Society continues push toward COI transparency

Conflict of interest (COI) is a topic that has long raised eyebrows and prompted whipsers throughout the House of Medicine. ASPS has been proactive in its efforts to provide a comprehensive strategy to increase transparency while communicating and managing conflicts and answers related questions across all areas of the Society.

A heavy push for increased transparency surrounding conflict of interest throughout ASPS began in 2014 with the inception of the Society's Conflict of Interest Task Force. Then headed by current ASPS President Jeffrey Janis, MD, the task force (which also included Paul Cederna, MD; Bryan Gamble, MD; Peter Hetzler, MD; Lynn Jeffers, MD; Joseph Losee, MD; and ASPS legal counsel Mike Reed, JD) formed in the wake of the Physician Payments Sunshine Act going into law in 2010 and the first postings by the Centers for Medicare and Medicaid services reporting payment information on its Open Payments Program website in 2014.

"We have had full disclosure of COI for years before inception of the task force – especially at board level," Dr. Janis recalls. "But we wanted to be as transparent as possible and take the lead on developing a thorough, comprehensive policy on managing conflicts of interest, which is why the COI Task Force was created."

The COI Task Force reviewed available best-in-class documents during its 15-month deep dive into the topic, including the Code of Interactions with Companies put out by the Council of Medical Specialty Societies (CMSS). Rather than simply signing on and adopting that particular code, however, Dr. Janis says the task force began a "robust and arduous" process of looking at how other organizations deal with COI, consolidating the Society's own information and data and ultimately producing a "Constitution-like document" from which ASPS could move forward in establishing its COI policies.

"The presence of a COI is not in the issue," he says. "It's more important to determine how we manage COI in a comprehensive and transparent way. The perception or optics of a COI is just as important as a COI. We needed a management strategy for both real and perceived conflicts."

The perils of failing to provide proper disclosure can threaten a physician's career. In March 2018, for example, federal prosecutors announced charges against five New York doctors for participating in a bribery and kickback scheme designed to boost sales of Subsys, a spray form of fentanyl, produced by Insys Therapeutics. According to a report in The New York Times, Insys paid the doctors – in some cases more than $100,000 per year – to prescribe millions of dollars' worth of the drug. Payments were funneled through a "speakers bureau" that amounted to little more than social gatherings at high-end restaurants, where no educational information was provided and attendance sign-in sheets were forged.

ASPS member Mark Clemens, MD, who severed his own ties with industry in 2015 when he became chair of the Society's BIA-ALCL Subcommittee, says the indictments should serve as a wake-up call to any doctor working with industry.

"Part of the original intention of conflict of interest [disclosure] is to inform patients, when a certain medication or treatment is prescribed for them, whether there is a financial incentive for the physician to make that decision," he says. "That does not occur. Transparency is disclosing why one may choose 'X brand' over 'Y' or 'Z' when you're financially benefitting from it.

"Direct or indirect compensation is one type of financial conflict but also can include paying below market costs for devices they use when given in higher quantities," he adds. "Fifty percent off agent or device costs may be gifted to a high prescriber. That's a financial benefit not listed on any disclosure but may be a main driver of what a physician is likely to use for that patient."

Although ASPS members might debate the positive or negative effects of physicians having ties to industry through medications, medical devices, research, consultancy, stock options, patents, dinners, travel expenses or a variety of other options can have on the specialty, the Society has put itself on course to ensure those ties remain accurately communicated.

A clearer picture

The document to guide ASPS through members' COI was ultimately approved by the Executive Committee and Board of Directors, and the task force evolved into a standing committee, currently chaired by Dr. Hetzler. The committee serves in both an advisory and consultative role to the ASPS Board of Directors, Executive Committee, Nominating Committee, officers of both ASPS and The PSF, and the editor-in-chief of PRS on all COI matters. Issues that fall under the committee's purview include members' affiliations with for-profit and not-for-profit organizations and how to resolve COI issues, including addressing these them in advance of board or executive committee meetings to preempt any influence of bias from entering into discussions or official votes.

Dr. Hetzler notes that this is not limited to financial ties – it can be everything from being a leader or member of another organization related to the issue, to receiving a free pen from a company or group under discussion. There are four different options the Society follows for recusing members who have a COI from meetings. Officer(s), with the assistance of legal counsel, will require a member with a real or perceived COI to do one of the following:

Remain in the room while the matter is being discussed, but not speak or vote
• Provide his or her opinion and leave the room while the matter is considered and voted upon
• Remain out of the room while the matter is being considered and voted upon

"Everybody is cooperating with this," Dr. Hetzler notes. "That's what's so wonderful. The Society pressed for this, adopted it and we're living by it. It's thrilling to see the amount of transparency this is creating and the confidence in this system by our members."

Sharing more info

Still, some members say the Society can do more to make their peers' conflicts more transparent. ASPS past President Edward Luce, MD, Memphis, who serves as an associate editor of PRS and has published on the topic of COI in the journal, singled out presentations at various meetings – including Plastic Surgery The Meeting – as a sticking point for many. Dr. Luce says the audience doesn't really get the chance to judge the potential for bias as slides that list speakers' disclosures neither list the dollar amounts tied to those disclosures nor remain on display long enough for the audience to digest.

"The slide's up there for nanoseconds," he says. "That's not right. Whether it has nine lines of disclosures or two, it doesn't matter. The audience should be able to read it."

Dr. Clemens agrees and says the audience should also be made aware of the dollar quantity tied to those disclosures.

"If you receive a coffee mug from a company, technically that's COI, though few would argue it is relevant to physician decision-making" he says. "But if you receive $4 million in royalties off a patent from that company, own equity and are employed as a medical director, it's the exact same line on a disclosure slide that you have a potential conflict of interest."

Although specific dollar amounts might not yet be shared in presentations, there has been movement toward clarifying members' financial ties to industry. The ASPS Executive Committee and Board of Directors recently adopted the COI Committee's recommendation to institute a more specific set of ranges for members' financial disclosures. If members do receive financial benefits from a company, they are required to list their disclosure within the following ranges:

• $100-$1,000
• $1,001-$5,000
• $5,001-$10,000
• $10,001-$50,000
• $50,001-$100,000
• $100,001-$200,000
• $200,001-$500,000
• $500,001-$1 million
• more than $1 million

It could be argued any physician's (or company's) financial information is available thanks to passage of the Sunshine Act, which makes physicians' financial disclosures available online at websites including openpayments.cms.gov and the "Dollars for Docs" section on ProPublica.org. You can also find out how much certain companies are contributing to the House of Medicine.

"The question is why should our members have to do that?" Dr. Luce asks. "Why should members have to sit there and bring up on their cellphones openpayments.gov, find Dr. John Doe, who is now speaking, eliminate the other Dr. Does, to come up with that figure? The number should just be up on the slide – and not for a nanosecond."

Dr. Hetzler agrees and says members' disclosure data should be more easily accessible to their peers. He notes the COI Committee is discussing the best way to provide that within the Society to end the reliance on websites that publish information gained through the Sunshine Act.

In the interest of improved transparency, Dr. Hetzler says that a speaker's range should be included on a presentation slide – and displayed long enough to read.

"Unless you publicly disclose the dollar amounts, you're not going to convince an audience that just saying you have a relationship is enough," he says. "If you find out Dr. Doe is getting a $1 million from Brand 'X' and they're talking about Brand 'X' in that presentation, you're going to look at it a lot differently in the audience than if Dr. Doe was only getting $100 from that company."

That would be a positive development, says Dr. Clemens, who argues the Sunshine Act and public reporting of data on federal websites has actually done more harm than good for presentations at various societies' meetings.

"The Sunshine Act has a number of errors in it, and inaccuracies are impossible to have retracted," he says. "All you can do is have an asterisk placed by the figure, but it's still part of your permanent record.

"I have yet to see a patient make a decision based on utilizing the Sunshine Act," Dr. Clemens adds. "But from the podium and in the journal, we see one physician using it as a weapon to try to discredit another physician he or she doesn't agree with. That's a disheartening consequence. Physician conflicts are ubiquitous – whether financial, academic, career advancement, national notoriety – and inherent to a fee-for-service model."

Dr. Luce counters that openpayments.cms.gov does allow physicians to dispute discrepancies and notes that publications from multiple specialties have accepted peer-reviewed articles that use the website as a research database.

Even if dollar amounts aren't listed on screen, Dr. Janis points out that speakers at ASPS events undergo rigorous screening to ensure any messages broadcast are not beholden to outside influence. Presentations undergo a rigorous vetting process that includes requiring full written disclosure from speakers on record, and strictly following ACCME Standards for Commercial Support that discuss what needs to be disclosed and rectified ahead of a presentation. If there are instances of COI, ASPS obtains from the speaker a signed agreement to only use peer-reviewed, scientifically sound evidence to support his or her presentation (no industry slide decks or evidence of industry payment for presentations are permitted).

The talks also have to be submitted in advance for independent review to ensure they are free from bias. The extent to which ASPS has pushed for this level of transparency recently earned ACCME's second consecutive six-year accreditation with commendation – the highest such honor it can bestow on an organization.

Still moving forward

While specific financial disclosures would provide greater insight to an audience, it might not be information that all speakers, researchers or leaders would be willing to share.

"I think there is a hesitancy among plastic surgeons to say, 'I made $100,000 as a consultant to a company' – that they will be discredited or lose their position at the podium or never have their work published, but that fear does not materialize," Dr. Clemens says. "Instead, disclosure should be a transparency that helps inform people about the content they're receiving – whether you're a physician or a patient."

Dr. Hetzler agrees and says he understands there could be some hesitation about sharing even dollar ranges by members, but the Society's quest for transparency is of paramount importance over any hesitation or potential feelings of embarrassment.

Dr. Clemens has experience with the subject. From 2012 to 2015, he was a consultant with Allergan; in 2015, he was given the opportunity to chair the ASPS BIA-ALCL Subcommittee. Given his ties to a breast implant manufacturer, however, the COI Committee recommended to the Executive Committee that Dr. Clemens would have to either cease being a paid consultant and speaker for Allergan to maintain his position as chair, or be limited to serving as a member. Dr. Clemens concedes it was a tough decision, but he understood the importance of optics while also being on a committee – let alone serving as chair. As a result, he ceased consulting for Allergan or any company.

"The decisions I made were pragmatic," Dr. Clemens says. "It enabled me to do my research and have positions I needed to have. Let me be clear: I do not begrudge anyone for taking money from a company in any quantity. I see having equity and compensation from a company and not disclosing it in a quantifiable way that people can understand as problematic. I want to see that system improved upon."

In addition to financial disclosures being shared on presentation slides or at least made more accessible to members, plastic surgeons with whom PSN spoke also suggested adding disclosures to patients' informed consent forms so there's better transparency if a medication or treatment from a company the doctor has a stake in is prescribed.

Although some doctors contacted for this article argue that any conflicts of interest should preclude members from positions on committees or even work groups, Dr. Janis reiterates that working with industry should not be considered a negative mark on any physician. The Society simply needs to be able to manage that work doesn't lead to even the appearance of an unfair bias.

"Innovation is often borne out of a collaboration between surgeons and industry," he says. "That is something to be respected rather than rejected. We should not look down on someone who gives a presentation or publishes a paper if he or she has industry ties – as long as they are properly disclosed and managed, and as long as that person presents sound scientific evidence."

Dr. Hetzler insists that goal of the COI Committee – and that of the Society – is to make disclosures as transparent as possible, and the work done in the past three years alone speaks volumes about commitment by ASPS to that end. Although the Society's work in the past three years toward resolving COI has drawn kudos and recognition from other medical organizations, the nature of an ever-changing specialty means the Society cannot stop monitoring the issue.

"This is a moving target," Dr. Janis says. "Standing still is falling behind. When is the first version of something the last version of it? That never happens – especially in plastic surgery. If we are to maintain our position at forefront of this issue, we must keep our finger on the pulse of what's going on in field of medicine, adapt and evolve. After all, that is what we do every day in plastic surgery and this topic should be no different."