Page 4 - Mid Valley Times 4-28-22 E-Edition

Serving the Readers of the Reedley Exponent, Dimuba Sentinel and Sanger Herald.
A Mid Valley Publishing Newspaper
Founded March 26, 1891, in a two-story building on the corner of 11th and F streets, by A.S. Jones
Guest Column
Activists should stop
monkeying around with
lifesaving research
By Matthew R. Bailey
Guest columnist
Alzheimer's research is a matter of life and death. But it also involves a lot of monkey business — literally. The scientists working to cure Alzheimer's rely heav- ily on monkeys because humans and monkeys share ex- tremely similar pre-frontal cortices, the part of the brain
that controls memory, concentration and personality. Nonhuman primates are the key to understanding and defeating the fatal dementia, which currently af- flicts about 6 million Americans — and is projected to plague 14 million of us by 2060, unless a breakthrough
is achieved.
Unfortunately, misguided animal activists are mak-
ing scientists' jobs much harder by pressuring lawmak- ers to preclude using nonhuman primates to develop therapeutics for diseases. If they get their way, they'll slow down -- and potentially prevent -- medical discover- ies that could save millions of American lives.
The U.S. Food and Drug Administration reviews pre- clinical animal research data to evaluate the safety and efficacy of drugs, medical devices and other therapeutics before approving them for manufacturing and distribution to American consumers. Until animals respond positively to a potential treatment in pre-clinical evaluation, research- ers cannot conduct clinical trials on human subjects.
That's especially true when it comes to hard-to-treat neurodegenerative diseases like Alzheimer's, as well as neurodevelopmental disorders like autism and psychiat- ric illnesses like anxiety or depression. The brain chem- istry of primates — human and nonhuman alike — is so complex that alternative methods of testing, such as computer modeling, could never deliver the same de- gree of accuracy scientists get from monkeys.
That's why just last year New York University re- searchers tested a new Alzheimer's therapy on elderly monkeys. The treatment led to 59 percent fewer plaque deposits of the protein associated with Alzheimer's and stopped the disease from progressing. Researchers are hoping to begin human trials soon.
Of course, animals aren't just helpful for studying brain disorders. For decades, they've played a crucial role in nearly every medical breakthrough, including COVID-19 vaccines and treatments. Researchers in the public and private sector worked collaboratively for years to perfect the mRNA technology behind the vac- cines from Pfizer-BioNTech and Moderna, relying on animals for their tests. The successful vaccination of nonhuman primates paved the way for Food and Drug Administration approval.
The FDA has also recently approved several new CO- VID-19 treatments that prevent severe illness once some- one gets the virus. Pfizer successfully trialed its antiviral pill in December 2020 with animals. That opened the door to human trials in March 2021. The now-approved drug reduces hospitalization and death by 89 percent.
The federal government understands the value of hu- man life and the crucial role that nonhuman primates play in protecting it. Scientists at the U.S. Department of Defense, Centers for Disease Control and Prevention, National Institutes of Health and other federal agencies humanely use animals in their research to control bio- logical threats like COVID-19 and the H5N1 "bird" flu.
Animal research continues to represent one of our best hopes for discovering lifesaving medical treat- ments. We need nonhuman primates and other research animals, followed by human clinical trials, to discern that kind of information.
In the next several decades, researchers will likely find new breakthroughs to beat back some of the most stubborn diseases humanity faces. But they likely will still need animals to do it.
Matthew R. Bailey is the president of the Foundation for Biomedical Research (www.fbresearch.org). This piece originally ran in Florida Today.
Cinco De Mayo Pageant, Street Faire back this week as live events
Fred Hall — Publisher Emeritus Jon Earnest — Editor
Dick Sheppard — Editor Emeritus
Thursday, April 28, 2022 | A4 | Mid Valley TiMes Editorial & Opinions
QUOTE
“A good friend can tell you what is the matter with you in a minute. He may not seem such a good friend after telling.”
— Arthur Brisbane (1864-1936) "The Book of Today"
Two more live community events that had fallen by the wayside because of the coro- navirus pandemic in 2020 — in one case reduced to a video event — return this weekend for the public to enjoy as live events.
Live audiences will once again be able to attend the an- nual Dinuba Cinco De Mayo Pageant, which is scheduled for 6 p.m. Saturday, April 30 at the Dinuba High School audi- torium. Debbie Rojas with the pageant wants to let the public know that you can buy a ticket at the door to support the seven candidates for 2022 Cinco De Mayo Queen.
This year's queen candi- dates in alphabetical order are Patricia Guzman Garcia, Victo- ria Ann Garza, Estefani Quin- tero, Denis Gonzalez Reyes, Christina Sanchez, Saffron San- chez and Yaretzi Corpus Solis. The 2021 Queen, Citlali Garcia, will be on hand to crown the newly-chosen winner. There
will be contestant interviews and a talent competition.
Best of luck to all the can- didates, and welcome back to a live pageant!
A day later on Sunday, May 1, the Greater Reedley Cham- ber of Commerce and Martens Chevrolet will be bringing back another longtime annual (but twice-interrupted) tradition – The Reedley Street Faire & Car Show. Absent the past two years because of the pandemic, the show returns to again liv- en up a five-block stretch of G Street in downtown Reedley.
Activities run from 10 a.m. to 4 p.m., and are highlighted by the Nomads Car Show at Pi- oneer Park, plenty of food and drink along with a Beer & Wine Garden, craft and retail ven- dors, information booths and a variety of entertainment for children including train rides and bounce houses. For the adults, there will be live music from Thee Fabulous Enchant- ments on stage from 11:30 a.m.
to 1:30 p.m. The Street
Faire and Car
Show tradition-
ally has been
the springtime
complement to
the city's big-
gest show of
the year, the Reedley Fiesta in October. It should be another fun time for residents and visi- tors. Remember your sunblock and enjoy!
•••
Yet another bad vehicle ac-
cident on Fresno County's rural roads this past week, this time near Reedley, should serve as a reminder to always be on the lookout for stop signs and cross traffic that has the right of way. Please drive with ex- treme care — as well as sober – on our roads, and keep our community safe from unnec- essary tragedy.
Jon Earnest is news-sports editor for The Tiimes.
Jon Earnest
This bill will accelerate patients' demise
By Guy Anthony
Guest columnist
New Jersey Congressman Frank Pallone, Jr. recently in- troduced a bill that could delay patients' access to lifesaving treatments -- and even take FDA-approved medicines away from patients who are already using them. As a Black man living with HIV and a lifelong advocate for patients, I fear this legislation will have disastrous consequences for millions of Americans, especially the most vulnerable among us.
The bill essentially neuters the FDA's "accelerated approv- al" pathway, which regulators established at the height of the HIV/AIDs epidemic. In the late 1980s and early 1990s, thou- sands of Americans were dy- ing from this disease each year. Patient groups pleaded with the FDA to expedite the approval of promising treatments.
Regulators listened -- and in 1992 created a pathway to ex- peditiously assess the efficacy of treatments for serious and life-threatening conditions like HIV. Rather than measuring "clinical benefit" — an increase in long-term survival rates, for instance — the FDA began as- sessing HIV medications based on "surrogate endpoints" — markers that are likely to pre- dict clinical benefit, such as higher t-cell counts that enable the immune system to suppress the virus.
The pathway gave patients
faster access to medicines that saved their lives. Had the drugs gone through the traditional ap- proval process, it would have taken additional years to defini- tively prove they extended life expectancies.
Drugmakers still have to conduct confirmatory trials to ensure the medications ulti- mately provide the anticipat- ed clinical benefit. Only after these trials are complete can drugs receive traditional FDA approval.
The accelerated approval pathway has extended and saved thousands of HIV pa- tients' lives. Between 1992 and 2010, roughly 40 percent of the drugs approved through the ac- celerated pathway treated HIV. The FDA later granted all of them traditional approval.
I can't help but think how my story could have been different, had I not had immediate access to some of these treatment op- tions when I was diagnosed with HIV. I wasn't even 20 years old. But thanks to cutting-edge drugs, I've lived a fairly normal life for the past 17 years.
All told, more than 260 drugs treating conditions rang- ing from HIV to cancer to rare diseases have gotten to patients quicker thanks to the acceler- ated approval pathway.
They also offer greater health gains than medications approved through the tradi- tional FDA pathway, according to research in Health Affairs.
Despite the success of ac-
celerated approval, Congress- man Pallone have taken aim at the pathway. His bill could pull medicines off the market if post-accelerated-approval studies haven't been completed within five years. It could sub- ject drugmakers to criminal penalties if they don't conduct confirmatory trials with "due diligence" — in other words, on a vaguely defined timetable set by bureaucrats. And it could deter patients from weighing in on a medication before the FDA withdraws its approval.
These draconian measures could discourage drugmakers from applying for accelerated approval. After all, why would a manufacturer make efforts to recruit and retain patients in complex, expensive clinical tri- als just for the FDA to pull its drug from the market?
Minority patients will suffer disproportionately from such decisions. That's because Amer- icans of color bear the outsized burden of the life-threatening illnesses typically targeted by drugs given accelerated ap- proval.
For these Americans and countless others, drugs given accelerated approval often mean the difference between life and death. Preserving this critical pathway will help en- sure future patients have a chance at life -- just as I had.
Guy Anthony is the presi- dent and CEO of Black, Gifted & Whole. This piece originally ran in the New Jersey Star-Ledger.