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Inside Health Policy – Sequestration Could Take Toll on Cancer Research, Drug Approvals

Inside Health Policy – Sequestration Could Take Toll on Cancer Research, Drug Approvals


Cancer research advocates and lawmakers say the sequestration’s effects on the National Institutes of Health and the National Cancer Institute could have a devastating impact on the development of new cancer treatments

, with one stakeholder saying the mandatory across-the-board cuts could also impact FDA’s oncology drug review times — an area where the agency has traditionally been fast in reviewing products. The Obama administration signaled Friday that the upcoming sequestration could result in an 8.2 percent cut to the NIH budget, a scenario that United for Medical Research said “would jeopardize the entire medical research ecosystem, from research labs to private industry jobs to patients’ health.”

On Wednesday (Sept. 12), two days before the Office of Management and Budget unveiled its detailed analysis of the pending sequester, the American Association for Cancer Research released an annual progress report on cancer research that emphasized the need for continued research. At a press briefing, members of the organization said they were especially concerned about how possible sequestration cuts could affect research at health agencies like NIH, where they say the budget has already essentially been flat for the past decade.

“Right now the frustrating reality is that our ability to deliver the promise of science to patients is in peril due to a decade of stagnate budgets at the NCI and NIH and the looming threat of automatic budget cuts in January of next year, AACR’s CEO Margaret Foti said at the briefing. “As Congress addresses the tough spending decisions in the coming months, the decisions that they make should be reflective of the challenges that face our nation.”

Foti said the United States spends around $200 billion a year on treating patients for cancer while investing only $5 billion into cancer research. Factoring in biomedical inflation during the past 10 years, NIH has already lost $6 billion that would support research. If sequestration cuts mandated by the Budget Control Act take effect in January, the agency would have to absorb another 8 percent cut, the report said.

One of the report’s authors added that the budget cuts would come as cancer researchers are becoming more innovative and strategic in attacking cancer cells, and as FDA was approving more effective treatments.

“By exploring this growing body of knowledge about cancer biology, we’ve been more strategic and innovative than ever before in the way we attack cancer,” said Frank McCormick, director of the University of California San Francisco’s comprehensive cancer center. “This has quickened the pace of developing new ways to prevent, diagnose and treat cancer.”

He said that innovation was best highlighted by the fact that within the last 12 months the FDA had approved nine new oncology drugs, two of which were part of entirely new classes of drugs and another that treats pre-cancerous lesions on the skin, allowing patients to avoid cancer all together.

Further, McCormick said the majority of the new cancer treatments were more effective and less toxic than older treatments, which meant they were not only saving the lives of patients but also improving patients’ quality of life.

Another cancer research advocate said the sequestration cuts would not only put some research on hold but also impact FDA review times for oncology drugs.

“It is a very scary prospect,” said Friends of Cancer Research Executive Director Jeff Allen, who did not participate in the report. “I think having these sequestration cuts go through pretty immediately is concerning. I think where it will take a huge toll is that initially any new projects will be put back maybe years.”

Allen said if NIH, for example, had already allocated funds to a multi-year drug trial and that trial was in its second year when the sequestration cuts hit, the agency would be obligated to continue funding that trial before it could move ahead with any new research projects.

He added FDA will also come up against those budget cuts which could have a major impact on its review times for oncology drugs.

Last week, Tufts University released a study which found that during 2007-2011, FDA oncology drug approval times were 10 months shorter than those of the European Medicines Agency and that FDA typically had a 10-month shorter review time for oncology drugs than non-oncology drugs. Last year, Friends of Cancer Research published a similar study and Allen said if FDA’s budget were cut that pattern could change.

“If they face cuts in staff, it’s going to be hard for them to maintain those review times,” he said.

Lawmakers are also raising issues with the potential cuts to biomedical research. In a statement read at the briefing, Rep. Rosa DeLauro (D-CT) said the cuts could have an incalculable effect on American families.

“As this report suggests, our investments in lifesaving biomedical research have not kept pace with medical inflation,” the lawmaker said in the statement. “Unless we act before January, the deep automatic cuts that were a part of the Budget Control Act could mean a drastic cut to NIH and NCI as well as to many other fundamental priorities of middle class and working families all across this nation. The losses to human well-being if these cuts go into effect are incalculable.”

The Triple Negative Breast Cancer Foundation, a breast cancer research advocacy group, also praised the AACR report and said it would urge legislators to work together to look for alternatives to cutting cancer research budgets.

“Private foundations like ours do a lot, but a strong federal commitment to breast cancer research is crucial to find breakthrough therapies for patients,” said Lori Redmer, executive director of Triple Negative Breast Cancer Foundation. “Besides policy and regulation, an important form of commitment is federal investment in research, and looming reductions are of grave concern to the more than 25,000 women in the U.S. that will be diagnosed with triple negative breast cancer this year.”