An Earmark in the Making?

NCI Urged to Boost Gastric Cancer Funding

By Matthew Bin Han Ong

A group of members of both chambers of Congress is urging NCI to increase funding for research in gastric cancers—the latest in a string of advocacy initiatives to carve out fiscal support for specific diseases.

“Deadly gastric cancer is on the rise in young people,” reads a Nov. 26 letter from five members of the Senate. “Gastric cancer receives by far the lowest amount of research funding for the common cancers at NCI, at only $12 million in 2012. That amounts to only 0.4 percent of the entire NCI FY 2012 budget for common cancer research.”

The letter, addressed to NCI Director Harold Varmus, is a response to Varmus’s reply to an earlier letter from members of the House of Representatives.

“We ask you to increase the federal research for stomach cancer in order to stem these dangerous trends,” the Senate letter states.

The letter from the senators, as well as the July 22 letter from 39 House members, was the result of lobbying efforts by Debbie’s Dream Foundation, an advocacy group focused on stomach cancer founded in 2009.

“We met with a number of representatives and we got tremendous interest from the members of Congress who talked to their constituents who are facing this,” DDF Advocacy Committee Chair Kristin Fitzgerald said to The Cancer Letter. “We particularly want to advocate that stomach cancer is rising in young people—it had primarily been a disease of older people in the past, but that trend is really changing.”

The Senate letter was signed by: Sens. Mark Kirk (R-Ill.), Sherrod Brown (D-Ohio), Robert Menendez (D-N.J.), Marco Rubio (R-Fla.), and Brian Schatz (D-Hawaii).

Jon Retzlaff, managing director of science policy and government affairs at the American Association for Cancer Research, said earmarking for specific diseases is harmful to research.

“Because of the broad scope of the AACR, we are very concerned about all of the more than 200 different types of cancer,” Retzlaff said to The Cancer Letter. “In fact, in 2013, more than 580,350 Americans will die from one of these more than 200 types of cancer.

“Therefore, while we can certainly understand and appreciate the interest and need for advocacy groups to draw attention to their particular disease, we also don’t believe earmarking for one particular type of cancer is advisable, especially when so much of the funding from NIH and NCI is in vital discovery research, which benefits all diseases.

“In addition, there are also scientific opportunities that exist today to conduct research on many of the different pathways that are implicated in numerous cancers.”

A similar campaign launched by the Pancreatic Cancer Action Network in 2012 resulted in a bill that required NCI to develop scientific frameworks for “recalcitrant” cancers (The Cancer Letter, Aug. 3, 2012).

At the time, the political momentum made outside critics—as well as some NIH and NCI officials—cringe at the prospect of interest groups competing for Congressional earmarks that would be doled out based on severity of disease and the advocates’ ability to mobilize political clout.

Ultimately, Congress passed a watered-down version of the bill. The initial text of the bill threatened to touch off a “disease Olympics” and dilute NCI’s authority to set research strategy, critics said (The Cancer Letter, Jan. 4).

Measures targeting specific diseases are a slippery slope, Varmus said at the time.

“One thing that I would very much object to that was part of the original bill is an effort to take decision-making about grant-making out of the hands of the NCI and putting it in the hands of advocacy groups, not just because inherently it’s wrong, but very quickly, every other advocacy group would say, ‘I want that too!’ And then we have chaos.”

So far, DDF’s advocacy hasn’t resulted in a legislative directive from Congress.

“I think that we have not yet determined where our strategy will proceed once we hear back from NCI,” Fitzgerald said. “I think that’s entirely going to depend on their response.”

The House letter cites estimates from the American Cancer Society: 21,600 new cases of gastric cancer will be diagnosed in 2013, and 10,990 men and women will die from the disease within the year. At stage IV, the five-year survival rate for gastric cancer is 4 percent.

In responding to the letter, Varmus said the expected frequency of gastric cancer in 2013 represents a substantial decrease compared to over 80 years ago.

“Since 1930, the age-adjusted mortality rate from this cancer has decreased by more than 80 percent and incidence by more than 50 percent in the past 30 years,” Varmus wrote in a letter dated Aug. 23. “However, as you noted in your letter, recent data from an NCI epidemiology study has suggested an increase in the incidence of diffuse gastric cancer in U.S. whites 25-39 years of age, although gastric cancer continues to arise far more frequently in older age groups.

“At this time, it remains to be determined if this observed increase, derived form a retrospective analysis of a relatively small number of cases, will be confirmed in additional studies and, if it is, what factors may account for the increase,” Varmus wrote.

The letters are posted on The Cancer Letter website.

Neither Congress nor DDF have suggested a target figure for gastric cancer research, according to Fitzgerald.

NCI’s breast cancer program received over $600 million in 2012, and NCI’s funding for pancreatic cancer is about $105 million, according to the institute’s portfolio.

“I hesitate to make comparisons to other diseases in terms of that,” Fitzgerald said. “Congress is very careful about putting numbers in any kind of research. However, there has been language in the appropriations bills reports for several years in a row asking that NCI dedicate resources and attention to this issue.

“Now, unfortunately, it’s hard to control the appropriations bills becoming law.”

Fitzgerald said her organization would consider every avenue of support.

“I will expect that our advocacy will continue until we are able to make progress on this disease,” Fitzgerald said. “I am hopeful that, given the severity of this disease and the young age of the people that are being diagnosed with stomach cancer, that that would help to make the case for the importance of the research that will stem the tide.”

A former congressional staffer, Fitzgerald joined DDF after her husband died of stage IV gastric cancer in 2009 at 37 years old, eight months after being diagnosed.

“I am going to be an optimist with continued advocacy,” Fitzgerald said.

Varmus: TCGA Data is Available to Researchers

The various forms of gastric cancer are being evaluated as part of The Cancer Genome Atlas—a comprehensive sequencing, characterization and analysis of the genomic changes of more than 20 types of cancer.

TCGA is a joint effort of NCI and the National Human Genome Research Institute.

According to Varmus, more than 300 gastric tumors are being analyzed by TCGA, with more cases being added in the near future.

“The first publication concerning gastric cancer from the TCGA network should appear in the next six months, and will include analysis of all major subtypes of gastric cancer,” Varmus wrote in his reply to the House letter. “Preliminary analysis suggests that the current definition of gastric cancer subtypes by histology is imprecise and can be refined by analysis of the tumor genome, and that gastric cancers have a number of recurrent oncogenic abnormalities, some of which are restricted to particular gastric cancer subtypes.

“Importantly, several of these genetic abnormalities may be amenable to testing candidate inhibitors for therapeutic intervention in the near future.”

The completed data from TCGA gastric cancer samples are available to researchers for analysis.

“NCI has made access to this data a priority by funding the development of web sites that allow researchers to search for genetic alterations in any cancer studied by TCGA,” Varmus wrote. “For example, researchers can use one cancer genomics portal to identify mutations in any particular gene of interest or determine the association between genetic abnormalities and clinical outcome.”

However, the impact of TCGA on gastric cancer will be minimal without efforts by the NCI to assist researchers in utilizing the genomic data, lawmakers said.

“Very little foundational research data exists for gastric cancer; thus, gastric cancer researchers are greatly in need of federal assistance to ensure that promising gene candidates identified in TCGA research are able to be investigated to make progress in this field,” the members of Congress wrote. “Though the TCGA information will be available on the cancer genomics portal, researchers need funding in order to develop the research data necessary to apply and receive NCI research grants.”

DDF and its constituents want to see a return on federal investment in TCGA, Fitzgerald said.

“Think of the money Congress has spent on the TCGA analysis,” Fitzgerald said to The Cancer Letter. “Enormous amounts of money have been spent to create this data, so we’ve got an investment there in creating this data.

“I think those at NCI would need to really seriously evaluate what kinds of funding that would be necessary in order to see that investment reach fruition. What we are asking is for their assistance to ensure that it does reach fruition.”

DDF: Gastric Cancer Funding is “Affirmative Action”

Asked whether DDF’s efforts would potentially erode NCI’s peer review process and ability to set research strategy, Fitzgerald said the group’s mission is more about leveling the playing field and getting the small players in.

“For example, if you have a lot of money and you have a lot of foundational research, you can draft a grant application that will get funded because you can show the potential for scientific discovery based on your previous research,” Fitzgerald said. “You have the funding to make further investigation to prove those discovery potentials, and you can get a successful grant research application funded.

“The current situation works for folks like that.

“In the past, as a country, we have said, ‘Gosh, everybody’s trying to get into college. But gosh, only the people that really have the ACT prep and all these things are able to get in.’

“Well, then we made affirmative action and we said, ‘OK, some groups are having a harder time getting in, well, let’s help those groups so that we’re able to make an equal playing field, whether or not you have the same degree of resources going in.’

“That would be my parallel here.”

Increasing funding for lower-incidence cancers such as stomach cancer is therefore, a “process question,” Fitzgerald said.

“I think that takes away from it this idea that you are pitting one cancer against another, or advocating that one particular cancer gets one thing versus another,” she said. “I think that we have some of these smaller cancers that don’t have that foundational research knowledge, that don’t have those foundation dollars, that don’t have those grant dollars, and that, nonetheless, really want to make potential progress in these diseases, and patients are waiting for them to make that same degree of progress.”

The future of gastric cancers depends on the creation of an attractive, well-funded research market, Fitzgerald said.

“When you have this disparity in situations for researchers in one area, and not others, researchers are more apt to go towards the areas where it’s going to be easier to get resources,” Fitzgerald said.

“And so we are not looking at just what happens with this data, and what research and progress comes from that, it’s who even goes into the field, which will determine the data and the research 20 years from now.”

Fitzgerald said she understands that NCI’s budget has been flat for years, and that sequestration reduces funds for cancer research. DDF is advocating for NCI’s overall budget to be increased to $5.24 billion in fiscal 2014—about $460 million above current funding levels.

“I don’t, by any stretch of the imagination, suggest that it’s easy to make these kinds of decisions, particularly when you are in a situation where your funding is being cut,” Fitzgerald said.

“Nonetheless, as a country and as an institution, we have a responsibility to each of our patients who is facing cancer to make progress.”