Drug Promotion
&
Conflict of Interest

Introduction

This page covers conflicts of interest that occur once a drug is approved and placed on the market.
It focuses mainly on conflicts pertaining to promotional schemes, from classic drug advertising to the launch of purely promotional studies, including the sponsoring of scientific meetings, the distribution of samples, the financing of patient organizations. These conflicts mainly originate with the pharmaceutical industry. They mostly affect physicians and patients.

Other issues included on this page are lobbying, off-label use, reimbursement (false claims). Issues regarding whistleblowing appear on this page when they originate from a company and on the Transparency page when they originate from a public administration.

Information about conflicts of interest before a drug is approved is found on the Research webpage. 

Conflicts of interest arising as the marketing authorization is been requested and processed are reviewed on the Drug Approval webpage.

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United States

Statutes |FDA (guidance - warning letters - reports) | Court Cases | GAO | OIG | FTC | DOJ | State attorneys | Self-regulation

Statutes

• Medicare Anti-Kickback Statute - 42 U.S.C. §1320a–7b. Criminal penalties for acts involving Federal health care programs
• False Claims Act ("Qui Tam") (FCA), 31 U.S.C. § 3729-3733
• Whistleblower Protection Act of 1989, 5 U.S.C. 1211
• Food and Drug Administration Modernization Act (FDAMA), 21 U.S.C. 353(c). 
• Prescription Drug Marketing Act of 1987
• Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 117 Stat. 2066
• 21 CFR 99 - Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
• 21 CFR 200 - General (Secs. 5, 7, & 200)
• 21 CFR 201 - Labeling (Secs. 10, 100, & 200) 
• 21 CFR 202 - Prescription Drug Advertising
• State of Vermont. Title 33, human services, chapter 19, medical assistance, 33 VSA 2005: pharmaceutical marketers, (2006)
• State of Minnesota. chapter 151, pharmacy, 151.461 gifts to practitioners prohibited, (2006)

FDA (guidance - warning letters - reports)

Guidance

• Guidance for Industry, Accelerated Approval Products: Submission of Promotional Materials - Draft (1999)
• Guidance for Industry, Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements - Draft - Labeling Example - Labeling Example; Consumer-Friendly Version
• Guidance for Industry, Consumer-Directed Broadcast Advertisements - Questions and Answers (1999)
• Guidance for Industry, Consumer-Directed Broadcast Advertising of Restricted Devices - Draft (2004)
• Guidance for Industry, "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms - Draft (2004)
• Guidance for Industry, Industry-Supported Scientific and Educational Activities (1997)
• Guidance for Industry, Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling - Draft (1999)
• Guidance for Industry, Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Management Companies (PBMs) - Draft (1997)

Warning letters and Untitled letters

N.B. FDA DDMAC warning letters and untitled letters are available from the FDA web site, classified by date starting with year 2006 at http://www.fda.gov/cder/warn/warn2006.htm.

Below, you will find the direct link to the relevant letter (clicking on the name of the company at issue) and, in some cases, to the disputed promotional material (clicking on the name of the product at issue).

• Allergan (Acular) (May 25, 2007)
• Enzon (Abelcet) (May 21, 2007)
• KV Pharmaceutical (Clindessé) (May 17, 2007)
• GSK (Flonase) (May 7, 2007)
• Schering (Nasonex) (May 7, 2007)
• Alcon (Ciprodex) (April 20, 2007)
• Dusa (Levulan) (April 20, 2007)
• Takeda (Rozerem) (March 5, 2007)
• Cephalon (Provigil) (February 27, 2007)
• MGI (Gliadel) (January 29, 2007)
• Daiichi (Evoxac) (January 12, 2007)
• Wellspring (Dyrenium) (December 2006)
• AstraZeneca (Seroquel) (November 16, 2006)
• Ligand (Ontac) (October 23, 2006)
• BioMarin (Orapred) (October 11, 2006)
• Alcon (Nevanac) (October 10, 2006)
• Dava VoSpire (September 21, 2006)
• Reliant (Rythmol) (September 14, 2006)
• Astellas (Prograf) (August 31, 2006)
• Lilly (Alimta) (July 27, 2006)
• GSK (Zovirax) (June 30, 2006)
• PrimaPharm (Hydase) (June 29, 2006)
• Sandoz (Bupropion) (May 26, 2006)
• Boehringer Ingelheim (Spiriva) (May 25, 2006)
• Bioniche Pharma (Sotradecol) (April 4, 2006)
• Intermune (Infergen) (March 28, 2006)
• Mayne Pharma (M.V.I.-12) (February 2, 2006)
• Sankyo (Benicar) (January 6, 2006)
• Duramed (Cenestin) (January 1, 2006)
• Medicis (Loprox) (January 4, 2006)
• Biogen (Zevalin) (December 15, 2005)
• Ista (Vitrase) (November 2, 2005)
• Critical Therapeutics (Zyflo) (November 8, 2005)
• Nephrx (Calcitriol) (September 29, 2005)
• Alcon (Travatan) (September 22, 2005)
• Eli Lilly (Cymbalta) (September 9, 2005)
• Allergan (Lumigan) (September 6, 2005)
• SuperGen (Nipent) (August 18, 2005)
• Actelion (Tracleer) (July 20, 2005)
• Pfizer (Zyvox).(July 20, 2005)
• Cytogen (Quadramet) (July 18, 2005)
• Hoffman-La Roche (Fuzeon) (July 15, 2005)
• Abbott (Survanta) (July 15, 2005)
• Endo (Lidoderm) (6/28/2005)
• Dutch Ophthalmic (VisionBlue) (June 28, 2005)
• Eli Lilly (Strattera 1 & 2 ) (June 14, 2005)
• Pfizer (Zoloft) (May 6, 2005)
• Watson (Ferrlecit) (May 5, 2005)
• Alcon Laboratories (Cipro HC Otic) (April 27, 2005)
• Bayer (Levitra) (April 13, 2005)
• United Therapeutics (Remodulin) (April 13, 2005)
• Pfizer (Zyrtec) (April 4, 2005) 
• Boehringer Ingelheim (Aggrenox) (March 22, 2005)
• AstraZeneca (Crestor) (March 8, 2005)
• Presutti Laboratories (Tindamax) (March 3, 2005)
• Amgen (Enbrel) (February 18, 2005)
• Centocor (Remicade) (February 11, 2005)
• GSK (Coreg) (January 31, 2005)
• Pfizer (Celebrex & Bextra) (January 20, 2005)
• AstraZeneca (Crestor) (December 21, 2004) 
• Schering (Foradil) (December 9, 2004)
• Barr (Seasonale) (December 29, 2004)
• Boehringer Ingelheim (Micardis) (November 24, 2004)
• Pfizer (Viagra) (November 10, 2004)
• Bradley (Pamine) (November 9, 2004)
• Mallinckrodt (Tramadol) (November 1, 2004)
• Abbott (Kaletra) (October 29, 2004)
• Boehringer Ingelheim (Atrovent) (September 23, 2004)
• Boehringer Ingelheim (Viramine) (September 22, 2004)
• Alza (Viadur) (September 21, 2004)
• Ortho-McNeil (Topamax) (September 14, 2004)
• Janssen (Duragesic) (September 3, 2004)
• Cubist (Cubicin) (August 17, 2004)
• Abbott (Norvir) (July 10, 2004)
• GSK (Paxil) (July 2004)
• Vivus (Muse) (May 25, 2004)
• Fujiwasa (Prograf) (May 7, 2004)
• Pfizer (Zyrtec) (April 22, 2004)
• Novartis (Diovan) (April 21, 2004)
• Janssen (Risperdal) (April 19, 2004)
• Wyeth (Effexor) (March 18, 2004)
• Corixa (Bexxar) (March 16, 2004)
• Aventis (Allegra) (December 30, 2003) 
• Xcel (Migranal) (December 19, 2003)
• Organon (Follistim) (December 12, 2003)
• Pfizer (Camptosar) (November 17, 2003)
• Aventis (Taxotere) (December 11, 2003)
• MedImmune (Ethyol) (October 28, 2003)
• Pfizer (Covera) (October 24, 2003)
• AstraZeneca (Merrem) (October 3, 2003)
• Guildford (Gliadel) (September 29, 2003)
• Genentech (Nutropin) (August 25, 2003)
• Novartis (Lamisil) (August 22, 2003)
• Galderma (Splage) (August 19, 2003)
• BMS (Pravachol) (August 7, 2003)
• Gilead (Viread) (July 29, 2003)
• Alcon (Cipro) (July 18, 2003)
• Berlex (Yasmin) (July 10, 2003)
• Novartis (Zelnorm) (June 27, 2003)
• GSK (Flonase) (July 19, 2003)
• King and Spaulding (Amnesteem) (June 18, 2003)
• Novartis (Zaditor) (June 18, 2003)
• Roche (Xeloda) (May 29, 2003)
• Santen (Quixin) (February 20, 2003)
• Purdue (OxyContin) (January 17, 2003)
• Berlex (Climara) (January 6, 2003)
• Aventis (Taxotere) (December 15, 2002) 
• Johnson & Johnson (Retin-A) (December 3, 2002)
• Novartis (Transderm Scop) (December 3, 2002)
• Janssen (Reminyl) (November 20, 2002)
• Women's Capital Corp. (Plan B) (November 19, 2002)
• Xanodyne (Methotrexate) (November 14, 2002)
• Takeda (Actos) (November 7, 2002)
• Wyeth (Suprax) (November 5, 2002)
• Actelion (Tracleer) (October 30, 2002)
• Boehringer Ingelheim (Mobic) (October 24, 2002)
• Forest (Celexa) (September 13, 2002)
• Pfizer (Geodon) (September 3, 2002)
• Biovail (Cedax) (August 22, 2002)
• Pfizer (Lipitor) (August 12, 2002)
• Elan (Zanaflex) (August 5, 2002)
• TAP (Prevacid) (August 2, 2002)
• Roche (Accutane) (July 25, 2002)
• Pfizer (Neurontin) (July 1, 2002)
• Roche (Tamiflu) (May 16, 2002)
• GSK (Imitrex) (May 13, 2002)
• Pfizer (Zyrtec) (April 30, 2002)
• Gilead (Viread) (March 14, 2002)
• Pharmacia & Upjohn (Xalatan) (January 16, 2002)
• Elan (Zanaflex) (January 16, 2002)
• Roche (Xeloda) (January 9, 2002)
• Lilly ICOS (IC351) (January 3, 2002)
• Cephalon (Provigil) (January 3, 2002)
• ICN (Efudex) (December 18, 2001) 
• Pharmacia (Genotropin) (December 13, 2001)
• AstraZeneca (Nolvadex) (December 10, 2001)
• BMS (Pravachol) (December 3, 2001)
• Connectics (Luxiq) (November 15, 2001)
• Berlex (Magnevist) (November 20, 2001)
• Fujiwasa (Protopic) (November 14, 2001)
• Berlex (Quadramet) (November 9, 2001)
• Omni Nutraceuticals (Inholtra) (October 12, 2001)
• B.F. Archer (Melagesic) (October 12, 2001)
• Procter & Gamble (Actonel) (October 9, 2001)
• AstraZeneca (Zomig) (October 9, 2001)
• Novartis (Comtan) (October 3, 2001)
• Galderma (Differin) (October 1, 2001)
• Merck (Vioxx) (September 17, 2001)
• Novartis (Transderm) (August 31, 2001)
• GelTex (Renagel) (August 17, 2001)
• Connectics (Luxiq) (August 13, 2001)
• Roche (Tasmar) (August 2, 2001)
• SkyePharma (DepoCyt) (July 26, 2001)
• BMS (UFT) (July 20, 2001)
• Merck (Cancidas) (July 19, 2001)
• GSK (Avendia) (July 17, 2001)
• Genzyme (Cerezyme) (July 13, 2001)
• Kos (Nisaspan) (July 13, 2001)
• Alza (Ditropan) (July 12, 2001)
• Pfizer (Lipitor) (July 12, 2001)
• AstraZeneca (Arimidex) (July 9, 2001)
• Pharmacyclics (Xcytrin) (July 3, 2001)
• Bayer (Avelox) (June 29, 2001)
• Pfizer (Neurontin) (June 29, 2001)
• GSK (Avandia) (June 28, 2001)
• Alza (Doxil) (June 28, 2001)
• Berlex (Fludara) (June 28, 2001)
• GSK (Navelbine) (June 28, 2001)
• Schering (Temodar) (June 28, 2001)
• Janssen (Sporanox) (June 27, 2001)
• PharmaMar (Ecteinasicidim) (June 25, 2001)
• Aventis (Lovenox) (June 25, 2001)
• Merck (Fosamax) (June 20, 2001)
• Allergan (Lumigan) (June 8, 2001)
• Sanofi-Synthelabo (Plavix) (June 8, 2001)
• Bayer (Vardenafil) (June 6, 2001)
• Maxim (Ceplene) (May 31, 2001)
• Supergen (Nipent) (May 10, 2001)
• Sanofi-Synthelabo (Plavix) (May 9, 2001)
• Shire (ProAmatine) (May 7, 2001)
• Novo Nordisk (Prandin) (May 1, 1001)
• Pfizer (Erostrep) (April 16, 2001)
• Aventis (Nilandron) (April 10, 2001)
• Novartis (Miacalcin) (April 2, 2001)
• Roche (Xenical) (March 30, 2001)
• Braintree (Miralax) (March 29, 2001)
• BMS (Pravachol) (March 29, 2001)
• Baxter (Brevibloc) (March 26, 2001)
• Allergan (Lumigan) (March 26, 2001)
• Praceis (Plenaxis) (March 26, 2001)
• Lifecycle Ventures (Ceftin) (March 16, 2001)
• BMS (Ifex) (March 13, 2001)
• Aventis (Amaryil) (March 8, 2001)
• Alcon (Patanol) (March 6, 2001)
• Fujiwasa (Protopic) (February 16, 2001)
• OraPharma (Minocycline) (February 13, 2001)
• Novartis (Femara) (February 2, 2001)
• Pharmacia (Celebrex) (February 2, 2001)
• Pharmacia (Celebrex) (February 1, 2001)
• Abbott (Mivacron) (January 17, 2001)
• Bracco (MultiHance) (January 9, 2001)
• AstraZeneca (Prilosec) (January 3, 2001)
• Maxim (Histamine) (December 27, 2000) 
• Forest (Levothroid) (December 27, 2000)
• Schering (Nasonex) (December 8, 2000)
• Pharmacia (Detrol) (December 7, 2000)
• Wyeth (Protonix) (November 28, 2000)
• Cubist (Daptomycin) (November 22, 2000)
• American Regent Lab. (Venofer) (November 21, 2000)
• SmithKline Beecham (Argatroban) (November 20, 2000)
• Lilly (Sarafem) (November 16, 2000)
• Alza (Ditropan) (November 16, 2000)
• BMS (Vaniqa) (November 15, 2000)
• Searle (Celebrex) (November 14, 2000)
• Shire (Adderall) (November 9, 2000)
• Pfizer (Zithromax) (November 9, 2000)
• Watson (Norco) (October 23, 2000)
• SmithKline Beecham (Avandia) (October 20, 2000)
• Collagenex (Periostat) (October 17, 2000)
• Johnson & Johnson (Renova) (October 13, 2000)
• Wyeth (Effexor) (October 11, 2000)
• Allergan (Alphagan) (September 22, 2000)
• Lilly (Evista) (September 14, 2000)
• Ciba Vision (Rescula) (September 8, 2000)
• King (Altace) (September 7, 2000)
• Synsorb (Synsorb) (September 5, 2000)
• AstraZeneca (Diprivan) (September 1, 2000)
• Searle (Ambien) (August 24, 2000)
• Schering (Claritin) (August 18, 2000)
• Shire (Fareston) (August 7, 2000)
• Genentech (Nutropin) (July 28, 2000)
• Allergan (Azelex) (July 24, 2000)
• DuPont (Innohep) (July 20, 2000)
• AstraZeneca (Nolvadex) (July 20, 2000)
• Dupont (Sustiva) (July 18, 2000)
• Hemispherx (Ampligen) (July 7, 2000)
• Jerome Stevens (Thryox) (July 3, 2000)
• Block drug Company (Atridox) (June 29, 2000)
• Roche (Rocephin) (June 28, 2000)
• Ligand (Targretin) (June 28, 2000)
• Boehringer Ingelheim (Viramune) (June 27, 2000)
• Bausch & Lomb (Alrex) (June 27, 2000)
• Sanofi-Synthelabo (Eloxatin) (June 22, 2000)
• Aventis (Allegra) (June 14, 2000)
• Alcon (Ciloxan) (June 12, 2000)
• SmithKline Beecham (Famvir) (June 9, 2000)
• Alza (Doxil) (June 7, 2000)
• Alza (Ditropan) (June 1, 2000)
• AstraZeneca (Accolate) (May 26, 2000)
• Schering (Claritin) (May 26, 2000)
• Purdue (OxyContin) (May 11, 2000)
• Glaxo (Flovent) (May 9, 2000)
• Novartis (Neoral) (May 8, 2000)
• Lilly (IND promotion) (May 4, 2000)
• Glaxo (Lotronex) (April 28, 2000)
• Celgene (Thalomid) (April 21, 2000)
• Roche (Tamiflu) (April 14, 2000)
• TAP (Uprima) (April 12, 2000)
• BMS (Tequin) ( April 10, 2000)
• Searle (Celebrex) (April 6, 2000)
• Organon (Remeron) (April 6, 2000)
• Allergan (Alocril) (April 4, 2000)
• Janssen (Duragesic) (March 30, 2000)
• Sepracor (Xopenex) (March 23, 2000)
• BMS (Avapro - Glucophage - Taxol) (March 16, 2000)
• TAP (Prevacid) (March 15, 2000)
• Schering (Claritin) (March 14, 2000)
• Glaxo (Relenza) (March 13, 2000)
• Glaxo (Flonase) (March 10, 2000)
• Ozelle (Anvirzel) (March 7, 2000)
• Medicis (Loprox) (March 7, 2000)
• Novartis (Neoral) (March 7, 2000)
• Elan (Corlopam) (February 15, 2000)
• AstraZeneca (Prilosec) (February 4, 2000)
• Pfizer (Viagra) (February 2, 2000)
• Knoll (Synthroid) (January 28, 2000)
• Wyeth (Sonata) (January 27, 2000)
• Sigma-Tau (Camitor) (January 24, 2000)
• Jones Pharma (Levoxyl) (January 21, 2000)
• Year 1999: http://www.fda.gov/cder/warn/warn1999.htm
• Year 1998: http://www.fda.gov/cder/warn/warn1998.htm
• Year 1997: http://www.fda.gov/cder/warn/warn1997.htm

FDA Sanctions

• Louisiana Ophthalmologist Fined $1.1 Million by FDA for Clinical Study Violations, (November 5, 2003)
• Schering Plough Signs Consent Decree with FDA, Agrees to Pay $500 million (May 17, 2002)
• Tamar, Nordenberg, Maker of Growth Hormone Feels Long Arm of Law, FDA Consumer magazine (1999)

FDA reports 

• CDER, DDMAC, Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs — Summary of FDA Survey Research Results, Final Report (November 19, 2004)
• Office of Medical Policy, Division of Drug Marketing, Advertising, and Communications. Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs: Preliminary Survey Results
• FDA, DDMAC, FAQs
• FDA, DDMAC, Research page with survey results

Court Cases

• State of West Virginia ex rel. Johnson & Johnson Corp., Supreme Court of Appeals of West Virginia, (June 27, 2007) (learned intermediary doctrine rejected because of direct-to-consumer advertising)
• Warner-Lambert v. Apotex, 316 F. 3d 1348 (Jan.16, 2003) (off-label use of Neurontin/gabapentin, off-label use, patent infringement in ANDA)
• United States ex. rel. Franklin v. Parke-David (Neurontin)
• United States ex rel. Paul McDermott v. Genentech (Rituxan) (off-label promotion / false claims)
• U.S. v. National Treasury Union, 115 S. Ct. 1003, 1018 (1995)

GAO

• Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising (GAO-07-54) (November 2006)
• Information on False Claims Act Litigation (GAO-06-320R) (January 2006)
• FDA Oversight of Direct-to-Consumer Advertising Has Limitations (GAO-03-177) (October 2002)

OIG (guidance, safe harbors, advisory opinions)

OIG Guidance

• Corporate Responsibility and Health Care Quality: A Resource for Health Care Boards of Directors (2007) - and press release
• Publication of OIG’s Guidelines for Evaluating State False Claims Acts, 71 Fed. Reg 48552 (August 21, 2006)
• Notice, OIG Compliance Program Guidance for Pharmaceutical Manufacturers, Notice, 68 Fed. Reg. 23731 (May 5, 2003)
• See also, OIG Draft Compliance program guidance, 67 Fed. Reg. 62057 (October 3, 2002)
• See also, OIG Solicitation Notice, 66 Fed. Reg. 31246 (June 11, 2001)
• OIG, 62 Fed. Reg. 67393 (December 24, 1997)
• OIG, 1994 Special Fraud Alert, 59 Fed. Reg. 65372 (December 19, 1994)

OIG Safe harbors

• 42 C.F.R. 10001.952
• Proposed Rule: Safe Harbor for Certain Electronic Prescribing Arrangements Under the Anti-Kickback Statute (2005)
• Proposed Rule: Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute (2002)
• Proposed Rule: Safe Harbor Under the Anti-Kickback Statute for the Waiver of Medicare SELECT Beneficiary Coinsurance and Deductible Amounts (67 FR 60202) (2002)
• Solicitation of New Safe Harbors under the Federal Anti-Kickback Statute and Special Fraud Alerts (1999)
• Final Rule: Federal Health Care Programs, Fraud and Abuse, Statutory Exception to the Anti-Kickback Statute for Shared Risk Arrangements (1999)
• Final Rule: Clarification of the Initial OIG Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions under the Anti-Kickback Statute (1999)
• Fact Sheet: Federal Anti-kickback Law and Regulatory Safe Harbors (1999) - Press Release: Inspector General Announces Eight New Anti-kickback Statute Safe Harbors
• Final Rule: Safe Harbors for Protecting Health Plans (61 FR 2122) : Revised final rule addressing the three managed care safe harbors originally promulgated in the 11/05/92 interim final rule. Revised final rule addressing the three managed care safe harbors originally promulgated in the 11/05/92 interim final rule. (1996)
• Safe Harbor Anti-Kickback Provisions (59 FR 37202) : Proposed clarifications to the original safe harbor provisions published on 07/29/91. (1994)
• Proposed Rule: Additional Safe Harbors Provisions Under the Anti-Kickback Statute (58 FR 49008): Proposed rule designed to incorporate seven additional safe harbor provisions.(1993)
• Interim Final Rule: Safe Harbor for Protecting Health Plans (57 FR 52723): Sets forth three new safe harbors addressing managed care plans through interim final rulemaking.(1992)
• Final Rule: OIG Anti-Kickback Provisions (56 FR 35952): Final rulemaking promulgating the 10 original safe harbor provisions.(1991)
• Proposed Rule: OIG Anti-Kickback Provisions (54 FR 3088): Proposed original 10 safe harbor provisions.(1989)

OIG Advisory opinions

• OIG Advisory Opinion No. 06-14 (September 2006)
• OIG Advisory Opinion No.06-09 (August 2006)
• OIG Advisory Opinion No. 06-03 (April 2006)
• OIG Advisory Opinion No. 04-15 (November 2004)
• OIG Advisory Opinion No. 04-03 (June 2004)
• OIG Advisory Opinion No . 03-3 (February 2003)
• OIG Advisory Opinion No. 02-13 (October 2002)
• Prescription Drug Promotion Involving Payments and Gifts: Physicians' Perspectives
• Promotion of Prescription Drugs through Payments and Gifts (1990)

OIG reports and speeches

• Testimony of Lewis Morris, chief counsel to the OIG, on allegations of waste, fraud and abuse in pharmaceutical pricing (February 9, 2007)
• Special Advisory Bulletin, Offering Gifts and Other Inducements to Beneficiaries (August 2002)
• OIG, Report, Prescription Drug Promotion Involving Payments and Gifts, Physicians' Perspectives, OIE-01-90-00481(1992)
• OIG, Report, Prescription Drug Promotion Involving Payments and Gifts, OIE-01-90-00480 (1991)

FTC

• R. Dennis Murphy, Consumer Perceptions of Qualified Health Claims in Advertising (July 2005)
• Comments of the FTC before the Food and Drug Administration: In the Matter of Request for Comments on Consumer-Directed Promotion (December 2003)
• Comments of FTC before the Food and Drug Administration In the Matter of Request for Comments on Agency Draft Guidance Documents Regarding Consumer-Directed Promotion (May 2004)
• Comments of the FTC on the Survey regarding the Assessment of Physician and Patient Attitudes Toward Direct-to-Consumer (DTC) Promotion Drugs (September 24, 2001)
• Comments of the FTC on First Amendment Issues (September 13, 2002)

DOJ 

• Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks (February 7, 2008)
• Merck Settles Clean Water Act Violations at its Montgomery County, Pennsylvania Pharmaceutical Plant(December 13, 2007)
• BMS to pay more than $515 million to resolve allegations of illegal drug marketing and pricing (Sept.28, 2007)
• Aventis pays more than $190 million to settle drug pricing fraud matters (September 10, 2007)
• Medicis Pharmaceutical to Pay U.S. $9.8 million to Resolve False Claims Allegations, (May 8, 2007)
• United States joins suit against pharmaceutical manufacturer Boehringer Ingelheim Roxane, Inc. (January 19, 2007)
• InterMune to pay nearly $37 million for unlawful marketing of Actimmune (October 26, 2006)
• U.S. announces $155 million settlement of Medco False Claims case (October 23, 2006)
• Serono to pay $704 million for the illegal marketing of AIDS drug (October 17, 2005)
• GlaxoSmithKilne Pays $150 million to settle drug pricing fraud case, (September 20, 2005)
• Schering-Plough to pay $345 million to resolve criminal and civil liabilities for illegal marketing of Claritin (July 30, 2004)
• Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion (Neurontin) (May 13, 2004)
• Tap Pharmaceutical Products Inc. and seven others charges with health care crimes; company agrees to pay $875 million to settle charges (October 3, 2001)
• Guidance on the Use of the False Claims Act in Civil Health Care Matters (1998)
• False Claims Act Cases: Government Intervention in Qui Tam (Whistleblower) Suits

State Attorneys 

• State of Washington, Washington to Receive Share of $19.5 Million Settlement with OxyContin Maker (May 8, 2007)
• State of Arizona, Terry Goddard Announces $19.5 Million Settlement Over OxyContin (May 8, 2007)
• State of Illinois, Attorney General Madigan Reaches Agreement with Pharmaceutical Company over its Promotion of Pain Reliever OxyContin (May 8, 2007)
• Office of the Attorrney General of the State of Arizona, $70 million Settlement with GlaxoSmithKline (August 10, 2006)
• Office of the Attorney General of the State of California, Lockyer Sues 39 Major Drug Companies for Inflating Prices, Bilking California Taxpayers (August 25, 2005)
• Pharmaceutical Marketing Disclosures: Report of Vermont Attorney General William H. Sorrell (May 10, 2005)
• Office of New York State Attorney General, Press release, Settlement Sets New Standard for Release of Drug Information, Glaxo to Establish "Clinical Trials Register" with Information on All Company Drugs (August 26, 2004) - Consent Order - Assurance of Discontinuance
• Office of New York State Attorney General, Press release, Major Pharmaceutical Firm Concealed Drug Information, GlaxoSmithKline Misled Doctors About the Safety of Drug Used to Treat Depression in Children (June 2, 2004) - Complaint
• Pharmaceutical Marketing Disclosures: Report of Vermont Attorney General William H. Sorrell (February 25, 2004)
• Office of New York State Attorney General, Press release, Ads for Leading Antibiotic Found to be Misleading, Pfizer Pays $6 Million To Settle Case and Fund Public Service Announcements (January 6, 2003)
• Complaint of The People of the State of New York, by Eliot Spitzer, Attorney General versus Pharmacia Corp.(February 13, 2002)
• Office of New York State Attorney General, Press release, Spitzer Reaches Settlement with Thyroid Drug Maker, Multi-State Agreement Means $2 Million For New York (July 29, 1999)
• Amended Complaint, State of West Virginia, ex. rel. McGraw, Attorney General versus Purdue Pharma (Oxycontin)

Self-regulation 

• PhRMA Guiding Principles Direct to Consumer Advertisements About Prescription Medicines (November 2005)
• PhRMA, Code on Interactions with Health Care Professionals
• PhRMA, PhRMA Statement on Direct-to-Consumer Advertising (July 20, 2006)
• PhRMA, Members Named to PhRMA’S DTC Guiding Principles Review Panel (April 26, 2006)
• PhRMA, America’s Pharmaceutical Industry Announces Guidelines on Direct-to-Consumer Advertising (August 2, 2005)
• PhRMA, PhRMA Chief Medical Officer Testifies on DTC Advertising (September 29, 2005)
• PhRMA, PhRMA Adopts New Marketing Code (April 19, 2002)
• AMA, Press release, AMA calls for temporary moratorium on direct-to-consumer advertising of new prescription drugs (June 2006)
• AMA, E-5.015 Direct-to-Consumer Advertisements of Prescription Drugs
• AMA, E-8.03 Conflicts of Interest: Guidelines
• AMA, E-8.06 Prescribing and Dispensing Drugs and Devices
• AMA, E-8.061 Gifts to Physicians from Industry
• ACCME Standards for Commercial Support: Standards to Ensure the Independence of CME Activities ("SCS") (2004 updated)
• ACCME, Standards for commercial support of continuing medical education
• ACCME, Preamble to the 2004 Updated ACCME Standards for Commercial Support
• ACCME, FAQs, Standards for Commercial Support, 1: Independence
• ACCME, FAQs, Standards for Commercial Support, 2: Resolution of Personal Conflicts of Interest
• ACCME, FAQs, Standards for Commercial Support, 3: Appropriate Use of Commercial Support
• ACCME, FAQs, Standards for Commercial Support, 4: Appropriate Management of Associated Commercial Promotion
• ACCME, FAQs, Standards for Commercial Support, 5: Content and Format Without Commercial Bias
• ACCME, FAQs, Standards for Commercial Support, 6: Disclosures Relevant to Potential Commercial Bias
• ACEP (American College of Emergency Physicians), Gifts to Emergency Physicians from the Biomedical Industry (June 2002)
• ACEP, Gifts to Emergency Physicians from the Biomedical Industry, Policy Resource and Education Paper (April 2005)
• ACGME (Accreditation Council for Graduate Medical Education), Principles to Guide the Relationship between Graduate Medical Education and Industry (September 2002)

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European Union

Statutes | UK MHRA | Self-regulation | UK ABPI

Statutes

Title VIII and VIIIa of the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC.

UK MHRA

• Blue Guide: Advertising and Promotion of Medicines in the UK.
• Memorandum of understanding between MHRA, PMCPA and ABPI
• Guidance Note 26: Disease awareness campaigns guidelines
• Medicines Advisory Liaison Group (MALG) minutes (24 January 2006)
• Medicines Advisory Liaison Group (MALG) minutes (21 July 2005)
• Medicines Advisory Liaison Group (MALG) minutes (21 January 2005)
• MAIL 152
• Advertising complaint form
• Advertising complaints investigations
• Guidance on the review of advertising by the Independent Review Panel
• Announcing the availability of a new medicinal product – MAIL 151 (September/October 2005)
• Advertising: Presentation of clinical data – MAIL 148 (March/April 2005)
• The new Blue Guide: advertising and promotion of medicines in the UK – MAIL 148 (March/April 2005)
• Advertising: Naming of competitor company in outcome reports of complaints investigated - MAIL 146 (November/December 2004)
• Advertising: corrective statements - MAIL 146 (November/December 2004)
• How we investigate complaints – MAIL 145 (September /October 2004)
• Advertising to the public: Linked medicines - MAIL 144 (July/August 2004)
• Scientific Advice Meetings - MAIL 144 (July/August 2004)
• Advertising medicines: Prescribing information - MAIL 143 (May/June 2004)
• Advertising medicines: As safe as placebo? - MAIL 142 (March /April 2004)
• Advertising: multi-buy offers - MAIL 142 (March/April 2004)
• "Fast-acting" and “24 hour” relief claims - MAIL 141 (January /February 2004)
• Advertising: Reports of completed investigations to be published – MAIL 140 (November/December 2003)
• Advertising: The work of the unit - MAIL 130 March/April 2002
• The Report of the Independant Review Panel for Advertising 2004
• Most recent investigated complaints

Self-regulation

• EFPIA, updated code of ethics (October 2007)
• Information on Prescription-only Medicines for Patients and the Public: EFPIA Principles and Guidance Notes (November 2005)
• EFPIA, Joint Declaration of CPME and EFPIA on the Cooperation between the Medical Profession and the Pharmaceutical Industry (June 2005)
• EFPIA, European Code of Practice for the Promotion of Medicines (Adopted by EFPIA - November 2004) - (254KB)
• EFPIA Code of Practice for the Promotion of Medicines - Q&A with respect to articles 9 & 10 (March 2006)
• Guidelines for Internet Web Sites Available to Health Professionals, Patients and the Public in the EU (October 2001)
• Former European Code of Practice for the Promotion of Medicines (Adopted by EFPIA - 1993) - (50KB)
• ABPI, Code of Practice for the Pharmaceutical Industry (UK)
• ABPI, Code of Practice Authority - Reviews each year from 2001 in February, May, August and November (for example May 2006)
• ABPI, NHS and Pharmaceutical Industry Working Together For Patients 2005
• Pharma.be, Code de Déontologie (Belgium)
• National Code of Practice for the Marketing of Medicinal Products(Finland)
• Charte de la Visite Médicale (in French only) (France)
  Référentiel des Bonnes Pratiques de la Visite Médicale des Entreprises du Médicament (in French only)
• Code of Practice of the German Pharmaceutical Industry(Germany)
• Code of Practice on the Promotion of Prescription only Medicinal Products(Greece)
• Code of Pharmaceutical Practice for the Pharmaceutical Industry (Ireland)
• Code of Professional Conduct (Italy)
• Rules Governing Drug Information (Norway)
• Code Pharmaceutical Ethics(Poland)
• Code of Ethics for the Pharmaceutical Industry's Promotional Practices(Portugal)
• Code of Practice for Advising, Introducing and Informing on Prescription Medicines(Slovenia)
• Code of Practice for the Promotion Medicines(Spain)
• Rules Governing Drug Information(Sweden) - Agreement on forms of cooperation between pharmaceutical companies and medical professionals in the public healthcare sector - Comments to the Agreement (in Swedish only)
• Code of Conduct for Pharmaceutical Advertising(The Netherlands)
• Code of Conduct(Slovakia)
• Code of Ethical Promotion Practices for Medicinal Products (Turkey)

UK ABPI Code of Practice Authority

• May 2007 review
• February 2007 review - cover letter
• November 2006 review - cover letter
• August 2006 review - cover letter
• May 2006 review - cover letter
• February 2006 review - cover letter
• November 2005 review - cover letter
• August 2005 review - cover letter
• May 2005 review - cover letter
• February 2005 review - cover letter
• November 2004 review - cover letter
• August 2004 review - cover letter
• May 2004 review - cover letter
• February 2004 review - cover letter
• November 2003 review - cover letter
• August 2003 review - cover letter
• May 2003 review - cover letter
• February 2003 review - cover letter
• November 2002 review - cover letter
• August 2002 review - cover letter
• May 2002 review - cover letter
• February 2002 review - cover letter

Various

• France, Chapitre II.A. du 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

Swissmedic | OFAS | OFCOM |Parlement | Tribunaux | Auto-réglementation

Swissmedic

• Publicité pour les médicaments sur internet – Exigences définies par Swissmedic; règles applicables à partir du 1er janvier 2007, Journal 8/2006
• « La publicité pour les médicaments sur Internet » : questions posées lors de la séance d’information (novembre / décembre 2006)
• L’admissibilité des rabais dans le cadre de l’article 33 alinéa 3, lettre b de la Loi sur les produits thérapeutiques (6 décembre 2003) et Journal Swissmedic 11/2003, p.985
• Art. 33 LPTh: disposition sur la publicité - et en même temps une norme "anti-corruption"? (24 janvier 2006)
• Swissmedic lutte contre le commerce illégal et contre les infractions aux dispositions sur la publicité (24 janvier 2006)
• Zum Verbot des Versprechens und Annehmens geldwerter Vorteile gemäss Artikel 33 des Heilmittelgesetzes insb. in Zusammenhang mit der Unterstützung der Weiter- und Fortbildung von Medizinalpersonen durch die Pharmaindustrie, Journal Swissmedic 1/2006, p.20
• Swissmedic, Vente de médicaments par Internet (22 juillet 2004)

OFAS

• Recommandation concernant la promesse, l’acceptation et l’offre d’avantages matériels liés à des médicaments ; obligation de répercuter les avantages (21 décembre 2001)
• Recommandation portant sur les avantages matériels dans le domaine de la formation post­gra­duée et continue (20 janvier 2002)
• Recommandation concernant la répercussion des rabais obtenus dans le domaine hospitalier lors de l’achat de médicaments prêts à l’emploi (15 mars 2002)
• Recommandation concernant la répercussion des avantages obtenus dans le secteur ambulatoire lors de l’achat de médicaments prêts à l’emploi (11 juillet 2002)

OFCOM

• Site de l'OFCOM concernant la publicité et le parrainage
• Directives en matière de parrainage (avril 2007 - juin 1999)
• Révision de l'ordonnance sur la radio et la télévision (ORTV), Rapport sur les résultats de la consultation (October 24, 2006), p.9
• Décision OFCOM v. Presse TV AG (TV advertising for medical products) (9 septembre 2005)
• Circulaire concernant la publicité et le sponsoring (mai 2002)
• Available decisions of the OFCOM

Parlement

• Rapport de la Commission de la sécurité sociale et de la santé publique du 11 novembre 2005 sur les initiatives déposées par les cantons de Genève et du Valais
• Motion du Groupe démocrate-chrétien (05.3016) - Gagner de l'argent sur le dos de l'assurance obligatoire en consommant des médicaments? - Réponse du Conseil fédéral du 25 mai 2005
• Question de Alain Berset (04.1132) - Réponse du Conseil fédéral du 22 décembre 2004
• Problèmes lors de la mise en fonction de Swissmedic et évaluation de la situation actuelle, Rapport de la Commission de gestion du Conseil des Etats du 25 août 2004
• Question ordinaire urgente de Odilo Schmid (03.1101) - Les modèles publicitaires poussant à la consommation de médicaments sont-ils admissibles - Réponse du Conseil fédérale du 26 septembre 2003
• Postulat Paul Günter (02.3657)- Révision d'urgence de l'article 33 LPTh - Réponse du Conseil fédéral du 25 juin 2003
• Proposition genevoise de résolution du 4 février 2003 demandant la modification de l'article 33 de la loi fédérale sur les médicaments et les dispositifs médicaux (initiative cantonale)
• Interpellation de Cécile Bühlmann (02.3572) - Corruption du corps médical - Réponse du Conseil fédéral du 9 décembre 2002
• Postulat Meinrado Robbiani (02.3237) - Rabais sur les médicaments achetés par les hôpitaux - Réponse du Conseil fédéral du 11 septembre 2002
• Question de Hans Rudolf (02.5218) du 2 décembre 2002- Loi sur les produits thérapeutiques.Violations des dispositions de la section 5 - Réponse du Conseil fédéral
• Interpellation de Liliane Maury Pasquier (02.3139) - Des bénéfices supplémentaires pour l'industrie pharmaceutique? - Réponse du Conseil fédéral du 14 juin 2002

Conseil fédéral

• Message concernant la Convention des Nations Unies contre la corruption du 21 septembre 2007 (07.078) (FF 2007 p.6931) + Convention des Nations Unies contre la corruption

Tribunaux

• Arrêt du Tribunal fédéral dans l'affaire Schering (9 mai 2007) (2A.20/2007)
• Arrêt du Tribunal fédéral dans l'affaire Pfizer (10 août 2006) (2A.63/2006)
• Arrêt du Tribunal fédéral dans l'affaire Zambon (23 juin 2006) (2A.607/2005)
• Arrêt du Tribunal fédéral dans l'affaire Zur Rose (16 novembre 2006) (2P.32/2006)
• Arrêt du Tribunal administratif genevois (9 mai 2006) dans la cause Zur Rose

Auto-réglementation

• Ligue suisse contre le rhumatisme, Directives en matière de sponsoring (novembre 2006)
• SGCI Chemie Pharma Schweiz, ASSGP,  Intergenerika, Interpharma, vips, Code de bonnes pratiques de l’industrie pharmaceutique en Suisse (Code pharmaceutique) du 4 décembre 2003
• Rapport annuel 2005
• N° 3 (début mai 2005) : Choix de la procédure en cas de violation du Code pharmaceutique par un concurrent
• N° 5 (mi-avril 2005) : Référence aux essais cliniques, à la littérature médi-cale ou à d’autres données dans la publicité pour les médicaments destinée aux professionnels
• N° 4 (mi-avril 2005) : Séparation des textes rédactionnels et de la publicité dans les médias destinés aux professionnels
• Rapport annuel 2004
• N° 3 (septembre 2004) : Comparaisons dans la publicité destinée aux professionnels
• N° 2 (août 2004) : Preuves des affirmations de la publicité pour les médicaments destinée aux professionnels
• N° 1 (août 2004) : Champ d’application géographique du Code pharmaceutique
• N° 2 (mai 2004) : Différencier clairement les médicaments des produits alimentaires dans la publicité pour les médicaments destinée aux professionnels
• N° 1 (février 2004) : Manifestations pour la formation postgraduée et continue

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International

WHO

• Pauline Norris et al., Drug promotion - what we know, what we have yet to learn, Reviews of materials in the WHO/HAI database on drug promotion (2005)
• Criteria for Medicinal Drug Promotion (1988)

WMA

• Statement concerning the relationship between physicians and commercial enterprises(initiated March 2002, approved 2004)

IFPMA

• IFPMA Code of Pharmaceutical Marketing Practices (2006 revision)
• IFPMA Code of Pharmaceutical Marketing Practices (2000)
• See also: Medicines Australia. Code of Conduct. Edition 14. Canberra: Medicines Australia (2003): 

OECD

• Anti-corruption instruments and the OECD guidelines for multinational enterprises (2003)
• Business Approaches to Combating Corrupt Practices (2003)
• The OECD Guidelines for multinational enterprises: text, commentary and clarifications (2001)
• Codes of conduct - Exploring their economic significance (2001)
• Corporate Responsibility: Results of a fact-finding mission on private initiatives (2001)
• Making Codes of Corporate Conduct Work: Management Control Systems and Corporate Responsibility (2001)
• The OECD Guidelines for Multinational Enterprises (revision 2000)
• The OECD Guidelines for Multinational Enterprises: Decision of the Council (2000)
• Codes of corporate conduct - an expanded review of their contents (2000)
• Codes of corporate conduct: an inventory (1999)
• Kathryn Gordon and Maiko Miyake, Deciphering Codes of Corporate Conduct: A Review of their Contents (2000)

Others

• The Ottawa Statement on Trial Registration - home page
• Principles for international registration of protocol information and results from human trials of health-related interventions
• Principles of operationalisation for international trial registration

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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

• AMNews, Ethics forum, Tell patients about gifts? Or just say no? (January 7, 2007)
• BMJ, News, R. Watson, EC proposals fail to distinguish between information and advertising, 336 p.792 (2008)
• BMJ, T. Richards, Purely medicinal? 336 p.693 (2008)
• BMJ, Editorial, Fiona Godlee, Doctors and the drug industry, 336 (2008)
• BMJ, News, Annabel Ferriman, Royal college sets up working party to improve relations between doctors and drug industry, 336 p.24 (2008)
• BMJ, Jeanne Lenzer & Schannon Brownlee, Doctor takes "march of shame" to atone for drug company payments, 336 p.20-21 (2008)
• JAMA, B. Psaty & W. Ray, FDA Guidance on Off-Label Promotion and the State of the Literature From Sponsors, 299 p.1949 (2008)
• JAMA, News, Mike Mitka, Critics Say FDA's Off-Label Guidance Allows Marketing Disguised as Science, 299 p.1759 (2008)
• Nature, Editorial, Turning a blind eye, 14 p.1 (2008)
• NEJM, R. Stafford, Regulating Off-Label Drug Use - Rethinking the Role of the FDA, 358 p.1427 (2008)

2007

• Annals, Jeremy A. Greene, Pharmaceutical Marketing Research and the Prescribing Physician, 146 p.742 (2007)
• Annals of Family Medicine, Dominick L. Frosch, Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising, 5 p.6 (2007)
• Annals, David Grande, Prescriber Profiling: Time to Call It Quits, 146 p.751 (2007)
• AMNews, Kevin O'Reilly, Legislation targets drugmaker gifts, incentives to physicians (November 19, 2007)
• AMNews, Bill would make drug firms disclose gifts to doctors (October 1, 2007)
• BMJ, Observations, Goldacre, Journalists: anything to declare? 335 p.480 (2007)
• BMJ, Richard Smith, Should medical journals carry drug advertising? Yes, 335 p.74 (2007)
• BMJ, Gareth Williams, Should medical journals carry drug advertising? No, 335 p.75 (2007)
• BMJ, News, Janice Hopkins Tanne, FDA may allow drug and device companies to promote "off-label" uses, 335 p.1129 (2007)
• BMJ, News, Anna Sayburn, Drug companies expected to get more leeway in communicating with patients in Europe,  335 p.1128 (2007)
• BMJ, Janice Hopkins Tanne, US makers of joint replacements are fined for paying surgeons to use their devices, 335 p.1065 (2007)
• BMJ, News, Bob Burton, Drug industry loses bid to block disclosure of doctors' gifts, 335 p.12 (2007)
• BMJ, News, Janice Hopkins Tanne, US campaign aims to end industry gifts, speaking fees, and travel for doctors, 334 p.385 (2007)
• BMJ, Alastair Kent, Should patient groups accept money from drug companies? Yes, 334 p.934 (2007)
• BMJ, Barbara Mintzes, Should patient groups accept money from drug companies? No, 334 p.935 (2007)
• BMJ, Fred Charatan, Drug makers end free lunches, News, 334 p.64-65 (2007)
• JAMA, J. Ross et al., Pharmaceutical Company Payments to Physicians, Early Experiences With Disclosure Laws in Vermont and Minnesota, 297 p.1216 (2007)
• JME, Sharrel L. Pinto et al., Physicians' intent to comply with the AMA's guidelines on gifts from the pharmaceutical industry, 33 p.313 (2007)
• Lancet, Editorial, Democrats on drugs, 369 p.79 (2007)
• NEJM, Eric G. Campbell, Doctors and Drug Companies, Scrutinizing Influential Relationships, 357 p.1796 (2007)
• NEJM, Julie M. Donohue et al., A Decade of Direct-to-Consumer Advertising of Prescription Drugs,357 p.673 (2007)
• NEJM, Robert Steinbrook, Election 2008 - Campaign Contributions, Lobbying and the U.S. Health Sector, 357 p.736
• NEJM, Miriam Shuchman, Drug Risks and Free Speech - Can Congress Ban Consumer Ads?, 356 p.2236 (2007)
• NEJM, Eric Campbell et al., A National Survey of Physician - Industry Relationships, 356 p.1742 (2007)
• NEJM, Robert Steinbrook, Guidance for Guidelines, 356 p.331 (2007)
• PLOS, Adriane Fugh-Berman & Shahram Ahari, Following the Script: How Drug Reps Make Friends and Infl uence Doctors, 4 p.e150 (2007)
• PLOS, Michael A. Steinman et al., Characteristics and Impact of Drug Detailing for Gabapentin, 4 p.e134 (2007)

2006

• Archives, Steven D. Pearson et al., A Trial of Disclosing Physicians' Financial Incentives to Patients, 166 p.623  (2006)
• Annals, M. Steinman et all, Narrative Review: The Promotion of Gabapentin: An analysis of Internal Industry Documents, 145 p.284 (2006)
• BMC Public Health, Douglas E Ball et al., Advertising and disclosure of funding on patient organisation websites: a cross-sectional survey, (2006)
• BMC Family Practice, Roberto Cardarelli†et al., A cross-sectional evidence-based review of pharmaceutical promotional marketing brochures and their underlying studies: Is what they tell us important and true? 7:13 (2006)
• BMJ, Nina Vinther Andersen, Dispute over conflicts of interests leads to changes for medical society, 333 p.1240 (2006)
• BMJ, News, Annette Tuffs, Sponsorship of patients' groups by drug companies, 333 p.1238 (2006)
• BMJ, News, Bob Burton, [Australian] Regulator finds advertising of complementary product "misleading", 333 p.1141 (2006)
• BMJ, News, Janice Hopkins Tanne, US television science news is sometimes public relations in disguise, 333 p.1089 (2006)
• BMJ, News, Rory Watson, Cancer group denies company funding will influence its agenda, 333 p.874 (2006)
• BMJ, News, Owen Dyer, Industry group suspends drug company for breaching code, 333 p.717 (2006)
• BMJ, News, Andrew Jack, Drug companies' lobbying of ministers has little effect on NICE, 333 p.719 (2006)
• BMJ,Steve Hickey, Censorship of medical journals, 333 p.45 (2006)
• BMJ, Joel Lexchin & Donald W Light, Commercial bias in medical journals, Commercial influence and the content of medical journals, 332 p.1444-1447 (2006)
• BMJ, News, Michael Day, Industry association suspends drug company for entertaining doctors, 332 p.381 (2006)
• JAMA, B. M. Psaty and D. Rennie, Clinical Trial Investigators and Their Prescribing Patterns: Another Dimension to the Relationship Between Physician Investigators and the Pharmaceutical Industry,  295(23) p.2787 (June 21, 2006)
• JAMA, Troyen A. Brennan et al., Health Industry Practices That Create Conflicts of Interest, A Policy Proposal for Academic Medical Centers (January 2006)
• JME, M A Morgan et al., Interactions of doctors with the pharmaceutical industry, 32 JME 559-563 (2006)
• JME, M Sillender, Can patients be sure they are fully informed when representatives of surgical equipment manufacturers attend their operations? (2006)
• Lancet, Funding of patients' groups, 368 (July 1, 2006)
• NEJM, Robert Steinbrook, For sale: Physicians' Prescribing Data, 356 p.2745 (2006)
• PLOS, Peter R. Mansfield et al., Educating Health Professionals about Drug and Device Promotion: Advocates’ Recommendations, 3(11) p.451 (2006)
• PLOS, Ray Moynihan and David Henry, The Fight against Disease Mongering: Generating Knowledge for Actionp.191(2006)>
• PLOS, Joel Lexchin, Bigger and Better: How Pfizer Redefined Erectile Dysfunction p. e132 (2006)
• PLOS, Christine B. Phillips, Medicine Goes to School: Teachers as Sickness Brokers for ADHD p. e182 (2006)
• PLOS, Leonore Tiefer, Female Sexual Dysfunction: A Case Study of Disease Mongering and Activist Resistance p. e178(2006)
• PLOS, David Healy, The Latest Mania: Selling Bipolar Disorder p.e185 (2006)
• PLOS, Kalman Applbaum, Pharmaceutical Marketing and the Invention of the Medical Consumer p. e189 (2006)
• PLOS, Iona Heath, Combating Disease Mongering: Daunting but Nonetheless Essential p.e146 (2006)
• PLOS, Steven Woloshin, Lisa M. Schwartz, Giving Legs to Restless Legs: A Case Study of How the Media Helps Make People Sick p.e170 (2006)
• PLOS, Maggini et al., Cholinesterase Inhibitors: Drugs Looking for a Disease? p.e140 (2006)
• PLOS, Barbara Mintzes, Disease Mongering in Drug Promotion: Do Governments Have a Regulatory Role? p.e198(2006)
• PLOS, Bernhard Baune, Phillipa Hay, Suicide Rates and Antidepressant Prescribing: A Casual or Causal Relationship? p.e220(2006)
• PLOS, Fugh-Berman et al., Advertising in Medical Journals: Should Current Practices Change? p.e130 (2006)
• PLOS, Drowning or Thirsting: The Extremes of Availability of Medical Information p.e165 (2006)
• PLOS, Almasi et al., What Are the Public Health Effects of Direct-to-Consumer Drug Advertising? p.e145 (2006)
• PLOS, Yavar Moghimi, The “PharmFree” Campaign: Educating Medical Students about Industry Influence p.e30 (2006)
• Prescrire, 15 ans d'observation et un constat: rien à attendre de la visite médicale pour mieux soigner, 272 p. 383 (2006)
• E. Doran et al., Empirical uncertainty and moral contest: A qualitative analysis of the relationship between medical specialists and the pharmaceutical industry in Australia, 62(6) Social Science & Medicine p.1510-1519 (2006)

2005

• Archives, Wendy Levinson et al., The Effect of Physician Disclosure of Financial Incentives on Trust, 165 p.625 (2005)
• BMJ, Rebecca Coombes, Drug industry’s new code criticised for lacking teeth, 331 (November 26, 2005)
• BMJ, Fiona Godlee, Say no to the free lunch, 330 (April 16, 2005)
• BMJ, News, Lynn Eaton, Drug company is reprimanded by UK regulator, 330 p.865 (2005)
• BMJ, News, Tony Sheldon, Pfizer [in the Netherlands] found guilty of breaching code, 330 p.162 (2005)
• BMJ, News, Zosia Kmietowicz, Drug company is censured for offering perks to prescribing nurses, 330 p.984 (2005)
• BMJ, R E Ferner, The influence of big pharma, Wide ranging report identifies many areas of influence and distortion, 330 p.855 (April 16, 2005)
• BMJ, Des Spence, The age of entitlement, 331 p.1279  (November 26, 2005)
• BMJ, David Spurgeon, Companies may face tighter regulation over promoting drugs, 329 p.998 (October 30, 2004)
• JAMA, Richard Kravitz et al., Influence of Patients' Requests for Direct-to-Consumer Advertised Antidepressants: A Randomized Controlled Trial, 293(16) p.1995 (2005)
• JAMA, Direct-to-Consumer Advertising and Physician Prescribing (2005)
• JAMA,  Direct-to-Consumer Advertising: A Haphazard Approach to Health Promotion (2005)
• JAMA, Sierles et al., Medical Students' Exposure to and Attitudes About Drug Company Interactions: A National Survey (September 7, 2005)
• American Journal of Medicine, Adair and Holmgren, Do drug samples influence resident prescribing behavior? A randomized trial (August 2005)
• The Lancet, Patrick Vallance, Developing an open relationship with the drug industry, 366 (September 24, 2005)
• The Lancet, Taking a closer look at drug advertisements 366 (August 13, 2005)
• NEJM, Ernst R. Berndt,To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs, 352 (4) (January 27, 2005)
• NEJM, Steinbrook, Commercial Support and Continuing Medical Education, 352 p.534-535 (2005)
• MJA, KJ Harvey et al., Pharmaceutical advertisements in prescribing software: an analysis, 183 p.75 (2005)
• MJA, Doctors, drugs, information and ethics: a never-ending story, 183(2) (July 18, 2005)
• PLOS, Richard Smith, Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies (May 2005)
• Prescrire, La visite médicale trompe toujours énormément, 259 p.191 (2005)
• June McKoy et al., Caveat Medicus, Consequences of Federal Investigations of Marketing Activities of Pharmaceutical Suppliers of Prostate Cancer Drugs, 23 (34) Journal of Clinical Oncology p.8894 (December 1, 2005)
• Michele M. Spence et al., Direct-to-Consumer Advertising of COX-2 Inhibitors: Effect on Appropriateness of Prescribing, 62 Medical Care Research and Review p.544-559 (2005)
• Charles Mather, The pipeline and the porcupine: alternate metaphors of the physician-industry relationship, 60 Social Science & Medicine p.1323 (2005)

2004

• BMJ, O. Dyer, Journal rejects article after objections from marketing department. 328 p.244 (2004)
• BMJ, News, Lynn Eaton, GPs asked not to demand payments from drug company representatives, 329 p.72 (2004)
• BMJ, News, Ray Moynihan, Drug company [Janssen] targets US state health officials, 328 p.306 (2004)
• NEJM, David Blumenthal, Doctors and Drug Companies, 351 (18) p.1885 (October 28, 2004)
• NEJM, David M. Studdert et al., Financial Conflicts of Interest in Physicians’ Relationships with the Pharmaceutical Industry — Self-Regulation in the Shadow of Federal Prosecution, 351(18) p.1891 (October 28, 2004)
• The Lancet, Harvey Black, Dealing in drugs (November 6, 2004)  xxx
• Lancet, Ivan Oransky, Bloggers beware: conflicts of interest and diabetes, 368 p.1641 (2004)
• Academic Medicine, Sacha Agrawal et al., A Prospective Before-and-After Trial of an Educational Intervention about Pharmaceutical Marketing, 79(11) (November 2004)
• Nature, Tinker Ready, Courts crack down on drug marketing strategies, (July 2004)
• MJA, WA Rogers et al., The ethics of pharmaceutical industry relationships with medical students, 180 p.411 (2004)
• AMA, Report of Board of Trustees, Section on prescribing data, p.119-126  (2004)

2003

• Am J Bioeth, Dana Katz et al., All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving, 3 p.39 (2003)
• Am J Bioethics,  Mansfield PR. Bribes for doctors: a gift for bioethicists? 3 p. 47 (2003)
• Archives, AS Brett et al., Are gifts from pharmaceutical companies ethically problematic? A survey of physicians, 163 p. 2213 (2003)
• BMJ, Smith, Medical journals and pharmaceutical companies: uneasy bedfellows. 326 p.1202 (2003)
• BMJ, Ray Moynihan, Who pays for the pizza? Redefining the relationships between doctors and drug companies, Disentanglement. 326 p.1193 (2003)
• BMJ, C. Watkins et al., Characteristics of general practitioners who frequently see drug industry representatives: national cross sectional study, 326 p.1178 (2003)
• BMJ, E. Wager, How to dance with porcupines: rules and guidelines on doctors' relations with drug companies, 326 p.1196 (2003)
• BMJ, Andrew Herxheimer, Relationships between the pharmaceutical industry and patients' organisations, 326 p.1208-1210 (2006)
• BMJ, Jane Smith Food, flattery, and friendship, 326(2003)
• BMJ, Jeanne Lenzer Lay campaigners for prostate screening are funded by industry, News, 326 p.680 (2003)
• CMAJ, Barbara Mintzes et al., How does direct-to-consumer advertising (DTCA) affect prescribing? a survey in primary care environments with and without legal DTCA (2003)
• JAMA, Mello et al., Direct-to-consumer advertising and shared liability for pharmaceutical manufacturers (2003)
• JAMA, J. Dana and G. Loewenstein, A social science perspective on gifts to physicians from industry, 290 p.252 (2003)
• JAMA, D. Grande and K. Volpp, Cost and quality of industry-sponsored meals for medical residents, 290 p.1150 (2003)
• JAMA, JE Bekelman et al., Scope and impact of financial conflicts of interest in biomedical research: a systematic review, 289 p.454 (2003)
• JAMA, AS Relman, Defending professional independence: ACCME's proposed new guidelines for commercial support of CME, 289 p.2418 (2003)
• Lancet, Fletcher, Adverts in medical journals: caveat lector, 361 p.10 (2003) xxx
• Lancet, P. Villanueva et al.,Accuracy of pharmaceutical advertisements in medical journals, 361 p.27 (2003)
• Prescrire, Le bilan du Réseau d'observation de la visite médicale est toujours aussi accablant, 23 p.225 (2003)
• Prescrire, Visite médicale: non merci, 23 p.221 (2003)
• Prescrire, Le 'best of' 2002, 23 p.142 (2003)
• Morris A. Fisher, Physicians and the Pharmaceutical Industry: A Dysfunctional Relationship, 46(2) Perspectives in Biology and Medicine p. 254-272 (2003)
• Dana Katz et al., All Gifts Large and Small: Toward an Understanding of the Ethics of Pharmaceutical Industry Gift Giving, 3(3) The American Journal of Bioethics p.39-46 (2003)

2002

• Annals, Susan L. Coyle, Physician–Industry Relations. Part 2: Organizational Issues, 136 p.403(2002
• Annals, Susan L. Coyle, Physician-industry relations, Part 1: Individual physicians, 136 p.396 (2002)
• BMJ, Barbara Mintzes et al., Influence of direct to consumer pharmaceutical advertising and patients’ requests on prescribing decisions: two site cross sectional survey (2002)
• BMJ, News, Charles Marwick, US tackles drug company gifts to doctors, 325 p.795 (2002)
• BMJ, H. Simmonds, Complaints about advertising of medicines are encouraged, 324 p.850 (2002)
• NEJM, MB Rosenthal et al., Promotion of prescription drugs to consumers, 346 p.498 (2002)
• JAMA, Choudhry et al., Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry (February 6, 2002)>
• MJA, Paul Komesaroff & Ian Kerridge, Ethical issues concerning the relationships between medical practitioners and the pharmaceutical industry, 176 Med J Aust p.118 (2002)

2001

• Am J Med, MA Steinman et al., Of principles and pens: attitudes and practices of medicine housestaff toward pharmaceutical industry promotions, 110 p.551 (2001)
• BMJ, Amina Hussain and Richard Smith, Declaring financial competing interests: survey of five general medical journals 323 p.263 (2001)
• BMJ, David Carvel, Reviews, Personal views, 323 p.1259 (2001)
• BMJ, News, Tony Sheldon, Drug company [in the Netherlands] fined for excessive hospitality, 322 p.382 (2001)
• JAMA, McCormick et al., Effect of Restricting Contact Between Pharmaceutical Company Representatives and Internal Medicine Residents on Posttraining Attitudes and Behavior(Octrober 24, 2001)
• JAMA, AS Relman, Separating continuing medical education from pharmaceutical marketing, 285 p.2009 (2001)
• JAMA, Michael E. Dieperink & Lisa Drogemuller, Industry-Sponsored Grand Rounds and Prescribing Behavior, 285 p.1443 (2001)
• P. McGettigan, Prescribers prefer people: The sources of information used by doctors for prescribing suggest that the medium is more important than the message, Br J Clin Pharmacol, 51 p.184-189 (2001)

2000

• JAMA, Ashley Wazana, Physicians and the Pharmaceutical Industry, Is a Gift Ever Just a Gift? (January 19, 2000)
• JAMA, JP Kassirer, A piece of my mind: financial indigestion, 284 p.2156 (2000)
• JAMA, SR Hill et al., Problems with the interpretation of pharmacoeconomic analyses: a review of submissions to the Australian Pharmaceutical Benefits Scheme, 283 p.2116 (2000)
• NEJM, Bodenheimer, Uneasy Alliance - Clinical Investigators and the Pharmaceutical Industry (May 18, 2000)

1999

• Am J Med, RP Ferguson et al., Encounters with pharmaceutical sales representatives among practicing internists, 107 p.149 (1999) xxx
• Am J Med, M. Chren, Interactions between physicians and drug company representatives. 107 p.182 (1999) xxx
• JAMA, Hollon. Direct-to-consumer marketing of prescription drugs: creating consumer demand (1999)
• JAMA, Holmer. Direct-to-consumer prescription drug advertising builds bridges between patients and physicians (1999)
• P.A. Glassman et al., Pharmacological advertising revenue and physician organizations: how much is too much?. West. J. Med. 171(1999), pp. 234–235

1998

• BMJ, News, Judy Siegel-Itzkovich, [Israeli] Doctors banned from drug company trip, 317 p.370 (1998)
• Lancet, News, Alicia Ault, US FDA ordered to allow off-label data dissemination, 352 p.555 (1998)

1997

• Acad. Med., WS Sandberg et al., The effect of educational gifts from pharmaceutical firms on medical students' recall of company names or products, 72 p.916 (1997)
• Pharmacoeconomics , JA Sacristán et al., Publication bias in health economic studies. 11 p.289 (1997)

1996

1995

• CMAJ, B. Hodges, Interactions with the pharmaceutical industry: experiences and attitudes of psychiatry residents, interns and clerks, 153 p.553 (1995)
• JAMA, Ziegler et al., The accuracy of drug information from pharmaceutical sales representatives (April 26, 1995)
• C. Landefeld et al., A 4-year study of the volume of drug advertisements in leading medical journals. 10 J Gen Intern Med p.111 (1995)

Pre-1995

• Acad. Med., JW Banks and AG Mainour, Attitudes of medical school faculty towards gifts from the pharmaceutical industry, 67 p.610 (1992)
• Annals, D.A. Kessler, Addressing the problem of misleading advertising,  116 p. 950–951(1992)
• Annals, M.S. Wilkes et al., Pharmaceutical advertisements in leading medical journals: experts' assessments, 116 Ann Intern Med p.912 (1992)
• Annals, American College of Physicians, Physicians and the pharmaceutical industry, 112 p.624 (1990) [no link]
• Archives, PR Lichstein et al., Impact of pharmaceutical company representatives on internal medicine residency programs, A survey of residency program directors, 15 p.1009 (1992)
• BMJ, RE Ferner and DK Scott DK, Whatalotwegot—the messages in drug advertisements, 309 p.1734 (1994)
• BMJ, News, F B Charatan, Drug company [Roche] settles over antibiotic claim, 309 p.690 (1994)
• CMAJ, J. Lexchin, Interactions between physicians and pharmaceutical industry, 149 p.1401 (1993)
• JAMA, P.A. Rochon et al., Evaluating the quality of articles published in journal supplements compared with the quality of those published in the parent journal, 272 p.108 (1994)
• JAMA, MM Chren and CS Landefeld, Physicians' behavior and their interactions with drug companies: a controlled study of physicians who requested additions to a hospital drug formulary, 271 p.684 (1994)
• JAMA, T. Randall, Kennedy hearings say no more free lunch — or much else — from drug firms, 265 p.440 (1991)
• JAMA, WP McInney et al., Attitudes of internal medicine faculty and residents towards professional interaction with pharmaceutical sales representatives, 264 p.1693 (1990)
• JAMA, MM Chren et al., Doctors, drug companies and gifts, 262 p.3448 (1990)
• NEJM, Robert S. Stern , Drug Promotion for an Unlabeled Indication -- The Case of Topical Tretinoin, 331 p.1348 (1994)
• NEJM, DF Thompson, Understanding financial conflicts of interest, 329 p.573 (1993)
• NEJM, DR Waud, Pharmaceutical promotion — a free bribe? 227 NEJM, p.351(1992)
• NEJM, David Kessler, Drug promotion and scientific exchange, 325 p.201 (1991) 
• NEJM, Arnold Relman, Salaried Physicians and Economic Incentives, 319 p.784 (1988)
• NEJM, Arnold Relman, Doctors and the Dispensing of Drugs, 317 p.311-12 (1987)
• NEJM, Stephen Goldfinger, A Matter of Influence, 316 p.1408 (1987)
• NEJM, Arnold Relman, Practicing Medicine in the New Business Climate, 316 p. 1150-51 (1987)
• NEJM, Arnold Relman, Editorial, Dealing with Conflicts of Interest, 313, p.749-51 (1985)
• NEJM, Kenneth Miller et al., Undesirable Marketing Practice in the Pharmaceutical Industry, 313 p.54 (1985)
• NEJM, Arnold Relman, Investor-Owned Hospitals and Health-Care Costs, 309 p.370-72 (1983)
• NEJM, Arnold Relman, Editorial, The New Medical-Industrial Complex, 303 p.963 (1980)
• Rebecca K. Schwartz et al., Physician Motivations for Nonscientific Drug Prescribing, 28(6) Sot Scr Med p.577(1989)
• Avorn J, et al., Scientific versus commercial sources of influence on the prescribing behavior of physicians, Am J Med. 1982; 73:4-8 (1982).

Company sources

• Eli Lilly Grant Registry - Disclosure of Grants and Contributions Funded by Eli Lilly
• The Lilly Grant Process
• Lilly Grant Registry Report

Historical sources - historical overview

• Jeremy A. Greene, Attention to 'Details': Etiquette and the Pharmaceutical Salesman in Postwar America, Social Sutides of Science 34/2 p.271(2004)
• Harry M. Marks, Revisiting "The Origins of Compulsory Drug Prescriptions", American Journal of Public Health 109 (1995)
• Rebecca Dresser, Pharmaceutical Company Gifts: From Voluntary Standards to Legal Demands, 36(3) Hastings Center Report p.8 (2006)

Various other sources / journals

• Essential Action, A Call for pharmaceutical industry disclosure of charitable and educational donations (July 26, 2007)
• Center for Media and Democracy, Diane Farsetta and Daniel Price, Fake TV News: Widespread and Undisclosed, A multimedia report on television newsrooms' use of material provided by PR firms on behalf of paying clients, (April 6, 2006)
• Rebecca Dresser, Pharmaceutical Company Gifts: From Voluntary Standards to Legal Demands, 36(3) Hastings Center Report p.8 (2006)
• 3(3) The American Journal of Bioethics (2003):
  • Howard Brody, Pens and Other Pharmaceutical Industry Gifts, p. 58-60
  • Karine Morin & L. J. Morse, The Ethics of Pharmaceutical Industry Gift Giving: The Role of a Professional Association, p. 54-55
  • Joel Lexchin, Voluntary Self-regulatory Codes: What Should We Expect?   p. 49-50
  • Allan Brett, Cheap Trinkets, Effective Marketing: Small Gifts from Drug Companies to Physicians, p. 52-54
  • Sharon Terry, Banning Pens and Pads Misses the Main Point, p. 63-65
  • Carson Strong, Lunch with Lilly: Who Pays?   p. 62-63
  • Jeffrey Berger, Pharmaceutical Industry Influences on Physician Prescribing: Gifts, Quasi-gifts, and Patient-Directed Gifts, p. 56-57
• Marc A. Rodwin & A . Okamoto, Physicians' Conflicts of Interest in Japan and the United States: Lessons for the United States, 25(2) Journal of Health Politics, Policy and Law p. 343-375 (2000)

top of the page

Specific Drugs

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

Plan B

• 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)

• The Drugs and their labels (US): Lilly's Prozac = fluoxetine;  Pfizer's Zoloft = sertraline;  GSK's Paxil = paroxetine;  Luvox = fluvoxamine;  Celexa = citaloprem;  Lexaprotin;  Wellbutrin;  Effefox; Serzone; Remeron;  Symbiax
• The Drugs and their EPAR (EU): Lilly's Prozac = fluoxetine;  Pfizer's Zoloft = sertraline;  GSK's Paxil = paroxetine; Luvox = fluvoxamine; Celexa = citaloprem; Lexapro; Wellbutrin; Effefox; Serzone; Remeron; Symbiax
• The Drugs and their professional information (CH): Prozac = fluoxetine; Zoloft = sertraline; Paxil = paroxetine; Luvox = fluvoxamine; Celexa = citaloprem; Lexapro; Wellbutrin; Effefox; Serzone; Remeron; Symbiax
• UK Department of Health
• Swissmedic's press release
• FDA's Talk Paper
• FDA Advisory Committe hearing
• FDA and Mosholder's testimony
• Congress' investigation
• FDA patient information sheet for Paxil/paroxetine
• GSK's Clinical Trial Register, Welcome page
• GSK's list of studies for paroxetine
• AHRQ, Comparative Effectiveness of Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression (January 2007)
• Transcript of FDA Advisory Committee meeting (December 13, 2006)
• GSK's Dear Healthcare Professionnal Letter (May 2006)
• PLOS Medicine, Serotonin and Depression: A disconnect between the advertisements and the scientific literature, 12(2) p.322 (December 2005)
• BMJ, Eli Lilly: Correction and apology, 330 p.211 (2005)
• Senator Grassley Seeks Complete Information from Food and Drug Administration (September 10, 2004)
• Statement of FDA Robert Temple, Hearing: FDA's review of the safety and efficacy concerns in anti-depressant drugs for use in pediatric populations (September 2004)
• GSK's Dear Healthcare Professional Letter (May 2004)
• Letter of The House Committee on Energy and Commerce to GSK, seeking clinical trial data on antidepressants (February 2004)
• BMJ, David Spurgeon, GlaxoSmithKline staff told not to publicise ineffectiveness of its drug, 328 p.422  (2004)
• BMJ, Dyer, GlaxoSmithKline faces US lawsuit over concealment of trial results, 328 p.1395 (2004)
• Lancet, Whittington et al., Selective serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data, 363 p.1341–1345 (2004) [xxx]
• NEJM, E. Turner et al., Selective Publication of Antidepressant Trials and Its Influence on Apparent Efficacy, 358 p.252 (2008)
• NEJM, Richard A. Friedman & Andrew C. Leon, Expanding the Black Box - Depression, Antidepressants, and the Risk of Suicide, 356 p.2343 (2007)
• Frank J. Ayd, The Chemical Assault on Mental Illness, The Antidepressants, American Journal of Nursing (1965)

SSRIs in children

• BMJ, News, Dyer, Teen suicide rate rises as prescribing of SSRIs falls, study finds, 335 p.531 (2007)
• FDA, Main Page on Antidepressant Use in Children, Adolescents, and Adults
• State of New York General Attorney Spitzer, settlement agreement with GSK
• FDA, Review and Evaluation of Clinical Data Placebo Controlled Antidepressant Studies in pediatric patients (2004)
• FDA, Medical Review of the pediatric Fluoxetine application
• FDA, Statistical Review of the pediatric Fluoxetine application
• Eli Lilly, Briefing Document for Advisory Committee, Comments on Behalf of Eli Lilly and Company (13 September 2004)
• FDA, Black box warning, Class Suicidality Labeling Language for Antidepressants
• FDA documents on the Psychopharmacologic Drugs Advisory Committee's Joint meeting with the Pediatric Advisory committeee of September 13-14, 2004
• NY State Attorney General, Settlement sets new standard for release of drug information (August 26, 2004)
• NY State Attorney General, Assurance of discontinuance (August 26, 2004)
• NY State Attorney General, Statement regarding decision by GlaxoSmithKline to post summaries of clinical trial (June 18, 2004)
• NY State Attorney General, Statement regarding a decision by GlaxoSmithKline to release Paxil Data (June 14, 2004)
• NY General Attorney, GlaxoSmithKline Misled Doctors About the Safety of Drug Used to Treat Depression in children (June 2004)
• Complaint by General Attorney Spitzer, State of New York v. GSK (June 2, 2004)

• Statement by the NY State Psychiatric Association

• CSPI, SSRI Use in Children: An Industry-Biased Record (2004)
• Lancet, News, Ivan Oransky, FDA questions antidepressant safety for children, 362 Lancet p.1558 (2003)
• Pediatrics,  Laurel K. Leslie et al., The Food and Drug Administration’s Deliberations on Antidepressant Use in Pediatric Patients, 116 p.195 (2005)

Zyprexa

• BMJ, Jeanne Lenzer, Drug company seeks to suppress internal memos, News, 334 p.59 (2007)

Coxibs: Vioxx

• 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, Dieppe et al., Lessons from the withdrawal of rofecoxib, 329 p.867-868 (2004)
• BMJ, News, Liza Gibson, Spanish drug editor wins case brought by Merck, Sharp & Dohme, 328 p.307 (2004)
• BMJ, News, Liza Gibson, Drug company sues Spanish bulletin over fraud claim, 328 p.188 (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
• 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)
• 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)
• TMT Review of COX-2 Committee Voting (2005)

Serivastim - Serono

• FDA, Office of Criminal Investigation, Report Fiscal Year 2005 p.19-20 (2006)
• Ross Kerber, AIDS Activists remain wary of drug maker, Boston Globe (November 14, 2005)
• US DOJ, press release, Serono to pay $704 million for the illegal marketing of AIDS drug (October 17, 2003)
• US DOJ, Remarks of Attorney General Gonzales at the press conference regarding agreement with Serono Labs (October 17, 2005)
• US v. Serono Labs, Alleged violations
• Serono Settlement Agreement