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Tuesday, October 15, 2013

ONLINE FIRST: How Cancer Centers Are Coping with the Government Shutdown





Cancer centers have had to cope in numerous ways with the consequences of the government shutdown, most especially with the effect on research due to stalled National Cancer Institute grant applications and cancelled site visits.


In a few cases, centers are struggling with the closure of other NCI programs -- specifically, the Cancer Information Service, and a lack of communication about the logistics of NCI clinical trials that were under way at the time of the shutdown.


In addition, a huge concern is that the National Institutes of Health Clinical Center is not accepting new patients, including those with cancer.


“As long as the shutdown continues, the NCI will remain committed to advancing our common cause -- research to control cancer -- as best we can within the limits of the law,” NCI Director Harold Varmus, MD, said in an email sent on October 11 to NCI staff, grantees, advisors, and reviewers.


NCI staff members who are exempt from the government furlough are mostly in the organization’s intramural programs and are needed “to preserve ongoing research protocols, ensure laboratory safety, care for experimental animals, and, especially, serve our patients at the Clinical Research Center,” the NCI Director wrote.


However, with the shutdown, “the NCI’s grant review cycle could be significantly delayed, threatening a smooth restart of NCI’s support of extramural research, even if the NIH reopens relatively soon.”  


Grant Processing on Hold

While grant applications are being accepted at, the NIH Office of Extramural Research is discouraging submissions, and “applications will not be processed further until normal business operations are restored through Congressional appropriations,” the email continued. In addition, the Department of Health and Human Services is operating the “Payment Management System” so that individuals with existing grants with no restrictions can continue to access funds, he said.


The government shutdown happened “right at the turn of the calendar, so new grant submissions are problematic,” said Stan Gerson, MD, Director of the NCI-designated Case Comprehensive Cancer Center of Case Western University and University Hospitals Case Medical Center Seidman Cancer Center. “There’s no feedback or engagement, so it has slowed down the review process.”


Fred Hutchinson Cancer Research Center’s ongoing operational and administrative interactions with federal agencies are on hold, including the submission of federal grant applications, the flow of funds, and communication with federal program personnel, according to a statement from the center.


While NIH-funded clinical trials are proceeding normally at St. Jude Children’s Hospital, “long-term, the government shutdown could affect clinical trials currently in development and pending grants,” said a spokesperson for the center.


NIH-funded research also continues at the University of Texas MD Anderson Cancer Center, said Jim Newman, Director of External Communications. Grants yet to be funded and new grants submissions, however, remain stalled since the offices that process those grants remain closed, he said.


Nancy E. Davidson, MD, Director of the University of Pittsburgh Medical Center CancerCenter and University of Pittsburgh Cancer Institute, co-leads a committee that reviews new breast cancer trials for the NCI, but all activities were cancelled for October. “That means that new trial designs are being shelved until this crisis passes,” she said in a statement. “This may not affect a patient today but it will in the very near future.”


Cancelled Site Meetings

The NCI’s Division of Extramural Activities (DEA) has postponed several site visits to evaluate re-competing centers and large grant applications, as well as a dozen meetings to review grant applications, Varmus said.


Some centers -- for example, the Mayo Comprehensive Cancer Center and Georgetown University Lombardi Cancer Center -- have already experienced cancellations.


In a statement, Louis M. Weiner, MD, Director of the Georgetown Lombardi Comprehensive Cancer Center, said, “The cancellation of the NCI site visit for our core grant renewal is an inconvenience and is disappointing, but doesn’t change our day-to-day mission of conducting important cancer research and patient care. We will work with the NCI when the government reopens to determine our next steps.”


“It’s important to keep this in perspective,” he continued. “I think many will acknowledge that what is potentially disastrous is the ongoing research that has been either lost or destroyed.”


One Center Does Have Several Trials in Limbo

While most of the cancer centers contacted for this article weren’t experiencing any interruptions to their current clinical trials, Case Comprehensive Cancer Center was an exception: “We’re struggling with an issue unique to us,” Gerson said. “The center had been studying a drug obtained from the NCI in three or four small early-phase clinical trials that were actively recruiting. However, just prior to the shutdown, the NCI informed Case CCC that the trials should stop because the drug supply was running out.


“But they didn’t offer us a solution or any mechanisms for dealing with the problem,” he continued.  “We don’t know who made [the drug] for them. And now, because of the shutdown, we’re frozen out. We don’t have access to the drug, and patients are stuck in the middle of a clinical trial.”


This is an example of the types of issues that impact the day-to-day activities of cancer centers, he said. “We can’t do without the NCI for a day, let alone several weeks.”


A Shuttered Information Service

Another consequence of the government shutdown is Fred Hutchinson having to place 86 of its employees, who were fully funded by federal contracts to operate the NCI’s Cancer Information Service, on temporary leave.


According to a statement form the center, these employees provided a free, bilingual service and responded to more than 10,000 phone calls, emails, and live-help chat sessions a month from cancer patients and their families, as well as from health professionals and the general public.


No New Admissions to NIH Clinical Center

Care for patients already enrolled in the 1,437 clinical studies under way at the NIH Clinical Center continues during the government shutdown. However, the center is not accepting new patients unless they have a condition deemed to be imminently life threatening or unless they meet the eligibility criteria for an existing protocol. Patients may also be considered if the protocol offers some hope for an improved outcome, according to an NIH statement.


Based on these criteria, the center enrolled 12 patients between October 1 and 8. Usually, about 200 new patients are enrolled weekly -- approximately 15 percent of those are children, and about 33 percent of these children have cancer.


“We’re concerned about the NIH not accepting new patients at the center,” said J. Leonard Lichtenfeld, MD, MACP, Deputy Chief Medical Officer of the American Cancer Society. While the ACS call center has not seen an increase in complaints about access to government-funded clinical trials, as the shutdown continues potential problems may arise, he said.


In addition to not accepting new patients, basic and translational research and the initiation of new protocols are also on hold at the NIH Clinical Center. Other suspended activities include training of graduate students and postdoctoral fellows, scientific meetings at NIH facilities, and travel of NIH scientists to meetings.


Problems Extend Beyond Shutdown

Even when the government reopens, cancer centers will have to deal with funding challenges, Gerson said. “There is no continuation budget for the NIH, so new commitments cannot be made.”

Moreover, the sequestration that was in place before the shutdown is already negatively impacting scientific discovery.

The debt limit also looms as a potential source of concern, Lichtenfeld said, adding that not raising it may have a negative impact on federally funded cooperative medical groups: “This may have a direct impact on patients, so this issue is on our radar screen,” he said. 

One Patient’s Experience

An early indicator of the potential challenges awaiting patients has been illustrated through the much-publicized experiences of Michelle Langbehn, 30, of Auburn, California, who has fibrosarcoma. She was trying to enroll in an NIH Clinical Center trial at the time of shutdown and was told that if she qualified for the study she would not be able to receive treatment until the government reopened. “The NIH offers so many great potentially life-saving trials that can’t enroll patients because of the shutdown,” she said.


Her physicians had initially detected a tumor on her kidney in 2011 when she was 12 weeks pregnant with her daughter, now a year and a half old. At that time, surgeons removed half of her kidney and the tumor, which was misdiagnosed as benign.


In February 2012, she gave birth, and shortly thereafter began to experience neck pain, the result of metastasis to her spine and skull. She underwent spinal fusion and tumor resection in May 2012, followed by radiation and chemotherapy. After nine months of undergoing cycles of gemcitabine and docetaxel, her oncologist told her she could continue her current regimen, start oral chemotherapy, or consider a clinical trial.


“Since my immune system was recovering [more slowly] after each cycle of Gemtax [gemcitabine/paclitaxel], I felt it was time to look at the clinical trials available,” she said. She applied for a study evaluating cabozantinib at the NIH Clinical Center. “It showed promising results for other types of cancer, and there was some preliminary data that showed it might be promising for me, so I contacted the clinical trial coordinator and immediately started working on the paperwork.”


Her files were soon in order, but a week before the shutdown the trial coordinator informed her that while her records would still be evaluated, her potential enrollment would have to be put on hold if the government were to stop operating.


She has since been informed that she isn’t eligible for the study and is extremely limited in what other trials she can investigate due to the ongoing shutdown -- “I’ve started looking at other avenues, but the vast majority of trials go through the government,” she said.


Langbehn stressed that having the full support of her oncologist during this process has been invaluable. “My oncologist has been supportive and fantastic, but patients are really left to be their own advocate,” she said, adding that she also has a tremendous amount of support from her friends and family.


Even if the government were to open tomorrow, Ms. Langbehn noted that the process of getting research under way would be like, “starting up a train”-- “You have to get that momentum going with getting everything reopened. It’s not going to be a fast process.”