Federal Court Essential 'Discovery' !!!!!!

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

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/ DePuy’s 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 point” for 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 degilman@egilman.com Department 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 study’s 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/DePuy’s clinical trial of the PHS: the “Multi- center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty” (PIN Study). J&J/DePuy’s 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/DePuy’s 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.

Dallas Federal Court Trial Begins: J&J DePuy Pinnacle Hip

http://www.wfaa.com/story/news/health/2014/09/03/hip-implantspinnaclelawsuit/15041145/

National hip implant trial begins in Dallas

Byron Harris, 1:51 p.m. CDT September 4, 2014

Plaintiffs claim the DePuy Pinnacle hip was not properly tested before being marketed to orthopedic surgeons

DALLAS — A national court case involving thousands of hip implant patients suing a subsidiary of Johnson & Johnson is now underway in Dallas.

The focus is the DePuy Pinnacle hip, which the company quit selling in August 2013.

The pool of plaintiffs is so large that a handful of so-called "bellwether" plaintiffs have been selected from more than 6,000 people who have filed suit. This smaller pool of cases will be argued before juries, and the verdicts will be used to determine settlements against Johnson & Johnson.

Opening arguments in Kathleen Herlihy-Paoli vs. DePuy began Wednesday before U.S. District Judge Ed Kinkeade in downtown Dallas.

Paoli, of Missoula, Montana, got a DePuy Pinnacle implant in 2009. She has now had a combined total of five implants on both her hips, and was hurt by metal-on-metal wear in the DePuy devices that were placed in her body.

Metal-on-metal wear of chrome and cobalt components can create adverse health effects in some patients.

Paoli's attorney, Mark Lanier of Houston, argued that DePuy did not properly test the Pinnacle device before releasing it to the market. Under an FDA provision called 510K, medical devices that substantially resemble other devices already on the market can be released with less stringent testing than original designs.

Lanier told the jury that DePuy ignored failures of the Pinnacle device, and made hundreds of millions of dollars in profits while marketing the device to orthopedic surgeons.

DePuy's attorney, Richard Sarver of New Orleans, said Paoli's problems were caused by improper implantation of the device. He also contended that DePuy never improperly paid physicians to use its devices, and that the medical community has long known of the risks of metal particles.

Joleen Chambers of the Failed Implant Device Alliance has been arguing for increased scrutiny of medical devices for years.

"Before these companies get to market their product, they should have post-market surveillance in place so we can track the devices in real time, permanently," she told News 8.

Chambers has been a vocal opponent of the FDA's role in approving hip implants. "It's [the FDA] not working to prove that these devices are safe before they go to market," she said.

The trial is expected to continue for several weeks.

Last fall, Johnson & Johnson settled a case for $2.5 billion relating to another DePuy hip design involving 8,000 patients.

E-mail bharris@wfaa.com

COURTROOM RULES DO NOT ALLOW PATIENT ADVOCATE TO TAKE NOTES ON COMPUTER 

FOLLOW THE TRIAL HERE.

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https://www.linkedin.com/jobs2/view/19275115?trk=biz-overview-job-post

Director, Federal Affairs, Medical Devices

Johnson & Johnson - Washington, DC, US

Posted September 4, 2014

Job description

Director, Federal Affairs, Medical Devices-8659140703

Johnson & Johnson is currently recruiting for a Director, Federal Affairs, Medical Devices. This position is located in Washington, DC and requires up to 25% travel.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

With $71.3 billion in 2013 sales, Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 127,000 people in 60 countries throughout the world.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Director, Federal Affairs will be responsible to develop, implement and direct federal lobbying activities in support of the corporation’s medical device legislative and policy priorities primarily focused on J&J’s Global Orthopedics business (world’s largest orthopedics company).

A key component of the position is to represent the corporation both internally and externally on federal affairs matters relating to the Centers for Medicare and Medicaid Services, Food and Drug Administration, congressional relations, Administration outreach, relevant trade associations and affiliated patient and physician stakeholder organizations. Some of the official assignments may also require coordination with additional business partners including the pharmaceutical and consumer operations within the Enterprise.

The Director, Federal Affairs will work internally and externally on matters relating to the specific medical device & diagnostics businesses in collaboration with specific franchises as well as represent federal affairs on numerous broader-based healthcare issues and activities. He or she will also work on health care policy and corporate priority assignments within US Government Affairs as determined by managers, such as building relationships with identified stakeholders i.e.: congressional caucuses, patient, physician and other professional societies and stakeholder organizations.

This position requires the incumbent to interact with internal J&J colleagues including US Government Affairs, International, Health Policy Group, J&J Corporate Communications, Law, J&J operating company and Corporate personnel and senior management – specifically J&J’s Global Orthopedics business. External customers including: Members of the US Congress, Administration, state officials and additional J&J customers. This position will report to the Senior Director, Federal Affairs, Medical Devices & Diagnostics.

Qualifications

A minimum of a Bachelor’s Degree is required. An MBA, Masters, JD and/or equivalent graduate degree is preferred with concentration in healthcare policy, political science, communications or business administration preferred. A proven record of success in policy development and advocacy is required. A minimum of 10 years of experience in government affairs or public policy is required. A minimum of 5 years of health policy experience is required. Thorough knowledge of communications, Federal and/or State government policy and legislative process is required. Candidate must be a self-starter with exceptional initiative and ability to work effectively with minimal supervision. Excellent oral and written skills are required.

BE VITAL in your Career; be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-District of Columbia-Washington

Organization: Johnson & Johnson Services Inc. (6090)

Job Function: Government Affairs

Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.

Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Our Family of Companies comprises:

The world's premier consumer health company.

The world's largest and most diverse medical devices and diagnostics company.

The world's third-largest biologics company.

And the world's sixth-largest pharmaceuticals company.

We have more than 250 operating companies in 57 countries employing 120,200 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

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