© Oxford University Press 2007.
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National Cancer Act: A Look Back and Forward
Thirty-five years have passed since a stroke of President Richard Nixon's pen gave the National Cancer Institute special status within the National Institutes of Health. At the 1971 signing of the National Cancer Act, the NCI budget was $200 million and fiscal constraint was the theme of the day. Today, the budget is $4.8 billion, and again, budget worries loom large.
While many of the same challenges remain—access to high-quality cancer care, competing research priorities, and inconsistent funding—some prominent researchers argue that the National Cancer Act, by vaulting cancer to the top tier of the national agenda, paved the way for great accomplishments.
"The National Cancer Act was quite revolutionary," said Margaret Kripke, Ph.D., of the University of Texas M. D. Anderson Cancer Center. "It led to development of funding initiatives that have really supported the cancer research and treatment community. Simply having the dollars available designated for cancer research is really very important."
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Kripke is part of the three-member President's Cancer Panel, which along with the National Cancer Advisory Board, is one of the so-called special authoritie's that the National Cancer Act provided to help NCI move more quickly—and with appropriate advice—to combat cancer. The act also made the NCI director a presidential appointee who administers the National Cancer Program and authorized NCI to submit a budget directly to the president. It solidified the cancer centers program by giving them a broad mandate to be "centers for clinical research, training, and demonstration of advanced diagnostic and treatment methods." The act established 15 cancer centers; today there are 61 NCI-designated cancer centers.
"There's been a whole host of remarkable achievements in a fairly short period," said Richard Schilsky, M.D., chairman of the Cancer and Leukemia Group B cooperative group and associate dean for clinical research at the University of Chicago. "We clearly have many more effective drugs for treating cancer." Since the 1970s, cures have been developed for many childhood cancers, virtually all adjuvant therapy for solid tumors were developed, and bone marrow transplants became a potential cure for certain hematologic malignancies.
Between 1949 and 1971, about 30 drugs were approved for cancer patients. Today, more than 300 exist. Schilsky points to two drugs approved last year for kidney cancer, a disease that for decades was one of the most difficult cancers to treat. "Now we are prolonging lives of kidney cancer patients," he added. Plus, median survival for colorectal cancer has more than doubled because of new treatments that improved upon the only option that existed from 1950 to the 1990s—5-fluorouracil.
Schilsky said he was also struck recently while chatting with a patient in the clinic receiving intravenous cisplatin—and eating lunch. "Cisplatin is the ‘gold standard’ for producing nausea and vomiting," Schilsky noted. "For years, patients were retching into buckets. But here was a patient watching television and eating lunch while getting the drug. Our supportive care therapies are dramatically better than before.
Researchers are also buoyed by the new figures showing that, along with mortality rates, the actual number of cancer deaths has declined 2 years in a row—despite the growth and aging of the U.S. population.
Impact Could Be Bigger
Several scientists see upcoming challenges as a signal that NCI's priorities need to shift if the country wants to see deaths continue to decline. One is the growth of the elderly population, ages 70–100. "We're not well prepared to take care of this population, whose care is complicated by comorbidities," Kripke warned. "The impact of that on cancer centers and oncologists is going to be really quite dramatic."
Other challenges are more longstanding, such as access to high-quality care for poor as well as rich. Otis Brawley, M.D., director of the Georgia Cancer Center at Emory University, has published studies showing that "6% of black women in metropolitan Atlanta who are diagnosed with early-stage breast cancer don't get surgery to remove the tumor."
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"We have a whole bunch of people who aren't getting the fruits of research that came to us 100 years ago," Brawley said. "We are incredibly concerned that colon cancer has become much more treatable, even curable, but there are people who can't afford the cure." And the issue is more than access; it's quality as well. "There's a tendency to think that every mammogram is the same. But the equality of the film and the person reading it can be highly variable in the United States," he said.
If we had adequate breast cancer screening and care for all women, Brawley contends, 20% fewer women would die of the disease each year. If 40,000 women are dying of breast cancer each year, 8,000 lives could be saved. He expects the same kind of impact would be felt in colorectal cancer as well—if screening and the new curative drugs were available to all who needed them.
"There's no question that the community is sending us and Congress a very clear message that we have a lot of problems with health care delivery and huge issues around cancer in terms of access," acknowledged NCI Director John Niederhuber, M.D. "We need to do a better job of developing technologies of early detection and ways to screen for and prevent cancer. As part of our responsibility, we have to add to the equation research to get this access question addressed."
Lee Hartwell, Ph.D., president and director of the Fred Hutchinson Cancer Research Center since 1997, wants to see more focus on prevention. "The whole gestalt of our approach to cancer control is too dominated by the pharmaceutical companies," says the 2001 Nobel Prize winner. Using drugs as the primary weapon against cancer has not been very effective, given the billions of dollars spent by both NCI and big pharmaceutical companies. "We ought to admit that this is not the panacea for cancer and have a much more balanced approach to the whole problem, where prevention and earlier detection has a much greater chance of providing benefit."
Most patient advocates agree that prevention is the key. "We need to bring the mission back to ensuring that our efforts are in the direction of improving patient outcomes," said Carolina Hinestrosa, executive vice president for programs and planning at the National Breast Cancer Coalition.
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Her model is the Department of Defense (DOD) Breast Cancer Research Program, which, with a total budget of $1.8 billion, has awarded about 4,500 grants. Its mission is the eradication of breast cancer, and advocates are involved at every level. The focus of the DOD program is on innovation, to challenge conventional paradigms. "I talk about the DOD model because we really strongly believe that it is very much needed," she said.
Olufunmilayo Olopade, M.D., a professor in the departments of medicine and human genetics at the University of Chicago, agrees that the emphasis should be on prevention. Instead of developing drugs with exorbitant prices, she'd like to see a national policy to reduce obesity.
Olopade won a 2005 MacArthur fellowship for her research on patterns of gene expression in breast cancer patients in Africa and the United States. She hopes it will enable doctors to bring treatment to a personal level. "I think our society is individualistic enough for people to take personal responsibility for their own health." She said people should be able to go to the doctor and find out their risk for certain cancers, just like they get their blood pressure and cholesterol levels now. Then they can work to reduce the risks that are relevant to them. "Science that gets us to that point should be the investment."
The field of biomarkers may have its detractors, but Hartwell has great hope for the field as a potential entrée to prevention and early detection. He said NCI is supporting what it should in biomarker discovery. "We'll know in 3–5 years whether there's a lot of fruit on that vine." For biomarkers, science is at the early stages of testing technologies and protocols. "Once we get it working, there will be lots of biomarkers." He likened it to the Human Genome Project. "Once automation and quality control were in place, the whole thing took off. We're assessing our technologies now and developing new methods for assaying proteins sensitively."
Special Priority
The goal of the National Cancer Act was to establish a more direct relationship between NCI and the president. "When it first started, members of the President's Cancer Panel had great access to the White House," said Kripke, who is currently serving her second term on the panel. "That obviously has diminished over the last few years. I'd like to see cancer back up on the national political agenda. That's what drives funding and drives progress."
The "bypass budget" hasn't been a direct line to the president either, but it has served a different purpose, added Richard Klausner, M.D., NCI director from 1995 to 2001. He said he's particularly proud of how he revamped the bypass budget during his tenure. "I think the bypass budget and the way we articulated extraordinary opportunities and put a cost on it was very influential in what became the doubling of the NIH budget," he said. "It was never meant to be a true budget. But it engaged people on the congressional side and all stakeholders, which makes it a very powerful authority."
From his new perch as NCI director, Niederhuber said his favorite authority, granted a few years after the National Cancer Act, is the federally funded research and development center in Frederick, Md. NCI–Frederick does basic research with a heavy emphasis on technology and drug development. It's run by the government contractor SAIC.
"It provides the NCI the ability to work in a contractual fashion to accomplish things in a more rapid way," Niederhuber said. One example is NCI's RAID (rapid access to interventions development) program. RAID was launched in 1998 to help investigators develop small-molecule drugs and biologics. To date, 13 small-molecule and 11 biologic agents developed with RAID help have proceeded to clinical trials.
All About the Money
Whatever the main concerns are within the cancer program, "we have to recognize that cancer is a huge, huge problem, and we are grossly underfunded," explained Larry Norton, M.D., deputy physician in chief for breast cancer programs at Memorial Sloan-Kettering Cancer Center.
Norton says the nation's priorities are off kilter. The drug companies, philanthropies, and the federal government together spend just $11 billion per year on cancer, he said. In the same period that the NIH budget doubled, the tobacco industry more than doubled its advertising and promotional expenditures, spending $15.2 billion in 2003, according to the Centers for Disease Control and Prevention.
"We need the American public to become appropriately outraged," Norton says.
Others aren't so sure that asking for more is appropriate. "Because NIH has been growing so much since its founding, that's the model we're in and it's not sustainable," Hartwell said. "It would probably be better if there were a clearly defined inflation rate for biomedical research that was maintained without big fluctuations—then the system would probably adapt."
Niederhuber would be happy to just keep up with inflation when other pressures on the nation's budget, like the war and bioterrorism, are so great (the president's 2008 budget request is slightly down, from $4.791 billion under the continuing resolution to $4.782 billion under the proposal submitted to Congress last month). Then "when the storm clouds clear," the various parties can agree on an appropriate growth rate for research and development in industry and academia—"maybe inflation plus 0.5% or 1% per year. It would put this investment on much more stable ground and this would be seen by young people as a stable opportunity for a career."
"We are in an economic crisis at a time of extraordinary potential," said Klausner, who recently launched a life sciences investment fund in Seattle called the Column Group. "I don't think the answer to that is simply more money." He called the current model of research funding "totally elastic," arguing that every time the budget is increased, demand increases out of proportion. "We can't tell Congress we have to grow infinitely. It's going to take a very hard, courageous, and honest look at how decisions are made, how strategy is set, and what is the balance between truly collaborative problem-solving research and individual investigator–initiated research."
"The most important thing is to be able to end programs that have run their course and be able to use the funds for new things and change directions," Hartwell offered. He admits that can be difficult with the amount of congressional intervention he sees.
"My advice [to the NCI director]: Turn off the phone."
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