At night, a drug firm gets the last word: A promo for the heart drug Multaq stood on each doctor’s nightstand Wednesday.
Who arranged this commercial barrage? The society itself, which sold access to its members and their purchasing power.
Last year’s four-day event brought in more than $5 million, including money for exhibit booths the size of mansions and company-sponsored events. This year, there are even more “promotional opportunities,” as the society describes them.
Concerns about the influence of industry money have prompted universities such as Stanford and the University of Colorado-Denver to ban drug sales representatives from the halls of their hospitals and bar doctors from paid promotional speaking.
Yet, one area of medicine still welcomes the largesse: societies that represent specialists. It’s a relationship largely hidden from public view, said David Rothman, who studies conflicts of interest in medicine as director of the Center on Medicine as a Profession at Columbia University.
See also: The Heart Rhythm Society Responds to ProPublica’s Questions — below
Professional groups such as the Heart Rhythm Society are a logical target for the makers of drugs and medical devices. They set national guidelines for patient treatments, lobby Congress about Medicare reimbursement issues, research funding and disease awareness, and are important sources of treatment information for the public.
Dozens of such groups nationwide encompass every medical specialty from orthopedics to hypertension.
“What you’re exploring here is the subtle ways in which the companies and professional societies become partners and — wittingly or unwittingly — physicians become agents on behalf of the interests of the sponsoring company,” said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.
“It has a not very subtle effect on medicine,” said Nissen, an expert on the impact of industry money.
‘This is our business’
Nearly half the $16 million the heart society collected in 2010 came from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms, the group’s website disclosed.
Officials of the Heart Rhythm Society say industry money does not buy influence and is essential to developing new treatments. Still, on Thursday the group unveiled a formal policy that, among other things, requires more detailed disclosure of board members’ industry ties.
“This is our business,” said Dr. Bruce Wilkoff, the incoming society president. “We either get out of the business or we manage these relationships. That’s what we’ve chosen to do.”
The society is one of a handful of groups that make public details about their finances. Most don’t. As non-profits, they must disclose their tax returns but not their specific sources of funding.
Sen. Charles Grassley, R-Iowa, requested the information from the Heart Rhythm Society and 32 other professional associations and groups that promote disease awareness and research.
Their responses and reporting by ProPublica showed wide disparities in money the groups accept from medical companies, what they disclose and how they manage potential conflicts of interest.
With billions of dollars at stake, companies can court entire specialties by helping to bankroll doctors’ groups. The Heart Rhythm Society’s 5,100 members represent a particularly lucrative market.
One implantable cardioverter defibrillator — a device that jolts the heart back to a normal beat — can cost more than $30,000. A single electrophysiologist, a physician specializing in heart-rhythm disorders, can implant dozens a year. World sales of the devices totaled $6.7 billion last year, according to JPMorgan.
All the defibrillator manufacturers are at this week’s conference, including market leaders Medtronic, Boston Scientific and St. Jude Medical, which together gave the society $4 million last year.
These companies and others not only provided financial support to Heart Rhythm but paid many of its board members: Twelve of 18 directors 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.
Board members at other medical societies have similar arrangements. The American Society of Hypertension does not post disclosures on its website, but records provided to Grassley show that 12 of its 14 board members had financial ties to medical companies.
Grassley, the top Republican on the Senate Judiciary Committee, said these groups commonly say the money doesn’t affect what they do, but he has doubts. “I don’t think it’s believable,” he said. “There are a lot of incestuous relationships that really bother me.”
Big Booths Boost Devices
As competition among cardiac-device makers has intensified, so have questions about whether their products are being used and marketed appropriately.
In January, a study in the Journal of American Medical Association found that more than one in five patients who received cardiac defibrillators did not meet science-based criteria for getting them.
Weeks later, the Heart Rhythm Society disclosed it was assisting a U.S. Justice Department investigation of the issue.
Two of the society’s biggest funders — Boston Scientific and St. Jude Medical — 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.
Top sponsor Medtronic also has disclosed to shareholders that the Department of Justice is investigating the advice it gave purchasers on how to bill Medicare for defibrillators and payments it made to buyers of the devices.
In a statement, Medtronic said societies play an important role in educating physicians about their devices. Boston Scientific declined to comment, and St. Jude did not respond to questions.
At this week’s conference, Medtronic is front and center with a 12,000-square-foot booth to demonstrate its products and allow physicians to examine them.
Medtronic spent $543,000 at last year’s meeting on a similar exhibit, part of $1.6 million it paid to prominently display its name around the conference and fund educational grants. The Minnesota device maker also paid unspecified speaking or consulting fees to eight of the society’s 18 board members.
Labeling the HRS Convention
These slides show “promotional opportunities” – and their asking price – that the Heart Rhythm Society offered to medical industry sponsors at its 2011 conference. Not everything was sold.
The spending befits the company’s dominance of the world market for implantable defibrillators. It sold more than $3 billion worth last year.
Next booth down is the 8,100-square-foot spread of rival Boston Scientific, with $1.6 billion in defibrillator sales last year. The company spent $1.5 million on the society in 2010 and paid speaking or consulting fees to seven board members.
Physicians must traverse these and other booths to reach “Poster Town,” where the latest research findings, a big draw of the gathering, are displayed. “It’s very hard to get through there without being accosted,” said Dr. Paul D. Varosy, director of cardiac electrophysiology at the Department of Veterans Affairs’ Eastern Colorado Health Care System.
‘Tag and Release’
Through the years, groups such as the Heart Rhythm Society have expanded the range of sponsorships they offer to drug and device makers. Companies can now fund Wii game rooms or put their names on conference massage stations and on the shirts of the masseuses.
Some deals give companies more than name exposure. Last month, the American College of Cardiology attached tracking devices to doctors’ conference ID badges. Many physicians were unaware that exhibitors had paid to receive real-time data about who visited their booths, including names, job titles and how much time they spent.
Dr. Westby Fisher, an Evanston, Ill., electrophysiologist, called the practice “Tag and release.” College officials say they’ll do a better job of notifying doctors next year.
Attendees at the Rhythm Society conference also have tracking badges. Society officials say exhibitors are not getting doctors’ personal information.
Two years ago, the American Society of Hypertension teamed with its biggest donor, Daiichi Sankyo, to create a training program for drug company sales reps. The society says about 1,200 Daiichi reps have graduated — at a cost of $1,990 each — allowing them to put the “ASH Accreditation symbol” on business cards.
In fiscal 2009, Daiichi gave the society more than $3.3 million — more than 70% of its total industry funding — according to financial records it provided Grassley. Daiichi makes four hypertension drugs.
“I think it’s an obscenity,” said former ASH president Michael Alderman, professor emeritus at Albert Einstein College of Medicine in New York City. “I can see how it would play out in the doctor’s office: ‘I’m a Daiichi sales rep. But let me tell you something: The American Society of Hypertension is backing me.’”
Alderman and some other prominent members of the group quit after a dispute in 2006 about industry influence.
Current ASH President George Bakris said the training program is science-based and doesn’t focus on specific drugs. The reps “ought to know what they are talking about,” he said.
The 1,900-member group has revised its policies since 2006, he said. Financial conflicts disclosed by board members, however, are available only to members, who must request them in writing and explain why they want them, according to the group’s conflict of interest policy.
Click Here to See How the Heart Society Sells Access
A Question of Influence
Bakris and leaders of several other professional groups say industry funding is essential for much of what they do. It reduces conference registration fees, subsidizes the cost of continuing medical education courses and provides money for disease awareness.
Dr. Jack Lewin, chief executive of the American College of Cardiology, said the money is helping build registries of cardiac procedures that track side effects and flag whether physicians are using devices in the right patients.
The “circus element” of the exhibit booths doesn’t unduly influence attendees, Lewin said. “I don’t buy a soft drink just because of the advertising… I buy it because I like it.”
Researchers say companies are not spending millions solely for altruistic reasons. “If it weren’t influencing the doctors, they wouldn’t be doing it,” said Dr. Gordon Guyatt, a health policy expert at McMaster University in Ontario.
There are fledgling efforts to push medical societies toward stricter limits on industry funding: 34 groups have signed a voluntary code of conduct calling for public disclosure of funding and limits on how many people on guideline-writing panels have industry ties.
“The general feeling is that the societies need to be independent of the influence of companies,” said Dr. Norman B. Kahn Jr., chief executive of the Council of Medical Specialty Societies, which helped draft the code.
Grassley, too, is continuing his efforts to make the groups publicly accountable. In initial responses to his December 2009 request for information, some said they planned to post financial information on their websites. This week, the senator followed up with letters to some groups, asking why they hadn’t done so.
He hopes the political pressure succeeds: “You might conclude that maybe they don’t want to give the information out because it might be embarrassing.”
Follow on Twitter: @charlesornstein, @tracyweber
Read a related stories on the ProPublica website: Heart Society’s Tip Sheets Fail To Mention Risks.
The Heart Rhythm Society Responds to ProPublica’s Questions
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.
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 websiteindicate 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.
Q. Four funders—Medtronic, Boston Scientific, St. Jude and Sanofi—account for 30 percent of the group’s annual budget. Is this reliance on a small group cause for concern? Why or why not?
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 theradio 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.
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