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Oncology Times:
doi: 10.1097/01.COT.0000340695.46201.2e
Eric Rosenthal reports

Melanoma Added to Cancers Funded by Department of Defense Research Dollars

ROSENTHAL, ERIC T.

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A secret Congressional champion made melanoma and, as the official announcement put it, “other skin cancers as related to deployments of service members to areas of high exposure” the recipient of an extra $4 million in research funding to be administered through the United States Department of Defense (DoD)'s Peer-reviewed Cancer Research Program.

Figure. ERIC T. ROSE...
Figure. ERIC T. ROSE...
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Following passage by the House and Senate, and signing by President Bush, melanoma joined breast, prostate, and ovarian cancers as the only ones singled out for funding through the DoD's US Army Medical Research and Materiel Command (USAMRMC)—the pot of money originally discovered by the National Breast Cancer Coalition (NBCC) in 1992 when National Institutes of Medicine research funding was capped. (Also included in the program at one time was chronic myelogenous leukemia, but that is not currently funded, a DoD spokesperson said.)

The $4 million was part of a bill providing for a total of $16 million for peer-reviewed cancer research programs not currently included in the DoD's portfolio.

Although melanoma was specifically mentioned, other areas of oncology lumped into the 2009 Appropriations Conference Report's $12 million portion included pediatric brain tumors, genetic cancer research as related to exposure to environments unique to military lifestyle, and non-invasive cancer ablation research.

C. Randy Lomax, Chairman of the Melanoma Research Foundation (MRF) and an eight-year survivor of melanoma, told OT that his organization took the lead in the lobbying effort to make more money available for the underfunded research area.

But he said he had no idea that it would be earmarked money for melanoma and other skin diseases until the resolution came through the House.

“We were operating under the principle that we would clearly have to identify a champion [in Congress], but we never identified that one champion,” Mr. Lomax said. “We approached lots of people from the cancer coalition, including [co-chairs] Senator Sam Brownback [R-KS] and Senator Dianne Feinstein [D-CA], and Senator Edward M. Kennedy [D-MA], but it was very serendipitous, and we don't know who was responsible for adding melanoma.”

Edward Long, Senior Vice President for Congressional Relations with Capitol Associates, is a melanoma survivor who sits on the Board of the Melanoma Research Foundation. After serving as a volunteer with MRF, he is now on retainer as a lobbyist and led the foundation's campaign to secure funding through the Congressionally Directed Medical Research Program (CDMRP).

“This was not initiated by DoD; it was directed by Congress,” he explained. “So it's now up to DoD as to how they translate this language. It's premature to state right now how it will be used. I had worked with Senator Harkin when he conceived the idea and offered the amendment on the floor.”

Mr. Long was referring to 1992 when he served as legislative director for Senator Tom Harkin (D-IA) and was working with NBCC President Fran Visco to locate additional funds for breast cancer.

Figure. C. RANDY LOM...
Figure. C. RANDY LOM...
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Mr. Long said he wrote the amendment that created the new DoD cancer research funds, which were part of the peace dividend resulting from the end of the Cold War, and that DoD commissioned the Institute of Medicine to conduct a study on the best way to run the program that was ultimately assigned to the USAMRMC.

The effort netted $210 million for breast cancer research in 1993, which has grown to about $2.1 billion since its inception, according to Ms. Visco, who said that breast cancer will receive another $150 million for fiscal year 2009.

“I don't have any comment on other diseases getting money,” she told OT. “That's up to Congress. I know over the years we've run into problems with Congress because they said they didn't want to make this another NIH.

“But people are able to make their case and convince Congress this is the right thing to do, and I think that's fine as long as these are peer-reviewed programs. We really care about the breast cancer program, and as long as it continues to be funded we are pleased.”

Mr. Long said that the National Cancer Institute says it funds melanoma and other skin cancers at $97 million, but that the actual amount “could be anywhere between 50 percent and 70 percent, because all the money is not direct” and is often bundled with other cancers.

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‘Will Probably See More Melanoma in the VA in Next 20 Years’

He said the $4 million was not really an earmark, but rather targeted funding, and with 130,000 troops in Iraq, many of them men and women in their 20s, “you're probably going to see a higher incidence of melanoma and other skin cancers in the VA in the next 20 years.”

“This is consistent with the needs of servicemen,” he said, “and that's why the military should be doing this program. However, the program is subject to annual appropriations, so next year in 2010 there will be no money in the budget submitted by the Pentagon, and since it's all Congressionally directed you have to go back to Congress every year to get this funded.”

Mr. Long said that he and others approached other members of Congress in addition to the senators mentioned earlier, including Senators Jack Reed (D-RI) and Patrick Leahy (D-VT) and Congressman Dave Obey (D-WI).

“I don't know who did this for us, but someone put it in. I can't tell you who the champion was, but it was a product of all that effort. It was a case of we threw it up against the wall and somebody grabbed onto it.

“I thought we would be on the peer-review medical program list, but this is where things are serendipitous. We just got lucky. Politics is about pushing, pushing, pushing. You create a circumstance where you have an opportunity to be lucky. We just pushed and pushed and pushed and threw it out there and asked for $5 million and it happened with $4 million.”

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Why No Congressional Champion?

OT learned that if money was not specifically earmarked for a particular member of Congress's district, then there was no requirement for being identified with the bill, which could explain why no champion came forward.

Since the DoD funding would be subject to the peer-review process, the funds would not directly benefit any one senator's or representative's constituency.

Although the Melanoma Research Foundation directed the lobbying, other skin cancer organizations were involved, including the National Melanoma Alliance, created by the MRF, and the National Council on Skin Cancer Prevention, which includes the American Academy of Dermatology and the SHADE Foundation.

Mr. Lomax said his organization has been very concerned that without sufficient funding there will be a brain drain of investigators interested in melanoma, and that the foundation provided $1 million in research grants in 2008, comprised of 14 career development awards of $50,000 each a year for up to two years, and three established investigator awards of $100,000 each for up to two years.

“So we're viewing this [DoD money] as four times more money being contributed to what's being given out to melanoma research. We are certainly planning to leverage our influence with the NCI by saying what the heck are we doing for melanoma. Here we have a guy running for President of the United States [Republican candidate Senator John McCain, a three-time melanoma survivor] who may be the next President and you guys are doing incredibly little for us.”

Ironically, several sources speculated that if Senator McCain were elected, that he would be likely to shut down the DoD program because he has said he is opposed to earmarks and targeted appropriations.

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‘Screaming Need’

The President of the Society for Melanoma Research, David E. Fisher, MD, PhD, Chief of Dermatology at Massachusetts General Hospital and Director of the Melanoma Program in Medical Oncology there, is a member of MRF's Scientific Advisory Committee.

Dr. Fisher said there is a “screaming need” for additional melanoma research funding now: “There is a single crucial coincidence that is basically a shameful state of affairs for 2008. On the one hand, the incidence of melanoma is increasing, with a steeper slope than any other cancer; and on the other hand, the cause—the environmental carcinogen for melanoma, ultraviolet radiation—is probably better understood than for any other cancer.

“That dramatic rise continues to go up despite the sunscreen era. We've had sunscreen for several decades, and incidence still continues to rise. And when soldiers are in the Middle East and sitting in the rays and getting their sunburns, that risk is only going to go up.”

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‘Translational Opportunities Knocking on the Door’

He said the progress for treating advanced melanoma has essentially gone nowhere, with no significant change in several decades.

“Coupled with the discoveries at the molecular level within the last five to 10 years [including the 2002 discovery of the BRAF gene mutation that generated a cascade of understanding about the genetic underpinnings of melanoma], there has been a huge groundswell of excitement.

“It's a clear quantifiable achievement, and there is now a huge amount of information we now know about melanoma—about the mutations within specific oncogenes, the disruptive tumor-suppressor genes, the nature of lesions in one part of the body as compared with other parts of the body that are basically describing to us why a melanoma behaves like a melanoma in terms of its invasiveness and resistance to therapy.

“What this has done is essentially march the science of melanoma biology right up to the precipice where the translational opportunities are knocking on the door. And rarely if ever has there been an example where we are sitting at such a growth opportunity for understanding of the biology of the disease. And coupled with that we are absolutely bankrupt as to therapy, since we have essentially no standard therapies to offer, unlike with so many other cancers.”

Dr. Fisher said we're now on the “precipice of being able to ask mechanism-driven clinical question,” something that has not previously been the case, since researchers have made what have mostly been intelligent guesses, “where we've said here's another cancer drug, let's see if it works in melanoma.”

With a series of pathways, pharmaceutical companies can work on a series of small molecules that are drugs that could hit this target, he said, noting that advanced melanoma has not been viewed as a big market but that since the bar has been so low and pharma has not been particularly adverse to melanoma, that it may be attractive as a smaller market.

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‘Remarkable Partnership’

Another member of MRF's Scientific Advisory Committee as well as a member of the Board of Directors, Lynn M. Schuchter, MD, Professor of Medicine and Interim Chief of Hematology/Oncology at Abramson Cancer Center of the University of Pennsylvania, where she leads the melanoma program, called the DoD funding significant, especially since the melanoma community considers the disease to be underfunded, although she'd still like the amount to be higher.

She noted that the Society for Melanoma Research had commissioned a Roadmap for Melanoma outlining the key targets for research and therapy that needed to be addressed by 2010, and that this money would be helpful.

“This effort has been a remarkable partnership between advocacy, the foundation, and the scientific community,” she said. “We really did work together. The NCI brought us together to talk about what we needed, and the scientific community spent an unbelievable amount of time preparing for the meeting.

“We had work groups with the top people in the field, and identified what our needs were, and this grew out of that. To get this language into the Congressional Record by MRF, the NCI needed to bring together a group of melanoma investigators to discuss priorities.”

OT tried to contact Captain E. Melissa Kaime, MD, US Navy Medical Corps, who directs the Congressional Directed Medical Research Program, but she was on leave when this article went to press. But Gail Whitehead, Public Affairs Coordinator, did respond and said that although the $4 million for melanoma and related skin diseases would end up in the medical command, it wasn't certain at the time whether it would go to CDMRP or another unit that was already doing related skin cancer research.

Figure. DAVID E. FIS...
Figure. DAVID E. FIS...
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“There are different units within the medical command,” she explained, “and some do research themselves and some take on administration of various projects. We have nothing to do with selection [of the cancers funded]; we are basically only on the receiving end, and our response to Congress is always, yes sir.”

She said for new areas of research, the CDMRP puts together a set of representative stakeholders, which includes both consumer organizations as well as expert scientists in the field for a peer-review panel, and can very quickly set up a program.

Exactly where the money will be specifically allocated should be sorted out within a few weeks, she said, adding that the CDMRP's story is “How do you create new ways to bring fresh new ideas into the science for a specific disease?”

© 2008 Lippincott Williams & Wilkins, Inc.

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