The American Recovery and Reinvestment Act of 2009
In the time since the preparation of this white paper, $1.1 billion of federal funds have been provided by Congress, through the American Recovery and Reinvestment Act of 2009 (ARRA), to increase national capacity for clinical effectiveness research. AHRQ (Agency for Healthcare Research and Quality) has received $700 million of these funds, of which $400 million will be transferred to the Office of the Director of NIH (National Institutes of Health) to conduct or support comparative effectiveness research (CER) activities.
An additional $400 million will be allocated at the discretion of the Secretary of HHS (Department of Health and Human Services) to:
“…accelerate the development and dissemination of research assessing the comparative effectiveness of health care treatments and strategies, through efforts that: (1) conduct, support, or synthesize research that compares the clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions; and (2) encourage the development and use of clinical registries, clinical data networks, and other forms of electronic health data that can be used to generate or obtain outcomes data.”
The recommendations from an Institute of Medicine consensus committee report and from a newly established Federal Coordinating Council on CER within HHS will be considered by the secretary's office in designating activities to receive funds. Members of the 15-member council will be federal employees or officers appointed by the President, at least half of which will have clinical expertise.
To improve the effectiveness and value of the care delivered, the nation needs to build its capacity for ongoing study and monitoring of the relative effectiveness of clinical interventions and care processes through expanded trials and studies, systematic reviews, innovative research strategies, and clinical registries, as well as improving its ability to apply what is learned from such study through the translation and provision of information and decision support. Several recent initiatives have proposed the development of an entity to support expanded study of the comparative effectiveness of interventions. To inform policy discussions on how to meet the demand for more comparative effectiveness research (CER) as a means of improving the effectiveness and value of health care, the Institute of Medicine (IOM) Roundtable on Value & Science-Driven Health Care convened a workshop on July 30–31, 2008, titled Learning What Works: Infrastructure Required for Comparative Effectiveness Research. Box S-1 describes the issues that motivated the meeting's discussions: the substantial and growing interest in activities and approaches related to CER; the lack of coordination of key activities, such as the selection and design of studies, synthesis of existing evidence, methods innovation, and translation and dissemination of CER information; shortfalls and widening gaps in the workforce needed in all areas of CER; the opportunities presented by the recent calls for expanded resources for work on the comparative effectiveness of clinical interventions; the growing appreciation of the infrastructure needed to support this work; and the need for a trusted, common venue to identify and characterize the need categories, begin to estimate the shortfalls, consider approaches to addressing the shortfalls, and identify priority next steps.
The medical science has advanced at an extraordinary pace in the past 5–6 decades. Advances in medical science eliminated several communicable diseases, conquered majority infectious diseases, and controlled and modified many lifestyle-associated diseases. The growth achieved in various disciplines of medicine was through well-planned studies. The scientific journals spread new knowledge,[1,2,3,4] push forward the frontiers of the current knowledge in every aspect,[5,6,7] allow publication of creative ideas, and form the basis for ongoing innovations. The most notable Framingham Heart Study began in the town of Framingham, Massachusetts, in 1948 with 5209 cohorts and identified the common factors or characteristics that contribute to cardiovascular diseases and led to changes in day-to-day lifestyle and disease reduction. The broader aim of the medical research is to know what the truth is so that a correct or a most appropriate health care/management plan for a particular patient or for the community can be chosen with an objective to benefit patients and the society.
Academic institutions promote and support research by providing intramural grants; additionally, many government agencies including Indian Council of Medical Research, Department of Biotechnology funds research. Extramurally funded researches, innovations, and development of medical implants/prosthesis are considered more important and weighted higher. Federal grants for research are generally liberal for acclaimed researchers. The researcher is rewarded in many ways including career promotion, awards, acknowledgment among peers, and one-upmanship among colleagues and competitors. The notable medical developments/innovations commercialized are heart–lung machine, coronary and vascular stents; cochlear implant, imaging technologies, video-assisted surgery, ventilatory and circulatory support devices, in vitro fertilization techniques, laboratory equipment, and stem-cell banks. These medical advances are among the highly acclaimed achievements of the past century and were made possible by the research efforts of pure scientists, technologists, basic laboratory researchers, and clinicians. The clinician is the final link that delivers the fruits of research and development to the patients and society. These advances helped millions of patients worldwide. The researchers developing these innovations and molecules are acclaimed worldwide, and the manufacturers commercializing them made extraordinary monetary gains.
Importance Inaccurate clinician expectations of the benefits and harms of interventions can profoundly influence decision making and may be contributing to increasing intervention overuse.
Objective To systematically review all studies that have quantitatively assessed clinicians’ expectations of the benefits and/or harms of any treatment, test, or screening test.
Evidence Review A comprehensive search strategy of 4 databases (MEDLINE, EMBASE, Cumulative Index of Nursing and Allied Health Literature, and PsycINFO) from the start years to March 17-20, 2015, with no language or study type restriction, was performed. Searches were also conducted on cited references of the included studies, and experts and study authors were contacted. Two researchers independently evaluated methodologic quality and extracted participants’ estimates of benefit and harms and authors’ contemporaneous estimates.
Findings Of the 8166 records screened, 48 articles (13 011 clinicians) were eligible. Twenty studies focused on treatment, 20 on medical imaging, and 8 on screening. Of the 48 studies, 30 (67%) assessed only harm expectations, 9 (20%) evaluated only benefit expectations, and 6 (13%) assessed both benefit and harm expectations. Among the studies comparing benefit expectations with a correct answer (total of 28 outcomes), most participants provided correct estimation for only 3 outcomes (11%). Of the studies comparing expectations of harm with a correct answer (total of 69 outcomes), a majority of participants correctly estimated harm for 9 outcomes (13%). Where overestimation or underestimation data were provided, most participants overestimated benefit for 7 (32%) and underestimated benefit for 2 (9%) of the 22 outcomes, and underestimated harm for 20 (34%) and overestimated harm for 3 (5%) of the 58 outcomes.
Conclusions and Relevance Clinicians rarely had accurate expectations of benefits or harms, with inaccuracies in both directions. However, clinicians more often underestimated rather than overestimated harms and overestimated rather than underestimated benefits. Inaccurate perceptions about the benefits and harms of interventions are likely to result in suboptimal clinical management choices.
There is considerable controversy about the causes of regional variations in health care expenditures. Using vignettes from patient and physician surveys linked to fee-for-service Medicare expenditures, this study asks whether patient demand-side factors or physician supply-side factors explain these variations. The results indicate that patient demand is relatively unimportant in explaining variations. Physician organizational factors matter, but the most important factor is physician beliefs about treatment. In Medicare, we estimate that 35 percent of spending for end-of-life care, and 12 percent of spending for heart attack patients (and for all enrollees) is associated with physician beliefs unsupported by clinical evidence.
Low reproducibility rates within life science research undermine cumulative knowledge production and contribute to both delays and costs of therapeutic drug development. An analysis of past studies indicates that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28,000,000,000 (US$28B)/year spent on preclinical research that is not reproducible—in the United States alone. We outline a framework for solutions and a plan for long-term improvements in reproducibility rates that will help to accelerate the discovery of life-saving therapies and cures.
Context Some research findings based on observational epidemiology are contradicted by randomized trials, but may nevertheless still be supported in some scientific circles.
Objectives To evaluate the change over time in the content of citations for 2 highly cited epidemiological studies that proposed major cardiovascular benefits associated with vitamin E in 1993; and to understand how these benefits continued being defended in the literature, despite strong contradicting evidence from large randomized clinical trials (RCTs). To examine the generalizability of these findings, we also examined the extent of persistence of supporting citations for the highly cited and contradicted protective effects of beta-carotene on cancer and of estrogen on Alzheimer disease.
Data Sources For vitamin E, we sampled articles published in 1997, 2001, and 2005 (before, early, and late after publication of refuting evidence) that referenced the highly cited epidemiological studies and separately sampled articles published in 2005 and referencing the major contradicting RCT (HOPE trial). We also sampled articles published in 2006 that referenced highly cited articles proposing benefits associated with beta-carotene for cancer (published in 1981 and contradicted long ago by RCTs in 1994-1996) and estrogen for Alzheimer disease (published in 1996 and contradicted recently by RCTs in 2004).
Data Extraction The stance of the citing articles was rated as favorable, equivocal, and unfavorable to the intervention. We also recorded the range of counterarguments raised to defend effectiveness against contradicting evidence.
Results For the 2 vitamin E epidemiological studies, even in 2005, 50% of citing articles remained favorable. A favorable stance was independently less likely in more recent articles, specifically in articles that also cited the HOPE trial (odds ratio for 2001, 0.05 [95% confidence interval, 0.01-0.19; P < .001] and the odds ratio for 2005, 0.06 [95% confidence interval, 0.02-0.24; P < .001], as compared with 1997), and in general/internal medicine vs specialty journals. Among articles citing the HOPE trial in 2005, 41.4% were unfavorable. In 2006, 62.5% of articles referencing the highly cited article that had proposed beta-carotene and 61.7% of those referencing the highly cited article on estrogen effectiveness were still favorable; 100% and 96%, respectively, of the citations appeared in specialty journals; and citations were significantly less favorable (P = .001 and P = .009, respectively) when the major contradicting trials were also mentioned. Counterarguments defending vitamin E or estrogen included diverse selection and information biases and genuine differences across studies in participants, interventions, cointerventions, and outcomes. Favorable citations to beta-carotene, long after evidence contradicted its effectiveness, did not consider the contradicting evidence.
Conclusion Claims from highly cited observational studies persist and continue to be supported in the medical literature despite strong contradictory evidence from randomized trials.
IDSA, and in particular, Yale's Eugene Shapiro, JJ Halperin, and Gary Wormser, are afraid of criminal charges. JJ Halperin was the main fraudster on both the Neurology group's and IDSA's committees. Halperin committed this secondary crime as a coverup, since he was the lead author in the report where Lyme is a cause of Lou Gehrig's Disease in about half the cases of Lou Gehrig's Disease, and if you look at the report, these dead people did not have the bogus Steere/Dearborn Lyme antibody profile. They would have been "seronegative" or tested negative to Lyme, allowing them to progress into disability and death. This is beyond doubt or question.
Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support.
Methods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus.
Results 30 studies were included. Research funded by drug companies was less likely to be published than research funded by other sources. Studies sponsored by pharmaceutical companies were more likely to have outcomes favouring the sponsor than were studies with other sponsors (odds ratio 4.05; 95% confidence interval 2.98 to 5.51; 18 comparisons). None of the 13 studies that analysed methods reported that studies funded by industry was of poorer quality.
Conclusion Systematic bias favours products which are made by the company funding the research. Explanations include the selection of an inappropriate comparator to the product being investigated and publication bias.