12-02-2021  8:33 am   •   PDX and SEA Weather
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NORTHWEST NEWS

Sen. Manning on the Year Ahead and the Year That Was

Prominent BIPOC Caucus member concerned with gun regulation, access to Covid-19 testing

Dozens of Oregon Workers Fired for Not Getting COVID Shot

Officials in Oregon say at least 99 state workers have been fired for failing to get vaccinated against COVID-19.

Attorney General Rosenblum Says She Won’t Run for Governor

Attorney General Ellen Rosenblum on Monday put to rest rumors and officially said she will not enter Oregon’s crowded race for governor.

Portland’s Black Population Grew in the Last Decade, but That’s Not the Whole Story

The Black population in North and Northeast Portland declined by 13.5% over the last 10 years as more than 3,000 Black residents moved away, new numbers from the 2020 census show.

NEWS BRIEFS

Oregon's Cannabis Industry Could Be More Vulnerable Than Ever

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Open Enrollment Deadline Is Dec. 15 for Health Insurance Coverage Starting Jan. 1, 2022

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Commissioners From Three Counties Select Lawrence-Spence to Fill Senate District 18 Vacancy

District 18 includes portions of west Portland and Tigard. ...

Congressional Black Caucus Issues a Statement on the Passing of Former Congresswoman Carrie P. Meek

Meek, the first Black person to represent Florida in Congress since the post-Civil War Reconstruction, died Sunday, Nov. 28 at her...

Vsp Global Partners With Black EyeCare Perspective to Eliminate Inequities and Increase Representation of People of Color in the Eye Care Industry

Partnership includes scholarships, leadership development, and outreach to prospective optometrists ...

Yakama Nation approves school district use of Warrior image

YAKIMA, Wash. (AP) — Yakama Nation officials said this week they will allow a rural school district in central Washington to continue the use of the Wahluke Warrior image while a plan for respectful usage is developed. The Yakima Herald-Republic reports the Wahluke School...

Christmas tree buyers face reduced supplies, higher prices

ALAMEDA, Calif. (AP) — Even Christmas trees aren’t immune to the pandemic-induced shortages and inflation plaguing the economy. Extreme weather and supply chain disruptions have reduced supplies of both real and artificial trees this season. American shoppers should expect...

No. 25 Arkansas beats Missouri, caps best season since 2011

FAYETTEVILLE, Ark. (AP) — Sam Pittman grinned for almost the entirety of his postgame press conference Friday night. The Arkansas coach and his team had done something no others ever had. The No. 25 Razorbacks capped their regular season with a 34-17 victory over Missouri,...

Mizzou's Drinkwitz returning to Arkansas for rivalry game

FAYETTEVILLE, Ark. (AP) — Just 45 miles of interstate highway separate Eli Drinkwitz from where he started and where he is now as Missouri's head football coach. Raised in the small Arkansas town of Alma, Drinkwitz will come full circle Friday when his Tigers visit No. 25...

OPINION

State is Painting Lipstick on Its One-of-a-kind, Long-term-care Law

Starting in January, the unpopular law imposes a stiff new tax of 58 cents per 0 earned for every worker in the state ...

Giving Thanks

Just by being alive we can be sure of having moments of sadness as well as happiness. When you’re active in politics, you experience both wins and losses. Sometimes it can be hard to feel grateful. ...

Acting on Climate will Require an Emphasis on Environmental Justice

Climate change affects us all, but its effects aren’t distributed equally. ...

Small Businesses Cannot Survive With Current Level of Postal Service

At The Skanner News office we received an important piece of correspondence that was postmarked June 12, 2021, and delivered to us on November 4, 2021. ...

AFRICAN AMERICANS IN THE NEWS

Final goodbye: Recalling influential people who died in 2021

They both carved out sterling reputations as military and political leaders over years of public service. But both also saw their legacies tarnished by the long, bloody war in Iraq. Former Secretary of State Colin Powell and former Defense Secretary Donald Rumsfeld are among the...

Ball for 1st Black St. Pete mayor canceled over circus theme

ST. PETERSBURG, Fla. (AP) — A ball planned for the first Black mayor of a major Florida city has been canceled amid concerns its circus theme was inappropriate in the once-segregated city. The Junior League of St. Petersburg, which has thrown such balls since 2006, scrapped...

Florida law school creates Ben Crump social justice center

A law school in South Florida will announce on Thursday the creation of a social justice center named after Ben Crump, the Black civil rights attorney who has gained national notoriety representing victims of police brutality and vigilante violence. The Benjamin L. Crump Center...

ENTERTAINMENT

Dystopia, 'she-cession,' TikTok dances: We're over you, 2021

NEW YORK (AP) — The pandemic, politics, pervasive anxiety over the climate and the economy. Did 2021 leave us any time to ponder anything else? As we limp our way into a new year, there are a few more things we'd like to leave behind, from pop culture's obsession with all things apocalyptic to...

Smollett defense questions credibility of star state witness

CHICAGO (AP) — Jussie Smollett’s legal team on Thursday worked to dent the credibility of a star state witness who the day before testified that the former “Empire” actor recruited him and his brother to stage a racist, homophobic attack. Defense attorney Shay Allen...

Jacqueline Avant, wife of music legend, killed in shooting

BEVERLY HILLS, Calif. (AP) — Jacqueline Avant, a Los Angeles philanthropist and the wife of legendary music executive Clarence Avant, was fatally shot at their home in Beverly Hills, California, early Wednesday, police said. Police and paramedics arrived at the home after a...

U.S. & WORLD NEWS

EXPLAINER: Why was Michigan suspect charged with terrorism?

LANSING, Mich. (AP) — Michigan prosecutors on Wednesday charged a teen with terrorism in a deadly mass shooting...

US warns Russia as Kremlin talks about war threat in Ukraine

MOSCOW (AP) — The Kremlin voiced concern Thursday about a possible escalation of fighting in a separatist...

Biden launching winter COVID-19 booster, testing campaign

WASHINGTON (AP) — President Joe Biden is set to kick off a more urgent campaign for Americans to get COVID-19...

Paris archbishop who had 'ambiguous' relationship resigns

PARIS (AP) — Pope Francis on Thursday accepted the resignation of the archbishop of Paris, who unexpectedly...

US defense chief slams China's drive for hypersonic weapons

SEOUL, South Korea (AP) — America's defense chief rebuked China on Thursday, vowing to confront its potential...

UK court backs Meghan in dispute over privacy with publisher

LONDON (AP) — The Duchess of Sussex on Thursday won the latest stage in her long-running privacy lawsuit against...

Matthew Perrone AP Health Writer

WASHINGTON (AP) -- Federal health authorities recommended Thursday that the blockbuster drug Avastin no longer be used to treat breast cancer, saying recent studies failed to show the drug's original promise to help slow the disease and extend patients' lives.

The rare decision by the Food and Drug Administration is supported by many cancer experts but drew fierce opposition from cancer patients and some doctors who defend the drug and say it should remain available.

The ruling is a significant setback for the world's best-selling cancer drug and will likely cost Swiss drugmaker Roche hundreds of millions of dollars in lost revenue. Avastin is also approved for various types of colon, lung, kidney and brain cancer.

FDA officials stressed that the recommendation is only a preliminary step toward revoking the drug's approval for breast cancer. Roche has refused to voluntarily withdraw the indication, and the company said in a statement it would request a public meeting on the issue.

Drug companies almost always follow FDA requests, and agency officials said a meeting over the fate of Avastin would be the first of its kind. The agency said it will consider whether to hold the meeting in the coming months.

"Today's decision was a difficult one for the agency but certainly not unique," said Dr. Janet Woodcock, director of FDA's drug center. "The FDA is responsible for assuring that the products we approve for patients are both effective and safe."

The FDA approved Avastin for breast cancer in 2008 based on one study suggesting it halted the spread of breast cancer for more than five months when combined with chemotherapy. But follow-up studies showed that the delay lasted no more than three months, and patients suffered dangerous side effects.

"Given the number of serious and life-threatening side effects, the FDA does not believe there is a favorable risk-to-benefit ratio," said Dr. Richard Pazdur, FDA's chief of cancer drug review.

In a separate announcement Thursday, the European Medicines Agency said it would keep the drug available as a combination treatment with the chemotherapy drug paclitaxel - the same use rejected by the FDA.

FDA officials said the split opinion was due to differences in how Avastin was approved in the U.S. versus Europe. The FDA cleared the drug under its accelerated approval program, giving the agency the option to rescind approval if follow-up studies didn't confirm initial results. European regulators granted the drug full approval based on the same results, making it more difficult to reverse course when faced with weaker follow-up results.

If the FDA ultimately removes Avastin's breast cancer indication, doctors will still have the option to prescribe the drug "off-label," or without a federal approval, but many insurers do not reimburse drugs for such uses. Without insurance coverage, Avastin's enormous cost would put it out of reach for most patients. Roche sells the drug at a wholesale price of $7,700 a month. When infusion charges are included, a year's treatment with Avastin can run more than $100,000, though Roche caps spending at $57,000 per year for patients who meet certain financial criteria.

For the time being, the FDA said the drug will remain available and patient care will not be affected.

While vigorously opposed by thousands of cancer patients, the FDA's ruling is in line with the guidance of its outside panel of cancer experts, who voted 12-1 in July to rescind the drug's approval for breast cancer.

Cancer specialists said Avastin never lived up to its initial promise.

"The bottom line is that it doesn't work very well," said Dr. Albert Braverman, chief of oncology at State University of New York Downstate Medical Center. "I've seen the occasional patient have a brief remission, which is nice, but it's certainly not doing anything important. It's not saving anyone's life."

But some patients credit their survival to Avastin and say the FDA's decision could amount to a death sentence.

Christi Turnage of Madison, Miss., said her cancer has been undetectable for more than two years since starting therapy with Avastin. She was diagnosed with breast cancer in June 2006 and began taking the drug in 2008 after the tumors spread, or metastized, to her lungs. Breast cancer that spreads to other parts of the body is generally considered incurable.

"It's a miracle drug for me and for several of my friends, and to deny it to women being diagnosed with metastatic disease is wrong," Turnage said.

More than 9,500 cancer patients and friends and family signed a petition by Turnage urging the FDA to keep Avastin approved.

Dr. Julie Gralow of the Seattle Cancer Care Alliance said the drug appears to work in some subsets of patients and should remain available.

"It is clear that some breast cancer patients derive substantial benefit from Avastin. We don't know how to select those tumors or patients yet," said Gralow, who helped conduct the initial study of Avastin in breast cancer.

Barbara Brenner, director of Breast Cancer Action, a San Francisco-based advocacy group, said the group agrees with FDA's decision.

"It's never been shown to improve survival or quality of life. We know that people will be disappointed, but science has to dictate where we go with drug approval," Brenner said.

She added that women already receiving the drug should be allowed to keep getting it.

Roche reported Avastin sales of nearly $6 billion in 2009.

FDA rules bar the agency from considering cost when making drug approval decisions. But earlier this month the U.K.'s public health service rejected the drug for breast cancer, citing its high cost and limited benefit.

U.S. sales of Avastin for breast cancer generate an estimated $600 million annually, according to analyst David Kaegi of Switzerland's Bank Sarasin. When combined with lost revenue from the U.K., Kaegi estimated Roche's Avastin sales could fall by $1 billion.

The FDA granted Avastin accelerated approval for breast cancer in 2008 based on a study suggesting it delayed the spread of breast cancer for more than five months when combined with a popular chemotherapy drug. However, patients taking the drug did not actually live longer than those taking chemotherapy alone. And FDA officials reiterated Thursday that all four studies of Avastin conducted by Roche failed to show increased survival.

Avastin, which is grown from hamster ovary cells, was the first drug approved to fight cancer by stopping nutrients from reaching tumors. Such "targeted therapies" were thought to hold promise for eliminating chemotherapy, but that promise has gone unmet. Today drugs like Avastin are generally used as a second-line treatment after chemotherapy.

"I think a few years down the line it was becoming increasingly clear, at least to me, that this wasn't a particularly active drug, despite the initial presentation," said Dr. Braverman, referring to Avastin for breast cancer. "But people are sort of on a roll and it takes a while for things to die down."

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AP Medical Writer Marilynn Marchione contributed to this report from Milwaukee.

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