHOTOS: Riot police clash with protesters in Barcelona

BARCELONA, Spain (AP) — Police clashed with angry protesters in downtown Barcelona as well as outside the...

AP PHOTOS: Riot police clash with protesters in Barcelona

BARCELONA, Spain (AP) — Police clashed with angry protesters in downtown Barcelona as well as outside the...

Flooded bullet trains show Japan's risks from disasters

TOKYO (AP) — The typhoon that ravaged Japan last week hit with unusual speed and ferocity, leaving homes...

More victims, more damage found in Japan typhoon aftermath

NAGANO, Japan (AP) — The toll of death and destruction from a typhoon that tore through central and...

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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