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Philadelphia VA Hospital Brachytherapy Debacle: For The Want of One Competent and Industrious IT Person

This post should perhaps be subtitled "The Theatre of the Absurd." At Healthcare Renewal and other sites I've often commented on the remarkable accommodation given to IT personnel in hospitals, even when these personnel make capricious decisions that are contrary to the support of the mission of healthcare organizations, or contrary to the mission itself. I <a href="http://hcrenewal.blogspot.com/2009/03/health-it-project-success-and-failure.html">wrote that</a> many HIT problems observationally appeared due to ill-informed, capricious edicts of overempowered (relative to clinical leadership) MIS leaders, sanctioned by equally ill-informed executive leadership, for which the IT personnel were rarely held accountable. <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=clinical%20computing%20problems%20in%20ICU">Endangerment of ICU patients</a> via PC's entirely inappropriate for a biohazards environment, <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=Cardiology%20story">chaos in a critical procedure area</a> from IT complacency and incompetence, payment of millions of dollars for <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">HIT with gross defects rendering it unusable</a> by clinicians without consultation of in-house medical informatics expertise, and <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=cases&sloc=pharma">denial of access for hundreds of drug discovery scientists</a> to the informatics tools their own leaders said were essential to new drug discovery are just a few of the situations I've personally observed due to IT department whimsy. Remarkably, none of these situations nor others reported from numerous sources resulted in repercussions against the teflon-coated IT deities (other than, in some cases, generous promotions), thereby obstructing remediation of the attitudinal and competency problems that created the scenarios. If physicians had it this good, they'd be chopping off wrong limbs, removing the wrong organs, and failing to diagnose and treat with impunity. At my June 2009 posting regarding an unfolding clinical debacle of national import at the Philadelphia VA hospital entitled "<a href="http://hcrenewal.blogspot.com/2009/06/computer-and-other-mysteries-at.html">Bungled Brachytherapy, Computer Interfaces and Other Mysteries At The Philadelphia Veterans Administration Hospital</a>" I wrote: <blockquote>... I am uncertain how "computer interface problems" (in the <a href="http://www.philly.com/philly/news/homepage/20090621_Feds_see_wider_woes_in_VA_s_cancer_errors.html">Philadelphia Inquirer</a>, they were referred to as "glitches") prevented medical personnel from determining treatment success over several years. I would be most interested in hearing more about these "interface problems."</blockquote> That question has now been answered, and I am disappointed (but not surprised) at the results. Having rewritten a poor interface between a gamma scintillation camera and a PDP-11 computer in medical school during a nuclear medicine rotation at Boston City Hospital, allowing endusers to identify ROI's (regions of interest) with a light pen for automated calculation of intensities, I thought perhaps some arcane coding or driver configuration was the culprit at the VAMC Philadelphia. That was not the case: <a href="http://www.philly.com/inquirer/front_page/20090719_VA_radiation_errors_laid_to_offline_computer.html?viewAll=y">VA radiation errors laid to offline computer</a>By Marie McCullough and Josh Goldstein Philadelphia Inquirer July 19, 2009... It is not surprising, then, that NRC and VA investigators spent considerable time delving into why the calculations weren't done for more than a year at the Philadelphia VA. Their investigative reports blamed a "computer interface problem" - the same terminology Kao used during his testimony last month at a congressional hearing. The implication was that some intractable technology breakdown was behind the lapse in care [i.e., some cryptic problem requiring magical incantations and byzantine scripts that mere mortals could not understand nor remedy - ed.] In fact, technology had little to do with the breakdown, as James Bagian discovered when he led an inquiry at the Philadelphia VA and the veterans' health system's 12 other brachytherapy programs. Bagian, a Philadelphia-born physician and former astronaut who is now the national VA's patient-safety director, discovered that the "interface problem" was nothing more than the disconnected computer. Here's what else his inquiry found: The computer was initially unplugged so that another medical device could use the network port. Then, various departments dithered and ducked a request for an additional network port, which was finally installed - after a year. ["Various departments dithered and ducked?" Which departments, exactly? See below - ed.] Some doctors, physicists, and other professionals at the VA acknowledged it was "clinically inappropriate" to omit the post-implant calculations. Some said they had informed their "chain of command." When asked why they didn't tell the hospital's patient-safety officer, they said "it had not occurred to them to do so." ["Had not occurred to them to do so?" I've seen situations where physicians and scientists were afraid of IT leaders, due to the latter's often overinflated political influence and proficiency in playing games of political intrigue. Did this occur here, I wonder? - ed.] So, it appears that for the want of one network connection, installed by one competent, industrious, non-complacent IT person, a national scandal has erupted that has injured many patients. First, I ask the following questions regarding the "various departments" that "dithered and ducked" the responsibility to install an additional network connection in the brachytherapy suite: <ul><li>Was the job the responsibility of the Department of Medicine? The doctors and nurses? Could they have done so? </li><li>Perhaps it was the responsibility of the Public Relations Department (who now have to pick up the pieces?)</li><li>Was it the reponsibility of the Facilities Department? </li><li>Was it the responsibility of the Housekeeping Department?</li><li>Or, was it the responsibility of the IT Department and CIO? </li></ul> (If you need help answering these questions, stop reading now.) I also ask: <ul><li>Why was the IT department's failing to perform this task kept low profile through use of cryptic "interface problem" language that implied complex IT problems, as opposed to simple people problems? </li><li>Who originated this language?</li><li>Did they believe the truth could remain hidden? </li><li>Why do we use the term "medical malpractice" to describe negligence in medical care, not "provider glitch?" Why the different standards? </li></ul> I can visualize what went on behind the scenes in the IT department, refrains I have heard before - "we don't have the resources ... we need to hold more meetings to consider the issues ... it's the vendor's responsibility ... it's the network group's job, not the hardware group ... putting a new network outlet in there will cause packet storms and interfere with system XYZ ... we need to get consensus .... you [doctors] can't understand the complexities of the problem, but don't worry, we'll make it better ... hey, the docs don't need it anyway ..." What would happen to, say, the Facilities Department if a plumbing problem led to failure of a piece of vital equipment in the OR's, and they failed to repair it for a year? This is not to excuse the multiple layers of complacency among clinicians, safety staff, and others for toleration of this network denial situation and the lack of QC on the procedures themselves, but at the heart of this debacle is this attitude, which seems common in hospital IT departments: <blockquote style="font-style: italic;">"Doctors and nurses toil in hospitals so IT personnel can have comfy jobs and nifty computers."</blockquote> Perhaps on this occasion, IT leaders and personnel may end up on the witness stand and be held accountable, and perhaps lose their jobs instead of being promoted. However, even this is doubtful, and it has taken a congressional investigation led by Sen. Arlen Specter to get even this far, to simply find out that the mysterious "interface glitches" were a lack of a network jack due to laziness and complacency. Finally, I point out that it is hospital IT personnel upon whom clinicians will depend for acquisition and implementation of the HIT tools the President of the United States said are essential to changing the culture of healthcare. As I have written, before the IT profession can change the culture of healthcare (in a positive manner, that is), its own culture must change. IT personnel in hospitals must become part of the clinical team and support the mission of clinicians, not the other way around. July 22 addendum:<div> </div><div>I note again that multiple people failed here, including executives, physicians, safety officers, etc. I believe responsibility needs to be fairly assigned. However, IT needs to be included. I've witnessed or heard about too many HIT incidents where IT personnel and leadership remained scot-free when their behavior and attitudes were contributors or root causes.<div>As per my letter to the editor published in JAMA on July 22, "<a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards</a>", IT privilege and accommodation must stop. HIT is not business IT used for widget inventory or payroll. As the VA incident shows, patient lives and well being are at stake.July 24 addendum:More on this from a blog on medical physics, "The Sharp End of the Photon", <a href="http://www.drflounder.com/archives/406">here</a>:<blockquote>... the errors in the placement of the radioactive seeds went undiscovered for so long because post-implant dosimetry was not performed. This involves CT scanning the patient, finding the positions of the seeds and calculating the ultimate dose the patient received. In the NRC report, the explanation was that a problem with the interface between the CT scanner and the treatment planning computer prevented transferring the CT images.</blockquote>A "problem with the interface", indeed.Also provided is a link to testimonies from witnesses at the house.gov website, which are <a href="http://veterans.house.gov/hearings/hearing.aspx?newsid=438">here</a>.Notable is the absence of any testimony from IT leadership. The only allusion to IT is in testimony by the doctor who performed the procedures who stated:<blockquote>"There should be a method of categorizing systematic problems by level of urgency so that serious problems, such as those involving failures of medical equipment or transfer of patient-related data, will receive immediate attention from the proper personnel and be quickly resolved."</blockquote>Perhaps, but not in this case. A simple phone call to IT should have been adequate to resolve this particular simple problem. -- SS </div></div>

Philadelphia VA Hospital Brachytherapy Debacle: For The Want of One Competent and Industrious IT Person

This post should perhaps be subtitled "The Theatre of the Absurd." At Healthcare Renewal and other sites I've often commented ...

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STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF? Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously <a href="http://carlatpsychiatry.blogspot.com/2009/07/acre-academics-craving-reimbursement.html">described</a>, Stossel is planning the inaugural meeting next week of a group to counter those he calls pharmascolds. The group is named ACRE – Association of Clinical Researchers and Educators. Here is its website: <a href="http://www.acreonline.org/">http://www.acreonline.org/</a> For months, Stossel has been warning of the dire negative consequences that will result from tightened conflict of interest policies, but he has not presented any persuasive examples of damage to “productive relationships between industry and physicians involved in clinical research and educational outreach.” At the same time, Dr. Stossel has conveniently overlooked the shenanigans of the bad actors whom Senator Grassley exposed. Dr. Stossel is a blowhard, as I have described here <a href="http://hcrenewal.blogspot.com/2008/02/dr-stossel-sounds-off.html">before</a>. But wait! ACRE has found something! A News item in the July 2009 issue of Nature Medicine (“Conflict of interest rules seen by some as too stringent”) quoted one of the participants in the upcoming ACRE conference. Avi Markowitz, chief of oncology at UT Medical Branch, Galveston, came up with this example: Patients taking a Sanofi Aventis chemotherapy product may experience peripheral neuropathy, which can cause unpleasant sensations in the hands and feet. ‘Sanofi Aventis had been providing Markowitz and his UTMB colleagues with free blankets and gloves for those patients. Last fall, however, the university adopted stricter rules banning industry freebies. Now, Markowitz can’t even accept the unbranded blankets and gloves that Sanofi Aventis has offered to provide.’ Reading between the lines, it is a good bet that these items originally were branded. Whatever. And never mind that the patients receiving chemotherapy at UTMB are doubtless billed a hefty facility fee that must include comfort items like blankets and gloves. Since when does a chief of oncology need to beg for these basic patient care provisions from drug companies? Is this all that ACRE can come up with? The ACRE homepage warned sternly of “restrictive conflict of interest policies that often sever productive relationships between industry and physicians involved in clinical research and educational outreach.” Does Thomas Stossel’s whining and catastrophizing through ACRE come down to piffling items like blankets and gloves for chemotherapy patients? That’s it? Where’s the beef? At least ACRE has the good sense not to include on its program the smooth operators whom Senator Grassley outed – like Nemeroff at Emory, Schatzberg at Stanford, Kuklo at Walter Reed, Keller at Brown, Biederman at Harvard. Not even Stossel has been brazen enough to try to defend them. The Nature Medicine News item does close on a helpful note: 'Stossel would like to see abuses involving financial conflicts of interest treated more like cases of scientific misconduct. Rather than forcing everyone to abide by prohibitive rules, he says administrators should focus on weeding out those who misbehave.' I say Amen to that, even if it is a day late and a dollar short. We have arrived at our present state of discomfiture because the leaders of academic institutions and professional societies looked the other way for too long. They failed to do their job of reining in the ethical outliers. Grassley had to do it for them. As a result, the rest of us will be burdened with new regulations for years to come. Those who did speak up years ago were ignored or demonized. As the saying goes, every group gets the leadership it deserves. Those in academic medicine had better not count on Stossel and ACRE to lead them out of the wilderness. Bernard Carroll.

STOSSEL and ACRE: WHERE'S the BEEF?

STOSSEL and ACRE – WHERE’S the BEEF? Thomas Stossel from Harvard is at it again. As Daniel Carlat has humorously described , Stossel is plan...

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Irish Physicians Opt Out of Vital Patient Maintenance Care, Refuse to Release Records; Court Agrees

Well, no, actually. Irish physicians did not opt out of "maintaining" the healthcare of patients and refuse to release their medical records. Even imagining such an event is absurd. IT providers in Ireland did, however, opt out of caring for the HIT of 180+ hospitals and releasing the source code so others could do it: <blockquote><a href="http://www.herald.ie/national-news/courts/hse-fails-in-bid-to-secure-it-servicing-for-180-hospitals-1825034.html">HSE fails in bid to secure IT servicing for 180 hospitals</a> By Tim Healy Thursday July 16 2009 The HSE [<a style="font-style: italic;" href="http://www.hse.ie/eng/">Health Service Executive</a> - ed.] has failed to get a High Court order compelling a company to continue providing vital computer maintenance services for 180 hospital and other sites around the country. Ms Justice Mary Laffoy also refused to grant an injunction requiring the company, Eamon Keogh, trading as Keogh Software, Harold's Cross, Dublin, to temporarily release source codes necessary for someone else to maintain and fix the computer system's software. [In other words, traditional business computing customs of source code secrecy even in face of software orphancy shall apply - quite inappropriately - to healthcare, and providers and patients be damned. - ed.] The system is used by A&Es, radiology departments, HSE billing services as well as in environmental health areas and "parliamentary affairs" of the HSE. Keogh Software, which laid off all its staff providing the service on May 29, undertook to maintain the service until yesterday's judgment. The HSE had sought an injunction requiring it to continue to provide the service pending full court proceedings. Ms Justice Laffoy ruled that the issue of the release of the software source codes should be dealt with under an independent resolution procedure set up to deal with this eventuality. [By that time, the hospitals will have been forced to return to manual methods and then replace the systems, or run the risk of chaos and patient harm from defective software, assuming it functions at all - ed.] The judge also turned down a cross-application from Mr Keogh for an injunction requiring the HSE to pay for work done under a new fee agreement entered into by the parties on April 3 last. She also dismissed his application for an injunction waiving a HSE requirement that he produce a tax clearance certificate prior to payments being made. When the High Court heard applications from both sides last month for their respective injunctions, the judge was told the dispute was precipitated when operational problems were experienced in Naas Hospital's radiology information system [not an unimportant system - ed.] The HSE claimed Mr Keogh failed to respond properly to these while he (Keogh) claimed they were denied access to the system by the HSE [vendor denied access to malfunctioning RIS software needing remediation? I simply find that hard to believe - ed.] hnews@herald.ie - Tim Healy</blockquote> One wonders who will be held accountable if this unremediated, defective software results in patient harm or death. (I, however, doubt it will be the IT vendor.) Thus are the dangers of hospitals becoming dependent on an IT industry privileged and accomodated to the point of having no accountability (as in the U.S. as detailed by Koppel and Kreda in JAMA <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">here</a>). Thus are also the dangers of hospitals becoming dependent on proprietary HIT, and/or not having the expertise nor the source code required to fix bugs and perform maintenance themselves. I add that nearly our entire country is about to go that route. But at least the software will be "<a href="http://hcrenewal.blogspot.com/2009/06/mark-leavitt-head-of-cchit-behind-times.html">certified</a>" by the fierce watchdog group and safety advocate, the CCHIT. <a href="http://hcrenewal.blogspot.com/2009/06/open-letter-to-mark-leavitt-chairman.html">Fierce to its critics</a> and to its own organizational safety, that is (HIMSS, CCHIT's parent organization, is currently seeking to have CCHIT <a href="http://www.healthdatamanagement.com/news/stimulus-38650-1.html">declared the monolithic force for HIT 'certification'</a> in the United States). -- SS

Irish Physicians Opt Out of Vital Patient Maintenance Care, Refuse to Release Records; Court Agrees

Well, no, actually. Irish physicians did not opt out of "maintaining" the healthcare of patients and refuse to release their medic...

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Turning Patients into "Dialysis Dollars"

As we have discussed in previous posts (<a href="http://hcrenewal.blogspot.com/2007/12/relman-in-jama-on-threats-to-physicians.html">here</a> and <a href="http://hcrenewal.blogspot.com/2009/06/why-did-us-physicians-give-up-their.html">here</a>), prior to a US Supreme Court decision in 1975, physicians (and other professionals) were left free to set up and enforce their own codes of ethics. Until about 1980, the US American Medical Association (AMA) stated, <ul><li>"in the practice of medicine a physician should limit the source of his professional income to medical services actually rendered by him, or under his supervision, to his patients"</li><li>"the practice of medicine should not be commercialized, nor treated as a commodity in trade"</li></ul> The Supreme Court decision was widely construed as meaning that any promulgation by US professional organizations of ethical regulations that constrained any economic practices of their members was a violation of anti-trust laws. Thus, in 1980, the AMA dropped their prohibitions against the commercialization of medicine, and nobody, it appeared, tried to change the anti-trust law whose provisions the court interpreted. A vivid example of how physicians and patients may be caught in the cross-fires among health care corporations in this brave new era of commercialized health care was provided by a <a href="http://www.denverpost.com/commented/ci_12830453">recent report </a>in the Denver Post: <blockquote>News that Fortune 500 company DaVita Dialysis is moving its headquarters to Denver socked its competitors like a punch in the gut. To its rivals, the kidney-care giant is a bully armed with high-powered attorneys who use lawsuits as tools to intimidate. DaVita executives counter that they are simply strong competitors — they act as aggressors only when doctors or nurses or other dialysis companies break promises and double-cross them. Either way, a string of DaVita-filed lawsuits around the country — with two major battles boiling in Denver and Colorado Springs — shed light on the ruthless competition over dialysis patients in an industry that costs Medicare alone more than $8 billion per year. For years, DaVita's competition in Colorado's two largest cities was almost nonexistent. The mud began to fly last year when the second-largest group of Denver kidney doctors, called nephrologists, ended their exclusive affiliation with DaVita and partnered with a Massachusetts dialysis company entering the Denver market. Near the same time, the largest nephrology group in Colorado Springs dumped DaVita in favor of Liberty Dialysis, which recently opened two dialysis centers in the city. DaVita quickly sued doctors in both cities, plus a nurse battling breast cancer who quit her job at a DaVita dialysis center and took one with Liberty. The hostility between the companies is so intense, it's seeping down to the patients. 'With everything that is going on, you feel like you are becoming sort of a dialysis dollar,' said Julie Estes, a 53-year- old Colorado Springs woman who spends three days a week, four hours at a time, hooked to a dialysis machine in order to stay alive. DaVita says it 'paid millions' in 1998 to the doctors of Western Nephrology in Denver to retain them as medical directors of six dialysis centers in the metro area for 10 years. The doctors signed non-compete agreements, promising not to join forces with DaVita rivals or steal any of the California-based company's nurses. Patients are free by law to choose any dialysis center they want. But dialysis companies bank on the fact that snagging the most popular kidney doctors in town to serve as medical directors of their centers will bring in the most patients — and the most dollars. Every dialysis center is required by federal law to have a medical director to oversee the care of patients and the water purification system used to flush toxins from the blood of people with failing kidneys. It's a side job, separate from a nephrologist's practice, that some estimate takes only a couple of hours each week. Companies and doctors declined to say what salary comes with the job, but estimates range from $20,000 to $200,000 per year depending on the competitiveness of the market. After 10 years with DaVita, when they believed the non-compete agreement was about to expire, Western Nephrology doctors began making plans to become medical directors of shiny-new American Renal Associates dialysis centers opening in Denver with a flat-panel TV and heated, massage chair at every dialysis station. Four of the new centers are within 3 1/2 miles of existing Da Vita centers. The non-compete agreement that Western Nephrology doctors had signed for DaVita prohibited them from having relationships with competitors within a 35-mile radius. DaVita contends in its lawsuit that it found out about Western Nephrology's 'secret campaign' because the dialysis company they were working with applied for Medicare billing numbers for five new centers in the Denver area. In its counterclaim, American Renal Associates accused DaVita of violating federal antitrust law — the company had controlled at least 80 percent of the Denver market. DaVita lagged in updating its dialysis centers until competition was imminent, according to court records. And the claim accused DaVita of 'filing legal actions that are objectively baseless' merely as an 'anticompetitive weapon.' </blockquote> "Ruthless competition," "lawsuits as a tool to intimidate," "double crosses," flying mud, patients who feel like "dialyis dollars," non-compete agreements, medical directors paid according to "the competitiveness of the market," "secret campaigns?" - is this any way to run a health care system? As Dr Arnold Relman pointed out (see our previous posts linked above), through the 1960s there was some consensus that health care does not function like a pure market, partially because patients cannot function like steely-eyed consumers. They do not have enough information about the benefits, harms and costs of their possible choices. They have trouble understanding the ambiguity and uncertainty of the medical context. And most important, they may not be capable of the cold cognition the free market model requires, since they may be dealing with choices whose potential outcomes prompt extreme emotions, and in many cases, they may be too frightened, sick, or cognitively impaired to make fully rational choices. In particular, patients with end-stage kidney disease, requiring dialysis to maintain life, seem very different from some ideal, coldly cognitive consumers. So what in the world are they doing caught up in these sorts of disputes? I submit that real health care reform ought to help physicians and other health care professionals renew their professionalism, and put the provision of health care (and health education and clinical research) back in the hands of people who view these activities as callings, not purely as ways to get rich. Meanwhile, when you are a patient, be prepared to be treated merely like a source of revenue. PS - Please note that, as we have <a href="http://hcrenewal.blogspot.com/2009/03/meet-new-boss-same-as-old-boss-health.html">posted</a> before, the new US "czar" for health care reform is a former member of the board of directors of DaVita.

Turning Patients into "Dialysis Dollars"

As we have discussed in previous posts ( here and here ), prior to a US Supreme Court decision in 1975, physicians (and other professionals...

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Again, Logical Fallacies in Defense of Conflicts of Interest: a Rebuttal to Rothman et al Appears in JACC

Earlier this year, a remarkable commentary in JAMA suggested major reconsideration of the relationships among professional medical associations (PMAs) and health care corporations.(1) Because of the influence of PMAs on clinical care, education, research, and policy, Rothman et al suggested that these organizations sever most of their financial ties to corporations such as pharmaceutical, device, and biotechnology companies. The authors suggested that the only acceptable payments to PMAs from these companies are those for advertising in publications that is clearly labeled as such, and advertising exhibits in meetings, again that is clearly labeled. Furthermore, the authors suggested that people with current or recent (within the last two years) relationships with such corporations ought not to serve as officers or trustees of PMAs, and ought not to serve on program or practice guideline committees. Rothman et al thus suggested that professional medical associations return to their roots, to be advocates for their physician members, and those members’ core values, not marketers of drugs and devices, and promoters of the interests of health care corporations. The Journal of the American College of Cardiology (JACC) just published the first rebuttal of Rothman et al to appear in a peer-reviewed journal, written by Dr Alfred A Bove, President of the American College of Cardiology (ACC), one of the more influential PMAs.(2) Dr Bove contended that there is nothing wrong with the current relationships among corporations and PMAs, and PMAs should be free to relate to health care corporations any way they want. Dr Bove also asserted that “the assumptions that lead to ... [Rothman and colleagues’] conclusions can be challenged on many fronts.” However, in my humble opinion, Dr Bove supported these contentions with logical fallacies, rather than evidence and logic. Appeals to Authority, Fear, and Pity Early on, Dr Bove used a striking set of <a href="http://www.nizkor.org/features/fallacies/appeal-to-authority.html">appeals to authority</a>. (Note that his relevant quotes below appear in italics.) “There is no comment about trust or virtue as a characteristic of the medical profession.” “We are not to be bribed by a cheap pen or a free lunch.” “The authors' assumptions imply that physicians as a group are not responsible people, yet physicians are among the most responsible professionals.” These appear to be appeals to the traditional authority of the medical profession. Dr Bove simply asserts that physicians are inherently virtuous and deserving of trust, and thus no one could question the virtue of the profession. He then compounded these appeals to authority with a veiled appeal to fear. “The authors' assumption that the worst behavior is the average behavior of all physicians insults the profession.” As noted below, Rothman et al did not make this assumption, so the appeal in turn rests on a straw man argument. This appears to be <a href="http://www.nizkor.org/features/fallacies/appeal-to-fear.html">an appeal to fear </a>in that an “insulted” profession might be expected to take action, legal or otherwise, to avenge the insult. It also could be a form of <a href="http://www.nizkor.org/features/fallacies/appeal-to-pity.html">an appeal to pity</a>, in that the reader might be inclined to pity the poor “insulted” physicians. Straw Man Arguments The bulk of the editorial consisted of a string of straw man arguments. A <a href="http://www.nizkor.org/features/fallacies/straw-man.html">straw man </a>argument propounds a distorted, exaggerated, or misrepresented version of his opponent’s argument, and then attacks it, rather than his opponent’s actual argument. “The sole source for support of PMAs could only come from government or foundation grants....” Actually, Rothman et al included membership dues, and by implication, meeting registration fees, journal subscription fees etc as acceptable sources of support. “The article implies that all physicians who receive support from industry will forever be biased to support the products of the related pharmaceutical or device company.” Actually, Rothman et al seemed to assume that conflicts of interest might affect someone for up to two years, but not forever. Thus, they suggested that board members should be “conflict free for a 2-year period before assuming the position.” [The Rothman article] “also implies that industry does not work for the best interests of patients or the better [sic] public good, but only for profit.” Actually, Rothman et al stated “the pharmaceutical and medical device industries make important contributions to medical progress. Their role in the development and testing of new compounds and instruments is essential for the diagnosis and treatment of disease and disability.” “First, to assume that physicians would not be responsible for providing the best care for their patients after being associated with an industry study or consultation is inappropriate. The authors cited isolated examples of errant physicians who received large sums of money from industry and then promoted their products. They presume that all physicians are represented by these few—that we all have a price.” Actually, Rothman et al did not discuss any particular cases of “errant physicians.” What Rothman suggested was that gifts, even of “modest value,” can bias decision making, and that the receipt itself of the gift may itself be influential. However, if even modest gifts have some influence, it is logical that large financial transactions might have major influence. “Society understands that reward drives innovation, so expecting a financial gain from a commercial medical enterprise is not wrong. In fact, it is the only way that new ideas will move from the laboratory to the public good. Using public funds for manufacture and distribution would add an enormous burden to government costs and, based on past experience, would be unproductive.” Rothman et al were not remotely suggesting nationalizing the drug and device industries. “If one of us has an idea for a new device and needs industry to help refine its design, fund its development and manufacture, and establish its value by animal and clinical studies, this process should be honored, not condemned. Will the government fund the development of the next new drug? Would the government have funded the development and manufacture of an implantable pacemaker?” At the most, Rothman et al recommended not allowing physicians who are paid by companies in conjunction with their development work to serve as top leaders, and on certain committees of PMAs. They never broadly “condemned” physicians who work with industry to develop devices. “Governments have not shown an interest in funding the development of new drugs and devices. Industry raises the funds, takes the risks, and should reap the rewards for its role in creating a better life for our patients.” Actually, governments have helped development considerably by funding much of the underlying basic science research. Again, Rothman et were not remotely suggesting nationalization of drug development. Summarizing the Arguments So Dr Bove ended up by warning that the suggestions Rothman et al made about reducing institutional conflicts of interest affecting professional medical societies, and individual conflicts of interest affecting their leaders would “destroy the best of what we have in our science and industry,” that is, destroy biomedical and clinical science, and lead to nationalization of important forms of medical production. None of that was suggested or implied by Rothman et al. After positing this dire future, Dr Bove then asserted that professional societies ought to be entitled to money from industry limited only by their “professionalism.” Thus, “industry should be able to support unbiased programs aimed at educating physicians and other health care providers about the therapies available for the care of their patients. Professional societies should be able to receive unconditional educational grants to provide up-to-date information to their members on medical therapies.” Furthermore, “the proper relationships should allow us to work with industry and allow our professional societies to receive undesignated funds from industry to foster better patient care.” So, Dr Bove wound up where he started, asserting that doctors and professional societies are inherently virtuous, and thus should be trusted to do whatever they think is right, without any external scrutiny or accountability. Yet he never demonstrated the virtue of the ACC under his leadership, or of PMAs in general, or showed why they should be trusted. Why did the president of one of the nation’s most important medical associations publicly make such poor arguments to support his organization's current financial relationships with health care corporations? I can only speculate, but there may be some clues found by looking at what is publicly known about the current relationships of the ACC and its leaders to health care corporations. Publicly Disclosed Relationships Among the ACC and Its Leaders and Health Care Corporations My sources for these clues were a <a href="http://www.acc.org/about/overview/industry%20support%20revenue%20sources%20detail%202%2011%2008%20(revised%207%2031%2008%2016h00).pdf">report</a> on the ACC web-site on its relationships with health care corporations (through 2007), and the form 990s that the ACC is and the highly related ACC Foundation are required to file with the US Internal Revenue Service. (The form 990s are publicly available from GuideStar with a free membership. The ACC form is <a href="http://www.guidestar.org/FinDocuments//2007/311/781/2007-311781555-04a0f423-9O.pdf">here</a>, the ACCF, <a href="http://www.guidestar.org/FinDocuments//2007/135/641/2007-135641985-0494dd32-9.pdf">here</a>.) Perhaps unsurprisingly, it turns out that the ACC gets a large proportion of its income from industry. In 2007, it acknowledged receiving $35,882,095.15 from industry. The largest categories of industry support were "promotional/quality program support," $12,664,650; "charitable contributions," $7,603,639; and "exhibits" at meetings, $7,318,807; and "educational grants," $5,084,600. The total revenues of the ACC (which include the ACC Foundation), were $94,560,000, so that industry support accounted for 38% of total revenue. These figures should be compared to the revenue the society received from membership dues (found on its 990 form), $11,995,056, and the income it claimed from its annual scientific session, $8,400,632. So to put it another way, the ACC got about three times as much money from industry as it got from its members' dues, and almost twice as much money from industry as it got from dues and its annual meeting combined. So were the suggestions made by Rothman et al to be implemented by the ACC, it would stand to lose at least $28 million a year (given that in 2007, about $1 million of its industry revenue was from advertising , and about $ 7.3 million was from exhibits at meetings.) The organization's lavish revenues have allowed it to pay its full-time managers very well. In 2007, its CEO received $534,452 in total compensation; its general counsel, about $394,000; and its CFO, about $336,000. It seems obvious that were the organization to foreswear industry revenue, the organization's top full-time managers would be unable to continue to live in the style to which they are now accustomed to. In addition, the organization's form 990 reveals that it pays its supposedly voluntary officers and some of its trustees substantial amounts as well. In 2007, it paid its president $147,750; its president-elect, $80,000; its two immediate past presidents, $79,500 and $70,000; its vice president (at that time, Dr Bove), $63,751; its treasurer, $32,500; its secretary for the board of governors, $52,500; its board of governors chair-elect, $25,000; its immediate past board of governors chair, $25,000; and some trustees amounts from $1000 to $20,520. To my knowledge, it is unusual for a professional society to pay salaries to its voluntary officers (as opposed to full-time, hired managers.) However, given that the ACC does, it seems that were the organization to foreswear industry revenue, its officers' personal income might be threatened to some extent. Finally, Dr Bove has his own personal financial relationships with industry. Some were <a href="http://www.cardiosource.com/ACCELaudio/policies.asp">disclosed</a> because of his role on ACCs Cardiosource editorial board, including "Consultant Fees/Honoraria: Insight Telehealth Inc,""Research/Research Grants: Astella Pharma, INC," and "Royalty Income: Elsevier." In addition, in a 2008 article(3), he disclosed receiving speakers fees from Medical Seminars, Inc, and serving as a consultant to Vasocom Inc. For a 2009 conference, he also <a href="http://www.acc.org/education/programs/brochures/tct_09disclosure.pdf">disclosed</a> "modest" equity interests in Cardiovascular Therapeutics, and Merck. So, in summary, it seems that the ACC gets a very substantial portion of its revenue from health care corporations, and that were it to carry out the suggestions of Rothman et al, it would lose much of that revenue. Thus, it is not surprising that ACC leadership would take exception to Rothman and colleagues' point of view. This is not the first time that an ACC president has defeneded the organization's dependence on industry funding (see post<a href="http://hcrenewal.blogspot.com/2008/10/another-industry-supported-physician.html"> here</a>). However, as I said in that post, <blockquote> My questions are how could a society which requires such a substantial proportion, 38% of funding from commercial sponsors ignore the preferences of the sponsors for particular topics and content areas? How could such a society dare to allow criticism of the sponsors, their products, or their activities? Knowing that the society is dependent on this level of support, could society leaders really hold industry representatives at arms' length? Knowing that industry supplies more than one-third of their salaries, would society staff really keep industry outside of some bureaucratic, but not concrete 'firewall?' </blockquote> In addition, it now seems the ostensibly voluntary officers of the ACC may have a personal stake in the ACCs receipt of health care corporate funding, since it is the apparent policy of the organization to pay these officers five- and six-figure salaries. Dr Bove did not disclose this apparent conflict of interest, nor did he disclose his other personal financial relationships with industry. As we have noted before, people with conflicts of interest tend to have trouble making coherent, logical and evidence-based arguments for positions related to their conflicts. As Joe Collier wrote in the BMJ, "people who have conflicts of interest often find giving clear advice (or opinions) particularly difficult. "(4) In any case, a previous ACC president wrote about the importance of "disclosure" and "transparency" in dealing with conflicts of interest. Whether disclosure of conflicts is sufficient to manage them, at least Dr Bove could have done the courtesy of disclosing that he is actually a salaried employee of the ACC, and disclosing his personal financial relationships with industry so that readers could try to evaluate how these financial entanglements might have affected what he wrote. Summary In conclusion, the first published rebuttal of Rothman and colleagues' suggestions for ensuring the independence of professional medical associations from outside vested interests was not based on evidence, but on logical fallacies rather than clear reasoning, and failed to disclose its authors' relevant financial relationships. We will see if anyone can make a better attempt. ADDENDUM (17 July, 2009) - see <a href="http://brodyhooked.blogspot.com/2009/07/cardiologists-on-coi-tripping-over-your.html">additional comments </a>by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog. ADDENDUM (22 July, 2009) - see <a href="http://cardiobrief.org/2009/07/22/cardiology-strikes-back-bove-lewin-weber-black-defend-ties-to-industry/">this post </a>on the Cardiobrief blog, which alludes to the post above, but also discusses an interesting response by the CEO of the ACC to the Rothman paper, and adds original commentary on larger issues. References 1. Rothman DJ, McDonald WJ, Berkowitz CD et al. Professional medical associations and their relationships with industry. JAMA 2009; 301: 1367-1372. (Link <a href="http://jama.ama-assn.org/cgi/content/full/301/13/1367">here</a>.) 2. Bove AA. President's page: relations with industry: thoughts on claims of a broken system. J Am Coll Cardiol 2009; 54: 177-179. (Link <a href="http://content.onlinejacc.org/cgi/content/full/54/2/177">here</a>.) 3. Somers VK, White DP, Amin R et al. Sleep apnea and cardiovascular disease: an American Heart Association/ American College of Cardiology Foundation scientific statement from the American Heart Association Council for High Blood Pressure Research Professional Education Committee, Council on Clinical Cardiology, Stroke Council, and Council on Cardiovascular Nursing. Circulation 2008; 118: 1080-1111. (Link <a href="http://circ.ahajournals.org/cgi/content/full/118/10/1080">here</a>.) 4. Collier J. The price of independence. Br Med J 2006; 332: 1447-9. (Link <a href="http://bmj.bmjjournals.com/cgi/content/full/332/7555/1447">here</a>.)

Again, Logical Fallacies in Defense of Conflicts of Interest: a Rebuttal to Rothman et al Appears in JACC

Earlier this year, a remarkable commentary in JAMA suggested major reconsideration of the relationships among professional medical associati...

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Plan ahead: Document and share your health wishes with Google Health

Do you have medical records gathering dust in a pile somewhere? As a doctor and nurse on the Google Health team, we've both had a lot of experience working directly in the healthcare system, with all the bills, insurance forms and other paper documents that come with it. We know from firsthand experience how burdensome all of these documents can be and we would like to reduce the unnecessary use of paper in patient care. As a step in that direction, <a href="https://www.google.com/health">Google Health</a> recently added a feature which allows patients to <a href="http://www.google.com/support/health/bin/answer.py?hl=en&answer=145440">upload scanned paper documents to their Google Health</a> profile for safe storage and easy sharing. One of the most important documents you may want to store and share in Google Health is an "advance directive." An advance directive allows you to determine your end-of-life wishes so that your family and doctor can honor them if you get sick and are unable to communicate. The decision to sign an advance directive is an important and personal one, and Google Health now makes it a little bit easier. Google Health is now working with a leading advance directive provider, <a href="http://www.caringinfo.org/">Caring Connections</a>, that provides a free, downloadable form customized for all 50 states. To complete your form, <a href="http://www.google.com/intl/en/health/advanced-directive.html">download it</a>, print it out, complete it, scan it, and upload it to Google Health. Once you've uploaded the signed form, Google Health makes it easy to <a href="http://www.google.com/support/health/bin/answer.py?answer=138423&cbid=1xdstla864k45&src=cb&lev=answer">share it with your caregiver</a>. We hope someday we'll move beyond paper, but until then Google Health can help you store your paper medical records electronically, including an advance directive, in one safe place. Posted by Julie Wilner, R.N., Program Manager, Google Health & Roni Zeiger, M.D., Product Manager, Google Health

Plan ahead: Document and share your health wishes with Google Health

Do you have medical records gathering dust in a pile somewhere? As a doctor and nurse on the Google Health team, we've both had a lot of...

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Submit your ideas to change the face of broadband

Have an idea for how to expand high-speed Internet access across the United States? Here's your chance to have your voice heard. Under the terms of the recent <a href="http://www.recovery.gov/">economic stimulus package</a>, the Federal Communications Commission must deliver to Congress a National Broadband Plan by February 2010. Several weeks ago, we l<a href="http://googlepublicpolicy.blogspot.com/2009/06/google-submits-initial-comments.html">aid out Google's vision</a> for how to make broadband Internet available and affordable for every American — and <a href="http://gullfoss2.fcc.gov/cgi-bin/websql/prod/ecfs/comsrch_v2.hts?ws_mode=retrieve_list&id_proceeding=09-51&excludeInformal=Y&start=1&end=127&first_time=N">hundreds of others</a> have already submitted comments of their own. The FCC has <a href="http://www.pcmag.com/article2/0,2817,2349698,00.asp">called for</a> "maximum civic engagement" in developing a broadband strategy, and we're hoping to help them to achieve just that. We've teamed up with the <a href="http://www.spectrumpolicy.org/">New America Foundation</a> to launch a <a href="http://moderator.appspot.com/#16/e=a4977">Google Moderator page</a> where you can submit and vote on ideas for what you think the Commission should include in its National Broadband Plan. Two weeks from now we'll take the most popular and most innovative ideas and submit them to the official record at the FCC on your behalf. Google and the New America Foundation agree that public participation in this process is critical. Expanding access to broadband has the potential to transform communities across the country, spark economic growth, and <a href="http://googlepublicpolicy.blogspot.com/2007/08/americans-invented-internet-but.html">restore American competitiveness</a>. Now that the Commission has officially opened this proceeding, and with a new <a href="http://www.fcc.gov/commissioners/genachowski/">Chairman</a> at the helm, we think it's time to give people the opportunity to learn about the issue and to weigh in with their thoughts. And as the process continues to unfold at the FCC, we'll keep you informed of additional ways to share your views and voice your ideas to the agency. So do you have any good ideas? Submit them today on <a href="http://moderator.appspot.com/#16/e=a4977">Google Moderator</a> — and you just might help change the face of broadband in the United States. Posted by Richard Whitt, Washington Telecom and Media Counsel

Submit your ideas to change the face of broadband

Have an idea for how to expand high-speed Internet access across the United States? Here's your chance to have your voice heard. Under t...

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