VoiceofOC
Valley Fever Cases Increase, Yet Vaccine Remains Elusive
YESENIA AMARO and TRACY WOOD
October 7, 2012
Latest in an ongoing series on the ravages of Valley
Fever. Click here for previous installments of the series.
Just eight years ago, a vaccine to stop valley fever seemed
within reach.
Ambitious scientists at five universities had brought in
millions of dollars since 1997 from private donations and
government funding to develop a way to beat the fungus
before it ever had a chance to lodge in a person’s lungs
and wreak havoc on his or her organs.
Dr. Demosthenes Pappagianis in the lab inside Tupper Hall at UC
Davis where he and members of his research staff are developing a
valley fever vaccine. (Photo by: Brian Baer
In 2004, they announced they had selected a pathway to
pursue a vaccine. “A vaccine is at hand,” Dr. Richard
Hector, the director of the umbrella organization, the
Valley Fever Vaccine Project of the Americas, told an
excited group of scientists at Cal State Bakersfield.
But today early animal trials of experimental vaccines have ground to a halt, research funds have dried up
and the once thriving academic effort has slowed dramatically.
Private industry interest is critical to bringing a vaccine out of the laboratory and into doctors offices and
clinics. That has been the pattern for all modern vaccines, most recently including, the successful
development of a vaccine to prevent the virus that causes cervical cancer.
But there has been no interest by big pharmaceutical companies in investing in Valley Fever.
“Certainly we think that more attention is needed on finding new, effective treatments as well as
preventive measures like a vaccine,” said Dr. Benjamin Park, chief expert on fungal diseases at the U.S.
Centers for Disease Control and Prevention. Progress has been harmed by “neglect” and underinvestment,
he said.
Early Vaccine Effort Faltered
Scientists for more than half a century have grappled with efforts to develop a Valley Fever vaccine.
The disease is tricky. The fungus that causes it infects a person for life and can never be removed from
the body. But if a person successfully fights off the disease, he or she is immune to future infections.
That’s the reason people who grew up in areas where the fungus is prevalent often avoid serious illness
while people who visit the area or move there are hit harder.
When one vaccine was evaluated in the late 1970s and early 1980s and proved to be effective in mice and
monkeys, hundreds of people signed up for the human clinical trials.
But there was a problem.
Patients complained of very sore arms and swelling at the injection site, even at low doses. The shot was
so painful people dropped out of the trials.
Ultimately, that vaccine didn’t show conclusive protection, something some researchers attributed to the
low doses. For a vaccine potent enough to provide true immunization, people would have suffered too
much pain to make vaccination practical, said Hector, now a researcher at the UC San Francisco.
The vaccine had reached the phase three trial — human testing — which was as far as it could go, Hector
said. The trial failed, and scientists had to start from scratch looking for different vaccines.
That unsuccessful trial also left a lot of questions unanswered, said Dr. Thomas Larwood, a retired
Bakersfield physician who worked on the project.
“It didn’t keep people from getting cocci [valley fever],” Larwood said. “Did it keep them from getting
the [very serious] disseminated form? We don’t know.”
When Optimism Was in the Air
For more than a decade after those tests, vaccine research languished. Then in 1997, a Bakersfield-based
committee worked with Cal State Bakersfield to select five U.S. scientists to develop a new vaccine with
funding from the California HealthCare Foundation and the state of California.
The ambitious project was launched with a $1.5-million grant from the foundation, a $700,000 state fund
sponsored by Assemblyman Roy Ashburn, R-Bakersfield, and a contribution of more than $100,000 from
the Rotary Club.
Over the following decade, an additional $5 million came from the California HealthCare Foundation.
The federal government, the state, Kern County and nonprofit groups kicked in more. Total funding
reached about $16 million.
But progress has faltered on this promising research enterprise because of the exorbitant costs of
manufacturing and testing the experimental vaccine in today’s much more rigorously controlled research
environment. The early vaccine of the 1970s made it to human trials much more cheaply and easily at a
time when there were fewer quality control requirements and regulatory hurdles, Hector said.
Today, scientists are working on more sophisticated approaches that are more expensive and challenging.
For example, Dr. John Galgiani, a professor of medicine at the University of Arizona and the director of
the Valley Fever Center for Excellence, has been working on a vaccine built from a specific protein. The
work requires pristine laboratory conditions and advanced technology that greatly add to costs, he said.
If funding was there, Galgiani said, he would be able to take his vaccine to human testing. Because of
scarce resources, however, he has been forced to focus on to make the vaccine cheaper to manufacture.
Nearly all the money raised during the early excitement about a new vaccine has been spent, and
donations have dwindled, said Michael Cooper, president of the Valley Fever Americas Foundation,
which raises funds for the vaccine project.
Dr. Mark D. Smith, president and CEO of the California HealthCare Foundation, said the foundation
stopped supporting the vaccine project because the foundation is not set up to thoroughly evaluate such
scientific research.
“Basic science is extremely expensive,” Smith wrote in an email. “The researchers we funded had
encountered a number of technical and scientific obstacles (not uncommon in vaccine development). We
simply weren’t in a position to evaluate the merits of alternative research strategies, particularly at that
price.”
The start of the Great Recession in 2007 also took a toll on funding, and the state has had little
discretionary money during the ensuing budget crisis.
But in the wake of the Reporting on Health Collaborative’s series on valley fever, state Sen. Michael
Rubio, D-Shafter, said he intends to try to revive state funding for vaccine research. The Valley Fever
Americas Foundation and Kern County remain financially committed.
“We are still continuing to have different fundraising events, and we’re conducting health fairs and
different things to try to keep the grassroots going,” Cooper said.
The foundation has been able to invest close to $1 million over the years for the Valley Fever Vaccine
Project, he said, but he admits that’s just a fraction of what the project needs. Some of the biggest
donations to the foundation have come from the oil and natural gas industry. Aera Energy donated
$100,000 in 2005, and Chevron Products Co. donated $30,000 that same year, said Bob Parker, the
foundation’s treasurer.
Kern County has committed $50,000 for the current fiscal year.
Drug Companies Ignore Valley Fever
The amount of money raised to date is not enough to move a vaccine forward quickly. For a vaccine to be
brought to market would require, by some estimates, an additional $100 million in research funding. At
the current rate, it would take more than 60 years to raise that much money.
Galgiani estimated it would take $40 million just to begin human clinical trials.
That’s the kind of money only the pharmaceutical industry can provide. U.S. pharmaceutical companies
are working on about 300 vaccines for diseases, including HIV, pancreatic cancer and a host of other
conditions, including allergies to peanuts and cat hair.
But no U.S. pharmaceutical company is funding the development of a vaccine for Valley Fever, according
to a 2012 report compiled by the trade association Pharmaceutical Research and Manufacturers of
America (PhRMA).
The Reporting on Health Collaborative contacted nine U.S. pharmaceutical companies to ask what might
be holding back interest in funding valley fever research. Most companies didn’t return telephone calls
and emails, and others did not want to speak on the record.
Merck spokesman Robert Consalvo said it can take more than a decade to develop a viable vaccine.
Simply fronting the cost and managing the logistics of enrolling hundreds, if not thousands, of patients for
human studies can be a significant undertaking, Consalvo said.
To justify that kind of investment, drug companies often look for vaccines that will have a market that
will expand over time. The annual influenza vaccine, for instance, was initially marketed to parents with
young children, older adults and people with compromised immune systems. But the market has grown to
the point where everyone now is encouraged to get a flu shot. They are offered in drug stores and grocery
stores nationwide.
Valley Fever, so far, does not have the promise of a larger market on the horizon.
The Centers for Disease Control and Prevention found that officially more than 20,000 people came down
with valley Fever in 2011 nationwide, and multiple studies estimate that more than 150,000 people
actually contract the disease every year, with most of them never being properly diagnosed. In those states
where valley fever is prevalent, the rates of the disease are higher than those of many other common
illnesses, including chickenpox.
But with the vast majority of cases concentrated in California and Arizona, most of the country need not
worry about the disease.
And the lack of a well-organized, disciplined patient lobby, such as the ones around HIV or breast cancer,
doesn’t help the cause. Such patient groups always benefit from having a high-profile champion, and in
this case, the most obvious candidates for celebrity spokespeople — baseball players who train in Arizona
— aren’t speaking up.
Vaccine Research Limps Along
The five scientists who were part of the high-profile vaccine research effort from 1997 are nearing
retirement. One has died and another one is no longer doing valley fever research. Hector, who oversaw
the work being done by the five scientists, lost his job when funding at the UC San Francisco ran out
earlier this year.
The work of all five scientists reached the stage where they evaluated vaccines in mice, Hector said. One
of them, Galgiani at the University of Arizona, also evaluated his vaccine in monkeys.
Three out of the five original scientists still are pursuing the development of a valley fever vaccine with
small sources of funding, including some from the National Institutes of Health: Galgiani; Dr. Garry
Cole, who worked at the Medical College of Ohio in Toledo and is now at the University of Texas at San
Antonio; and Dr. Demosthenes Pappagianis at the UC Davis.
"All of the efforts are promising,” Hector said.
Pappagianis said the live vaccine being studied by Cole’s team is a “nice accomplishment,” Pappagianis
said. “It was an important development to have such a live vaccine available to prove that it can be
protective, but putting it to use could be problematic."
Live viruses are used to immunize humans, including vaccines for measles and rotavirus. But there’s still
considerable reluctance to do so, Pappagianis said, because of the fear that the vaccine might infect
people with the disease or cause a related infection. For many years, people with polio were given a live
vaccine and some of the recipients developed severe infections.
Asked how long and how much money it would take to make his vaccine available to the public, Cole
said: “That’s the million-dollar question.”
Kellie Schmitt from the Reporting on Health Collaborative contributed to this report.
© Copyright 2012, Voice of OC | Orange County's Nonprofit Investigative News Agency, Santa Ana, CA