Wednesday, December 8, 2021

Play

Latino groups say Nevada's new political maps have diluted their influence, especially in Las Vegas' Congressional District 1; and strikes that erupted in what became known as "Striketober" aren't over yet.

Play

Presidents Biden and Putin discuss the Ukrainian border in a virtual meeting; Senate reaches an agreement to raise the debt ceiling; and officials testify about closing the U.S. prison at Guantanamo Bay.

Play

Rural areas are promised more equity from the U.S. Agriculture Secretary while the AgrAbility program offers new help for farmers with disabilities; and Pennsylvanians for abandoned mine reclamation says infrastructure monies are long overdue.

Texas Researcher Puzzled Over New Alzheimer’s Drug Approval

Play

Friday, June 11, 2021   

HOUSTON -- News this week about a breakthrough treatment for Alzheimer's disease is getting mixed reactions from some researchers, including in Texas.

The drug attempts to treat a possible cause of the neurodegenerative disease, rather than only treating the symptoms.

Dr. George Perry, professor and Semmes Foundation Distinguished University Chair in Neurobiology at the University of Texas at San Antonio and editor of the Journal of Alzheimer's Disease, the largest subscriber publication in the field, said the announcement by the U.S. Food and Drug Administration (FDA) was a surprise, and for him, a disappointment.

"The trial that was done had over 3,000 people, cost over $1.5 billion to do, it was done exceptionally well. Now, the analysis that of the data after, mathematically, was ridiculous," Perry asserted.

Perry contended the FDA rushed to approve the drug, despite data he said demonstrated the treatment was not effective.

On Friday, a prominent Harvard drug researcher became the third member of the FDA's advisory committee to resign over the agency's decision to approve aducanumab, saying he's not convinced of its effectiveness. Harvard's Aaron Kesselheim called the FDA approval "probably the worst drug approval decision in recent U.S. history."

Researchers, such as Perry, said the FDA's decision to green-light the drug might discourage development of other treatments with greater cognitive benefits. He believes its approval could set the research community back 10 to 20 years, by discouraging funding to research more effective treatments.

"This was reviewed by a panel of experts; not experts in Alzheimer's disease, experts in data analysis for drug approval," Perry explained. "Eleven of them said that the data didn't show effectiveness, and one of them abstained, and the FDA approved it anyway."

In Texas, the Alzheimer's Association said at least 400,000 people are currently living with Alzheimer's, with an anticipated increase in cases of more than 22% expected by 2025.

Drug-maker Biogen has priced the drug at $56,000 a year for an average patient, but said the vast majority of Alzheimer's patients will be covered by Medicare, as many are over age 65.


This story was updated Fri., June 11, 3:10 p.m. MDT, to include information about the resignation of Aaron Kesselheim, and updated Mon., June 14, 5:45 p.m. to clarify concerns about the decision.


get more stories like this via email
BP's refinery in Whiting, IN covers 1,400 acres in northwestern Indiana, just a few miles from the Chicago loop. (Adobe Stock)

Environment

WHITING, Ind. -- International oil-and-gas producer BP will pay more than $500,000 to the federal government as part of a legal settlement over air …


Social Issues

SPRINGFIELD, Ore. -- Strikes that erupted in what became known as "Striketober" aren't over yet. After a two-day strike in October, health-care …

Social Issues

DENVER -- Women and low-income students disproportionately put their college careers on hold during the pandemic, according to a new report. Of the 1…


A proposal by Milwaukee City Alder Marina Dimitrijevic would provide 12 weeks of paid leave for new parents, regardless of their gender. (Adobe Stock)

Social Issues

MILWAUKEE, Wis. -- Like most of the nation, Wisconsin does not have a statewide paid parental leave policy, but in Milwaukee, a three-month paid …

Social Issues

HARRISBURG, Pa. -- With kids stuck at home early in the pandemic, a new report said child-abuse cases decreased in 2020, but children's advocates say …

The Minnesota Attorney General's Office says even when someone is facing serious financial pressure with a past-due loan, they often don't have to make snap decisions. To avoid scams, borrowers are urged to seek out free consultation. (Adobe Stock)

Social Issues

MINNEAPOLIS -- With forbearance protections ending during this stage of the pandemic, some struggling homeowners are sorting out their mortgage …

Social Issues

RAPID CITY, S.D. -- If South Dakota wants to turn out a thriving economy, quality affordable child care needs to be a vital component, according to a …

Social Issues

COLUMBUS, Ohio -- In a system plagued by a history of disparities, Ohio's child-welfare workers and children's advocates say it is time to reimagine …

 

Phone: 303.448.9105 Toll Free: 888.891.9416 Fax: 208.247.1830 Your trusted member- and audience-supported news source since 1996 Copyright 2021