Drug Approvals / Withdrawals
&
Conflict of Interest

Introduction

This page focuses on conflits that may arise when a drug is submitted for approval to the authorities. The sponsoring pharmaceutical company has an obvious interest in securing a speedy marketing authorization. The pharmaceutical agencies want to provide safe and effective medicines to patients as soon as reasonable, but need to balance this advantage with the risk of releasing on the market medicines whose risk/benefit ratio has not been studied or analyzed sufficiently.

United States

FDA | On the FDA | Statutes | OIG | GAO

FDA

Postmarketing study commitments

• Postmarketing study commitment database
• Postmarketing Study Commitments Frequently Asked Questions (FAQ)
• Report to Congress on Postmarketing Studies (April 2002)
• CBER, Report to Congress on Postmarketing Studies
• Guidance for Industry: Reports on the Status of Postmarketing Studies-Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997 (2006)
• Final Rule on Postmarketing Studies for Approved Human Drug and Licensed Biological Products, Status Reports (2000)
• Annual Notice 2005, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies
• Annual Notice 2004, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies
• Annual Notice 2003, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies
• Annual Notice 2002, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies
• Annual Notice 2001, Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Commitment Studies

Advisory Committees

• FDA Web Page on Waivers for Conflicts of Interest for Voting Members of FDA Advisory Committee Members
• FDA, Press release, FDA Announces Steps to Improve Advisory Committee Processes (November 15, 2007)
• Draft Guidance for FDA Advisory Committee Members and FDA Staff: Voting Procedures for Advisory Committee Meetings (November 2007)
• ERG Report, Measuring Conflict of Interest and Expertise on FDA Advisory Committees, (October 26, 2007)
• Draft Guidance for the public: FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers (October 2007)
• Draft Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees (March 2007)
• Draft Guidance for Industry, Advisory Committee Meetings - Preparation and Public Availability of Information Given to Advisory Committee Members (February 2007)
• Draft Guidance, The Open Public Hearing, FDA Advisory Committee Meetings (February 2005)
• Conflicts of interest and FDA Advisory Committee Meetings: A Study of Public Attitudes and Opinions (September 2004)
• FDA Guidance on Conflict of Interest for Advisory Committee Members, Consultants and Experts
• Disclosure of Conflicts of Interest and Waivers for Voting Members of FDA Advisory Committee Members (November 17, 2005)
• Policies and Procedures for Handling Conflicts of Interest with FDA Advisory Committee Members, Consultants, and Experts
• Draft guidance on disclosure of conflicts of interest for special government employees participating in FDA product specific advisory committees (January 2002)
• Guidance for Industry Advisory Committees: Implementing Section 120 of the Food and Drug Administration Modernization Act of 1997 (October 1998)
• Proposed Bill: The Enhancing Drug Safety and Innovation Act of 2006

Other financial disclosures

• Guidance, Financial Disclosure by Clinical Investigators (March 2001)
• Brief report: special government employee (SGE) financial disclosure survey (November 2001)
• Office of Government Ethics, Standards of Ethical Conduct for Employees of the Executive Branch (1997)
• Conflict of Interest and Fair Access Statement - To be completed by the FDA Principal Investigator

On the FDA (except for medical journals, see below)

• Center for Public Integrity, FDA Staff Travels on Drug Industry Dollars (March 30, 2006)
• Congressman Edward J. Markey, Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process (2005)
• GAO, Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process, (GAO-06-402) (March 2006)
• Hastings Center Report, Rebecca Dresser, A New Era in Drug Regulation? p.10 (2005)
• Institute of Medicine, Report Brief. The Future of Drug Safety. Action Steps for Congress (September 2006)
• Institute of Medicine, Assessment of the U. S. Drug Safety System
• New York Times, David Stout, Ex-F.D.A. Chief Pleads Guilty In Stock Case, (October 18, 2006)
• New York Times, Stephanie Saul, Former FDA Chief Is Charged with Conflict, (October 17, 2006)
• Public Citizen, FDA Medical Officers Report Lower Standards Permit Dangerous Drug Approvals (December 2, 1998)
• Public Citizen, Closed July meeting on Hemopure - lawsuit against the FDA - accompanying memorandum
• Union of Concerned Scientists - FDA survey brochure - Questions and findings - Additional questions - Comparison of UCS and IG surveys
• Review of the FDA’s Approval Process for the Vagus Nerve Stimulation Therapy System for Treatment-Resistant Depression, Committee Staff Report to the Chairman and Ranking Member, Prepared By the Staff of the Committee On Finance(February 2006)
• Merrill Goozner, FDA Woes, AARP Bulletin (May 2006)
• Committee on Government Reform, Opening statement of Chairman Tom Davis: risk and responsibility: the roles of FDA and pharmaceutical companies in ensuring the safety of approved drugs, like Vioxx (May 5, 2005) & list of related documents
• US Senate, Committee on Finance. Opening statement of US Senator Chuck Grassley of Iowa, Chairman, Senate Committee on Finance: hearing, FDA, Merck and Vioxx: putting patient safety first? (November 18, 2004)
• Ed Markey Report (Congressman), Conspiracy of Silence: How the FDA Allows Drug Companies to Abuse the Accelerated Approval Process (2005)

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Statutes and Regulations

• FDA Revitalization Act of 2007 - Food and Drug Administration Amendments Act of 2007 - section 701
• Prescription Drug User Fee Amendments of 2007
• Federal Advisory Committee Act (Pub. L. 92-463, § 1, Oct. 6, 1972, 86 Stat. 770)
• 18 U.S.C. 203 and 205.
• 18 U.S.C. 207.
• 18 U.S.C. 208
• 18 U.S.C. 209
• 18 U.S.C. 1905
• 21 U.S.C. 331 (j)
• 21 C.F.R.  13.10
• 21 C.F.R. 14
• 21 C.F.R. 19
• 21 C.F.R. 56.107

Proposed bills

• S. 3807: Enhancing Drug Safety and Innovation Act of 2006

OIG

• FDA's Monitoring of Postmarketing Study Commitments (June 2006)
• FDA’s Review Process for New Drug Applications, A Management Review (March 2003)
• The Orphan Drug Act, Implementation and Impact (May 2001)
• Review of the Food and Drug Administration’s Handling of Adverse Drug Reaction Reports (December 1999)
• Review of the Food and Drug Administration’s Citizen Petition Process (July 1998)
• Review of the Food and Drug Administration’s Handling of Issues Related to Conjugated Estrogens (May 1997)
• Postmarketing Studies of Prescription Drugs (May 1996)
• Report on the Audit of the Food and Drug Administration’s Prescription Drug User Fee Account for Fiscal Year 1994 (September 1995)
• Review of the Food and Drug Administration’s Processing of a New Drug Application for Therafectin (August 1995)
• Follow-up Review of the Food and Drug Administration's Generic Drug Management Information System (1992)
• Follow-Up Review of the Food and Drug Administration's Generic Drug Approval Process (September 1992)

GAO

• Improvement Needed in FDA’s Postmarket Decision-making and Oversight Process (March 2006)
• Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual (November 2005)
• Federal Advisory Committees, Additional Guidance Could Help Agencies Better Ensure Independence and Balance (GAO-04-328) (April 2004)
• Food and Drug Administration Should More Efficiently Monitor Inclusion of Minority Children (September 2003)
• Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities (September 2002)
• Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women (January 2001)
• Improvement Needed in the Foreign Drug Inspection Program (March 1998)
• Continued Vigilance Critical to Protecting Human Subjects in Research (March 1996)

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European Union

EMEA | EU Statutes |EU Court decisions | UK | France

EMEA

• EMEA; Policy on representation of EMEA Scientific Committees by its Members (EMEA/231477/2005) (10 May 2006)
• EMEA; Questionnaire on criteria to be fulfilled by patients’ and consumers’ organisations prior to involvement in the EMEA activities (EMEA/333929/2005 ) (24 October 2005)
• EMEA, Guideline on Data Monitoring Committees (EMEA/CHMP/EWP/5872/03 Corr) (27 July 2005)
• EMEA, The European Medicines Agency Road Map to 2010: Preparing the Ground for the Future p.14 (4 March 2005)
• EMEA, Criteria to be fulfilled by Patients’ and Consumers’ Organisations involved in EMEA Activities (EMEA/14610/04/Final) (February 7, 2005)
• EMEA, Committee for Orphan Medicinal Products - Rules of Procedures (COMP/8212/00 Rev 2) (8 December 2004)
• EMEA Procedure on the Handling of Conflicts of Interests for EMEA Scientific Committees Members and Experts (EMEA/H/5475/04/Final) (July 2004)
• EMEA Policy on the Handling of Conflicts of Interests for EMEA Scientific Committees Members and Experts (EMEA/H/31653/03/Final)
• Declaration of Interests Assessment Group’s ‘Rules of Procedure’ (EMEA/H/33606/03/Final)
• EMEA Code of Conduct EMEA/D/37674/99
• EMEA, Mandate, Objectives and Rules of Procedure for the CHMP Scientific Advisory Group on Diagnostics (SAG-D) (EMEA/CHMP/155989/2004, Rev.1)(January 20, 2006)
• CHMP Safety Working Party (EMEA/CHMP/SWP/142030/2004)
• Working Party on Similar Biological Medicinal Products (EMEA/CHMP/80650/2004)
• CHMP Scientific Advisory Group on HIV/Viral diseases (EMEA/CHMP/195677/2004 Rev. 1)
• CHMP Pharmacogenetics Working Party (EMEA/CHMP/101592/2004)
• CHMP Paediatric Working Party (EMEA/CHMP/49154/04)
• EMEA; Check of experts for meetings SOP 3021
• EMEA, Check of expert for product evaluation SOP 3022

EMEA drug lists

• EMEA, list of drug applications refused
• EMEA, list of drug applications withdrawn
• EMEA, list of approved drugs withdrawn
• EMEA, list of approved drugs (EPAR)

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EU Statutes

• Article 62 (2) of Council Regulation (EC) No. 726/04 of 31 March 2004 (O.J. No.L 136 of 30 April 2004)

EU Court Decisions

• Case T-326/99 - Judgment of the Court of First Instance of 18 December 2003 - Nancy Oliviery v. Commission and EMEA - opposition to marketing authorization

UK MHRA

• Code of practice on interests for chairmen and members of the Commission on human medicines
• Letter of consultation on conflicts of interest (2004)
• Declaration of interests: Members' interests

UK NICE

• 2007 Code of practice for declaring and dealings with conflicts of interests (April 2007)
• Item 6b, A code of practice for declaring and dealings with conflicts of interests (April 2007)
• A Code of practice for declaring and dealing with conflicts of interests (November 2006)
• Board meeting, item 6, revision to the code of practice (November 2006)

France AFSSAPS

• De nouvelles règles pour la prévention des conflits d'intérêts (13 octobre 2005)
• Tableau de classification des risques de conflits d'intérêts (13 octobre 2005)
• Notice explicative sur la déclaration d'intérêts (13 octobre 2005)
• La télédéclaration des intérêts : mode d'emploi (13 octobre 2005)
• Point VI du Règlement intérieur de la Commission d'autorisation de mise sur le marché
• Formulaire de déclaration publique d'intérêts
• Symposium, Les nouvelles règles sur la transparence
• Afssaps, Les déclarations d’intérêts des membres des conseils, commissions et groupes de travail 2005
• Afssaps, Les déclarations d'intérêts des membres des conseils, commissions et groupes de travail 2004
• De nouveaux outils pour renforcer la politique de l’Afssaps en matière d’expertise externe
• Rapport d'information fait au nom de la commission des Affaires sociales (1) sur les conditions de mise sur le marché et de suivi des médicaments, Par Mmes Marie-Thérèse Hermange et Anne-Marie Payet (2006)
• Rapport d'information fait au nom de la commission des Finances, du contrôle budgétaire et des comptes économiques de la Nation (1) sur le contrôle portant sur l’Agence française de sécurité sanitaire des produits de santé (AFSSAPS)
• Prescrire, Conflits d'intérêts à l'Agence française des produits de santé: il reste beaucoup à faire, 278 p.857-61 (2006)

Various

• France, Rapport d'information fait au nom de la commission des affaires sociales sur les conditions de mise sur le marché et de suivi des médicaments par Hermange et Payer (n° 382)

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Switzerland

Parlement et Conseil fédéral

Interpellations, Motions et Questions

• Interpellation de Andrian Amstutz (06.3041) - Recentrage de Swissmedic sur sa mission principale - Réponse du Conseil fédéral du 9 juin 2006
• Motion de Franziska Teuscher (05.3910)- Swissmedic. Transparence et indépendance (2005) - Avis du Conseil fédéral du 1er mars 2006
• Question de Franziska Teuscher.(05.1200) - Disparition de l'insuline animale sur le marché suisse - Réponse du Conseil fédéral du 1er mars 2006
• Interpellation. de Trix Heberlein (05.3601) - L'Etat entend-il reprendre à son compte la publication des informations relatives aux médicaments? - Réponse du Conseil fédéral du 2 décembre 2005
• Interpellation de Markus Wäfler (05.3571) - Prescription de psychotropes aux enfants et aux adolescents - Réponse du Conseil fédéral du 23 novembre 2005
• Motion de Oskar Freysinger (05.3670) - Diagnostic douteux et prescription aux enfants et adolescents de médicaments psychotropes dangereux - Réponse du Conseil fédéral du 23 novembre 2005
• Communiqué de presse de la Commission de gestion du Conseil des Etat du 11 novembre 2005 - La CdG-E satisfaite de l’évolution de Swissmedic
• Question de Franziska Teuscher (05.1094) - Swissmedic. Garantir l'indépendance du conseil de l'institut - Réponse du Conseil fédéral du 31 août 2005
• Motion de Marianne Kleiner (05.3391) - Produits utilisés en automédication. Simplification de la procédure d'autorisation pour les produits autorisés dans l'UE - Réponse du Conseil fédéral du 31 août 2005
• Question.de Walter Müller (04.1179) - Prescription abusive de Ritaline - Réponse du Conseil fédéral du 27 avril 2005
• Interpellation de Marianne Huguenin (04.3606) - Pommades pour mamelons contenant de la paraffine. Rôle de Swissmedic - Réponse du Conseil fédéral du 10 décembre 2004
• Interpellation.de Hermann Bürgi - Procédure d'autorisation de mise sur le marché applicable aux médicaments - Réponse du Conseil fédéral du 12 mai 2004
• Question de Philipp Stähelin (03.1137) - Médicaments retirés du marché - Réponse du Conseil fédéral du 25 février 2004
• Postulat de Simonetta Sommaruga (03.3402) - Dysfonctionnements dans l'exécution et la régulation dans le domaine des médicaments - Réponse du Conseil fédéral du 10 septembre 2003
• Motion de Pia Hollenstein (03.3365) - Le mercure dans la médecine - Réponse du Conseil fédéral du 3 septembre 2003
• Interpellation de Doris Leuthard (02.3762) - Dysfonctionnements chez Swissmedic? - Réponse du Conseil fédéral du 6 juin 2003
• Motion de Franziska Teuscher (02.3748) - Possibilité de consulter les dossiers relatifs à la procédure d'autorisation de médicaments - Réponse du Conseil fédéral du 26 mars 2003
• Motion de Franziska Teuscher (02.3747) - Interdiction de médicaments aux désignations trompeuses - Réponse du Conseil fédéral du 14 mars 2003
• Interpellation de Tony Bortoluzzi (02.3775) - Protection de la santé des enfants et des adolescents - Réponse du Conseil fédéral du 7 mars 2003
• Question ordinaire de Walter Donzé (02.1084) - Faut-il autoriser la vente libre des compléments alimentaires? - Réponse du Conseil fédéral du 20 septembre 2002
• Interpellation de Rudolf Strahm (02.3336) - Baisse des prix des produits pharmaceutiques - Réponse du Conseil fédéral du 11 septembre 2002
• Question ordinaire de Yves Guisan (02.1079) - Prescription de Ritaline - Réponse du Conseil fédéral du 4 septembre 2002
• Interpellation de Christianne Brunner (02.3243) - Prescription de Ritaline - Réponse du Conseil fédéral du 4 septembre 2002
• Interpellation de Simonetta Sommaruga (02.3168) - L'OICM a-t-il fait l'objet de pressions? - Réponse du Conseil fédéral du 14 juin 2002
• Interpellation.de Jost Gross (02.3151 ) -Médicaments génériques. Pourquoi la procédure d'autorisation de mise sur le marché est-elle si longue? - Réponse du Conseil fédéral du 14 juin 2002
• Interpellation.de Caspar Baader (01.3410) - Equilibrer la composition du conseil de l'Institut suisse des produits thérapeutiques - Réponse du Conseil fédéral du 7 novembre 2001
  

Rapports

• Problèmes lors de la mise en fonction de Swissmedic et Evaluation de la situation actuelle - Rapport de la Commission de gestion du Conseil des Etats du 25 août 2004.
• Réponses du Conseil fédéral du 12 janvier 2000 au rapport de la Commission de gestion du Conseil national, sur les occupations accessoires des fonctionnaires et les activités
• professionnelles d'anciens fonctionnaires, plus particulièrement sous l'angle des conflits d'intérêts.
• Rapport du 12 mars de la Commission de gestion du conseil national sur les occupations accessoires des fonctionnaires, plus particulièrement sous l'angle des conflits d'intérêts .

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Lois et ordonnances

• Articles 6a et 23 de la Loi fédérale sur le personnel de la Confédération (LPers) (RS 172.220.1)
• Article 91 de l'Ordonnance fédérale (OPers)
• Article 11 de l'Ordonnance fédérale du 19 décembre 2003 sur la rémunération et sur d’autres conditions contractuelles convenues avec les cadres du plus haut niveau hiérarchique et les membres des organes dirigeants des entreprises et des établissements de la Confédération (RS 172.220.12)
• Article 10 de la Loi fédérale du 20 décembre 1968 sur la procédure administrative (sur la récusation) (RS 172.021)
• Code de comportement de l’administration générale de la Confédération, du 1er janvier 1999
• Office fédéral du personnel, Lignes directrices relatives aux activités accessoires et aux charges publiques (27 mars 2006)

Swissmedic

• Mandat de prestations 2007-2010
• Précisions apportées par Swissmedic au sujet de l’autorisation de médicaments « connus de longue date » (janvier 2006)
• Rapport annuel 2006
• Rapport annuel 2005
• Rapport annuel 2004
• Rapport annuel 2003
• Rapport annuel 2002

VanTx Affair

• Basler Zeitung, Testpersonen sollen sicherer leben (4 février 2006)
• Swissmedic, Swissmedic a identifié les études VanTx (14 mars 2003)
• Swissmedic, dossier de presse, Focus essais cliniques (10 janvier 2003)
• Alfred Jost, Arrêt du 4 juillet de la IIème cour de droit public du Tribunal fédéral, Freiburger Ethik-Kommission International c. Bâle-Campagne, IDS n°3 (2003) 
• Débat du Conseil national, séance du 13 mars 2000 sur le projet de loi sur les produits thérapeutiques
• VanTx in liquidation

Various

• Jean Martin, La morale du médecin et la promotion pharmaceutique, 87 Bulletin des médecins suisses p.1600 (2006)
• Informations: oui, publireportages: non, 87 Bulletin des médecins suisses p.875 (2006)

International

OECD

• OECD webpage on Recent ethics codes and codes of conduct for public servants
• Conflict-of-interest policies and practices in nine EU Member States: A Comparative Review (December 2006)
• OECD Guidelines for Managing Conflict of Interest in the Public Service, September briefing 2005
• Recommendation of the Council on Guidelines for managing conflict of interest in the public service (2003)
• Managing conflicts of interest (June 2001)

Council of Europe

• Recommendation No. (2000)10 on codes of conduct for public officials (11 May 2000)

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Medical Journals

Classified first by date, and then by journal:
2008- 2007 - 2006 - 2005 - 2004 - 2003 - 2002 - 2001 - 2000
1999 - 1998 - 1997 - 1996 - 1995 - pre-1995

2008

• Nature, Editorial, A precarious position, 7 Nature Drug Discovery p.3 (2008)

2007

• BMJ, Bob Roehr, New US charity to foster drug research sparks fears of undue industry influence, 335 p.1069 (2007)
• BMJ, Linda R. Horton, Food and Drug Administration, Editorial, 334 p.55-56 (2007)
• BMJ, News, Janice Hopkins Tanne, Former FDA commissioner is fined $90 000 for failing to disclose conflicts of interest, 334 p.492 (2007)
• BMJ, News, Janice Hopkins Tanne, FDA proposes higher fees for drug approvals to cover postmarketing surveillance, 334 p.177 (2007)
• Lancet, News, Todd Zwillich, US FDA seeks more pharmaceutical industry cash, 369 p.357 (2007)
• NEJM, Clifford J. Rosen, The Rosiglitazone Story - Lessons from an FDA Advisory Committee Meeting, 357 p.844 (2007)
• NEJM, Jerry Avorn, Keeping Science on Top in Drug Evaluation, 357 p.633 (2007)
• NEJM, Gregory D. Curfman et al., Safer Drugs for the American People, 357 p.602 (2007)
• NEJM, Sean Hennessy & Brian L. Strom, PDUFA Reauthorization - Drug Safety's Golden Moment of Opportunity, 356 p.1703 (2007)
• NEJM, Mark McClellan, Drug Safety Reform at the FDA - Pendulum Swing or Systematic Improvement? 356 p.1700 (2007)
• NEJM, Jerry Avorn, Paying for Drug Approvals - Who's Using Whom? 356 p.1697 (2007)

2006

• Archives of Internal Medicine, Curt D. Furberg et al., The FDA and Drug Safety: A Proposal for Sweeping Changes 166 p.1938-1942 (2006)
• BMJ, News, Annette Tuffs, Germany's drug regulatory body is attacked, 333 p.1087(2006)
• BMJ, News, Janice Hopkins Tanne, Former FDA commissioner pleads guilty to two charges , 333 p.874 (2006)
• BMJ, News, Janice Tanne, New England journal endorses institute’s proposals for FDA, 333 p.772 (2006)
• BMJ, News, Janice Hopkins Tanne, FDA to clarify rules on advisory committee members, 333 p.278 (2006)
• BMJ, News, Jeanne Lenzer, Conflicts of interest are common at FDA, 332 p.991 (2006)
• Center for Public Integrity, Alexander Cohen, FDA Staff Travels on Drug Industry Dollars (2006)
• CMAJ, Wayne Kondro, Conflicts cause FDA to review advisory committees, 175 p.23 (2006)
• JAMA, Brian Strom, How the US drug safety system should be changed, 295 p.2072-2075 (2006)
• JAMA, Mike Mitka, Report Criticizes Lack of FDA Oversight, 296 p.920-922(2006)
• JAMA, Mike Mitka, Strengthening the FDA, 296 p.2194 (2006)
• JAMA, Peter Lurie et al. Financial Conflict of Interest Disclosure and Voting Patterns at Food and Drug Administration Drug Advisory Committee Meetings, 295(16) p.1921 (2006)
• Lancet, Is the FDA going easy on violators? 368 p.92 (2006)
• Lancet, Editorial, Institute of Medicine urges reforms at FDA, 368 Lancet p.1211 (2006)
• NEJM, Wood, A Proposal for Radical Changes in the Drug-Approval Process, 355 p.618-623 (2006)
• NEJM, Wayne A. Ray & C. Michael Stein, Reform of Drug Regulation - Beyond an Independent Drug-Safety Board, 354 p.194-201 (2006)
• NEJM, Avorn & Shrank, Highlights and a Hidden Hazard -The FDA's New Labeling Regulations, 354 p.2409-2411 (2006)
• NEJM, Gregory Curfman et al., Blueprint for a Stronger Food and Drug Administration, 355 p.1821 (2006)
• Prescrire, Conflits d'intérêts à l'agence française des produits thérapeutiques: il reste beaucoup à faire, 26 (278) Revue Prescrire p.857 (2006)
• Prescrire, Conflits d'intérêts sous surveillance, 26 (271) Revue Prescrire p.297-298 (2006)
• Prescrire, Conflits d'intérêts des leaders d'opinion : pas de transparence, 26 (269) p.139 (2006)
• Nancy Thai NGuyen et al., The Decision-Making Process of US Food and Drug Administration Advisory Committees on Switches from Prescription to Over-the-Counter Status: A Comparative Case Study, 28 Clinical Therapeutics p.1231 (2006)

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2005

• BMJ, Patrick C Waller et al., Drug safety and regulation, 331 p.4 (2005)
• BMJ, Jeanne Lenzer, New law aims to distance the FDA from the drug industry, News, 330 p.1106 (2005)
• JAMA, Howard Markel, Why America Needs a Strong FDA, 294 p.2489-2491(2005)
• Hastings Center Report, Lawrence Diller, Fallout of the Pharma Scandals: The Loss of Doctor's Credibility (2005)
• Lancet, Editorial, No place for conflict of interest, 365 p.1664 (2005)
• Lancet, Editorial, What is going on at the FDA? 366 Lancet p.1137 (2005)
• Lancet, Editorial, Safety concerns at the FDA, 365 Lancet p.727-728 (2005)
• NEJM, Steinbrook, Financial Conflicts of Interest and the Food and Drug Administration's Advisory Committees, 353 p.116-118 (2005)
• NEJM, Wood et al., A Sad Day for Science at the FDA, 353 p.1197-1199 (2005)
• NEJM, Wood, Women's Health and the FDA, 353 p.1650-1651 (2005)
• NEJM, Avorn, FDA Standards — Good Enough for Government Work? 353 p.969-972 (2005)
• NEJM, Okie, What Ails the FDA? 352 p.1063-1066 (2005)
• NEJM, Okie, Raising the Safety Bar — The FDA's Coxib Meeting, 352 p.1283-1285 (2005)

2004

• JAMA, Brian Strom, Potential for conflict of interest in the evaluation of suspected adverse drug reactions: a counterpoint, 292 p.2643-2646 (2004)
• Lancet, Richard Horton, Vioxx, the implosion of Merck, and aftershocks at the FDA, 364 Lancet p.1995-1996 (2004)
• Lancet, Editorial, Ejecting the FDA from the courtroom, 364 Lancet p.638 (2004)
• Lancet, News, Alicia Ault, FDA follows NIH in review of staff consulting activities, 363 Lancet p.1779 (2004)
• Lancet, News, Hannah Brown, Staffing levels, not industry, dictate FDA review times, 363 Lancet p.48 (2004)
  

2003

• Lancet, Derrick A Bennett & Andrew Jull, FDA: untapped source of unpublished trials, 361 Lancet p.1402-1403 (2003)
  

2002

• Lancet, Howard Mann, Clinical trial protocols: agreements between the FDA and industrial sponsors, 360 Lancet p.1345-1346 (2002)
• Lancet, Editorial, New leadership for the FDA, 360 Lancet p.1183 (2002)
• Lancet, Haroon Ashraf, US drug industry and FDA prepare for closer ties, 359 Lancet p.1923 (2002)

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2001

2000

1999

1998

• NEJM, Alastair J.J. Wood & Raymond Woosley, Making Medicines Safer — The Need for an Independent Drug Safety Board, 339 p.1851 (December 17, 1998)

1997

1996

1995

Pre-1995

• BMJ, Hemminki E. Study of information submitted by drug companies to licensing authorities, 280 p.833-6 (1980)

Other articles

• Merrill Goozner, Conflicts of interest in the drug industry's relationship with the government, 35 Hostra Law Review p.737 (Winter 2006) )
•  

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Specific Drugs

Information under this subheading may also appear on this site's "promotion page"

Avandia (rosiglitazone)

• BMJ, News, Bob Burton, Diabetes expert accuses drug company of "intimidation", 335 p.1113 (2007)
• FDA, Information for Healthcare professionals (August 14, 2007)
• FDA, News, Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk (August 14, 2007)
• Public Citizen, Diabetes Drug Avandia Should Be Removed From the Market, Public Citizen Tells FDA Advisory Committee(July 30, 2007)
• Public Citizen, Testimony Before the FDA Advisory Committee Meeting on Rosiglitazone (July 30, 2007)
• Public Citizen, Letter Demonstrating that the FDA Knew About Avandia Dangers, Urging Action (May 22, 2007)
• Public Citizen, Evidence Confirms Public Citizen’s Warnings About the Risks of Popular Diabetes Drug Avandia (May 21, 2007)
• FDA, News, FDA Issues Safety Altert on Avandia (May 2007)
• FDA, Transcript of FDA Press Conference on Avandia Advisory Committee Meeting (July 27, 2007)
• NEJM, Steve Nissen et al., Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes, 356 p.2456 (June 14, 2007)
• FDA Label
• Regulatory History
• David Willman, The Rise and Fall of the Killer Drug Rezulin, Los Angeles Times (June 4, 2000)

EPO (2007)

• NEJM, Robert Steinbrook, Erythropoietin, the FDA, and Oncology, 356 p.2448 (2007)
• NEJM, Fadlo R. Khuri, Weighing the Hazards of Erythropoiesis Stimulation in Patients with Cancer, 356 p.2445 (2007)
• Bayer, Press release, Current Trasylol® (aprotinin injection) News (October 2, 2006)

Ketek (2006-2007)

• NEJM, David B. Roth, The FDA and the case of Ketek, 356 p. 1601 (2007)

• NEJM, Janice Soreth et al., Ketek - The FDA Perspective 356 p.1675 (2007)
• Ketek access page at the FDA - Label - Q&A - 
• FDA, FDA Completes Safety Assessment of Ketek, New Safety Information to be Added to Product Labeling (2006/2007)

Plan B (2006-2005)

• FDA, Q & A on Plan B
• FDA, Docket 2006P-0223 on Plan B
• GAO, Decision Process to Deny Initial Application for Over-the-Counter Marketing of the Emergency Contraceptive Drug Plan B Was Unusual (November 2005)
• FDA, Transcript of December 16, 2003, meeting of the nonprescription drugs advisory committee
• Plan B Timeline
• BMJ, Janice Hopkins Tanne, FDA finally approves Plan B—but with restrictions, 333 p.461 (2006)
• BMJ, Janice Hopkins Tanne, FDA appointment is stalled as revelations emerge over Plan B, 333 p.317 (2006)
• JAMA, Brian Vastag, Plan B for "Plan B"?: FDA Denies OTC Sales of Emergency Contraceptive, 291 p.2805-2806 (2004)
• Hastings Center Report, Frank Davidoff, Sex, Politics, and Morality at the FDA: Reflections on the Plan B Decision, p.15 (2006)
• Lancet, Editorial, Politics trumps science at the FDA, 366 Lancet p.1827 (2005)

SSRIs (antidepressants) - go to the promotion page

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Coxibs: Vioxx (withdrawn in September 2004)

• Center for Science in the Public Interest, Conflicts of Interest on COX-2 Panel (February 25, 2005)
• FDA, Graham, Risk of acute myocardial infarction and sudden cardiac death in patients treated with COX-2 selective and non-selective NSAIDs (September 30, 2004)
• US, Senate, Committee on Finance, Hearings on Vioxx (November 18, 2004)
• FDA, Statement of Sandra Kweder, before Committee on Finance, United States Senate, November 18, 2004
• TMT Review of COX-2 Committee Voting (2005)
• CSPI's Integrity in Science Project, Conflicts of Interest on COX-2 Panel
• AHRP, FDA says it Screened Panelists for Conflicts of Interest (March 2005)

Journal articles

• Annals of Internal Medicine, Levesque et al., The Risk for Myocardial Infarction with Cyclooxygenase-2 Inhibitors: A Population Study of Elderly Adults (2005)
• Annals of Internal Medicine, Finckh & Aronson, Cardiovascular Risks of Cyclooxygenase-2 Inhibitors: Where We Stand Now, 142 p.212-214 (2005)
• Archives of Internal Medicine, Shaya et al., Selective Cyclooxygenase-2 Inhibition and Cardiovascular Effects: An Observational Study of a Medicaid Population, 165:181-186 (2005)
• Archives of Internal Medicine, Dai et al., National Trends in Cyclooxygenase-2 Inhibitor Use Since Market Release: Nonselective Diffusion of a Selectively Cost-effective Innovation, 165:171-177 (2005)
• Archives of Internal Medicine, Solomon & Avorn, Coxibs, Science, and the Public Trust, 165 p.158-160 (2005)
• BMJ, News, Bob Burton, Australian drugs regulator cancels registration of COX 2 inhibitor, 335 p.363 (2007)
• BMJ, News, Janice Hopkins Tanne, Merck appeals rofecoxib verdict, 334 p.607 (2007)
• BMJ, Janice Hopkins Tanne, NEJM editor gives pretrial evidence in Vioxx case, 332 p.255 (2006)
• BMJ, Janice Hopkins Tanne, NEJM stands by its criticism of Vioxx study, 332 p.505 (2006)
• BMJ, Janice Hopkins Tanne, Journal criticises Vioxx study for omitting three heart attacks, 331 p.1423 (2005)
• BMJ, Dieppe et al., Lessons from the withdrawal of rofecoxib, 329 p.867-868 (2004)
• JAMA, B. Psaty & R. Kronmal, Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment, 299 p.1813 (2008)
• JAMA; Graham, COX-2 Inhibitors, Other NSAIDs, and Cardiovascular Risk: The Seduction of Common Sense, 296 p.1653-1656 (2006)
• JAMA, Zhang et al., Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials, 296 p.1619-1632 (2006)
• JAMA, Topol, Arthritis Medicines and Cardiovascular Events--"House of Coxibs", 293 p.366-368 (2005)
• JAMA, Debabrata Mukherjee et al., Risk of cardiovascular events associated with selective COX-2 inhibitors, 286 p.954-959 (2001)
• JME, James & Cleland, Applying a research ethics committee approach to a medical practice controversy: the case of the selective COX-2 inhibitor rofecoxib, 30 p.182-184 (2004)
• Lancet, Zwillich, How Vioxx is changing US drug regulation, 366 (9499) p.1763-1764 (2005)
• Lancet, D. Graham et al., Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study, 365 (9458) p.475-481 (2005)
• Lancet, Jüni et al., Discontinuation of Vioxx, 365(9453) p.26-27 (2005)
• Lancet, P. Jüni et al., Risk of cardiovascular events and rofecoxib: cumulative meta-analysis, 364 (9450) p. 2021-2029 (2004)
• Lancet, Horton, Vioxx, the implosion of Merck, and aftershocks at the FDA, 364 (9450) p.1995-1996 (2004)
• Lancet, Vioxx: an unequal partnership between safety and efficacy, 364 (9442) p. 1287-1288 (2004)
• Lancet, News, Alicia Ault, First COX-2 inhibitor clears initial FDA hurdle, 352 p.1912 (1998)
• NEJM, David J. Kerr, Rofecoxib and Cardiovascular Adverse Events in Adjuvant Treatment of Colorectoral Cancer, 357 p.360 (2007)
• NEJM, Gregory D. Curfman et al., Expression of Concern Reaffirmed, 354 p.1193 (2006)
• NEJM, Bombardier et al., Response to Expression of Concern Regarding VIGOR Study, 354:1196-1199 (2006)
• NEJM, Gregory Curfman et al., Expression of concern: Bombardier et al., 343 p.2813 (2005)
• NEJM, Bruce M. Psaty & Curt D. Furberg, COX-2 Inhibitors — Lessons in Drug Safety, 352 p.1133-1135 (2005)
• NEJM, Drazen, COX-2 Inhibitors - A Lesson in Unexpected Problems, 352 p.1131-1132 (2005)
• NEJM, Nussmeier et al., Complications of the COX-2 Inhibitors Parecoxib and Valdecoxib after Cardiac Surgery 352 p.1081-1091 (2005)
• NEJM, Solomon et al., Cardiovascular Risk Associated with Celecoxib in a Clinical Trial for Colorectal Adenoma Prevention, 352 p.1071-1080 (2005)
• NEJM, Kim et al., Rofecoxib, Merck, and the FDA, 351 p.2875-2878 (2004)
• NEJM, Topol, Failing the Public Health -- Rofecoxib, Merck, and the FDA, 351 p.1707-1709 (2004)
• NEJM, Claire Bombardier et al., Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis, 343 p.1520-1528 (2000)

Court cases

• Web site for the multidistrict product liability litigation in the Merck/Vioxx case, U.S. District Court for the Eastern District of Louisiana, Judge Eldon E. Fallon
• Official Vioxx settlement website
• Vioxx settlement agreement dated November 9, 2007
• Merck press release of November 9, 2007, announcing the settlement and including links to the settlement documents
   
• In re Vioxx Products Liability Litigation, U.S. District Court for the Eastern District of Louisiana, August 14, 2007 (Lexis 60299) (on attorney-client privilege during discovery)
• In re Vioxx Litig., 928 A.2d 935 (Sup. Ct. N.J., July 31, 2007) (rejecting for forum non conveniens the action initiated in New Jersey by UK patients)
• In re Merck Securities Derivative & ERISA Litig., 493 F.3d 393 (3rd Cir. July 18, 2007)
• In re Vioxx Products Liability Litigation, U.S. District Court for the Eastern District of Louisiana, July 3, 2007 (Lexis 48367) (denying Merck's motion for summary judgment and rejecting Merck's argument of implied preemption)
• In re Vioxx Products Liability Litigation, 478 F. Supp. 2d 897 (E.D.La., March 22, 2007) (denying Merck's motions for summary judgment based on statutes of limitations)
• In re Vioxx Products Liability Litigation, 239 F.R.D. 450 (E.D.La. 2006) (on substantive law issues)
• In re Vioxx Products Liability Litigation, 448 F. Supp.2d 741(E.D.La. 2006) (on substantive law issues)
• In re Vioxx Prod. Liab. Litig., (Lexis 63430) (E.D.La., August 30, 2006) (rejecting for forum non conveniens the action initiated in Louisiana by French and Italian patients)
• In re Vioxx Products Liability Litigation, (Lexis 27587) (5th Cir. May 25, 2006)
• In re Merck & Co, Inc., (Lexis 27861) (D.N.J. May 5, 2006)
• In re Vioxx Products Liability Litigation, 360 F.Supp. 2d 1352 (2005) 

Case law on FDA preemption

• In re Vioxx Products Liability Litigation, U.S. District Court for the Eastern District of Louisiana, July 3, 2007 (Lexis 48367) (rejecting Merck's argument of implied preemption)
• In re Zyprexa Prods. Liab. Litig (E.D.N.Y. 2007)
• Sykes v. GSK, 484 F. Supp. 2d 289 (E.D.Pa. 2007)
• In re Vioxx Litig, (N.J. Sup.Ct. 2007)
• In re Bextra & Celebrex Mktg. Sales Practices & Prod. LIab. Litig. (N.D.Cal. 2006)
• Colacicco v. Apotex, 432 F.Supp. 2d 514 (E.D.Pa. 2006)
• Levine v. Wyeth, (Vt. 2006)
• Weiss v. Fujiwasa Pharm. Co., 464 F.Supp. 2d 666 (E.D.ky. 2006)
• Perry v. Novartis Pharma Corp., 456 F. Supp.2d 678 (E.D.Pa. 2006)
• McNellis v. Pfizer, (D.N.J. 2005)
• Medtronic V. Lohr, 518 U.S. 470 (1996)
• Abbott v. Am. Canamid Co., 844 F.2d 1108 (4th Cir. 1988)
• Hurley v. Lederle Labs, 863 F.2d 1173 (5th Cir. 1988)

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Cerivastatin - Lipobay / Bayer (2002-2001)

• BMJ, Charles Marwick, Bayer is forced to release documents over withdrawal of cerivastatin, 326 p.518 (2003)
• BMJ, Fiona Fleck, Bayer faces Swiss criminal probe over cerivastatin, News, 324:130 (2002)
• BMJ, Annette Tuffs, Bayer faces shake up after Lipobay withdrawn, News, 323 p.828 (2001)
• BMJ, Annette Tuffs, Bayer faces potential fine over cholesterol lowering drug, News, 323 p.415 (2001)
• BMJ, Fred Charatan, Bayer decides to withdraw cholesterol lowering drug, News, 323 p.359 (2001)

Hormone Replacement Therapy

• Lyytinen et al. Breast cancer risk in postmenopausal women using estrogen-only therapy, 108 Obstetrics and Gynecology p.1354-60 (2006)
• BMJ, Nathan J Coombs et al., Hormone replacement therapy and breast cancer: estimate of risk, 331 p.347 (2005)
• BMJ, Fay Crawford & Peter Langhorne, Time to review all the evidence for hormone replacement therapy, 330 p.345 (2005)
• BMJ, Philip Bath & Laura Gray, Association between hormone replacement therapy and subsequent stroke: a meta-analysis, 330 p.342 (2005)
• BMJ, Cosetta Minelli et al., Benefits and harms associated with hormone replacement therapy: clinical decision analysis, 328 p.371 (2004)
• BMJ, Klim McPherson, Where are we now with hormone replacement therapy?, 328 p.357 (2004)
• BMJ, Frances Griffiths, Taking hormone replacement therapy, 327 p.820 (2003)
• BMJ, E Løkkegaard et al., Relation between hormone replacement therapy and ischaemic heart disease in women: prospective observational study, 326 p.426 (2003)
• BMJ, News, Ray Moynihan, Drug company [Wyeth] secretly briefed medical societies on HRT, 326 p.1161 (2003)
• BMJ, Janice Rymer et al., Making decisions about hormone replacement therapy, 326 p.322 (2003)
• BMJ, Karl Michaëlsson et al., Hormone replacement therapy and risk of hip fracture: population based case-control study 316 p.1858 (1998)
• BMJ, Susanne Pérez Gutthann et al., Hormone replacement therapy and risk of venous thromboembolism: population based case-control study, 314 p.796 (1997)
• BMJ, W F M Potshuma et al., Cardioprotective effect of hormone replacement therapy in postmenopausal women: is the evidence biased? 308 p.1268 (1994)
• JAMA, Majumdar et al., Promotion and Prescribing of Hormone Therapy After Report of Harm by the Women's Health Initiative 292 p.1983-1988 (2004)
• JAMA, Writing Group for the Women's Health Initiative Investigators, Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women, Principal Results From the Women's Health Initiative Randomized Controlled Trial, 288 p.321-333 (2002)
• JAMA, Suzanne W. Fletcher & Graham A. Colditz, Failure of Estrogen Plus Progestin Therapy for Prevention, 288 p.366-368 (2002)

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Salmeterol - GSK

• Lancet, Peter Lurie & Sidney M Wolfe, Misleading data analyses in salmeterol (SMART) study, 366 p.1262 (2005)
• FDA, Labeling Changes for Drug Products that Contain Salmeterol, FDA Talk Paper (2003)
• GSK, Dear Healthcare Professionnal Letter (2003)

Protropin / Genentech (1999)

• FDA, Tamar Nordenberg, Investigators' Reports, Maker of Growth Hormone Feels Long Arm of Law (1999)

Seldane (terfenadine)  / Hoechst Marion Roussel (1998)

• FDA, Seldane and generic terfenadine withdrawn from market (February 27, 1998)
• FDA, FDA proposes to Withdraw Seldane Approval, (January 13, 1997)
• FDA press release (July 7, 1992)

Lotronex

• Lancet, News, Michael McCarthy, FDA recommends bringing controversial IBS drug back, 359 p.1491-1492 (2002)
• Lancet, Richard Horton, Lotronex and the FDA: a fatal erosion of integrity, 357 p.1544-1545 (2001)

Fen-Phen and other appetite suppressant drugs

• NEJM, Alexander Fleming, Editorial, The FDA, Regulation, and the Risk of Stroke, 343 p.1886 (2000)
• NEJM, Kernan, Phenylpropanolamine and the risk of hemorrhagic stroke, 343 p.1826-1832 (2000)
• NEJM, Heidi M. Connolly et al., Valvular Heart Disease Associated with Fenfluramine–Phentermine, 337 p.581-588 (1997)
• NEJM, Abenhaim et al., Appetite-suppressant drugs and the risk of primary pulmonary hypertension, 335 p.609-616 (1996)

Rezulin (troglitazone) / Warner Lambert / Glaxo Wellcome
(withdrawn in 1997 in Europe, in 2000 in the U.S.)

• Edwin Cole, Troglitazone: the lesson that nobody learned, 49 Diabetologia 1-6 (2006)
• Website accompanying Cole's article: www.troglitazone-story.net
• JAMA, David Graham et al., Liver Enzyme Monitoring in Patients Treated With Troglitazone, 286 p.831-833 (2001)
• FDA, Withdrawal of Troglitazone and Cisapride, 283 JAMA p. 2228 (2000)
• Public Citizen, Statement before the Food and Drug Administration Endocrine and Metabolic Drugs Advisory Committee meeting advising them to withdraw troglitazone from the U.S. Market  (March 26, 1999)
• Parke Davis, Dear Healthcare Professional letter (1999)
• ParkeDavis, Dear Healthcare Professional letter (July 28, 1998)
• Public Citizen, Petition to the Food and Drug Administration to ban troglitazone/Rezulin due to its causing several cases of liver failure (July 27, 1998)
• ParkeDavis, Dear Healthcare Professional letter (December 1, 1997)
• Dear Healthcare Professional letter (October 28, 1997)

Natrecor (nesiritide) / Scios - Johnson & Johnson

• JAMA, Paul J. Hauptman et al., Use of Nesiritide Before and After Publications Suggesting Drug-Related Risks in Patients With Acute Decompensated Heart Failure, 296 p.1877 (2006)
• Dear Healthcare Provider letter from Scios (July 13, 2005)

Rituxan (rituximab) / Genentech - Biogen - Roche

• FDA, Information page on rituximab
• FDA, 2006P-0089: Stay Approval of all Supplements to Biologics Licenses Issued to Genentech (BLA# 103705 ) and Biogen (BLA# 103737) for Rituxan (Rituximab)
• Andrew Pollack, Rheumatoid Arthritis Drug Is Approved, New York Times (March 11, 2006)
• Peter Loftus, Former worker sues Genentech over drug marketing, Dow Jones Newswires (January 11, 2006)
• United States of America ex rel. Paul P. McDermott v. Genentech (U.S. District Court for the District of Maine, Dec. 2006) xxx

Propulsid (cisapride) / Janssen

• MDL- 1355 Propulsid product liability litigation
• FDA, Janssen Pharmaceutica Stops Marketing Cisapride in the US (March 23, 2000)
• FDA, DDMAC; letter to Janssen (June 1998)

Trasylol (aprotinin) / Bayer

• Bayer, Bayer Issues Additional Guidance to Physicians on Trasylol®  (October 25, 2007)
• Bayer, FDA Advisory Committees Recommend Continued US Marketing Authorization for Trasylol(September 12, 2007)
• Bayer, Bayer Reports Findings of Trasylol Independent Investigation (August 16, 2007)
• Report on Trasylol for Bayer by Zuckerman Spaeder LLP (August 2007)
• Bayer Reports Findings of Trasylol Independent Investigation (August 16, 2007)
• Bayer, Press release, Bayer Appoints Independent Investigator to Review Trasylol® Study Issues (October 13, 2006)
• Bayer, Press release, Current Trasylol® (aprotinin injection) News (October 2, 2006)
• Bayer, Press release, Bayer Acknowledges That New Trasylol Study Was Not Disclosed Prior to Recent FDA Cardio-Renal Advisory Committee Meeting (September 29, 2006)
• FDA, FDA Statement Regarding New Trasylol Data (September 29, 2006)
• Trasylol FDA label

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Historical perspectives

Laetrile

• NEJM, A clinical trial of amygdalin (Laetrile) in the treatment of human cancer, 306 p.201-206 (1982)
• Lancet, News, Sarah Ramsay, FDA cracks down on laetrile online, 356 p.1011 (2000)
• CA Cancer J Clin, Unproven methods of cancer management. Laetrile, 41 p.187-92 (1991)
• S L Nightingale, Laetrile: the regulatory challenge of an unproven remedy, 99 Public Health Reports p.333 (1984)
• Benjamin Wilson, La montée en flèche et le déclin du Laetrile / The Rise and Fall of Laetrile
• NCI page on Laetrile
• MedlinePlus on bitter almond
• FDA, Lengthy Jail Sentence for Vendor of Laetrile—A Quack Medication to Treat Cancer Patients (June 22, 2004)
• DOJ, FDA, President of Queens Firm Found Guilty of Criminal Contempt For Violating Court Order Not to Market Bogus Cancer Cure Over the Internet (July 22, 2003)
• FDA, Carol Lewis, Online Laetrile Vendor Ordered to Shut Down (2001)
• FDA, Christian Brothers Corp. signs consent decree, (November 17, 2000)
• FDA, FDA Takes Action Against Firms Marketing Unapproved Drugs, (September 6, 2000)
• FDA, Warning Letter (April 21, 1999)
• FDA, Warning Letter (November 13, 1998)
• FDA, Warning Letter (October 28, 1998)
• FDA, Postscript on Laetrile (June 18, 1987)
• FDA, Oral History Program, Interview with Alexander M. Schmidt / Interview with William W. Goodrich
  

DES (Diethylstilbestrol)

• Lancet, Ellen F. M 't Hoen & MN Graham Dukes, Compensation for diethylstilbestrol injury, 369 p.173-174 (2007)
• Annals, Ruthann M. Giusti et al., Diethylstilbestrol Revisited: A Review of the Long-Term Health Effects, 122 p.778-788 (1995)
• Marieke Veurink et al., The History of DES, Lessons to be Learned, Pharm World Sci (2005) 27: 139–143
• Dolores Ibarreta & Shanna H. Swan, The DES story: long-term consequences of prenatal exposure

MER-29

• Paul D. Rheingold, MER/29 Story - An Instance of Successful Mass Disaster Litigation

Dalkon Shield

• CDC, Elevated Risk of Pelvic Inflammatory Disease Among Women Using the Dalkon Shield
• CDC, Current Trends IUD Safety: Report of an Nationwide Physician Survey
• CMAJ, Rioux et al., Long-term study of the safety of the Dalkon Shield and Gyne-T 200 intrauterine devices. 134 p.747 (1986)
• BMJ, Snowden & Pearson, Pelvic infection: a comparison of the Dalkon shield and three other intrauterine devices, 288 p.1570 (1984)
• Elizabeth Gibson, Judicial Management of Mass Tort Bankruptcy Cases  (2005)
• Elizabeth Gibson, Case Studies of Mass Tort Limited Fund Class Action Settlements & Bankruptcy Reorganizations (2000)