08-25-2019  6:14 am   •   PDX Weather    •   SEA weather  
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NORTHWEST NEWS

Records: Portland Spent $1,100 per Night for Aide's Hotel

Documents show that Portland Mayor Ted Wheeler's office billed city taxpayers jumi,123 a night for an aide's hotel accommodations while at a conference

Money Crunch After Planned Parenthood Quits Federal Program

Clinics begin charging new fees, tapping financial reserves and intensifying fundraising

New Hate Crime Law Kicks In

SB577 requires state to better track bias crimes

Mayor: Show Extra Love at Portland Businesses After Protests

The City of Portland and more are offering deals and free parking downtown this weekend in an effort to generate some of the revenue lost during last weekend's political protests

NEWS BRIEFS

Local Actors Star in Haunting, Stripped-Down Macbeth

This fall, Chantal DeGroat, Dana Green, and Lauren Bloom Hanover star in a stripped-down production of Macbeth, directed by Adriana...

Albina Ministerial Alliance to Host Community Forum on Police Association Contract Aug. 26

Forum will take place at Maranatha Church beginning at 6 p.m. ...

Travel Portland Opens New Director Park Visitor Center

Hosts “Celebrating All Things Portland” grand opening weekend celebration ...

Police are Trying to Connect Floyd Leslie Hill to His Loved Ones

The Portland Police Bureau is asking for the community's help in locating the loved ones of Floyd Leslie Hill who passed away on...

New maps chart possible course for estuary restoration

ASTORIA, Oregon (AP) — A new survey reveals the West Coast has lost about 85% of its historical estuary habitat, but the mapping could also help identify restoration opportunities and provide a baseline for predicting future changes.Though large estuaries like the Columbia River have been...

Deputies kill man who allegedly came at them with a knife

COTTAGE GROVE, Ore. (AP) — Deputies shot and killed a man they said came at him with a knife in Cottage Grove.The Lane County Sheriff's Office said it received a report of a dispute between a male and a female but that deputies were unable to locate them.They retuned around 1 a.m. Saturday,...

Ex-Clemson star Kelly Bryant takes over at QB for Missouri

COLUMBIA, Mo. (AP) — Barry Odom never seems stressed about the future, whether the Missouri coach is pondering tough sanctions handed down by the NCAA over a recruiting scandal or the fact that one of the most prolific passers in school history is now in the NFL.When it comes to the...

Missouri DE Williams pleads to misdemeanor, put on probation

COLUMBIA, Mo. (AP) — Missouri defensive end Tre Williams pleaded guilty to a misdemeanor and was sentenced to two years of unsupervised probation after prosecutors dropped a felony domestic assault charge.The Columbia Daily Tribune reports Williams pleaded guilty to peace disturbance and was...

OPINION

Why I’m Visiting the Border

People of color are feeling less safe today and any day when we see the realities of domestic terrorism and racially-motivated acts of violence ...

Why Lady Liberty Weeps

The original concept was to have Lady Liberty holding a broken shackle and chain in her left hand, to commemorate the end of slavery in the United States. ...

Avel Gordly's Statement in Advance of Aug. 17 Rally

'All we have on this planet is one another' ...

A National Crisis: Surging Hate Crimes and White Supremacists

Our history chronicles the range of hate crimes that have taken the lives of Latinos as well as Native Americans, Blacks, Jews, and the LGBTQ community ...

AFRICAN AMERICANS IN THE NEWS

Biggest ever Kentridge show explores Africa's history

CAPE TOWN, South Africa (AP) — Evocative videos, graphic tapestries, charcoal drawings, woodcut prints, sculptures and immersive sound installations combine in the largest-ever show by South African artist William Kentridge to explore compelling themes including South Africa's apartheid...

Oregon defends past nonunanimous jury verdicts to high court

SALEM, Ore. (AP) — Oregon's criminal justice system would be "overwhelmed" if the U.S. Supreme Court rules in an upcoming case that nonunanimous jury verdicts are unconstitutional, the state's attorney general has told the court.Attorney General Ellen Rosenblum said in an amicus brief on...

Tennis champ, trailblazer Althea Gibson honored at US Open

NEW YORK (AP) — Althea Gibson basked in a ticker-tape parade in New York a decade before Arthur Ashe won the 1968 U.S. Open.Gibson won 11 majors in three years from 1956-58, including the French Open, Wimbledon and U.S. Open singles titles. She integrated two sports — tennis and golf...

ENTERTAINMENT

Disney Legends honor prompts Robert Downey Jr. pot story

ANAHEIM, Calif. (AP) — Robert Downey Jr. says he had a wild Disneyland ride in his younger days.The "Iron Man" and "Avengers: Endgame" star, among those honored Friday as Disney Legends, said his first visit to the Southern California resort included a brief detention for "smoking pot in a...

Beyonce, Sinatra among those on Obama summer song playlist

NEW YORK (AP) — The Obama summer playlist has everyone from Drake and Beyonce to Steely Dan and Frank Sinatra. The former president calls it "some new, some old, some fast, some slow."Barack Obama tweeted 44 songs Saturday that he and his wife, Michelle, have been listening to. They include...

Obi-Wan, Lizzie McGuire join new Disney Plus platform

ANAHEIM, Calif. (AP) — Ewan McGregor is reprising his "Star Wars" role as Obi-Wan Kenobi in a new series, one of the many splashy projects that Disney is banking on to make its new streaming platform competitive.The as-yet untitled Disney Plus show drew big cheers when it was announced...

U.S. & WORLD NEWS

Luck announces retirement following Colts loss to Bears

INDIANAPOLIS (AP) — Andrew Luck watched one last game from the sideline Saturday.Then he said goodbye to...

Best the G-7 can do for global economy: not make it worse

BIARRITZ, France (AP) — The global economy craves a double shot of confidence right now. The most the...

Extinction bites: countries agree to protect sharks and rays

GENEVA (AP) — Countries have agreed to protect more than a dozen shark species at risk of extinction, in a...

Pope, urging prayers, says Amazon forest vital for our Earth

VATICAN CITY (AP) — Pope Francis said Sunday that the Amazon forest is vital for our Earth and is urging...

Hong Kong police fire tear gas, roll out water cannon trucks

HONG KONG (AP) — Police in Hong Kong used tear gas Sunday to clear pro-democracy demonstrators who had...

Israel says it thwarts imminent Iranian attack from Syria

JERUSALEM (AP) — The Israeli military attacked targets near Damascus late Saturday in what it said was a...

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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