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Hello, All: I thought this article is worthy of posting (sorry about the length). Specifically, check out paragraph #8 (my #s). I wonder where Bruce Agnew, author of article, is getting his info, and would he be interested in a follow up story from the parky side? Anybody interested in contacting him? The website for this article and NIH info is: http://www.enews.com/magazines/nih/current/960701-002.html The Journal of NIH Research 07/01/96 Clinical Research: Looking For Help In Unusual Places Bruce Agnew 1.The rhetoric this spring from NIH and other research advocates didn't sound like a particularly effective way to persuade managed-care health insurers to pick up more of the costs of clinical research. It sounded more like confrontational name-calling. 2.Managed-care operators are "efficiency-driven" and "not particularly receptive" to academic health centers seeking additional funds for education and research, NIH Director Harold Varmus told the Senate Labor and Human Resources Committee in March, as it began hearings on a new NIH Revitalization Act. 3."Financial pressures and the growth of managed care threaten the very existence of [academic health] centers," Sen.Edward Kennedy, D-Mass., declared on May 7, at a follow-up hearing of the committee. "Clinical research is in crisis today." 4."It is the managed-care industry that is seriously lagging behind," David Nathan, president of the Dana-Farber Cancer Institute in Boston--and chair of a special NIH Director's Panel on Clinical Research--told the May 7 hearing. "We will not be able to do very much for the state of clinical research unless insurance carriers and for-profit providers are forced to contribute to the research and teaching missions in a significant way." 5.But now, Nathan's 14-member study panel and the Senate committee both appear to be renouncing the use of force. Nathan's panel* instead has begun holding private talks with leading managed-care firms--and is finding that some companies, at least, are less obdurate than their reputation suggests. Nathan even sees a possibility of forging a new clinical-research partnership with them. "There are some issues that we may be at loggerheads over, but there's room for working it out," he said in an interview on June 11, although he added, "I'm not sure there's room for working it out with those who just dig in their heels and say, 'We're not going to talk.'" 6.Senate Labor Committee Chair Nancy Kassebaum, R-Kan., also apparently wants to work things out privately. In legislation she was preparing to introduce to reauthorize NIH, she was expected to abandon any idea of ordering insurers and managed-care operators to pay the ordinary medical costs of clinical-research patients (see April issue, page 22). After health insurers helped crush President Clinton's health reform program in 1994, and threatened to stymie a more modest effort co-sponsored by Kassebaum and Kennedy this year, Congress is hardly anxious to take on the industry once again. 7. Both the Nathan panel and Kassebaum's committee, however, will offer a smorgasbord of other ideas for easing pressures on U.S. clinical research, ranging from student-loan forgiveness for young clinical researchers to changes in peer review study sections to eliminate bias against clinical-research grant applications. Kassebaum's bill, which she was circulating in draft form to potential co-sponsors last month, may not become law this year because so little time is left in this congressional session. But even though Kassebaum is retiring at the end of this Congress, her bill will be the starting point when the new Congress turns to the question next year. 8, Among its other provisions, Kassebaum's bill was expected to elevate the National Center for Human Genome Research to full institute status. But, in response to pleas from NIH officials, the expected bill would impose no new disease-specific spending mandates on NIH. (It may pick up some specific mandates before becoming law; a new program for Parkinson's disease research is the leading contender.) 9.The Nathan panel plans to make formal recommendations to Varmus in November, although some of its proposals have already reached his desk informally. When the Nathan panel started its work on July 7, 1995, one of its first problems was that no one is quite sure how much clinical research NIH actually supports. According to Wendy Baldwin, deputy director for extramural research, NIH devoted $1.2 billion to conventional, multi-patient clinical trials in fiscal year 1995 and $4.7 billion to "human-subjects research" that required approval by Institutional Review Boards (IRBs). But the panel decided that neither of those categories of NIH spending defines clinical research: "Clinical trials" is too narrow and "human-subjects research" is too broad. For example, pure laboratory research using human tissue can require IRB approval, if the tissue donor is identifiable, but is by no means "clinical" research. Since then, the panel has defined its own area of interest as covering everything from single-patient "translational" research to large trials and outcomes research--or, as Nathan explains it, "research that is directly patient-oriented, in which an investigator actually makes contact with his or her human subject, a patient, or a large group of people." Baldwin has been analyzing new grant applications to determine how much NIH funding goes to such "patient-oriented" research, but she does not have an answer yet. However defined, clinical research is suffering today from a complex of ailments, members of Nathan's panel believe. Money,of course, is the root of all trouble. Efforts to cut the federal-government deficit have restrained the growth of NIH's budget,although NIH continues to get favored treatment from Congress, and the accelerating spread of managed-care plans is draining patients and revenues from the academic health centers. The Association of American Medical Colleges (AAMC) in Washington, D.C., estimates that one-third of the revenues from faculty members' clinical practices, which totaled $9 billion in 1993, is at risk to managed-care competition. From San Francisco to Boston, academic health centers have been merging, or discussing mergers, with other academic institutions or private hospitals to cut overhead and equipment costs. The percentage of medical students interested in research careers has been declining since 1989, while their average student-loan debt burden has been increasing, according to AAMC. Nearly one-third of 1995 medical-school graduates had debts of $75,000 or more, AAMC reported in its annual Trends MDRVMDNM survey in April. Nathan's panel thinks it can do something about that. At the panel's most recent meeting in May, a subcommittee headed by Jean Wilson of the University of Texas Southwestern Medical Center in Dallas offered a series of ideas for making clinical-research careers more attractive to medical-school graduates. They include a student-loan debt-forgiveness arrangement modeled on NIH's current debt-forgiveness program for minority researchers; a scholarship program patterned after the Howard Hughes Medical Institute's Resident Scholar program that brings graduate medical students to the NIH campus for a year of intensive research training; a career award program for more experienced clinical researchers that is designed to stabilize their salaries; and an earlier, formal introduction of medical students to clinical research. In Congress, Sens. Kennedy and Mark Hatfield, R-Ore., introduced legislation in January that included many of these ideas, including increasing the debt-forgiveness program to $35,000 a year and offering it to extramural clinical researchers. Kassebaum was expected to include much of the Hatfield-Kennedy bill in her proposed bill. Another subcommittee of the Nathan panel, headed by Guy McKhann, director of the Zanvyl Krieger Mind/Brain Institute at Johns Hopkins University in Baltimore, suggested a reshaping of the NIH-funded General Clinical Research Centers (GCRCs) that could have a significant impact on the way U.S. clinical research is conducted. Currently, NIH's National Center for Research Resources (NCRR) spends more than $140 million a year to support 75 GCRCs at 61 institutions throughout the country; more than 7,000 researchers use the GCRCs each year to conduct nearly 5,000 clinical-research projects funded by other grants, according to NCRR. But McKhann's subcommittee believes the GCRCs are hemmed in by NIH rules--such as a requirement that GCRC directors must be funded by NIH, not by other biomedical-research sponsors--that reduce their flexibility and restrict their influence in the academic health centers that house them. The subcommittee urged Varmus to strip down these rules and give GCRCs more flexibility. "We want the GCRC to become the central focus of clinical research--to be the site at which protocols are reviewed for the whole center to see whether or not they are scientifically valid," Nathan says. Members of Nathan's panel also appear to believe that NIH's peer review system is stacked against clinical-research grant proposals. Study sections generally score clinical-research applications lower than laboratory-research proposals the first time they review them (although study sections score revised clinical and lab-oriented proposals about the same). Study sections with few patient-oriented researchers among their members score clinical-research proposals particularly poorly. McKhann's subcommittee recommended that at least half the members of study sections that review clinical-research proposals should be patient-oriented researchers. The Division of Research Grants (DRG), which runs NIH's study-section system, isn't convinced that re-configuring study sections is the answer. But DRG officials are encouraging the scientific review administrators (SRAs) who manage individual study sections to group clinical applications together and to keep clinical researchers in mind when they assemble their panels. DRG also is closely monitoring applications in the area of clinical oncology as a test bed. "We're looking to see whether we need to make changes in certain areas," says Donna Dean, acting chief of DRG's referral and review branch. Of course, as in other areas of biomedical research, funding remains the major problem--and particularly, in the case of clinical research, funding from managed-care companies and insurers. Mandating that managed-care operators pick up a share of clinical-research costs is a political long shot, at least for now. But Nathan was encouraged after last month's meeting with managed-care officials about the prospects for voluntary support--perhaps even partnerships in supporting specific clinical trials. "There are two choices in this," Nathan says. "We either negotiate this, or we try to get laws passed. And the former is better than the latter." If Nathan's panel manages to achieve a negotiated solution, the earlier industry-bashing rhetoric may prove to have been a pretty good opening move after all. Apparently, the rules for jawboning an industry are very much like the old story about how to train a mule: First, you hit it between the eyes with a two-by-four--to get its attention. --bruce agnew *Members of the NIH Director's Panel on Clinical Research are: David Nathan, Dana-Farber Cancer Institute, Boston (chair); J. Claude Bennett, University of Alabama, Birmingham; Ezra Davidson Jr., King-Drew Medical Center, Los Angeles; Haile DeBas, University of California at San Francisco School of Medicine; William Friedewald, Metropolitan Life, New York City; Guy McKhann, Zanvyl Krieger Mind/Brain Institute, Johns Hopkins University, Baltimore; Herbert Pardes, Columbia University, New York City; William Peck, Washington University Medical School, St. Louis; Philip Pizzo, National Cancer Institute, Bethesda, Md.; Mary Polan, Stanford University School of Medicine, Stanford, Calif.; Leon Rosenberg, Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, N.J.; Judith Swain, University of Pennsylvania Hospital, Philadelphia; Samuel Thier, Massachusetts General Hospital, Boston; Jean Wilson, University of Texas Southwestern Medical Center, Dallas. Margaret Tuchan [log in to unmask]