Congressional Inquiries Research Articles

Power plays

Power plays

FDA Vows to Improve Drug-Safety Assessments

FDA Vows to Improve Drug-Safety Assessments

Cold Terror: How Canada Nurtures and Exports Terrorism around the World

COLD TERROR How Canada Nurtures and Exports Terrorism Around the World Stewart Bell Toronto: Wiley, 2004. xxviii, 244pp, $36.99 cloth (ISBN 0-470-83463-3)THE 9/11 INVESTIGATIONS Staff Reports of the 9/11 Commission Excerpts from the House-Senate Joint Inquiry Report on 9/11 Edited by Steven Strasser New York: PublicAffairs, 2004. 580pp, $22.95 paper (ISBN 1-58648-279-3)Anyone interested in the world of intelligence should read The 9/11 Investigations. It offers remarkable insight on the events of 11 September 2001, as well as the dynamics within the US intelligence community.The book is a compilation of statements, testimonies, and excerpts from inquiries, edited by Steven Strasser and introduced by Craig Whitney of the New York Times. It also contains a glossary of terms, a select chronology of terrorist attacks, and reproductions of key government documents, including the now-infamous 6 August 2001 presidential daily briefing entitled Bin Laden determined to strike the US. Those anxious about combing through the official 585-page 9/11 Commission Report will welcome this volume for its clarity. Those interested in historical context will appreciate Whitney's deft analysis of the commission and its findings compared to congressional inquiries on Pearl Harbor, the assassination of John F. Kennedy, Cuba, and Vietnam. Everyone worried about terrorism will be engrossed by the look inside the machinations of national security.Formally named the national commission on terrorist attacks upon the United States, the 9/11 commission was a bipartisan, independent panel created by congress and authorized by President Bush in November 2002. Between March 2003 and June 2004 it held 12 public hearings. It also heard testimony from top government officials, including the president and vice president. The 9/11 commission's final report was released in July 2004 in what was widely seen as a strong indictment of the US intelligence community.As Whitney details, this was not the first inquiry into 9/11. The house-senate joint inquiry convened in February 2002 to investigate the performance of intelligence agencies. After nine public hearings, 13 closed sessions, and over 300 interviews, it revealed severe shortcomings-especially with respect to interagency cooperation. However, the joint inquiry's final report, released in December 2002, was heavily censored. Moreover, it failed to delineate clear responsibility for intelligence failures, leaving the public and key members of congress unsatisfied.Whitney notes that the Bush administration opposed a more complete investigation. In October 2001, Republicans in the house defeated motions to create an independent inquiry with subpoena powers, citing national security concerns. By December, senators lieberman and McCain renewed the motion, but the Bush administration favoured the joint inquiry by congressional select subcommittees. However, by July 2002 considerable failures within the US intelligence community were already revealed, and under intense public pressure, Republicans agreed to support another, more open investigation. After several months of negotiations, in November 2002 the White House finally agreed. President Bush backed an independent and public inquiry provided that it finish within 18 months-before the 2004 elections. It did, and the 9/11 commission's final report painted a picture of institutional dysfunction within the intelligence community, concluding that the US government had no way of knowing what it actually knew.Based on this contention, The 9/11 Investigations dissects and condenses the commission's findings into two parts. The first contains staff statements and testimony-12 sections in total-covering terrorist entry into the United States, identification and watch-listing, aviation security, and the four flights on 9/11. There are also staff statements with excerpts of testimony from 14 top Clinton and Bush administration officials on diplomacy, the military, intelligence policy, national policy coordination, law enforcement and counterterrorism, threats and responses, the performance of the intelligence community, and reforming intelligence collection. …

Clinical gene transfer: education is the key.

Profound damage to public confidence in the discipline of gene therapy has been done in the past two years. The gene transfer incident at the University of Pennsylvania in 1999 and alleged financial conflicts associated with that trial, as well as subsequent revelations of massive underreporting of patient adverse events to the Recombinant DNA Advisory Committee (RAC) as required by the NIH Guidelines on Recombinant DNA Research, combined to cause much of this damage. In response to public concerns and congressional inquiries, relevant federal agencies, including the Food and Drug Administration (FDA), the Office of Biotechnology Activities (OBA) at the NIH, and the Department of Human and Health Services (DHHS), have tightened existing regulations and issued new rules and guidelines governing clinical gene transfer studies. One common feature among all of these federal activities is a call for education of investigators and team members to make them thoroughly familiar with all aspects of clinical gene transfer studies and to better protect patient safety. In response to this challenge, the ASGT sponsored a comprehensive Clinical Gene Transfer Training Course over a two-day period immediately preceding the Society’s 4th Annual Meeting in Seattle this past June. The training course was co-organized and cosponsored by the FDA, OBA, OHRP, and the Mount Sinai School of Medicine, and supported financially by only the OBA and the ASGT. Topics encompassed the following areas: 1. Planning for a Clinical Trial; 2. Preclinical Development of Gene Transfer Vectors; 3. Clinical Trial Design, Approval Process, and Trial Conduct; 4. Clinical Trial Compliance, Monitoring, and Oversight; and 5. Bioethics, Research Integrity, and Conflicts of Interest. Training course objectives were to provide education to basic scientists and trainees on the principles of Good Laboratory Practice (GLP) in generating and analyzing preclinical efficacy and pharmacology/toxicity data to support clinical translational research; production facility directors and staff members on the principles of Good Manufacturing Practice (GMP) in manufacturing and testing of gene transfer products for human applications; and clinical investigators and team members on the principles of Good Clinical Practices (GCP) in accordance with the International Conference on Harmonization (ICH) in conducting clinical trials. In addition, all registrants were educated on the relevant federal regulations and guidelines governing clinical gene transfer studies.

Unchained Melody: A Price-Discrimination-Based Policy Proposal for Addressing the MP3 Revolution

Recent innovations allow Internet users to access and trade digital music files without paying those who have produced the music. MP3 and other data compression algorithms allow digital files to easily fit on hard drives or portable discs, and software such as Napster and Gnutella allow music fans to trade files on the Internet. These new technologies are turning recorded music into a public good, since no one can be prevented from enjoying an inexhaustible supply of digital copies. We may expect private markets to provide less-than-optimal quantities of music as a public good. Indeed, foes of Napster claim that downloads are hurting sales of prerecorded CDs (Stern 2000, A03). Others, such as Napster attorney David Boies, argue that Internet music trading does not hurt sales of prerecorded CDs and may actually enhance them by whetting consumers' appetites for new music (E03). Recent congressional inquiries and civil lawsuits have heightened interest in this question: What effect does Internet music trading have on sales of prerecorded CDs? Controversy aside, Internet music trading demands study because it is a more efficient distribution system than the industry's traditional model.' With no costs of manufacturing, packaging, shipping, or retailing CDs, downloads can be offered at a marginal cost of virtually zero and can be enjoyed by music fans at the cost of just a few minutes of computer time. Internet music trading thus represents a tremendous

Death Without Dignity.

It all started here! This book gives the vivid recounting of the first nursing home corporation indicted for murder. This legal scenario focused public awareness on the absence of care in some long-term care (LTC) facilities and the plight of the frail elderly, with resultant congressional inquiries and the birth of the Omnibus Budget Reconciliation Act of 1987/Nursing Home Reform Act(OBRA-1987).

Ideologies of the Anesthetic: Professionalism, Egalitarianism and The Ether Controversy

ON 16 OCTOBER I846, AT MASSACHUSETTS GENERAL HOSPITAL IN Boston, William T. G. Morton, an unknown but enterprising dentist, successfully anesthetized a young man while the renowned surgeon John Collins Warren excised a facial tumor. During the procedure, the patient occasionally move[d], cr[ied] out, and utter[ed] extraordinary expressions, but later he reported that he had suffered no pain, only an awareness of a blunt instrument passed roughly across his neck.' The next day Morton anesthetized a female patient as another medical luminary, Dr. George Hayward, removed a fatty tumor from her shoulder. Aware of the significance of his success in front of Boston's most elite physicians, Morton immediately devoted himself to applying for a patent, to designing and manufacturing inhalers, to publishing promotional pamphlets, and to distributing a schedule of rates for the right to use his discovery. The discovery of etherization and Morton's entrepeneurial schemes generated a wide variety of texts within only a few years-biographies defending Morton, Congressional inquiries into priority claims, articles about patent rights, pamphlets on the nature of scientific discoveries, and medical treatises about pain. Like America's emerging medical profession, these texts are remarkably unstable: they make logical errors, connect unrelated issues, and speak to different audiences and to disparate concerns at the same time. They bear witness to the uncertain status of allopathic medicine in antebellum America and to the anxiety

A national computing initiative: a summary

One of the most significant reports in recent years that has brought about fundamental changes in the way that science is done in the United States was the LAX Report [2]. The LAX report as discussed below led to a number of major achievements including the establishment of the National Science Foundation Supercomputing Centers. In late 1986 in response to congressional inquiries, the Federal Coordination Council on Science, Engineering and Technology (FCCSET) recommended that expert panels be convened in order to assess high-performance computing. number of federal agencies including NSF, DOE, DOD, DARPA and NASA participated in a workshop organized by SIAM in early February 1987. There were thirty-seven participants (Table 1 ) in the workshop drawn from industry, academe and government including the national laboratories. This workshop wrote a report [1] entitled A National Computing Initiative. The Agenda for Leadership with senior authors H.J. Ravech6, D.H. Lawrie and A.M. Despain who chaired subpanels on Applications, Advanced Systems and Parallel Computing, respectively. The goal of the initiative as described in the report was to foster significantly improved computational technologies and promote innovative applications of high performance computing. This article summarizes the

A Seismological Shoot-Out at Diablo Canyon

The Pacific Gas and Electric Co.'s right to operate a nuclear power plant at California's Diablo Canyon has been contested for eight years at 36 federal and four state hearings, three licensing appeals, and two congressional inquiries. The utility announced that design errors in the structural supports were discovered just as the plant appeared ready for operation. Corrections will be technically straightforward, but the political and legal ramifications may cause further delays by supporting the claims of environmental groups that the plant cannot withstand an earthquake. A review of the debate indicates that the developing field of seismic engineering is still imprecise because the theoretical bases remain untested. (DCK)

Voting Behavior: the Vote on the Francis Amendment in the 1962 California Election

Subversive Activities. Initiative Constitutional. Declares existence, purposes, and objectives of world communist movement. Defines communist and subversive organizations and denies them political party status and any tax exemptions. Prohibits members of such organizations or advocates of subversive doctrines from holding public office or employment with state or any public agency, or from receiving any tax exemption. Requires teachers and other employees of public educational institutions to answer congressional and legislative committee inquiries concerning communist affiliation and subversion. Imposes conditions on use of public buildings and property.