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332813
Manipulation in data presentation to the U.S. Food and Drug Administration (FDA) and the public by DePuy Synthes


Tuesday, November 3, 2015

David Egilman, MD, MPH, Department of Family Medicine, Brown University, Attleboro, MA
Triet Tran, Department of Public Health, Brown University, Providence, RI
From 2008 to 2012, DePuy Synthes carried out extensive manipulation of data related to ion release from metal on metal (MoM) artificial hips in marketing materials. DePuy cherry-picked favorable results and failed to report unfavorable results. In 2009, DePuy used a graphic in their marketing materials which indicated that their MoM released the lowest level of serum Cobalt (Co) ions in-vivo.

Our review of published data indicates that DePuy cherry-picked the lowest value from their clinical studies and compared these levels to the highest values from competitor products’ studies. In addition, they compared different size head diameters and post-surgical time frames to make it appear that their product produced the lowest ion levels. DePuy presented interquartile range instead of the actual range of metal ion levels in their studies. Since the distribution of metal ion levels is positively skewed, the interquartile upper value is notably lower than the true maximum value. DePuy has never published these maximum values.

In 2012, DePuy presented manipulated data to the FDA. They recalculated the 1 and 2-year data with a cherry-picked sample so that all the upper values of Co ion decreased. Additionally, DePuy hid the 5-year data of Co level in serum because it indicated that ion levels increased in years 2-5, which was not consistent with their previous claims. The FDA does not monitor or regulate marketing materials for “grand fathered” or 510K “substantially similar approvals.

Professor David Egilman MD, MPH is the consulting expert for the plaintiff in the upcoming DePuy Pinnacle Hip trial

Learning Areas:

Biostatistics, economics
Ethics, professional and legal requirements
Public health or related laws, regulations, standards, or guidelines

Learning Objectives:
Identify how corporations mislead the decision-making process of the public and health administrators Explain the lies behind the marketing numbers presented to health administrators by corporations Demonstrate the extent of how far corporations go in order to lie to the public an health administrators

Keyword(s): Statistics, Marketing

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I have been working as a researcher in a DePuy's hip legal case.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

Back to: 4089.0: Health Administration Posters: Session 3