Researchers(behaving(badly:( Misconduct(in behaving(badly:(Misconduct(in(clinical ... and$inapposite$inacon.$ Researchers(behaving(badly:(Misconduct(in(clinical(trials!

  • View
    220

  • Download
    5

Embed Size (px)

Text of Researchers(behaving(badly:( Misconduct(in behaving(badly:(Misconduct(in(clinical ......

  • Researchers behaving badly: Misconduct in clinical trials

    Charles Seife Professor

    Arthur L. Carter Journalism Ins7tute at NYU

  • Copyright 2015 American Medical Association. All rights reserved.

    From: Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed LiteratureJAMA Intern Med. 2015;175(4):567-577. doi:10.1001/jamainternmed.2014.7774

  • Fraud in published clinical trials?

    We found hundreds of OAI inspec7ons, and hundreds of cases of fraud in clinical trials

    We iden7fied 78 publica7ons associated with those clinical trials

    Of those 78 publica7ons, 3 had any men7on of the fraud in the text, as a retrac7on, a correc7on, or an expression of concern

  • The Journal of Thoracic and Cardiovascular Surgery v. 144, no. 2, pp. 377-382.

  • Investigative Ophthalmology & Visual Science, August 2001, v.52, no.9, pp. 616--6173

  • Novel an7coagulants

    Rivaroxaban (Xarelto) RECORD 1: 3 of 13 (23%) audited sites OAI/unreliable RECORD 2: 4 of 10 (40%) RECORD 3: 1 of 5 (20%) RECORD 4: 8 of 16 (50%) (En7re RECORD 4 study deemed unreliable by FDA)

  • Novel an7coagulants Apixaban (Eliquis) ARISTOTLE Fraud in China; suspected widespread Site 1200: evidence of altera7on of records prior to

    inspec7on FDA recommended exclusion of 24 of 36 Chinese sites

    from analysis

  • Novel an7coagulants Apixaban (Eliquis) All-cause mortality: Everything included: p = 0.0465 Site 1200 excluded: p = 0.0565 W/O 24 China sites: p = 0.0379

  • Novel an7coagulants Dabigatran (Pradaxa) RE-LY:

  • Fraud in published clinical trials? We found hundreds of OAI inspec7ons, and hundreds of cases of fraud in clinical trials

    We iden7fied 78 publica7ons associated with those clinical trials

    Of those 78 publica7ons, 3 had any men7on of the fraud in the text, as a retrac7on, a correc7on, or an expression of concern

    Serious, known, misconduct is usually going unreported in the literature!

  • Four months later: How many correc7ons/EoCs/retrac7ons?

    0

  • Six months later: How many correc7ons/EoCs/retrac7ons?

    0 For every fraud ac7on, there is an equal and inapposite inac7on.

  • Researchers behaving badly: Misconduct in clinical trials

    Charles Seife Professor

    Arthur L. Carter Journalism Ins7tute at NYU

    Journals ----------------

  • Burning ques7ons What really happened? Who did the fabrica7on? Few bad eggs, or ins7tu7onal?

    When did the fabrica7on happen? Why did it go on for so long?

    Where did the fabrica7on happen? Just Houston, or more widespread?

    Why did the fabrica7on happen? Which tests were affected? Which drug companies have to redo these tests? Which drugs were affected? Are they on the market? What did FDA do w/r/t affected drugs?

  • What has FDA said about drugs tested by GVK Biosciences?

  • Researchers behaving badly: Misconduct in clinical trials

    Charles Seife Professor

    Arthur L. Carter Journalism Ins7tute at NYU

    Journals ----------------

    ------------