More than one year after House Majority Leader Kevin McCarthy secured $5 million in federal funding to launch a five-year clinical trial of a drug used to treat valley fever, health providers are struggling to enroll patients.
Just 48 people have signed up across California and Arizona, and in Bakersfield — which sees more cases than anywhere else in the state — Kern Medical Center hasn't enrolled a single person, according to Dr. Dennis M. Dixon, chief of the National Institutes of Health bacteriology and mycology branch.
Disease experts initially set a goal of enrolling 1,000 patients in October 2016 when the National Institutes of Health, U.S. Centers for Disease Control, Duke University and a handful of health providers teamed up to launch the FLEET Trial, short for Fluconazole as Early Empiric Treatment.
“It’s been tough with the whole study,” said Dr. Royce Johnson, clinical director of the Valley Fever Institute at Kern Medical Center. “No one has been anywhere near as successful as we anticipated with enrolling patients. Some places have done better, but no one has done well.”
The trial aims to answer this question: How effective is the early treatment of valley fever with the antifungal drug Fluconazole? The drug, long prescribed off-label to treat the disease, has never been clinically tested among patients until this trial.
Testing patients in a clinical trial could allow doctors to tell valley fever patients definitively whether their health will improve if prescribed the drug, said Dr. John Galgiani, director of the Valley Fever Center for Excellence at the University of Arizona.
Valley fever, or coccidioidomycosis, is a respiratory disease caused by inhaling microscopic fungal spores that live in loamy soil throughout the southwestern United States. The vast majority who breathe in the spores don’t develop symptoms, but others come down with a flu-like illness and an extreme fatigue that can last months. In other cases, the spores spread into the bloodstream, leading to a host of health issues, and in rare cases death.
The FLEET Trial sought to recruit patients with community-acquired pneumonia who may have valley fever. Researchers have determined that valley fever is responsible for causing community-acquired pneumonia in about one in three Arizona patients.
Half of all enrollees would be treated with a placebo and the other half with Fluconazole.
The study has so far enrolled 17 people in Arizona, which recorded more than 6,000 cases in 2016, and 31 people in California, which recorded more than 5,300 cases the same year. Researchers have been aiming for 1,000 enrollees, with the assumption that about 200 to 300 will have valley fever, Dixon said.
The lack of enrollees doesn’t stem from a shortage of patients, Johnson said. Plenty of people in the region come down with valley fever, but nobody has wanted to donate their time to a trial, which requires at least three follow-up visits within the first 42 days, plus lab work and X-rays, Johnson said.
“We’re prepared to do the medical part of this, but patients say they don’t want to come. People have even turned down being paid $100,” Johnson said. The multiple visits required by the trial are especially hard on very ill patients, he added.
Other potential enrollees worked and couldn’t devote time to the study, while others were pregnant — making them ineligible — or lived in distant, rural parts of Kern County.
In response, Kern Medical Center is in the process of hiring a project manager who could bring the trial to the patients, making home visits to collect data as a way to attract more enrollees.
“If we get a project manager, maybe we can do more to take the study to the patient, rather than making the patient come to the study,” Johnson said.
The NIH responded to the low enrollment numbers by bringing on board the Kaiser Southern California health system, which maintains centers in Antelope Valley and Bakersfield, Dixon said.
“Getting these centers fully up and running resulted in 17 patients enrolled in January alone, our best monthly enrollment to date,” Dixon said.
That might not be enough, however, to get patients over one of the biggest hurdles in participating.
When patients enroll in clinical trials, they are sometimes lured by the opportunity of being prescribed a promising pharmaceutical otherwise unavailable to the general public.
But Fluconazole is a widely used and readily available drug with a track record of improving patient health, Galgiani said. Some patients may worry they would blindly be prescribed a placebo, and as a result, might not recover as quickly as they would have with Fluconazole.
“It gets in the way of enrollment,” Galgiani said. “If the drug is in everybody’s pharmacy, why bother going into a clinical trial? Why not just get going with a prescription?”
Meanwhile, some advocates have questioned why $5 million — a significant amount of federal funding for valley fever — would be allocated for the trial of a drug that has a track record of success, instead of putting the money toward other drugs in development.
Nikkomycin Z, for example, has shown promise in eliminating fungal spores in lab mice. Researchers in Arizona began human clinical trials last year, but ran out of pills, stalling the trial. The cost of manufacturing those pills would cost roughly $1 million to $2 million, and an additional $50 million to bring it to market, Galgiani said in August.
Dixon said knowledge about those drugs and vaccines is important, and that the NIH is actively supporting research on both Nikkomycin Z and a vaccine called Delta CPS-1, but that “they are not yet available for clinical practice.”
The decision to choose Fluconazole for a trial came down to timing.
Five years ago, valley fever gained national attention. The Center for Health Journalism Collaborative — a group of 10 different news outlets coordinated by USC’s Center for Health Journalism — began publishing a years-long series of stories titled “Just One Breath” that spotlighted the struggles of valley fever patients, the lack of funding the disease receives and the difficulties researchers have faced for decades while fighting to find a vaccine or cure. In response, McCarthy gathered leaders from the NIH and CDC for an unprecedented symposium in Bakersfield to brainstorm ways to address the toll the disease had taken.
The FLEET Trial was born.
“The NIH was trying to respond to increased enthusiasm from Congress,” Galgiani said. “The question was, ‘What could you do right now?’”
At the time, other potential drugs weren’t ready for a trial. Researchers took aim at Fluconazole, wanting to know definitively whether patient health would improve faster with the drug.
“On one hand, you can say: ‘Is it worth knowing the answer to?’ That’s valid,” Galgiani said. “On the other hand, if somebody says you might be sick for two or four weeks, and we know if we treat you it would be only two weeks, would you take the treatment? Maybe, if you were sick, you would want to know the answer to that question.”
LEMOORE — In the event of a major injury or trauma, minutes can be what stands between life and death.
Many times a police officer is the first on scene at an accident, and to help officers better assist those injured Leprino Foods donated $4,500 to the Lemoore Police Officer’s Association (LPOA) so that Lemoore officers would have trauma kits for each officer.
The kits include two tourniquets, a heavy duty bandage, two chest seals and QuikClot. All of these items are used in different situations to stop bleeding. All officers have a first aid kit that does not include the items in the trauma kit.
The kits were purchased from the Visalia Police Officer’s Foundation as part of its “Kits for Cops” program.
The first-aid kits officers are given are not equipped to handle some of the injuries police see like stabbings and shootings, said Thomas Higgins, the executive director of the Visalia Police Officer’s Foundation.
Higgins said the foundation’s program was first just to give trauma kits to officers in Tulare County but has now expanded to Kings County. The foundation hopes to expand in Fresno County too.
“These kits could literally save a life,” Higgins said.
Mark Pescatore, a corporal for Lemoore Police Department and board member for LPOA, said all Lemoore officers have access to a trauma kit. There are also extras in case more officers are hired.
Pescatore said the kits are not in use yet because officers have not received training on how to use the items in the kit. The training is not scheduled yet and will come from emergency personnel from Kaweah Delta Health Care District.
Each kit costs $100. Higgins said they have received donations from businesses, community organizations and individuals. He said the foundation is not making a profit on this program and that every dollar goes toward buying kits.
Pescatore said the kits have a shelf life of around five years.
HANFORD — The city is one step closer to getting more rooftops, and a proposed development will be like nothing Hanford has ever seen.
During the Hanford City Council meeting on Tuesday, a public hearing was held to discuss a planned unit development that was previously denied by the Planning Commission.
Alejandro Clark, the developer of the project, went to Council to appeal the commission’s decision and make a case for his project. His plan is to build a 26-lot gated community that sits on a 4.19-acre parcel located at the southern intersection of Greenfield Avenue and Fitzgerald Lane.
The Planning Commission denied the project due to an “inability to make required findings” pertaining to zoning ordinance requirements. The subdivision proposes deviations to the city’s standard lot size, width, depth and street width.
The project is known as an “infill development,” where vacant parcels that are difficult to work with are turned into developments with smaller-than-normal lot sizes.
The planned development contains lots with very small yards, no sidewalks and a small shared park area. There is also no street parking; besides parking in garages and driveways, there are designated areas with additional parking stalls.
Three residents spoke in favor of the project while two residents living in homes to the east of the proposed project spoke out against the project, citing issues with privacy, traffic and the aesthetic of the planned project.
The developers revised the project based on these same concerns that were brought up during the Planning Commission, including changing a planned two-story home into a single-story home to avoid privacy issues.
“If we don’t develop this project and get it done, it will become a blight,” Clark said.
Alex Dwiggins, a civil engineer at Zumwalt-Hansen and Associates, said it’s part of the city’s general plan to include housing developments that attract a wide array of lifestyles and also encourage infill projects.
“Not everybody in town wants a 10- or 12,000 square-foot lot and some people might like the security of living in a gated community,” Dwiggins said, adding the city currently has water, sewer and storm drain access ready to be used in the area.
Warren Thompson, architect for the project, said these type of infill projects have become popular in places like Fresno, where there are “forgotten” parcels that are otherwise hard to develop.
“They’re selling so fast, you can’t believe it,” Thompson said.
Thompson said the homes have a French-style theme aimed at comfortable living for people who don’t want the maintenance of a large yard.
When it was their turn to speak, council members were receptive to the idea of this kind of development project. Council members looked to the success of Copper Valley, which is a smaller-lot, gated subdivision on the city's northern outskirts that is popular.
“In terms of Hanford, there seems to be a theme of leaving vacant lots for decades, or abandoned unused buildings for decades and we need to start addressing some of those things,” Councilman Justin Mendes said.
“I think this is a fantastic project,” Councilwoman Diane Sharp said, adding she was looking for something similar to these kinds of homes when she moved back to Hanford several years ago. “The look of these [homes] is like nothing else that exists in Hanford.”
A motion to bring the issue back before council at a later meeting to vote on upholding the appeal was passed by a vote of 4-1, with Vice Mayor Sue Sorensen voting “no.”
The decision to approve the development will not become final until Council votes on a resolution at the upcoming meeting, but there seems to be no indication Council members will change their minds about moving forward.
HANFORD — In an unusual development, Todd Pate, who is accused of the 2013 killing of his wife, Melanie Pate, has decided to represent himself in his upcoming jury trial.
Phil Esbenshade, Kings County managing deputy district attorney, said Pate filed a waiver on Wednesday, thus waiving his right to counsel, among other rights.
He said this means Pate will make his own opening and closing arguments, call his own witnesses and cross-examine them. Adam Nelson will still be Pate’s standing attorney, but he will essentially be on his own during the trial, Esbenshade said.
Esbenshade said the DA’s office doesn’t anticipate this new development to interfere with the set trial date of April 23. He also said this change doesn’t procedurally alter the trial and it will proceed like any other normal trial.
Pate’s trial in August 2016 ended in a hung jury and mistrial because one of the 12 jurors felt the evidence did not support a conviction of first-degree murder.
Pate previously pleaded not guilty to the charges, but in February 2017, he entered a plea of not guilty by reason of insanity.
Esbenshade said Pate’s plea has not changed and said the guilt phase of the trial will begin first, followed by the sanity portion of the trial.
HANFORD — Monologues are about as stripped-down and bare as performative art can get. One speaker, one microphone, one audience. And sometimes you don’t even need the mic.
The Hanford Multicultural Theater Company will present the city’s first monologue slam March 31 and April 1.
The event will feature up to 30 artists, each given three minutes to give a compelling spoken monologue for the audience and judges. The winner will receive $500.
“Our associate artistic director, JP Rapozo, brought up the idea of the slam,” said Hanford Multicultural Theater Company Artistic Director Silvia Gonzalez. “He said, ‘a lot of big cities are doing them and Hanford should be the first small city.’"
Rapozo came in third at a recent monologue slam, Gonzalez said. And Gonzales, herself a performer and a playwright, also participated in monologue slams while in living in Chicago, where she studied improvisational acting at Second City.
“I loved the opportunity to go up in front of a crowd and perform urban poetry,” she said. “Sometimes you’d have to wait until 2 a.m., but that was part of the fun.”
Performers can sign up for the event now at www.hanfordmtc.com.
The monologues can be from plays, TV shows, movies or even written by the performer. However, all pieces must be contemporary, written after 1930. Otherwise, there are no content guidelines in place and there will be no censorship of words. However, performers cannot use multimedia effects or dangerous or messy items like food, candles, liquids or open flames.
But what’s the difference between a monologue slam and its more popular artistic cousin, the poetry slam?
“There can be no difference,” Gonzalez said. “It just depends on your take on the subject matter. Poetry on a mic is dramatic and lends itself to these performances.”
The event is planned to take place in front of the Bastille downtown. All performers will take the stage the first night, with the top eight to 10, returning for the next night’s finals to perform again for the judges’ final scores.
Any age is welcome and the slam already has a couple of youngsters signed up. Gonzalez’ elementary school-aged improv students, Even and Nikol Jorgens, will perform at the event.
Gonzalez said that younger participants will take the stage early in the event.
And while the monologue slam is there for performers to speak on issues they’re passionate about and to perform for a crowd, it’s also an event that is a little different for fans of performance art.
“When the audience receives the monologue, I want them to enjoy it. I want every monologue to be a crowd-pleaser,” Gonzalez said.
The theater company also has plans for an outdoor production of a famous contemporary play that Gonzalez couldn’t name until the rights to it have been paid for. The play, whatever it ends up being, is set to be performed in front of the courthouse downtown sometime around the Fourth of July.
Gonzales said that, should the company’s plan to make the monologue slam an annual event, the three pillars of its event schedule will be a summer play in the park, the monologue slam in spring and its annual Dia de Los Muertos event.