- Davids versus Goliaths: Pharma and academia threats to individual scientists and cliniciansBennett CL, Olivieri N, Hoque S, et al. Davids versus Goliaths: Pharma and academia threats to individual scientists and clinicians. JoSPI. Published online June 24, 2022. doi:10.35122/001c.36564
- Merck Created Hit List to "Destroy," "Neutralize" or "Discredit" Dissenting DoctorsCBS News, by Jim Edwards, updated 5/6/2009
- Merck's Doctor hit list"We may need to seek them out and destroy them where they live," -- Wedekind, J. (2009). Merck's Doctor hit list. Multinational Monitor, 30(3), 4. https://link.gale.com/apps/doc/A208110981/AONE?u=morenetsbumc&sid=googleScholar&xid=ddde56c2
- Big Pharma’s Big FinesPropublica, by Lena Groeger, 2/24/2014
- Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote“As the agreed statement of facts filed in court today demonstrates, Abbott promoted Depakote to control behaviors in elderly dementia and schizophrenia patients without significant evidence of its effectiveness for that use, and even after clinical data established that it was not effective,” said Timothy Heaphy, U.S. Attorney for the Western District of Virginia." -- United States Department of Justice, Office of Public Affairs, 5/7/2012
- Biogen agrees to $900 million drug kickback settlement on eve of trialReuters, by Nate Raymond, 7/20/2022
- $3 Billion GlaxoSmithKline Settlement Spurred by WhistleblowersNational Whistleblower Center, 7/2/2012
- Glaxo Agrees to Pay $3 Billion in Fraud SettlementNPR, by Carrie Johnson, 7/2/2012
- GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data"GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA)." -- United States Department of Justice, Office of Public Affairs, 7/2/2012
- Tough on Crime? Pfizer and the CIHR"Pfizer has been a “habitual offender,” persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial results. Since 2002 the company and its subsidiaries have been assessed $3 billion in criminal convictions, civil penalties and jury awards. The $2.3-billion settlement in September 2009 – a month before Dr. Prigent's appointment – set a new record for both criminal fines and total penalties. " -- Evans R. G. (2010). Tough on Crime? Pfizer and the CIHR. Healthcare policy = Politiques de sante, 5(4), 16–25.
- Pfizer Hit with Largest Criminal Fine in US HistoryFindlaw.com, by Caleb Groos, 9/2/2009 "Drugmaker Pfizer Inc. and one of its subsidiaries agreed to pay $2.3 billion to settle civil and criminal charges regarding its marketing of the drug Bextra. As part of the settlement, Pfizer pled guilty to a felony violation of the Food, Drug, and Cosmetic Act for marketing the drug with the intent to deceive and mislead the public."
- Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer: to Pay $2.3 Billion for Fraudulent Marketing"Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. " -- United States Department of Justice, Office of Public Affairs, 9/2/2009
- Drug Maker Pfizer Agrees to Pay $23.85 Million to Resolve False Claims Act Liability for Paying Kickbacks“Pfizer used a third party to saddle Medicare with extra costs,” said United States Attorney Andrew E. Lelling. “According to the allegations in today’s settlement agreement, Pfizer knew that the third-party foundation was using Pfizer’s money to cover the co-pays of patients taking Pfizer drugs, thus generating more revenue for Pfizer and masking the effect of Pfizer’s price increases." -- United States Department of Justice, Office of Public Affairs, 5/24/2018
- Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations Investigations Allegations Include Off-label Marketing and Kickbacks to Doctors and PharmacistsU.S. Department of Justice, Office of Public Affairs, 11/4/2013
- Johnson & Johnson to pay $2.2 billion to end U.S. drug probes"Johnson & Johnson’s conduct “recklessly put at risk” the health of children, dementia patients and others to whom the drug was prescribed at a time it was only approved by the U.S. Food and Drug Administration to treat schizophrenia, Holder said." -- Reuters, by David Ingram, Ros Krasny, 11/4/2013
- Pharmaceutical Giant AstraZeneca to Pay $520 Million for Off-label Drug Marketing" The United States contends that AstraZeneca promoted the unapproved uses by improperly and unduly influencing the content of, and speakers, in company-sponsored continuing medical education programs. The company also engaged doctors to give promotional speaker programs on unapproved uses for Seroquel and to conduct studies on unapproved uses of Seroquel. In addition, the company recruited doctors to serve as authors of articles that were ghostwritten by medical literature companies and about studies the doctors in question did not conduct. AstraZeneca then used those studies and articles as the basis for promotional messages about unapproved uses of Seroquel." -- U.S. Department of Justice, Office of Public Affairs, 4/27/2010
- 10 Amazing Facts About Pfizer's $2.3B Bextra Settlement"Whose brand name will be tarnished by the company pleading guilty to a crime? Not Pfizer's. Rather, it's "Pharmacia & Upjohn Company," which will cop to felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. P&U is, of course, a Pfizer acquisition." -- CBS News, by Jim Edwards, updated 9/2/2009
- Justice Department Announces Largest Health Care Fraud Settlement in Its History Pfizer: to Pay $2.3 Billion for Fraudulent Marketing"Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. " -- United States Department of Justice, Office of Public Affairs, 9/2/2009
- Pfizer Medical Fraud Settlement
This link opens in a new window
"Justice Department attorneys and Health and Human Services Secretary Kathleen Sebelius held a news conference dealing with a health care-related settlement. The federal government announced the largest medical fraud settlement in U.S. history. Pfizer will pay $2.3 billion to settle charges of promoting its drugs for uses not approved by the Food and Drug Administration." -- C-Span, 9/2/2009 - Pfizer, Inc.; Withdrawal of Approval of a New Drug Application for BEXTRA[FR Doc. 2013-18657 Filed 8-1-13; 8:45 am] Federal Register. Food and Drug Administration, 08/02/2013
- Pfizer fined $2.3 billion for illegal marketing in off-label drug caseABC News, by Rita Rubin, 10/2/2009
- Pfizer to settle Bextra, Celebrex lawsuitsReuters, by Ransdell Pierson, 10/17/2008
- Pfizer Whistleblower Tells His Bextra StoryNPR, Scott Hensley, 9/3/2009
- Fatal French clinical trial failed to check data before raising drug doseRanderson, J. Fatal French clinical trial failed to check data before raising drug dose. Nature (2016). https://doi.org/10.1038/nature.2016.21190
- Man who died in French drug trial had ‘unprecedented’ reaction, say expertsThe Guardian, 3/7/2016
- New clues to why a French drug trial went horribly wrongScience.org, by Hinnerk Feldwisch-Drentrup, 6/8/2017
- Non-clinical toxicology evaluation of BIA 10-2474A. Wallace Hayes, Klaus Weber, Paul Moser & Patrício Soares-da-Silva (2021) Non-clinical toxicology evaluation of BIA 10-2474, Critical Reviews in Toxicology, 51:1, 65-75, DOI: 10.1080/10408444.2020.1867821
- Regulatory safety pharmacology evaluation of BIA 10-2474A.Wallace Hayes, Peter Pressman, Paul Moser, Patrício Soares-da-Silva,
Regulatory safety pharmacology evaluation of BIA 10-2474, Journal of Pharmacological and Toxicological Methods, Volume 102,
2020,106677, ISSN 1056-8719, https://doi.org/10.1016/j.vascn.2020.106677
- Chinese Trial Misconduct Delayed Bristol-Myers MedicineBloomberg.com, 7/8/2013, Drew Armstrong
- Clinical Trial Fraud UncoveredSicence.org blog post by Derek Lowe, 7/12/2013
- 'Fraud' found at China site for key study of Pfizer and Bristol's EliquisFierce Biotech, 7/9/2013
- Roller Coaster Path to Approval for Eliquis Uncovered by FDA DocumentsNEJM Journal Watch CardioExchange Archive, Larry Husten, 6/24/2013
- Eliquis patient siteBMS (Bristol Myers Squibb)
- AMAG PHARMACEUTICALS ANNOUNCES THE PUBLICATION OF THE PROLONG TRIAL EVALUATING 17-OHPC in the American Journal of PerinatologyAMAG Pharmaceuticals news release 10/25/2019
- CDER proposes withdrawal of approval for MakenaFDA, 10/5/2020
- F.D.A. Rushed a Drug for Preterm Births. Did It Put Speed Over Science?"The agency’s accelerated approval program for certain drugs has come under intense scrutiny because some medicines stay on the market despite limited evidence that they work." -- New York Times, by Christina Jewett, 3/25/2022
- The FDA must pull Makena off the marketStatNews.com, by Adam C. Urato, 11/14/2019
- HYDROXYPROGESTERONEClinicalTrials.gov
- MAKENA- hydroxyprogesterone caproate injection
DailyMed, U.S. National Library of Medicine, National Institutes of Health
- Diabetes drug victims demand justice in French trialABC News, by Nicolas Vaux-Montagny and Alex Turnbull, Associated Press, 9/23/2019
- Mediator: French weight-loss drug trial over ‘up to 2,000’ deaths beginsBBC News, 9/23/2019
- Mediator drug: French pharmaceutical firm fined over weight loss pill"A French drug maker has been found guilty of aggravated deceit and involuntary manslaughter over a weight loss pill at the centre of a major health scandal." -- BBC News, 3/29/2021
- Paris court fines Servier 2.7 million euros over weight-loss drugReuters, /29/2021
- Molnupiravir’s authorisation was prematureBMJ 2022;376:o443
- Molnupiravir: From Hope to Epic Fail?Focosi D. Molnupiravir: From Hope to Epic Fail? Viruses. 2022 Nov 19;14(11):2560. doi: 10.3390/v14112560. PMID: 36423169; PMCID: PMC9694535.
- After the PANORAMIC Study — Whither Molnupiravir?Blog entry from NEJM Journal Watch, 1/17/2023
- Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial"PANORAMIC was a UK-based, national, multicentre, open-label, multigroup, prospective, platform adaptive randomised controlled trial." -https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02597-1/fulltext
- WHO updates its treatment guidelines to include molnupiravirWorld Health Organization 3/3/2022
- Emails offer look into whistleblower charges of cronyism behind potential COVID-19 drug Demoted pandemic official expressed concern about safety of unproven coronavirus drug"Pharmasset, abandoned it in 2003 after discovering its mutagenic properties. Schinazi says the small chemical tweaks made to increase the ingredient's bioavailability and transform it into EIDD-2801 are unlikely to change its mutagenicity. "Thank goodness someone is raising the red flag," about EIDD-2801, Schinazi says. "You don't develop a drug that's mutagenic. Period." Science.org, 5/13/2020, by Jon Cohen, Charles Piller
- Why Merck's Celebrated Covid Pill Could Be Riskier Than People ThinkNathan-Kazis, Josh. "Why Merck's Celebrated Covid Pill could be Riskier than People Think." Barron's (Online), 2021. ProQuest, https://www.proquest.com/trade-journals/why-mercks-celebrated-covid-pill-could-be-riskier/docview/2579035226/se-2?accountid=14196.
- Merck asks FDA to authorize anti-COVID pill for emergency useFox Business, by Daniella Genovese
- Merck’s COVID-19 pill could carry serious safety concerns, scientists warnFox News, by Shiv Sudhaker
- COVID-19 Treatments: What We Know So FarYale Medicine, by Kathy Katella, 11/29/2022
- Molnupiravir (Synonyms: EIDD-2801; MK-4482)MedChemExpress.com
- Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2Holman, W., Holman, W., McIntosh, S. et al. Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2. Trials 22, 561 (2021). https://doi.org/10.1186/s13063-021-05538-5
- Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002)Clinicaltrials.gov, "Brief Summary: This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo. The primary hypothesis is that molnupiravir is superior to placebo as assessed by the percentage of participants who are hospitalized and/or die through Day 29"
- Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity against SARS-CoV-2Painter, Wendy P et al. “Human Safety, Tolerability, and Pharmacokinetics of Molnupiravir, a Novel Broad-Spectrum Oral Antiviral Agent with Activity Against SARS-CoV-2.” Antimicrobial agents and chemotherapy, vol. 65,5 e02428-20. 1 Mar. 2021, doi:10.1128/AAC.02428-20
- Two COVID-19 antiviral pills advance to late-stage trialsc&en (Chemical & Engineering News), by Megha Satyanarayana, 9/7/2021
- Pfizer says COVID-19 pill cut hospital, death risk by 90%"The FDA has set a public meeting later this month to review Merck’s pill, known as molnupiravir. The company reported in September that its drug cut rates of hospitalization and death by 50%. Experts warned against comparing preliminary results because of differences in the studies, including where they were conducted and what types of variants were circulating...Although Merck’s pill is further along in the U.S. regulatory process, Pfizer’s drug could benefit from a safety profile that is more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck trial due to a potential risk of birth defects, Pfizer’s drug did not have any similar restrictions. The Merck drug works by interfering with the coronavirus’ genetic code, a novel approach to disrupting the virus." -- KY3.com, AP, By MATTHEW PERRONE
- Supercharging New Viral Variants: The Dangers Of Molnupiravir (Part 1)Forbes.com, by William A. Haseltine, 11/1/2021
- Harming Those Who Receive It: The Dangers Of Molnupiravir (Part 2)Forbes.com, by William A. Haseltine, 11/2/2021
- $3 Billion GlaxoSmithKline Settlement Spurred by WhistleblowersNational Whistleblower Center, 7/2/2012
- BMJ Author Video - Study329
- This link opens in a new window
Vimeo video, Dr. Jon Jureidini, Clinical Professor, Critical and Ethical Mental Health Research Group, University of Adelaide, Adelaide, Australia - Glaxo Agrees to Pay $3 Billion in Fraud SettlementNPR, by Carrie Johnson, 7/2/2012
- GlaxoSmithKline faces US lawsuit over concealment of trial resultsDyer O. (2004). GlaxoSmithKline faces US lawsuit over concealment of trial results. BMJ (Clinical research ed.), 328(7453), 1395. https://doi.org/10.1136/bmj.328.7453.1395
- GlaxoSmithKline to pay $3bn in US drug fraud scandalBBC News, 7/2/2012
- GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data"GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA)." -- United States Department of Justice, Office of Public Affairs, 7/2/2012
- No academic matter: Study links retractions to patient harmRetractionWatch, Adam Marcus, 6/13/2011
- No correction, no retraction, no apology, no commentDoshi P. No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility BMJ 2015; 351 :h4629 doi:10.1136/bmj.h4629
- Paroxetine—The Antidepressant from Hell? Probably Not, But Caution RequiredNevels, R. M., Gontkovsky, S. T., & Williams, B. E. (2016). Paroxetine-The Antidepressant from Hell? Probably Not, But Caution Required. Psychopharmacology bulletin, 46(1), 77–104.
- PaxilDrugwatch
- Study 329BMJ 2015;351:h4973
doi: https://doi.org/10.1136/bmj.h4973 (Published 17 September 2015) - Study 329 [Wikipedia article]"Study 329 was a clinical trial which was conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder ... study 329 became controversial when it was discovered that the article had been ghostwritten by a PR firm hired by SmithKline Beecham; had made inappropriate claims about the drug's efficacy; and had downplayed safety concerns." -- Wikipedia
- The Truth About "Study 329"Psychology Today, Christopher Lane, 9/16/2015
For information on Thalidomide, please see this guide page: Thalidomide
- Trovan Fact SheetPfizer
- What do Pfizer’s 1996 drug trials in Nigeria teach us about vaccine hesitancy?Brookings Institution, by Belinda Archibong and Francis Annan, 12/3/2021
- Pfizer accused of testing new drug without ethical approval"An official inquiry has been set up into allegations that the drug manufacturer Pfizer did not obtain official approval before testing a new drug on children during a meningitis epidemic in Nigeria five years ago." -- Wise J. Pfizer accused of testing new drug without ethical approval. BMJ. 2001 Jan 27;322(7280):194. PMID: 11159610; PMCID: PMC1119465.
- In this Nigerian city, Pfizer fears loom over the vaccine rolloutBy Ibrahim Garba and Danielle Paquette. (2021, March 20). Washingtonpost.Com.
- Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests"Court documents filed by the plaintiffs said that “most tragically, Pfizer purposely … low-dosed the control drug” and did not tell families that free, approved treatment was available at the same hospital from Médecins Sans Frontières." -- Lenzer J. (2006). Secret report surfaces showing that Pfizer was at fault in Nigerian drug tests. BMJ (Clinical research ed.), 332(7552), 1233. https://doi.org/10.1136/bmj.332.7552.1233-a
- Pfizer pays out to Nigerian families of meningitis drug trial victimsThe Guardian, David Smith, 8/12/2011
- Did Pfizer Bribe Its Way Out of Criminal Charges in Nigeria? WikiLeaks cables shed new light into one of Big Pharma's darkest hours"The trial data were so sloppy that the FDA refused to even consider approval of Trovan for children or for meningitis. Although the antibiotic hit the market in 1998, it quickly resulted in a rash of complications due to liver toxicity, including six deaths. Less than two years after its launch, the drug itself was finished."-- The Atlantic, by Walter Armstrong, 12/27/2010
- FDA issues public health advisory for Pfizer's TrovanThe Pharma Letter, 09/06/1999
- Families sue Pfizer on test of antibioticLewin, Tamar. "Families sue Pfizer on test of antibiotic." New York Times, 30 Aug. 2001, p. C1. Gale General OneFile, link.gale.com/apps/doc/A77707086/ITOF?u=morenetsbumc&sid=bookmark-ITOF&xid=b13dab5f. Accessed 6 July 2022.
- Pfizer: Nigeria drug trial victims get compensationBBC News, 8/11/2011
- Pfizer’s Nigerian NightmarePerlroth N. Pfizer’s Nigerian Nightmare. Forbes. 2008;182(12):66
- Unforeseen side effects ruined one blockbusterPetersen, Melody. "Unforeseen side effects ruined one blockbuster." New York Times, 27 Aug. 2000, p. BU11. Gale General OneFile, link.gale.com/apps/doc/A64688137/ITOF?u=morenetsbumc&sid=bookmark-ITOF&xid=d18b2401. Accessed 6 July 2022.
- At Vioxx Trial, a Discrepancy Appears to Undercut Merck's DefenseBerenson, A. (2005, July 20). At Vioxx Trial, a Discrepancy Appears to Undercut Merck's Defense. New York Times, C1(L). https://link.gale.com/apps/doc/A134180962/AONE?u=morenetsbumc&sid=bookmark-AONE&xid=99c000e6
- Cardiologist testifies Merck withheld dataBoston.com Business, by Bloomberg News, 3/10/2006
- COMPOUND SUMMARY RofecoxibPubChem, National Institutes of Health (NIH)
- Expert: Merck Previously Knew of Vioxx Heart Risks"Cardiologist Eric Topol of the Cleveland Clinic testified that drugmaker Merck had scientific evidence of Vioxx's cardiac hazards as far back as 1999 -- well before it pulled the drug from market in September 2004." -- NPR, Snigdha Prakash, 12/5/2005
- FDA, Merck and Vioxx: Putting Patient Safety First?United States Senate Committee on Finance, full committee hearing, 11/18/2004
- Looking back and looking ahead: Vioxx, drug safety, and the legacy of Sen. Michael EnziStatNews.com, by Stephen Northrup, 12/21/2020
- Merck Created Hit List to "Destroy," "Neutralize" or "Discredit" Dissenting DoctorsCBS News, by Jim Edwards, updated 5/6/2009
- Merck Paid for Medical ‘Journal’ Without DisclosureSinger, Natasha. "Merck paid for medical 'Journal' without disclosure." New York Times 14 May 2009: NA(L). Business Insights: Global. Web. 20 Jan. 2022.
- Merck withdraws arthritis drug worldwideBMJ 2004;329:816
- The Tale Of Merck's Fake Medical Journal As Told At A Vioxx Trial In AustraliaDrug Injury Watch, 4/30/2009
- U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of VioxxUnited States Department of Justice, Office of Public Affairs, 4/19/2012
- Vioxx (rofecoxib) Questions and AnswersU.S. Food & Drug Administration