It has been almost five months since the “investigative journalist” shop ProPublica published a story about physician-industry payments. Today they published a series of articles in the USA Today and Vermont Public Radio on industries relationships with medical societies. Unfortunately, nothing has changed in their approach about reporting the innovation and collaboration physicians have with industry, which improves the lives of millions of Americans. Instead of actually “investigating” the nature of such payments, ProPublica uses the same framing bias it created last year in announcing its “Dollars for Doc” series.
This means that all ProPublica did in their “investigating” was ask outright industry critics, such as Steven Nissen and David Rothman, their opinions about such payments, and they failed to include any opposite perspectives. Had they done so, they would have realized that physicians overwhelming value industry, and the research grants, clinical trial funding, and continuing medical education grants they provide (as shown by a recent survey). They also completely ignore any of the life saving/extending benefits of the collaboration, but that is for another article.
As usual, ProPublica fails to even acknowledge the positive benefits of physician-industry collaboration and the negative effects that patients, physician training, and education would suffer if such relationships were further impaired.
Nevertheless, ProPublica decided to shift away from a story on individual payments to physicians, and this time “examine” industry financial information about medical professional associations. Specifically, last year, Senator Charles Grassley (R-IA), who has been a vocal supporter of transparency in physician-industry payments, requested information from the Heart Rhythm Society (HRS) and 32 other professional associations and groups that promote disease awareness and research. This week, Senator Grassley published the payments on ProPublica’s website for all 32 groups and followed up with many of the societies to ask why they had not posted their information on their website or responded to his initial request.
According to ProPublica’s analysis, the Heart Rhythm Society’s “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.” Their main concern is that because professional societies can represent a large number of doctors, companies see them as a “lucrative market” to influence.
The problem with this assertion however, was clearly identified by an interview that ProPublica authors Charles Ornstein and Tracy Weber did with the Heart Rhythm Society’s president Dr. Douglas L. Packer and president-elect Dr. Bruce L. Wilkoff.
During this interview, Drs. Packer and Wilkoff specifically recognized that, “advances in electrophysiology depend on a collaborative relationship between physicians and industry, who have for decades worked together to develop life-saving devices.”
Moreover, they asserted that HRS “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.”
Because collaborating with industry is so essential to HRS, Drs. Packer and Wilkoff asserted that the society examines their “policies and procedures on an ongoing basis to avoid conflicts of interest, the potential for misunderstandings or perceptions of bias.” But the original ProPublica article attacking HRS doesn’t include any of these quotes. Instead, this interview is a separate piece, kept away from readers eyes. And clearly, the ProPublica authors ignored another physicians perspective about the legitimate relationships electrophysiologists have with industry that improve patient care and outcomes.
Consequently, Drs. Packer and Wilkoff then explained that although half of HRS funding comes from industry sources, HRS “is seeking new more diverse revenue streams that support their mission.” Nevertheless, they pointed out that because of the funding HRS has received, the organization has been able “to help 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.” ProPublica of course does not address the potential negative impacts on public awareness reduced industry funding could have on patients and prevention efforts.
Next, ProPublica tries to criticize HRS for accepting sponsorships at its annual scientific meeting, something that is practically commonplace at all annual or regional scientific meetings and any convention taking place in the world. Drs. Packer and Wilkoff explained that such sponsorship provides advertising opportunities for participating exhibitors. Moreover, they asserted that while 30% of their funding for such meetings comes from Medtronic, St. Jude, Boston Sceintific, and Sanofi-Aventis, this is no cause for concern because HRS has “thorough policies and procedures in place for working with industry and is comfortable identifying and managing various interactions with industry.”
They further recognized that HRS “seeks multiple supporters for its educational programs in order to avoid the perception that programs are tied to a specific company.” In addition, “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.”
With respect to HRS leaders, Drs. Packer and Wilkoff recognized that although 16 of 18 HRS board members had relationships with one or more drug or device manufacturers in 2010-11, such a concern is misplaced given HRS’s transparency requirements. They recognized that “HRS leaders are required to disclose their relevant financial, commercial, professional and institutional relationships,” and 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.” In addition, HRS’s Ethics Committee reviews all disclosures and rules for interactions with industry on an annual basis and updates policies and procedures as needed. Members are required to recuse themselves when necessary.
ProPublica Article
While ProPublica was fair enough to interview Drs. Parker and Wilkoff, their main article neglected to incorporate a fair balance of what they had to say about the importance of physician-industry collaboration. Instead, the main article on HRS focused on how last year’s annual meeting “brought in more than $5 million, including money for exhibit booths and how this year, there are even more promotional opportunities.” However, industry support of annual meetings is commonplace and necessary. As Drs. Parker and Wilkoff recognized, “the Heart Rhythm Society’s first and foremost concern is to provide effective and appropriate treatment options to our patients.”
To achieve this goal, they recognized that, “it is imperative that we interact with industry to develop better therapies and test them thoroughly in rigorous clinical trials.” And for that reason, HRS believes 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. Furthermore, HRS uses information from the Food and Drug Administration (FDA) to get updates about new products, safety alerts and drug recalls. When new or updated information is disseminated by the FDA relative to electrophysiology, HRS first determines whether it has an impact on patient care. If so, HRS disseminates the FDA’s updates whether industry products are cast in a positive or negative light.
Consequently, they also noted that a full description of the Society’s safeguards to prevent industry bias can be found in their “Guidance for the Heart Rhythm Society Pertaining to Interactions with Industry,” which was released on May 5 at Heart Rhythm 2011, the Society’s 32nd Annual Scientific Sessions. The document is a great example of the introspection that continually occurs at the Society to review and update their safeguards, policies and procedures to appropriately monitor relationships and provide optimal oversight.
Despite the clear and strong efforts HRS has made, ProPublica still decided to criticize such relationships. They use outspoken industry critic David Rothman to assert that industry relationships with medical societies are still “hidden from public view” and are a “logical target for drug/device makers” because 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.” Moreover, they also cite industry critic Steve Nissen, who talks about the “subtle ways” companies and professional societies become partners and — wittingly or unwittingly — physicians become agents on behalf of the interests of the sponsoring company. Of course, ProPublica cites no experts or physicians on the other side of the argument who find tremendous value in physician-industry relationships and collaboration.
Furthermore, what ProPublica clearly ignores, is that without the funding from industry, such societies would not have the resources, staff, or level of expertise to conduct even the lowest level of these activities, such as research or guidelines. Government does not fund non-profit medical societies, and they are run by practicing physicians, whose time is already minimal.
Consequently, the article goes on to describe how half of the money HRS got was from makers of drugs, catheters and defibrillators used to control abnormal heart rhythms, the group’s website disclosed. But as HRS noted, their new policy, among other things, requires more detailed disclosure of board members’ industry ties. Despite their strong efforts for transparency and strong policies to address potential conflicts, ProPublica tries to drag HRS through the dirt by suggesting they are as bad as the companies who fund them; companies who have “paid millions since 2009 to settle federal allegations that they improperly paid kickbacks to unidentified physicians to use their cardiac devices.” But the rare minority of a few physicians wrongdoing is not indicative of the 5,100 physicians represent. If we judged members of Congress by the few unethical members who committed illegal acts, America would have no trust in our government.
While ProPublica focuses only on the numbers (money) that companies pay for getting an exhibit booth, advertising, or consulting, they fail to recognize the more important number: how many lives are saved or improved because of the new technologies and treatments these companies make and teach their doctors about. These booths at annual meetings allow physicians to examine a company’s products, learn about them, and even use them.
Another problem with the series of articles ProPublica ran on HRS dealt with the tip sheets they provide to patients. For example, they point to one sheet, which says that implantable cardioverter defibrillators—devices that automatically deliver shocks to restore normal heart rhythms—are “99% effective,” but the sheet doesn’t mention that the devices may also deliver unnecessary and painful jolts , which can damage a patient’s quality of life. While the information on this sheet should certainly be checked, the problem is that ProPublica suggests that the omission of risk information is due to HRS accepting money from industry, which makes these devices.
Drs. Packer and Wilkoff said industry support does not influence educational offerings or the group’s positions on appropriate treatments. Specifically, they noted that, “the most-informed discussion of the risks and limitations of treatments are best conducted between a patient and his/her physician and that the website “is not intended to cover all aspects of any medical condition. It is generalized and is not intended as specific medical advice.”
What is problematic about this assertion, as ProPublica clearly states, “there is no evidence of a quid pro quo.” So with no evidence, what do they rely their assertions on for such “assumptions” that drug company support is causing HRS to omit risk information? ProPublica relies on comments from “those who study conflicts of interest in medicine who say industry money may subtly affect what groups say—or don’t—about the products made by their financial supporters.” That sounds like a clear conflict of interest to us. COI experts saying there is influence, when there is “no evidence” of such. In other words, ProPublica relies on industry critics such as Nissen and Rothman who make their names and careers publishing papers and criticizing industry, when the reality in this case is, as ProPublica states, “there is no evidence.” Hardly what we would call, investigative journalism.
Discussion
While ProPublica will continue to raise doubt—since that is what they are being paid for—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. Lewin further recognized that, “exhibit booths don’t unduly influence attendees. He said, “I don’t buy a soft drink just because of the advertising… I buy it because I like it.”
In the end, the overwhelming majority of medical societies, such as the Heart Rhythm Society, that accept support from industry believe that “transparency, along with the policies and procedures in place to safeguard against conflicts of interest, misunderstandings and perceptions of bias, help to ensure that societies remain effective in board considerations and decisions.”
Many of these societies believe that collaboration—with appropriate boundaries—is not bad, but is actually “required for producing creative solutions for patients.” However, these organizations recognize 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.”
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