Editor's note: This story originally appeared with an incorrect headline. The institute has treated roughly between one-eighth and one-fifth the number of patients originally forecast, depending on the original projection. In a story from 2010, Dr. William Harvey projected 2,000 patients a year. After this story was published on Oct. 18, DaVida Plummer, Hampton University's Assistant Vice President of Media/Marketing, said the projection was 1,200.
Virginia's only proton therapy center completed treatment on just 52 cancer patients from mid-September 2014 to mid-June 2015, according to its own numbers.
Hampton University Proton Therapy Institute in Hampton, an independent, free-standing facility billed as the largest of its kind in the world, treated its first patient for prostate cancer in September 2010. Since then, HUPTI has averaged about 250 patients a year, roughly one-eigth of initial projections.
"I still have high hopes for it. The baby isn't born full-grown. It's just like any other new business. I'm not discouraged at all," said Hampton University President William Harvey, who projected treatment of 2,000 patients annually at the outset.
By September 2015, its fifth anniversary, it had treated a total of 1,274.
Harvey described HUPTI as "a start-up," but conceded that it's not at optimal operation.
Proton therapy, a highly targeted form of radiation, is used to treat a variety of cancers, including head and neck, brain, lung, breast and gastrointestinal in addition to prostate. It allows the delivery of high doses of radiation even when tumors are close to sensitive organs, while sparing surrounding healthy tissue.
It claims better quality-of-life outcomes, but at almost double the cost of conventional radiation. And to date, no definitive studies support those claims. Even some proponents, including the lead physician at the proton center at Massachusetts General Hospital in Boston, question any greater efficacy for prostate cancer.
HUPTI has been affected by a trifecta of issues: decreasing insurance reimbursements, its independent status and increasing competition.
In 2010, HUPTI was the fourth proton center to open in the U.S. The first, Loma Linda in California, opened in 1990, and has treated more than 10,000 patients, or about 400 annually, also way below its 1,500-a-year capacity. Now there are 17 centers operating in the U.S. and a dozen more under construction, according to the National Association for Proton Therapy, a 25-year-old advocacy organization.
Eight of the nation's top 10 cancer centers either offer proton therapy or are developing the capacity, according to John Frick, the association's interim executive director. The Mayo Clinic has built two, Emory in Atlanta is developing one, as is Johns Hopkins in Baltimore, and two Washington, D.C., hospitals have them in the works.
Harvey points to those developments as evidence of the importance and market for proton therapy. "That gives me goose bumps to think that we were five years ahead of Johns Hopkins," he said, shrugging off the notion of impending competition from a cluster of three new hospital-affiliated centers in the D.C./Baltimore area.
HUPTI, which dropped its membership in the proton therapy association last year, is the only treatment center in the U.S. operating independently of a hospital or health system.
Because it lacks the leverage of a large health system, Frick said, it faces a greater struggle to obtain insurance coverage for patients — a problem for all proton centers because of the high costs.
Local health systems have shown no interest in partnering with HUPTI. In the absence of corralling such a "strategic partner," Harvey proffered the possibility of offering naming opportunities for wealthy individuals and soliciting contributions from foundations as ways to bolster revenues.
HUPTI's independence presents another challenge, Frick said — physicians are reluctant to make referrals outside their health systems.
"The challenge, like any new medical technology, is that the people who don't have access to it are going to be very critical," he said.
A Hampton University employee described it as a problem with "vertical integration," as health systems typically refer their patients to available treatments in-house.
Also, the Veterans Administration, once considered a potential source of patients, does not include proton therapy in its approved treatment protocol for prostate cancer, according to Daniel Henry, a spokesman for the VA Medical Center in Hampton.
Hampton's not alone in struggling to attract patients. Last year, the center at Indiana University, the third established in the U.S., also an independent entity, closed after 10 years in business. It treated about 200 patients a year, well below the 850 projected when it opened.
It attributed its low patient volume and lack of profitability to overall advances in cancer treatments, decreasing insurance reimbursement rates and aging equipment. Its cyclotron, which powers proton radiation, was built in 1976 and was repurposed for proton therapy in 2004.
Radiation oncologist Allan Thornton, who has led treatment at HUPTI from its beginning, was the founding medical director at Indiana. Andrew Chang, a pediatric specialist at HUPTI, also worked at the Indiana center. "It was successful while I was there," said Thornton, citing 75 patients a day. He attributed its demise to its location in a town of 85,000, poor economic planning and the university "deciding to fly its flag higher."
The buzz around Indiana when it opened was that it would attract patients and families from throughout the Midwest "and pump millions of dollars into the area economy."
When HUPTI followed six years later, Harvey predicted that the $225 million facility — primarily funded by bonds and built on 5.5 acres donated by the city of Hampton, which also gave $1.3 million to staff both the facility and "skin of color" research at Hampton University — would treat 2,000 patients annually and bring in up to $50 million a year directly and indirectly to the local economy.
The Hampton City Council was told that $1 million in tax benefits to the city had already been identified before the gift was approved. City Manager Mary Bunting estimated that direct tax revenue from patient and family spending in the city would be $934,000 annually.
A year later, in 2011, a fiscal impact report by the Thomas Jefferson Program in Public Policy at the College of William and Mary projected that the institute would generate almost $15 million in property taxes for Hampton over 10 years and almost $200 million in direct spending along with 850 jobs through a "multiplier effect."
To date, the institute has paid just over $500,000 a year in Hampton property taxes, according to city records — about one-third of the report's estimate.
The report further projected that HUPTI would be treating patients at maximum capacity by August 2012 and that out-of-town patients would spend approximately $3 million in the region annually.
The revenue projections were based on Harvey's proposal to build a 50,000-square-foot office building on an additional five acres that HU had purchased and a 110-room hotel to house those coming from around the country and the world for the typically month-long daily treatment — five days a week for a few minutes each day for 39 days.
The total in direct taxes from the combined enterprises would be $1.3 million a year, said Assistant City Manager James A. "Pete" Peterson.
But in 2012, 60 percent of the center's patients were local.
The additional projects have not materialized.
Medically, Harvey touted proton therapy as a panacea for treating the local African-American community, which he noted suffers some of the highest rates of prostate cancer in the state — 60 percent higher than whites.
While the institute has met its prediction that prostate cancer would account for almost two-thirds of all treatments, the vast majority of patients have been white males, not African-Americans. In fact, overall, by mid-June, black males had accounted for 286 patients, less than half the number of their white counterparts, according to Keith Gregory, HUPTI's executive director.
Meanwhile, the number of those with cancer keeps growing. While heart disease tops mortality rates nationwide, in Virginia cancer is the No. 1 killer, with the city of Hampton particularly hard-hit with the second-highest rates in the state. HU representative Bill Thomas, citing the Weldon Cooper Center for Public Service, said Virginia will see more than 70,000 cases of prostate cancer, 64,000 of lung cancer and 63,000 of breast cancer by 2020.
"There's plenty of cancer to go around unfortunately," said Harvey, wryly. That's why he maintains the proton center is not only a lifesaver for patients in the region but also a sustainable entity.
To get off the ground, HUPTI had to navigate the state's certificate of public need process, or COPN, applying first in 2005 for the facility, then again in 2008 for the addition of two combination CT/PET scanners.
The regulatory mechanism, which has been dropped by more than 20 states, is designed to protect existing treatment modalities, lower the cost of health care and ensure patient access to care. Offering a new treatment modality in Virginia, HUPTI sailed through the often-contentious process with no opposition.
"Given its potential status as a truly regional, national, and possibly international proton beam therapy referral center, there appear to be no other feasible alternatives available," wrote the state's regulators.
In its 2008 application, HUPTI cited the importance of proton therapy for pediatric cancer treatment in sparing healthy tissue.
In 2012, after two years in operation, it had treated nine children.
After crafting an agreement with anesthesiologists at Children's Hospital of the King's Daughters in Norfolk in September 2012, it has bumped that to 64. Many come as part of the SAH Global agreement with Thornton and his partners that has brought 50 self-paying patients from Saudi Arabia, Yemen, Bahrain, and other countries in the Middle East. Those countries have government-sponsored health care, Thornton said. "We have a very large pipeline and a major commitment to the (Persian Gulf coast countries)," he said.
Thornton is consulting on the building of a facility in Qatar.
The Hampton institute projected a positive cash flow in its second full year of operation, based on "a very conservative" 1,650 patients annually, for an anticipated profit of $384,063 from gross revenues of $4.95 million, or $3,000 per patient. (For its first year, it projected 660 patients for a loss of $9,597 on gross revenues of $1.98 million.) The state reviewers noted that "the proposed project appears to be financially feasible in the long-term," and "it is anticipated that the total capital and financing costs will be funded from ongoing patient revenues."
In fact, the state has been chipping in regularly with a base payment of $510,000 annually. In 2013, it gave an additional $1.5 million "to support research on proton therapy used in the treatment of cancer." And its most recent contribution included a bump of $250,000 for a $760,000 annual contribution to assist HUPTI with debt held for $75 million in equipment.
"We're operating within the black if we only deal with operations," Harvey said, adding that he'd obtained favorable refinancing for some of the original bond issues. He has persistently criticized the state for its level of funding. "It's the only state that has not provided support to the tune of $10 million," he said in a 2012 interview. In fact, over the years, the state has given close to $5 million to the private enterprise.
As part of COPN approval, HUPTI has another financial obligation — it's required to provide 2.2 percent of its gross revenue in charitable care, a benchmark that area hospitals also must meet.
According to HU spokeswoman Da'Vida Plummer, it has provided approximately $1.1 million in such care annually. Since 2011, each October it has held a Gala of Hope fundraiser to help meet the needs of those unable to afford its services; the event has raised $1.5 million over the years, Plummer said.
Currently, Medicare insurance — the government-subsidized program for those age 65 and over and some younger people with disabilities — provides the backbone for proton therapy. It covers treatments for most localized tumor sites, including prostate, breast, lung, head and neck. At HUPTI, 47 percent of patients fall under Medicare, a percentage that has held steady over all five years.
Nationwide, in 2013, Medicare paid $40 million for 41,000 proton therapy treatments given by about 30 providers. By comparison, in the same year, Medicare paid $530 million for 1.3 million IMRT (intensity modulated radiation therapy) procedures performed by 1,526 providers. IMRT uses highly targeted traditional radiation to treat a variety of cancers at about half the cost of proton therapy.
In 2012, HUPTI oncologist Christopher Sinesi billed Medicare for 105 intermediate and 2,796 simple treatments. That same year Thornton billed for 138 "intermediate" treatments and 565 "simple" treatments. In 2013, Thornton's numbers rose to 212 and 735 respectively.
The institute billed $2,700 to $3,200 for each treatment.
Medicare allowed $815 to $847.
However, the SAH Global agreement that brings patients from the Mideast has seen steady growth and now accounts for about 10 percent of patients, Thornton said.
Because of the expense compared to traditional radiation, most commercial insurers followed Aetna's lead in 2013 and now cover proton therapy on a case-by-case basis only. At the time, Thornton expressed the fear that it would become a two-tier health system in which only the wealthy could afford proton therapy. "It's a fight. It's a constant challenge but I'm not going to give up," he said, noting that he spends 20 percent of his time on insurance appeals.
Though proponents, including NAPT's Frick, cite several studies in support of proton therapy's use for less common cancers, such as ocular, the promised definitive studies on better quality-of-life outcomes — particularly for prostate treatment, which accounts for the bulk of patients nationwide — have not appeared. (A much-anticipated Massachusetts General multiyear study is due to conclude next year.)
There are no data to support improved outcomes, said radiation oncologist Mark Chisam who uses IMRT for prostate treatment at Riverside. "All we have are retrospective and prospective studies and they show no difference on quality of life or side effects," he said. The radiologists' national group, ASTRO, likewise hasn't endorsed one over the other.
Frick also touted proton therapy's superiority for left breast cancer in protecting the heart and for lung cancer, as well as some long-term studies that show a reduction in risk of developing secondary cancers.
"There's more research supporting proton therapy as superior than there was when IMRT was adopted 10 years ago," Frick said, adding that randomized clinical trials aren't possible ethically as no one would be willing to sign up for extra radiation to healthy tissue. Thornton concurred. From HUPTI's own patient records, he cited a rectal bleeding complication rate of 1 percent after prostate treatment. He compared that to 7 to 9 percent experienced by patients after traditional radiation. He added that many of the tumors he treats, such as chordomas, are so rare that comparisons aren't possible.
"I know in my heart of hearts that it's better," Thornton said.
Much of HUPTI's support has come through funding for research. Early on, it received $14 million in federal research grants for prostate and breast cancers from the Navy over six years. In 2009, it received a one-time grant of $1.3 million from the Army.
Recently, its focus has been on the health of African-American men, who have the highest incidence of cancer of any group, according to the National Cancer Institute.
In August, HUPTI partnered with HU's Cancer Research Center in a two-year study funded by a grant through the university's Minority Men's Health Initiative to examine the genetics and biological factors associated with prostate cancer in African-Americans.
"They're more likely to have more aggressive tumors," said Luisel Ricks-Santi, director of the research center, adding that African-Americans also tend to get prostate cancer earlier.
The team is collecting 60 samples in collaboration with Howard University and the Hampton VA Medical Center to determine genetic expression and to identify tumors that are slow-growing and less aggressive.
The research will help to determine which men should receive treatment, said Ricks-Santi.
And HUPTI is there to provide a treatment option.
Salasky can be reached by phone at 757-247-4784
Prostate cancer awareness
The Hampton Roads Prostate Health Forum and sponsors will host a 5K run and 1-mile walk; free prostate cancer tests and exams for the first 100 men.
When: 8:30 a.m. Saturday Oct. 24; registration starts at 7 a.m.
Where: Hampton University Proton Therapy Institute, 40 Enterprise Parkway, Hampton
Cost: $25 for the run by Oct. 9, $30 after; $10 for the walk.
Gala of Hope
The 5th annual Gala of Hope fundraiser to support patient care at the Hampton University Proton Therapy Institute will be held at the Hampton Roads Convention Center, Hampton, on Friday, Oct. 23, at 6:30 p.m. The formal event includes a plated dinner, silent auction and the band Party on the Moon. For information, call 757-251-6800.