A Systematic Review of the Relationship between Plastic Surgery and the Medical Industry

Abstract

Background

The nature and extent of medicine’s relationship with the medical industry is currently a heated issue in medicine. Although the ethical implications of this relationship have been widely discussed in medical journals and the popular media, it is unknown how the current interest in industry issues has affected Plastic Surgery. The aim of this systematic review was to characterize the literature of the past two decades that examines Plastic Surgery’s relationship with the medical industry.

Methods

Three medical databases were searched using Plastic Surgery and industry-related search terms. The quality of selected articles was assessed by two reviewers. The specific data abstracted included the venue of the industry interaction discussed within the article: (1) physician education programs, (2) research partnerships, and (3) clinical settings. Within each of these categories, a comprehensive taxonomy was created to categorize the thematic content of the articles’ discussion.

Results

Of the 465 articles gleaned by the search, 21 met the inclusion and exclusion criteria and were included in the final review. All 21 articles were of a review or editorial-type nature and the majority (57%) discussed the nature or effects of industry’s presence within the clinical setting.

Conclusion

This systematic review revealed the literature’s cursory analysis of Plastic Surgery’s relationship with the medical industry. This project highlighted the need for Plastic Surgery to examine the ethical implications of industry’s support and engagement within the field. Improving this literature is necessary for plastic surgeons to understand and adhere to current standards on acceptable practices.

Within the last five years, physicians of every specialty and type of practice have come under fire from their colleagues,^1–7 professional medical associations,⁸ and even the law^{9, 10} and Congress^{11, 12} for their financial ties to pharmaceutical and medical device manufacturers. In addition to a great deal of attention in high-impact medical journals, the issues have also been treated with heated rhetoric in the popular media,^13–15 with journalists accusing physicians with industry ties as being “entangled in unholy alliances”¹⁶ and of “losing their balance of values as if in the grip of a python.”¹⁷

These issues received prominent national exposure in the spring of 2005 when the U.S. Department of Justice publically began an investigation into the financial relationships between five orthopaedic device manufacturers and orthopaedic surgeons. The five companies (Biomet, DePuy Orthopaedics of Johnson and Johnson, Smith and Nephew, Stryker Orthopaedics, and Zimmer) produce over 90% of the hip and knee implants used in the United States.¹² The intent of the investigation was to uncover whether federal Medicare-Medicaid Fraud and Abuse Anti-Kickback statutes had been violated by the financial transactions between the device companies and their surgeon partners. The alleged violations of the anti-kick back statutes, which prohibit “any remuneration”¹⁸ to physicians for goods or services that are paid for by Medicare or Medicaid, included fraudulent consulting and royalty contracts, inappropriate gifts, and payments to surgeons for using particular implant devices.¹⁹

This investigation pushed discussion of the ethical nature of medicine’s ties to industry into the public spot light. In an effort to avoid extensive federal intervention into healthcare policy and the embarrassment of legal investigations into their own specialty fields, professional medical associations and prominent physician leaders began to advocate for the development of internal protocols that would regulate industry relationships. Subsequently, many professional medical associations, for example the American Association of Orthopedic Surgeons and the American Psychiatric Association, have developed specific guidelines pertaining to their members’ interactions with industry.^11,20

Because these issues are not unique to any particular specialty, we feel it timely to investigate the scope of industry discussion within the Plastic Surgery literature. Fortunately, Plastic Surgery has not yet been in the spot light of these investigations, but with statements from the Department of Justice officials like, “I’ve dealt with the supply issue, now I need to deal with the demand issue”²¹ and “What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,”²² it appears that scrutiny is now turning toward physicians and no specialty is immune to these examinations. This project will systematically review the Plastic Surgery literature that pertains in some way to the relationship between the field of Plastic Surgery and the medical industry. Specifically, our aims are to define the current understanding and interest in this issue as presented in the Plastic Surgery literature and provide guidance for the future research direction regarding this relationship.

Material and Methods

Search Criteria

To gain a current perspective of industry issues within the Plastic Surgery literature, we systemically searched the MEDLINE, PyscInfo, and ISI Web of Science databases. Because we wanted a current perspective on this issue, we chose to retrieve only articles that were published after 1990 and had as a main theme some aspect of the relationship between Plastic Surgery and the medical industry. In each of the three databases, the details of the search terms and boolean operators was the following: “(Plastic Surgery OR reconstructive surgery OR cosmetic surgery) AND (industry OR ethics OR conflict of interest OR financial support OR accountability OR professionalism OR research bias OR kickbacks OR reimbursement incentives).” Within MEDLINE, the “Keywords” and “Exploded MeSH Headings” fields were used in our search, whereas within the PyscInfo and ISI Web of Science databases, the fields searched were “Keywords” and “Topics.”

Inclusion/Exclusion Criteria

Each article gathered by the search was assessed for content. Articles were excluded from further review if their topic did not fall within the domain of Plastic Surgery, if they did not address issues of industry relationships, if they were a duplicate or non-English language article, or if they were published before 1990.

Analysis of Article/Study Characteristics

The articles on the finalized inclusion list were read in entirety to ensure their adherence to the inclusion/exclusion criteria. Using the classification systems of previous systematic reviews concerning financial conflicts of interest and medical ethics,^{23, 24} we classified the included articles into one of the following five types, based on their publication type: (1) Quantitative research, (2) Qualitative research, (3) Non-research, Editorial/Commentary, (4) Non-research, Case Study/Series, (5) Non-research, Letter to the Editor. Other data abstracted pertaining to article characteristics included the year of publication and details of the author’s affiliation, including the location of their institution (American or international) and type of practice (academic or private practice).

Venue of Industry Interaction

A review of the mainstream medical literature that examines industry issues clearly revealed three primary venues for physician-industry interactions: physician education programs, research partnerships, and within the clinical setting. We constructed the following taxonomic system based on these venues and classified the articles accordingly: (1) Industry’s involvement in Physician Education, (2) Industry’s involvement in research, and (3) Physician-industry interaction in clinical practice.

We chose these three categories because, from a national perspective, these are the three areas where industry presence has been scrutinized. An examination of these areas demonstrates the pervasiveness of industry’s reach in the medical field. One recent review article from JAMA revealed that over 50% of the nationwide $3 billion budget for Continuing Medical Education (CME) programs is paid for by drug and medical device manufacturers.²⁵ Due to their high level of support, industry representatives often have roles in CME curriculum development, speaker choice, and other administrative details.^{26, 27} Within the research field, one study published in JAMA determined that industry is responsible for approximately 60% of the funding for all medical research.²⁸ Finally, in a recent survey of over 1500 physicians, 94% reported interacting with industry representatives within the clinical setting.⁷ Of these, the majority constituted receiving either meals or drug samples (83% and 78% respectively), although more than one-third of the respondents had received monetary reimbursements for meetings or CME costs.⁷

Results

Study Retrieval

The systematic search yielded 339 articles from MEDLINE, 37 from PyscInfo, and 89 from ISI Web of Science, giving a total of 465 articles. Upon reviewing the articles and applying the inclusion/exclusion criteria, we eliminated 444 articles, leaving a total of 21 articles to be included in our final review. A selection flow diagram of this process is presented in Figure 1 (FIGURE 1). The articles included in the review are listed in Table 1. (Table 1) Tables 2 and 3 present the data on the study characteristics as well as the details on how the articles were categorized based on their themes. (Tables 2 and 3)

Figure 1.

Flow diagram of systematic search and abstract review process

Table 1.

List of citations of articles included in review

List of Reviewed Citations

Atiyeh BS, Rubeiz MT, Hayek SN. Aesthetic/Cosmetic Surgery and ethical challenges. Aesth Plast Surg. 2008; 32: 829–839.

Ault A. Silicone breast implants may be close to US approval. The Lancet. 2003; 362: 1384.

Dowden RV, Reisman NR, Gorney M. Going off-label with breast implants. Plast Recon Surg. 2002; 110: 323–329.

Gladfelter J. Safely re-integrating silicone breast implants into the plastic surgery practice. Plast Surg Nurs. 2006; 26: 128–131.

Goldberg DJ. Legal ramifications of off-label filler use. Clin Plast Surg. 2006; 33: 597–601.

Gorney M. Plastic Surgery pitfalls. Clin Plast Surg. 1999; 26: 149–159.

Krieger LM, Shaw WW. Wall Street’s assessment of Plastic Surgery-related technology: A Clinical and Financial Analysis. Plast Recon Surg. 2000; 105: 609–616.

McCollough EG. Minimally invasive-minimally effective. Arch Facial Plast Surg. 2007; 9: 293–294.

Meyers AD. Facial Plastic Surgery web site ethics. Arch Facial Plast Surg. 2001; 3: 58–60.

Miller MJ. Tissue engineering. Clin Plastic Surg. 2003; 30: 91–103.

Parker R. Cosmetic surgery in Australia: a risky business? Jour of Law and Med. 2007; 15: 14–18.

Pearson H. In the eye of the beholder. Nature. 2003; 424: 990–991.

Reisman NR. Ethics, Legal issues, and consent for fillers. Clin Plast Surg. 2006; 33: 505–510.

Rohrich RJ. Full disclosure: conflict of interest in scientific publications. Plast Recon Surg. 2006; 118: 1649–1652.

Rohrich RJ. Plastic Surgery Journals: A meeting of minds in Berlin. Plast Recon Surg. 2007; 120: 2101–2105.

Rohrich RJ. Use of off-label and non-approved drugs and devices in Plastic Surgery. Plast Recon Surg. 2003; 112: 241–243.

Sclafani AP. Understanding physician responsibilities and limitations for drug and device off-label use. Facial Plast Surg Clin of North Amer. 2007; 15: 251–254.

Scott L. Liability concerns about implanted material may hurt device availability. Modern Healthcare. June 28, 1993: 90.

Smith DJ. A matter of industry. Ann Plast Surg. 1996; 36: 558.

Webster TJ. Projections for nanomedicine into the next decade: But is it all about pharmaceuticals? Inter Jour Nanomed. 2006; 3: i.

Zbar R, Taylor LD, Canady JW. Ethical issues for the plastic surgeon in a tumultuous health care system: dissecting the anatomy of a decision. Plast Recon Surg. 2008; 122: 1245–1252.

Table 2.

Study Characteristics

Publication Type	Number of Articles
Editorial/Commentary	20
Letter to the Editor	1
Author Affiliation
American Institution	19
International Institution	2
Academic Institution	16
Non-Academic Practice	5
Year of Publication
1990–1994	1
1995–1999	2
2000–2004	7
2005–2009	11

Table 3.

Data Abstraction Details: Articles are arranged alphabetically by primary author

Author	Title	Year	Affiliation	Location	Venue	Theme ‡
Atiyeh	Aesthetic/Cosmetic Surgery and ethical challenges	2008	Academic	International	Clinical	2
Ault	Silicone breast implants may be close to US approval	2003	Non-Academic	American	Educational	4
Dowden	Going off-label with breast implants	2001	Academic	American	Clinical	3
Gladfelter	Safely re-integrating silicone breast implants into the plastic surgery practice	2006	Non-Academic	American	Educational	4
Goldberg	Legal ramifications of off-label filler use	2006	Academic	American	Clinical	3
Gorney	Plastic Surgery pitfalls	1999	Academic	American	Clinical	1
Krieger	Wall Street’s assessment of Plastic Surgery-related technology: A Clinical and Financial Analysis	2000	Academic	American	Research	6
McCollough	Minimally invasive-minimally effective	2007	Non-Academic	American	Clinical, Educational	2,4
Meyers	Facial Plastic Surgery web site ethics	2001	Academic	American	Clinical	1,2
Miller	Tissue engineering	2003	Academic	American	Research	6
Parker	Cosmetic surgery in Australia: a risky business?	2007	Academic	International	Clinical	2
Pearson	In the eye of the beholder	2003	Non-Academic	American	Research	6
Reisman	Ethics, Legal issues, and consent for fillers	2006	Academic	American	Clinical	3
Rohrich	Full disclosure: conflict of interest in scientific publications	2006	Academic	American	Research	6,7
Rohrich	Plastic Surgery Journals: A meeting of minds in Berlin	2007	Academic	American	Clinical, Research	2,7
Rohrich	Use of off-label and non-approved drugs and devices in Plastic Surgery	2003	Academic	American	Educational	5
Sclafani	Understanding physician responsibilities and limitations for drug and device off-label use	2007	Academic	American	Clinical	2,3
Scott	Liability concerns about implanted material may hurt device availability	1993	Non-Academic	American	Clinical	1
Smith	A matter of industry	1996	Academic	American	Educational, Research	4,5,8
Webster	Projections for nanomedicine into the next decade: But is it all about pharmaceuticals?	2008	Academic	American	Research	6
Zbar	Ethical issues for the plastic surgeon in a tumultuous health care system: dissecting the anatomy of a decision	2008	Academic	American	Clinical	1

^‡1 – Ethical concerns with industry gifts, 2 – Effects of printed advertisements, 3 – Ethics of industry advocating off-label device uses, 4 – Ethics of industry involvement in physician education programs, 5 – Physicians’ responsibility to self-educate on industry products, 6 – Importance of collaboration between plastic surgeons and industry, 7 – Importance of financial disclosure in published manuscripts, 8 – Ethical concerns with industry exerting influence to get papers accepted

Results of Analysis of Article/Study Characteristics

All the articles were “review” or “commentary” articles. Also, the majority of the industry-related literature in Plastic Surgery comes from American authors (90%) associated with academic institutions (76%), indicating the focus of these concerns in American academic institutions which often receive substantial amounts of grant funding for medication and medical device research. Finally, with 11 of the articles (52%) being written in 2005 or later, we see that industry topics have been discussed more frequently in recent years.

Venue of Industry Interaction

The discussion of twelve of the articles (57% of the review) focused on industry’s interactions in the clinical setting, whereas 7 (33%) and 5 (24%) of the articles focused on industry’s presence in research and physician education venues, respectively. Eighteen of the articles discussed industry’s role in only one venue, while three discussed industry’s presence in two venues.

Thematic Content

Within each group of articles, we read and identified the themes and issues presented by each article. Within the “clinical setting” group, 6 of the 12 articles discussed the effects of printed advertisements of industry products on physicians’ medical decision-making and called for physicians to seek objective information about industry products. One of these six articles called for outlawing advertisements in medical journals. Four of the 12 articles discussed the potential for ethical concerns to arise when physicians receive gifts or kickbacks from medical device manufacturers. Finally, 4 of the 12 articles discussed the ethical concerns of industry representatives meeting with physicians with the purpose of influencing them to use products for “off-label” purposes.

We used the same methodology to categorize the issues that were discussed within the other groups of articles. Of the 5 articles that discussed industry’s influence in physician education programs, 3 discussed the ethical concerns of industry involvement in CME programs and called for the institution of internal (i.e. non-governmental) regulations of industry funding of CME. The remaining 2 articles discussed the biases inherent in physicians receiving education about products from the manufacturers and recommended that physicians assume responsibility to objectively educate themselves about industry products.

Finally, within the group of 7 articles that discussed industry’s presence in research settings, 5 discussed the importance of collaboration between plastic surgeons and industry for optimizing the new product development process. Two of the articles discussed the importance of disclosure of industry ties in manuscripts that present the results of clinical research, as well as the importance of transparency of industry sponsorship of research in order to preserve the integrity of the Plastic Surgery specialty. Finally, one of the articles discussed the ethical concerns involved with industry exerting influence to have papers or presentations get accepted by journals or meetings.

Discussion

In the last few years the relationship between the medical industry and the field of medicine has come under intense scrutiny. This is in part due to the high-profile Department of Justice investigation into the orthopedic device industry, which finally resulted in the device companies agreeing to a $310 million out-of-court settlement between the five of them.¹² Given the national interest in these issues and because Plastic Surgery is not immune to scrutiny in this area, we undertook this systematic review with the intent of assessing the state of industry discussion in the Plastic Surgery literature. Although our review revealed the industry issues that were discussed, we found several notable biases in this literature that impede a comprehensive understanding of the nature and extent of industry relationships within the field.

A recent study estimated the current body of Plastic Surgery literature to consist of over 100,000 publications.²⁴ Out of this many articles, only 21 addressed some aspect of the relationship between the medical industry and Plastic Surgery, despite the interest this topic has received in many high impact medical journals over the last several years. This demonstrates that the current understanding of industry issues within the field is only cursory and research in this arena is needed in order for Plastic Surgery to fill in these gaps in knowledge. Because Plastic Surgery is a diverse and innovative field that is constantly exposed to new devices and products, industry representatives have a constant presence within this specialty. For this reason, it is important that plastic surgeons are aware of industry’s presence within the different realms of their practices, as well as the current regulations that monitor their engagement. The paucity of discussion of these topics in the literature makes it difficult for plastic surgeons to be aware of the pertinent issues regarding this relationship.

Given that our extensive search rendered only review-type publications, it is impossible to define and quantify exactly how and to what extent industry is engaging Plastic Surgery. Numerous other specialties have undertaken research projects that provide better insight into these questions, including: (1) studies that systematically reviewed the level of industry support for clinical trials,^{23, 24, 29} (2) surveys addressing the types and frequencies of their physicians’ interactions with industry representatives,³⁰ (3) surveys of the financial interests that their specialty’s physicians and academic departments have in pharmaceutical and medical device manufacturing companies,^{31, 32} and (4) studies of the role of industry in funding and planning CME events for their specialty.⁸ Scientific studies of this nature provide valuable knowledge about a specialty’s level of engagement with industry in different settings and these types of projects should be undertaken within Plastic Surgery as well.

Furthermore, given that the majority of the voices that have spoken out about industry issues come from academic departments, it is important to discover how non-academic plastic surgeons are affected by industry interactions and their opinions on what steps need to be taken to ensure an optimal relationship for both parties. It is important that the literature present a perspective on industry issues that is representative of a balanced sampling of different practice-settings, because undoubtedly their interactions with industry are of a different nature.

Following the Department of Justice investigation into the orthopedic industry, the nation’s most influential professional medical associations responded by drafting new codes of conduct to regulate industry interactions with the medical profession. In July 2008, the American Medical Association’s (AMA) Council on Ethical and Judicial Affairs presented its report “Industry Support of Professional Education in Medicine,” which mandated that “individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations must not accept industry funding to support professional education activities. Exceptions should be made for technical training when new diagnostic or therapeutic devices and techniques are introduced.”³³ These suggestions were never officially adopted by the AMA, however, because the AMA House of Delegates voted to reject the Council’s recommendations in June, 2008.

The Institute of Medicine (IOM) and the American Association of Medical Colleges (AAMC) developed similar reports that attempt going even further in regulating industry’s role within different aspects of the medical field. The IOM’s 2008 report on a series of hearings titled “Conflict of Interest in Medical Research, Education, and Practice” calls for the United States Congress to universally enforce the disclosure of financial relationships (over a threshold amount) between industry and physicians/researchers on a public website.³⁴ This recommendation is expected to be made into a law under Congress’ 2009 “Physician’s Sunshine Act” in the very near future, which requires that companies disclose any annual payments to physicians that exceed $100 or be fined $1 million.³⁵ The IOM’s report also deals with physicians’ interactions with industry representatives in the clinical setting, and calls for a zero-tolerance prohibition of all gifts from medical companies to physicians. The report also recommends that guidelines be developed that would define needs-assessments and market-value compensation rates for any work (consulting or other) for which physicians receive industry funding. The IOM also called for a zero-tolerance, no-industry funding policy concerning Continuing Medical Education (CME) programs.³⁴

In 2006, the AAMC responded to industry issues by initiating the Task Force on Industry Funding of Medical Education, which undertook a two-year study on industry funding of medical education. The results of this study and the task force’s recommendations were released in a 2008 report. Their report advises that academic medical centers prohibit industry representatives from giving gifts (of any type or dollar amount) to physicians or students and also that faculty participation in industry-funded conventions be disallowed.³⁶ Many academic centers and medical schools have responded by adopting many of the report’s guidelines and have instituted general-type funds that companies can contribute to in lieu of funding or gift-giving to particular faculty.³⁷

In a similar fashion, the Advanced Medical Technology Association (AdvaMed), an association whose members produce over 90% of the medical devices and diagnostic products sold annually in the United States, instituted a Code of Ethics in 2004 that allows for its members to contribute to “third-party operated” research organizations that autonomously distribute the funds to physician-researchers.³⁸ This system allows manufacturing companies, which collectively have paid over $2 billion to the Federal Government in legal settlements for violating Medicare/Medicaid Anti-Kickback laws,³⁹ to donate to field-advancing research in a way that stands up to outside ethical scrutiny.

Given that the professional associations (AMA, IOM, AAMC, AdvaMed) that authored these reports and guidelines are influential within both the medical fields and the medical industry, it is certain that the physician-industry relationship has been redefined. Although several previously-successful business practices must be abandoned, the remodeled partnership can still be mutually successful for both medicine and industry, and the goals of advancing both fields can be jointly achieved within the bounds of the new strict procedures. By following the new regulations, both parties can be assured that their interactions are transparent, ethically defensible, and will hold up to external scrutiny.