healthy4u: Heart Rhythm Society

ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir.  (The full ProPublica version is <a href="http://www.propublica.org/article/medical-societies-and-financial-ties-to-drug-and-device-makers-industry">here</a>.)  It's worth doing a little reading between the lines to see its further implications. The Basic Story The story focused first on the annual meeting of the Heart Rhythm Society (HRS), a sub-specialized medical society for cardiologists who specialize in electrical or rhythm disorders.  The meeting seemingly has become a giant marketing opportunity, supported by $5 million in industry money, in which practically every flat surface became a medium for advertising.  (The ProPublica article included multiple pictures of branded items from carpets in the exhibit halls to the backs of the seats in shuttle buses.) Also, <blockquote>St. Jude Medical adorns every hotel key card. Medtronic ads are splashed on buses, banners and the stairs underfoot. Logos splay across shuttle bus headrests, carpets and cellphone-charging stations. At night, a drug firm gets the last word: A promo for the heart drug Multaq stood on each doctor’s nightstand Wednesday.</blockquote> Then reporters Charles Ornstein and Tracy Weber looked at the HRS as a whole, noting that half the society's total income comes from industry, and "<a href="http://www.propublica.org/documents/item/heart-rhythm-society-disclosure-of-relationship-2011-2012">Twelve of 18 directors</a> are paid speakers or consultants for the companies, one holds stock, and the outgoing president disclosed research ties, according to the society’s website, which does not specify how much they receive."  Furthermore, "Two of the society’s biggest funders — <a href="http://www.propublica.org/documents/item/88080-boston-scientific-settlement-agreement">Boston Scientific</a> and <a href="http://www.propublica.org/documents/item/88081-st-jude-settlement-agreement">St. Jude Medical</a> — have paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices. Neither company admitted wrongdoing." The article raised tantalizing questions and implied others, but despite the reporters' best attempts, leaders of the HRS and their defenders failed to address them.  Their failure to grapple with the real issues is to me the most disturbing part of the story. Why Take the Money? ProPublica published a <a href="http://www.propublica.org/article/the-heart-rhythm-society-responds-to-propublicas-questions">companion piece </a>consisting of questions to and responses from the HRS President, Dr Douglas L Packer, and President-Elect, Dr Bruce L Wilkoff. The first response was the rationale for taking the money: <blockquote>Advances in electrophysiology depend on a collaborative relationship between physicians and industry....</blockquote> Later, <blockquote>It is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials. </blockquote> This response is very common from physicians and other health professionals defending relationships with industry. Note that this response, similar to previous ones, is off the point. The issue is not all relationships with industry. It is about relationships in which industry pays people, or in this case, a group of people for purposes not always clear, but when clear are related to marketing. Payments from industry to physicians and health professionals are not necessary for collaboration. If the goal is innovation and development of therapies, how is that supported by payments to a medical society to provide marketing opportunities? Why Subject the Meeting Attendees to All That Advertising? Much of the money received by the society was obviously for marketing purposes. The effect of these payments was the advertising barrage noted above. So the obvious questions are: is it beneficial for the society to expose its members and other meeting attendees to all this marketing?  Should making its members accessible to marketing be a major part of the society's activities? When <a href="http://www.propublica.org/article/the-heart-rhythm-society-responds-to-propublicas-questions">questioned by ProPublica</a>, the organization's leadership evaded: <blockquote>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. </blockquote> Very few people quoted in the ProPublic series ventured to defend the marketing onslaught. There was only this. In a <a href="http://www.propublica.org/article/heart-docs-reject-claims-of-bias-from-industry-money">newer follow up article</a>, Chris Ornstein quoted meeting attendees with similar sentiments: <blockquote>'I’ve always been rather offended that people who aren’t doctors think I’m susceptible to bribes and corruption,' [Raleigh, NC electophysiologist Dr Mark] Englehardt said. 'A lot of what you learn about products is from people that sell the products. … You have to learn it somewhere.'</blockquote>Note that the good Dr Englehardt lead off by invoking a <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw-man fallacy</a>. Being influenced by advertising is not the same as taking bribes. No one accused those attending the conference of taking bribes. More importantly, his argument in favor of advertising invoked a <a href="http://www.iep.utm.edu/fallacy/#False%20Dilemma">false dilemma</a> (or false dichotomy). There certainly are sources of information about products, and particularly about electrophysiologic devices, beyond manufacturers' advertising.  The choice is not simply ignorance versus advertising. Others merely sought to minimize the harms of exposure to so much advertising. For example, one of the HRS' defenders, who not coincidentally runs a much larger medical society, which also has had its issues with its extensive ties to industry, (look <a href="http://hcrenewal.blogspot.com/search/label/American%20College%20of%20Cardiology">here</a>) said: <blockquote>The 'circus element' of the exhibit booths doesn’t unduly influence attendees, [CEO of the American College of Cardiology Jack] Lewin said. 'I don’t buy a soft drink just because of the advertising… I buy it because I like it.'</blockquote> Maybe not, but the analogy may not be apt. Furthermore, we have seen a stream of physicians, other health professionals, and academics deny that they are influenced by marketing or monetary incentives. It is hard to believe, however, that industry would spend so much trying to influence opinions without some evidence that the money provides some results. In addition, most people seem to lack insight about what influences their opinions, especially when consciously admitting such influence might threaten their self-image. On the other hand, the follow-up article also noted: <blockquote>Some doctors acknowledged that the corporate barrage must have some effect. 'I hope not, but I’m certain that it does,' said Dr. Christopher Conley of Nashville, Tenn. 'I’m sure the companies do their own research. They wouldn’t be here, they wouldn’t be putting all this money out if it didn’t influence people.'</blockquote> It seems obvious that all the advertising was meant to sell products. It seems unlikely that marketers spend so much money without some reason to believe it would have an effect. Even if it had little effect, was there any benefit to selling all that marketing space that would counter-act one glaringly obvious harm? By raising so much money from such obvious and widespread marketing, the Cardiac Rhythm Society meeting is liable to be viewed more as a marketing event than a serious scientific or professional venue. Is It a Professional Society, or a Marketing Firm? As noted above, accepting so much money for such a large marketing presence at its national meeting makes the Heart Rhythm Society appear to resemble a marketing firm.  Other information revealed by ProPublica increases the apparent similarity.  Societies are groups of people who gather for a common purpose.  Medical societies ought to be groups of doctors who gather for common purposes, usually including promoting their own professional interests and upholding professional values.  They typically used to convene meetings for educational or advocacy purposes, and publish journals or other media.  Thus their typical sources of revenue could be dues, meeting registrations, and subscription and similar fees.  However, as noted above, half of the Heart Rhythm Society's budget comes from industry, specifically "from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms,"<a href="http://www.propublica.org/article/medical-societies-and-financial-ties-to-drug-and-device-makers-industry"> according to ProPublica.</a>  The picture was similar in 2009.  I reviewed the organization's most recent (2009) financial disclosure (990 form) filed with the US Internal Revenue Service and made <a href="http://www.guidestar.org/FinDocuments//2009/042/694/2009-042694458-06074ec3-9.pdf">available to the public by Guidestar</a>.  In that year, the organization's total revenues were $14,772,708.  Revenues from "grants and sponsorships" were $4,061,883 and from annual meeting exhibits were $3,065,750, for a total of $7,127,633.  So only about half of the society's revenues came from traditional sources, including meeting registration ($4,749,974) and dues ($1,513,361).  Given that some of the registration fees doubtless came from industry attendees, and some product sales ($212,298) and royalties ($511,760) also came from industry sources, the organization's revenue makes it appear at least at least as much like a marketing firm as a medical society.  Note that one group of beneficiaries of this industry largess was the organization's paid managers.  The 990 form listed eight executives who made over $150,000 a year in the worst years so far of the Great Recession.  Its CEO received total compensation of $532,691.  His compensation used 3.6% of the organization's total revenue.  Moreover, the majority of the Heart Rhythm Society's board and officers have major ties to manufacturers of drugs and devices used in the diagnosis and treatment of heart rhythm problems.  As noted above, 12/18 directors were found to have ties to the companies which advertised at the meeting.  Perusal of disclosure forms which the Society, to its credit, does make public <a href="http://www.hrsonline.org/About/Governance/bot_10.cfm">here</a>, revealed only three of 20 officers and directors who had nothing to disclose in 2011-12. The current President, Dr Douglas L Packer, had two pages of disclosures, including 10 different device or biotechnology companies from whom he got "significant" (over $10,000) grants or royalty income.  Many other board members and officers had "significant" financial relationships, consulting/ honoraria, speakers' bureau membership, equity interests, with drug, biotechnology, or device companies which make products relevant to cardiac rhythm disorders.   The leaders of the society asserted their ability to "manage" industry relationships: <blockquote>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. </blockquote> Later, when directly questioned about the implications of receiving half the organization's funding from industry, they evaded again: <blockquote>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. </blockquote> Half of the organization's revenues come from industry, and the organization is willing to expose its meeting attendees to a barrage of advertising to obtain most of these revenues. Providing such advertising does not seem to maintaining "a neutral position." Do its leaders really mean that this proportion of support has no influence on them or how the organization is run? Nearly all the organization's officers and directors have their own financial relationships with industry. Do they really think that these relationships have no effect on their thinking? Would the leaders be indifferent to losing half of the organization's financial support and their own personal financial relationships with industry? If they would not be indifferent to this eventuality, can they argue they are uninfluenced?  Would the organization's CEO, whose compensation is over 3% of the organization's total revenue, be indifferent to a decrease of 50% in that revenue?  If not, could he be uninfluenced by the source of this revenue? Summary: Why Pay Dues to a Marketing Firm? As health care dysfunction has gotten worse over the years, as costs rise, access falls, and quality stagnate, as physicians are subject perverse incentives and deceptive marketing, as the medical research literature has been suppressed and manipulated, there have been surprisingly few responses from medical societies.  The case study provided by ProPublica of one such society suggests one reason why.  Medical societies seem to behave increasingly like marketing firms.  The majority of their revenue may not come from their members.  They may be willing to subject their members to a flood of marketing to make more money.  Their leaders may have extensive relationships with industry.  Their paid managers may be dependent on industry revenue for out sized compensation. If medical societies have come to resemble marketing firms, is it any wonder that they have not spoken up against the commercialization of health care, even when the result has not been good for physicians' core values?  But in that case, why would physicians who care about their patients and their core values want to belong and pay dues to marketing firms?  Inquiring minds want to know.... Maybe physicians should only join medical societies that really act like medical societies. For further discussion in the blogsphere, see <a href="http://gooznews.com/?p=2811">this post</a> by Merrill Goozner on the GoozNews blog, <a href="http://brodyhooked.blogspot.com/2011/05/new-from-propublica-medical-specialty.html">this post</a> by Howard Brody on the Hooked: Ethics, Medicine and Pharma blog, <a href="http://carlatpsychiatry.blogspot.com/2011/05/lub-dub-lub-lub-lub-dubka-ching.html">this post</a> by Daniel Carlat on the Carlat Psychiatry blog, and<a href="http://pogoblog.typepad.com/pogo/2011/05/pharma-medical-device-industries-buying-influence-with-medical-advocacy-groups.html"> this post</a> by Paul Thacker on the Project on Government Oversight blog.

Has the Heart Rhythm Society Become More Like a Marketing Firm?

ProPublica's and USA Today's joint investigation of one medical society's ties to industry has created a stir. (The full ProPub...

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