Teratology Society
Newsletter
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Teratology Society Newsletter |
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13, Number 2
Table of Contents Message
from the President
Submitted by Kenneth Lyons Jones, M.D.
This year
we have tried to encourage input and collaboration with perinatal epidemiologists
and those involved in maternal/fetal medicine. Thus we will have a symposium
on Spontaneous Abortion and a session on the Affects of Diabetes and Hypertension
on Pregnancy Outcome. The Teratology Society appreciates the support and participation of the 2003 Annual Meeting Sponsors and Exhibitors. The Annual Meeting was held at the Loews Philadelphia Hotel in Philadelphia, Pennsylvania, June 21-26, 2003.
2003 Annual Meeting Sponsors
2003 Annual Meeting Exhibitors
Submitted by William Slikker, Jr., Ph.D. Thanks to all of you, it has been an excellent year for the Teratology Society. The attendance at the Annual Meeting was terrific with outstanding scientific presentations from national and international scholars. The Program Committee, chaired by Shelley Tyl, provided the membership with a multidisciplinary and prestigious series of speakers and interactive sessions. The Education Committee, chaired by Dana Shuey, delivered two well received courses including the traditional day course and the mini-sunrise session. The excellent progress of our new three part Journal, Birth Defects Research, was summarized by the three Editors-in-Chief, and the chair of the Publication Committee, Barbara Abbott. Your commitment to our Journal, as demonstrated by quality submissions, will guarantee its continuing success. A Society that remembers its past accomplishments is better prepared for a successful future. Our historian, Ron Jensh, provided an outstanding service for the Society by providing an entire booth of memorabilia, pictures and other important documents summarizing the amazing history of our Society. We are all indebted to Ron for the beautifully illustrated and printed history he provided. The activities of the Student Affairs Committee are of paramount importance to the future of our Society. Under the quality leadership of Jack Bishop, the Student Affairs Committee provided guidance and support for students to join the Society, attend and present at the Annual Meeting, and compete for scholarly awards. The coordination of the student activities, including their audiovisual assistance for each scientific session and education course, was successfully accomplished by this Committee. As part of their overall experience at the Annual Meeting, the students also benefited from the well coordinated Student Career Event organized and sponsored by MARTA/MTA. The tremendous level of volunteerism within our Society is truly exceptional. The efforts of the Membership Committee led by Tom Flynn, to recruit and maintain our most precious resource, were simply outstanding. The stable and able hand of the Nominations and Election Committee, chaired by Mary Alice Smith, selected a prestigious slate of nominees. Robert Felix and Sidney Beck, chairs of the Website and Constitution and By-Laws Committees, respectively, initiated valuable efforts that will continue throughout this year. The Public Affairs Committee, led by Tina Chambers, continued to provide the excellent content for Workshops, press releases and position papers. I know of no other society that benefits more than Teratology from such loyal and energetic service from its members. The Society is also blessed with those very special members and associated contributors including the Sustaining Members, Charles River Laboratories, Pfizer, Inc., WIL Research Laboratories, Inc., ClinTrials BioResearch, Ltd. (CTBR), Coca-Cola Company, GlaxoSmithKline, Hoffmann-La Roche, Inc., Pharmacia & Upjohn, Inc., Abbott Laboratories, Bristol-Meyers Squibb, Chevron-Texaco, Covance Laboratories, Eastman Kodak Company, Eli Lilly and Company, Mitretek Systems, Procter & Gamble Company, Sanofi-Synthelabo Research, Schering-Plough Research, Wyeth-Ayerst Research, and Annual Meeting Sponsors, Centers for Disease Control, Chevron-Texaco, Clin Trials BioResearch, LT.,(CTBR), Covance Laboratories, Dupont Haskell Laboratory for Health and Environmental Sciences, Eli Lilly and Company, Endo Pharmaceuticals, Inc., Environmental Protection Agency, FDA-Office of Women’s Health, Health Canada, March of Dimes, Merck Research Laboratories, Inc., National Institute of Environmental Health Sciences, Pfizer, Inc., TAP Pharmaceutical Products, Inc., WIL Research Laboratories, Inc., that provide support for our Society’s activities. Once again, thank you all for your generous contributions. I also want to thank my fellow elected officers, especially George Dearlove and Melissa Tassinari who have completed their cycle of service and have volunteered for more. My special appreciation goes to the past president, Jan Friedman, whose steady mentorship was of great value to me personally. The day to day operation of the Society is in the capable hands of AIM, and I want to thank the staff and their leadership, Tonia Masson, for their outstanding support of the Society. And finally, I thank the entire membership for the opportunity to serve the Teratology Society.
Treasurer’s Report, submitted by John Rogers, Ph.D. The latest news on the financial front is that, with the majority of the precincts reporting, the 2003 Annual Meeting is looking like a financial success. The planned budget for the meeting included total expenses of $265,269, and as of July 31, 2003 we have spent $238,065, about 10% under budget. There are a few outstanding expenses yet to be paid, but we held the line on spending very well. On the income side, we had predicted revenues of $261,829, including $20,000 commission from the hotel in Philadelphia. As of July31,2003 we have received $253,654, and this does not include the hotel commission. (Recall, we began negotiating for commissions from our hotels several years ago, and this money has from the start been earmarked to reduce registration costs for the next Annual Meeting. This has been a great success every year so far.) Adding in that income, we should exceed our predicted revenue fairly handsomely, and the net income from the meeting should be well in excess of $25,000. The business office once again did a marvelous job on all phases of planning and executing the Annual Meeting. While we all experienced the scientific excellence of the meeting, its great to know that we generated a good income at the same time. Contributions to the Annual Meeting were strong, including grants, corporate contributions and the success of the PAC Workshop. We need to keep up the momentum on contributions for 2004! The Continuing Education course, the Behavioral Workshop and the minicourse were all scientifically as well as financially excellent, and greatly enhanced the meeting. As we are getting in a strong financial position, I hope that the membership will continue to contribute ideas for other enhancements to the Annual Meeting as well as other Society functions throughout the year. The year-to-date financial report is not all bright, however. Membership dues continue the downward trend of the past few years. Membership dues for 2003 as of July 31, 2003 totalled $31,474, compared to $34,608 for 2002 dues as of the same date last year. Many of us know colleagues that participate in the meeting or other Society activities but are not members, or others who have let their membership lapse. We all need to encourage these friends to join the Society and keep their membership current. With the new journals, enhanced website, and ever-better annual meetings, this is an exciting time to be in the Teratology Society. Despite the many recent successes we can enumerate, expanding our membership remains as a top unmet priority. Council is working hard on this, and holding joint or co-localized meetings with other societies is one avenue being hotly pursued. A broad membership effort to recruit new people and disciplines into the Society, however, is an important mechanism to which we can all contribute. Lastly, several of you have brought up the idea of having a financial page on the website, and I have been remiss in not getting that going by now. I am putting together something to bring to Council at the upcoming interim meeting. At a minimum, this page will include our approved annual budget, our balance sheet, and a listing of our current investments. Any suggestions as to the content of the page are of course encouraged. As always, please don’t hesitate to e-mail me (rogers.john@epa.gov) with any comments, suggestions or questions about the finances of the Society.
Submitted by Bruce A. Buehler, M.D. The Student
Affairs Committee was very pleased with the excellent presentations by
the student awardees and competitors this year. The papers were of highest
quality and the presentations were superb and well presented. I think
it is a tribute to the Society that we encourage young, new investigators
to present their work in front of a large and interested audience. It
is my hope this year that the attendance at the Student Awards Presentations
will be even larger and that all mentors, supervisors, and colleagues
will consider nominating individuals in their laboratory for these prestigious
awards. The committee works very hard to provide a forum for young researchers
to demonstrate their skills; to make themselves available for future potential
positions; and to create a scientific atmosphere during the meetings.
With all of the expert presentations in other areas, and the expertise
at the meeting, I truly believe it is an obligation of all members of
the Teratology Society to support those young researchers in the beginnings
of their career through participation in the Student Research Competition.
I look forward to another excellent session in 2004 with outstanding young
researchers. Thank you.
Submitted by by Mike Narotsky, Ph.D.
The Continuing
Education Course will be offered June 26 - 27, 2004 and will be entitled
“Signaling Pathways and Tissue Interactions in Organ-System
Development.” The format of the course will consist of
an introductory talk giving an overview of signaling and development,
three talks on developmental processes, and four talks on specific organ
systems. Although the line-up of speakers is still being finalized, confirmed
speakers (and their topics) include: Claudia Kappen (patterning), Barbara
Abbott (morphogenesis and differentiation), Rocky Tuan (bone and cartilage),
Ida Smoak (heart), Drucilla Jane Roberts (gastrointestinal tract and derivatives),
and Scott Stadler (genitourinary tract). Submitted by Christina Chambers, Ph.D., MPH The Public Affairs Committee has recently completed a statement on tobacco use in pregnancy which will be submitted for publication in BDR Part A. The Committee is currently working on a statement on maternal obesity. The Committee hosted a one-day workshop at the Annual Meeting this year. This event was designed to give clinicians the opportunity to develop recommendations for communicating risks regarding animal data in the pregnancy label. The Committee would like to thank the sponsors of this event, including OTIS, NBTS, the CDC, the FDA Office of Womens Health, Merck and Pfizer, for their support and participation in the planning process. A summary of the workshop proceedings is being prepared for publication. The Committee welcomes three new members this year: Cindy Moore from the Centers for Disease Control and Prevention, Chris Stodgell from the University of Rochester, and Gary Kimmel from the U.S. Environmental Protection Agency.
Submitted by Bruce Beyer, Ph.D., DABT Extensive revisions were made to the Constitution & By-Laws 2 years ago. Now that everyone has had a year to absorb the changes in our Journal and Society, please review the Constitution and By-Laws at http://teratology.org/members/constitution.htm and submit any proposed changes to a Committee member or any member of Council. A complete list of Councilors and Committee Members can be found at http://teratology.org/members/directory.htm. We look forward to hearing from you soon.
Nominations
and Elections Committee The Teratology Society Nominations Committee needs YOUR help. The Nominations Committee is developing a slate of candidates for Vice-President Elect, Councilor, and Treasurer. We need volunteers and nominees who are willing to commit the necessary time and energy to successfully fulfill the requirements of each office. We especially encourage volunteers. Please email your suggestions and comments to any of the Committee Members: Bruce Kelman
(Chair), bkelman@globaltox.com The Committee must submit a final slate and alternates to Council by December 1, 2003, so now is the time to act. These leadership positions are crucial to the future of your Society. Make your voice heard by participating in one of the most important membership activities we have: nominate a candidate.
Philip E. Mirkes, Ph.D., Editor As Editor of Birth Defects Research Part A: Clinical and Molecular Teratology (BDRA), I want to take this opportunity to update you on journal activities since my last email update. The first 8 months of operation for BDRA have passed, and we are now scheduling manuscripts for the December issue. For the first 8 months, the average review time has been 15.8 days, and the average time from submission to decision has been 24.6 days. Almost 50% of manuscripts come from our international community. Wiley’s “Early View” feature is now activated: that is, Wiley will be publishing BDRA articles electronically, each with its own e-publication date, within 2 weeks of receiving corrected proofs. Thus, electronic publication of your article will predate print publication by at least 1 month. It has been exciting to see the promise of electronic publication become a reality so quickly! Finally, I would like to thank our authors, for submitting their interesting manuscripts to BDRA, and our reviewers, who contribute their valuable time and expertise to the process. I have included below a description of the various categories of manuscripts that are appropriate for submission to BDRA. I look forward to seeing your manuscript submitted to BDRA. BDRA Manuscript
Categories: Brief Report. Narrower in scope than Original Articles, Brief Reports may present results of studies involving small sample sizes, introduce new methodologies, report new developments, or describe preliminary results that are experimentally well documented. The Methods should be sufficiently detailed to permit replication of the work. Results and Discussion should be separate sections. Brief Reports should not exceed 2000 words of text, 2 tables or figures, and 25 references. The abstract should follow the same form (structured) and word length (not >250 words) as required for Original Articles. Review. Review articles focus on topics of broad scientific interest to investigators in the area of birth defects research. Although such articles are usually solicited by the Editors, the journal will consider author-initiated proposals. Please contact the editorial office if you wish to propose a review article. Case Report. These articles may describe one or more cases of a unique or rare clinical syndrome. The abstract for a Case Report should be structured as Background, Case(s), and Conclusions. The text should use the following format: Introduction, Case Report, and Discussion. The Discussion is expected to place the subject(s) of the Case Report in the context of the published literature on the same or related birth defect and to discuss the possible pathogenesis of the malformation. Hypothesis. These articles present new data that lead to a specific hypothesis warranting further research (see BDRA 67 (3):149-153, 2003 and 67 (6):403-408, 2003 for examples). The format of Hypothesis articles should follow those outlined for original articles. Teratogen Update. These articles review in detail the epidemiology, animal data, pharmacokinetics, toxicokinetics, or mechanism of action of a particular teratogenic agent or group of agents, e.g., anticonvulsants. These in-depth articles are usually solicited by the Teratogen Update Editor, but the journal will consider proposals from potential authors. Guidelines. These articles set forth guidelines related to the understanding and prevention of birth defects (see BDRA 67 (3): 193-201, 2003 for an example). Guidelines should be formatted with the same organization as original articles. Workshop Summary. Summaries of workshops with a focus on birth defect-related topics will be considered. Authors interested in submitting such a summary should contact the editorial office. Commentary. These are typically solicited by the Editor and are published in the same issue as the article that is the focus of the commentary. Correspondence. Letters to the Editor must refer to an article that appeared within the previous 2 months. The text of the letter should be brief (not >500 words), and the letter may include 1 table or figure and 10 references. No new data may be presented. Letters to the Editor will be sent to the authors of the initial article for response. If accepted, both letters will be published in the same issue. Book review. Books referred to the journal for possible review will be screened by the Book Review Editor for broad appeal to the general readership. Authors should include several suggestions for experts in the field who would be highly qualified to review the book.
George Daston, Ph.D., Editor Birth Defects Research B: Developmental and Reproductive Toxicology continues to make excellent progress. Four issues have been published at this point, and a fifth is in the hands of the publishers. We are meeting our page budget of just under 600 pages per year, with a mix of original research and focused review articles. We are averaging 23 days from submission to first decision, and about two months from submission to final decision. The review times are actually decreasing from this already good pace, primarily thanks to the on-line review system (and, of course, our terrific editorial board). I hope you have had a chance to look at the journal. We’ve been able to make use of color in every issue, all of which has been provided free to the authors. The color figures, along with the color cover, and the great content of the journals, makes it a pleasure to read. I believe that BDRB is meeting an important need of the membership, a belief that is supported by your continuing submission of manuscripts. I hope that you share my belief and continue to send us your papers. Ultimately, the success of the journal is in your hands. Please continue to send us your manuscripts. I promise you a fair and rapid review. Since ours is a new journal, we don’t have a large backlog of manuscripts, so the time between acceptance of your paper and appearance in print will be short.
Rocky S. Tuan, Ph.D., Editor BDRC-Embryo Today: Reviews provides scientists and clinicians with state-of-the-art review articles that capture exciting advances in the fields of embryology, developmental biology, and teratology. The unifying theme is the “embryo” as an integrative system for scientific investigation. The format will include authoritative review articles and tutorials that critically evaluate emerging knowledge and technical advances in embryology, developmental biology, and teratology in a multidisciplinary manner. The overall goal of BDRC- Embryo Today: Reviews is to present a coherent synthesis of basic principles and concepts of embryology targeted for a broad audience consisting of developmental biologists, biomedical scientists, and clinicians. Special emphasis will be on topics that cover embryology, abnormal development, and embryonic development as it relates to clinical medicine. BDRC – Embryo Today: Reviews is currently published quarterly. For 2003, the journal has a page budget of 384 pages or four issues of 96 pages each. The Editorial Board has adopted a topical format for each quarterly issue, with six to eight articles per issue. For Volume 69, the topics are:
Three issues have been published so far. Topics planned for 2004 include; 1) Extracellular Matrix in Development, and 2) Neural Crest. Topics are selected upon consultation between the Editor and the Associate Editors, and prospective authors are invited to submit a review manuscript on their area(s) of expertise. All manuscripts are submitted in electronic format and a web-based on-line submission system is currently being set-up. The manuscripts are reviewed by the Editor and/or an Associate Editor(s). The Editor is assisted by a half-time Editorial Assistant. With three issues of BDRC – Embryo Today: Reviews in print, the experience with the publisher has been very satisfactory. In particular, Wiley has provided a generous number of gratis color pages, which has effectively allowed the authors to include eye-catching graphics to illustrate concepts and pathways in their review articles. Wiley is also aggressively marketing the journal. From all indications, reception of BDRC – Embryo Today has been excellent, in both the teratology and developmental biology communities. Considerations are being given to introduce the journal to the clinical academic communities as an information platform for birth defects that are of specific relevance to clinical subspecialties.
Submitted by George Dearlove, Ph.D., DABT The 24th Annual Meeting of the American College of Toxicology will be held at the Renaissance Washington, DC Hotel, November 2-5, 2003. For complete details please visit the American College of Toxicology Web site at www.actox.org. The meeting will start on Sunday with continuing education courses: Study Director Training will be a full day course; Cytometry Applications in Toxicology, Toxicology Testing for Preventive Vaccine Development, and Target Organ Toxicity (Liver, Kidney and Heart will be reviewed) will be offered as half day courses and ICH Harmonization Process course will be presented as a Mini-Course. Seven Scientific Symposia will be offered along with Keynote addresses by Francis Collins, M.D., Ph.D. on the Human Genome and George Lambert, M.D. on “Autism and the Environment: Is there a Linkage?”. There will also be a “Great Debate” featuring four scientists trying to answer the question: “Do the Benefits of Statins as Currently Used Outweigh the Risks?”
Submitted by J. M. Friedman, M.D., Ph.D The 53rd Annual Meeting of The American Society of Human Genetics will be held on November 4-8 in Los Angeles, California. Highlights include plenary symposia on the Future of Genomics and Genetics, the Cancer Genome Project, and Cancer Genetics and Epigenetics. There will also be sessions on Transcription Factors and Human Disease, the Genetics of Syndromic and Non-Syndromic X-Linked Mental Retardation, Transgenic Models of Complex Behavioral Phenotypes, Craniofacial Development and Disorders, Inhibiting the Expression of Pathogenic Mutations, How New Syndromic Identifications Are Affecting Empiric Risks for Non-Syndromic Birth Defects, and the Interconnected Biology of the Chromosome Instability Syndromes, among many others. More information about the meeting is available online at http://www.ashg.org/genetics/ashg/menu-annmeet.shtml.
Submitted by Anthony R. Scialli, M.D. The March of Dimes is a national voluntary health agency whose mission is to improve the health of babies by preventing birth defects and infant mortality. Founded in 1938, the March of Dimes funds programs of research, community services, education, and advocacy. The organization has chapters in all 50 states, the District of Columbia and Puerto Rico. “A major barrier to improved birth outcomes in the U.S. is the absence of a comprehensive public health surveillance and information system that tracks birth outcomes,” says Dr. Jennifer L. Howse, president of the March of Dimes Birth Defects Foundation. During the 1990s, the March of Dimes took a lead role in the successful effort to win passage of the Children’s Health Act of 2000. This legislation authorized expanded research, prevention, and services on a variety of childhood health problems, including the creation of a National Center on Birth Defects and Developmental Disabilities (NCBDDD) at the Centers for Disease Control and Prevention. March of Dimes public affairs volunteers and staff continue to engage in advocacy activities at the local, state, and federal levels to improve the health of mothers and babies. An example is the March of Dimes advocacy for a Food & Drug Administration-mandated single program to stringently monitor and restrict the clinical use of Accutane (isotretinoin), similar to the system currently in place for thalidomide. On Capitol Hill on December 11, 2002, the medical director of the March of Dimes, Nancy S. Green, M.D., testified at a hearing on the drug held by the House Energy and Commerce Committee. “No pregnant women should take isotretinoin, and no women taking isotretinoin should get pregnant,” Dr. Green told lawmakers. The March of Dimes is developing targeted, cost-effective partnerships to carry out its mission in several regions of the world, including Central and South America, Asia, Eastern Europe, Africa, and Western Europe. It also works to strengthen parent/consumer organizations worldwide and to increase international attention to and funding for prevention and care of birth defects in developing countries. Research investments made by the March of Dimes in 2001 totaled more than $26.5 million, with some 450 scientists receiving support to investigate questions in developmental biology; to search for genetic therapies for birth defects; and to shed light on the perplexing mystery of what triggers preterm labor. Citing the dramatic rise in the number of babies born prematurely in this country, in January 2003 the March of Dimes launched a $75 million, five-year national campaign to increase awareness of the growing problem and decrease the rate of premature birth. In 2001, more than 476,000 babies, or nearly 12 percent of live births, were born too soon – before 37 completed weeks – in the U.S. The campaign will also advocate for an increase of $10 million annually in federally funded research into the causes of prematurity. The March of Dimes is constantly exploring new and more effective ways to educate the public, the news media, health professionals, and policymakers about the impact of birth defects. Among the current education programs supported by the March of Dimes are:
Submitted by Janine E. Polifka, Ph.D. The Organization of Teratology Information Services (OTIS) is announcing a new a survey to find out why women who take Accutane™ (isotretinoin), a drug used to treat severe acne, continue to get pregnant despite warnings that the drug causes serious birth defects if taken during pregnancy. Funded by the Centers for Disease Control and Prevention’s National Center on Birth Defects and Developmental Disabilities and Office of Women’s Health, the grant was awarded to the Utah Pregnancy RiskLine (PRL), a Teratogen Information Service (TIS) and OTIS member. “Our goal is to reduce the number of pregnancies exposed to isotretinoin,” says the study's principal investigator, John C. Carey, M.D., M.P.H., Professor of Pediatrics and PRL Medical Director. Before prescribing isotretinoin doctors must make sure women are using two forms of birth control and understand the birth defects risks. “Despite these efforts an increasing number of women continue to get pregnant while using isotretinoin,” added Carey. The project will survey women throughout North America who took isotretinoin during pregnancy. The TIS will, first, provide birth defects counseling to the pregnant woman with an exposure. The programs will then gather information about the amount of drug used, how the product was dispensed, birth control methods used and how women perceived the manufacturer's new pregnancy prevention program called S.M.A.R.T.® (System to Manage Accutane Related Teratogenicity). Roche Laboratories voluntarily created the program for women who use Accutane™. “Data from this project will help us know whether the S.M.A.R.T. program works,” says Christina Chambers, University of California at San Diego and Epidemiologist on the project “Information from the survey will help us understand which pregnancy prevention strategies work best. We can then share this information with health care providers, pharmaceutical companies and the public.” More than 2 million people use isotretinoin for cystic acne in the U.S. each year. Isotretinoin has been identified as the most potent and damaging human teratogen; the risk following embryonic exposure (days 14-60) includes a 35% risk for major malformations [central nervous system, cardiac, craniofacial, thymus/parathyroid]; a 40% risk for spontaneous abortion; and a 16% risk for prematurity. In some cases, the mothers had been treated with isotretinoin for less than a week. At five years of age, 47% of the children exposed during embryogenesis performed in the subnormal range on neuropsychological examinations. Subnormal intelligence without structural defects has been observed in roughly 25% of children exposed during the embryonic period. The extent of damage with exposure during the second and third trimester is not yet known. “The risk of serious birth defects with isotretinoin use is high, and many pregnancies are unplanned,” commented Dr. José Cordero, director of the CDC's National Center on Birth Defects and Developmental Disabilities. “We support the development of effective programs that can inform women about the risks, and assist them in avoiding pregnancy while using this medication.” To refer clients for counseling on the birth defects caused by isotretinoin and to enroll in the survey, pregnant women should call the OTIS toll-free number: 1-866-626-OTIS (6847). For more information about the project, email the study coordinator jrobertson@utah.gov.
A workshop on testing strategies and design of safety studies in juvenile animals will be held on November 19-20, 2003. The purpose of the workshop is to provide a forum for industry, academic, and regulatory discussion of the process(es) to determine when juvenile animal studies are necessary, and to propose appropriate study designs and testing strategies for these studies. The workshop is being organized by the ILSI Health and Environmental Sciences Institute’s (HESI) Developmental and Reproductive Toxicology Technical Committee. The organizing committee includes representatives from U.S. EPA, U.S. FDA, the European Agency for the Evaluation of Medicinal Products (EMEA)/Committee for Proprietary Medicinal Products (CPMP), and ILSI HESI. The workshop will be held in Washington, DC, and is strictly limited to 125 participants. For information contact Mr. David Sandler at ILSI HESI (dsandler@ilsi.org).
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