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Original Contribution  |   July 2020
Evaluating Financial Conflicts of Interest Among Contributors to Clinical Practice Guidelines of the American College of Obstetricians and Gynecologists
Author Notes
  • From the Department of Obstetrics and Gynecology (Drs Wright, Frye, Solis, Guevara, and Smith) and the Center For Health Sciences (Drs Checketts and Vassar) at Oklahoma State University in Tulsa. Dr Wright is a fourth-year resident. 
  • Financial Disclosures: None reported. 
  • Support: None reported. 
  •  *Address correspondence to Micah R. Wright, DO, Oklahoma State University, OB/GYN Residency Program, 717 S Houston Ave Ste 200, Tulsa, OK 74127-9023. Email: micahrw@okstate.edu
     
Article Information
Obstetrics and Gynecology / Practice Management / Professional Issues
Original Contribution   |   July 2020
Evaluating Financial Conflicts of Interest Among Contributors to Clinical Practice Guidelines of the American College of Obstetricians and Gynecologists
The Journal of the American Osteopathic Association, July 2020, Vol. 120, 462-470. doi:https://doi.org/10.7556/jaoa.2020.059
The Journal of the American Osteopathic Association, July 2020, Vol. 120, 462-470. doi:https://doi.org/10.7556/jaoa.2020.059
Abstract

Context: Patient care is an essential part of the practice of obstetrics and gynecology, and patient care is directed by clinical practice guidelines. To increase the validity of these guidelines, we must make sure that there is no outside influence by financial conflicts of interest.

Objective: To investigate the existence of and reporting patterns regarding payments received by contributors to guidelines from the American College of Obstetricians and Gynecologists (ACOG), ACOG executive committee members, and companies making these payments and to examine the compliance of those receiving payments to ACOG's conflict of interest policies.

Methods: The Center for Medicare and Medicaid's Open Payments database was used to search practice bulletin committee members and practice bulletin collaborators from 2014-2016, as well as current executive committee board members. Open Payments was also used to evaluate companies that provided payments, and amounts were totaled. The main outcome measure was the monetary values of payments received and the compliance with disclosure statements enforced by ACOG. Manufacturer payments to physicians in the database were analyzed descriptively.

Results: General and research payments were calculated among 65 physicians in the Open Payments database: 44 physician members of both the obstetrics and the gynecology practice bulletin committees, 4 2016 ACOG executive board physician members, and 17 contributing physician authors. Research payments accounted for greater than 78% of all payments. Consulting, travel and lodging, and speaking fees totaled greater than $90,000 and contributed to more than 90% of the total amount of general payments. Food and beverage payments contributed to 10% of all general payments. Three covered members were noncompliant with the financial conflicts of interest guidelines, receiving industry payments exceeding $5000.

Conclusion: A small number of companies provide the majority of contributions; however, there is no evidence to suggest bias toward manufactures within ACOG practice bulletins. Future investigations into pharmaceutical manufacturer payments, specifically for consulting fees, may be warranted. (Clinical Trial Registry UMIN-CTR, UMIN000029165)

A substantial body of evidence affirms the detrimental effects of financial conflicts of interest (FCOI), including their influence on physicians’ prescribing practices and interpretations of clinical trial results.1 A retrospective study of industry payments to physicians found that obstetrics and gynecology (OB/GYN) ranked fourth out of 35 medical specialties for receipt of industry payments to individual physicians.2 The same study also reported that OB/GYN physicians as a whole received 3.1% of the overall total payments received by all physicians, ranking the specialty seventh among the 35 listed specialties.2 Recently, a study of more than 279,000 physicians across multiple specialties found that industry-sponsored meals with a mean value of less than $20 were associated with increased rates of prescribing the brand name medication being promoted, at significantly higher costs to Medicare beneficiaries. 
In the field of OB/GYN, standardization of practice is an important therapeutic goal due to widespread variability in clinical practice.3 Standardization of practice is critical to avoid repetitious errors within patient management. Clinical practice guidelines (CPGs) are created, in part, to improve standardization and encourage the delivery of evidence-based patient care. Limited evidence has suggested that a physician's adherence to CPG recommendations may be a basis for exoneration in lawsuits and may decrease the likelihood of attorneys taking up a particular lawsuit.4 On the other hand, failure to comply with CPGs may make physicians culpable in malpractice litigation.5 The development of CPGs under an ethically driven, transparent process (including a systematic review of the evidence) is highly desirable. 
The American College of Obstetricians and Gynecologists (ACOG) practice bulletins provide recommendations that are widely considered the clinical standard for management in the OB/GYN community. These practice bulletins make recommendations based on the quantity and quality of evidence. Some research would suggest that many obstetrics and gynecology practice bulletins contain recommendations based on low-quality evidence (level C); in particular, 37% of the practice bulletin recommendations are based on expert opinion.6 Since expert opinion has been shown to be subject to bias,7 transparent and bias-limiting safeguards must be adopted for writing and revising ACOG practice bulletins. 
The passage of the Physician Payments Sunshine Act of the Patient Protection and Affordable Care Act8 (hereafter referred to as Open Payments) has provided a means to verify the FCOI of practice bulletin committee members and contributors by creating a publicly accessible mechanism to monitor the nature of payments that physicians receive from the pharmaceutical and device industry. 
Open Payments Information
This federal program requires applicable group purchasing organizations and applicable manufacturers (Figure 1) to submit annual payment data or transfers for any value greater than $10 paid to physicians or teaching hospitals. Payments are divided into the following categories as identified in Open Payments: 
Figure 1.
Mean general payment from 2014-2016 for physicians of all specialties, all obstetrics and gynecology (OB/GYN) physicians, practice bulletin (PB) committee members, PB contributing physicians, and executive committee members for 2016. aNumber of physicians receiving payments is shown in parentheses.
Figure 1.
Mean general payment from 2014-2016 for physicians of all specialties, all obstetrics and gynecology (OB/GYN) physicians, practice bulletin (PB) committee members, PB contributing physicians, and executive committee members for 2016. aNumber of physicians receiving payments is shown in parentheses.
■ General payments: Consulting fees, speaking fees, honoraria, gifts, entertainment, food and beverage, travel and lodging, education, and so forth 
■ Research payments: Payments associated with a research study, including basic and applied research and product development 
■ Associated research payments: Funding for a research project or study for which the physician is named as a principal investigator 
■ Ownership: Ownership and investment interest in companies, which describes both the actual dollar amount invested and the value of the ownership or investment interest; records may have 1 or both of these values associated with them 
Practice Bulletin Committee
Part of our investigation examined the practice bulletin committee structure. Each committee has 11 members, 1 executive board member, and 2 junior physician members. ACOG states that committee membership is for a 1-year term; however, individuals may be reappointed for up to 3 years unless there is a membership term policy. Committee members that are selected as chairs may serve up to 2 additional years. Continued committee service depends on satisfactory performance. 
In this study, we sought to evaluate whether potential biases could exist within ACOG practice bulletins by investigating the nature of payments made to practice bulletin committee members for OB/GYN, physicians collaborating on bulletin development, and ACOG executive committee members. We investigated compliance of committee members and collaborating physicians with ACOG's FCOI policies. Finally, we examined the companies dispensing payments to the practice bulletin authors to determine whether these companies manufacture and sell products related to the practice bulletin topic. 
Methods
We conducted a cross-sectional study of the Center for Medicare and Medicaid's Open Payments database; therefore, this study did not meet the regulatory definition of human subject research as defined in 45 CFR 46.102 (d) and (f) of the Department of Health and Human Services’ Code of Federal Regulations and was not subject to institutional review board oversight. This study is registered in the University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR, UMIN000029165), and data from this study are publicly available on figshare (https://figshare.com/s/35e75498a58ca31678b0). In developing the methods for this study, we consulted Mitchell et al.9 
We limited our search to January 2014 to December 2016, as Open Payments data are not available before 2014. Our search was confined to a list of practice bulletin committee members and physicians collaborating with bulletin development located on ACOG's website (https://access.acog.org/eweb/ACOGResponsivePage.aspx?webcode=commlist&site=congress). Executive board committee members from 2016 were also included in this search. 
We used the Centers for Medicare and Medicaid Services Open Payment Database (https://www.cms.gov/openpayments/) to manually input names. Data from 2016-2017 were extracted by M.R.W. We excluded members who were not physicians, as data are not available for nonphysicians using Open Payments. In cases of duplicate search results due to common names, middle initials were used when possible. We also matched physicians by institution and location. If physicians’ names were not returned from searches or did not match the information provided by Open Payments, they were considered to have received $0 in payments from industry. 
To ensure the validity of our data, each author was searched twice, once by the primary investigator (M.R.W.) and again by another team member (L.S. or C.G.). This review process was accomplished by reentering each physician's first and last name into Open Payments, selecting the correct physician from the search returns, and verifying all payment data. Any discrepancies were flagged and resolved jointly between the investigators. Third-party adjudication was not needed. 
We included all general payments and research payments reported from 2014-2016, which encompassed direct payments, indirect payments, or other transfers of value made to physicians by applicable manufacturers or commercial donors. We did not set a minimum dollar value threshold for including members in data extraction. After conducting this search, the information associated with each author was organized, including payment type, payment source, payment subtype, individual payment amount, and total payment amount. Company payments were organized by payment category, total amount received by each group, and type of payment. 
ACOG FCOI Policy
Among our objectives was to evaluate whether practice bulletin committee members adhered to ACOG's FCOI policies. Within ACOG's policy statement addressing FCOI, 2 separate groups, covered individuals and noncovered individuals, were identified and held to different standards for reporting.11 This policy states that “a ‘covered individual’ (executive board members, committee chairs, task force chairs, and executive staff) or the covered individual's spouse shall not have a FCOI in excess of $5000 (except in blind trust, exchange traded funds, or through mutual fund investments) in an individual pharmaceutical company or an individual manufacturer of medical instruments, devices, or equipment. Covered individuals are also not permitted to accept anything of value in excess of $50 at a time, with a maximum annual limit of $250 for their personal use from a single pharmaceutical company or a manufacturer of medical instruments, devices, or equipment, except for items for clinical investigations or studies conducted according to federal requirements.” ACOG's FCOI policy states that “no covered individual is allowed to be on a speaker's bureau of a pharmaceutical company or a manufacturer of medical instruments, devices, or equipment, or to have a consulting or advisory arrangement with a pharmaceutical company or a manufacturer of medical instruments, devices, or equipment, except in relation to clinical investigations or studies conducted in accordance with federal requirements.” Finally, “no covered individual is permitted to serve on a corporate board of a pharmaceutical company or a manufacturer of medical instruments, devices, or equipment.”10 
Results
Of the 128 physicians identified, 65 were found to be listed in the Open Payments database as having received at least 1 form of general payment from an applicable manufacturer, and 10 were listed as receiving specific research payments. Of the 65 physicians with payment data available, 44 were members of both the obstetrics and the gynecology practice bulletin committees, 4 were members of the 2016 ACOG executive board, and 17 contributed to the bulletins. Eleven physicians were recorded as receiving greater than $1000 in general payments, 2 received greater than $5000, and 1 received greater than $10,000. 
Open Payments reported that the mean general payment for OB/GYN physicians in 2014, 2015, and 2016 was $2060.76 (22,759 total physicians), $1322.04 (833 total physicians), and $769.24 (804 total physicians), respectively. The mean general payments for all physicians in 2014, 2015, and 2016 were $3379.13 (623,466 total physicians), $3269 (630,104 total physicians), and $3273.71 (629,470 total physicians), respectively (Figure 2). Over the 3 years of payments evaluated, the median general payment received by all physicians included in our study was calculated at $147.11, with a mean of $2845.77. 
Figure 2.
Payments received by practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins and American College of Obstetricians and Gynecologists (ACOG) executive committee members. General payments excluding food and beverages were calculated separately. Data are stratified by payment type. Abbreviation: PB, practice bulletin.
Figure 2.
Payments received by practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins and American College of Obstetricians and Gynecologists (ACOG) executive committee members. General payments excluding food and beverages were calculated separately. Data are stratified by payment type. Abbreviation: PB, practice bulletin.
General payments from 2014-2016 totaled to $101,575.21 from 47 companies; 44 Practice Bulletin members received a total of $60,403.03 (59% of the total across all 3 years), 17 physicians who contributed to the bulletins received $40,680.74 (40%), and 4 executive board members (2016 only) received a total of $526.59 (0.005%). To show a more accurate representation of payments, general payments to physicians were broken down into categories. Among all general payments, food and beverage payments totaled $10,599.21, and the remaining $90,973 comprised other general payment categories (honoraria and consulting, travel and lodging, and speaking fees; Figure 3). 
Figure 3.
Amount of general payments by top contributing companies to practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members. aNumber of physicians receiving payments represented in parenthesis.
Figure 3.
Amount of general payments by top contributing companies to practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members. aNumber of physicians receiving payments represented in parenthesis.
Top contributing companies were identified as those making contributions greater than $1000. A total of 47 companies were identified as making payments to 56 physicians included in our analysis, but only a small number of companies, 13 in total, were marked as top contributors, with 2 contributing greater than $20,000; 2, greater than $10,000; 1, greater than $5000; and 8, greater than $1000 (Figure 4). 
Figure 4.
Research payments by companies to obstetrics and gynecology practice bulletin committee members, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members.
Figure 4.
Research payments by companies to obstetrics and gynecology practice bulletin committee members, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members.
Of the 128 physicians in our sample, 10 were listed as receiving research payments directly. These received a mean research payment of $28,191, with a median of $13,437. Research payments from 2014-2016 totaled to $371,198.86; 5 practice bulletin members received a total of $114,983.37 of that total (31%), and 5 physicians who contributed to the bulletins received $256,215.49 (69%; greater than $5000, and 8 greater than $1000. 
We found that 3 covered individuals accepted more than $50 as a single payment from a pharmaceutical company or individual manufacturer, with 2 of the 3 accepting more than $250 annually from the same pharmaceutical company or individual manufacturer. 
Discussion
Our study evaluated financial relationships between industry manufacturers and practice bulletin committee members, collaborating physicians, and ACOG executive board committee members. Our data were compiled from the Center for Medicare and Medicaid's Open Payments database. 
In our study, general payment and research payment total amounts were calculated among each group. Because a large amount of research funding is industry sponsored, it is common for academic physicians to receive these payments.11 Fees for consulting, travel and lodging, and speaking totaled greater than $90,000 and contributed to more than 90% of the total amount of general payments. 
General payments received by ACOG-covered physicians, practice bulletin members, and collaborating physicians should be monitored, as evidence suggests that small gifts and meals (which are considered general payments) can affect prescribing practices.11 Academic medical centers may find benefit in staffing physicians who receive industry payments, since this arrangement could bridge the gap between academia and industry.11 While such ties certainly have value, they can also create conflicts in both academics and guideline development,11 which can potentially lead to compromised research and patient care. 
National campaigns are advocating increased use of CPGs in practice, including the American Heart Association's “Get With the Guidelines” and the American College of Cardiology's “Guidelines Applied in Practice.”12-14 Furthermore, the media and members of Congress have recently increased their focus on FCOI among individual physicians, researchers, and in individual clinical trials, which has caused FCOI to become a preoccupation in medicine.12 The National Academy of Medicine's 2009 report defined FCOI as “a set of circumstances that creates a risk that professional judgment of actions regarding a primary interest will be unduly influenced by a secondary interest.”15 The presence of FCOI can be highly significant, propagating bias in CPG recommendations that may lead to compromised patient care compared with isolated cases of bias from industry payments alone.12 
The current study can be easily reproduced and verified owing to the ease of access to Open Payments. Little research has been undertaken to specifically evaluate the FCOI present among those who contribute to OB/GYN practice bulletins. The OB/GYN practice bulletin committee chairs are held accountable to follow the covered individual FCOI policy, members who do not hold the position of committee chair are held accountable for ACOG's disclosure policy of reporting industry payments but are not identified as covered individuals. Members are required to submit a disclosure form detailing all financial (exceeding $100), business, or other interest in a company, organization, service, or product that might affect or be affected by ACOG activities. ACOG has very specific and strict FCOI guidelines. These guidelines also clearly define the consequences that these individuals are held liable for if FCOI are not properly reported. 
This study should encourage conversation about the best practices to reduce or eliminate the possibility of bias within CPGs. The study did have several limitations, including the possible inaccuracies of Open Payments data, or misinterpretation during the coding phase of our study. For example, there could be multiple physicians within the Open Payments database going by the same name, leading to potential inaccuracies during data extraction. In addition, Open Payments provides physicians 45 days to dispute any payments sent to Open Payments in their name. However, this process has been inefficient: only 4.8% of physicians successfully reviewed their data in the program's first year,16,17 meaning that it is unlikely that potential inaccuracies were amended. In cases where physicians had no reported payments, it is possible that they received payments and these payments were not reported to the Open Payments database. It is also possible that research payments were given to academic institutions through payments to an individual; however, this information is not portrayed through the open payments database when searching payments made to physicians. 
Patient care is an essential part of the practice of OB/GYN, and patient care is directed by the CPGs. The idea that CPGs are being influenced by FCOI could increase doubt in the validity of CPGs. Our study found no evidence of bias within practice bulletins and only minimal FCOI among those involved in the development of ACOG CPGs. However, we feel that FCOI policies could be expanded further to include all who contribute to practice bulletins and committee opinions. 
We would advocate for an FCOI policy with standards similar to those of the National Academy of Medicine, which include disclosure policies for all committee members (including public/patient representatives), as well as all current and planned FCOI and institutional conflicts of interest. Certain members of the practice bulletin committee are not held accountable by the covered individual policy. We advocate for a policy addressing their position to set clear standards for members. Our findings would also advocate for FCOI policies being more specific toward identifying circumstances in which individuals could be found to be noncompliant. Our data showed that 3 covered physicians were found to be noncompliant with the covered individual COI policy. This finding causes concern because of the straightforward FCOI policy covered individuals are held to. Detailing specific payment limitations (eg, consultant, speaker for an educational event, travel and lodging coverage) would allow covered individuals, as well as other members, to adhere to the policies. One step toward minimizing biased recommendations is to limit authors who receive payments from the pharmaceutical and device industries from participating on CPG panels in situations in which an FCOI could be perceived. Implementing these changes would promote continued compliance with the policies of the National Academy of Medicine and ACOG. 
Conclusion
CPGs help form a reliable, evidence-based method to practice medicine. To validify CPGs, it is imperative that no bias exist between governing bodies and industries that could influence change in CPGs. By investigating industry payments to members of guideline committees, we aimed to shed light on potential financial relationships that could cloud the quality of patient care. 
Author Contributions
All authors provided substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; all authors drafted the article or revised it critically for important intellectual content; all authors gave final approval of the version of the article to be published; and all authors agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
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ACOG conflict of interest policy for executive board members, committee chairs, task force members, and executive staff. American College of Obstetricians and Gynecologists website. https://www.acog.org/-/media/project/acog/acogorg/files/pdfs/acog-policies/conflict-of-interest-policy-board-members-committee-chairs-task-force-chairs-executive-staff.pdf. Accessed June 9, 2020.
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Figure 1.
Mean general payment from 2014-2016 for physicians of all specialties, all obstetrics and gynecology (OB/GYN) physicians, practice bulletin (PB) committee members, PB contributing physicians, and executive committee members for 2016. aNumber of physicians receiving payments is shown in parentheses.
Figure 1.
Mean general payment from 2014-2016 for physicians of all specialties, all obstetrics and gynecology (OB/GYN) physicians, practice bulletin (PB) committee members, PB contributing physicians, and executive committee members for 2016. aNumber of physicians receiving payments is shown in parentheses.
Figure 2.
Payments received by practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins and American College of Obstetricians and Gynecologists (ACOG) executive committee members. General payments excluding food and beverages were calculated separately. Data are stratified by payment type. Abbreviation: PB, practice bulletin.
Figure 2.
Payments received by practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins and American College of Obstetricians and Gynecologists (ACOG) executive committee members. General payments excluding food and beverages were calculated separately. Data are stratified by payment type. Abbreviation: PB, practice bulletin.
Figure 3.
Amount of general payments by top contributing companies to practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members. aNumber of physicians receiving payments represented in parenthesis.
Figure 3.
Amount of general payments by top contributing companies to practice bulletin committee members for obstetrics and gynecology, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members. aNumber of physicians receiving payments represented in parenthesis.
Figure 4.
Research payments by companies to obstetrics and gynecology practice bulletin committee members, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members.
Figure 4.
Research payments by companies to obstetrics and gynecology practice bulletin committee members, physicians contributing to the bulletins, as well as American College of Obstetricians and Gynecologists executive committee members.