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Liddy Shriver Sarcoma Initiative

The Shocking State of NCI Funding

An ESUN Article

Joan Darling, PhD
Environmental Consultant
Lincoln, Nebraska

"There are three kinds of lies: lies, damn lies, and statistics."
Popularized by Mark Twain, origin unknown.

Editor’s Note: Joan is a biologist. She is also mother of two, one of whom is a ten-year survivor of alveolar rhabdomyosarcoma treated on protocols developed with funding from the NCI. Joan is an active volunteer for a variety of childhood cancer and sarcoma organizations and spends much of her spare time as Co-List manager of the ACOR Rhabdo-Kids mailing list, as a Patient Advocate for the Children's Oncology Group, and as a board member of the Sarcoma Alliance.

The NCI and Its Budget

At a time when science is on the verge of making breakthroughs in understanding cancer genetics and biochemistry and translating these breakthroughs into more effective and less toxic treatments, the budget of the primary Federal agency that funds cancer research and clinical trials, the National Cancer Institute (NCI) has been significantly cut from the level of funding it has requested every year since 1997. The shortfall in Fiscal Year 2007 funding for the NCI is more than $1.1 billion. NCI funding has been responsible for most of the advances in the understanding of cancer biology and increases in survival rates that have occurred during the last 25 years. Some say that increases in NCI funding are not needed. I believe this is the exact opposite of what Congress should do. It should fund the NCI at the level of funding that it has requested to get its job done.

The National Cancer Institute's Mission (as described on its website) The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government's principal agency for cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation of state-of-the-art cancer treatments into clinical practice. The National Cancer Institute coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients. Specifically, the Institute: Supports and coordinates research projects conducted by universities, hospitals, research foundations, and businesses throughout this country and abroad through research grants and cooperative agreements. Conducts research in its own laboratories and clinics. Supports education and training in fundamental sciences and clinical disciplines for participation in basic and clinical research programs and treatment programs relating to cancer through career awards, training grants, and fellowships. Supports research projects in cancer control. Supports a national network of cancer centers. Collaborates with voluntary organizations and other national and foreign institutions engaged in cancer research and training activities. Encourages and coordinates cancer research by industrial concerns where such concerns evidence a particular capability for programmatic research. Collects and disseminates information on cancer. bul let Supports construction of laboratories, clinics, and related facilities necessary for cancer research through the award of construction grants.

There is a need to restore and increase the NCI budget

I am most familiar with the implications of NCI funding cuts from my volunteer work with a cancer cooperative group. Pooling resources is particularly important for the less common cancers, such as pediatric cancers and adult sarcomas, as it produces results faster and allows more treatments to be tested. The Children’s Oncology Group (COG) is a cancer cooperative group – a group of health-care institutions that combine their resources in order to conduct clinical trials of new treatments. The bulk of the funding for the cancer cooperative groups comes from National Cancer Institute (NCI) grants. The NCI is part of the National Institutes of Health (NIH), an agency of the Federal Government.

Pediatric cooperative groups have been in existence for the past 50 years, and in that time they have been primarily responsible for the increase in the survival rate for pediatric cancers from about 10 percent to almost 80 percent overall (see Progress in Childhood Cancer). Right now, the COG includes over 200 hospitals, and is the only U.S. cooperative group that designs and implements clinical trials for pediatric cancers including sarcomas (see COG Institutions).

Over the last couple of years, there has been an alarming reduction in funding for the COG and other cooperative groups, due to cuts in the NCI budget. Despite the documented success of pediatric cooperative group clinical trials, the COG has had to postpone or cancel new clinical trials, and will have to cut accrual in trials by 400 children this year (personal communication). The Southwest Oncology Group (SWOG) and the Eastern Cooperative Oncology Group (ECOG) have both announced that they are closing trials for sarcoma patients and other types of rare tumors as a result of funding (Ref. 1).

Despite such alarming decisions, there may be resistance on the part of some legislators who are desperate to cut the federal budget to continue to fund the NCI at the levels that are needed. I believe that they do not understand some of the issues involved, as statistics have been used that appear to show that NCI does not need further funding. So here are some opinions, some facts and, I admit, some statistics for those who dispute the need for an increased NCI budget.

Claim: The NIH budget doubled during the early 2000s, so further increases in the NCI budget aren’t needed.

There are several inaccuracies in this statement:

1. The NCI budget didn’t double during the NIH doubling years
   During the NIH doubling period of 1998 to 2003, the NCI budget went from $2.55 billion in 1998 to $4.6 billion in 2003 (Ref. 2). Without considering inflation, this was an increase of 80 percent, not the 100 percent increase that doubling would entail. If inflation is taken into consideration, this increase is even less. Furthermore, from 2002 to its peak in 2005 at $4.87 billion, the NCI budget increased less than 20 percent, and even those gains started being reversed in 2006 (see Table 1 below).
   
   
2. Funding levels are declining and are not adequate to meet NCI needs
   The fiscal year FY 2007 budget is proposed for $4,753,609,000, a decrease of $39,747,000 below the FY 2006 enacted level of $4,793,356,000 (Ref. 3). With the exception of 1998, when the amount appropriated still increased from the previous year, 2006 and 2007 are the only two years since 1973 that NCI has requested less in funding than in previous years (Ref. 4). I do not know the rationale for this, given the need for more expensive research into targeted therapy.
   
   This FY 2007 budget amount is even worse when compared to the original budget request for 2007. Table 1 compares what the NCI has requested and what has been funded from 1997 to 2007 (Refs. 4, 5, and 6). During the period of doubling (1998-2001), NCI was funded at between 86 percent and 94 percent of what was requested (bolded years). However, from 2002 to the present, the NCI has been funded at only between 78 and 83 percent of what was requested.
   

   Table 1: NCI Budget Requests and Appropriations, 1997-2007

   Year	NCI Budget Requested (billions)	NCI Budget Appropriated (billions)	Percent Funded
   1997	2.98	2.37	80
   1998	2.70	2.55	94
   1999	3.19	2.92	92
   2000	3.87	3.33	86
   2001	4.13	3.76	91
   2002	5.03	4.19	83
   2003	5.69	4.62	81
   2004	5.98	4.75	79
   2005	6.21	4.87	78
   2006	6.17	4.79	78
   2007	5.89	4.75 (proposed)	81 (proposed)

   
   
   
3. In my opinion the NCI is funded at shockingly low levels given the prevalence of cancer in the U.S.
   The table below compares the NCI budget as a percent of the total US budget in 1997, just before the period of NIH doubling, with the proposed budget in 2007. It also looks at the amount adjusted for inflation (constant 2000 $), and as a percent of the total US budget.
   
   It is clear that the period during which the NIH budget doubled (1998 to 2003), the NCI budget increased, but at a smaller rate. The 2003 NCI budget was only 80 percent larger than the 1997 budget, instead of 100 percent larger if it had doubled. The increase in the NCI budget is even smaller when inflation is taken into consideration.
   
   Many of the increases in the NIH budget were for other programs, as can be seen by the steadily eroding percentage of the NCI budget compared to the NIH budget – a drop from 23 percent of the NIH budget in 1997 to only 17 percent of the budget in 2007. Please note that the NCI budget is a fraction of a percent of the total U.S. budget – at most about one-fifth of one percent. Also note that the percentage is slipping back to where it was ten years earlier.

Table 2: NCI Budget Relative to NIH and US Budgets

Year	Total US Budget Real$ (billions) *	Total US Budget Constant 2000$ (billions) *	NIH Budget Real$ (billions) *	NCI Budget Real$ (billions) **	NCI Budget Constant 2000$ (billions) ***	NCI Budget as percent of NIH Budget ****	NCI Budget as percent of US Budget ****
1997	1,600	1,700	10.6	2.4	2.6	23	0.15
2001	1,900	1,800	16.4	3.7	3.5	22	0.20
2003	2,200	2,000	21.8	4.6	4.2	21	0.20
2006	2,600	2,200	26.7	4.8	4.1	18	0.20
2007 (proposed)	2,800	2,300	27.0	4.7	3.9	17	0.17

* (Ref. 7). ** (Ref. 4), *** NCI budget in real dollars times (total US budget in 2000$/real$) for each year. **** NCI budget divided either by NIH budget or Total US budget (real$) for each year. 

Real$ vs. Constant 2000$ We all know how inflation makes every dollar we earn go less far each year. Just as a gallon of milk or a gallon of gas costs more in 2007 than it did in 1997, so does the cost of a research laboratory, or a clinical trial. Comparing real dollars does not take inflation into account when trying to determine funding trends. By comparing all the amounts in constant dollars, in this case relative to the year 2000, we can get a better picture of the "buying power" of the NCI budget. For specific information on biomedical research inflation, see the Biomedical Research and Development Price Index.

The table above frankly shocked me. I had not realized how few dollars the Federal Government spends per capita on cancer research. Funding levels are incredibly inadequate considering the significance of cancer in our society. In my opinion the NCI is funded at outrageously low levels given the prevalence of cancer in the U.S.

If the population of the US is approximately 300 million, then the 2007 proposed budget spends less than $16 per person for the NCI. Considering that over 41 percent of Americans might develop cancer at some time during their lives (Ref. 8), we all should be concerned about this pitiful amount of funding. If we just consider the 10 million Americans (Ref. 9) who will be diagnosed this year or who are survivors of cancer, the proposed funding for 2007 is $475 per person with cancer. Especially knowing the human toll cancer takes, that seems horrendously low.

This is a war, and just as others argue for other wars, we can not say oh, well, we gave money last year, forget it this year. The battle goes on, and those who have been fighting the battle along with those who will join in the future, are relying on us not to give up.

Claim: NCI funding should support basic research, not drug trials.

I think there may be confusion between "drug trials" and "clinical trials". Although some clinical trials test new drugs, most do not. This confusion apparently comes from a misunderstanding of the nature of cancer clinical trials designed and implemented by NCI-funded cooperative groups. My knowledge comes mostly from being involved in the COG clinical trial process, but I believe this is true for other cooperative groups as well. Although most of the children enrolled on clinical trials are not on trials of new drugs, COG has a very active developmental therapy program that currently has several trials of new agents available for kids with solid tumors such as sarcomas.

For the most part, COG clinical trials do not test new drugs. These trials test new treatment protocols that put together multi-modal treatments in different combinations, dosages, or timings. Some might not test any drugs, but rather look at radiation and surgical treatments. Others might look at combination chemotherapy in conjunction with other modes of treatment, possibly by including an additional drug to standard treatments. Still others might look at survivor health, supportive care during treatment, or even collect tumor samples for use by basic researchers.

I was once a believer that most cancer research funding should support basic research, but my volunteer time with the COG has made me aware that translational research – the ability to take the knowledge gained from basic research and translate it into clinical benefits – is just as important.

Clinical Trial Cost Clinical trials funded by NCI grants will be sorely hurt if funding is cut. In talking to researchers, I have found out that NCI funding covers only part of the cost to a hospital of opening, meeting regulatory requirements, collecting data, conducting and administering a clinical trial. This is true for cooperative groups in general, and further funding cuts could put many of these trials in jeopardy.

I can not go into depth here with an explanation of why clinical trials need to continue to be funded by NCI. Instead, I refer anyone interested to "Restructuring the National Cancer Clinical Trials Enterprise," which is a June 2005 report of the National Cancer Advisory Board’s Clinical Trials Working Group. It is important to note that the recommendations in this study will be implemented only if the NCI requested "new investments" are funded as part of NCI’s Budget Request for Fiscal Year 2007. At the moment, they are not.

The cancer cooperative groups are proposed to be cut by 10 percent from the previous budget. Considering the number of trials run by these groups, this is likely to result in approximately 95 fewer trials this year, either by being closed early, or by not being opened. As mentioned earlier, COG has been told to cut enrollment by 400 children.

If funding for the existing clinical trial structure is cut without these new initiatives being funded, then the Federal Government will be dismantling a system that worked (although possibly not as efficiently as desired) but will not be replacing it with anything else, much less something better.

Claim: The pharmaceutical companies will develop new treatments, so the government doesn’t need to fund drug trials.

It is extremely unlikely that for rare cancers such as sarcomas, or for childhood cancers, pharmaceutical companies can or will pick up the slack without major incentives from the government to do so. To the best of my knowledge, the cuts in NCI funding are not balanced by any incentives for the pharmaceutical industry. The reason is simple – pharmaceutical companies are driven by the profit motive, and it is extremely expensive to develop new drugs. Thus, their research will be for the "big" cancers that affect many people. In addition, there are additional layers of regulatory protection for research on children. Without incentives, pharmaceutical companies generally steer clear of doing studies on children. In fact, most of the chemotherapy agents used on children now are used off-label. It is almost always through the cooperative group trial system that tests for safety or efficacy are done on children, and most children are treated on trials sponsored by the NCI.

As an example, I searched NCI’s Clinical Trial Database on Feb. 10, 2007 for Soft Tissue Sarcoma, Child clinical trials for treatment. I found 36 trials listed, of which 28 were in the U.S. Here is the breakdown of those 28 trials:

• 5 were COG trials, which are at are multiple institutions
• 6 were at 2, 3, or 4 institutions
• 17 were single hospital trials

Of these 28 trials, here is the sponsorship:

• 14 are funded by the NCI
• 1 by NIH
• 2 and a half are sponsored by pharmaceutical companies (the other half of the third is funded by NCI)
• The rest were sponsored by the institution

Therefore, of 28 U.S. trials for children with soft tissue sarcoma that are listed, only three had any pharmaceutical company connection. Of the 11 clinical trials being run at more than one institution, 9 are funded by NCI. Thus if NCI funding for these trials is cut, access to trials will be seriously reduced, more than just the number of trials would indicate. Families would either have to travel to a single institution that offers the trial, which might not be possible, or forgo getting what could be the best possible treatment for their child. The loss of NCI support without some sort of encouragement of private funding would be devastating to these children and their families.

Claim: Increased funding will not result in faster advances in cancer treatment.

At the moment, NCI funds less than one-tenth of the research proposals it receives. In talking to cancer researchers, I’ve found that many of the proposals that are not funded receive "excellent" ratings by peer reviewers, but there is just not enough money to fund them. Established experts are not getting funding due to cuts, and this has the potential to turn an entire generation of young researchers away from trying to start up laboratories focused on cancer research.

Looking at the numbers for Fiscal Year 2007 alone (see tables above), we can see how large the shortfall will be:

Initial NCI request (billions)	$5.89
Funding at same level as last year, including increase for inflation	$4.97
President’s request	$4.75

Thus, compared to what NCI has asked for, the shortfall is $1,140,000,000. Compared to what was funded this year, the shortfall is $220,000,000. Compared to its inflation adjusted high, it will be down $2,800,000,000. How can these numbers not be disastrous?

Will additional research funding result in more progress? It has to. After all, the ONLY way that advances in cancer treatment will be made is through research, and the more lines of research that are being followed, the more likely that breakthroughs will be made.

Claim: Money for NCI stays in DC, and does not support cancer research throughout the country.

This is false. NCI supports cancer research throughout the country. See Ref. 10 for details on how much funding has come back to your state.

Claim: Private funding will step in to fill the gap.

The amount of funds needed to make up the shortfall is so large that one can not expect individual contributions to make up for cuts in NCI funding. This is particularly true for pediatric cancers. Children with cancer can not advocate for themselves, and their families are often financially strained by the demands of treatment. Many parents, myself included, must quit their jobs to take care of their child during treatment. It is not likely that they will be able to provide the many millions of dollars needed to fund all the research that needs to be done.

Conclusion

In my opinion, the most tragic result of the NCI funding cuts is that it hurts those most in need of Federal support. It is the rarest cancers, such as sarcomas and childhood cancers, that will be – that already are - feeling the pinch, and these are the least likely to find funding from other sources. There are enough people with the "big" cancers that fundraising and the pharmaceutical industry will step in to fill a void. But frankly, there isn’t another likely source of money sufficient to meet the needs of research into "little" cancers such as sarcomas and childhood cancers.

And that is a shame, not just for those of us affected by these cancers, but possibly for everyone at risk for any type of cancer. Sarcomas and childhood cancers are among the "simplest" cancers – the ones that show how few genetic changes it takes to go from a normal cell to a neoplasm. In many sarcomas, it is one chromosomal translocation.

Science has always made the fastest progress when researchers solve the simple problems first and then build on those answers to solve more complex problems. The genetics of the flatworm and the slime mold were understood long before scientists started studying the human genome. Sarcomas and childhood cancers are the cancer equivalent of flatworms and slime molds and because of that, understanding them will likely lead to advances in understanding all cancers.

Although I would much prefer to see funding for cancer research expand dramatically, if cuts must be made, then absolutely the last cuts should be to sarcoma and childhood cancer research. For the sake of the people who are directly affected, Federal funding is the best source of money; for the sake of everyone else, the payoffs might be great from research into these "simplest" cancers.

Acknowledgement: I would like to acknowledge the invaluable assistance of MiMi Olsson in locating a number of the documents cited in this article.

Editor's End Note: There are, as you might expect, some important implications for the funding of sarcoma research and clinical trials due to the current amount of federal funds appropriated for NCI. See the editorial, An Urgent Call to Action, in this issue of ESUN, including its end note.

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References

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