SAN FRANCISCO—The year 2002 has been an uncertain year politically, with difficult domestic and foreign policy questions, not to mention the threat of international bioterrorism, but cancer researchers who follow the trends in Washington say the coming fiscal year promises to be a healthy one for medical research funding in general, and for cancer research in particular.
President Bush's proposed Fiscal Year 2003 budget will continue the doubling of the National Institutes of Health budget, with funding of $27.3 billion. And the National Cancer Institute's bypass budget request of $5.69 billion—more than $1.5 billion more than in the president's FY2002 budget—has a good chance of passing.
So said Anna D. Barker, PhD, Chair of the American Association for Cancer Research's Science Policy and Legislative Affairs Committee, speaking at a Legislative Update session at the Annual Meeting.
The question to address now, she said, is what will happen after FY2003.
“The president has given us an incredibly healthy budget for the National Cancer Institute, but FY2003 will be the last year of the NIH budget-doubling program, so we need a strategy beyond that. We don't have one, and certainly cancer doesn't have one.”
Dr. Barker, President and CEO of Bio-Nova in Portland, OR, said President Bush seems more committed to cancer research than any president before him. His mother and father are actively involved in supporting cancer research, and the president lost his younger sister to leukemia.
President Bush is proposing an increase of $515 million for the NCI, a 12.2% increase, but Dr. Barker said the overall budget has some funding sources for cancer research that are less apparent.
“The president has put almost $775 million in the budget earmarked for cancer but to go to other agencies—an interesting way to get an increase,” she said. “But it has yet to be determined how the NCI figures into that additional money.”
Cancer is undergoing “almost a sea change” in funding that will be available, Dr. Barker said, though she warned that the budget is not a done deal. “There are a lot of competing agendas, especially bioterrorism—we don't have a clue what that will cost.” And if the big-money budget is cut substantially after FY2003, scientists at all levels of seniority will feel the pinch.
President as CEO
President Bush is something of a CEO in his approach in that he likes to invest but he also wants to see a return on investment, Dr. Barker said, noting that legislators at the state and federal levels are also demanding accountability from researchers.
“They want to see a return on investment, but scientists aren't very good at that. Most of us are used to saying ‘look how good my science is,’” she said. “What Congress wants to know is whether we are spending this money wisely. That's easy to answer—just the demand for informatics, proteomics, and genomics is staggering. But we aren't doing a very good job of telling people that.”
Dr. Barker said cancer scientists need a coordinated strategy for FY2003, an agreement on mechanisms that would show Washington and the state governments that cancer research is moving forward.
Key Policy Issues
Meanwhile, 2002 is an election year and stem cell research and cloning are coming back on the political agenda “big time,” Dr. Barker said. And conflict-of-interest legislation is wending its way into a bill that might be voted on this year.
“The scientific community keeps trying to win the argument convincing politicians about the criticality of stem cell research,” she said, “but we are not going to win that argument this year.”
An argument that could be lost is on cloning. Dr. Barker said there are two factions in this debate, those who support cloning for therapeutics and the reproductive cloners.
“If you take therapeutic cloning off the table, the chances are the following year you will have to take stem cell research off the table,” she said. “Our job is to educate Congress on the value of stem cell research and try to keep ourselves out of the middle of the cloning argument. On Capitol Hill the issue is cloning but cloning is going to move us back to stem cell research.”
“The scientific community keeps trying to win the argument convincing politicians about the criticality of stem cell research, but we are not going to win that argument this year.”
AACR has a position statement supporting stem cell research and supporting investigating the value of therapeutic cloning, she said, but it's doubtful there will be much progress on those issues any time soon.
A member of the audience suggested after the session that scientists talk to legislators and emphasize the basic science aspects of cloning.
“The clinical applications are really very slim, and we should get away from the thinking that cloning will be therapeutic,” said Tim Mulcahy, PhD, Associate Dean for Biological Science and Professor of Human Oncology at the University of Wisconsin-Madison. “Emphasize the importance it will have on basic science and research.”
Dr. Barker agreed, but observed that “there's nowhere to hide on the issue of cloning—whatever you do is wrong. “
Another attendee, Skip Lockwood, Vice President of Programs for the National Prostate Cancer Coalition, noted that much of the opposition to cloning comes from members of the religious community who don't understand the science.
“But the science community does not talk to the religious community or talk to them in a way they understand,” he said. “The AACR should pull together and talk to [religious leaders] and explain what this is about.”
Conflicts of interest
This year might also bring conflict-of-interest legislation that has far-reaching consequences for science.
“There is a bill currently pending [HR4697] that is going to affect anything you do” as a scientist, Dr. Barker said. “If you do anything in drug development, Congress is attempting to take you out of the picture completely.”
She said this will be a blow to medical translational research, as more people in academic laboratories form companies or take pieces of companies.
“That is the only way they are going to get their research out into the market place,” she said. “But if this conflict of interest legislation goes through, if you have ever had anything to do with a molecule in any point in its life cycle you would not be allowed to do a clinical trial on it. This is over the top.”
Another hot issue, privacy legislation, had a bill enacted, but that was then pulled back by the Bush administration last year, and has since undergone some favorable changes, Dr. Barker said.
“Now it is in our favor. As stringent as it is, it isn't as bad as it was.”
As with conflict of interest, privacy legislation will affect everything done in clinical research, she said.
“The IRB process, the oversight process, anything regarding privacy is going to be a lot more extensive. We won't be able to live with these rules; just in terms of costs, the IRB rules will be onerous, and epidemiology will be impossible.”
But nothing is certain at this point, and Dr. Barker said that since this is an election year it is hard to know what will happen to the Patient's Bill of Rights.
William G. Nelson, MD, PhD, a member of the AACR board who is also on the Legislative Affairs Committee, said the extreme use of patient privacy regulations is disturbing.
“The notion is to protect people, such as when health care coverage is withdrawn, but research will almost be stopped when it comes to using people's tissues,” said Dr. Nelson, who is Associate Professor of Oncology, Urology, Pharmacology, Medicine and Pathology at Johns Hopkins University and Director of the Molecular Pharmacology Program and Co-Director of the Division of Experimental Therapeutics.
“Would accumulated tissue banks have to be destroyed because the patients did not get informed consent?,” Dr. Nelson asked.
He said such legislation could also close state cancer registries, and there is a fear that unscrupulous people would traffic in the data for profit.
And he wondered how far the conflict-of-interest legislation would go. “If you speak at a [pharmaceutical company] seminar, does that mean you have been corrupted forever?” he asked. “Congressmen are very hungry to know what the consequences will be of these conflict-of-interest bills.”
Battle Plan for Cancer
Dr. Barker urged AACR members to voice their support for Senator Dianne Feinstein (D-CA), who has taken a specific interest in cancer research and treatment (OT, 4/02, p 1). Senator Feinstein has organized a National Legislative Action Committee to promote the bill she calls her “battle plan” on cancer.
“The senator's National Legislative Action of 2002 is a ‘new National Cancer Act’ if you will,” Dr. Barker said. The bill would increase the percentage of research grants approved by the NCI, boost the number of cancer researchers, speed research into treatment, and encourage production of orphan drugs.
It would also require the Food and Drug Administration to regulate tobacco, and would require insurance plans to reimburse physicians for managing a cancer patient's overall care.
Dr. Barker said the Feinstein legislation is not perfect. For example, clinicians have problems with the “cancer manager” aspects of the bill.
“That said, though, Senator Feinstein is the only senator we have seen in our lifetime who has taken the trouble to write a bill that ensures a five-year significant increase for the NCI, increased training for young MDs and PhDs, deals with nursing shortages, and increases enrollment for clinical trials,” Dr. Barker said.
She emphasized that the senator is eager to hear from oncologists with comments about the bill, both pro and con. She is also trying to promote clinical trials through reimbursement issues, and hopes to involve the private sector by proposing substantial orphan-drug incentives for anticancer agents.
Regarding the bill that Sen. Dianne Feinstein has introduced, Dr. Barker said: “Write her and thank her for writing this bill, and offer your suggestions on how to improve it.”
“Write her and thank her for writing this bill, and offer your suggestions on how to improve it.” Dr. Barker urged. “It is unlikely this bill will be passed this year but it will get a lot of attention, and in 2003 it might have a good shot. Now is the time.”
Campaign to Attract Nurses Underway
Johnson & Johnson has launched a three-year, $20 million effort to attract more people into the nursing profession. As part of the effort, called “The Campaign for Nursing's Future,” the health care products manufacturer will distribute recruitment materials to schools across the country, offer scholarships for nursing students and faculty, and run a nationwide advertising blitz celebrating nurses and their contributions. There is also a Web site, “Discover Nursing,” accessible at www.becomeanurse.com, that provides searchable links to hundreds of nursing scholarships, more than 1,000 accredited nursing education programs, and information on nursing specialties and career paths.
The Oncology Nursing Society, which is actively engaged in finding solutions to the growing shortage of nurses, expressed strong support of the campaign.
“We certainly applaud the effort Johnson & Johnson is making to encourage more people to consider nursing as a career,” said ONS President Judy E. Lundgren, RN, MSN, AOCN. “This is a fine example of what a company in the private sector can do to address the current nursing shortage that is expected to become worse in coming years.”