Season 01:Episode 06:
The Tamiflu Trials
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Medical experts are rushing to see which drugs might help treat COVID-19. There are dozens of candidates: Remdesivir, Hydroxycloroquin, Actemra, Kevzara, Favipiravir, the list goes on. They better pick the right one; because billions of dollars of public money is at stake, not to mention 100s of thousands -- if not millions -- of lives.
We don’t know what will happen with COVID-19 drug research. But the story of past pandemics might give us a clue. To prepare for Swine Flu and Bird Flu, governments spent billions stockpiling a drug called Tamiflu. You’d think governments used the best evidence-based advice, but the story of Tamiflu raises questions about how money shaped the process.
On this episode, we open up the black box of pharmaceutical and public health expertise. We tell the story of a drug, from its days as middling flu treatment through its meteoric rise to international blockbuster. How do experts decide what makes a good drug, and how do pharmaceutical companies make billions from pandemic panic?
Guests:
- Deborah Cohen is a correspondent for BBC Newsnight, and former investigative journalist and editor at the BMJ
- Tom Jefferson is an epidemiologist and Cochrane researcher.
- Melanie Sinclair is a former medical ghost writer
- Jeanne Lenzer is an independent investigative journalist and author.
- Stephen Toovey is an infectious disease doctor and Roche-affiliated consultant and researcher
Key References
BMJ. TAMIFLU IN THE BMJ. Interactive Timeline. Duncan Jarvies.
Bodenheimer, Thomas. “Uneasy Alliance — Clinical Investigators and the Pharmaceutical Industry.” New England Journal of Medicine, vol. 342, no. 20, 2000, pp. 1539–1544., doi:10.1056/nejm200005183422024.
Brownlee, Shannon, and Jeanne Lenzer. “Does the Vaccine Matter.” The Atlantic, Nov. 2009, https://www.theatlantic.com/magazine/archive/2009/11/does-the-vaccine-matter/307723/.
Burns, William. “How Tamiflu Became a Global Blockbuster.” Financial Times, 6 Sept. 2009,
Cohen, D. “Complications: Tracking down the Data on Oseltamivir.” Bmj, vol. 339, no. dec08 3, 2009, doi:10.1136/bmj.b5387.
Cohen, D., and P. Carter. “WHO and the Pandemic Flu ‘Conspiracies.’” Bmj, vol. 340, no. jun03 4, 2010, pp. c2912–c2912., doi:10.1136/bmj.c2912.
Dyer, Owen. “Cochrane Reviewer Sues Roche for Claiming Tamiflu Could Slow Flu Pandemic.” Bmj, 2020, p. m314., doi:10.1136/bmj.m314.
Gupta, Yogendra Kumar et al. “The Tamiflu fiasco and lessons learnt.” Indian journal of pharmacology vol. 47,1 (2015): 11-6. doi:10.4103/0253-7613.150308
HOFFMANN-LA ROCHE INC. Pediatic Advisory Committee Breifing Document. Tamiflu® (RO 64-0796) PAC Briefing Document. 2008
Holmes, Paul. “Tamiflu Launch Media Campaign.” PRovoke, PRovoke Founder/Chair, 17 Oct. 2014, www.provokemedia.com/latest/article/tamiflu-launch-media-campaign.
Jack, A. “Tamiflu: ‘a Nice Little Earner.’” Bmj, vol. 348, no. apr09 2, 2014, doi:10.1136/bmj.g2524.
Jefferson, T O et al. “Neuraminidase inhibitors for preventing and treating influenza in healthy adults.” The Cochrane database of systematic reviews ,3 CD001265. 19 Jul. 2006, doi:10.1002/14651858.CD001265.pub2
Jefferson, T., et al. “Oseltamivir for Influenza in Adults and Children: Systematic Review of Clinical Study Reports and Summary of Regulatory Comments.” Bmj, vol. 348, no. apr09 2, 2014, doi:10.1136/bmj.g2545.
Jefferson, Tom. “Re: Tamiflu Email Exchanges with Roche: BETA Site | The BMJ.” BMJ, www.bmj.com/tamiflu/roche/rr/610792. 2014
Kaiser, Laurent, et al. “Impact of Oseltamivir Treatment on Influenza-Related Lower Respiratory Tract Complications and Hospitalizations.” Archives of Internal Medicine, vol. 163, no. 14, 2003, p. 1667., doi:10.1001/archinte.163.14.1667.
Lenzer, J. “Why Aren't the US Centers for Disease Control and Food and Drug Administration Speaking with One Voice on Flu?” Bmj, vol. 350, no. feb05 8, 2015, doi:10.1136/bmj.h658.
Martin, C., et al. “Oral Oseltamivir Reduces Febrile Illness in Patients Considered at High Risk of Influenza Complications.” International Congress Series, vol. 1219, 2001, pp. 807–811., doi:10.1016/s0531-5131(01)00359-4.
Nicholson, Kg, et al. “Efficacy and Safety of Oseltamivir in Treatment of Acute Influenza: a Randomised Controlled Trial.” The Lancet, vol. 355, no. 9218, 2000, pp. 1845–1850., doi:10.1016/s0140-6736(00)02288-1.
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, Japan. Pharmaceuticals and Medical Devices Safety Information.No. 235. April 2007 . Tokyo. https://www.pmda.go.jp/files/000153157.pdf
Roche. 2009 Annual Report. Roche Group, 2009.
TAMIFLU® (oseltamivir phosphate) capsules, for oral use. Highlights of Prescribing data. Updated 12/2018. FDA
Tinari S, Häner H, Padrutt R. The Tamiflu Saga – A pandemic business. Falo and Rundschau : RSI and SF 1 2011 Jan 120
Toovey, Stephen et al. “Post-marketing assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: an updated review.” Advances in therapy vol. 29,10 (2012): 826-48. doi:10.1007/s12325-012-0050-8
Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and Safety of the Oral Neuraminidase Inhibitor Oseltamivir in Treating Acute Influenza: A Randomized Controlled Trial. JAMA. 2000;283(8):1016–1024. doi:10.1001/jama.283.8.1016
Tricco, Andrea C et al. “Non-Cochrane vs. Cochrane reviews were twice as likely to have positive conclusion statements: cross-sectional study.” Journal of clinical epidemiology vol. 62,4 (2009): 380-386.e1. doi:10.1016/j.jclinepi.2008.08.008
US Department of Health and Human Services. DRAFT- Pandemic Influenza Preparedness and Response Plan. August 2004
USFDA. Centre for Drug Evaluation and Research.. Application Number: 021087. Medical Review Memo. October 25, 1999
USFDA. Department of Health and Human Services. Letter to Joanna McNamara, Hoffman-La Roche Inc.. April 4, 2000.
USFDA. Centre for Drug Evaluation and Research. Approval Package for: NAA 021246/S-027 Trade Name: TAMIFLU. 07/02/2007
USFDA. Office of Good Clinical Practice, Office of Special Medical Programs. GUIDANCE DOCUMENT. Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions. Washington, D.C., USA. JUNE 2017
WHO Guidelines on the Use of Vaccines and Antivirals during Influenza Pandemics. World Health Organization Department of Communicable Disease Surveillance and Response. 2004. WHO/CDS/CSR/RMD/2004.8’
Credits
This episode was produced by Audrey Quinn and Gordon Katic. Editing from Acey Rowe and Gordon Katic. Franklynn Bartol was our research assistant, with fact checking from Aurora Tejeida and Polly Leger. Dr. Joel Lexchin and Professor Sergio Sismondo provided research guidance.
Our theme song and original music is by our composer, Mike Barber. Dakota Koop is our graphic designer. Our production manager is David Tobiasz, and executive producers are Gordon Katic and Sam Fenn.
Thanks to Hannah Arbour for Japanese translation, and Shungo Kano for voicing.
This episode was funded in part by the Social Science and Humanities Research Council of Canada. This is part of wider project looking at trends in pharmaceutical research and policy. Dr. Joel Lexchin at the University of Toronto and Professor Sergio Sismondo at Queens University in Kingston are the research advisors on that project.
Cited is produced out of the Centre of Ethics at the University of Toronto, which is on the traditional land of Mississaugas of the Credit, the Anishnabeg, the Chippewa, the Haudenosaunee and the Wendat Peoples. Cited is also produced out of the Michael Smith Laboratories at the University of British Columbia -- that’s on the unceded territories of the Musqueam, Squamish, and Tsleil-Waututh Nations.
