Reporters Charles Ornstein and Tracy Weber sent the Heart Rhythm Society a set of questions about potential conflicts of interest regarding the group’s acceptance of drug and device industry marketing money. The responses below were provided by the group’s president, Dr. Douglas L. Packer, and president-elect, Dr. Bruce L. Wilkoff.
Q. What is the Heart Rhythm Society’s philosophy with respect to accepting industry funding?
A. Advances in electrophysiology depend on a collaborative relationship between physicians and industry, who have for decades worked together to develop life-saving devices. The society collaborates with clinicians, scientists, allied professionals, government agencies, other societies and industry to advance electrophysiology/pacing and to accomplish its mission to improve the care of patients by promoting research, education and supportive resources for patients and their families.
The HRS is proactive in examining our policies and procedures on an ongoing basis to avoid conflicts of interest, the potential for misunderstandings or perceptions of bias.
Q. Figures in the financial report on your website indicate that half of HRS funding comes from industry sources. That proportion has gone up considerably from 2006. Do you believe the current figure is too low, too high or about right? Please explain.
A. Due to the current policies and procedures we have in place to manage collaborations with industry, the Heart Rhythm Society is seeking new more diverse revenue streams that support our mission. It is important to note that the society has received funding that has helped the public understand heart rhythm disorders through awareness initiatives such as the Apples and Oranges: Sudden Cardiac Arrest Awareness Campaign, which helped to raise government and public awareness of this deadly disease in order to save lives.
Q. Items at your conference—from key cards to newspaper wraps—are available for sponsorships. What is the purpose of these sponsorships? Does the livelihood of the organization depend on them? Do the ads have an impact on what your members buy and use in their practices?
A. The Heart Rhythm Society offers sponsorship opportunities at the annual scientific sessions to provide advertising opportunities for participating exhibitors. Approximately 50 percent of the revenue for the annual scientific sessions is generated by industry in a combination of exhibit space rental (largest), sponsorship/promotional advertising opportunities, unrestricted educational grants and exhibitor office suites. The society does not collect data or ask attendees if sponsorship or advertising impacts their purchase decisions.
A. Due to thorough policies and procedures in place for working with industry, the Heart Rhythm Society is comfortable identifying and managing various interactions with industry. Additionally, the society seeks multiple supporters for its educational programs in order to avoid the perception that programs are tied to a specific company. The society has sufficient measures in place to prevent undue influence from industry or introduction of industry bias into HRS-sponsored educational programs, research, scientific documents and policy initiatives.
Q. Sixteen of your 18 board members had relationships with one or more drug or device manufacturers in 2010-11. Are these relationships cause for concern? Why or why not?
A. The Heart Rhythm Society strives to be a transparent entity. HRS leaders are required to disclose their relevant financial, commercial, professional and institutional relationships. Additionally, the society also places restrictions on its president and president-elect, who are prohibited from receiving income from commercial entities that have the potential for conflict of interest during the year(s) in which they hold the position. As charged by its Ethics Committee, the society reviews all disclosures and rules for interactions with industry on an annual basis. We make updates to our policies and procedures as needed.
Q. Most of the experts you appointed to your 2008 device guideline committee had conflicts, including the chair of the panel. Other groups, including the American College of Cardiology, are changing that balance. Will HRS do so as well? Why or why not? What are the potential problems to having guideline writers with conflicts?
A. The Heart Rhythm Society requires that at least one of the chairs of a clinical guidance writing group not have any relationships with industry that would apply to the document.
This policy takes into consideration that relationships with industry do not necessarily bias opinions or recommendations and that experts in the field should not be restricted from full participation in a writing group provided they recuse themselves if there is a conflict of interest. The priority on selection of authors is based on level of expertise, judgment and writing ability.
Q. Some doctors have criticized HRS and ACC for the afibprofessional.org website because they say it promoted Multaq even though the drug has turned out to have serious limitations. Do you believe this is an appropriate criticism? Why weren’t the industry ties of the editor and lecturer initially disclosed on the site? Should industry funding be accepted for non-CME educational material?
A. Afibprofessional.org is a non-CME professional site funded by nonrestricted grants from multiple sponsors. Similar to a journal publication, the site is overseen by an editorial board headed by Dr. Kenneth Ellenbogen. As editor, Dr. Ellenbogen is required to not have any conflicts of interests in companies that contribute to the site. The editorial board has complete control and oversight on how the monies are used and what content will be posted. Industry does not have any review or input into the content of programs.
The Heart Rhythm Society was concerned about the criticisms that were raised and carefully evaluated the circumstances that led to these concerns. The initial complaints about the website were in part due to a production flaw that did not hold the launch of the site until all the content was completed and educational commentary added to ensure balance. The site was updated and all disclosures linked within 72 hours of initial launch. Moreover, the lecturer you note, Dr. Eric Prystowsky, disclosed full details of his relationship with industry during his lecture.
[Editor’s note: Ellenbogen's disclosure form on the afibprofessional.org website, as of earlier this week, listed a financial relationship with Sanofi-Aventis, one of the site's sponsors. ProPublica listened to a recording of the lecture, and Prystowsky did not mention his relationship with Sanofi. He handed in a disclosure form prior to the lecture, and it was posted later to the website.]
Q. Some members have said that they believe HRS has supported the increased use of implantable cardioverter defibrillators (ICDs) without providing sufficient information on side effects and populations excluded from clinical trials. Is that a fair criticism? Why or why not?
A. The society’s position on the use of ICDs is well-stated in the HRS-endorsed, evidence-based guidance available on our website. This guidance informs the utilization of devices.
Q. HRS officials wrote letters and testified in 2009 in support of Medicare coverage of cardiac ablation for Afib. A Medicare Evidence Development & Coverage Advisory Committee voted that more research needed to be done on senior populations. Why did HRS advocate for broader coverage if the evidence did not yet support it?
A. HRS did not advocate for broader coverage in this situation. In 2009, the Society’s expert insights emphasized that large multicenter prospective trials will be needed to better define the relative benefits and risks of catheter ablation, and until the results of such studies become available, catheter ablation of atrial fibrillation should be considered only in patients who have failed at least one antiarrhythmic medication and have symptomatic AF. There are published studies demonstrating the safety and efficacy of AF ablations in senior patients.
Q. The International Board of Heart Rhythm Examiners, which shares an office and CEO with HRS, offers training for device sales reps, among others. Does this present a conflict for the society, because a sister group receives money to train the reps that will sell devices to HRS members?
A. The International Board of Heart Rhythm Examiners does not provide training of any kind to industry representatives.
Q. Your group is offering exhibitors a novel opportunity this year with the radio frequency identification (RFID) badges. Which exhibitors have signed up for this, and what is the cost to participate? How does the use of these cards square with a study published in HeartRhythm Journal in January 2010 that RFID readers can cause complications to pacemakers and ICDs?
A. At this year’s annual scientific sessions, the Heart Rhythm Society will employ RFID badges. Exhibitors will not be offered an opportunity to purchase nor will they freely receive the information the society gathers from RFID readers. Exhibitors can purchase RFID information from a third-party source regarding the number of visitors to their booth only—contact information will be excluded. They do not obtain this information from the society or pay us any funds for this information.
Furthermore, all attendees were given the option to opt-out and receive a badge without an RFID embedded. This is an acceptable option for attendees with implantable cardioverter defibrillators or pacemakers.
Q. You indicate that RFID technology at the conference was being handled by a third-party company. Does HRS receive any funds or other in-kind contribution from that company for being able to place RFID readers/badges at the conference? You also indicated that contact information is not shared with exhibitors. Will they be told names of attendees at their booths, affiliations of those doctors, their city/states and how long they spent at the booth? This information was recently conveyed as part of the ACC’s meeting.
A. The Heart Rhythm Society does not receive royalties or any other in-kind contributions for RFID technology at our annual Scientific Sessions. The exhibitors will not receive names, contact information or affiliations of attendees, but city and state information will be captured as well as length of time spent at the booth.
Q. Your website includes patient information, including sheets on treatments. In reviewing the sheets on cardiac defibrillators and catheter ablation, they make no mention of risks, limitations or groups for whom these treatments are not recommended. Should these sheets include a more-complete discussion so patients can make informed decisions?
A. The Heart Rhythm Society believes that the most-informed discussion of the risks and limitations of treatments are best conducted between a patient and his/her physician. Please note: We include physician and patient information on our website, but also provide the following:
“Please note: As mentioned, this website is not intended to cover all aspects of any medical condition. It is generalized and is not intended as specific medical advice. Those with questions or who need more information should check with their physician or use the Society’s Find a Specialist tool, which is a publicly searchable directory of the Society’s physician members (e.g., Cardiologists, Electrophysiologists, Interventionalists, etc.) who have requested to have their contact and practice information listed for patient and physician referral purposes.”
Q. Some researchers on conflicts of interest say that when a medical society receives half of its funding from industry, it is codependent on them and therefore will—consciously or not—avoid criticizing the products they make. How would you respond?
A. The Heart Rhythm Society’s first and foremost concern is to provide effective and appropriate treatment options to our patients. It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials. For this reason, we believe that interacting with industry is not inherently wrong with the correct measures in place to mitigate the possibility of conflicts of interest.
Moreover, the Society maintains a neutral position on all products and services offered by industry. The U.S. Food and Drug Administration is our source for information about new products, safety alerts and drug recalls. When new or updated information is disseminated by the FDA relative to electrophysiology, we first determine whether it has an impact on patient care. If so, we disseminate the FDA’s updates whether industry products are cast in a positive or negative light. Again, our priority and concern is to our patients.
A full description of the Society’s safeguards to prevent industry bias can be found in our “Guidance for the Heart Rhythm Society Pertaining to Interactions with Industry,” which will be released on Thursday, May 5, 12:15 p.m. PT at Heart Rhythm 2011, the Society’s 32nd Annual Scientific Sessions. This document is a great example of the introspection that continually occurs at the Society to review and update our safeguards, policies and procedures to appropriately monitor relationships and provide optimal oversight.
Q. You indicate that you intend to diversify your sources of funding. What does diverse mean? Are you seeking non-industry funding and, if so, from where?
A. Diverse means “from multiple sources.” HRS receives revenues from 10+ different categories ranging from industry funding to membership dues, to product sales, to investment income. All current and future sources of revenue align with our mission and strategic goals. Our Form 990 tax return (available on www.guidestar.org, or upon request) details our multiple revenue sources.
Q. You indicate that the society strives for transparency. But is transparency enough when so many board members have relationships with the companies that fund the society and have commercial interests in selling their products?
A. The Heart Rhythm Society believes that transparency, along with the policies and procedures we have in place to safeguard against conflicts of interest, misunderstandings and perceptions of bias, will help to ensure that we remain effective in board considerations and decisions. We believe that collaboration—with appropriate boundaries—is not bad, but is actually required for producing creative solutions for our patients. We know that some risk of perception of bias may be necessary in order for us to continually provide life-saving and life-enhancing solutions to our patients. However, the Society insists on transparency and adherence to multiple safeguards. This is fundamental to the medical endeavor.
Q. Several of your major funders are under investigation by federal prosecutors or have paid millions to settle allegations that they gave kickbacks to electrophysiologists for using their products. Is it appropriate for these companies to exhibit at your conference?
A. The Heart Rhythm Society is not involved in these matters and as a result, can't really speak to them.