The D&T Report
2007; Wiley; Volume: 36; Issue: 4 Linguagem: Inglês
10.1002/dat.20126
ISSN1932-6920
Tópico(s)3D Printing in Biomedical Research
ResumoDialysis & TransplantationVolume 36, Issue 4 p. 174-181 The D&T ReportFree Access The D&T Report First published: 20 April 2007 https://doi.org/10.1002/dat.20126AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Amgen and Roche are duking it out over the right to sell epoetin, the anemia drug that improves quality of life for dialysis patients. Amgen (the maker of Epogen and Aranesp) is suing Roche, which is trying to release its product, Mircera (a longer-acting form of epoetin), in the United States. Amgen claims that Mircera is nothing more than its own patented Epogen molecule with a pegylated group attached. Because Amgen's European patents on Epogen expired in 2004, the company has seen other, similar drugs (including some generics) invade the marketplace on that continent. The company is now trying to prevent the same thing in the United States by accusing Roche of patent infringement. Market-share battles among corporate giants are never pretty, but the recent findings of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) and the Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE) studies make this slugfest particularly ugly, as neither study showed a significant benefit associated with keeping hemoglobin levels high—at least with respect to cardiovascular outcomes. (See “Studies at a Glance,” page 176.) Based on these findings, the FDA is now urging nephrologists to review their dosing policies, and the National Kidney Foundation (NKF) is reconsidering its anemia management guidelines. Assuming physicians and dialysis centers heed these warnings, the drug companies could find themselves squabbling over slices of a somewhat smaller pie. But the CHOIR and CREATE trial offer another lesson as well, namely about the realities and limits of drug-company influence. Concerns over the extent of that influence often center around industry sponsorship of drug trials, including say in which studies get published and how to establish dosing and clinical targets. Although CHOIR and CREATE were sponsored by Ortho Biotech (which currently markets epoetin in the United States) and its parent company Johnson & Johnson, they were published, widely discussed, and have already impacted patient care, even though their findings could hardly have been what the companies hoped for. In general, drug companies are large and perhaps deserving targets of suspicion, but in this case at least, those inclined to look on the bright side might conclude that editorial and scientific independence are not completely dead. Recommendations for Anemia In its 2006 Clinical Practice Guidelines for anemia management, the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKFKDOQI) recommended that hemoglobin be maintained at 11-13 g/dL. This seems reasonable, even in light of CHOIR and CREATE, but interestingly, the upper limit of 13 g/dL is higher than the ceiling of 12 g/dL recommended in the 2000 version of the guidelines. Yet in an editorial published in The Lancet following publication of the two studies, Robert Steinbrook, MD, associate professor at Dartmouth Medical School, Hanover, N.H., pointed out that, at least through 2005, 50% of dialysis patients in the United States had hemoglobin levels that exceeded 12 g/dL, including 20% with levels above 13 g/dL. He offered several possible explanations for this situation: Medicare reimburses dialysis facilities more for epoetin use than for actual dialysis, and large, for-profit dialysis chains can negotiate volume discounts with Amgen and other pharmaceutical companies. He also pointed out that in fiscal year 2005, the NKF received more than $7 million from Amgen and Ortho Biotech, the Johnson & Johnson subsidiary that currently markets epoetin in the United States.1 Additionally, DaVita stated that epoetin accounted for about 25% of its dialysis revenues, and last October Amgen became the sole supplier of Epogen and Aranesp to Fresenius through 2011.2, 3 Fallout Still, as soon as CHOIR and CREATE were published, the FDA warned health-care professionals that the CHOIR findings, in particular, “underscore Those who fear that drug companies exert inordinate influence over prescribing practices should feel encouraged that, when faced with consistent and incontrovertible evidence, even multinational corporations with billions of dollars at their disposal must defer to the facts. the importance of following the currently approved prescribing information for Procrit, Epogen, and Aranesp, including the dosing recommendation that 4 the target hemoglobin not exceed 12 g/dL.”4 The KDOQI anemia workgroup met in February to review its anemia recommendations, and (as of this writing) was planning to release a statement in mid-March regarding any proposed changes to its guidelines. Additionally, Congress is now considering eliminating separate reimbursement for epoetin in favor of bundling it with other dialysis-related products and services, although it is not clear if the results of the CHOIR and CREATE trials had any influence over this undertaking.5 (See “New Congress: New Challenges for Dialysis Providers,” this issue, page 238, for an in-depth analysis of these congressional proceedings.) Bottom Line For patients across the spectrum of chronic kidney disease, the optimal hemoglobin target range is 11-12 g/dL, leaning toward the higher end of this range for patients for whom quality of life is a concern.6 Those who fear that drug companies exert inordinate influence over prescribing practices should feel encouraged that, when faced with consistent and incontrovertible evidence, even multinational corporations with billions of dollars at their disposal must defer to the facts. Anemia drug companies could find themselves squabbling over slices of a somewhat smaller pie. As we go to press: Roche has temporarily suspended enrollment in its clinical trial of CERA in patients with lung cancer, due to safety concerns stemmed in part by the progression of the cancerous tumors.7 Additionally, on March 9, the FDA announced a black box warning (the highest level of warning for drug information) for Aranesp, Epogen, and Procrit, advising physicians to adjust ESA dosage to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions.8 D&T Briefs PATIENTS Renal Prom Dazzles Young Patients More than 150 teenage kidney patients and their dates, friends, and hosts donned their dancing shoes and turned out for the 8th Annual Renal Teen Prom sponsored by the Renal Support Network (RSN) at Notre Dame High School in the Los Angeles suburb of Sherman Oaks, Calif., in January. The prom is the brainchild of Lori Hartwell, founder and president of RSN. Hartwell spent the ages of 12 through 24 on dialysis, so she knows how these adolescents feel. “I wanted to find a venue to reach out to other kids,” says Hartwell. “They need to see other teens who have this illness, and to know someone's going to accept them.” The prom has a therapeutic benefit beyond an evening of fun, Hartwell explains. The patients form long-lasting friendships and derive a feeling of hope, which “you need if youre going to do all the stuff you have to do to take care of yourself. It's a very important component of a patient's well-being. That internal inspiration is key to the patient's ability to believe they have a future.” All in all, more than 450 people attended this year's event, including 40 volunteer hosts from the senior class of Notre Dame, and celebrity guests likeSinbad and Gary Sinise. For more information about the prom, contact the RSN at (818) 543-0896 or visit www.rsnhope.com. BUSINESS Nephros to Test Hemodiafiltration Module The FDA has conditionally awarded Nephros an investigational device exemption to begin a human clinical trial for its OLpur H2H hemodiafiltration (HDF) module and OLpur MD 220 Hemodiafilter. At press time, trials were expected to begin in March or April. Leonard Stern, MD, FACP, FASN, associate professor of Clinical Medicine at Columbia University, College of Physicians and Surgeons in New York, will act as coordinating principal investigator during the trial. Nephros and Dr. Stern anticipate that the introduction of online HDF to the clinical arena for dialysis-dependent patients will provide a significant improvement in dialysis care when compared with conventional hemodialysis. They also believe that this new treatment method offers the promise of improving quality of life while reducing both morbidity and mortality in this patient population. INTERNATIONAL Fresenius and Amgen Enter Partnership in Europe Fresenius and Amgen Europe have agreed to collaboration for Aranesp (darbepoetin alfa). Under the agreement, Fresenius will devote efforts to assist Amgen in distributing scientific information regarding the treatment of anemia to nephrologists and other renal care professionals. The new agreement will run for three years. The two companies have also agreed to establish a joint research project aimed at further improving treatment outcomes for European kidney patients. They will facilitate a working group of European scientific experts in the renal field that will analyze practices in the treatment of chronic kidney disease and will publish their findings for improved therapeutic options. The working group will be led by renowned independent scientists in the field of nephrology, and the focus of the first research efforts will be anemia and bone mineral disease affecting patients with kidney failure. ASSOCIATIONS NKF Launches Patient Education Prog The NKF is rolling out an online education program for patients with kidney disease that will be introduced at the NKF Spring Clinical Meetings this month. The centerpiece of the program is a comic-strip style graphic novella that visually tells the story of a group of patients and their healthcare team in a dialysis center similar to hundreds of centers across the United States. The program will follow these characters through the ups and downs of crises, conflicts, discoveries, and triumphs: the shock of being diagnosed with kidney disease, coping with the diagnosis and feelings about going on dialysis, role-reversals in family relationships, job-related stress, sticking with the kidney-healthy diet, managing multiple related conditions, dealing with personal issues and much more. The NKF will update the program six times a year to spotlight new issues and to continue to offer new tools to empower patients. For more information on how to participate in the program, contact the NKF at (800) 622-9010 or visit www.kidney.org. References 1 Steinbrook R. Haemoglobin concentrations in chronic kidney disease. The Lancet 2006; 368: 2191– 2193. 2 DaVita Inc. 2005 Annual Report, page 9. 3 Fresenius Medical Care announces sourcing and supply agreement with Amgen. [Fresenius Medical Care website]. October 19, 2006. Available at www.fmc-ag.com/internet/fmc/fmcag/agint-pub.nsf/content. Last accessed March 8, 2007. 4 Food and Drug Administration Center for Drug Evaluation and Research. Information for health-care professionals: erythropoiesis stimulating agents (ESA). FDA alert posted November 11, 2006. Available at www.fda.gov/cder/drug/InfoSheets/HCP/RHE_HCP.htm. Last accessed March 8, 2007. 5 Perrone M. Medicare proposal could slow Amgen sales. Businessweek.com. March 1, 2007. Last accessed March 2, 2007. 6 Singh, AK. The target hemoglobin in patients with chronic kidney disease. Medscape Nephrology. January 29, 2007. 7 Reuters News Service. Roche, citing safety, halts trial enrollment. Wall Street Journal. February 26, 2007: A15. 8 U.S Food and Drug Administration. FDA Strengthens Safety Information for Erythropoiesis-Stimu-lating Agents (ESAs). Alert posted March 9, 2007. Available at www.fda.gov/bbs/topics/NEWS/2007/NEW01582.html. Volume36, Issue4April 2007Pages 174-181 ReferencesRelatedInformation
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