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  1. #1

    Sooner or later...

    National Journal
    SCIENCE: Petri-Dish Politics
    by Neil Munro

    Government officials at the National Institutes of Health will distribute more than $16 billion in grants to university scientists this year. NIH's budget has doubled over the past five years, but the grant money flows out with scant media attention and minimal oversight from Congress or direction from the White House. Panels of university scientists decide who gets the grants, and many of the panelists are either colleagues or professional rivals of the grant-seekers. "Because the [research] mission is so noble, it seems so apolitical," said Craig Snyder, a medical-research lobbyist for Ikon Public Affairs in Washington. "But in the real world, the allocation of the dollars is influenced by politics of all kinds."

    Plenty of time-tested reasons have shaped the current process, and many medical advances have emerged. But on the other hand, plenty of scientists say the process is secretive, that it caters to well-connected groups, and that it underfunds practical therapies in favor of long-term basic research. Requests for NIH grants undergo peer review by scientists who "fund their friends, and their friends fund them.... It is a very corrupt, nepotistic system," said Dr. Arif Khan, a psychiatrist and researcher who owns and operates the Northwest Clinical Research Center in Bellevue, Wash. Robert Beck, executive director of the Autism Society ofAmerica, complained that from the 1950s to the 1980s, research on autism was dominated by the theories of Bruno Bettelheim and his allies, ensuring "multiple generations of kids were totally misdiagnosed." It was only pressure from parents that forced NIH to change, he said.

    NIH has many safeguards in place: peer review of study results, ethics guidelines, extensive data collection, and most important, reliance on the rigors of the scientific method. But scientists and advocates alike point to one area that they say represents the most significant current case of politics in science: stem-cell research. The high-stakes technologies involving stem cells have put the normal politics of science into overdrive.

    The political struggle pits at least two rival technologies, each with its own political support group in Washington, against each other: the one based on stem cells drawn from human embryos, and the other using stem cells from adults. Each side makes a case for its cells' disease-curing potential. The arguments are spilling out of scientists' back rooms and revealing much about the little-known politics of biomedical research.

    "It is difficult for the scientists [working with adult stem cells] to get publicity and to get funding," said Helen Blau, a top-level scientist at Stanford University. Ammon Peck, a scientist at the University of Florida, blames this situation on the embryonic-cell faction: "Those working on embryonic stem cells," he said, "have turned and stabbed those working on adult stem cells in the back" by inaccurately criticizing their published papers. This goes on, he added, even though many adult-cell researchers support embryo-cell research.

    Scientists are reluctant to reveal their intramural fights, said Blau. By speaking out on this issue, "I could get in a very big mess [with] everybody," she said.

    The Tommy Thompson Factor

    In a nationally televised announcement on August 9, 2001, President Bush said he would fund research on about 60 colonies of stem cells that had already been extracted from embryos. He also said he would fund research on adult cells. " Most scientists, at least today, believe that research on embryonic stem cells offers the most promise because these cells have the potential to develop in all of the tissues in the body," Bush said. "I also believe that great scientific progress can be made through aggressive federal funding of research on umbilical cord, placenta, adult, and animal stem cells, which do not involve the same moral dilemma."

    Social conservatives oppose the embryo-cell research because it requires the creation and destruction of many human embryos. They also worry that the research will accelerate the development of commercial genetic engineering, which could give parents some technological control over the bodies and personality traits of their prospective children.

    Supporters of embryo-cell research argue that it offers the best hope for treating many diseases and provides the best laboratory models for testing theories, potential products, and therapies. They also say that politicians should not regulate scientists -- not even federally funded ones. In the months leading up to Bush's speech, advocacy groups, led by high-tech universities with their affiliated scientists and allied biotech companies, and supported publicly by several disabled celebrities, lobbied against curbs on embryo-cell research. They were aided by Tommy G.Thompson, secretary of the Health and Human Services Department, which oversees NIH.

    Three days after Bush's speech allowing some embryo-cell research, Thompson announced that embryo-cell research has "got to have some opportunity to catch up to what's going on in adult stem cells ... upwards to $100 million, more than likely, will be apportioned to the embryonic-stem-cell portion of research." A year after the speech, Thompson met with advocates of the research to urge them to seek more federal support. He also announced the formation of a top-level NIH Stem-Cell Task Force to promote embryo-cell research.

    Thompson first dealt with the issue of embryo cells while serving as governor of Wisconsin. The state university at Madison is a leader in medical research and is ranked No. 14 nationally in federal research funds received; in 2000, its share was $263 million. In 1998, James Thomson, a researcher at Madison, announced a breakthrough -- he had extracted stem cells from a human embryo. The university has since transferred the resulting patent to its affiliate, the Wisconsin Alumni Research Foundation. The foundation, which was created in 1925, commercializes the university's technology and annually generates $30 million for additional research at the university.

    For a modest fee, the foundation will allow university scientists to develop the embryo-cell technology further, often with NIH funds. If the resulting technology is saleable, the foundation, the scientist, and the investors will bargain for the commercial rights. This practice is commonplace at U.S. universities because it affords a low-cost, low-risk means of converting basic science into new commercial products, companies, and jobs. Many state governments subsidize this deal-making. For example, last year California passed new laws and offered additional funds to encourage embryo-cell research in the state's universities.

    In 2000, Thompson, then governor of Wisconsin, committed $150 million to create the state's Biostar program to launch new companies from technology developed at Madison. In response, the alumni foundation promised to put an additional $80 million toward the effort. "We are poised to become the nation's leading biotechnology center-in terms of both research and job creation," Thompson declared. Thompson was unavailable for comment. HHS spokesman William Pierce said that Thompson does not direct the task force, and that grant-approval decisions are made by NIH.

    The NIH Funding Game

    The NIH Stem-Cell Task Force that Thompson established is charged with advising senior officials on the best ways to promote all kinds of stem-cell research. But "the place where we think the NIH may need to give a helping hand is in the area of human embryonic stem cells,"said James Battey, head of the NIH Institute on Deafness and Other Communication Disorders and chairman of the task force. "For the most part, the adult-stem-cell agenda is moving forward at a very nice pace."

    By March 2003, NIH's institutions, under the guidance of the task force, had awarded a total of $25.4 million in grants. They included $6.2 million for growing more embryo stem cells at eight centers; one is at Madison, and at least three, including BresaGen in Australia, are overseas. NIH also awarded funds to train about 100 scientists on embryo cells in Wisconsin, and $14.8 million for embryo-cell projects suggested by 12 outside researchers. At least three of these 12 projects are in Madison.

    Another 14 new stem-cell programs are starting up under the auspices of the task force, and many of them will likely include some adult-cell work. No embryo-cell spending target has been set for next year, Battey said, but spending will grow as more scientists trained in embryo-cell work apply for funds.

    Battey's task force consists of 14 NIH scientists and officials, and 10 outside advisers. All are expert scientists, but in the increasingly integrated economy, many have also formed close ties with other scientists, businesses, and political advocates. For example, one of the advisers is Irving Weissman, the Stanford University researcher who has been the leading opponent of curbs on embryo-cell research or human cloning. Weissman chaired a panel, created by the private National Academy of Sciences, that in 2002 urged Congress to permit the cloning of human embryos for research. Weissman has formed at least two companies and heads a privately funded center at Stanford that plans to create new colonies of embryonic stem cells, perhaps through embryo cloning.

    Another outside member of the task force is Thomson, the Madison researcher who grew the first colony of stem cells taken from an embryo. If embryo cells become widely used, Thomson, as the inventor of the technique, will reap income and professional opportunities, and his university employer will also benefit. Another member, Brigid Hogan, of Vanderbilt University, also stands to gain if her embryo-cell patents are widely used. Her patents have already been licensed to BresaGen, the Australian firm that has received NIH funds for growing embryonic stem cells.

    Many scientists inside and outside NIH share educational and professional ties. For example, panel chairman Battey said he had worked beside Weissman at Stanford: "I trained in the lab next door.... Science is like that; it is one of the nice things -- you get to know people," he said. These ties extend beyond the laboratory. One of the 12 embryo-cellgrants went to Viviane Tabar, at Memorial Sloan-Kettering Cancer Center in New York City. She used to work at NIH with Ron McKay, an NIH official who sits on Battey's panel. Both Tabar and McKay are exploring the possible use of embryonic stem cells in treating Parkinson's disease. Both have ties to companies working in the field: McKay helped start NeuralStem, in Gaithersburg, Md., and Tabar has conducted research with the founders of Advanced Cell Technology, a Massachusetts company that has tried to clone human embryos.

    Grants, especially the prestigious NIH grants, help advance scientists' careers. The members of Battey's task force include several rainmakers who themselves regularly win large NIH grants and distribute them to university officials and scientists working under them. From 2000 to 2002,Thomson received at least four grants worth a total of $819,000; Weissman got at least 24 grants worth $11 million; and James P. Kushner, of the University of Utah, received at least 22 grants worth $7 million. Thomson also received one of the 12 embryo-cell grants the task force oversees.

    Their mix of professional standing, expertise, and economic clout guarantees the task force members a good audience in Washington. Indeed, Kushner has enjoyed praise from Sen. Orrin G. Hatch, R-Utah. In June 2001, Hatch broke ranks with his social-conservative allies and, in a letter to Secretary Thompson, announced his support for embryo-cell research. In the letter, Hatch urged Thompson to "convene the National Institutes of Health Human Pluripotent Stem Cell Review Group ... chaired by Dr. James Kushner of the University of Utah [to] become a key forum to provide information and advice for policy makers."

    Most of the task force's members and advisers are working on the basic science of embryo cells, rather than working with patients and seeking therapies using the patients' adult cells. In one working group, "the emphasis of the group was very much embryonic stem cells," said member Darwin J. Prockop of Tulane University Medical School. "I kept trying to introduce adult stem cells, [but] that was not much on the agenda." Prockop has ameliorated brittle-bone disease in five children by using the children's own adult stem cells.

    NIH's traditional focus on basic science rather than therapies has long been criticized by patient advocates. NIH is really "the National Institutes of Science; ... curing people with diseases is very low on their priority list," said James Kelly, a wheelchair-bound activist who argues that adult-cell research is the fastest route to new therapies.

    Battey counters, "I know of no scientists who would not be thrilled to see something they did in the lab result in improved treatment for human beings. You're not going to have therapies without science." But when asked whether the panel includes too few scientists who treat patients, Battey said, "It is a valid point."

    But overall, Battey said, the task force is "quite well balanced." He added that the members have "different opinions,different things at stake ... [and] they are universally respectful of each other's opinions." In case of disagreements, "we do everything we can to see which side of the argument the [scientific] evidence favors."

    Separately from the task force initiative, NIH also funds much work on adult stem cells. Last year, at least 91 grants were awarded for stem-cell research in California, Massachusetts, New York, and Pennsylvania, according to NIH's Web site. These four states received 40 percent of NIH's research grants. Of the 91 grants, 16 worth a total of $6.7 million were directed toward embryo-cell research, and 21 grants worth $5.7million were allocated to developing therapies from adult stem cells. The remaining $15.8 million went to a variety of basic-research projects related to stem cells.

    Peer Pressure

    Each of the 26,000-plus grant applications made annually to NIH undergoes two levels of peer review by panels of respected outside scientists, most of whom are employed by universities. The reviewers rate the scientific quality of the proposal and the reputation of the applicant. NIH officials fund the highest-rated grants until all allocated funds are disbursed.

    To manage conflicts of interest, NIH officials track the peer reviewers' various professional and business ties, as well as the proliferating ties between universities and companies. The grant applications are passed to the reviewers who have the fewest, or no, conflicts of interest. The identities of the peer reviewers remain unpublished, reducing the possibility of pressure from colleagues, but also diminishing the opportunity for informed oversight from the outside.

    One persistent problem, say NIH officials and outsiders, is excessive caution. An application that proposes innovative or breakthrough research, but lacks a large body of supporting data, can be rejected too easily, said Brent Stanfield, deputy director of NIH's Center for Scientific Review and a member of the peer-review group for Battey's Stem-Cell Task Force. To help offset this tendency, NIH urges reviewers to give extra consideration to innovative research, young scientists, and scientists outside the main research universities.

    Despite NIH management, the reviewers allow their multiple interests to influence their decisions improperly, many scientists say. For example, it was only recently, Prockop said, that NIH promised him $1 million per year to create the first bank for adult stem cells, a center similar to the eight embryo-cell centers NIH is already funding. "We had to fight for it for a year and half. It was a real struggle because people who don't believe [in adult-cell research] don't look at the data," he said.

    "There is much professional jealously and politics in science, so [some scientists] don't want their competitors to get ahead," said Peck of the University of Florida. Peck has used stem cells from adult mice to eliminate their diabetes symptoms, and the university has transferred the technology to a company Peck co-owns. This success puts Peck in competition with a member of the grant-making task force, NIH researcher Ron McKay, who treated diabetic mice with mouse-embryo stemcells to slight or minimal effect.

    In some cases, scientists say, the politics deters a researcher from even applying for a grant. Michel Levesque, the director of neuro-functional surgery at Cedars-Sinai Medical Center in Los Angeles, is one such researcher. Four years ago, he took stem cells from a Parkinson's patient, multiplied them in a laboratory, and injected them back into the patient's brain. Last year, he announced that his treatment had reduced the patient's symptoms by 84 percent, restoring him to health.

    Because the patient's level of dopamine -- a brain chemical -- did not return to normal, his experiment contradicted the dominant theory among Parkinson's researchers. The theory, supported by advocates of embryo-cell research, says that embryo cells can cure Parkinson's by restoring normal dopaminelevels. Neural Stem, partly owned by task-force member McKay, is one company trying to develop this technology.

    NIH, said Levesque, "is like a fraternity more than anything else....It is the buddy system, [and to enter it] you have to have a very good track record in academia and spend your whole life in academia." Commercial rivalries matter, he said, because many university scientists receive funding from companies interested in selling the products of their research.

    When asked about Levesque's work, Battey said he was "not familiar with the individual or his work." He also said Levesque should publish his experiment in a peer-reviewed journal, and he dismissed Levesque by comparing him to the Raelian cult, which claimed in 2002 that it had produced healthy cloned babies.

    There's also a lot of pressure from within the scientific community to hide its internal fights from the media and government, said Stanford's Blau. Scientists who raise these topics outside their professional community can suffer retaliation, she said.

    David Prentice, a professor at Indiana State University, says he has suffered retaliation for disagreeing with his colleagues. He saw his teaching load doubled and his laboratory space halved after he worked in 2002 as an adviser to Sen. Sam Brownback, R-Kan. Brownback is leading the campaign to curb embryo-cell research and to ban the cloning of human embryos. "I came back, and I was assigned six [teaching] courses -- 14 credit hours. With that many hours, I qualified for overload pay" and can't spare time for research or for NIH grant applications, Prentice said.

    His supervisor, Charles Almaner, said Prentice's laboratory is stills somewhat larger than his colleagues', and that he was given a slightly increased teaching load because of his teaching skills.

    Several other researchers said they dared not comment about this debate because they feared informal retribution from colleagues who can withhold the support necessary to get jobs, grants, or publishing opportunities. Other scientists say the disputes are a normal part of science, especially when a new technology upends existing assumptions and careers. "Whenever you have a paradigm shift, people want extraordinary proof for extraordinary claims.... It's part of the normal, healthy process of science," said Margaret Goodell, a scientist at Baylor College of Medicine who specializes in adult cells.

    High-Level Politics

    Higher-level politics also intrude, scientists say. NIH officials, as well as the science community's research journals, are downplaying adult-cell research to protect the embryo-cell programs from political opposition in Congress, Blau said.

    "The scientific community is afraid too much publicity for adult stem cells ... would kill embryonic-stem-cell research, [so] it is difficult for the [adult-stem-cell] scientists to get publicity and to get funding," she said.

    Blau is well regarded in her field. In 2000, 2001, and 2002, she won 20 grants from NIH worth a total of $5.7 million. With some of that money,she has shown that adult bone-marrow cells are "plastic" enough to convert into muscle and other cells, boosting the prospects for therapies based on adult stem cells. Her work, and that of other researchers, has upended the long-standing belief that adult cells cannot convert into different cells.

    No one doubts that embryo stem cells are more plastic than their adult counterparts-after all, every human grew from a single, highly plastic,embryo cell. But if adult cells were sufficiently plastic to treat diseases in all 200 types of human cells, and to form stable organs, such as livers and kidneys, "then we would not need embryonic stem cells," said David Baltimore, head of the California Institute ofTechnology and a prominent opponent of curbs on embryo-cell research.

    Congressional opponents of embryo-cell research frequently cite advances in adult-cell research as one reason to end federal support for research into embryo cells. "What's hurting us most is the incredible political pressure and the propaganda of 'Why don't you use adult stem cells?' " said embryo-cell researcher Tabar. But, she added, within the limits set by Bush, NIH officials "are being very helpful."

    This high-stakes fight over plasticity has also helped slow work by another top-level researcher, Catherine Verfaillie, at the University of Minnesota. A few years ago, she said, she had difficulty obtaining grants for her plasticity research. But after getting an NIH grant in 2001, she demonstrated how stem cells from bone marrow can be grown in very large numbers and converted into blood, lung, liver, and other types of cells for therapies. Asked about the delayed grants, she said that "a lot of interests," including professional and commercial ties, help shape scientists' views. NIH officials "are pushing hard to get the [embryo-cell] side off the ground, but funding should be side-by-side" with adult-cell research, she said. Verfaillie said she supports embryo-cell research, although it has "not really yet" provided her laboratory with useful data.

    The opposition from NIH and the scientific community to adult cells would fade, Blau said, if Congress stopped blocking embryo-cell research." By blocking one type, they're blocking the whole field," shes aid.

    But Battey disputes the charge that adult-cell research is being limited. "I'm not sure I've seen credible evidence" to back up that claim, Battey said. If it were, "you would expect it to be revealed" by NIH's internal data, he said.

    This sharp disagreement over the plasticity of adult cells has not upset the belief among most scientists that legislators should not regulate science. Most of adult-cell research's strongest supporters, including Blau, Verfaillie, and Prockop, say the technology is not developed enough to justify ending grants for embryo cells. Congress is loath to regulate the adult-cell scientists, and is deadlocked on embryo-cell research.

    Even the White House stays clear of the dispute. The White House's Office of Management and Budget did not propose any spending levels for different types of stem-cell research in the 2004 budget, despite the social conservatives' desire to see adult cells favored. When asked in December whether OMB had favored one avenue over the other, Director Mitchell E. Daniels Jr. said, "There are about 4,000 questions you could ask me that are in the purview of this job, but that's one you really ought to ask Jack Marburger," the White House science adviser.

    When asked, Marburger said, "No one has the expertise or the ability to predict where science breakthroughs come, so we rely on the scientific community to direct the program in some detail." Stem-cell funding,he added, "is a question too detailed for us to give priority guidance, [so] we leave that up to the specific institutes within the NIH.... It's down in the weeds."

    Many scientists see the NIH grant-making process this way: Because it is run by humans, it is imperfect, but because it is run by scientists, it is better than a process run by legislators. "Most scientists would prefer the peer-review system to any other," said Battey. "It is like democracy -- it has got its limitations, but nobody has come up with anything better."

    Prockop made the same point in defense of the peer-review system. He also said that in science, facts eventually trump politics, especially when a theory produces tangible therapies. Sooner or later, he said, "the truth will come out.... That's the way it works."

    Neil Munro
    National Journal

  2. #2
    Ok. Now see . . . tell me I'm smoking something. Tell me that my previous post wasn't correct. Tell DA that his comments have not been right on the money.

    The politics surrounding this debate are incredible. And you and I are paying the price for it.

    I didn't need this article to tell me this. The very fact that ASC, OEG and the other therapies stopped in their tracks in this country when the ESC debate broke out tells us all we need to know.

    Bottom line. If ASC, OEG or some other non-patentable cure therapies arises, that means alot of researchers and the bio-tech firms will lose out on a lot of money.

    Funny how I've been accused of being anti ESC which could not be farther from the truth.

    I wonder if others could be considered anti-ASC????

    ASC is being ignored. Researchers have talking about this for some time . . . now publicly. Do you realize the risk they run by doing this? Which only leads to one conclusion, they feel so left out that they got nothing to lose.

    I've said it before and I'll say it again. Researchers got nothing on other professionals when it comes to cannibalizing one another. This is just sad.

    And sick.

  3. #3
    Senior Member Leo's Avatar
    Join Date
    Jul 2001
    Yankton, South Dakota
    Your right Lar's and DA also, it would be nieve to think politics ain't running the show. Now what's even sadder and sicker is that the disability national org's are in that bed. They not only don't encourage reaserch but by not doing so squash it. (most anyway) A happy gimp in a chair is a good gimp.

    The light is that we have some great folks here busting thier ass, with the view of reality.

    Pray that I can make it happen and can give reports from China. IMO the road to a cure begins with flights to China.

  4. #4
    In my opinion the point that's being overlooked is the NIH apparently wants to force researchers towards ESCs regardless of where the science logically says they should focus their work (if cures are the goal).

    The article concludes that "sooner or later" the truth will out. Personally, sooner or later I'll be dead.

    Btw, if the Chairman of the NIH panel charged with advising its stem cells course never heard of Dr. Levesque, then likens him to the Raelians, then we're really in trouble.

  5. #5
    I am saddened by Neil Munro's attack on NIH. Neil Munro seems to be suggesting that we should politicize NIH so that his anti-ESC political agenda can take over the NIH. It is sad. I don't know who Arif Khan or Robert Beck is but they definitely do not represent the views of any scientist that I know.

    I am surprised by the statement from Helen Blau. Dr. Blau must be one of the best funded researchers by NIH for her adult stem cell research. She holds 6 grants from four NIH institutes: NIGMS, NICHD, NIA, and NCI. Most scientists typically hold at most 1 or 2. She is featured on the NIH web site. In fact, she received one of the most prestigious awards in biology for her adult stem cell work (1999 Excellence in Science Award from the Federation of American Societies for Experimental Biology). She is getting plenty of publicity and funds for her work. The implication that she is having difficulty getting publicity and funding for adult stem cell research is hard to believe.


  6. #6
    On the contrary, Dr. Young, Neil Munro's article didn't seem like an attack to me at all. He simply reported facts and quotes.

    On the other hand, I'm saddened that you should choose to ignore the inescapable facts, quotes, and conclusions this article presents: i.e., that NIH directs the course of American research (and to a certain extent worldwide research) based on its profit potential for a core group of "insiders" and its perceived good for Science, NOT the good of the sick and disabled.

    Dr. Young, before you were an administrator you were a physician. I wish you'd be one again.

  7. #7
    Iacapo, besides founding and being the principle administrator for CareCure, Dr. Young has a Ph.D., M.D. and is Director of the Center for Collaborative Neuroscience at Rutgers University. He is a graduate of the Reed College (B.A. 1971), the University of Iowa (Ph.D., 1975), and Stanford University (M.D., 1977), Dr. Young was Director of Neurosurgery Laboratories at NYU/Bellevue Hospital in New York for 20 years and moved to head Neuroscience at the Faculty of Arts and Sciences (FAS) at Rutgers, the State University of New Jersey in 1997. His current work focuses on spinal cord injury and its treatments.

    He is also the founder of the National and International Neurotrauma Society. He was one of the lead researchers behind Methylprednisone which is the ONLY FDA approved treatment for acute SCI.

    I don't quite understand the hostility behind the tone of your post but in light of all that Dr. Young has selflessly accomplished for this community, I don't think it's too much to ask that you at the very least, use a tone more reflective of respect in the future. One can disagree without being rude and condescending.

  8. #8
    Originally posted by Iacapo:

    On the other hand, _I'm_ saddened that _you_ should choose to ignore the inescapable facts, quotes, and conclusions this article presents: i.e., that NIH directs the course of American research (and to a certain extent _worldwide_ research) based on its profit potential for a core group of "insiders" and its perceived good for _Science_, NOT the good of the sick and disabled.
    Dr. Young has made, IMO, indirect references to these points on numerous occasions. As far as the NIH directing the course of research, Dr. Young has stated more than once that if we want focus on SCI, get Congress to add a line item to a bill instructing the NIH to build a clinical trial network. An established clinical trial network would help attract new researchers.

    Think about it: researchers do want to help out. If you were a researcher and you wanted to help people, where would you go? A field that is basically stuck in basic research because there is no established infrastructure for transitioning laboratory studies to human therapies? Or one that has a stable system for getting your work into helping humans?

    Those are my thoughts for the time being.


  9. #9
    Senior Member X-racer...'s Avatar
    Join Date
    Jul 2001
    Eugene, OR
    SINeca most states have stocking laws are you sure your not violating them with Dr. Young


  10. #10
    Originally posted by seneca:

    I don't think it's too much to ask that you at the very least, use a tone more reflective of respect in the future. One can disagree without being rude and condescending.

    That's a two way street Seneca.

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