| 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 |