Peter Doshi

Peter Doshi, PhD, is an associate professor in the Department of Practice, Sciences, and Health Outcomes Research.

Peter Doshi, PhD, is an associate professor at the University of Maryland School of Pharmacy and senior editor at The BMJ. His research focuses on the drug approval process, how the risks and benefits of medical products are communicated, and improving the credibility and accuracy of evidence synthesis and biomedical publications.

Doshi campaigns for greater transparency of clinical trial data and has received wide recognition for his work. In 2013, the New York Times reported on Doshi’s work to increase public access to clinical study reports.  The same year he was also chosen for The Wired “Smart List.” In 2015, he received a New Investigator Award from the American Association of Colleges of Pharmacy. Doshi has presented on the topic of clinical trial data sharing to the Institute of Medicine in 2013 and 2014, and served on advisory panels to the European Medicines Agency regarding its policy on proactive publication of clinical trial data.

Much of Doshi’s research has examined the science and politics of influenza policy.  His most cited publication is a Cochrane systematic review of neuraminidase inhibitors for influenza. This review—the first Cochrane review to be based exclusively on clinical study reports and other regulatory documents—challenged previous understandings of the drugs’ effectiveness and raised new questions about their safety, and led to governmental inquiries in the United Kingdom. It is cited as a milestone in the James Lind Library, which chronicles the evolution of fair tests and research synthesis.

Doshi leads the RIAT Support Center. The Restoring Invisible and Abandoned Trials (RIAT) initiative enables researchers everywhere to address two long-standing problems in the biomedical literature: non-publication and misreporting of trials. The RIAT Support Center aims to accelerate the correction of the scientific record of clinical trials by making publications more accurate and more complete, addressing these problems of publication bias and reporting bias.

Doshi earned an A.B. in anthropology from Brown University, an A.M. in East Asian Studies from Harvard University and Ph.D. in history, anthropology, and science, technology and society from MIT. During his PhD, he was an intern at the Japanese Ministry of Health, Labour and Welfare, a research student at the National Institute of Infectious Diseases, Tokyo, and studied as visiting researcher at the University of Tokyo Center for Biomedical Ethics and Law. Doshi completed a fellowship in comparative effectiveness research at Johns Hopkins before joining the faculty at the University of Maryland School of Pharmacy.

Grants

Between 2011 and 2014, Doshi was a co-recipient of a UK National Institute for Health Research grant to carry out a Cochrane review of neuraminidase inhibitors (PI: Carl Heneghan, University of Oxford). In 2015, Doshi received a New Investigator Award from the American Association of Colleges of Pharmacy to fund a PhD student to study consumer medical information about the possible harms of statins (PI: Peter Doshi). From 2015 to 2016, Doshi was a co-investigator on a Patient-Centered Outcomes Research Institute funded grant to compare data from multiple sources (PI: Kay Dickersin, Johns Hopkins University). From 2015 to 2018, Doshi has been a co-investigator in a Cochrane Methods Innovation Fund sponsored project to develop guidance regarding when to use regulatory data in Cochrane reviews (PI: Tom Jefferson). Beginning in 2018, Doshi will be a collaborator on a Canadian Institutes of Health Research funded project “Beyond Transparency in Pharmaceutical Research and Regulation” (PI: Matthew Herder, Dalhousie University, 2018-2022). Doshi is principal investigator of the RIAT Support Center, which was funded by the Laura and John Arnold Foundation (2017-2022).

Please visit the BMJ editorial staff website for a statement of competing interests.

Publications

Writing/speaking on Covid-19:

  1. “The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture” (The BMJ, Nov 1, 2023)
  2. “Concerns about this Cochrane review of COVID-19 vaccines” (Rapid response on Cochrane Library, Oct 23, 2023)
  3. “How many bite the hand that feeds them? Industry funding of self-censorship” (The BMJ, Sep 19, 2023)
  4. “Update: Key Pfizer covid-19 vaccine trial dataset was released in March 2023, and judge orders Moderna and Pfizer 12-15 year old data be made public” (Rapid response on bmj.com, Aug 3, 2023)
  5. “How the case counting window affected vaccine efficacy calculations in randomized trials of COVID-19 vaccines” (Journal of Evaluation in Clinical Practice, July 15, 2023)
  6. Letter to the editor regarding FDA postmarketing vaccine safety study (Vaccine, June 16, 2023)
  7. “We tried to improve COVID vaccine labeling — the FDA said ‘no thanks’” (The Hill, June 9, 2023)
  8. “Sources of bias in observational studies of covid-19 vaccine effectiveness” (Journal of Evaluation in Clinical Practice, March 26, 2023)
  9. “mRNA Covid-19 Vaccines: Another ‘Too big to fail’ Phenomenon?” 34 minute talk given to POLI-COVID-22 conference, Turin, Italy (Nov 21, 2022)
  10. “California COVID misinformation law goes too far” (San Francisco Chronicle, Oct 25, 2022)
  11. “Key Pfizer covid-19 vaccine trial dataset still not released” (Rapid response on bmj.com, Oct 7, 2022)
  12. Open letter to the CEOs of Pfizer and Moderna, requesting clinical trial data (Aug 31, 2022)
  13. “Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults” (Vaccine, Aug 31, 2022)
  14. Our complete July 1 response to Full Fact query regarding their July 28, 2022 fact check
  15. “Serious adverse events of special interest following mRNA vaccination in randomized trials” Preprint; not peer reviewed (Jun 17, 2022)
  16. “Improving the integrity of science: the role of investigative journalism” 10 minute roundtable talk at the “Whistling at the Fake” conference, May 6, 2022 (script)
  17. Public statement at FDA VRBPAC advisory committee meeting to discuss long term planning for Covid-19 vaccines, April 6, 2022 (video begins at 5:34:44; script)
  18. “The end of the pandemic won’t come from biology or medicine — it will come from us” (Washington Post, Feb 10, 2022)
  19. “Universities should stop mandating COVID vaccinations” (Baltimore Sun, Feb 8, 2022)
  20. “Covid-19 vaccines and treatments: we must have raw data, now” (The BMJ, Jan 19, 2022)
  21. “Evaluating covid-19 vaccine efficacy and safety in the post-authorisation phase” (The BMJ, Dec 23, 2021)
  22. “The end of the pandemic will not be televised” (The BMJ, Dec 14, 2021; followup letter Jan 25, 2022)
  23. Roundtable talk, “Four reasons to reject covid-19 vaccine mandates,” Maryland State Medical Society, Nov 6, 2021 (slides; script)
  24. Testimony at expert panel on federal vaccine mandates and vaccine injuries. Nov 2, 2021 (video begins at 1:18:38 and 2:26:37; slides on request; script — Update: original video removed by YouTube.)
  25. “Enabling access but ensuring people retain the right to choose” Comments submitted to FDA VRBPAC advisory committee meeting, Oct 26, 2021. (formal comments)
  26. “Covid-19: Spreading vaccine “misinformation” puts licence at risk, US boards tell physicians” (The BMJ, Oct 1, 2021)
  27. Public statement at FDA VRBPAC advisory committee meeting, Sep 17, 2021. 3 minutes. “Safety and efficacy of a 3rd dose” (video begins at 4:30:27; script; slides)
  28. “Transparency of covid vaccine trial data” 8 minute talk in The BMJ’s “Known Unknowns” webinar series (Sep 9, 2021)
  29. “Vaccine mandates: a new form of ‘institutional segregation’” (Baltimore Sun, August 31, 2021)
  30. “Does the FDA think these data justify the first full approval of a covid-19 vaccine?” (BMJ Opinion, Aug 23, 2021)
  31. “Transparency of COVID-19 vaccine trials: decisions without data” (BMJ Evidence Based Medicine, Aug 9, 2021)
  32. “Covid-19 vaccines for children: hypothetical benefits to adults do not outweigh risks to children” (BMJ Opinion, July 13, 2021)
  33. Public statement at FDA VRBPAC advisory committee meeting to discuss Covid-19 vaccines in children, June 10, 2021 (video begins at 4:08:35; slides; script)
  34. “Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year” (BMJ Opinion, June 8, 2021)
  35. “Covid-19 vaccines: In the rush for regulatory approval, do we need more data?” (The BMJ, May 18, 2021)
  36. “FDA response to BMJ on reports of death after covid-19 vaccination” (Rapid response on bmj.com, April 21, 2021)
  37. “Response to Gupta and colleagues” (Rapid response on bmj.com, April 8, 2021)
  38. “Incorrect Statement” (comment posted on jama.com, Mar 2, 2021)
  39. Public statement at FDA VRBPAC advisory committee meeting to discuss Janssen’s EUA application, Feb 26, 2021 (video begins at 4:46:40; script)
  40. “Transparency & Covid-19 vaccines.” 8 minute talk in The BMJ’s Known Unknown webinar series (Feb 25, 2021)
  41. “How to Fix the Coronavirus Vaccine Rollout: Don’t Pressure the Vaccine-Hesitant.” (New York Times, Jan 7, 2021)
  42. “Pfizer and Moderna’s “95% effective” vaccines—we need more details and the raw data” (BMJ Opinion, Jan 4, 2021)
  43. “Did the FDA understaff its review of the Pfizer/BioNTech vaccine?” (Stat News, Dec 17, 2020)
  44. “How to Expand Access to COVID Vaccines without Compromising the Science” (Scientific American, Dec 17, 2020)
  45. “Let’s be cautious and first see the full data” (Public statement at FDA VRBPAC advisory committee meeting to discuss Pfizer’s EUA application, Dec 10, 2020; video begins at 3:11:04 slides and script)
  46. “Determining the infectious potential of individuals with positive RT-PCR SARS-CoV-2 tests” (Clinical Infectious Diseases, Dec 4, 2020)
  47. “Covid-19 Vaccine Trials.” Short talk to the Global Investigative Journalism Network (Dec 3, 2020)
  48. “Pfizer and Moderna’s ‘95% effective’ vaccines—let’s be cautious and first see the full data” (BMJ Opinion, Nov 26, 2020)
  49. “Covid-19 Vaccine Trials” (Public statement at FDA advisory committee (VRBPAC) meeting, Oct 22, 2020; video begins at 5:21:23; slides and script)
  50. “Will covid-19 vaccines save lives? Current trials aren’t designed to tell us” (The BMJ, Oct 21, 2020)
  51. “Covid-19 vaccine trial protocols released” (The BMJ, Oct 21, 2020)
  52. “How clinically serious is SARS-CoV-2 infection for children and young adults?” (Rapid response on bmj.com, Oct 12, 2020)
  53. “Are We Testing Coronavirus Vaccines the Right Way?” (New York Times, Sept 22, 2020)
  54. “Covid-19: Do many people have pre-existing immunity?” (The BMJ, Sept 17, 2020)
  55. “Covid-19: Should doctors recommend treatments and vaccines when full data are not publicly available?” (The BMJ, Aug 24, 2020)

Current PubMed search results for “Doshi Peter”

Current Google Scholar search results for “Peter Doshi”

Many of Doshi’s publications are available for free through special links listed on the University of Maryland, Baltimore’s Digital Archive.  (To access the free, full-text, look for the “External Resource/s: Full Text” link on each article’s individual webpage.)

Selected publications

  • Doshi P, Dickersin K, Healy D, Vedula SS, Jefferson T. Restoring invisible and abandoned trials: a call for people to publish the findings. BMJ. 2013 Jun 13;346:f2865. doi:10.1136/bmj.f2865 (Free full text)
  • Doshi P, Jefferson T, Del Mar C. The imperative to share clinical study reports: recommendations from the tamiflu experience. PLoS Med. 2012 Apr 10;9(4):e1001201. doi:10.1371/journal.pmed.1001201 (Free full text)
  • Doshi P, Goodman SN, Ioannidis JPA. Raw data from clinical trials: within reach? Trends in Pharmacological Sciences 2013;34(12):645-647. doi:10.1016/j.tips.2013.10.006
  • Persaud N, Doshi P. North American regulatory agencies can and should make clinical trial data publicly available. Canadian Medical Association Journal. 2015 Oct 13;188(2):96-7. doi:10.1503/cmaj.150679
  • Doshi P. Influenza vaccines: Time for a rethink. JAMA Intern Med. 2013 Mar 18;173(11):1014-1016. doi:10.1001/jamainternmed.2013.490
  • Doshi P. 2008. Trends in recorded influenza mortality: United States, 1900-2004. Am J Public Health. 98(5):939-945. doi:10.2105/AJPH.2007.119933
  • Jefferson T, Jones M, Doshi P, Spencer EA, Onakpoya I, Heneghan CJ. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. BMJ. 2014 Apr 9;348:g2545. doi:10.1136/bmj.g2545 (Free full text; also see full Cochrane Review)
  • Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open. 2013 Feb 26;3(2):e002496. doi:10.1136/bmjopen-2012-002496 (Free full text)
  • Hung A, Sieluk J, Doshi P. The Untapped Potential of Pharmacy Leaflets for Informing Patients About Drug Benefits and Risks. JAMA Intern Med. 2016 Jan;176(1):11-2. doi: 10.1001/jamainternmed.2015.6656.
  • Sieluk J, Palasik B, dosReis S, Doshi P. ADHD medications and cardiovascular adverse events in children and adolescents: cross-national comparison of risk communication in drug labeling. Pharmacoepidemiol Drug Saf. 2017 Mar;26(3):274-284. doi:10.1002/pds.4164
  • Doshi P. Influenza: marketing vaccine by marketing disease. BMJ. 2013;346:f3037. doi:10.1136/bmj.f3037 (Free full text)
  • Doshi P, Hur P, Jones M, Albarmawi H, Jefferson T, Morgan DJ, et al. Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011. JAMA Intern Med. 2017 Oct 1;177(10):1452-1459. doi:10.1001/jamainternmed.2017.3820

Selected Op-Eds and Blog Posts

  • Doshi P, Jefferson T. 2012. Drug data shouldn’t be secret. New York Times op-ed
  • Doshi P, Mandl K, Bourgeois F. 2016. Tamiflu For All? Evidence Of Morbidity In CDC’s Antiviral Guidelines. Health Affairs Blog
  • Doshi P. 2017. Speed vs safety in the FDA’s new drug approvals—speed wins, again. BMJ Opinion
  • Doshi P. 2020. Are We Testing Coronavirus Vaccines the Right Way? New York Times op-ed
  • Doshi P. 2020. How to Fix the Coronavirus Vaccine Rollout: Don’t Pressure the Vaccine-Hesitant. New York Times op-ed

Selected Video and News Features

Contact Information:
Peter Doshi
School of Pharmacy
220 Arch Street
Floor 12, Room 01-228
Baltimore, MD 21201
Phone: +1 410 706 0527
Fax: +1 410 706 5394
Email: pdoshi@rx.umaryland.edu