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| Dr. Paul Volberding |
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| Dr. Doug Dieterich |
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| Dr. Ron Mitsuyasu |
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Epoetin alfa and beta (also known as erythropoietin or EPO) are natural hormone-like substances found in the body that stimulate the bone marrow to produce red blood cells. In the U.S., genetically engineered recombinant epoetin alfa is known by the trade names Epogen and Aranesp (marketed by Amgen) and Procrit (marketed by Ortho Biotech/JNJ), and is one of the most profitable and expensive drugs in the world. Erythropoietin drugs can increase the risk of tumor growth, blood clots, heart attack, and stroke.
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From the cancer literature: "Erythropoeitin (EPO) may shorten survival in cancer patients and in fact fuel tumor growth, a growing body of evidence suggests." Nature Medicine, vol 9, no 12, 2003, p1439
| From the renal disease/dialysis literature: "Caution is required in administering large doses of epoetin to achieve target hematocrit." Seminars in Dialysis, vol 17, no 3, 2004, p181
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Whither similar voices of moderation or scientific circumspection in HIV medicine?
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| Introducing... The "Anemia in HIV Working Group," est. 1998 |
(Members of the working group were, according to Ortho employee George J. Leitz, selected by Dr. Paul Volberding, who himself was chosen by Ortho Biotech to chair the panel.)
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"I'd hope that doctors would appreciate that, even in the era of potent HIV therapy, anemia remains common and that there is a growing consensus that it not only compromises the quality but also the duration of life."
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| Paul A. Volberding, MD |
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(from an interview with Reuters Health (06/07/04) shortly after the release of his CID clinical management guidelines for HIV-infected patients on behalf of the Anemia in HIV Working Group, which advocated for expanded use of the drug)
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Excerpts from their recently published work:
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| From Volberding PV: “Anemia in HIV Infection: Clinical Impact and Evidenced-Based Management Strategies," published in the journal Clinical Infectious Diseases (May 2004) |
Dr. Volberding and the AHIVWG recommend an increase in the threshold hGb for starting epoetin alpha treatment, an increase in the target hGb level and an increase in the hGb level for which stopping epoetin alpha treatment is advised: "If correctable causes of anemia have been ruled out and the hemoglobin level is <13 g/dL in men and <12 g/dL in women, initiate epoetin alfa therapy at a dosage of 40,000 U once per week. Continue epoetin alfa therapy until symptoms have resolved and hemoglobin levels of 13 g/dL for men or 12 g/dL for women are achieved, then maintain hemoglobin levels by dosage titration or increasing the dosing interval." (CID, May 2004)
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| Accompanying treatment algorithm (reproduced below) appears to advise continuing epoetin alfa use until a Hb threshold of 15 g/dL is crossed. |
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| Table 6 rx algorithm |
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| From Henry DH, Volberding PV, Leitz GH: “Epoetin Alfa for Treatment of Anemia in HIV-Infected Patients: Past, Present, and Future,” published in the Journal of Acquired Immune Deficiency Syndrome (October 2004) |
Drs. Henry, Volberding and Leitz (an Ortho employee) lay out the case for expanded usage of epoetin alpha in HIV-infected patients: "Epoetin alfa holds promise in many aspects of HIV disease management, such as reduced transmission, increased survival, reduced sensory neuropathy, and improved cognitive-motor function. The benefits of epoetin alfa may also extend to correcting ancillary effects of HIV disease, such as hypogonadism and impaired sexual function." (JAIDS, October 2004)
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| From Dieterich DT: TheBody covers the 39th IDSA Meeting (Oct. 27, 2001)
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"Epoetin alfa has virtually no side effects and is used by injection once weekly. For anemia there is no reason not to use epoetin alfa that I can think of -- it is an ideal pharmaceutical product!" [exclamation point his]
Dr. Dieterich was reporting on:
M.S. Saag (UAB); A.M. Levine (USC); G.J. Leitz (Ortho Biotech), P.J. Bowers (Ortho Biotech) Once-Weekly Epoetin Alfa Increases Hemoglobin and Improves Quality of Life in Anemic HIV-Positive Patients (Poster 708)
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| Douglas T. Dieterich, MD |
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| From Saag MS, Bowers P, Leitz GJ: “Once Weekly Epoetin Alfa Improves Quality of Life and Increases Hemoglobin in Anemic HIV+ Patients,” published in AIDS Research and Human Retroviruses (October 2004) |
Saag, Levine and their two JNJ co-authors exclaim: "Our data suggest the quality-of-life may continue to improve as Hb increases beyond [13 g/dl], as the slope of the line indicates a continuing trend."
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| Michael S. Saag, MD |
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| From M Saag, P Volberding and the CME Division of the University of Alabama School of Medicine: |
Among their unsubstantiated recommendations and assertions: consideration of epoetin-alfa treatment "in HIV-infected men with hemoglobin levels <12 g/dL" and that "successful treatment of anemia probably contributes to avoiding end-organ damage such as myocardial infarction and stroke."
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| Current Membership of the Anemia in HIV Working Group |
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| Ronald Mitsuyasu, MD |
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| Paul V. Volberding, MD |
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| Alexandra M. Levine, MD |
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| BLACK BOX WARNING (09-Mar-07): The FDA issues sweeping safety warning about heart and cancer risks from overuse of a family of anemia treatments. |
Aggressive Treatment of Anemia Questioned (NYT, 11/30/06) (related news)
Independent scientists say they believe that kidney patients are receiving too much of the drugs in part because clinics make bigger profits for providing higher doses.
Clinical practice guidelines for treatment of anemia are drawn up by the National Kidney Foundation, which received $4 million from Amgen (maker of Epogen and Aranesp) last year alone. "The guidelines are funded by industry, by and large," said Dr. Daniel Coyne, professor of medicine at Washington University in St. Louis. "They write guidelines that are opinion-based, by and large, and favor industry or would appear to favor industry."
"There are substantial sums of money involved here," said Kerry Willis, vice-president for medical and scientific activities. The worldwide market for anemia drugs will reach almost $10 billion in 2006.
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| Howard A. Grossman, MD |
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| Michael S. Saag, MD |
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| Richard E. Chaisson, MD |
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| Donna Mildvan, MD |
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| Douglas T. Dieterich, MD |
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Dr. Chaisson has diclosed that he serves as a consultant for Tibotec-Virco, a subsidiary company, like Ortho Biotech, of Johnson & Johnson Inc. Dr. Mildvan has not identified any paid consulting, research funding or paid speaking engagements with Ortho Biotech. Dr. Dieterich receives research funding from, serves as a consultant for and is a member of the Speaker's Bureau for Ortho Biotech.
Sources:
http://www.medscape.com/viewprogram/159_authors
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| Victoria Sharp, MD |
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| Patrick Sullivan |
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| Renslow Sherer, MD |
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Founding Anemia-HIV Working Group members who have since dropped away:
Donald Abrams, MD
Charles C.J. Carpenter, MD
Ann C. Collier, MD
John Doweiko, MD
Roy "Trip" Gulick, MD
Scott Hitt, MD
Richard Moore, MD
John Phair, MD
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[see 3/22 NYTimes report (pdf)]
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