Funding shortage shuts cancer trials

By Mike Nagle

- Last updated on GMT

Related tags: Nih, Finance

Up to 95 clinical trials testing experimental anticancer drugs may
have to be delayed or closed altogether because of federal funding
cuts, according to the Cancer Cooperative Groups.

The funding shortage is the result of a ripple effect beginning with the US government's 2008 budget proposal, which kept US National Institutes of Health (NIH) funding flat for the fourth year in a row. This caused one of the NIH centres, the National Cancer Institute (NCI) to suffer a budget cut and this, in turn, has affected the groups they fund, including the Cancer Cooperative Groups.

The cuts to the ten US groups (nine adult groups and one paediatric group) will affect up to 3,000 cancer patients and it is likely they will not be able to participate in another clinical trial.

As well as keeping overall funds essentially steady, the US President also recently signed legislation to reserve a significant proportion of agency funds for multidisciplinary research.

The NIH Reform Act 2006, signed last September, creates a so-called 'Common Fund' of up to 5 per cent of the agency's annual funds, which will be used for trans-NIH research. The money will come from the NIH's 27 centres and institutes, which will contribute an equal percentage of their individual budgets.

Combined with essentially flat government funding for the NIH as a whole, the Common Fund will reduce the number of new grants the NIH can afford to award, cutting a swathe through innovative research.

A spokesperson for the NCI, which receives the largest slice of the NIH budget, told DrugResearcher.com that 85 per cent of the NCI budget is already committed to multi-year grants. He explained that a budget reduction could have a ripple effect in future years, which would primarily affect newly awarded grants.

In the fiscal 2008 budget, the president proposed to keep NIH funding essentially level, requesting $28.85bn (€22.97bn) of funding for the NIH. Although that represents a $232m - or 0.8 per cent - increase over last year the estimated annual inflation rate of biomedical research is almost five times higher, at 3.7 per cent.

The funding shortage becomes even more apparent once the $200m reserved for the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria, is taken into account, leaving an actual increase of a mere $32m. The Common Fund is set to be 1.7 per cent of the total funds for 2008, which is nearly half a billion dollars. To put that in perspective, that is nearly as much as the NIH intends to spend on obesity research as a whole ($590m).

On top of flat funding, the Common Fund and research inflation, the spokesperson at the NCI also said that there are various "taps"​ that can erode the NCI budget, such as higher utility rates and funds to pay expenses at other Department of Health and Human Services agencies, such as the Centers for Medicare and Medicaid Services' telephone hotlines for the Medicare prescription drug plan. On average, an increase of approximately $30m must be budgeted to address these needs.

According to the NIH's Office of Portfolio Analysis and Strategic Initiatives, the Common Fund is intended to help "achieve a functional integration of the NIH by bringing together diverse components of the agency for a common scientific purpose for areas of science that cut across or fall between the missions of institutes and centers. The need for this type of functional integration is especially great in a time of both unprecedented scientific opportunities and limited resources."

The Association of American Medical Colleges (AAMC) said it:"fully supports the creation of a Common Fund to support trans-NIH initiatives,"​ although it "strongly believes that increases in this fund should not come at the expense of ongoing research programs, and we are pleased that the current legislation provides a reasonable rate of growth for the Common Fund that is linked to the growth of the overall NIH budget."

Although the President proposes a budget, it is Congress that actually passes legislation to provide funding. Congress only passed the fiscal budget for 2007 last week, with the NIH funded through a Congressional Continuing Resolution before that.

Related topics: Preclinical Research

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