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Thread: Support this advocate!

  1. #1
    Senior Member Leo's Avatar
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    Support this advocate!

    From Legislative forum,

    This guy needs our support, just read and check out his attitude and thinking, could we ask for a better advocate. I'll write up a sample letter we can use unless someone beats me to it. We need to let our legislators know, this guy is on the right track and we want them to support him.

    Check out this link to the dang headache he's facing with sub agencies he has no power over, couldn't give me his job, but he's trying.

    http://www.nih.gov/icd/


    By Neil Munro, National Journal

    In the six years since 1997, Congress has doubled the National Institutes of Health's medical-science budget, which this year stands at almost $28 billion. Now Congress wants results.

    The money flows to scientists at NIH and also to research centers scattered throughout legislators' districts. The rising tide of funds has helped to boost many local economies, but, so far, the money has produced limited benefits for patients, in part because scientists direct so much of it to their colleagues for basic research. NIH's research promises a big payoff someday, but, given the complexity of human biology, converting hopes into therapies can take 10, 15, or even 20 years.

    In Congress, the debate over the benefits of increased NIH funding is shaped by politicians' ambivalent approach to their oversight of the science sector. Administration officials and legislators want better management at NIH, but they are reluctant to second-guess scientists' spending policies. They want NIH to develop treatments more quickly but are loath to shift money away from basic science and into near-term therapies. They want more transparency in NIH's activities, but they also want to minimize regulation of science and technology.

    These policy dilemmas were fully visible on Oct. 2 at a joint House-Senate hearing on a possible reorganization of NIH. Sen. Judd Gregg, R-N.H., chairman of the Senate Health, Education, Labor, and Pensions Committee, lauded the institutes' scientific accomplishments but also questioned funding priorities: "Does [the NIH] peer-review process adequately balance results to the population as a whole, the health care results?" he asked. "Where are we closest to getting something, versus just the academics and the basic science?"

    This debate is likely to gather momentum next year and culminate in the first reauthorization of the institutes since the NIH Revitalization Act of 1993. The complexity of the science that NIH sponsors, and the reluctance of politicians to redirect the prestigious and lucrative science sector, have opened up opportunities for NIH Director Elias Zerhouni.

    Independently of the Health and Human Services Department, within which NIH resides, Zerhouni is promoting his five-year "road map," which would focus management resources and $2.1 billion on his stated priorities, expand clinical testing, and remove some of the obstacles that delay the evolution of treatments from the laboratory bench to the hospital bed.

    National Journal interviewed key players and representatives of powerful political forces in the debate over re-engineering NIH. Their comments reflect the varying experiences of different constituencies and reveal the difficulty of instituting change.

    A New Map for NIH: Director Elias Zerhouni

    Zerhouni told legislators at the joint hearing that his road map would create new offices and programs to accelerate important research and to help the director coordinate some of NIH's myriad research projects. Currently, nearly all of those projects are run by the directors of NIH's 27 autonomous institutes and centers.

    Over the decades, Congress has created and funded these institutes and centers to focus research on priorities such as cancer, drug abuse, medical imaging, and the human genome. Congress appropriates nearly all funds directly to the 27 centers, not to the NIH director. For example, the National Cancer Act of 1971 created the National Cancer Institute and gave its director the authority to submit budget requests directly to the president, bypassing both the NIH director and the Office of Management and Budget. In 2002, Congress appropriated $4.17 billion to the NCI. The cancer institute has asked for $6 billion for 2004.

    This decentralized process leaves the NIH director with little management clout. Under a 1992 authorization law, the director is allowed to reassign only 1 percent of the NIH budget.

    Zerhouni argues that the scale and style of modern science demands much greater coordination among the "27 old cats." He told Congress that lack of coordination leaves promising treatments on the shelves for many years. He cited the anti-cancer drugs tamoxifen and Gleevec as examples. "If I could leave one contribution as a director," he said in an interview, "it is to say, 'It is important for an agency of the critical nature of NIH to have a sense of where the elephant needs to be steered.'" He added, "Even though it has 27 parts, it is still an elephant that has to go somewhere."

    Zerhouni said he doesn't need legislative approval to implement the first stage of his road map in 2004. But some of the more-ambitious elements, such as new planning groups and multidisciplinary research projects, require authority and funding from Congress.

    "I would like for them to mandate such a process-it would serve everyone-and also to fund it, because right now it's almost a voluntary plan," he said. "You can't leave the dynamics of change to a voluntary exercise."

    The Power of Research: Harold Varmus

    Zerhouni said he developed his plan with advice from "300 to 400-plus of the top leaders in science," including his immediate predecessor at NIH, Harold Varmus.

    At the joint hearing, Varmus said the directors of the 27 centers "are under tremendous pressure from their constituencies to try to fund more grants [for them] rather than donate money to a common pool." During his term from 1993 to 2000, he said in a later interview, "we got very little support for trans-NIH activities."

    Varmus, however, is not just Zerhouni's predecessor. He's now the president and chief executive officer of the Memorial Sloan-Kettering Cancer Center in New York City. It's a big enterprise: He's got 8,000 employees, treats 19,000 patients a year, and managed $1.1 billion in revenue in 2002. More than 80 percent of the center's annual revenue comes from patients, but the center also got $240 million in 2002 from a mixture of grants, patent royalties, contracts, and other sources.

    Industry paid Sloan-Kettering much of that $240 million budget chunk in exchange for the use of the cancer center's patents and for the center's testing of promising medications on patients. But $83 million came from NIH grants.

    NIH awards 85 percent of its sizable budget to outside scientists and their employers. Over the decades, roughly 220,000 scientists at 2,800 institutions, including Sloan-Kettering, Stanford University, and Harvard University, have received this funding. These research centers convert the grants into new discoveries, then into patents and tested therapies, and-eventually-into successful products and treatments in the nation's $1.4 trillion health care market.

    That kind of economic power gives the research sector enormous political power, making Varmus's support for Zerhouni's plan all the more significant. Nevertheless, Varmus predicted that although he endorses an "extreme change" that would give much greater authority to the NIH director, such a change "is just not going to happen." In a fallback position, Varmus argues that NIH should create "clusters" of centers, allowing each center to retain much of its autonomy while promoting coordinated research on priorities such as brain science, cancer, "human development," and internal medicine.

    Varmus also backs Zerhouni's efforts to bolster the clinical trials that NIH funds. Thousands of trials are launched every year to test promising medical therapies on patients. But an expanded effort is needed, Varmus said, partly because there are too few patient-volunteers to test all of the candidate therapies. Even in places such as Sloan-Kettering, he said, "we have difficulty in providing enough time and incentives for our best clinicians to do clinical research."

    Advocating Cures: The Cancer Community

    Each of the 27 NIH centers has its supplicants and lobbyists, all hoping to promote cures for particular diseases-and funds for their own projects. The centers distribute their grants according to the advice of peer-review groups drawn from pools of academic and research-center experts. This gives NIH officials free access to the best scientists' expertise, and has led to medical advances that have extended the lives of millions of Americans. But the advice comes entangled with the peer-review scientists' professional, financial, and personal interests. As a safeguard, NIH officials try to minimize conflicts of interest in the peer groups, and they keep control of funding decisions. But most of the NIH officials making the decisions are also scientists, and they have their own ties to the complex of professional and commercial centers within the scientific community.

    The way an NIH center interacts with advocacy groups is illustrated well by the National Cancer Institute. NCI customarily sends a draft copy of its budget for comment to roughly 450 outsiders who work in cancer-research centers, patient groups, hospitals, and universities. Through this budget-review process, "the concerns of the scientific community and the patient-advocacy community are taken into account," said Carolyn Aldige, founder and president of the Cancer Research and Prevention Foundation, based in Alexandria, Va. The foundation, she said, "represents the interests of the research community...as well as the patient community." Aldige gets a draft copy of the NCI budget for review, but, she said, "I rarely disagree with the way [it] is drafted." The chairman of Aldige's foundation is Catherine Bennett, a vice president at Pfizer, the pharmaceutical company.

    Zerhouni's call for greater central coordination at NIH raises "a concern that the [NCI] budget could be tapped for other purposes," said Aldige, who is also president of the National Coalition for Cancer Research. The coalition brings together 26 groups of doctors, scientists, managers, patients, and donors. The current director of the NCI, Andrew von Eschenbach, is a former board member of the coalition.

    The American Cancer Society boasts 2 million unpaid volunteers, and 20 million donors who give an average of $32 a year.

    "Our approach is not to be a pass-through, a front for other groups," said John Seffrin, CEO of the ACS, which also opposes any constraints on the cancer institute's independence. "I know of not a single cancer group ... that believes any diminution of [NCI's] importance is desirable," he said. Indeed, Seffrin argues, the system has worked so well for patients that NIH's 26 other centers would gain from similar independence. He says that the 27 centers already cooperate, and that Zerhouni hasn't presented any cases where rivalries among the centers stymied research.

    A Patient's Resolve: Will Ambler

    In 1992, at age 24, Will Ambler was paralyzed in a motorcycle accident. Doctors don't have a cure for his spinal cord injury, so he sought help from various scientists. But he found none willing to turn away from the laboratory to test possible treatments on patients, Ambler said from his home in Solvang, Calif. This focus on science rather than therapy, he said, is driven by scientists' preference for professional success, and also by NIH funding policies. NIH "provides funding for scientists if they show scientific progress; they don't have to deliver [therapeutic] results," he said.

    Ambler and a group of like-minded patients have raised $200,000 to hire their own university researcher to investigate whether paralyzed rats can be treated with their own stem cells. If the animal tests are successful, the scientists will then need to test whether Ambler's own stem cells can repair his damaged spinal cord. The test, for which Ambler will pay $50,000 of the cost, will likely be performed by Dr. Michel Levesque, director of neural repair at Cedars-Sinai Medical Center in Los Angeles. He has already used one adult patient's stem cells to eliminate most traces of the patient's Parkinson's disease.

    Most patients, Ambler said, lack the knowledge and resources to challenge the scientists and doctors who are promising cures. "Right now, there is no power at all in the hands of the patient, whether it is knowledge, or money, or some kind of structure that provides an equal footing." To fix the problem, he said, doctors should give patients more information, and NIH should pressure scientists to convert science into therapies and give them rewards when they do. "To effect a change, you have to rock the boat."

    Respected scientists echo Ambler's complaints about NIH funding priorities. Helen Blau of Stanford University and Catherine Verfaillie of the University of Minnesota have argued, for example, that NIH officials are underfunding research on the capability of adult stem cells to repair damaged organs. Rival scientists within some NIH peer groups have made it difficult to get grants for such research, charged Levesque of Cedars-Sinai. He hopes that other NIH panels that focus on emerging therapies will provide funding for a planned 15-patient test of his Parkinson's treatment.

    But these endless rivalries among scientists and research centers, according to Zerhouni, provide a valuable benefit. He says they impose a discipline on NIH policies, and he points out that advisory panels and NIH analysts also provide a check on policies. His road map includes a new program to award grants from the NIH director's office to nonmedical experts, young scientists, and others doing groundbreaking research. Zerhouni is also keenly aware of the complaints from Gregg, Ambler, and many others about the slow conversion of science into health care. The answer, he said, "is not so much a question of incentives, [but rather] removing the obstacles." Still, NIH will remain focused on science, not therapies, he said. "We're not changing the balance, we're supercharging the NIH."

    Setting Ethical Limits: Daniel Callahan

    To some extent, scientists' self-interest provides ethical limits on research. For example, many scientific groups are pushing for a genetic privacy law, partly out of concern that without it, patients will refuse to enroll in clinical trials.

    But in their competitive profession, many scientists are reluctant to let ethical concerns restrain their research, said Callahan, a director at the Hastings Center, an ethics think tank based in Garrison, N.Y. In seminars for young scientists, he said, "we try to spend quite a bit of time explaining how to get away with being socially active and not be shot by their peers." Such career concerns are valid, he said, because scientists depend on peer friendships for grants, jobs, and publishing opportunities. "Professionals can gossip and ruin reputations in a way that is very hard to pin down," and fear of that punishment keeps many from raising objections to a line of research. "There's very little incentive for a scientist to look at a major development and say, 'Gee, there's a problem; let's slow down.'"

    To minimize this social pressure, Callahan said, NIH should foster a "critical mass" of scientists willing to suggest ethical limits. He proposes a standing NIH panel that has a majority of nonscientists, but includes enough scientists to ensure credibility with the outside scientific community. The panel he envisions would not have authority over spending, but would report regularly to NIH and to Congress.

    Such a panel could highlight for the public and Congress the enormous political consequences of NIH's advances, Callahan said. For example, retirees' wonderfully lengthened lifespans are increasing the total cost of health care; new brain-related research is changing the public's understanding of free will, child-rearing, and mental health; embryo-related research is creating the potential for a commercial marketplace in "designer children."

    At the hearing, Zerhouni firmly defended scientists' self-governance, but he also acknowledged the value of oversight by NIH, advisory panels, and the Office for Human Research Protections at HHS. NIH welcomes whistle-blowers, Zerhouni said: "We want to provide every incentive to every scientist out there [to raise ethical questions], because it is in the best interests of science." To make his case, Zerhouni cited the science sector's response to the death of Jesse Gelsinger during an experiment at the University of Pennsylvania that was overseen by researcher James Wilson. Before the 1999 experiment, Wilson "was at the top of the world," Zerhouni said. "He was one of the touted stars of biomedical research, and when the Jesse Gelsinger thing happened, he lost his scientific reputation, he lost his job, his own boss lost his job, the entire university system was redone. Where's Jim Wilson now? He's gone." Wilson was unavailable for comment. In July 2003, Wilson resigned from the university's gene-therapy institute. He now heads a 12-person team investigating cystic fibrosis, Ebola disease, and other health issues. In 2002 and 2003, Wilson won 14 NIH grants worth at least $4.6 million, according to NIH's Web site.

    Many groups are pushing for ethical changes in NIH practices.The Alliance for Human Research Protections, based in New York City, wants tighter oversight of NIH's clinical trials, for example. Other groups call for changes in medical research to reduce the costs of drugs, and additional research focusing on women and minorities.

    Voicing Minorities' Concerns: Rep. Stephanie Tubbs Jones

    Nearly every player in the NIH debate says that politics should not interfere with science. And nearly every player also says that politics does indeed shape science. Ohio Democrat Jones used her time in the Oct. 2 joint hearing to plead for more attention to minorities' health issues. She told Zerhouni and Varmus, "I come here to Congress as a result of political stands that I take ... [and] some of the research that has been done specific to African-Americans and minorities came as a result of the political push of the body politic." She added, "I don't want you to be swayed by the issues of political life, but I also don't want you to be immune to the importance of the body politic saying to you, 'This is an issue that is important.'"

    "I agree entirely with your point," Varmus responded. "That's the body politic bringing facts and figures to us, and it's an important role you play." But Varmus also noted that it is science that shapes funding decisions for disease research. And Zerhouni, without agreeing to Jones's request, replied, "Society...[is] the basis upon which we work."

    Jones and Sen. Barbara Mikulski, D-Md., are pushing the Uterine Fibroid Research and Education Act of 2003. They say that one-quarter of all American women in their 30s and 40s-and a much higher percentage of African-American women-will need medical care for the condition, which can cause heavy bleeding and fertility problems. Yet NIH spends only $5 million a year researching its causes and treatments. The bill authorizes twice that amount.

    Calling-Softly-for Improvement: Rep. Mike Rogers

    Push-back from the science sector can make it difficult for Congress to impose change on NIH. In July, social conservatives in the House drafted an amendment to strip a total of $1.7 million-a tiny percentage of the NIH budget-from five NIH grants. One funded a study of drugs and sexually transmitted diseases among prostitutes in San Francisco; another funded a study in which students were paid to drink alcohol and view pornography; a third supported research on the relationship between pandas and humans in China. The legislators and their staffs drafted the amendment because they did not expect NIH officials to drop the grants at their request. Rep. Pat Toomey, R-Pa., led the effort for the amendment, which failed on a vote of 210-212.

    Toomey and his allies lost partly because most Democrats and some Republicans were receptive to lobbying by universities and professional societies. These groups cast the amendment as an attack on the peer-review process, which scientists prefer over alternatives that would give a bigger role to politicians or other nonscientists. Also, the House's debating rules barred Toomey from offering an amendment to redistribute the $1.7 million to other research into diseases such as juvenile diabetes or breast cancer. But reluctance to micromanage NIH also played a critical role.

    Toomey's faction hoped to win support from Michigan's Rogers, a rising star in the GOP leadership. But Rogers told Zerhouni at the Oct. 2 hearing that he voted against the amendment "because I wanted to make sure that you had the right and ability to make those decisions, and Michigan State University actually was doing some research [on the pandas] that ... made a lot of sense."

    Rogers's message to Zerhouni was mixed, however. He promoted his bill authorizing NIH to spend $60 million a year on pain-management research, and urged NIH to make its operations and spending more transparent to legislators. Getting information from NIH about the disputed grants was difficult and demeaning, Rogers said in an interview.

    "There is a culture that is very homogenous in the NIH ... [and] if they don't feel they have to be accountable, that's another problem." Zerhouni's consolidation plan may help by giving Congress a single go-to office at NIH, Rogers said. But he added that he was not slamming NIH, only calling for improvements. "We're doing great things [at NIH]. Let's do incredible things."

    Reluctant to Regulate: Congress

    The tale of the five grants reflects the deep divisions in Congress over NIH oversight. Legislators are often willing to boost popular research-the doubling of NIH's budget is proof-but don't want to direct funding decisions.

    Liberal Democrats are reluctant to regulate scientists, academics, and their allied professionals, partly out of ideological sympathy for intellectual exploration, and partly because those groups help generate many jobs. Free-market Republicans are as loath to regulate job-creating universities as they are to regulate job-creating companies, even when university researchers challenge social conservatives' positions on human experimentation and genetic engineering.

    The result is that Congress steadily increases NIH appropriations but can't settle the many policy disputes created by that spending. This reality was evident at the Oct. 2 joint hearing. Sen. Hillary Rodham Clinton, D-N.Y., used her time to ask NIH to test existing therapies and gauge which best serve patients, eliciting a demurral from Zerhouni. Rep. Henry Waxman, D-Calif., decried the Toomey amendment as political interference in sex-related research, but then acknowledged that left-of-center groups also have their agendas for research. Rep. John Dingell, D-Mich., the ranking member of the House Energy and Commerce Committee, used his time to ridicule the administration's outsourcing initiative, which would put some NIH jobholders in competition with outside contractors. Dingell said the policy is driven by "ideological idiots" in the administration and is causing great disruption to NIH administrative staff. "I trust the scientists," he said. "I try to see this thing [NIH] as a national treasure outside the general political hurly-burly."

    But Dingell also endorsed continued oversight of NIH. The Republican leaders who control the House "don't know how to do oversight," he said, "and are not predisposed to do it," partly because the GOP also controls the executive branch. So far, Republicans "have put a huge amount of money into research, yet they didn't put a lot of money into administration to see that it was well spent."

    Both Republicans and Democrats support Zerhouni, not least because his road map promises to improve NIH without forcing Congress to micromanage spending or settle painful, high-stakes ethical debates. Zerhouni's plan "falls in line with the tradition of excellence that the NIH has always shown," said an Oct. 22 statement from Rep. Michael Bilirakis, R-Fla., who chairs the House Energy and Commerce Committee's panel on health.

    Gregg wrapped up the three-hour hearing with a strong indication that he favors a much bigger role for Zerhouni, and no suggestion that he envisions a greater role for legislators or other nonscientists. "There are things which apparently we must do in order to give the director the authority to accomplish the many things that we are talking about," he told Zerhouni. "Give us some suggestions, so that we can sort of help you to help all of us."

    "All you have to decide is what to do with the time that is given you."
    Gandolf the Gray

  2. #2
    Excellent article Leo, thanks. the NIH is clearly challenged by the need to foster basic science and find solutions to some of the nation's most pressing health care needs. Zerhouni's road map calls for change in the way NIH centers are managed, structured and funded. The challenges he faces are daunting to say the least. Here are a few passages from the article that elucidate the conservatism and bureaucracy within the NIH that Zerhouni hopes to address with his plan and some of the reasons why promising therapies have been slow to reach the market.

    They [administration officials and legislators] want NIH to develop treatments more quickly but are loath to shift money away from basic science and into near-term therapies.
    Over the decades, Congress has created and funded these institutes and centers to focus research on priorities such as cancer, drug abuse, medical imaging, and the human genome. Congress appropriates nearly all funds directly to the 27 centers, not to the NIH director.
    This focus on science rather than therapy, he [Will Ambler] said, is driven by scientists' preference for professional success, and also by NIH funding policies. NIH &ldquoprovides funding for scientists if they show scientific progress; they don't have to deliver [therapeutic] results,&rdquo he said.
    His road map includes a new program to award grants from the NIH director's office to nonmedical experts, young scientists, and others doing groundbreaking research. Zerhouni is also keenly aware of the complaints from Gregg, Ambler, and many others about the slow conversion of science into health care. The answer, he said, &ldquois not so much a question of incentives, [but rather] removing the obstacles.&rdquo Still, NIH will remain focused on science, not therapies, he said.
    Such career concerns are valid, he [Daniel Callahan]said, because scientists depend on peer friendships for grants, jobs, and publishing opportunities. &ldquoProfessionals can gossip and ruin reputations in a way that is very hard to pin down,&rdquo and fear of that punishment keeps many from raising objections to a line of research.
    To make his case, Zerhouni cited the science sector's response to the death of Jesse Gelsinger during an experiment at the University of Pennsylvania that was overseen by researcher James Wilson. Before the 1999 experiment, Wilson &ldquowas at the top of the world,&rdquo Zerhouni said. &ldquoHe was one of the touted stars of biomedical research, and when the Jesse Gelsinger thing happened, he lost his scientific reputation, he lost his job, his own boss lost his job, the entire university system was redone.
    [This message was edited by seneca on 11-12-03 at 09:09 PM.]

  3. #3
    The NIH is a little like a huge aircraft carrier. If it is going to make a turn, it has to start turning early and the ship takes a long time to turn. NIH is beginning to turn. It is important, however, that we be very careful not to jettison good science along the way. Since its inception, NIH has been the most successful program funded by the federal government, in large part because it has not been politicized. Many other countries have attempted to emulate the NIH with less success in part because they have not been able to prevent political interference with the scientific process.

    In my opinion, the distinction between "basic" and "applied" science is not important. The really important distinction is good and bad science. Good science has impact on people and bad science does not. Creating therapies takes time and we must be careful about not turning off the spigot on knowledge essential for understanding mechanisms of diseases which lead to therapy.

    The discussion has to involve more than just the NIH. The NIH does not have the resources or capability to do all the clinical trials. NIH research can provide the ideas and proof of concept but ultimately the testing and scaling therapies so that they can be made available to many people must be done by the pharmaceutical industry. Many people have now pointed out that the pharmaceutical industry has now reached a point where they must begin to move away from focussing all their attention on blockbuster drugs and start investing in therapies for smaller diseases and conditions.

    We also need to stop thinking of the NIH as a monolithic institution. NIH is successful because it chooses the best science available in the nation and gives the scientists 3-5 year grants to do what they want to do with relatively little restrictions. Thus, NIH is really the biomedical scientific enterprise in the United States. It can help encourage scientists to develop in certain directions, provide resources to improve efficiency, and facilitate the transfer of knowledge. But, it cannot dictate the science that is being done. That must come from the scientists themselves.

    Wise.

  4. #4
    Senior Member Leo's Avatar
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    So Wise, If I understand your opinion. You give this guys opinion the thumbs down? And the NIH is doing a fine job as is?

    "All you have to decide is what to do with the time that is given you."
    Gandolf the Gray

  5. #5
    Agreed about the aircraft carrier and enterprise analogies Dr. Y.

    But, doesn't the NIH then, to some extent, foster scientific "careerism"?

    Science for the sake of science is good but science for the sake of (human) application is better imo.

  6. #6
    Leo, I support and agree with much of what Neil Munro says.

    Zerhouni has been turning the wheel of the ship very hard towards clinical application and there is now movement within NIH to implement. I think that debate is focussing on the wrong tool to change scientific direction. The tool many people seem to be advocate is imposition of short-sighted policies and "management of science" in the United States. I think the trend to politicize NIH is not good. Since scientists are the ones who need to be changed, the focus should be on a national debate on the direction of science rather than trying to push the policy from top down.

    Dr. Elias Zerhouni is proposing drastic changes of NIH with his "roadmap". I agree with most of his proposals. The point of the article is that the recent political pressures for NIH to do more clinically relevant science has given him more power. In the short time that Zerhouni has taken over the helm of NIH, he has become the most powerful director of NIH in the history of the institution.

    In the past, individual directors of NIH have had a great deal of power. Each director went to the White House and Congress to present their case for more funding for their particular sector of research. The NIH Director had little power and had to rely solely on his/her power of persuasion. Zerhouni is seeking to change this approach, arguing for greater coordination amongst the institutes. The changes are couched in terms of committees and planning groups but it is being centralized.

    Varmus, the previous NIH director, was the first nobel laureate (I believe, to my knowledge) and active scientist to head NIH. He started the trend that is continuing of appointing active scientists to the leadership. However, as Varmus knows and said, it will be very unlikely that the various constituencies of each institute would allow so much power to flow to the Director of NIH. For example, the cancer research lobbyists will strongly oppose a structure where the National Cancer Institute will be told what to do by a Director who might have other priorities. They are legitimately afraid that if much power concentrates in one person, the funding of NIH will become politicized.

    Let me give you some examples of how science can be politicized.

    1. "Hot Areas". In the past year, I estimate that over 10% of the NIH budget has been reallocated towards bioterrorism research. For example, probably over a billion of the new funds are being spent on vaccines for organisms that have been identified as potential bioterrorist weapons, i.e. anthrax and smallpox.

    2. "Outsourcing". NIH is subject to the administration policies that require centralization and out-sourcing of work. Outsourcing is of particular concern because it is requiring NIH to spend many millions of dollars every year figuring out what jobs could be done by private contractors. The problem is that once the jobs are contracted out, NIH no longer retains control over the work. In areas such as peer review, grant management, and human resources, NIH is not only losing control but is losing many of its career administrators who have been one of the reasons why NIH has been so successful.

    3. Centralization. Centralization of power means that the White House can more easily put significant pressure on NIH to do what the White House wants. For example, the White House can decide that they really want to end embyronic stem cells research even in animals. In the past, a President or a Secretary of Health had to get NIH to come to a consensus on such issues. However, with centralization of power, a President just has to put some pressure on a few people that he/she appoints and billions of dollars can be shifted from one priority area to another with virtually no public discussion.

    Wise.

    [This message was edited by Wise Young on 11-13-03 at 03:38 PM.]

  7. #7
    Senior Member Max's Avatar
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    NIH may petition Bush on stem cells

    NIH may petition Bush on stem cells
    Associated Press

    WASHINGTON -- If it turns out White House restrictions are slowing federally funded studies of embryonic stem cells, the head of the National Institutes of Health says he will ask President Bush to revisit the issue.

    Elias Zerhouni said Wednesday in an interview with The Associated Press that research into the medical uses of embryonic stem cells is still at an early stage and that the 78 cell lines approved by the White House are enough to meet scientific needs.

    If studies show that there is a need for more cell lines, and if the White House policy is stunting research, Zerhouni said, "I'll be the first to go the president and say we have reached a point where we need a debate here."


    But he maintained that the current policy "is appropriate" for the stage the science is in now.

    Embryonic stem cells form during the early days after conception. Researchers, principally through mouse studies, have found that the cells can be prompted to grow into virtually any kind of cell in the body. Some scientists believe it is possible the cells could be transformed into new tissue that could be used to treat diabetes, spinal cord injuries and perhaps Alzheimer's and Parkinson's disease.

    Many religious groups oppose such research because it involves the killing of human embryos. Bush ordered NIH not to fund any research on stem cells harvested from embryos killed after Aug. 9, 2001. NIH identified 78 cell lines that met all the restrictions, and 12 of those lines are now available for study.

    But many stem cell scientists say the policy severely restricts research that ultimately could benefit millions of patients. Some contend, for instance, that none of the 12 NIH cell lines now available could be used to treat patients because they were grown using mouse cells and may contain rodent viruses.

    Zerhouni said that although scientists believe stem cell research could provide new treatments for disease, there has been no research proving that embryonic stem cells can be medically useful. He said there are fundamental safety questions that must be answered first before stem cells should be considered for therapeutic use. And those questions, he said, can be adequately answered using the existing approved cell lines.

    The limiting factor in embryonic stem cell research is not the number of cell lines available for study, said Zerhouni, but the number of researchers trained to do the work.

    "We don't have many people who understand embryonic stem cells," he said. "That is why we are doing training courses, funding laboratories so we can get more people trained in the field."

    Critics have said that by restricting federal funding of embryonic stem cell studies, the White House policy may cause the United States to lose its worldwide lead in medical research because some other countries, such as the Britain, do not have such restrictions.

    Zerhouni, however, said that there are no home grown embryonic stem cell lines now available in Britain without restrictions. He said the British system requires research proposals to go through elaborate checks.

    The U.S. government, he said, is the only one openly and easily providing stem cells to researchers. Hundreds of specimens have been sent to labs in the United States and other nations, he said.

    A report by a team of scientists at Johns Hopkins University said it would be unethical and risky to treat patients with any of the 12 available cell lines because they were all cultured using mouse cells as nutrients. The report said that this could possibly expose patients to an animal virus that could not be controlled by the human immune system.

    Zerhouni noted that Food and Drug Administration experts have examined this issue and concluded there are safety practices in place to evaluate the risks if a researcher ever proposes to use one of the approved cell lines to treat patients.

    "There is no absolute that says anything that is grown on a mouse feeder cell is not to be used clinically," said Zerhouni.


    Copyright © 2003 Associated Press.

    http://www.billingsgazette.com/index...-stemcells.inc

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