By early 2024, Penn State leaders faced a dilemma. For the university to achieve a long-sought goal, its cancer institute needed to significantly ramp up operations: more patients, more clinical research trials.
But mounting evidence showed the cancer center’s clinical research unit had serious and intractable problems, according to internal records obtained by Spotlight PA. Feeling overworked and undervalued, employees were leaving en masse. Patient safety was at risk, and internal reports called for reducing the number of research projects.
In 2023, a consulting group hired by Penn State interviewed cancer center employees and reviewed a sample of research studies. The group found a spike in errors and a culture of fear and silence. Records obtained by Spotlight PA show that a summary of the findings was shared with university leaders, including Karen Kim, dean of the College of Medicine.
The consultants offered a long list of solutions, which they warned would require not only financial investment, but sweeping and unpopular changes — including, potentially, to the cancer center’s leadership. But several months later, as the group was implementing part of the plan, Penn State abruptly canceled their contract.
A restructuring could have delayed its push for federal recognition. For more than two decades, various Penn State leaders have said the institute will join the ranks of the most elite cancer centers in the country. In pursuit of that goal — National Cancer Institute designation — the university poured hundreds of millions of dollars into its institute. Success will largely hinge on Penn State’s ability to build and run a robust research enterprise that benefits local cancer patients.
But a Spotlight PA investigation found that clinical cancer research at Penn State has been mired in potentially dangerous problems. Hundreds of pages of internal records obtained by the newsroom, as well as interviews with dozens of people connected to the program, reveal chronic issues with staffing, leadership, and research that undermined the university’s push for federal designation. An internal report from January 2024 said the center’s clinical research unit, a key part of its ambitions, relied on “workarounds, manual processes, and personal heroics.”
Meanwhile, the center’s leader, Raymond Hohl, was the subject of a series of damning internal reviews of his care of patients, as well as his leadership. Hohl, the doctor chosen to lead Penn State to the prestigious federal designation, was a major obstacle to the cancer center reaching its goals, Spotlight PA previously reported.
Penn State declined to make top officials, including Hohl and Kim, available for interviews. In a statement, health system spokesperson Scott Gilbert said: “Penn State operates a world-class Cancer Institute, constantly working to expand our ability to treat many different types of cancers, including rare and difficult-to-treat cancers. Our Penn State Cancer Institute physicians, nurses, researchers and staff members maintain the deepest commitment to high quality standards of care and leading-edge research as they treat cancer patients at Penn State Health every day.”
From the moment Penn State broke ground on the cancer center in the 2000s, National Cancer Institute designation has been its goal.
The federal designation was created in 1971 as part of President Richard Nixon’s “war on cancer,” after a panel of experts recommended funding a nationwide network of centers. With a critical mass of researchers and resources, the experts argued, these centers offered the best hope for “the expanded attack” on the disease.
For any institution, achieving designation is a major undertaking that requires millions of dollars and years of coordinated effort. Pennsylvania already has four cancer centers that have earned the highest rating from the National Cancer Institute: three in Philadelphia and one in Pittsburgh. However, Penn State argues that many of the roughly 4.2 million people in the mostly rural region around Milton S. Hershey Medical Center are unlikely to drive several hours to the nearest big city for treatment.
When its application for designation was rejected in 2011, Penn State redoubled its efforts and hired Hohl to lead the center in 2014.
Success could provide immense benefits for the region. Designated centers can offer the most innovative clinical trials and provide patients with specialized care they cannot get elsewhere. Some research suggests that cancer patients have better survival rates when they are treated at designated centers.
There would be perks for the university as well. The label could help it secure more research funding and bolster recruitment of top doctors and researchers. It would also be a powerful status symbol, confirming Penn State’s place among the ranks of the elite: Designated centers often highlight the fact that they are among the roughly 5% of U.S. cancer centers that have achieved the distinguished status.
A track record of successful clinical trials is essential to achieve National Cancer Institute designation. These trials offer patients the chance to help test new treatments and further scientists’ understanding of cancer. The studies are subject to strict ethical and safety standards to protect patients and ensure they are not subjected to unnecessary risks.
At Penn State, however, the cancer center’s clinical trials office, which manages the research projects, was deeply dysfunctional. Between 2017 and 2023, Penn State hired half a dozen consulting groups, but records obtained by Spotlight PA show leaders in the cancer center struggled to address the root causes of problems.
A 2023 audit that examined a subset of active cancer trials detailed a series of mistakes. Employees had mislabeled medications for patients who shared the same last name and inaccurately recorded patients’ weights, which are used to determine the amount of medication they receive. The errors were caught before they reached patients, according to a summary of the audit, but there was a “concerning, reoccurring theme” that staff were confused about how to proceed because of “lack of documentation, proper notification, or incorrect use of the electronic systems.”
In at least six other instances, the same report found, patients missed doses of medication or experienced other changes to their treatment because of staff difficulties with a paper-based records system. In a statement, a spokesperson for Penn State said the cancer institute has made “ongoing enhancements” to its medical records systems since 2023.
For the studies assessed in the report, the number of research errors jumped from 20 in 2019 to 68 in 2022, and was on track to spike further in 2023, when the audit was completed.
The cancer institute also had a problem with “zombie studies,” research projects with no actual participants, according to a follow-up review by the auditors in early 2024. These studies still eat up resources to keep active. Some doctors were also opening studies even though there weren’t enough suitable patients in the health system, the audit found.
Alongside the research problems, inadequate IT systems created extra work and contributed to employee dissatisfaction in the clinical trials office, according to the review. Inefficiencies within the unit resulted in “lost revenue, staff stress, high turnover, low morale, and a significantly reduced capacity to conduct safe and effective trials,” the 2024 report said. Staff also didn’t have the resources they needed to do their work, including necessary laboratory space, printers, binders, and office stationery, the review found.
Worse, these problems were happening while Penn State was operating at a fraction of the scale it would need to realize its ambition of National Cancer Institute designation. The cancer center’s goal, according to a 2022 strategic plan, was to have at least 300 patients per year taking part in clinical trials. Internal records show the cancer center was “significantly below” that number. (Penn State declined to say how many patients were enrolled in clinical trials in recent years.)
Not having enough patients on clinical trials is a “fatal flaw” when applying for federal designation, said Donald “Skip” Trump, former president of Roswell Park Comprehensive Cancer Center, an NCI-designated center in Buffalo, New York, in an interview with Spotlight PA.
Between 2016 and 2023, Penn State’s internal plans repeatedly stressed the need to enroll more cancer patients in trials and get studies up and running faster.
In May 2023, however, some university officials argued that pushing forward with new trials undermined efforts to ensure that existing research projects were run safely and effectively, according to a presentation reviewed by Spotlight PA. Likewise, in 2023 and 2024, records show that a consultant suggested reducing the number of studies in progress to lessen the workloads of staff who were already stretched thin.
Kim, the medical school dean, reviewed the consultant’s recommendation in late 2023, according to documents obtained by Spotlight PA. While open to some of the ideas, she responded in an email that she did not want to slow the opening of new trials.
Some cancer center employees blamed the institute’s problems on the university’s research oversight board, which reviews and approves clinical studies to protect the welfare of participants. Internal records show the group suspended research in the center at least twice in the past decade because of problems. For years, the cancer institute cycled on and off of improvement plans: An issue would be identified, a corrective plan would be implemented, things would temporarily improve, then similar issues would resurface.
In 2023, the research oversight board told university leaders, including Kim, that problems with cancer research were happening at a disproportionate rate in recent years, according to emails and documents obtained by Spotlight PA.
While experts say a natural tension exists between researchers and an institution’s federally mandated research oversight body, records and sources suggest that the dynamic at Penn State was particularly strained.
Some people connected to the program told Spotlight PA they believed the oversight board’s approach was aggressive to the point of disruption — a former senior researcher described it as “paralyzing scrutiny.” One internal assessment, from January 2024, said the group applied “inconsistent and sometimes inadequate review processes.” In response to complaints, emails show, the oversight board altered some reporting requirements, created more consistent review standards, and changed the typeface of its letters. Bolding certain words, Penn State researchers had complained, “was offensive.”
Even after these changes, the cancer institute continued to be a major source of problems for the oversight board. In a 2023 letter to cancer institute leaders, a senior research official questioned whether they recognized the recurring issues as systemic.
By then, Hohl, the center director, faced serious problems on multiple fronts.
Between early 2022 and mid-2023, Penn State Health conducted at least 10 internal reviews into Hohl’s care of patients. Those reviews found unexplained delays in care and sloppy recordkeeping that resulted in several patients receiving extra doses of chemotherapy by accident, Spotlight PA reported.
Other internal reviews shared with university leaders concluded that Hohl oversaw a “toxic,” hostile work environment, according to documents the newsroom obtained. A January 2024 report said employee trust in cancer center leaders was “fractured.” Four people connected to the institute told Spotlight PA that because they feared Hohl would misrepresent what they had said, they adopted an informal rule not to meet one-on-one with him.
Under Hohl, cancer center employees left in droves. Reports from 2023 and early 2024 linked the departures to a culture of fear and mistrust. One described “apathy” among research staff; another noted “a culture where people do not feel appreciated, heard, or want to work.” During the 2023 audit, research staff questioned why they should speak candidly if their words could later be used against them. In an interview for a separate review the prior year, one employee described the cancer center’s culture as an “‘I’ll get you’ system.”
In the years leading up to the audit, about 20 doctors resigned or retired, records show. At the same time, the staggering level of turnover among employees running clinical trials contributed to many of the problems in that office. One report from around this time put the rate of turnover at 75%; another described it as “alarmingly high.”
The result was a woefully understaffed office that left some employees to straddle multiple roles. The research oversight board told cancer center leaders in a 2023 letter that the need to constantly train new staff might explain the center’s “continued mistakes” in managing research projects. “People are working too hard and not getting paid for it,” a report from early 2024 found.
With the near-constant departures, the clinical trials office had at most, about 25 employees at any given time. Similar units at peer institutions employed more than 100 people, according to a 2022 analysis by the medical college.
The analysis recommended “bulk hiring” at least 70 clinical trials employees if the cancer institute was to achieve its goal of obtaining federal designation within the next decade. In a competing analysis, Hohl estimated that the clinical research unit needed an additional 151 people.
However, a May 2023 presentation for medical college administrators said that the cancer center often looked to hire new employees as a knee-jerk response to problems. Increased hiring was “essential,” the presentation said, but shouldn’t occur “without a clear plan on what needs to be fixed.”
Penn State did not respond to specific questions about how many people have been hired in the cancer center since 2023, but a spokesperson said in a statement there have been “significant increases” to the number of nurses and support staff.
The wider university also contributed to the cancer center’s problems, internal records obtained by Spotlight PA show. A 2022 medical college analysis found that Penn State had no coherent vision for the cancer institute or what role the various parent organizations — the medical college, university, and health system — should play, despite $410 million invested between 2012 and 2022.
“You spend that kind of money, there should have been a plan,” one person familiar with the cancer center’s operations told Spotlight PA.
The medical college’s review said the cancer center was “significantly behind where it needs to be” to reach federal designation and that a “comprehensive transformation” was needed, along with an estimated 10 more years and an additional $1.2 billion.
For a time, it appeared that the Penn State Cancer Institute would commit to major changes.
In the summer of 2023, leaders at the highest levels of the university, including Penn State Health CEO Steve Massini, Chief Operating Officer Deborah Addo, and the hospital’s chief medical officer Robert Harbaugh, all of whom have since left those positions, as well as Kim, weighed severe punishment for Hohl, records show. They considered curtailing his ability to treat patients or removing him as director. (Prior to publication, Spotlight PA contacted these people directly and through Penn State’s communications staff. They did not respond to requests for comment.)
Instead, Penn State placed the director on a two-month performance improvement plan. He remains in the position, though his oversight of clinical care was quietly removed in May 2024. Penn State declined to explain why.
The consulting group hired by Penn State’s medical college to audit the cancer center’s research and working conditions helped draft a wide-ranging improvement plan in late 2023. Records obtained by Spotlight PA show the consultants were going to help update Penn State’s documentation systems, standardize some processes, and create a staffing plan.
But in early 2024, as the group was implementing the plan, Penn State abruptly ended the consultants’ contract, according to three people with knowledge of the situation. Penn State declined to say why, or specify what changes were made in response to the findings.
That summer, Kim told university trustees that Penn State plans to apply for federal designation in 2027.