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Return to Table of Contents Editorial: Re-aim blame for NIH's hard times Author s ; : Bishop JM, Varmus H Reference: Science. 2006 Apr 28; 312 5773 ; : 499. Published Abstract: Anxiety and anger are rife among the biomedical research community over the dwindling fortunes of the National Institutes of Health NIH ; . The anxiety is justified: Success rates for grant applications have fallen, on average, from over 30% in 2003 to under 20% and to even less at some Institutes ; , and the Bush administration's budget projections imply further declines. But the anger is another matter: Much of it is mistakenly directed at NIH itself and threatens to undermine the credibility of the agency with both its federal patrons and its public constituencies. Between 1999 and 2003, NIH enjoyed extraordinary largesse as Congress and two successive administrations doubled its budget to about $27 billion. During this period, as expected, NIH awarded more multiyear grants, committing itself to increasing fiscal obligations in the ensuing years. At the same time, the average grant size grew beyond the rate of inflation and the number of applications also rose significantly. After such expansion, a gradual decline toward more customary increases is required to ensure that substantial uncommitted funds are available for new grants. But the hoped-for "soft landing" did not occur. Most federal budgets, including NIH's, have flattened in the service of larger budgetary agendas, such as tax cuts and financing the war in Iraq. Congress has turned a skeptical eye on NIH, demanding to know at an unrealistically early stage what exceptional benefits the doubling has brought to those suffering from diseases and asking why NIH cannot prosper with its doubled budget. Now, facing its third consecutive year of sub-inflationary increases, NIH is likely to have 11% less spending power in 2007 than it did in 2004. Rather than galvanizing political action to restore at least inflationary budgetary increases, these developments have precipitated an irrational response from some members of our research community. They have begun to blame the agency itself, accusing the NIH administration of mismanagement and ill-conceived adventures. The favorite whipping boy is the recently developed NIH Roadmap. The contents of the Roadmap were shaped a few years ago by extensive consultations with extramural scientists, not invented unilaterally by the NIH leadership, and represent a response to converging forces, including demands from Congress--and from diverse physicians, disease-research advocates, and scientists--for a greater sense of mission, more risk-taking, and expanded interdisciplinary research. In its first couple of years, the Roadmap has launched laudable programs, supported mainly by highly competitive awards to individual investigators, to encourage creative but high-risk research the Pioneer Awards new approaches to biomedical computing, structural biology, nanomedicine, and chemical biology; and a reconfiguring of the infrastructure for clinical research. Despite its high ambitions, the Roadmap has required no more than a modest 1.2% of the NIH budget. "Shelving" the Roadmap, as called for by one recent commentary, * would not heal NIH's financial maladies. But it just might persuade Congress and other potential critics that members of the biomedical research community are hopelessly inured to change and less concerned about the commonweal than the professional well-being of scientists. What then is to be done? First, stop blaming NIH--it is a victim, not a culprit, and it urgently needs our collective help. Second, redirect the hue and cry to Congress and the White House. Professional societies and disease-advocate groups have taken up the cause, but investigators in the trenches have been singularly silent. And third, support NIH in its efforts to manage resources prudently: Understand the nature of its difficulty and the rationale for restricting the size of awarded grants; encourage favored treatment of applications from scientists seeking their first awards; and accept opportunities to provide advice by serving on NIH's advisory and review. AWP spread. For example, as noted above, Watson reported its AWP to various industry compendia, but disclosed WAC, direct price and average sale price to only a very few, if any, outside entities. Also as noted above, Watson needed to keep the AWP high, but at a level that would not "set off alarms with reimbursement." Watson effectively hid the AWP spread from co-payors and payors. VIII. DIRECT DAMAGE SUSTAINED BY CO-PAYORS AND PAYORS 565. 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The Siharath plaintiffs argued that bromocriptine, the active ingredient in the drug Parlodel, caused hypertension, seizures and ischemic strokes. The plaintiffs further contended that Parlodel, through bromocriptine, could also cause hemorrhagic strokes. On a motion to exclude the plaintiffs' expert testimony of causation, the determinative issue was whether the epidemiological evidence relied upon by the plaintiffs' experts was sufficiently reliable and relevant to establish causation. The Siharath court explained, "the burden is on Plaintiffs to show that well-conducted epidemiological studies do show a statistically significant relationship between Parlodel[ ] and seizures and stroke. It is not defendant's burden to show the lack of such relationship."32 The Siharath plaintiffs brought forward four epidemiological studies which investigated a possible association between Pqrlodel and stroke. After examining the plaintiffs' epidemiological evidence, the Siharath court concluded that each of the studies, for separate reasons, lacked the requisite reliability to support the plaintiffs' arguments that Parl0del could cause seizures and hemorrhagic strokes.33 Since "no evidence [had] been offered of an increase in postpartum strokes after [Parlodel] was approved for suppression of lactation [and] no evidence [had] been offered of a decrease of postpartum strokes after the approval for suppression of lactation was withdrawn, " the court questioned whether "the causation opinions of plaintiffs' experts [were] merely speculative and not based on scientific knowledge."34 Thus, it was improper to simply extrapolate from one chemical to another, or to lump chemicals together: studies where exposure to the chemical is unverified, unquantified, unidentified, or otherwise speculative cannot provide reliable foundational support for a causation opinion concerning that chemical.35 As Siharath demonstrated, in order for epidemiological evidence or any other type of reliable scientific knowledge to be relevant, it must, at a minimum, address the specific agent. More disclaimer - please read: this web site provides general information: do not use the information on these pages as a substitute for evaluation and treatment by a professional health care provider!
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