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Disclosures, What Is Necessary and Sufficient?

2016; Lippincott Williams & Wilkins; Volume: 122; Issue: 2 Linguagem: Inglês

10.1213/ane.0000000000000742

1526-7598

Kirk H. Shelley, Steven J. Barker,

Clinical Laboratory Practices and Quality Control

Shelley: In this issue, we have an article regarding continuous noninvasive hemoglobin monitoring (SpHB©) technology by Drs. Barker, Shander, and Ramsky entitled “Continuous Noninvasive Hemoglobin Monitoring: A Measured Response to a Critical Review.”1 As most anesthesiologists are aware, Masimo has introduced a new monitor that reports a real-time measurement of hemoglobin levels. Like with the introduction of any new monitoring technology, fundamental questions arise including the following: How well does the new technology measure the phy siologic parameter in question (e.g., hemoglobin)? Will this new measurement allow for the guidance of therapeutic interventions (e.g., transfusions)? Will these therapeutic interventions change clinical outcomes (e.g., avoid unnecessary transfusions)? These debates are critical to our specialty and are ongoing. Even well-established monitors such as the pulse oximeter are not immune to such controversy.2 Shelley: In this editorial, we will not examine the aforementioned questions but rather the controversy brought up by the article itself. The issues that intrigued me with this article are 2-fold. First, who should be allowed to participate in this conversation? Second, if the device contains proprietary or secretive technology, should the manufacturer be compelled to disclose it? The first question arises from the convoluted path the SpHB article, in this issue of Anesthesia & Analgesia, took to arrive at my desk. It had already undergone extensive review and revision as a potential review article. The authors were acknowledged as the preeminent experts in the field, specific reviewers’ concerns were meticulously dealt with, and the authors wanted to expand the debate regarding the clinical use of this new technology (e.g., advancing the concept of the value of trend monitoring). From my perspective, the “800-lb gorilla in the room” was the question of conflict of interest (COI). All 3 authors had extensive relationships with the manufacturer with the lead author being on the Board of Directors, Chair of the Scientific Advisory Board, and a paid consultant for Masimo. In our present climate, this represents a significant dilemma for an academic journal. Barker: The authors of this The Open Mind article do not have a COI by the correct definition of the term. They are expressly representing the point of view of Masimo and that is clearly stated in the Introduction of the article, wherein the authors are described as “clinical advisors to Masimo.” This relationship could not have been made any clearer. Our alternative point of view of SpHb needed to be expressed to provide balance to the 3 previously published editorials by Rice, Gravenstein, and Morey, which were 1-sided criticisms of this new technology.3–5 Shelley: As a way of context, starting in September 2014, under the Physician Payment Sunshine Act, payments and gifts made to physicians and teaching hospitals by medical device and pharmaceutical companies must be publicly available on a database. Even before this, the ever-tightening guidelines on continuing medical education had increasingly precluded the involvement of inventors, and designers of new technology (personal experience), in medical education. The rationale for excluding such individuals from continuing medical education, and potentially even university-based research activities, is founded on the idea that commercial COI leads to unavoidable bias. The assumption is that a simple disclosure is insufficient to overcome this bias. The unambiguous message, to me at least, is that physicians working with the medical device and pharmaceutical industry, or on projects that might lead to commercial products, are simply too tainted to be trusted. Barker: Dr. Shelley states that COI policies have evolved to a point where they have “precluded the involvement of inventors and designers of new technology in medical education.” We would be very sad if our “Brave New World” had reached that point. We do not believe that it has and doubt that Dr. Shelley believes that. On the contrary, again to stimulate debate, a serious researcher in patient monitoring who has never had any sort of involvement with any industrial entity probably does not exist. There are exceptions, but this statement is at least as reasonable as “precluding the involvement.” Shelley: Ultimately, the SpHB paper was rejected as a review article and found a home, after further revision, in The Open Mind section. To quote the journal’s description: “The Open Mind is a forum for thoughtful, scholarly, and well-referenced reader perspectives. The Open Mind is intended to stimulate discussion. Submissions to The Open Mind must be intellectually rigorous.” The alternative, suggested by one of the reviewers, was “As submitted, this manuscript could perhaps be a white paper published independently by the manufacturer but does not meet the threshold for publication in a scientific journal.” I will leave it to the reader to determine the correctness of this choice. Shelley: Before passing judgment, I would ask the reader to consider that these authors represent the intellectual “think tank” of Masimo. Their opinions are important and influential. The direction of this premier technology company is being driven, in part, by their concepts and vision of clinical care needs. They need to be heard. I believe that an open dialogue between the academic and the industrial communities is critical for the advancement of anesthesiology technology. This article might represent an excellent starting place. Barker: This is precisely the goal of our article: to stimulate discussion and debate on the present and future role of continuous hemoglobin monitoring, a discussion in which all points of view are expressed. Shelley: As the title of this editorial implies, there is more at stake here than simply giving voice to alternative interpretations. Concerning shadows remain despite the brightness of the Sunshine Act, specifically the proprietary and secretive nature of the SpHB technology. It is clear that Masimo has no intention of disclosing the technology and physiology behind the SpHB measurement. This is reminiscent of William Morton’s addition of dye and perfume to diethyl ether on September 30, 1846, to disguise its simple nature. It took John Collins Warren’s (Harvard Professor of Surgery) insistence on the day of the second demonstration for Morton to disclose the truth. Shelley: This is not the first time I have written regarding such concerns. In 2005, I was the coauthor of an editorial criticizing the proprietary nature of the bispectral index measurement.6 It outlined how we would never accept proprietary pharmaceuticals and that, likewise, the disclosure of medical technology is critical for its advancement. The fact that a decade later this would still be debated is, in my opinion, completely and utterly unacceptable. Barker: We come to Dr. Shelley’s view on mandatory disclosure of “the proprietary and secretive nature of SpHb technology.” By this statement, I assume he means that the signal processing algorithms for the Masimo SpHb must be openly published. By extension, this means that all proprietary technology for patient care devices must be fully disclosed to the public. This may be a lofty ideal for a perfect world, but it is not the world in which we live. Medical device companies compete with one another for business; their customers are hospitals and care providers. This healthy competition (pun intended) takes 2 forms: 1) “ours is cheaper” and 2) “ours is better.” We all hope that the second form is dominant, but both are very real. If one company has a product that is either better or unique (like in the case of SpHb), then they deserve to win that competition and profit from it. That is how technology continues to advance in a capitalist system. Take away that incentive, and you will end progress. Masimo has learned by sad experience that if you disclose the details of a signal processing algorithm, other entities will promptly copy it and produce it, particularly those not bound by U.S. patent laws. Taken to its logical conclusion, that would destroy incentive for private companies to develop new technology. Shelley: I personally have had this SpHB device fail spectacularly, with a Masimo representative in the operating room, with the device reporting an SpHb reading of 18 g/dL with a PI (Perfusion Index) >3.0, whereas the laboratory hemoglobin was measured as 6 g/dL in a patient who was visibly undergoing massive blood loss (Yale University, April 2013). Particularly galling to me is the fact that I am likely one of only a handful of people in the world who could make an educated guess as to why the technology failed at that particular moment (massive ventilator-induced venous blood modulation caused by profound hypovolemia in a patient in deep Trendelenburg position). When this case was brought to Masimo’s attention, the answer I was given was that the issue “was fixed with the Rev-K SpHB sensor.” I can only sigh in response to such answers. I personally will not allow “black boxes” into my operating rooms. The SpHB technology, as it stands now, is way too dark for me. Barker: Improving patient care is the number one priority, and Masimo has a very strong record on that issue. However, like all private companies, Masimo must also answer to its stockholders, a fact of life. Protecting “intellectual property” is something that all private companies must do to survive in a free enterprise world. This is a concept that merits continued debate, and therefore we thank Dr. Shelley for raising the issue. Shelley: In closing I will repeat the concluding paragraph from my decade-old editorial: Medical science has, in some ways, returned to its origins, but instead of patent medicines, manufacturers now sell products with secret algorithms. Ultimately, regulatory authorities should mandate disclosure of the algorithms employed by medical devices used in patient care as a condition of certification. Until regulatory agencies can be convinced of the potential problems caused by the current practice, individual clinicians can help to improve the situation. Physicians should refuse to purchase a new “wonder” monitor without understanding exactly how the numbers and waveforms are generated. If medical device manufacturers find that health care providers demand a detailed explanation of how their devices work as a condition of purchase, they will ultimately have to release their algorithms. It worked for Dr. Warren in the Etherdome. DISCLOSURES Name: Kirk H. Shelley, MD, PhD. Contribution: This author helped write the manuscript. Attestation: Kirk H. Shelley approved the final manuscript. Conflicts of Interest: The author has no conflicts of interest to declare. Name: Steven J. Barker, MD, PhD. Contribution: This author helped write the manuscript. Attestation: Steven J. Barker approved the final manuscript. Conflicts of Interest: Steven J. Barker is on the Board of Directors, Masimo; Chair, Scientific Advisory Board, Masimo; and is a paid consultant, Masimo. This manuscript was handled by: Maxime Cannesson, MD, PhD.