Federal funding and the 40 years’ war on cancer

Government bureaucracy may be thwarting funding of breakthrough cancer research

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The story in Cleveland's Plain Dealer was headlined "Cleveland State University professor's promising cancer research hits an academic wall," and suggested that tortuous bureaucracy at the National Institutes of Health's (NIH) National Cancer Institute (NCI) was thwarting funding of breakthrough research by Dr. Michael Kalafatis, a university professor and research biochemist.  

On the university's website, the "gee-whiz" aspect accelerates: "Over $5 billion is invested annually by the federal government alone in research to cure cancer, and a significant number of researchers are working tirelessly to think about what to do with these abnormal cells. How do they develop? Are we born with them or do they grow over time? Can you get rid of them? Can you stop them from turning deadly?†The questions are endless. Dr. Kalafatis believes he has found an answer and that it is possible to kill abnormal cancer cells without damaging the surrounding healthy cells. Dr. Kalafatis has discovered a unique application for a substance he calls CancerX, that has consistently shown promise in extinguishing cancer."

The article goes on to relate Kalafatis' success with in vitro experiments in which CancerX "killed the abnormal cancer cells," followed by similar results in vivo in collaboration with scientists from the Taussig Cancer Institute at the Cleveland Clinic, where results achieved "reduction and eradication of seven different types of human cancer cells implanted in mice (xenografts)." Kalafatis submitted his findings to the Developmental Therapeutic Program (DTP) at the NCI to independently substantiate his evidence. As reported on the website, "the first two rounds of tests achieved successful results on 52 different strains of human cancer cells."

In the typically collegial world of academic research, the first question may be, why cloak the molecular identity of "CancerX" in secrecy? One reason is revealed in speaking with Kalafatis, who laments that the molecule—a type of CK2 inhibitor—is patented, and the patent holder has, in effect, barred him from its further use. He is currently negotiating with the patent holder and notes that the recent publicity given to his work has helped in this process.  

The second question may be, "Is this another example of benchtop fusion?"—a one-off reported result that sounds too good to be true? While the jury is still out regarding an answer in the case of Kalafatis' research, the NIH and NCI are known to be skittish about funding transformative research.

A New York Times article—part of its series titled "Forty Years' War," published June 27, 2009, noted that "Among the recent research grants awarded by the National Cancer Institute is one for a study asking whether people who are especially responsive to good-tasting food have the most difficulty staying on a diet. Another study will assess a web-based program that encourages families to choose more healthful foods. Many other grants involve biological research unlikely to break new ground. For example, one project asks whether a laboratory discovery involving  colon cancer also applies to breast cancer. But even if it does apply, there is no treatment yet that exploits it."

The NCI has spent $105 billion since President Richard M. Nixon  declared war on the disease in 1971, the Times points out, while the American Cancer Society, the largest private financer of cancer research, has spent about $3.4 billion on research grants during the period. The Times quotes Dr. Raynard S. Kington, at the time acting director of the NIH, which includes the cancer institute, as saying, "We have a system that works overall pretty well, and is very good at ruling out bad things—we don't fund bad research," he said. "But given that, we also recognize that the system probably provides disincentives to funding really transformative research."

One problem may be inherent in the way government agencies work. For example, in November 2008, the NCI launched the Advanced Technologies Partnerships Initiative (ATPI). Among the collaborations announced so far is the effort by Geospiza and SAIC-Frederick Inc., a government contractor for the NCI in Frederick, Md., to adapt Geospiza's software platform to a new generation of rapid, high-resolution gene sequencing technology to potentially accelerate cancer research and help develop new treatments—hardly a groundbreaking concept. In fact, among its 14 announced partnerships, only three are directed toward developing cancer therapies or treatment.

When queried, an ATPI spokesperson says work is ongoing and no results have been published as of yet.

Even renowned researchers such as Dr. Paul Bunn, a James Dudley professor at the University of Colorado and executive director of the International Association for the Study of Lung Cancer, are frustrated by the relative lack of funding in their field. He notes that lung cancer was formerly self-induced and refractory to treatment, but that neither circumstance any longer applies.

The era of personalized medicine has arrived, and lung tumors are being routinely biopsied, with the epithelial growth factor receptor (EGFR) status of particular significance. Erlotinib and gefitinib work 75 percent of the time, he says, with some patients still benefitting after seven years of use. A newer drug, crizotinib, is an ALK inhibitor under study in patients with advanced non-small cell lung cancer (NSCLC) carrying the echinoderm microtubule-associated protein-like 4 anaplastic lymphoma kinase (EML4-ALK) fusion gene. About 5 percent of patients with lung cancer or NSCLC carry the EML4-ALK fusion gene. Patients with this gene inversion are typically non-smokers who do not have mutations in the EGFR gene. Approximately 4 percent of the 220,000 Americans diagnosed with lung cancer each year have the ALK fusion gene, and 45,000 newly diagnosed NSCLC patients are ALK-positive worldwide.

"More money could be well spent," Bunn says.

He points out that new drug therapies improve outcomes, and when new companies are spun out of academia, they create economic opportunities and jobs. In fact, the hotly disputed federal stimulus has created an ARRA-NCI funded mechanism referred to as Grand Opportunity (GO) grants, one of which is funding the Lung Cancer Mutation Consortium, comprising 13 leading cancer centers which will investigate 10 mutations, with all work being done in CLEA labs, then treat each case with a specific therapy— erlotinib, gefitinib, crazotinib or something brand new. In the first year of the two-year-funded effort, 700 patients with stage IV adenocarcinoma out of the targeted 1,000 have been recruited, Bunn notes, but with just one more year before funding runs out, achieving breakthough results may be, as Lord Wellington said of his chances at Waterloo, "a damn near-run thing."

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