Person and concern [data source] Avenue through which concerns were first communicated Concerns First threat or intimidation tactic Funder of source of concern
Clinical Trial Data (n=10)
2001: Topol[@129141; @129185; @129212; @129225; @129234] Manuscript galleys were forwarded by Topol to Merck for review and comment Rofecoxib associated cardio-vascular toxicity Merck sent letters to US physicians alleging that Topol’s data analysis was wrong and attempted to “trash” Topol[@129185] Merck
2001: Singh[@129139] Singh reported concerns to Merck Rofecoxib associated cardio-vascular toxicity Pharmaceutical executive called Singh’s Chairman and requested that Singh be fired[@129139] None
1982: Wilmshurst[@129134; @129137; @129165; @129233] 1982: Presented safety and efficacy findings to manufacturer of amrinone[@129165] 1982: Clinical studies with amrinone identified severe toxicity and minimal benefit 1982: Corporate executives initially offered Wilmshurst funds not to publish his findings. After this offer was refused, corporate executives threatened a lawsuit if the findings were submitted to a journal[@129165] Grants from the St Thomas's Hospital Cardiac Research Fund; the St Thomas's Hospital Endowment Committee.
2003: Henke[@129117; @129122] 2003: Lancet Epoetin - Mortality and tumor growth in the oncology setting 2007: CEO of the manufacturer of an erythropoiesis stimulating agent (ESA) threatened Henke at a meeting at corporate headquarters Roche
1999: Buse[@129195; @129235] 1999: Presented at medical society meeting Rosiglitazone - Cardio-vascular toxicity 1999: GlaxoSmith-Kline Research and Development Chair reported that Buse was “for sale” made other negative comments to Buse’s department chair. GSK
2005: Wilmshurst[@129165; @129244; @129245; @129298] Presented findings to NMT Inc on safety and efficacy of the STAR-Flex device that was evaluated in the MIST clinical trial. Patent foramen ovale closure device - Clinical trial results: 33% of sixty-five patients with device implanted to close patent foramen ovale continued to have shunts 2006: NMT Inc threatened libel suit in United Kingdom if Wilmshurst published his findings from the MIST trial. Four libel suits were filed beginning in 2007 NMT Inc.
1996: Olivieri[@129138] Research Ethics Board sub-mission Deferiprone - Lack of efficacy and severe toxicity 1996: Law suits were threatened and then filed[@129138] Medical Research Council of Canada; Apotex
2005: Blumsohn[@129135; @129190; @129218] 2004: wrote to editors of Journal of Bone and Mineral Research stating that abstracts had been submitted with his name but without his know-ledge Risedronate - Omission of data on bone resorption findings for 40% of risedronate-treated clinical trial participants The University of Sheffield threatened academic discipline and possible termination.[@129218]
Blumsohn later received a severance agreement.
Proctor and Gamble
2010: Jiang[@129136] 2010: Draft of meeting abstract sent to company; presentation was blocked. Risedronate - Irregularities in reporting of bone radiograph findings among clinical trial participants Censure by the University of Sheffield for abstract submission, in alleged breach of prior contract with another pharma company.[@129136] Procter and Gamble
1990: Dong[@129148; @129150] 1990: Study report sent to manufacturer Thyroxine - Similar efficacy of generic and brand-name drug. 1995: Boots Pharma threatened litigation if Dong submitted her findings for publication, hired private investigators to follow her, and attacked her reputation Boots Pharma
Meta-analysis (n=2)
2007: Bennett[@129117; @129157; @129288; @129297] Proceedings of ASCO Epoetin and darbepoetin - Mortality and tumor growth 2007: Vice President for Research of Amgen, an ESA manufacturing corporation threatened Bennett at a medical conference National Cancer Institute
2004: Mosholder; (Meta-analysis )[@129241] FDA Advisory Board meeting presentation about anti-depressant associated suicide[@129241] Anti-depressant - Association of suicidality in children and adolescents 2004: FDA officials conducted internal
investigation to identify who had “leaked” Mosholder’s findings to the press
Employee of FDA
Case series (n=3)
2007: Frachon 9,70,123 L’Agence nationale de securement du médicamentent des produits de sante
presentation in France
Cardiac valvular problems with benfluorex Servier executives threatened and filed lawsuits against Franchon INSERM
1996: Kern[@129152; @129219; @129287] 1996: Draft abstract presented to Micro-fibres Inc. for review and comment Textile product - Described “flock worker’s syndrome” among workers at Microfibres, Inc Microfibres threatened to file suits if the abstract were presented at a medical conference. None
2006: Thomsen[@129158; @129159; @129160; @129161; @129241] Presented findings at a medical conference Gadodiamide - Nephrogenic systemic fibrosis developed among chronic kidney disease patients on dialysis after gadodiamide contrast injection for magnetic resonance angiogram 2009: General Electric threatened libel suit. A lawsuit was filed in the United Kingdom. None
Registry data (n=2)
2003: Mangano[@129287] Published manuscript with safety findings in the NEJM[@129287] Valdecoxib-associated risks of heart attack and stroke Pfizer threatened and filed a lawsuit; hired a person to steal data from Mangano’s laboratory. Pfizer
2006: Graves
[@129247; @129248]
Findings were presented at orthopedic surgery conference DePuy Prosthetic Hips - Identified high failure rate of hip prostheses failure 2007: DePuy sent out “white paper” claiming that Grave’s results were due to poor operative skills of surgeons Australian Orthopedic Association
Case-control study (n=3)
2005: Graham[@129140; @129238; @129285] Graham reported findings at a Senate committee meeting Rofecoxib
associated infarct and sudden death toxicity
FDA officials sought transfer of Graham to Commissioner’s Office; threatened disciplinary action; told journal editors that Graham was “a dangerous demagogue and bully” Employee of FDA
1996: Rich[@129123; @129143; @129236; @129237] Rich presented at the American Thoracic Society Conference Anorexin drugs - Primary pulmonary hypertension After a television interview, Wyeth Vice President threatened harm if Rich participated in another interview Institut de Recherches Servier and the Belgian Federal funds
2000: Brass[@129120; @129249] Findings presented to Roche Phenyl -propanol-amine (PPA): Identified possible association of PPA products with hemorr-hagic stroke 2000: Pharmaceutical employee threatened to sue Brass if he sent safety data to FDA; also disparaged Brass to others Roche
Clinical observation (n=7)
1988: Cliché[@129213; @129214] Cliché reported clinical details of two patients[@129213; @129214] Anorexin drugs - Each case developed severe cardiac disease Corporate employees in drug safety department warned that bad things would happen if more adverse events were reported None
1991: Healy[@129162] Presented suicide risk concerns at the U of Toronto Anti-depressant - Identified anti-depressant associated suicide risk 2000: Pharmaceutical corporation hired private investigators to tail Healy None
2007: Nargol[@129232] Findings were presented to DePuy DePuy Prosthetic Hips - Identified risks of prosthetic break-down 2007: DePuy claimed that Nargol’s procedures were faulty None
2003: Hampshire (FDA Adverse Event Reports review)[@129169; @129187] Presented findings to FDA supervisor Ivermectin and
pyrantel was linked to deaths and toxicity of 522 and 5,000 dogs,
respectively, in FDA safety database.
Wyeth hired private investigators, asked FDA commissioner to reassign Hampshire; FDA supervisor requested criminal charges be filed against her[@129169] FDA Employee
2000: Hayes (animal studies)[@129128; @129145] Findings were submitted to EPA Atrazine - Feminization of atrazine-exposed male frogs 2000: Threatened by corporate vice president Syngenta initially; then, National Science Foundation
2002: Chapela (plant studies)[@129146; @129189] 2002: Findings were submitted to Nature Maize corn - Abnormalities in genetically modified product 2002: Threatened by corporate executives that professional harms would occur None
2014: Narchasm[@129170; @129171; @129172] 2014: Presented his findings to a Wall Street Journal Reporter 2014: Uterine morcellator was linked to spread of uterine sarcoma to lungs 2014: Device manufacturer threatened libel suit; hired private investigators; spread rumors about Narchasm to medical community[@129170; @129171] None