Division of Extramural Activities Annual Report 2002
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Medical Advisory Board September 1, 2006–August 31, 2007
hoWard hughes medical iNstitute 2007 annual report What’s Next h o W ard hughes medical i 4000 oNes Bridge road chevy chase, marylaNd 20815-6789 www.hhmi.org N stitute 2007 a nn ual report What’s Next Letter from the president 2 The primary purpose and objective of the conversation: wiLLiam r. Lummis 6 Howard Hughes Medical Institute shall be the promotion of human knowledge within the CREDITS thiNkiNg field of the basic sciences (principally the field of like medical research and education) and the a scieNtist 8 effective application thereof for the benefit of mankind. Page 1 Page 25 Page 43 Page 50 seeiNg Illustration by Riccardo Vecchio Südhof: Paul Fetters; Fuchs: Janelia Farm lab: © Photography Neurotoxin (Brunger & Chapman): Page 3 Matthew Septimus; SCNT images: by Brad Feinknopf; First level of Rongsheng Jin and Axel Brunger; iN Bruce Weller Blake Porch and Chris Vargas/HHMI lab building: © Photography by Shadlen: Paul Fetters; Mouse Page 6 Page 26 Brad Feinknopf (Tsai): Li-Huei Tsai; Zoghbi: Agapito NeW Illustration by Riccardo Vecchio Arabidopsis: Laboratory of Joanne Page 44 Sanchez/Baylor College 14 Page 8 Chory; Chory: Courtesy of Salk Janelia Farm guest housing: © Jeff Page 51 Ways Illustration by Riccardo Vecchio Institute Goldberg/Esto; Dudman: Matthew Szostak: Mark Wilson; Evans: Fred Page 10 Page 27 Septimus; Lee: Oliver Wien; Greaves/PR Newswire, © HHMI; Mello: Erika Larsen; Hannon: Zack Rosenthal: Paul Fetters; Students: Leonardo: Paul Fetters; Riddiford: Steitz: Harold Shapiro; Lefkowitz: capacity Seckler/AP, © HHMI; Lowe: Zack Paul Fetters; Map: Reprinted by Paul Fetters; Truman: Paul Fetters Stewart Waller/PR Newswire, Seckler/AP, © HHMI permission from Macmillan Page 46 © HHMI for Page 12 Publishers, Ltd.: Nature vol. -
Crawford E-Transcript.Ptx
VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. CONDUCTED ON WEDNESDAY, MAY 24, 2006 Page 1 1 UNITED STATES DISTRICT COURT 2 EASTERN DISTRICT OF NEW YORK 3 - - - - - - - - - - - - - - X 4 ANNIE TUMMINO, et al., : 5 Plaintiffs, : 6 v. : No. 05-CV-366(ERK/VVP) 7 ANDREW C. VON ESCHENBACH, : (Korman, C.J.) 8 as Acting Commissioner of : (Pohorelsky, M.J. 9 The Food & Drug : 10 Administration, : 11 Defendant. : 12 - - - - - - - - - - - - - - X 13 14 Videotaped Deposition Of 15 LESTER M. CRAWFORD, D.V.M., Ph.D. 16 Washington, D.C. 17 Wednesday, May 24, 2006 18 9:11 a.m. 19 20 Job No. 1-78974 21 Pages 1 - 244 22 Reported by: Jacquelyn C. Jarboe L.A.D. REPORTING & DIGITAL VIDEOGRAPHY - (800) 292-4789 (202) 861-3410 (800) 292-4789 (301) 762-8282 (703) 288-0026 (410) 539-3664 VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. CONDUCTED ON WEDNESDAY, MAY 24, 2006 Page 2 1 Videotaped deposition of LESTER M. CRAWFORD, 2 D.V.M., Ph.D., held at the offices of: 3 4 5 Arnold & Porter LLP 6 555 Twelfth Street, Northwest 7 Washington, D.C. 20004 8 (202) 827-1152 9 10 11 12 13 14 Pursuant to agreement, before Jacquelyn C. 15 Jarboe, Notary Public in and for the District of 16 Columbia. 17 18 19 20 21 22 L.A.D. REPORTING & DIGITAL VIDEOGRAPHY - (800) 292-4789 (202) 861-3410 (800) 292-4789 (301) 762-8282 (703) 288-0026 (410) 539-3664 VIDEOTAPED DEPOSITION OF LESTER M. CRAWFORD, D.V.M., PH.D. -
FDA Finally Approves Plan B—But with Restrictions
FDA finally approves Plan B—but with restrictions New York Janice Hopkins Tanne The US Food and Drug Administration has finally approved the emergency contraceptive Plan B for sale over the counter to women aged 18 or over. Plan B is a two pill, high dose regimen of the oral contraceptive levonorgestrel. It is about 90% effective in preventing pregnancy when taken within 72 hours of unprotected sex. Plan B will be available towards the end of the year at a cost of $25 (£13; €20) to $40. Women will have to request it from a pharmacist in a pharmacy that is licensed to sell it or from a health clinic. They will have to show government issued identification, such as a driver’s licence, proving they are aged 18 or older. Younger women will need a doctor’s prescription. Men aged 18 or older will also be able to buy the drug for their partner, a move that has raised concern that they may buy it for women under 18. It will not be sold at petrol stations or in convenience stores. The manufacturer, Barr Pharmaceuticals, will survey pharmacies to see that they follow the rules. The FDA’s acting commissioner, Andrew von Eschenbach, approved Plan B three days after President Bush said that he supported approval of the drug for women aged over 18, with prescription only access for younger women. In his approval letter Dr von Eschenbach noted that buyers of nicotine patches and some other drugs already had to prove they were at least 18. The approval came nearly three years after the FDA’s own expert advisory committees and professional staff recommended that the drug be available over the counter for women of all ages. -
Structure & Symmetry
HAPPY HOLIDAYS ASBMB MEMBERS December 2008 Structure & Symmetry American Society for Biochemistry and Molecular Biology J\\PfliGifk\`ej n`k_*.#'''>=G$kX^^\[FI=Zcfe\j 8 $@C- 9 "@C- : ; >=G$kX^^\[Kil\FI=Zcfe\jXi\kiXej]\Zk\[`ekf?<B)0* Z\ccjXe[k_\kX^^\[gifk\`ejXi\m`jlXc`q\[[li`e^@C$- `e[lZ\[elZc\XikiXejcfZXk`feJK8K*#gXe\c8Xe[9 Xe[`e Ôcfgf[`XXe[jki\jjÔY\i]fidXk`fe8Zk`e#gXe\c:Xe[; % Kil\FI= Fi`>\e\jXclk\j >\efd\n`[\FI=Zcfe\j k_\>=Gg`fe\\ij ]fik_\`iEfY\c ]fikX^^\[gifk\`e\ogi\jj`fe Gi`q\XnXi[ ×:$k\id`eXckX^f]>=G ×J\hl\eZ\m\i`Ô\[Xe[^lXiXek\\[ ×<Xj`cpj_lkkc\[`ekf)'[\jk`eXk`fem\Zkfij ×KiXej]\Zk`fe$i\X[p1('l^gcXjd`[;E8 fi`^\e\%Zfd&fi] ORG-041-GFPTaggedAd_ASBMB_v7.indd 1 10/20/08 12:29:39 PM contents DECEMBER 2008 ON THE COVER: Captivated by the symmetry society news of molecular structure, Sung-Hou Kim has been a 2 From the Editor leader in revealing symmetry 3 President’s Message through his studies in crystallography and 5 Letters to the Editor structural genomics. 30 6 Washington Update 12 Retrospective: Anthony G. San Pietro FASEB releases new Breakthroughs in special interest Bioscience. 6 13 Science’s Role in Foreign Policy 14 ASBMB Round Table: Jim Wells and Mary Woolley 16 Keeping Women in Science 19 Grammar and Writing Tips 2009 meeting 20 The 2009 Fritz Lipmann Lectureship: Douglas C. Rees 21 The 2009 ASBMB Merck Award: John Kuriyan 22 The 2009 FASEB Excellence in Science Award: Susan Lindquist science focus 30 Sung-Hou Kim: Consummate Crystallographer departments 7 News from the Hill 10 Member Spotlight 23 Education and Training A leaky pipeline for women scientists. -
1 United States District Court Eastern District of New York
Case 1:05-cv-00366-ERK-VVP Document 285 Filed 03/30/09 Page 1 of 52 PageID #: <pageID> UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW YORK -----------------------------------------------------------------X ANNIE TUMMINO et al., Plaintiffs, MEMORANDUM & ORDER - against - No. 05-CV-366 (ERK)(VVP) FRANK M. TORTI,∗ Acting Commissioner of the Food and Drug Administration, Defendant. -----------------------------------------------------------------X KORMAN, J.: Plan B is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy after sexual intercourse. When used as directed, it can reduce the risk of pregnancy by up to 89 percent. Plan B acts mainly by stopping the release of an egg from an ovary. It may also prevent sperm from fertilizing an egg that has been released or, if fertilization has already occurred, block implantation of the resulting embryo in the uterus. Plan B does not have any known serious or long-term side effects, though it may have some mild and short-term side effects, such as nausea or abdominal pain, in some users. The approved dosage of Plan B is two pills taken 12 hours apart, each containing 0.75 mg of levonorgestrel, a synthetic hormone similar to the naturally occurring hormone progesterone. Because the drug works best when taken within 24 hours of sexual intercourse, it is commonly referred to as a “morning-after pill.” Nevertheless, the drug is effective if the first dose is taken within 72 hours of sexual intercourse. ∗ Pursuant to Federal Rule of Civil Procedure 25(d), Acting Commissioner Frank M. Torti has been substituted for former Commissioner Andrew C. -
Vrwinter06weblinked.Pdf
eterinary REPORT WINTER 2006 | VOL. 29 | NO. 1 2 Meet David Williams State-of-the-art 3 small animal surgery suites and ICU/ER College Unveils Facility Plan 25 Thank You, College Supporters Equine Sports Medicine Clinic Academic Commons, to support expanded veterinary class size Dean’s Column In this issue Spotlight on the Veterinary Teaching Features Hospital New Clinical Department By Herb Whiteley Head . 1 For many alumni and friends of the College, the Veterinary Teaching Facility Plan . 2 Hospital is the most visible and tangible aspect of our institution. The Ugandan Connection . 4 This is where your beloved companion animals and valuable agricul- tural assets—or those of your referred clients—receive expert care. Illinois Program Has Global This is where your future veterinarian or your future colleagues in Impact on Animal Health . 5 practice receive their capstone education. Without a Operation Polar Bear . 6 This is where the newest surgical approaches, best diagnostic tests, doubt, the and state-of-the-art treatment protocols are developed and tested. Joan Embery . 7 Without a doubt, the Veterinary Teaching Hospital participates in Veterinary News from the Zoos . 7 all aspects of our mission and vision, contributing indispensably to the Teaching College’s leadership in veterinary education, scholarship, and public engagement. Hospital College News . 8 This past summer, the teaching hospital became an independent participates College unit equivalent to the three academic departments and the Research News . .10 in all aspects Veterinary Diagnostic Laboratory. A new faculty-level position, director New Faces . .12 of the Veterinary Teaching Hospital, was created. of our mission This leader will work very closely with Dr. -
NIH Conflict of Interest Regs Revised
OCTOBEROCTOBER 2005 www.asbmb.org Constituent Society of FASEB AMERICAN SOCIETY FOR BIOCHEMISTRY AND MOLECULAR BIOLOGY NIH Conflict of Interest Regs Revised SEE PAGE 30 FOR NEW CLARA BENSON TRAVEL FELLOWSHIP AWARD Held in conjunction with EB2006 Custom Antibodies Your Way! Choose the protocol that is right for you! QwikScreen ™: 65 day, 2 rabbit protocol - 4 immunizations, 3 bleeds/rabbit (~100ml serum), customer supplied peptide/protein - Options: Peptide synthesis, immunograde Conjugation to carrier u ELISA u u Animal extensionsMS analysis $685 Standard: 80 day, 2 rabbit protocol - 5 immunizations, 5 bleeds/rabbit (~ 200ml ser Options: um), ELISA, customer supplied peptide/pr Peptide synthesis MS Check™ peptide sequence confirmation u HPLC purified peptide Affinity purification otein - Pinnacle: $975 u HPLC and MS analysis u Complete Affinity Purified Protocol- Animal extensions 2 rabbit pr 5 bleeds/rabbitotocol, (~ 200mlepitope serum), design, peptide PhD technical synthesis support, (up to 20mer),5 immunizations, HPLC purified to ~85%, 5+mg peptide to customer, ELISA, evaluation period, affinity purification, and morMS Check™ peptide sequence confirmationNo Hidden Charges! e… - Discounts for Multiple Protocols$1795 , Includes peptide sequencing by CID MS/MS– u Guaranteed Peptide Let our enthusiasm for scienceExpert workTechnical for SupportFidelity! P: 508.303.8222 www.21stcenturybio.com Toll-free: 877.217.8238 F: 508.303.8333 you! E: [email protected] www.asbmb.org AMERICAN SOCIETY FOR BIOCHEMISTRY AND MOLECULAR BIOLOGY OCTOBER -
Carefirst Doctors Earn $1.4 Million in P4P Rewards
46 Practice Trends I NTERNAL M EDICINE N EWS • November 15, 2006 P OLICY & PRACTICE tive care. During the first year, participat- CMS Curbs Improper Claims ing physicians will be paid for reporting Medicare is on track in 2006 to further re- Ex-FDA Chief Crawford Guilty Pilot P4P for Small Practices baseline information. In the 2 succeeding duce the number of fraudulent and inap- Former Food and Drug Administration The Centers for Medicare and Medicaid years, practices will submit quality data; propriate claims being submitted. CMS is Commissioner Lester M. Crawford, Services is seeking 800 solo and small- to they can earn up to $10,000 per physician reporting that 4% of claims were im- D.V.M., has pleaded guilty to lying about medium-sized group practices to partici- or up to $50,000 per practice for meeting proper in 2006, down from 5% the previ- stock he held during his tenure, in viola- pate in a 3-year pilot pay-for-performance benchmarks endorsed by the National ous year and from 14% in 1996, leading to tion of federal conflict-of-interest and project. The Medicare Care Management Quality Forum. The measures are similar $11 billion less in improper payments over stock ownership rules. Dr. Crawford was Performance Demonstration is limited to to those being used in Medicare’s Physician the last 2 years. To determine the error charged with two misdemeanors and is practices in Arkansas, California, Massa- Voluntary Reporting Program. At the end rate, CMS randomly sampled 160,000 scheduled to be sentenced Jan. 22 in Fed- chusetts, and Utah that are the main of the 3-year project, CMS and the Agency claims submitted from April 2005 to eral District Court in Washington. -
Emergency Contraception: Plan B
Order Code RL33728 CRS Report for Congress Received through the CRS Web Emergency Contraception: Plan B November 9, 2006 Judith A. Johnson Specialist in Biomedical Policy Domestic Social Policy Division Erin D. Williams Specialist in Bioethical Policy Domestic Social Policy Division Vanessa K. Burrows Legislative Attorney American Law Division Congressional Research Service ˜ The Library of Congress Emergency Contraception: Plan B Summary On August 24, 2006, the Food and Drug Administration (FDA) announced the approval of an application to switch Plan B, an emergency contraceptive, from a prescription-only drug to an over-the-counter (OTC) drug for women 18 years of age and older. Plan B will only be sold in pharmacies or healthcare clinics. It will continue to be dispensed as a prescription drug for women 17 years old and younger. Plan B is a brand of post-coital contraceptive that is administered within a few hours or days of unprotected intercourse. Emergency contraception prevents pregnancy; it does not disrupt an established pregnancy. Approval of the switch to OTC status for Plan B has been controversial. Some Members of Congress urged the FDA to deny OTC status for Plan B. Individuals who are critical of the decision to switch to OTC believe that Bush Administration policy and FDA actions were based on political and ideological considerations rather than on sound science. Conservative religious and pro-life groups believe Plan B may increase unsafe sexual activity and should be used only under the supervision of a healthcare professional and, therefore, should not be available OTC. Their major concern with Plan B, however, is that it might prevent the implantation of an embryo in the uterus, which to pro-life groups constitutes abortion. -
Lester Crawford
PROFILE Lester Crawford Veterinarian Lester Crawford has been nominated to be who directs the Washington-based Center for Science in the Public Commissioner of the US Food and Drug Administration. Can he Interest (CSPI), warns that Crawford’s “past… in industry raises ques- provide the agency with the leadership it so desperately needs? tions about his appropriateness to lead the beleaguered [FDA],” which Jacobson refers to as an “agency in crisis, especially on the drug side.” Whether FDA is truly in crisis is debatable, but Crawford will be work- President George W. Bush gave Lester Crawford a special valentine this ing in a politically sensitized atmosphere where drug safety is high on year, telling him on February 14 that he was being nominated to be com- the agenda not only of liberals but also of staunch conservatives, such as missioner of the Food and Drug Administration (FDA). A long-term, if Republican Senator Charles Grassley from Iowa and Republican Senator only quietly ardent, suitor to the post, Crawford has served four separate Michael Enzi from Wyoming. The day after Crawford was nominated stints at the agency, including twice as acting commissioner. he announced plans to form a new drug safety oversight board, whose Little wonder, then, that he was relaxed enough around the time of reviews will include biotech therapeutics, and to open new channels for the White House announcement in mid-February to display some of disseminating information about product safety for the sake of “greater the glad-handing and wisecracking -
Former FDA Commissioner Pleads Guilty to Two Charges New York Janice Hopkins Tanne
Former FDA commissioner pleads guilty to two charges New York Janice Hopkins Tanne Lester Crawford, the former commissioner of the US Food and Drug Administration, pleaded guilty in a district court in Washington, DC, last week to two charges: conflict of interest and failing to disclose financial holdings in companies that the FDA regulated. Each charge carries a maximum penalty of a year in prison and a fine. Dr Crawford will be sentenced on 22 January 2007. Dr Crawford’s lawyer, Barbara Van Gelder, told the Associated Press news agency that she expected Dr Crawford to be fined and placed on probation. The Washingtonian magazine said she is the lawyer to call if “you find yourself drawn into an awkward congressional investigation, or worse, a grand-jury investigation by the Justice Department or the US Attorney’s office” (Washingtonian Dec 2004, p 94). The US Department of Justice had charged Dr Crawford with failing to disclose investments on forms required of senior officials at the FDA. He made false statements saying that he and his wife had sold stocks in organisations regulated by the FDA, such as PepsiCo, Sysco, Kimberly-Clark, and Embrex, or did not declare their holdings. He also did not disclose income from holdings in Embrex stock options or from ownership of Kimberly- Clark or Sysco stock. The conflict of interest charge related to Dr Crawford’s ownership of Sysco and PepsiCo stock and his role as chairman of the FDA’s obesity working group, which made recommendations about relabelling the energy content of food products, such as soft drinks. -
Ensuring a Stable Supply of Influenza Vaccine Erica Seiguer
JULY 2005 Issue Brief Protecting the Nation’s Health: Ensuring a Stable Supply of Influenza Vaccine Erica Seiguer For more information about this ABSTRACT: The looming threat of an influenza pandemic concerns government study, please contact: officials worldwide as they attempt to address shortages and flaws in the vaccination Mary Mahon system. Currently, only two vaccine manufacturers are licensed for U.S. production. Public Information Officer This fact, combined with the complexity of production, has resulted in a supply that The Commonwealth Fund can be easily interrupted. Policymakers are considering various options to spur 1 East 75th Street New York,NY 10021-2692 research and development, stabilize the supply of vaccines, and improve their priori- Tel 212.606.3853 tization and distribution. Fax 212.606.3500 E-mail [email protected] * * * * * Policy Context Recent flu vaccine production problems have underscored the uncertainty of an adequate and stable vaccine supply. For the 2004–2005 flu season, the U.S. supply is about 65 million doses, compared with the 100 million expected, due to the suspension of production at one of the two vaccine manufac- turers licensed by the Food and Drug Administration. Mismatches between supply and demand for vaccines in both directions have become common occurrences in recent years.The social and economic consequences of yearly influenza epidemics are significant. About 36,000 Americans die each year from influenza, and approximately 200,000 are hospitalized.The annual direct costs of medical care are estimated at $1 billion to $3 billion. When compounded with the indirect costs to business of declines in worker productivity (both from employee absenteeism due to illness and for caring for family members), costs for the 2004–2005 season are expected to Additional copies of this and 1 other Commonwealth Fund total $20 billion.