Congress Seeks ASH Expertise for Hearings on Performance-Enhancing Drugs
Performance-enhancing drugs have been a central issue on Capitol Hill in recent months, with scandals in professional baseball leading to congressional investigations into the illegal use of both anabolic steroids and, more recently, human growth hormone (HGH). In the midst of all the controversy, another substance with supposed performance-enhancing properties began to interest Congress: vitamin B12. Most notably, pitcher Roger Clemens claimed that his trainer Brian McNamee injected him with B12, rather than with the more dangerous (and illegal) HGH.
For insight into the effects of medically inappropriate use of B12 and other therapeutic agents, the House Committee on Oversight and Government Reform contacted ASH. Several ASH members provided background on the issue for congressional staff, including the economic and medical impact of its inappropriate over-use nationwide, both among athletes and non-athletes. Dr. Ralph Carmel, a hematologist at New York Methodist Hospital, provided specific information on the taking of B12 by injection (as Mr. Clemens claims he did), including the specific method of delivery and potential side effects.
The Committee also invited Dr. Susan Shurin, noted hematologist and Deputy Director of the National Heart, Lung, and Blood Institute (NHLBI), to testify at a hearing on February 12. Dr. Shurin emphasized that giving B12 to healthy athletes is not medically sound, noting that, while the vitamin is indeed useful in treating B12 deficiencies that can lead to "pernicious anemia… [difficulty] with position sense, nerve damage, depression, memory loss, and dementia," there is no evidence linking B12 to improved athletic performance in an otherwise healthy person. "Claims are made that vitamin B12 administration will improve energy levels, memory, concentration, and mood. All of these are true when persons deficient in vitamin B12 are treated; however, there is no evidence at all of those clinical benefits when the vitamin is given to persons who are not deficient," Shurin said. She also told the Committee that, except in the case of specific medical conditions such as inflammatory bowel disease that would prevent gastrointestinal absorption of B12, there would be no reason to inject the vitamin rather than take it orally.
The congressional hearing concerning the use of B12 was part of a series of nationally televised hearings related to the use of performance-enhancing drugs by major league baseball players. As a result of these hearings, former NY Yankee Roger Clemens is under investigation for perjury and Members of Congress have concluded that there is a need for greater oversight of the way such agents reach the public.
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NIH to Enhance Peer-Review System
By Roy L. Silverstein, MD
Dr. Silverstein is Professor of Molecular Medicine and Chairman of the Department of Cell Biology at the Lerner Research Institute. He is also Chair of the ASH Committee on Government Affairs.
The NIH peer-review system is not exactly a sinking ship, but the boat is taking on water at an alarming rate and has reached a "tipping point" with respect to efficiency and efficacy. The problem stems from a large increase in grant applications submitted to NIH (now an astounding 80,000/year), an NIH budget that is not keeping up with inflation, and an overburdened research community that is not as willing to serve on study sections. In response to these stresses on peer review, NIH Director Elias Zerhouni assembled a working group to study the problem and make recommendations for change. They solicited input from all stakeholders, including professional societies, such as ASH, and received nearly 3,000 specific comments on their Web site — a strong indication of the importance of the issue and anxieties evoked by any discussion of peer review at times of funding uncertainty. The detailed draft report can be viewed online.
The report identified key principles and significant challenges and outlined a series of potential "actions." Among the more interesting and controversial recommendations were to shorten the length of the application and the reviewers' summary, eliminate "unscoring" (triage) for the lower tier of applications, add a "not recommended for resubmission" rating, eliminate amended applications so all would be considered de novo, and focus review on scientific merit and impact, rather than on specific weaknesses of approach. Noting that the current NIH scoring system is out of step with principles of modern psychometric science, the group recommended aligning applications and reviews with explicit criteria (e.g., impact, investigator, innovation/originality, plan, and environment [including institutional support]). The panel also suggested several strategies to address problems related to poor competitiveness of first-time grant applicants and clinical research projects and with review of "transformative" and multidisciplinary research. To reduce stress on science support systems, the panel made several recommendations that are sure to raise some hackles, including establishment of a minimum-percent effort (e.g., 20 percent) for investigators on research grants and re-examination of incentives in the current NIH system that drive expansion of the research enterprise. The implication is that NIH should pay less and universities/medical centers should pay more.
The report also noted less controversial recommendations. These included enhancing and standardizing training of reviewers and study section chairs, developing incentives for successful scientists to serve on study sections, continuing to pilot use of electronic review tools, introducing more flexibility into the system for reviewers, developing two-way communication between reviewers and applicants, and mandating periodic data-driven assessment of the entire peer-review process.
An implementation plan will soon be developed by NIH, but whatever form the final renovations take, it is highly likely that the relationships between the extramural research committee and the NIH are going to change dramatically.
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ASH Comments on Final Draft of the NIH 2007-2008 Peer Review Self-Study
ASH submitted remarks to NIH in response to the Final Draft of the NIH 2007-2008 Peer Review Self-Study that was submitted to NIH Director Elias Zerhouni at the end of February. The Final Draft marked "the end of the diagnostic phase of the peer-review enhancement effort" and provided the research community with only a brief time period to respond and submit comments.
The notes submitted by ASH on March 17 reflected the Society's concerns with the brief amount of time set aside for comments and a number of the proposals put forth in the Final Draft and encouraged "the NIH director to solicit broad input from the multiple NIH stakeholders in developing the second phase (implementation) of the plan."
These comments followed comments submitted last year by the Society in response to a request for information seeking "comments regarding NIH's support of the biomedical and behavioral research, including peer review." The remarks offered the Society's support of maintaining the peer-review process, encouraging senior investigators to serve on study sections, and finding ways to make the entire process less burdensome.
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Clinical Alert
Update on Heparin Recall
On February 11, 2008, the U.S. Food and Drug Administration (FDA) advised health-care practitioners to limit use of Baxter's injectable blood-thinning drug heparin due to serious allergic reactions and hypotension in patients who receive high "bolus" doses of the drug. Since then, Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable heparin. They have also recalled all of their multi-dose and single-use vials of heparin. And, as a precautionary measure, they have recalled heparin lock flush solutions.
Then on March 21, a second supplier, B. Braun Medical Inc., began recalling lots of heparin as a precautionary measure. To date, the company has not received any adverse event reports related to this issue.
Supplies of heparin have been recalled in France, Italy, and Denmark because they are contaminated or are suspected of being contaminated. Batches of the drug have recently been recalled in Germany and Japan, as well.
After launching an investigation in both the United States and abroad, the FDA found a heparin-like compound present in some of the active pharmaceutical ingredients produced by Scientific Protein Laboratories (Baxter and Braun's supplier). The contaminant has been indentified as a modified form of a cheap and widely used dietary supplement sold to relieve joint pain. FDA officials are currently investigating whether the compound, chemically modified chondroitin sulfate, was intentionally added or was added by accident. In either case, it is not part of the prescribed manufacturing process. Heparin is made from the intestines of pigs, and chondroitin sulfate can be produced from pig cartilage.
For more information, including questions and answers on heparin sodium injection, go to the FDA's Web site.
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ASH Recognized on Senate Floor for 50 Years of Hematologic Research and Advancement
On February 14, 2008, Senator Arlen Specter (R-PA) congratulated ASH on its 50th anniversary during a speech on the floor of the U.S. Senate. Below is the text of his speech as published in the Congressional Record.
Mr. President, I congratulate the American Society of Hematology — ASH — on its 50th anniversary and to pay tribute to the contributions they have made in preventing and eliminating blood-related diseases.
The Society has grown substantially from its 200 members at its inception in 1958, to over 15,000 members presently, and is recognized as the world's premier organization in research promotion, clinical care, education, training, and advocacy in the field of hematology.
Society members consist of practitioners and researchers who have been able to translate federal research dollars into effective treatments for millions of people afflicted with diseases that were at one time untreatable and fatal. The blood and blood-related diseases studied and treated by hematologists include disorders such as leukemia and lymphoma, thrombosis, anemia and bleeding, and congenital disorders such as sickle cell anemia, hemophilia, and thalassemia. The advancements in remedies of these disorders are a direct result of the continuing efforts made by the ASH.
I sustained an episode with Hodgkin lymphoma cancer two years ago. That trauma, that illness, I think, could have been prevented had that war on cancer declared by President Nixon in 1970 been prosecuted with sufficient intensity. All of us know people who have been stricken by fatal diseases and many other maladies. It is my hope that other organizations will use the success of the ASH as an example in contributing to this nation's desire for finding cures for the most fatal diseases.
As chairman, and now ranking member of the appropriations Subcommittee on Labor, Health and Human Services, I have been an ardent supporter of securing federal funds for the National Institutes of Health, the crown jewel of the federal government, maybe the only jewel of the federal government. Health is the country's No. 1 capital asset, and the American Society of Hematology has contributed to its success.
Hematologists have been instrumental in pioneering the use of hydroxyurea in the treatment of sickle cell disease and have developed the first successful cure of childhood leukemia. Moreover, hematologists were responsible for the research that led to Gleevec, the first anticancer drug developed to target a molecular problem that causes chronic myelogenous leukemia.
The American Society of Hematology has played an important role in the unprecedented growth and advancement of hematology research. With so many great successes over the past 50 years, I am confident the next 50 years will bring ASH and its over 15,000 members even more accomplishments in treating and eliminating blood diseases.
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2008 State-of-the-Art Symposium Goes to Windy City
At the 2008 State-of-the-Art Symposium (SAS), attendees will meet with leading experts in hematology and discuss the latest discoveries, research, and treatment options for hematologic malignancies. The next SAS, Advances in Hematologic Malignancies, Myelodysplasia, and Myeloproliferative Diseases, will take place on September 12-13, 2008, in Chicago, IL.
This clinically focused event will provide a state-of-the-art educational program, including lectures on myeloproliferative disease, myeloma, leukemia, and lymphoma, as well as multiple opportunities for networking. Program co-chairs Stephanie A. Gregory, MD, and Alan F. List, MD, will lead an internationally renowned team of speakers to present the current cutting-edge approaches to managing a variety of hematologic disorders.
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FDA ODAC Recommends Approval of Romiplostim for Adults with ITP
By James George, MD
Dr. George attended this meeting as a consultant for Amgen and has also been an investigator for the clinical trials related to the development of romiplostim.
On March 12, 2008, the FDA's Oncology Drug Advisory Committee (ODAC) unanimously recommended approval of the first of a new class of treatments for ITP ― romiplostim ― developed by Amgen. These agents stimulate platelet production by mimicking the effect of thrombopoietin. There was no issue about efficacy; platelet counts are increased to safe levels even in patients who are refractory to many previous treatments, including splenectomy. However, there was concern about safety. In studies of ITP, several patients developed an increase of marrow reticulin; this appeared to be reversible with discontinuation of romiplostim. Data were also presented from a preliminary, non-randomized study in patients with myelodysplasia. Several patients developed an increase of myeloblasts that also appeared to be reversible with discontinuation of romiplostim. Therefore, the FDA had recommended that romiplostim be approved with a strict risk-management assessment program that would restrict off-label use. The preliminary outline of the plan includes direct shipment of romiplostim to physicians for each patient, with monitoring of the patient's course by a case manager. With current concerns that the FDA has not adequately supervised new drugs following approval, this type of restricted access may become more common.
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EHA-ASH International Fellowship Award Letter-of-Intent Deadline
Don't miss this exciting research support opportunity! The EHA-ASH award is a partnership between the American Society of Hematology (ASH) and the European Hematology Association (EHA) that gives hematologists in their fellowship or early in their careers the opportunity to establish new collaborations and experience research (both clinical and laboratory-based) in a different environment. The letter-of-intent deadline for the 2008 EHA-ASH International Fellowship Award is September 4. Please note that eligibility is not limited to fellows.
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Has Someone Made a Difference in Your Career?
By nominating that person for the ASH Mentor Award, you can help recognize and reward outstanding mentors who have helped shape your career path. ASH grants two awards each year to outstanding mentors: one in basic science and one in clinical investigation. May 5 is the deadline for nominations.
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Highlights of ASH® 2008
Drs. Ari Melnick and Jane Winter led a distinguished panel of speakers at Highlights of ASH. The expert panel of speakers included Richard Larson, MD; Amit K. Verma, MD; Selina Luger, MD; Mitchell Weiss, PhD, MD; James George, MD; Robert Orlowski, MD; Neil E. Kay, MD; Barbara Konkle, MD; and Mark Crowther, MD, MSC, FRCPC.
The stimulating educational sessions covered myelodysplasia, acute leukemia, microRNAs, ITP, TTP, thrombophilia, multiple myeloma, lymphomas, CLL, thrombosis, and the impact of microarray and molecular studies on personalized diagnosis and therapy.
If you missed this informative meeting, you can still experience it for yourself by purchasing the Program Book or a DVD-ROM. The DVD features audio from each of the 11 sessions synced to the speaker's slides. Purchase your copy of the meeting DVD-ROM and Program Book through the ASH Store.
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