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

Response to letter to the editor on “Survivorship of a modular acetabular cup system: medium- to long-term follow-up”

“…Dr. Egilman's expert report forms the basis for the article written by Dr. Egilman et al. [2], and Dr. Egilman's LTE coauthors were all paid to assist him with this expert report. Readers will want to consider this apparent conflict of interest when evaluating the reasons for the many inaccuracies in Dr. Egilman's LTE.…”

“…DePuy is aware that up to 3 sites may have had subjects who provided consent to a release of medical records retrospectively for study participation; Dr. Egilman's earlier article [2] states that he is aware of only 2 such sites. Regardless of when consent to a release of medical records was provided, patients who were enrolled into the PIN Study received substantially the same standard of care that they would have received if not enrolled in the study, and obtaining consent to the release of medical records was the initial procedure to allow investigators the ability to provide patient data to DePuy.

“Dr.

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An Introduction to the Journal of Scientific Practice and Integrity

“…8 Considerable attention has been paid to tobacco, 9,10 asbestos, [11][12][13] oil, Big Pharma, medical device companies, and the food and beverage industry. 9,10,[14][15][16][17][18][19][20] Policy changes in the last decades of the 20 th century have created a new climate for scientific research, particularly in the U.S., by increasing the number of industry-academic partnerships. 21 The often cited U.S. Bayh-Dole Act of 1980 allowed university researchers, small businesses, and nonprofit institutions to obtain private patents on federally funded research.…”

Letter to the editor on “ Survivorship of a modular acetabular cup system: medium- to long-term follow-up”

“…Drs. Kindsfater and Lesko acknowledged that at least one site enrolled patients into the PIN study retrospectively, but J&J/DePuy included 93 patients total across 10 separate sites, who signed informed consents after their surgery [1], [5], [6]. Dr. Kindsfater testified about nonconsecutive enrollment at his own site, stating that he would not include “the street person” [7].…”

“…Drs. Kindsfater and Lesko omitted these failures because including them “… without also including further follow-up on all unrevised hips from a similar search of sources outside data collection methods in this study would have introduced bias [1].” Contradictorily, J&J/DePuy included external data when they transferred 31 patients from a stem study into the PIN study [6], [11]. One case report form suggests that J&J/DePuy transferred data from a third source, a company registry called “CaptureWare” [5].…”