Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Thursday, December 28, 2017

21% of clinical trials published in high- impact general medicine journals were motivated by marketing purposes rather than scientific objectives

http://www.tandfonline.com/doi/full/10.1080/08989621.2017.1405259
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Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system
Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon & David S. Egilman
To cite this article: Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon & David S. Egilman (2018) Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system, Accountability in Research, 25:1, 37-66, DOI: 10.1080/08989621.2017.1405259


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ABSTRACT
In 2001, DePuy, a wholly-owned subsidiary of Johnson & Johnson (J&J/DePuy), initiated a seeding study called the Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty(PIN Study). J&J/DePuy designed this study to develop new business opportunities during the launch of their Pinnacle Hip System (PHS) and generate survivorship data for marketing. This arti- cle, the first review of a seeding trial for a medical device, examines internal company documents relating to the PIN Study; the analysis herein focuses on the integrity of J&J/ DePuys research practices in conception, implementation, and analysis. J&J/DePuy violated the study protocol and manipulated data; consented participants in violation of stan- dards protecting human subjects; and did not secure Institutional Review Board approval for all study sites. J&J/ DePuy used PIN Study results as the fundamental selling pointfor the PHS. Medical device seeding trials are distinct from previously-documented pharmaceutical seeding trials because companies can profit directly from device sales and because these studies may be the first clinical evaluation of the device (as was the case for the PIN Study). Seeding trials are malleable marketing projects, not rigorous scientific studies. Regulatory bodies, physicians, and others should be vigilant for persuasive marketing accounts disguised as science.
Introduction
Seeding trials are clinical trials designed by pharmaceutical and medical device companies to promote the use of their products. They are typically conducted as part of a marketing strategy for products that are either under review, cleared, or recently approved by the U.S. Food and Drug Administration (FDA) (Hill et al. 2008; Krumholz, Egilman, and Ross 2011; Sox and Rennie 2008). Hill et al. recognize that [s]eeding trials are
CONTACT David S. Egilman page2image5869920degilman@egilman.com page2image5870128Department of Family Medicine, Brown University 8 North Main St, Suite 404 Attleboro, MA 02703, USA
Color versions of one or more of the figures in the article can be found online at
www.tandfonline.com/GACR.
Published with license by Taylor & Francis Group, LLC © 2017 [Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon, and David S. Egilman] This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http:// creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.


designed to appear as if they answer a scientific question but primarily fulfill marketing objectives(Hill et al. 2008). Seeding trials typically demonstrate four traits as follows (Hill et al. 2008; Kessler et al. 1994):
  1. (1)  Marketing objectives influence study conception and design.
  2. (2)  Marketing objectives influence data collection and analyses.
  3. (3)  The studys marketing goals are concealed from doctors, patients, and
    Institutional Review Boards (IRBs).
  4. (4)  The study sponsor implements unscientific research practices.
In a recent descriptive study, Barbour et al. also found that seeding trials tended to recruit patients from a large number of study sites so that the average number of patients per site was very small (Barbour et al. 2016). These researchers concluded that 21% of clinical trials published in high- impact general medicine journals were motivated by marketing purposes rather than scientific objectives (Barbour et al. 2016).
There are several systematic reviews of company documents regarding the use of seeding trials to promote pharmaceuticals (Hill et al. 2008; Krumholz, Egilman, and Ross 2011). This is the first study of a seeding trial that was designed to promote the sale of a medical device.
Confidential internal documents made public as a result of recent litiga- tion against Johnson & Johnson and its subsidiary DePuy Synthes, offer an insight into a seeding trial conducted with the Pinnacle Hip System (PHS) implant. The PHS is a four-part modular artificial hip for total hip replace- ment surgeries, including metal, polyethylene, and ceramic liners (see Figure 1). The metal-on-metal (MoM) configuration of the PHS was the subject of recent litigation against J&J/DePuy alleging product liability and personal injury for this product.
This analysis focuses on J&J/DePuys clinical trial of the PHS: the Multi- center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty(PIN Study). J&J/DePuys previously-confidential internal documents were systematically reviewed for characteristics of a seeding trial, and it was found to display all four features described above. Internal documents show that J&J/DePuys marketing department conceived of the PIN Study in 1999 and subsequently had an integral role in the design, funding, implementation, analysis, and dissemination of the findings. Document review and analysis also revealed the impact of marketing parti- cipation in the study conception, design, data collection and analysis, IRB, and informed consent. This systematic review contributes to the literature on seeding trials and litigation-generated data on corporate and regulatory behavior.

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Published with license by Taylor & Francis Group, LLC © 2017 [Joan E. Steffen, Ella A. Fassler, Kevin J. Reardon, and David S. Egilman]

This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted.

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