Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system

Figures & data

Figure 1. The Pinnacle Hip System (PHS). The PHS has four components: The shell or cup (Bantam®, Primary®, Duofix®, and Revision®); a liner made from Co-Cr-MO (Ultamet®, Ultamet XL®), polyethylene (Marathon® and Altrx®) or alumina ceramic (Biolox® Delta); a stem made from titanium (C-Stem®, Corail®, AML®, Endurance®, Prodigy®, Replica®, S-Rom®, Summit Duofix®, Summit Porocoat®, Summit Stem Cemented®); and a head made of Co-Cr-MO (M-Spec®, aSphere®) or alumina ceramic (Biolox® Delta).

Figure 2. Primary contents of the PIN Study poster presented at the 2007 AAOS conference. The false statements are boxed in red.

Table 1. PIN Study IRB approvals (deposition Exhibit Forster-20; deposition Exhibit Forster-21; deposition Exhibit Forster-22; deposition Exhibit Forster-23; deposition Exhibit Jewell-06; Exhibit PLT-03482; Exhibit PLT-03517).

Site number	Date of Earliest IRB Approval	Time from Earliest Patient Implant Date to IRB Approval	Number of Patient Implants Before IRB Approval	Number of Total Patient Implants Enrolled in Study
1	None	Never Approved	50	50
2	12/21/2004	~2.5 years	398	454
3	1/6/2005	~1.5 years	31	120
4	1/6/2005	~1.5 years	15	40
5	12/21/2004	n/a	0	30
6	12/8/2004	~3.25 years	181	277
7	Rejected 9/14/2005	Never Approved	71	71
8	1/26/2005	n/a	0	50
9	12/21/2004	n/a	0	88
10	None	Never Approved	32	32
11	3/17/2005	n/a	0	68
12	4/6/2005	n/a	0	49
13	6/22/2005	n/a	0	111
14	7/12/2005	n/a	0	59
17	6/1/2006	n/a	0	16
98	None	Never Approved	28	28
99	Unknown	?	?	50
		TOTAL:	806	1,593

Figure 3. Header for altered patient medical release from site ten (Exhibit PLT-03517).

Table 2. “Red Flags” to aid in the identification of seeding trials.

Examples of “Red Flags” for seeding trials

Study design may incentivize investigators to use one drug or device over another Study initiated just before or shortly after a drug or device reaches the market (Sox and Rennie 2008) Protocols lacking clear indication of what is being analyzed Research that is un-blinded and/or lacking a control (Sox and Rennie 2008) Studies with a short follow-up time (Sox and Rennie 2008) Studies with a high number of study sites and a low number of patients per site (Barbour et al. 2016) Studies with company employees as authors (Barbour et al. 2016)

Sox, H. C., and D. Rennie. 2008. Seeding trials: Just say “no”. Ann Intern Med 149 (4):279–80.

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Barbour, V. M., D. Burch, F. Godlee, C. Heneghan, R. Lehman, R. Perera, J. S. Ross, and S. Schroter. 2016. Characterisation of trials where marketing purposes have been influential in study design: A descriptive study. Trials 17 (31):1-10.

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