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Animal Ethics Biosafety Human Research Ethics Research Integrity

(US) Blood, Lies, and a Drug Trials Lab Gone Bad – WIRED (Brendan I. Koerner | October 2021)

Posted by Dr Gary Allen in Human Research Ethics, Research Integrity on November 20, 2021
Keywords: Clinical trial, Conflicts of interest, Human research ethics, Institutional responsibilities, International, Publication ethics, Research integrity

The Linked Original Item was Posted On October 12, 2021

A cluster of strewn pharmaceuticals with dollar signs printed on the face.

The system for testing pharmaceuticals in the US relies on contractors adhering to strict guidelines. But one of them chose profits over protocols.

THE EMAIL THAT Joe Hagood received in August 2017 was vague and brief, but too unsettling to ignore.

A shocking story from the US.  For us, accounts like this raise a contentious question: Should clinical trials only be conducted by not-for-profit bodies?  Is the status-quo hampered by too compromised by surmountable conflicts of interest?  We have included links to 18 related items.

Hagood worked at Medpace, a Cincinnati company that tests new drugs for pharmaceutical manufacturers. His job was to supervise the independent research centers that Medpace pays to handle the nitty-gritty of human trials: finding volunteers, dispensing medications, tracking side effects. The author of the unsettling email, Justina Bruinekool, was a staffer at one of those centers. She claimed to have an urgent reason for writing: Her employer was fraudulently conducting a major trial that Hagood was overseeing.

The email contained no evidence to support this jarring allegation, so Hagood thought it wise to tread cautiously; he worried that Bruinekool might be a disgruntled employee out to make trouble. In his reply, he thanked her for the tip and politely encouraged her to reach him on his cell phone.

A week passed before Bruinekool called. As soon as he picked up the phone, he could tell by her voice that she was genuinely frightened. A 36-year-old mother of three, including a daughter who would soon be off to college, Bruinekool could not afford to lose her $17-an-hour position at Mid-Columbia Research, the center where she worked. She asked for assurances that Medpace would never reveal her identity to her company’s owner, whom she knew had a vindictive streak.

Cartoon based around the concept of blood research
Blood, Lies, and a Drug Trials Lab Gone Bad - WIRED (Brendan I. Koerner | October 2021)
The system for testing pharmaceuticals in the US relies on contractors adhering to strict guidelines. But one of them chose profits over protocols.

Related Reading

(UK) What’s wrong with research culture? – Chemistry World (Rachel Brazil | September 2021)

(EU) How can institutions and funders help to police questionable research practices? – Nature Index (Dalmeet Singh Chawla | September 2021)

(New Zealand) Managing conflicts of interest: A guide for the public sector – Controller and Auditor-General (June 2020)

(Australia) Michael Briggs 1935-1986. Faked data on the safety of oral contraceptive preparations taken by millions of women – Dr Geoff (December 2017)

(Australia) Clinical Trials and Other Physician-Industry Interactions in Australia – Global Forum (Ric Day | January 2020)

Highlight negative results to improve science – Nature (Devang Mehta | October 2019)

Where Research Meets Profits – Inside Higher Ed (Colleen Flaherty | October 2019)

Disclosure of interests and management of conflicts of interest (NHMRC An Australian Code (2018) good practice guide | August 2019)

Establishing Rules for Ethicists and Ethics Organizations in Academic Publishing to Avoid Conflicts of Interest, Favoritism, Cronyism and Nepotism (Papers: Dr. János Tóth, et al | May 2019)

What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry – New York Times (Charles Ornstein and Katie Thomas | December 2018)

Why do medical journals keep taking authors at their word? – STAT (Ivan Oransky | September 2018)

Institutional Conflicts of Interest and Public Trust – JAMA Viewpoint (Francisco G. Cigarroa, MD | November 2018)

A Major Industry-Funded Alcohol Study Was Compromised. How Many Others Are Out There? – UnDark (Jeremy Samuel Faust | July 2018)

Financial Ties That Bind: Studies Often Fall Short On Conflict-Of-Interest Disclosures – KHN (Rachel Bluth | August 2018)

(US) Hidden conflicts? Pharma payments to FDA advisers after drug approvals spark ethical concerns – Science (Charles Piller & Jia You | July 2018)

The Dying Scientist and his Rogue Vaccine Trial – Wired (Amanda Schaffer | May 2018)

Authors of premier medical textbook didn’t disclose $11 million in industry payments – STAT (Adam Marcus and Ivan Oransky | March 2018)

‘World-class universities’ – The accountability gap – University World News (Paul Benneworth | October 2017)

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