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Vol. 14, No. 21 – July 14 – July 27, 2021 – Music Calendar

For more up-to-the-date listings go to VenturaRocks.com

Boatyard Pub
Ventura Harbor
Thursdays: Jim Friery; then Bluegrass Jam

Caffrodite Community Collective
1987 E. Main Street, Ventura
Fri 7/16: Tom Collins & tom Etchart

Cantara Cellars
126 N. Wood Road, Camarillo
Fri 7/16: Laith Al-Saadi
Sat 7/17: Ray Jaurique & the Uptown Brothers
Sun 7/18: Natalie Wattre
Fri 7/23: Josh Smith
Sat 7/24: Cash Cats

Canyon at Oxnard PACC
Oxnard Performing Arts Center
Sundays: The House Arrest Band (1-4 pm)

The Cave
4435 McGrath Street, Ventura
Music 5:30 – 8:30
Thursdays: Bobby Apostol
Fridays & Saturdays: Warren Takahashi

Channel Islands Harbor
3333 Peninsula Road, Oxnard
Concerts 4-6 pm
Sat 7/17: Psychedelic Summer
Sat 7/24: Brandon Ragan Project

Copa Cubana
Ventura Harbor Village
Tuesdays: McWorter Berghoff & Jones (7 pm)
Sat & Sun: Ken Devoe (Noon – 6 pm)

Crown & Anchor
2891 Thousand Oaks Blvd, Thousand Oaks
Thurs 7/15: Teresa Russell (5 – 8 pm)

Four Brix
2290 Eastman, Ventura
Music 6-8 pm on Fridays, Sat & Sun 1 – 3:30 pm
Fri 7/16: Brix Brothers
Sat 7/17: Teresa Russell & Stephen Geyer
Sun 7/18: Vanise Terry Band
Sun 7/25: Jacob Marquez & the Good Vibes

Grapes and Hops
454 E Main St, Ventura
Music 8 pm unless other noted
Thursdays: LA Jazz Experience (7 pm)
Fri 7/16: Davey Miller Trio
Sat 7/17: Dive Bar Steve (2 pm); Mojo Monkeys
Sun 7/18: Shawn Jones acoustic (2 pm)
Fri 7/23: The Tossers
Sat 7/24: Nick and the Oldies (2 pm); Duncan and the Dragon Slayers
Sun 7/25: The Swilly’s and Friends (2 pm)

The Greek
Ventura Harbor Village
Thursdays: Kenny Devoe (4-6 pm)

Keynote Lounge
10245 E Telephone Rd, Ventura
Sat 7/17: Red Rhythm
Fri 7/23: Pull the Trigger

Leashless Brewing
585 E. Thompson Blvd, Ventura
Music 6:30 pm except Sundays at 3 pm
Thurs 7/15: Rob Allen Quartet
Fri 7/16: T.C. King
Sat 7/17: Jacob Marquez
Sun 7/18: Tony D. Ellazzzer
Thurs 7/22: Kyle Smith
Fri 7/23: Brion Shearer & the Unreliable Villians
Sun 7/25: Brother Kimo Moya

Libbey Bowl
210 Signal Street, Ojai
Wednesdays: Ojai Summer Band
Fri 7/16: Grateful Shred
Sat 7/17: Big Bad Voodoo Daddy; Dr. T. & the Blues Criminals
Fri 7/23: Blue Oyster Cult

Made West Brewing
1744 Donlon Street, Ventura
Sat 7/17: RJ Bloke (4 pm)
Sun 7/18: Gianna Bella (3 pm)
Thurs 7/22: RJ Mischo (7 pm)

Manhattan Restaurant
5800 Santa Rosa Rd, Camarillo
Fri 7/16: Jackson Jones Trio (6:30 pm)

Margarita Villa
Ventura Harbor Village
Music 8-11; Sundays 5-8
Fri 7/16: Corsican Brothers
Sat 7/17: Crosscut 805
Sun 7/18: Doc Rogers Band
Fri 7/23: Reign
Sat 7/24: Bejammin’
Sun 7/25: John Young & Friends

Namba
47 S. Oak Street, Ventura
Sat 7/17: Francisco Leon

Ojai Underground Exchange
616 Pearl Street, Ojai
Fri 7/16: Women of Americana
Sat 7/17: Kelly’s Lot
Sun 7/18: Perla Batalla
Fri 7/23: Little Days
Sat 7/24: Eva & the Vagabond Tales

Prime Steakhouse
2209 E. Thompson Blvd
Ventura, CA
Music 6-9 pm
Tues: Danny D – “Dinner with Frank”

The Raven Tavern
1651 S. Victoria Ave., Oxnard
Fri 7/16: Vanise Terry Band
Sat 7/17: The Wild n Free
Fri 7/23: Foo Flannels
Sat 7/24: Simi Rat Pack

Relm
2390 Las Posas Rd., Camarillo
Fri 7/16: Jade Hendrix
Sat 7/17: Blanket of Clouds
Sat 7/24: Lucano Germann

Star Lounge
343 E. Main Street
Ventura, CA
Sat 7/17: CRV

Taqueria Jalisco
4275 Tierra Rejada Rd., Moorpark
Music 5-9 pm
Tuesdays & Fridays: Jim Friery

Tony’s Pizzeria
186 E. Thompson Blvd, Ventura
Thurs 7/15: Free Love Project

Vaquero y Mar
435 E. Thompson Blvd., Ventura
Fri 7/16: The Funnels, Johnny Knows No One

Ventura Music Festival
Pacifica High School, Oxnard
Fri 7/23: Aubrey Logan
Sat 7/24: Time for Three
Sun 7/25: Andrea Roberto

Winchesters
632 E. Main Street, Ventura
Music Thurs 5:30; Fri 7 pm; Sun 3 pm
Thurs 7/15: Bobby Hart & Friends
Fri 7/16: CRV
Sun 7/18: Medicine Hat
Thurs 7/22: Saint Pierre
Fri 7/23: Ray Jaurique & the Uptown Brothers
Sun 7/25: The Tosser

1901
740 South B Street
Oxnard, CA
Music 6:30 – 9:30 pm
Fri 7/16: Karen Eden
Sat 7/17: The Swillys
Fri 7/23: Teresa Russell

Vol. 14, No. 21 – July 14 – July 27, 2021 – Ventura Music Scene

by Pam Baumgardner

VenturaRocks.com

It’s easy to forget just how therapeutic live music can be. Music affects us, it affects our moods, and it can even change our outlook from grim to optimistic. If you’re stressed out, say for instance after having endured a world-wide pandemic and you could use some help easing back into being a social being again, then I highly recommend getting yourself out to enjoy live music. The genre is your choice of course, as it’s so subjective.

But you can’t go wrong with Big Bad Voodoo Daddy. They’ll be performing on Saturday, July 17 at Libbey Bowl, along with Dr. T. & the Blues Criminals. Tickets start at $28. And speaking of the Bowl, other dates include Grateful Shred on July 16, Blue Oyster Cult on July 23, Little River Band on August 7 and Ambrosia, John Ford Coley, and Peter Beckett of Player on August 22.

Back in the day I use to enjoy the music events at Zoey’s that were billed as “music in the round” meaning a number of artists would share the stage and take turns showcasing their original tunes with the other artists backing them up. So, I can only imagine that will be the same case scenario when the Ojai Underground features “Women of Americana” on Friday, July 16th. The live performance/broadcast live stream will feature the talents of Pi Jacobs, Manda Mosher, Celia Chavez and Arielle Silver. I trust Silver will choose selections from A Thousand Tiny Torches, her most recent release. According to her website, the album is an Americana Highways favorite album of 2020 and has been recognized in the numerous prestigious songwriting contests including International Songwriting Competition (ISC), Great American Song Contest and Music City Song Star. All four of these women are prolific singer/songwriters who will share the back stories on their carefully chosen musical selections. Two more shows at the Ojai Underground this week include Kelly’s Lot on Saturday, July 17, and a special concert with Ojai’s own, Perla Batalla on Sunday, July 18. More information and ticket information can be found at OjaiArtsExchange.com/underground.

Medicine Hat was ready to roll out their most recent release, Fences, when the pandemic hit, so that was put on hold. But now Robert Ramirez and Michelle Votrian have decided to have a “better late than never” record release party on Sunday, July 18, at Winchesters. CDs will be available along with a limited-edition version of their record on translucent orange vinyl.

Tequila & Tacos Music Festival will be held over the weekend of July 24 and 25 at what is being called Surfer’s Point Live, which is better known as the Ventura County Fair parking lot, the same location where Concerts in your Car were held. The Saturday date will feature the rescheduled Vanilla Ice and Tag Team show, along with Adelaide. Sunday they’ll have a tribute to Selena & Latina artists.

Don’t forget the Ventura Music Festival limited edition this year is a 100% vaccinated event. You’ll need to upload “proof” of your vaccination when ordering tickets in order to provide as safe an event as possible for their 2021 program. July 23 is Aubrey Logan, July 24 is Time for Three and July 25 it’s Andrea Roberto. All three concerts will be held at the Pacifica High School’s Performing Arts Center. Go to VenturaMusicFestival.org for ticket information.

Quick Notes: Tuesday Blues Days are packing in the dancers at Copa Cubana in the Ventura Harbor, this month they feature Shawn Jones and other artists; Bobby Hart & Friends play Winchesters on Thursday, July 15; this month’s Dinner & Music show at Caffrodite will be the jazz duo of Tom Collins & Tom Etchart on Friday, July 16; in honor of Buena High’s reunion weekend, the Funnels and Johnny Knows No One will be jamming on Friday, July 16 at Vaquero y Mar; the Jackson Jones Trio plays Manhattan of Camarillo on Friday, July 16; there’s a free concert at Peninsula Park in the Channel Islands Harbor featuring Psychedelic Summer performing the music of the 60s & 70s on Saturday, July 17; Ray Jaurique solo release, Soul Remedy, drops July 17 with a CD release party at Cantara Cellars; and it’s a night of deep Samba Brazilian music at Namba on Saturday, July 17 with Francisco Leon.

Do you have any music-related news or upcoming shows you want help publicizing? Please send all information short or long to [email protected], and for updated music listings daily, go to www.VenturaRocks.com.

Vol. 14, No. 21 – July 14 – July 27, 2021 – Forever Homes Wanted

Hi: I’m Pippa, a beautiful 4- year -old Bas-nji X in need of a new home. I was rescued from Animal Services where I was found as a stray.

My finders said I was good with kids (ages unknown) and I have some energy. It’s unknown how I’d do with other dogs or cats.

I was in a foster home for a short while. They said I was a great dog, but I kept jumping the short fence to torment the chickens.

If you have room in your heart and home for me, please fill out an application to meet me. CANINE ADOPTION AND RESCUE LEAGUE C.A.R.L.CARL Adoption Center-call 644-7387 for more information.

Easy going, resilient and affectionate, Josie is always ready to make a new friend. Her favorite activity is socializing, whether it’s meeting someone new or just hanging out a home with you. She loves walks, is crate trained and would love to have a calm and quiet home just like her.

Ventura County Animal Services – Camarillo location – 600 Aviation Drive
Josie A768745

Vol. 14, No. 21 – July 14 – July 27, 2021 – Harbor Patrol Blotter

Wed
6/23

 2:40pm, received report of a capsized sailing vessel near the Ventura Yacht Club. Officers responded, pulled the skipper from the water and dewatered the vessel. The skipper and vessel were towed to the launch ramp.

Thursday
6/24

 8:37am, dispatched to cardiac arrest at VHV I-dock. Officers responded with AMR/VFD to the call. Unfortunately, the patient was deceased for some time and responders were unable to revive the victim, a 70 y/o male.

8:01pm, dispatched to a fall victim at Ventura Marina Community. Officers responded, assisted VFD/AMR with the patient who was transported to hospital

Friday
6/25

 11:52am, dispatched to a stingray strike at Harbor Cove, tower 3. Officers responded with hot water to ease the pain of the poison in puncture wound.

Saturday
6/26

 4:25am, contacted by a group of swimmers practicing for a swim from Anacapa Island and utilizing lights/glow sticks to illuminate themselves while swimming.

7:50pm, an elderly male came to the office looking for lost property. The individual was suffering from Alzheimer’s and was eventually escorted to his home in the keys and reunited with his wife.

Sunday
6/27

 2:58am, received a report of a crane barge from VIM’s dock project adrift in a finger of VWM phase I. Officers responded with the fireboat and Rescue B17 to the incident. Officers were able to stabilize the barge with assistance from an employee of the construction company. Miraculously, only minor damage was caused by the large crane barge drifting into the marina.

Monday
6/28

 12:50pm, received a request to remove a dead sea lion near the Ventura Rivermouth at Surfers Point. Officers advised that the area is out of Harbor Patrols jurisdiction and recommended contacting City of Ventura and a local agency CIMWI (channel islands marina wildlife institute) to assist with removal

Wed
6/30

 10:03pm, educating several recreational vehicles parked throughout the harbor on City’s oversized vehicle ordinance and Port District’s no camping ordinance.

Thursday
7/1

 6:50pm, received a report of a disabled sailboat colliding with moored vessels in the Derector marina from TowBoat US. Officers responded in RB17 and investigated the boating accident; minor damage was observed and the disabled vessel was towed to the Port Districts longdock until it is towed South in the AM

Friday
7/2

 6:45am, received a request to assist Ventura PD with a wanted individual in the area of the launch ramp. Eventually the suspect was arrested without incident.

Saturday
7/3

 9:36am, received report of four personal watercraft operating recklessly in the surfline near Faria beach. Officers advised they will attempt to contact the group if they head back to Ventura Harbor. Contact was made at the launch ramp.

11:21am, dispatched to a fall victim on fishing vessel Pacific Dawn. Officers responded and assisted the patient off the vessel and to the AMR paramedics gurney then they transported the patient with a back injury from the fall.

4:45pm, received report of a water rescue near the entrance to the keys, barranca Officers responded in RB19, but were unable to reach the two paddle boarders who were beset by the wind and unable to paddle out of the barranca. The RWC was utilized to tow the pair. They were transported to launch ramp and released.

Sunday
7/4

 5:30am, observed Small Craft Advisory issued this afternoon for July 4th holiday

12:23pm, dispatched to an assault at the 4Points Sheraton. Patient refused care.

10:03pm, receiving multiple complaints about fireworks around the harbor. Officers were unable to locate offenders for various reports of illegal fireworks.

 

Vol. 14, No. 21 – July 14 – July 27, 2021 – Police Reports

by Cindy Summers

Police reports are provided to us by the Ventura  Police Department and are not the opinions of  the Ventura Breeze. All suspects mentioned  are assumed to be innocent until proven guilty  in a court of law.

Robbery Arrest

On December 6, 2020, Officers responded to a robbery that had occurred in the parking structure at the Pacific View Mall. In this incident, the two suspects chased the victim, The victim ran to his car and was attempting to get in his vehicle when 19 year old Ventura resident James Cruz began to fight with the victim as the other juvenile suspect acted as a lookout as the crime unfolded. Cruz forcibly removed property from the victim. The two suspects fled on foot after the robbery with the victim’s property.

An additional incident occurred on March 27, 2021, as the victim was in a parking lot in the 2000 Block of Victoria Av. The victim was talking to acquaintances when Cruz drove by, displayed a handgun, and shouted vulgarities at the victim.

Search warrants were served at the suspects’ residences by Ventura Police Detectives.

On June 30, Cruz, who was already in custody, was booked on additional charges of robbery and brandishing a firearm.

The additional juvenile suspect was arrested at his residence and booked into Ventura County Juvenile Hall for receiving stolen property stemming from the robbery.

Narcotics Arrest

On June 30, at 9:30 pm, Ventura Police Department patrol officers contacted a subject, 45 year old Ventura resident Jason Quinn in the parking lot of the 76-gas station. Quinn was displaying erratic behavior consistent with being under the influence of a controlled substance.

During the subsequent investigation, officers determined Quinn was under the influence of a controlled substance and recovered a large quantity of Fentanyl and evidence of narcotics sales on Quinn’s person and inside his vehicle.

As a result of the investigation, Quinn was arrested for under the influence of a controlled substance and possession of narcotics for sales.

A search of the Ventura County Superior Court shows that Jason Quinn has prior arrests for burglary, commercial burglary, weapons violations, conspiracy, narcotics violations including numerous arrests for narcotics sales.

Felony Assault Investigation and Arrest

On October 20, 2020, the Ventura Police Department began an investigation into an incident where a victim’s vehicle had the brake lines severed while it was parked at the Santa Clara parking structure. The victim drove away from the parking structure and the braking system of the vehicle began to fail. The victim was able to stop her vehicle before a catastrophic failure occurred.

During the investigation, it was determined that a former acquaintance of the victim, 54 year old Simi Valley resident Pedro Galindo, was responsible for severing the brake lines. A search warrant was conducted in January at Galindo’s residence in Simi Valley to seek physical evidence.

On July 1, 2021, enough information was obtained regarding the crime and an arrest warrant was issued. Ventura Police detectives located Galindo at his place of employment in Glendale and he was subsequently arrested for his outstanding warrant.

Galindo was booked into Ventura County Jail on charges of felony assault.

Robbery Arrest

On July 4, at 2:30 am, Ventura Police Patrol officers responded to a report of a robbery that had just occurred in the 1300 Block of Greenock Lane. The suspect confronted the two victims who were sitting in their parked vehicle. The suspect brandished a knife and stole watches from both victims. During the robbery, the suspect showed the victim’s a gang tattoo while also claiming to be a member of a local gang. After the robbery, the suspect fled in a dark colored sedan. The victims called 911 and followed the suspect vehicle.

Patrol officers arrived on scene and conducted a traffic stop on the suspect vehicle around the area of Telephone Rd and Chalmette Ave. A passenger in the vehicle, 32 year old Christopher Hernandez, was identified as the suspect and placed under arrest. Officers located the knife used in the robbery and recovered the stolen watches, which were later returned to the victims.

Hernandez was arrested and booked at Ventura County Jail for Robbery (felony) and Gang Enhancement (felony).

A search of the Ventura County Superior Court website revealed Hernandez has arrests for Domestic Battery and Battery with Serious Bodily Injury.

Stolen Vehicle and Possession of Stolen Firearm Arrest

On July 7, at approximately 12:30 pm, a Ventura Police Traffic Enforcement Officer was patrolling in the area of Chestnut St. and Thompson Blvd. when he observed a stolen Mazda SUV driving in front of him. The officer initiated a traffic stop and contacted the occupants.

During the investigation, it was determined 37 year old Wyoming resident Brandi Price was driving the car, and it was stolen in Los Angeles. Price also possessed Methamphetamine and drug paraphernalia. She was arrested and booked in Ventura County Jail for driving a stolen vehicle, possession of controlled substances, and paraphernalia.

The passenger, 55 year old Ventura resident Joseph Martinez, also had felony warrants for possession of narcotics and a firearm. He was placed under arrest and searched. During the search officers located a loaded stolen handgun. The gun was stolen in Santa Barbara. Martinez was booked in Ventura County Jail for possession of a loaded firearm in a vehicle, possession of a stolen firearm, and his warrants.

Catalytic Converter Theft with Arrest

On the July 7, at approximately 4:00 pm, Ventura Police Officers were contacted in the parking lot of Lowes, 500 S. Mills road, regarding a theft of a catalytic converter from a vehicle. Investigating officers learned that two male suspects were seen under a pick-up truck using a saw to remove the catalytic converter. After removing the catalytic converter, the two males entered a vehicle and fled the area. The suspects were last seen traveling northbound on Mills Rd.

Responding officers searched the surrounding area and located the suspect vehicle on Telegraph Rd at College Drive. Officers initiated an enforcement stop, and three occupants were detained while officers conducted an investigation. During the investigation, officers located two catalytic converters and tools to remove them inside the suspect vehicle.

Abel Mendoza, 25 year old Bakersfield resident and 34 year old Bakersfield resident Jose Avelardes were arrested for possession of burglary tools, grand theft, vandalism, and conspiracy. In addition to the above charges, 31 year old Bakersfield resident Kristina Lavidas was arrested for outstanding warrants and providing false identification to a police officer.

Cayetana Conrad (AKA Tani) studio

Cayetana Conrad (AKA Tani) studio is located in Studio74 at the Bell Arts Factory 432 N. Ventura Ave.

“I was born in San Francisco. My father was a writer and painter. My mother was an architect. All three of my siblings are in the arts. I went to college on the East Coast and raised my three children in Connecticut. In 2005 I moved back to California where I have always loved the light.

 “I currently live in Carpinteria, but enjoy the peaceful drive down to my studio at The Bell Arts Factory in Ventura every morning . When I start the nature and figure paintings which are done in oil paint , I always start with an intention, a loose plan , as opposed to the mixed media paintings which are done in acrylics and are completely intuitive. Aside from my Bell Arts Factory studio, some of my paintings can be seen at The Doora Collective on Main Street ( between Palm and Oak St.) in Ventura.”

Her work including mixed media and figures can be seen at Taniconrad.com For hours she is at her studion contact [email protected].

Picking up the Pieces A Group Exhibit by the Collage Lab

On July 2 Studio 99, at the Bell Arts Factory held a grand opening.

A reception was held from 5 – 8pm. This was also during the first in-person First Fridays art crawl of 2021!

The Collage Lab is a group of Ventura artists who create pictures using paper, photos, fabric and other mixed media. “Picking Up the Pieces” presented a selection of recent work reflecting thoughts, ideas, feelings and inspirations that carried the artists through the COVID lockdown. Featured artists are Janet Black, Karen Hoffberg, Darlene Roker, Wendy Winet, Janna Valenzuela, Karen L. Brown, Mary Kolada Scott, Joyce Lombard, Virginia Buckle and Tasia Erickson.

Exhibiting: July 2 – August 15, 2021

Gallery Hours: Fridays & Saturdays, noon – 4pm

and by appointment – 805-648-1235

Studio 99 is at the back of the Bell Arts Factory through the Wall Street entrance. 432 N. Ventura Ave.

Managing medicines for a person with Alzheimer’s

If the person lives alone, you may need to call and remind them to take meds.

People with Alzheimer’s disease may take medicines to treat the disease itself, mood or behavior changes, and other medical conditions. Caregivers can ensure that medicines are taken safely and correctly. Here are some tips to help you manage medications for someone with Alzheimer’s disease.

Know each medicine (prescription and over-the-counter) the person with Alzheimer’s disease takes. Ask the doctor or pharmacist:

Why is this medicine being used?
What positive effects should I look for, and when?
How long will the person need to take it?
How much should he or she take each day?
When does the person need to take the medicine?
What if the person misses a dose?
What are the side effects, and what can I do about them?
Can this medicine cause problems if taken with other medicines?
Managing medications is easier if you have a complete list of them. The list should show the name of the medicine, the doctor who prescribed it, how much the person with Alzheimer’s takes, and how often. Visit Tracking Your Medications: Worksheet for a template. Keep the list in a safe place at home, and make a copy to keep in your purse or wallet. Bring it with you when you visit the person’s doctor or pharmacist.

People with Alzheimer’s should be monitored when they start taking a new drug. Follow the doctor’s instructions and report any unusual symptoms right away. Also, let the doctor know before adding or changing any medications.

Use Medicines Safely
People with Alzheimer’s disease often need help taking their medicine. If the person lives alone, you may need to call and remind him or her or leave notes around the home. A pillbox allows you to put pills for each day in one place. Some pillboxes come with alarms that remind a person to take the medicine.

As Alzheimer’s gets worse, you will need to keep track of the person’s medicines. You also will need to make sure the person takes the medicines or give the medicines to him or her.

Some people with Alzheimer’s take medicines to treat behavior problems such as restlessness, anxiety, depression, trouble sleeping, and aggression. Experts agree that medicines to treat behavior problems should be used only after other strategies that don’t use medicine have been tried. Talk with the person’s doctor about which medicines are safest and most effective. With these types of medicines, it is important to:

Use the lowest dose possible
Watch for side effects such as confusion and falls
Allow the medicine a few weeks to take effect
It is recommended that people with Alzheimer’s should not take anticholinergic drugs. These drugs are used to treat many medical problems such as sleeping problems, stomach cramps, incontinence, asthma, motion sickness, and muscle spasms. Side effects, such as confusion, can be serious for a person with Alzheimer’s. These drugs should not be given to a person with Alzheimer’s disease. You might talk with the person’s doctor about other options. Examples of these drugs include:

Keep all medications locked up.
Check that the label on each prescription bottle has the drug name and dose, patient’s name, dosage frequency, and expiration date.
Call the doctor or pharmacist if you have questions about any medicine.
Medicines to Treat Alzheimer’s Disease
There are five medicines available to treat Alzheimer’s disease. It’s important to understand that none of these medicines can cure or stop the disease. What they can do, for some people, is help slow down certain problems, such as memory loss. Slowing down memory loss can allow many people with Alzheimer’s disease to be more comfortable and independent for a longer time.

NIA statement on FDA approval of aducanumab for Alzheimer’s disease

by Richard J. Hodes, M.D., Director, National Institute on Aging, National Institutes of Health

The FDA’s approval of the Biogen-Eisai drug, aducanumab, marks a milestone achievement in Alzheimer’s disease research. This drug is the first approved treatment shown to slow progression of this disease. It is also a reflection of the years of research and momentum we see in Alzheimer’s research more broadly.

FDA approved aducanumab to treat patients with Alzheimer’s using the Accelerated Approval pathway, under which the agency “approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.” FDA further stated that “at the end of the day, we followed our usual course of action when making regulatory decisions in situations where the data are not straightforward.”

The FDA also stated that “approval is based on a surrogate or intermediate clinical endpoint (in this case reduction of amyloid plaque in the brain).” Additionally, “drug companies are required to conduct post-approval studies to verify the anticipated clinical benefit. These studies are known as phase 4 confirmatory trials. If the confirmatory trial does not verify the drug’s anticipated clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.”

NIA thanks the many individuals who have participated in the clinical trials that have led us to this point. Advancements like this underscore the enormous importance of participating in clinical trials, today and in the future.

While the NIH provided no direct support for the drug development of aducanumab, our years of funding have been integral to this and other promising therapeutic approaches to treating Alzheimer’s disease. For example, NIA supported basic science investigations behind the discovery of immunotherapies like aducanumab, as well as translational research for next-generation immunotherapies. Additionally, the selection of participants for aducanumab clinical trials hinged on amyloid PET imaging, a technology that would not exist today without the publicly funded research supported by the NIA.

Today’s announcement is indeed significant, yet the work does not end here. Bolstered by significant investments in this research in recent years, NIA will continue to press forward with its robust and diverse research portfolio in the area of therapy development, building on the advancements we have achieved thus far. We will continue to evolve our understanding about Alzheimer’s and to develop more ways to detect, treat, and prevent this disease. We’re closer than ever to living in a world in which this condition may not take the enormous toll it does today.