Biotechnology Healthcare - Winter 2010 - (Page 12)
‘We need to view this in a more realistic light’
volves more patients, more cost, and therefore iopharma-sponsored research has been skewmore risk to the company. If you project a problem, ered in the past couple of years by payers and you don’t continue to invest millions of dollars on a journal editors skeptical of the industry’s motives. drug that may pose safety issues after it’s on the Senior contributing writer Michael D. Dalzell dismarket or that is not likely to be approved. cussed this phenomenon with Garrett Bergman, This is why companies work with experts in a MD, CSL Behring’s North American senior director particular disease state to help them for medical affairs. understand the disease better and design BIOTECHNOLOGY HEALTHCARE: In the past a rigorous study that will ensure comcouple of years, much has been written pany resources are used most effectively. about the evidence base being owned and No doubt, there is some good research published by proprietary interests. Increasthat’s been viewed with skepticism beingly, we’re hearing payer decision makers cause of perceptions, but I haven’t really say they don’t trust the evidence base. Is heard payers say they don’t trust the evisome very good research being painted dence base. with the same brush? Garrett Bergman, CSL Behring is in a space that is different Garrett Bergman, MD: As a rule, the MD from larger pharmaceutical companies; evidence base derives from studies that our products are designed to treat rare disare conducted following good clinical eases. Therefore, the base of patients with whom practice standards. Have there been exceptions? we work is quite small, comparatively speaking. So, Yes. But they are few and far between. The objective if you are interested in a disease that affects only of any study conducted to obtain product approval hundreds or even a few thousand people in the is to show relative safety and efficacy and the extent United States and you conduct a study in which up and likelihood of adverse effects. It’s in a pharmato even 50 percent of those individuals participate, ceutical company’s best interests to flag problems you may not be able to achieve the same level of roas early in the generation of clinical data as possibustness and statistical significance that could be ble, because each successive step in the study in-
safety data, Shojania determined that 15 percent of those reviews went out of date within a year, 23 percent were obsolete in two years, and the average review was overturned in five. A second answer might be found in the complexity of the evidence base that Keckley alluded to. “The challenge with evidencebased medicine is that for the practicing physician, the scientific rigor and details have become difficult to manage,” says Nilam Soni, MD, assistant professor of medicine at the University of Chicago. “How does a physician who went to medical school years ago keep up with and understand complicated statistics — the Chi-square method or even P values? These are common terms in the research literature, but may not be familiar to many practicing physicians.” Soni, whose research interests in-
clude EBM, says that although researchers may understand the information, they don’t have contact with patients. “So how does a practicing physician apply the information at the bedside?” A third answer — and the most cynical — says to follow the dollar. The second of the two reports to come out of the AHRQ compendia project examined the potential for conflict of interest in compendia development. In an April 2009 white paper, “Potential Conflict of Interest in the Production of Drug Compendia,” Ross McKinney, MD, and colleagues at the Duke Evidence-based Practice Center found that disclosure policies for each of the compendia varied, as did the dollar thresholds for reviewers’ financial ties with industry and the proportion of reviewers with conflicts of interest. One com-
pendium received significant funding from the pharmaceutical industry. McKinney’s examination stemmed in part from the controversy over the development of guidelines for the use of erythropoiesis-stimulating agents (ESAs) in patients with chronic renal disease who are treated for anemia. National Kidney Foundation guidelines issued in 2006 recommended greater use of ESAs than did previous guidelines. Among the 16 members of the guidelines committee, 14 had financial relationships with manufacturers that would benefit from the more generous guidelines. The committee dismissed evidence from randomized, controlled trials that did not support aggressive ESA use while ignoring two major studies that linked greater use with an increased risk of cardiovascular events. Within a year, CMS issued a na-
12 BIOTECHNOLOGY HEALTHCARE · WINTER 2010
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