By CHELSEA POLANIECKI AND CHANLY PHILOGENE Opioid overdoses are the leading cause of death for Americans under 50 years old. In fact, the majority of drug overdose related deaths involve an opioid. According to the National Center for Health Statistics, deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have more than quadrupled since 1999. The U.S. is currently experiencing an opioid epidemic, as more than 2 million Americans have become dependent on, or abused prescription pain pills and street drugs. Substance misuse is not only affecting the users but also their families, friends, and the healthcare system as a whole. Although improvements have been made to the way opioids are prescribed through clinical practice guidelines, the epidemic has continued to grow. The CDC has made several efforts to combat substance misuse and overdose but there is much more to be done, and you can help. The Robert Wood Johnson Foundation (RWJF) is committed to supporting those affected by this issue and launched the RWJF Opioid Challenge live, at Health 2.0’s Wintertech conference in January 2018. This innovation challenge calls for tech-enabled solutions that help identify resources, facilities, and educational content for support, as well as platforms for connecting patients, caregivers and peers for peer community. RWJF has teamed up with Catalyst @ Health 2.0 to identify and incentivize the development of tech-enabled solutions that should aim to support affected individuals (e.g. opioid users, caregivers, peers, family, etc.) and connect them to relevant resources. Every individual faces a different set of challenges, meaning that needs for recovery can be unique and varied.* The challenge is calling on innovators, developers, entrepreneurs and other bright minds to create tools to support those affected by opioid misuse.
In Phase I of the challenge, innovators will develop and design tech-enabled solutions. The judges, who bring a wide range of expertise to the table, will evaluate the submissions to determine the five teams who will move onto Phase II. These finalists will be awarded $5,000 each to create a fully functional application or tool. The finalists will also have an opportunity to demo their technology in front of a captivated audience of 2,000 investors, provider organizations, health plans and members of the media at the Health 2.0 Annual Fall Conference! With $100,000 in total prizes, we encourage innovators to put their best foot forward and create innovative solutions that will help impact the lives of those affected by opioid misuse. Check out the challenge website to learn more and pre-register to apply to the RWJF Opioid Challenge by March 22nd. Join the fight today and help support and connect those individuals and their families affected by opioid misuse. *This is not an exercise to develop tools for specific disease interventions or technologies for clinical therapy decision-making. Chelsea Polaniecki is a Program Manager and Chanly Philogene is an Intern at Catalyst @ Health 2.0. RWJF Opioid Challenge: You Can Help syndicated from https://storeseapharmacy.wordpress.com via Tumblr RWJF Opioid Challenge: You Can Help
0 Comments
By KIP SULLIVAN “[T]his is tough. I don’t know how to proceed…. Lord help the staff who must bring all this together.” That was how Dr. Francis Crosson, chairman of the Medicare Payment Advisory Commission (MedPAC), reacted to the commission’s baffling discussion at its January 11 meeting moments before it voted 14-2 to replace the Merit-based Incentive Payment System (MIPS) with something called the “voluntary value program” (VVP) (pp. 167-169 of the transcript ). MedPAC’s staff must now summarize the January 11 discussion and prepare a report for inclusion in MedPAC’s March 2018 report to Congress. MIPS is a pay-for-performance (P4P) scheme imposed on the traditional fee-for-service Medicare program by an act of Congress known as MACRA. MIPS requires that CMS measure performance on cost and quality at the level of the individual doctor, something MedPAC recently acknowledged can’t be done after spending 13 years claiming it could be done. The portion of the commission’s January 11 discussion that focused on the repeal of MIPS was not hard to understand. The commissioners agreed that MIPS cannot work for multiple reasons, the most important being that the pools of patients treated by individual doctors are too small to permit accurate measurement of cost and quality. “MIPS will not succeed in helping beneficiaries choose clinicians, helping clinicians … improve value, or helping the Medicare program to reward clinicians based on value,” explained MedPAC staffer Kate Bloniarz. (pp. 116-117) Only one of the 16 commissioners present (Dr. Alice Coombs) disagreed with that statement. Zen and the art of summarizing doubt It was the commissioners’ discussion about what to replace MIPS with that will be very difficult to summarize. That’s because the discussion consisted largely of expressions of doubt about the VVP, which is essentially a proposal that all doctors who treat Medicare patients either join a “group” (aka ACO) or lose 2 percent of their Medicare payments. The discussion, which followed a vague opening presentation by two MedPAC staff members, consisted of numerous questions posed to the staff that neither the staff nor Dr. Crosson could answer. Because so many issues remained unresolved, ten of the 16 commissioners (one was absent) expressed reservations about voting for the VVP. How does the staff or anyone else summarize a discussion like that? How does the staff explain why the commission voted to recommend the VVP to Congress when a majority of commissioners have multiple concerns about it? The two questions that got the most discussion were: Will functioning ACOs (as opposed to Potemkin village ACOs that have no internal cohesion) be available for all doctors to join, and; won’t CMS’s crude method of measuring “performance” punish doctors who treat poorer and sicker patients? These and other issues were raised not only at the January 11, 2018 meeting, but at five previous meetings in 2017. That these questions were still unanswered after six meetings is compelling evidence Dr. Crosson and the staff cannot answer them and never will. Yet despite the obvious discomfort around the table at the last meeting, not one commissioner proposed voting only on MIPS and putting off a vote on the VVP until more research could be done. Commissioners David Grabowski and Paul Ginsburg made it clear they would be willing just to repeal MIPS and leave discussion of a replacement for later, but they were ignored. That’s as close as the commission came to discussing a stand-alone “repeal” recommendation. Just before the final vote, Dr. Crosson, sensing he had a mutiny on his hands, promised the commission he would bring the VVP back for further discussion. For some reason, that satisfied the doubters. Dr. Crosson then put the entire motion to a vote, and by a margin of 14-2 the commission voted to recommend that Congress repeal MIPS and enact the VVP. [1] How will the staff characterize this vote in the upcoming March report? Does this vote mean MedPAC has committed itself to the VVP despite all the concerns expressed by commissioners, and despite chairman Crosson’s promise to continue the discussion about it? MedPAC’s record indicates the answer to the second question is yes. MedPAC’s modus operandi is to recommend evidence-free proposals – P4P, ACOs, “medical homes” are examples – with no details and to leave to Congress and CMS the impossible task of making MedPAC’s lead balloons fly. But the persistent questioning of the VVP proposal by so many commissioners over the course of six meetings, and their recent bad experience with MIPS, suggests MedPAC might rethink its hasty endorsement of the VVP. If that doesn’t happen – if MedPAC ultimately fails to retract its endorsement of the VVP, and Congress does repeal MIPS and authorize CMS to set up the VVP – the VVP will fail. In that event, MedPAC will have repeated the same cycle it just went through with MIPS. They will have voted for a vaguely worded, evidence-free recommendation to Congress; Congress will have enacted the recommendation into law; and the recommended nostrum will have failed. In that event, MedPAC will have to visit the scene of yet another crashed lead balloon and figure out what to do next. I will devote the rest of this article to demonstrating that the VVP in its current form is a lead balloon. I’ll do that by discussing two of the more important questions commissioners raised about the VVP that the staff failed to address over the course of an entire year. (I’ll stop here for a moment to report a very strange development at MedPAC. Sometime around December of 2016 or early in 2017, MedPAC’s staff removed all transcripts prior to September 2010 from their website, and made it impossible to right-click on and copy recent transcripts. On January 23, 2018, I asked an employee of the Geek Squad if he could copy the transcript of the last meeting. He could not.) Chronology of MedPAC’s latest lead balloon MACRA (Medicare Access and CHIP Reauthorization Act), which authorized MIPS, was signed by President Obama in April 2015. Although the fatal defects in MIPS were obvious the day Obama signed MACRA [2], MedPAC waited nearly two years to begin a discussion about whether MIPS could work. Instead of sounding the alarm immediately, MedPAC wasted the rest of 2015 discussing some vague principles that should guide CMS in developing the “alternative payment model” portion of MACRA. [3] MedPAC did not buckle down and start discussing the repeal of MIPS until its January 2017 meeting meeting. By then, CMS was already implementing MIPS. The commission’s discussion at that meeting made it clear the staff and most commissioners were ready to recommend the repeal of MIPS. But despite the fact that CMS was already implementing MIPS, the commission waited yet another year before formally recommending the repeal of MIPS. At the January 2018 meeting, Commissioner Alice Coombs criticized this delay. “In 2015, MedPAC did not say anything about eliminating MIPS,” she said. “In our report last year [the June 2017 report to Congress], I don’t remember a … recommendation ever saying anything [about repeal]. [W]e’ve shifted from maybe tweaking it to getting rid of it in twelve months’ time.” (p. 134) I have no idea how to explain the delay between April 2015, when Obama signed MACRA, and January 2017 when MedPAC finally started talking about repealing MIPS. I do know what caused the failure to act between January 2017 and January 2018: That was Dr. Crosson’s and the staff’s insistence that MedPAC should propose a replacement for MIPS at the same time they recommended its repeal. This insistence manifested the staff’s near-religious devotion to P4P despite a large body of evidence indicating P4P does not work at any level – at the individual physician level, the clinic or hospital level, or even at the level of large pools of providers. Because of this devotion, staff and Dr. Crosson could not bear the thought of repealing MIPS and thereby leaving 80 percent of the doctors and nurses who treat Medicare patients unmolested by P4P. (Eighty percent appears to be the commission’s latest estimate of the percent of Medicare “clinicians” who will not be in ACOs or other entities that qualify as “advanced alternative payment models” [APMs] under MACRA by 2019, the first year MIPS penalties and rewards kick in.) It was this blind insistence on forcing some form of P4P upon that 80 percent that caused the staff to link repeal with replacement right from the start of the repeal discussion in January 2017. The staff presented its replacement proposal – what they would eventually call the “voluntary value program” – at the January 2017 and March 2017 meetings. (For more details on these two meetings, see my report here) At both meetings, and at four subsequent meetings (October, November, and December 2017 and January 2018), commissioners peppered the staff with questions about the VVP – to no avail. Dr. Crosson and the staff resolutely refused to add any details to the vague VVP proposal first presented in January 2017. For example, all the staff would say about the “groups” that doctors would have to join in order not to lose 2 percent of their payments is that they must be “sufficiently large to have statistically detectable performance on population-based measures” such as use of “low-value” services and “healthy days at home” (see p. 12 of the transcript of the October 7 meeting). That was their story, and they stuck to it. The skeleton-like proposal the commission voted on at the January 11, 2018 meeting was identical to the skeleton-like proposal they first heard in January 2017. Two questions staff refused to answer To get some sense of how often commissioners sought to get answers from staff and how futile their efforts were, I review in this section the efforts commissioners made over the course of January 2017 to January 2018 to get answers to two important questions raised by the VVP proposal:
The first question was the one most frequently raised by commissioners, and the one most frequently dodged by Dr. Crosson and the staff. The importance of this question is obvious: If doctors are going to be penalized for not joining a “group,” MedPAC has an obligation to determine first that groups will be available for doctors to join. At the January 2017 meeting, commissioner Craig Sammit began the discussion of the VVP proposal with this question: “[D]o we have a sense of how accessible and feasible it will be for clinicians to join APMs? … [W]ill it be feasible for every clinician who wants to be in an APM to get into an APM?” (p. 248, transcript) David Glass’s reply on behalf of the staff indicated how little thought the staff had given to its proposal: “I guess it depends how it eventually works out;” and “I would say that’s a little hard to say right now.” (p. 249) One year later, it was still “a little hard to say.” When the January 2018 meeting rolled around, staff still had no answers to Dr. Sammit’s question. At the January 2018 meeting:
The staff was equally disinterested in addressing the commissioners’ concern that the VVP will harm the sickest and poorest Medicare beneficiaries. Numerous commissioners made it crystal clear, repeatedly, over the course of the six meetings held between January 2017 and 2018 that they expect the staff’s VVP proposal will worsen disparities via two mechanisms: Providers who treat the sick and the poor will be disproportionately exposed to the 2 percent penalty because they can’t form or join groups; and for those who do make it inside a group, CMS’s crude method of adjusting cost and quality scores for factors outside physician control will punish their group because the group treats sicker and poorer patients. The staff’s response to these concerns was brief and superficial. They simply threw out two phrases – “risk adjustment” and “peer grouping” – and alleged that these phrases represented adequate solutions, and said no more. [4] Understandably, by the time the January 2018 meeting occurred, many commissioners were still worried. “I get chills … thinking about the doctors who are in the trenches taking care of vulnerable patients [in] Watts or Compton,” said commissioner Coombs at that meeting. (p. 136) “[P]oor people will be hurt by this” said commissioner Nerenz. (p. 140) “The idea that we could actually be creating or encouraging a greater disparity in physicians who treat low-income populations, I think that’s something to worry about,” said commissioner Kathy Buto. (p. 148) Chairman Crosson was unfazed. “I do think this has been a thorough process,” he declared near the end of the January 11 meeting. (p. 147) That statement was so inaccurate it may accurately be called unethical. Lessons from another “repeal and replace” campaign All sentient readers will recall the sad ending of another “repeal and replace” campaign. It had a sad ending because it was driven by ideology, not evidence. MedPAC appears hellbent on repeating the same mistake Republicans made in declaring their intention to “repeal and replace” the Affordable Care Act. MedPAC linked repeal of MIPS with its replacement before they had time to research the replacement. MedPAC might as well have said, “We will replace MIPS with something terrific!” MedPAC thereby set itself up to repeat the MIPS fiasco and the Republicans’ “repeal and replace” fiasco. [5] As it became clear near the end of the January 2018 discussion of the repeal and replacement of MIPS that chairman Crosson was going to put the entire repeal-and-replace motion to a vote despite all the unanswered questions, commissioner Thomas raised the possibility of postponing the vote. “[P]erhaps we ought to take a step back and just say, ‘Are we headed in the right direction?’” he suggested. (p. 153) He went on to warn his fellow commissioners they were about to repeat their MIPS mistake. “I don’t want to replicate … MIPS,” he said, “where essentially you had something that was probably not as well thought out as it could have been, and yet it was put together and … made law and implemented.” (p. 164) It didn’t work. Dr. Crosson did promise to bring the VVP back for more discussion. Whether that was a victory for the ten doubting commissioners remains to be seen. Dr. Crosson then put the entire repeal-and-replace motion before the commission. Fourteen voted yes and only two voted no. It’s hard to see how this ends well. Either the VVP, possibly with a few tweaks, becomes law and fails, or MedPAC will retract its endorsement, which will raise questions about why they rushed to judgement. [1] Here is the wording of the recommendation that so concerned the commissioners which nevertheless passed by a 14-2 vote: “The Congress should eliminate the current merit-based incentive payment systems; and establish a new voluntary value program in fee-for-service Medicare in which clinicians can elect to be measured as part of a voluntary group; and clinicians in voluntary groups can qualify for a value payment based on their group’s performance on a set of population-based measures.” (p. 118) According to Chapter 5 of the commission’s June 2017 report to Congress, examples of the “population-based measures” the commission has in mind are: “potentially preventable admissions and emergency department visits; mortality and readmission rates after inpatient hospital stays; healthy days at home; patient experience; rates of low-value care; and relative resource use.” (p. 167) These measures, allegedly can be accurately calculated by CMS from claims data. [2] On April 12, 2015, three days before Obama signed MACRA, I posted a blog comment g predicting MIPS would fail. If I could see that so clearly at that time, why couldn’t MedPAC? [3] MedPAC staffer Kate Bloniarz identified the defects in MIPS for the first time at the commission’s October 2015 meeting, but she and the rest of the staff insisted the commission devote what time they had for MACRA to the “alternative payment model” portion of MACRA. (See her brief remarks on MIPS at pages 92 and 93 of the transcript ) [4] Readers who wish to see for themselves how superficial the staff’s response to the issues raised by commissioners were should read pages 5-8 of the transcript of the November 2017 meeting. [5] For a discussion of MedPAC’s history of endorsing vaguely articulated, evidence-free managed care notions, see my discussion of MedPAC’s endorsement of the “three pillars of MACRA” over the period 2003-2008.
MedPAC’s Repeal And Replace MIPs Campaign Will Not End Well syndicated from https://storeseapharmacy.wordpress.com via Tumblr MedPAC’s Repeal And Replace MIPs Campaign Will Not End Well By JASON CHUNG Just before the holiday break, in my new capacity as the Law and Technology Editor for The Health Care Blog, I had the opportunity to interview Dr. Brennan Spiegel, the Director of Cedars-Sinai Health Services Research, about his new digital health innovations as well as his views on the medtech and data privacy landscapes. Dr. Spiegel leads an interdisciplinary team which investigates how digital health technologies such as wearable sensors, smartphone applications and virtual reality can strengthen trust among patients and doctors, improve outcomes and cut costs. Below is a transcript of selected moments of our conversation. For further thoughts, I encourage you to attend the upcoming conference entitled “Virtual Medicine” at Cedars-Sinai on March 28-29th, 2018 where Dr. Spiegel and other digital health leaders will gather to discuss the medical VR revolution. Dr. Spiegel on AbStats, a new medtech device developed by his team to track the gastrointestinal rate – a new vital sign: JC: I’d like to start by asking you about the most recent thing you’ve got going on and I guess that would be AbStats. I’d like to just congratulate you and I was wondering if I could get on the record how you would quickly describe AbStats from your point of view and what it’s meant to do and how it’s meant to revolutionize care. BS: Yeah, sure. So AbStats is one of the few things we have going on now at Mount Sinai and it’s exciting. One, AbStats is the first FDA cleared wearable for for the gastrointestinal tract. It’s a digestion monitor that measures how quickly the GI system is moving JC: Okay. BS: It is essentially a new vital sign. We call it the intestinal rate. Just like the heart rate or respiratory rate, intestinal contractions have their own natural rhythm to them just like other parts of the body and what AbStats does is it has a small microphone in it and it listens to the sounds and vibrations of digestion. It can count the number of intestinal contractions per minute so the rate can be used for lots of different purposes. We initially tested it and published two papers validating it in post-operative management after surgeries. I’m not sure you are you a physician, I can’t recall your background… JC: Oh no, I’m an attorney. BS: You’re an attorney, yeah. So you know post-operation, one of the most common problems is that the bowel shuts down and it’s hard for people to eat and people can get sick and nauseous but at the same time hospitals want to get people out the door as fast as possible. So they try to advance the diet quickly as possible but there’s really never been guidance on how to do that so we developed a step initially to help surgeons and patients and nurses decide whether when and how quickly to advance the diet after an operation and we demonstrated that the sensor can accurately predict who is kind of getting into trouble and who is not terms of their stomach function. So that was the first opportunity.
We then wanted to expand beyond that to start thinking about AbStats just for calorie management in general and the idea here is that people eat food not necessarily because they’re hungry or because the natural rhythms of digestion call for it but rather because there’s food available or there’s a social environment that is supportive of eating or they’re stressed or depressed. The cognitive component of eating drives a lot of our behaviors and ultimately can lead to obesity and other problems of digestion and ingestion so the idea behind AbStats here is it could provide some objective feedback to tell the user where their body is at any moment in time. What we’re developing is a stoplight so I can tell you if you’re in the red zone, the yellow zone or the green zone for eating okay. If you’re still digesting your last meal and you feel the bunch of food on the table at six will tell you that it’s too early to eat because you’re still digesting now, you still might eat anyway and that’s no problem right but please still have feedback. Similarly, if you’re trying to lose weight just like if you’re trying to lose weight from exercise you might want to lose weight by eating less, run after and set a goal and track your digestion throughout the day and you can tell if you’re on track or if you’re overshooting your projections for the day. That’s something we’re working on right now is the technology and the apps to support calorie management. JC: That’s fascinating and so you view it as both a diagnostic tool and as a commercial product in that sense then. In that case, do you view it primarily as something that you can leverage as a commercial product much like a Fitbit or something that we’re packaging along with a Fitbit? BS: Yeah, so it actually has a diagnostic applications it all can be easily measure outcomes to see if treatments are actually working or not. So, I happen to be a gastroenterologist and we treat a lot of people with medicines that impact their intestinal function so this is also a way to monitor the effect of treatments but also consumer facing products like the Fitbit for the stomach… Right, it’s like with Fitbit you know you want to get 10,000 steps per day? It’s sort of a traditional goal and like that, we can use AbStats to calibrate the digestion rate is they want to get per day make sure they don’t overshoot their eating, so yeah in that sense, it’s like a Fitbit for the stomach. JC: That leads me to the next question which is what is your goal with this technology? Is it to get purchased by Fitbit and create a personal diagnostic machine or are you waiting and seeing and have you not thought that far ahead? BS: I’ve definitely thought a lot about it my and, you know, what’s important point for me is I’m a researcher and to me it’s vital to have scientific data and research, peer reviewed research, to support our claims. This is an FDA cleared device – we had it cleared in 2015 but we’re still working on it. It’s actually easy to get FDA clearance. The hard part is doing all the science and understanding that it’s not just the technical performance but the behavioral component – how do you actually get people to change their behaviors, how do you integrate this within care flow for doctors and patients and nurses. That was stuff we’ve been working on the last few years. JC: Absolutely and I guess the next thing I wanted to ask you about is the FDA process. I can understand the attorney’s point of view but what sort of other impediments did you face? What was the process like when innovating this product. I know that you have GI Logic and that you have institutional collaborators – what does it actually look like to get this kind of medtech innovation out there? BS: Sure, I mean it’s been a protracted process. It’s interesting because there’s so many different stakeholders involved that it’s important to keep the scientific goal in mind from the beginning. What I mean by that is, you know, it’s very convenient to develop a medtech device, make some claims about it and go out and sell it without ever having really tested it in the clinical trenches or with the end users understanding their preferences, attitude, knowledge, beliefs, and so on and I say all that because that’s my orientation. So from the beginning, as business partners have gotten involved I’ve always emphasized that until we have the scientific data we need I’m not going to support scaling this thing out in the community. JC: That’s not what everyone wants to hear. BS: Right, absolutely but I’m not going to stand until I feel comfortable that it does what it says it’s going to do even if it’s FDA cleared. We have to take the time to do it right because this is not a game – we’re talking about healthcare that enables life and quality of life. JC: Right, absolutely. And how has that process been for you. I mean obviously you can share with me as much or as little as you want but putting the science first obviously there’s a lot of med tech things out there with all kinds of claims coming from Silicon Valley. How has it been with your partners and has it been a challenge trying to get the science first mentality out there? BS: Yes, I mean there have been challenges but we’ve also found it’s actually worked out. You know, we have found an investor and a company that it has a strategic alignment and at the same time recognize the value of science and is willing to support that science and be patient with us because these things take time. It’s actually been really gratifying to find people who see the long term play. There’s a risk involved in that because maybe it does what we think it’s going to do and maybe it doesn’t. JC: I can imagine it’s also a high-risk high-reward sort of thing because once you’ve done all this legwork it’s much easier to market after the fact as well and it’s a lot easier to make claims on a legal basis without having to constantly worry whether somebody’s going to try to poke holes in it or sue you. BS: Well, it’s been so interesting. You’re right it is high-risk, high-reward I think about how we’ve gone about this and it seems like it’s the exact opposite of much of what I’m seeing out there. What I mean by that is what I often see is a device or product is developed and then it goes looking for an application and they try to figure out where is this product going to work who is it going to serve, what problem will it solve and then they sort of slot it in and hope it works without ever thinking about serving FDA clearance in many cases or the science or end-users. We’ve gone about it the opposite way. The first thing we did is we identified an unmet need. I’m a gastroenterologist. I saw we didn’t have any way to non-invasively monitor human digestion, which is a huge unmet need for us, so what about developing this thing. When I was at UCLA with our engineers it became an academic project and we’ve developed the technology quite quickly and it was relatively trivial to create the sensor. The hard part was then doing the work of testing it out with patients at different hospitals and we got FDA clearance. I mean I don’t know if there’s another product I can think of that gets FDA cleared and still two plus years later is not being sold. Look around and it’s only if something looks successful maybe we’ll get it cleared and then expand into other markets. JC: Because the FDA clearance process is relatively trivial do you think there’s a problem in the regulatory landscape? Do you do you think it’s the government’s role to examine the utility of the tech before it hits the shelves or do you think that’s a private market matter? BS: Right. You know, that’s as much a political question as it is sort of a scientific question and I think that it’s probably beyond what the government needs to regulate. The government, the FDA in particular, wants to know if there’s a new device how does it compare to a predicate device. In our case, all we said is we’re simulating an electronic stethoscope essentially. The hard part with medtech is generally not the technical and safety issues, although it can be, but the government should figure out that we’re not going to hurt people and that the device is going to do what it says it’s going to do. But just think about something like a blood pressure cuff. What I mean is that a blood pressure cuff is safe and it does what it’s supposed to do – it measures your blood pressure in millimeters of mercury and the number comes off of it. Well, the number unto itself doesn’t mean anything unless and until it’s been validated. Like, what does that mean you have 122 millimeters of mercury or pressure in your arteries. Well, unto itself that means absolutely nothing at the data point. There’s a reference data and information – a difference between information and knowledge and a difference between knowledge and wisdom – and the hard part, which is not the FDA’s chore is to figure out how do you go from data to information to knowledge to wisdom and my point is that’s up to the investigators and ultimately up to the market to determine. But, from a scientific standpoint we have to figure out how to provide value. We know we can measure, we can do it safely and accurately but for me to say your intestinal rate is 6mm what does that mean? So, educating the marketplace as well is a huge part of the endeavor. On VR and the potential to revolutionize patient recovery: JC: That brings me to the next part of what I wanted to talk to you about. I did a little bit of due diligence and read up on what you’ve been doing as a leader in the VR space. So what about that technology excites you? BS: Oh yeah, we’ve been very excited. So, when I first used virtual reality it was a mind-blowing experience and it was clear to me it can nudge the brain, even hijack the brain – more negative connotation – and it was powerful so I thought there’s got to be a way we can use this for positive things so that we can transport patients from jail cells or a hospital room to a beach or you know to swim… Swim with in the ocean or whatever. So, we’ve tried that and it’s clearly worked and the key is we’ve done clinical trials. We’ve published a number of trials now and we’ve just completed our largest trials to date which is a randomized controlled trial of 120 patients in the hospital and seen over a 50 percent reduction in pain with VR compared to about 10 to 15 percent with a control condition. What we’re now doing is try and understand can we reduce opioid prescribing in particular and are starting a new study with Traveler’s Insurance because they’re at the tip of the spear of the opioid epidemic and can we reduce opioid exposure amongst worker’s comp patients. So these are examples but it all requires science and hard-fought research to figure out if this works or not. It’s wonderful but what’s exciting to me is this is an innovative technology that clearly affects the mind and meaningful ways that are measurable and it’s drug-free so there’s a lot of advantages and a lot of the things that you can see using like calm spaces and you in the VR environment, those are specifically tailored as a medical device. JC: Do you think that VR needs to go through that sort of clinical testing? Obviously, you’re doing the clinical testing but do you think it needs to be regulated in any way or can you just get by using off-the-shelf tools to help people? BS: It’s, yeah, a little bit of both. So, okay off-the-shelf is fine and we use off-the-shelf experiences and visualizations right now and that’s fine but with pharmacotherapy if a developer or company wants to make a health claim like, “I’m going to reduce blood pressure with this intervention” or “I’m going to reduce anxiety”, yeah, it could be subject to the same rigorous evaluation as pharmacotherapy. In fact, we’ve just completed and will soon announce the results of an international working group of VR experts who are putting together a regulatory framework for how to evaluate and test new VR treatments. What we will propose in this document, which is going being submitted for publication now, is three phases of clinical trials just like Phase One, Two and Three for pharma companies – we’re calling them VR1, VR2 and VR3 trials – and VR1 is really all about human centered design principles. This means working with the end-users, the patient’s themselves and finding out what their preferences are and using best practices and human centered design to create the right experiences. VR2 is exposing them to patients in a clinical environment in an uncontrolled small pilot test and VR3 is a properly powered randomized control trial in a clinical environment. So that’s what we think is required for VR treatments to be at least scientifically valid. JC: If this isn’t made mandatory by regulation or by regulatory agencies, how do you get the money for that, to conduct the testing, if off-the-shelf can work? Should pressure to be follow VR principles come from funders, should it come from government, is it private industry’s responsibility – where do you think the money should come from for testing? BS: Yeah, the money for testing… Well, it just depends. I mean that’s a business decision so if a company wants to make an FDA claim or sell an approved project and product they have to pay for it just like a drug company does. But that may not be necessary right, they might just not have to make the claims but that just means they have to be careful how they market and talk about their treatment. You know, to make a claim that something is going to have a health effect, you’ve got to show it. You know, that’s the problem. People do it all the time but you know if we’re talking to doctors and nurses and patients and providers we’re going to ask questions. You know we’re not we’re not snake oil salesmen immediately. I guess that’s part of it in the sense that people make claims all the time and I get that enforcement has been lacking. There’s all sorts of medicines we use that are not FDA approved that we use it all the and we don’t need to go to the effort of getting it FDA approved because no one’s trying to convince doctors at this point that aspirin is good for you. Not everything needs to be FDA approved for it to be used you know used and that may end up being the case for a lot of VR treatments. But from a business development standpoint, it’s tough to make a living in VR. This is all this free stuff that works just as well as your product. Unless you think your product’s better but then prove it. JC: So, do you wish that there was better enforcement by, say, the FTC about claims that are made about products, particularly claims of health benefits? Because there’s a lot of claims that are out there. People say all kinds of things to sell their product with with very dubious backing and no trial… Do you think there should be a policeman for that kind of thing? BS: Right, so I don’t have an opinion about whether it should be more rigorous enforcement. Just consumers, and certainly health care professionals need to be smart about the claims made when hearing about any health technology – VR or otherwise. On the Importance of Distinguishing Health and Fitness Devices from Clinical Devices and Dealing with Data Privacy Concerns: JC: Last couple of things. I’ve read that you’ve been using and bundling Fitbits in order to track activity among patients during recovery while reading through your PLOS One abstracts. My work shows that people are kind of weary about giving out their personal fitness tracker information. In your experience, I was wondering how that was going if there were any updates in what you’ve been finding in terms of people giving up their data. BS: Yeah, that’s been really exciting but before I forget by the way, before we move on from VR, we’re going to have an international conference called Virtual Medicine at Cedars-Sinai on March 28th and 29th. We’ve invited really the world’s experts in medical and therapeutic VR to come and speak about this evolving field and we’re also going to have about 20 to 25 companies come in demo products so we’re really excited about this and you can check it out if you’re interested at virtualmedicine.org. JC: That sounds like a great event. Switching gears to Fitbits, so one of the ways I’m acquainted with The Health Care Blog is I actually spoke to Health and Human Services about the regulatory regime around personal fitness trackers and biometric data and how it’s not really clear in the United States. I was just wondering how you found in your usage if people’s attitudes have evolved regarding data privacy and how you use Fitbits on a day to day basis. BS: There’s two answers in this question. One is the general consumers and patients who won’t generally use the Fitbits unless it’s clear to them why they’re using it and how their data is being employed to make decisions or their well-being in addition to privacy concerns. However, when we use it in the context of defined protocols we’re seeing excellent adherence and so forth. We have a study right now where we’re working with heart cardiac patients to see if we can predict who’s going to have a heart attack before it happens. To achieve that requires pretty intense monitoring of a lot of different parameters, biomarker parameters, physiologic parameters, you know, quality of life parameters and in that study we’re using Fitbits. We have 86 percent compliance among our clients now and the difference there is that patient clearly understands why they’re using the Fitbit, how the data is being collected and used so we’re seeing excellent adherence. The other important thing is we have staff who talks with the patients and troubleshoots the device. They really put in the time and energy to explain why we’re doing this and that’s what works. JC: Is the data self-reported or do you have access to their to their online profiles? How do you get this information? BS: in that case we’re using a company called [FINOVATES?++++], they have an API and they just serve up the data directly so we have direct access 24/7 into all those patients’ activity data. It’s through HIPAA compliant channels, IRB approved and so on and yeah it’s been very successful. JC: How often does data security actually come up when talking to people? BS: Not that often. I’m going to guess about fifteen percent of the time they bring that up actively but they may think about it but not express it. I haven’t formally audited that right and it’s a tricky question. In terms of what do people do with the data, people just generally tend to be uneasy about it but they do it anyway because it brings benefits like doctors understanding exactly what’s going on with your recovery. JC: This brings me to my final couple questions. I’m an attorney and I’m curious to hear your thoughts on how you feel about that the need for more data from a medical professional point of view with how individuals value their data privacy. You mentioned that 15 percent actively ask about their data so what are your frustrations with the narrative that’s out there about big companies collecting your data and monetizing it? What can we do better in terms of medtech and the data that’s collected to reassure people that it’s not being used for nefarious purposes? BS: Yes, I’ve got a few thoughts about that. The first thing is I would distinguish health and fitness data from actual clinical data. That’s data being used for clinical decision-making in a healthcare system and there’s still not a whole lot of the latter. There’s an awful lot of consumer facing products like Fitbit and Apple watches and so on that aren’t necessarily FDA cleared and are widely used to measure features of health but they’re not necessarily being evaluated or analyzed by credentialed clinicians and in that world. Patients or users know that the companies have access to the data in different ways and to me that’s a different environment than the environment where I operate. I’m operating within the context of a healthcare system. We have a panel of patients we’re trying to take care and do it as effectively as possible with the least amount of cost as possible and provide value. And in that environment the narrative is very different so I don’t know that I’m answering your question other than know you I am splitting it into two different situations. JC: No, that’s great because the next thing that I can ask about is any frustrations you may have about medtech. Do you feel that some of medtech is or the language behind it is being hijacked by health and fitness data that’s out there? People that aren’t FDA cleared are dominating a lot of the news cycles right now. BS: I think so. I don’t know that I’d go so far as to say hijacked or that I feel that strongly about it. Until health care systems and investigators/researchers can demonstrate the value – and I truly mean value from a health economic standpoint of these programs – we can’t really complain about messages being hijacked or misconstrued through these sort of health and wellness app platforms. In fact, we have a paper that will be published in the next couple of weeks in the very first seminal edition of Eric Topol’s new journal, Digital Medicine, and in this new journal we have a meta-analysis where we are going to publish of all of the randomized control trials to date of using wearables versus a control condition in healthcare and the upshot is there’s no statistically significant benefit so far not using wearables to take care of people in terms of improving their health outcomes. So to me like we need to focus on figuring out whether when and how to use this technology rather than marketing messages or shaping public perception. The public will perceive it once we figure out how to access technology. We’ve definitely over-promised and under-delivered in my opinion on the claims for digital health broadly but I’m still a technophile. I’m can also just be techno-skeptical as well. AbStats, VR & the Future of Digital Health : A Conversation with Brennan Spiegel syndicated from https://storeseapharmacy.wordpress.com via Tumblr AbStats, VR & the Future of Digital Health : A Conversation with Brennan Spiegel By SABAH PERVEZ Earlier this week Health 2.0 held a TECHquality meetup focused on diversity in the digital health industry. We hoped that this event would foster an honest and frank discussion about how we can create diverse workplaces and develop inclusive technology for the people we serve. After speakers, Jean-Luc Neptune, Co-Founder at Athletik Health and Nyala Khan, VP of People at Baby+Co, shared their thoughts, meetup attendees were encouraged to share their own experiences and comments in relation to the topic at hand. Following an engaging and insightful discussion, where people of different backgrounds and walks of life shared their individual viewpoints, the hard questions remained, what more can we do to ensure that our workplaces are not only diverse, but inclusive? How do we ensure that the companies we build with people, embed the diverse perspectives of those people from the very start?
Year after year diversity reports show little improvement. This interactive infographic from Information is Beautiful shows a breakdown of employees by gender and ethnicity at some of the top tech companies. One of the many things that this infographic shows is that the percentage of Black and Latino employees hasn’t changed for many of the companies between 2014-2016. So when will it? How can we move the needle forward and convert conversation to real action? Down below are a couple of takeaways from our event, ones that allow us to not only educate ourselves in the right ways, but takeaways that we can use both as employers and employees of our respective organizations: Employers
Employees/candidates
If you have any additional platforms that we can add to this list, please feel free to comment below, we’d love to hear from you! Also, is your organization interested in keeping the conversation going? Partnership and sponsorship opportunities are available. Please email [email protected] for more information. Sabah Pervez is a Senior Program Manager at Catalyst @ Health 2.0. Diversifying Digital Health syndicated from https://storeseapharmacy.wordpress.com via Tumblr Diversifying Digital Health
“I wondered if that was how forgiveness works… not with the fanfare of epiphany but with pain gathering its things, packing up and leaving in the middle of the night.”
– from “The Kite Runner”
Just finished re-experiencing the exquisitely painful book “The Kite Runner” by Khaled Hosseini. It was just as beautiful yet totally different this time. For this second round, I listened to it over Audible, hearing the author’s own narration. Just as before, I am gasping and tearful with the book’s final words.
This particular quote near the end struck me so hard. I don’t remember it from before. That’s what’s so cool about returning to stories you’ve already known. You hear them with new ears. I’m sharing this today for someone pledging allegiance to a hurt or a grudge. Remember: when we least expect it, pain can tip-toe away like a thief in the night. And once it does, it’s up to us to let it go.
I kind of think life is like that. Just a series of forgivenesses waiting to happen. I think that’s why I love this book so much. And why I love people so much, too. We are all broken. But mostly? We are good. We are.
That is all.
_______________________
On forgiveness. syndicated from https://storeseapharmacy.wordpress.com via Tumblr On forgiveness. Is olive oil healthy? It is considered a highly nutritious and healthy oil due to its high levels of monounsaturated fatty acids and Vitamins A and K (unlike oils like canola, soybean, and vegetable oil, which are problematic). It also contains high levels of certain antioxidants. The Many Benefits of Olive Oil This staple of the… Continue Reading…Olive Oil Benefits (& How to Choose One that Isn’t Fake!) Olive Oil Benefits (& How to Choose One that Isn’t Fake!) syndicated from https://storeseapharmacy.wordpress.com via Tumblr Olive Oil Benefits (& How to Choose One that Isn’t Fake!) I so often feel like I can’t do anything because of depression. Look at the top photo. That is my life. I have had that objet cluttered and dusty for maybe years. It’s just one of the things in my apartment that I look at and see as failure. I see that I can’t do anything. I see that I can’t even clean up a small amount of clutter – clutter that can be found in so many corners of my apartment and life. Depression makes it so that I can’t do anything. However, while I feel this quite strongly, it may not, in fact, be entirely true.
via Tumblr I Can’t Do Anything Because of Depression – Or Can I? Tuna is a quick, easy protein choice that tastes great in a variety of dishes. My family enjoys it in recipes like this apple walnut tuna salad. This gluten-free tuna casserole recipe is another way to enjoy tuna as a healthier twist on the popular classic. Which Tuna Is Best? There are a few things… Continue Reading…Cheesy Tuna Casserole Recipe (Kid Friendly & Gluten Free) Cheesy Tuna Casserole Recipe (Kid Friendly & Gluten Free) syndicated from https://storeseapharmacy.wordpress.com via Tumblr Cheesy Tuna Casserole Recipe (Kid Friendly & Gluten Free) By, SAURABH JHA The good that doctors do is oft interred by a single error. The case of Dr. Hadiza Bawa-Garba, a trainee pediatrician in the NHS, convicted for homicide for the death of a child from sepsis, and hounded by the General Medical Council, is every junior doctor’s primal fear. An atypical Friday Though far from usual, Friday February 18th, 2011 was not a typically unusual day in a British hospital. Dr. Bawa-Garba had just returned from a thirteen-month maternity break. She was the on-call pediatric registrar – the second in command for the care of sick children at Leicester Royal Infirmary. As a “registrar” she was both a master and an apprentice – a juxtaposition of roles necessary for the survival of acute care in the NHS. Because there aren’t enough commanders, or consultants (attendings), in the NHS trainees must fill their shoes or else the NHS will collapse. The captain of the ship and Dr. Bawa-Garba’s supervisor, Dr. O’ Riordan, was not in the hospital but teaching in a nearby city. As horrendous as “attending not being in the hospital” sounds this, too, is not atypical in the NHS. Dr. Bawa-Garba’s colleagues, i.e. other registrars, were also away, on educational leave. Normally, a registrar each is assigned to cover the wards, the emergency department and the Children’s Assessment Unit (CAU). On that day, Dr. Bawa-Garba covered all three. She was new to the hospital, but with no formal induction – i.e. no explanation where things are and how stuff gets done in the hospital – she was expected to get along with the call and find her way around the hospital.
As anyone who has been a junior doctor in NHS can attest – the normal, the optimal, is unusual, and what is usual in British hospitals is remitting and relapsing chronic understaffing. The abnormal eventually becomes normal. You work through the anarchy. The anarchy is both the old normal and the new normal. Though the analogy isn’t exact, a registrar is the equivalent of a senior resident in the US. Registrars are the principle decision-makers in hospitals – that is, they function as both a senior resident and an attending. I recall during my internship the relief I felt when a registrar came to see the patient. They exuded confidence and competence. Often, the registrar was more useful than the consultant. Over the years, the distribution of responsibilities on trainee physicians has changed, and the registrar now assumes more of the work traditionally done by senior house officers (PGY 2 – 5) who, in turn, have become interns. The house officers (interns) have become supernumerary. Formerly, the senior house officer was the busiest person in the hospital – it is now the registrar. That day, Dr. Bawa-Garba was taking referrals from general practitioners and emergency physicians, surgeons and midwives, and responding to emergencies on the wards, along with the usual multiple inquiries which in hindsight turn out to be clinically irrelevant. She was also phoning pathology for results because the hospital IT system was down, and the results, let alone the abnormal results, weren’t automatically being populated in the electronic health record. She was performing skilled procedures like lumbar punctures because no one else in her team, which comprised an intern and a junior trainee, could. Triple booked, Dr. Bawa-Garba was making critical decisions and also doing the scut work, and teaching and supervising her team. To borrow an aviation analogy, she was flying the plane and serving food to the passengers. A boy in shock At 10:30 am she assessed Jack Adcock, a six-year old boy with Downs syndrome who was referred by the GP for nausea, vomiting and diarrhea. Jack was normally a lively chap, who had a past surgical history of a repaired atrioventricular canal defect, and was on enalapril. He was apyrexial, but looked dehydrated and sick. Dr. Bawa-Garba made a presumptive diagnosis of fluid depletion from gastroenteritis and administered an intravenous fluid bolus immediately, and started him on maintenance fluids. She requested a chest radiograph, sent off bloods for blood count, renal function and inflammatory markers, and drew blood gases, which showed that Jack was acidotic with a pH of 7 and a lactate of 11. The metabolic profile confirmed her working diagnosis of shock from gastroenteritis but, judging from the tests she ordered, pneumonia was in her differential. After the initial fluid bolus, Jack seemed to be trending in the right direction, metabolically. The repeat blood gas showed he was less acidotic, with a pH of 7.24, heading towards a normal pH of 7.4. At 3 pm, she looked at the chest radiograph which showed Jack had pneumonia. She prescribed Jack antibiotics, which were given at 4 pm. The radiograph had been exposed at 12:30 pm. Radiographs aren’t routinely interpreted by radiologists – there aren’t enough radiologists in the NHS. Jack was moved from the CAU to the ward. At 4:30 pm, she met Dr. O’ Riordan, her boss, in the hospital corridor. She showed him Jack’s blood gas results and explained her plan of action. Her boss did not see Jack. In the ward, Jack received enalapril. Dr. Bawa-Garba had not prescribed enalapril, and she clearly stated in her plan that enalapril must be stopped – the drug lowers blood pressure and is absolutely contraindicated in shock. Nor was enalapril given by the nursing staff – they stick to the doctor’s orders. An hour after receiving enalapril, Jack had a cardiac arrest. After vigorous attempts at resuscitation, interrupted for a minute by Dr. Bawa-Garba’s mistaking Jack for another child who was not for resuscitation, Jack was pronounced dead. Jack died from streptococcal sepsis. His circulatory system put up a fight, and he so bravely maintained his blood pressure that he deceived everyone about the true nature of his critical condition. His body had been fighting the bugs for some time and by the time he was assessed in the CAU it was so knackered that it could not even mount a temperature. There is plenty of ruin in the circulation. And Jack might have prevailed. The fatal dose of enalapril took the sails out of his resistance, and precipitated circulatory collapse. Reflections of an overworked trainee When a patient dies a part of the doctor dies. Privately, many doctors express their grief by excessive introspection, reliving the events to ask what could they have done differently – arguably the more conscientious a doctor, the more self-critical. To render the death of a six-year-old otherwise healthy boy as inevitable is to make medicine less humane. This is the nature of a medical error – whether you’re at fault or not you have to learn from it, and by conceding that you may have been wrong, you achieve closure. Clinical medicine is arguably shaped less by science and more by the many errors and the near-misses doctors face personally, or hear about from their colleagues. Clinical medicine is affect heuristic writ large. After Jack’s death, Dr. Bawa-Garba was distraught and her consultant encouraged her to record her failings in her electronic portfolio. Trainees are encouraged to record their mistakes, predominantly for pedagogy. She could have, if she wanted, written about the system failures of that day. But that would have been making excuses, and you don’t stick around in a field like pediatrics if you’re the sort who points fingers at others. Though the details of her reflections are not public, she is likely to have been merciless on herself. She likely admonished herself for not thinking about sepsis instantly, for not insisting that the chest radiograph be done immediately, for not reviewing the film sooner, for not starting the antibiotics immediately, and most of all, for not being clear that under no circumstances Jack be given enalapril. It is likely she omitted that she was doing the work of three registrars that day, that she had a long hiatus from clinical medicine, that she was new to the hospital, that her consultant did not help out. In a cruel twist her reflections, instead of purging her of guilt and delivering her from purgatory, would later deliver her to purgatory. To err is homicide The trust led an internal inquiry which identified several system issues which contributed to Jack’s death. Medical errors can be caused by system issues and physician factors. The American patient safety movement has taken the high road and placed the blame for medical errors on systems. The Tort system targets both individuals and systems. The truth is that both can contribute – no matter how good a system is, it can’t raise a severely incompetent physician. The opposite is also true, particularly in the NHS – no matter how good a physician, they can be brow beaten by the system. The British medicolegal system is not as primed with cash as the American system. Large payouts are uncommon. Jackpot justices are rare. Ambulance chasers are unheard of. There are no billboards advertising personal injury lawyers. Perhaps incidental to, or because of, the lack of large financial payouts for medical injuries in Britain, an unusually large number of physicians are prosecuted for manslaughter for patient death from medical error. Restitution of the deceased is, by definition, not possible, so families of the deceased press criminal charges against the physician for justice. The prosecution tries to prove that the physician was “criminally negligent” in erring. To be fair in cases such as Jack’s, it is not easy going after systems. The system is innominate and faceless. Who do you prosecute – Leicester Royal Infirmary? NHS England? The government? The taxpayer? It is easier going after individuals. It is easier believing that a particular doctor “killed” the child, than a system failed to save the child. Thus, a black, Muslim, female physician wearing a headscarf, who should have been the face of NHS’s glory became the face for all its failings. The first police inquiries did not find enough grounds for a prosecution. However, the Adcocks persisted – understandably given their circumstances. And it’s important to acknowledge that many people would have done exactly what the Adcocks did – you don’t lose a six-year old child to sepsis and just shrug your shoulders. The Trial Dr. Bawa-Garba, and the two nurses who were caring for Jack, were charged with manslaughter. The case against the pediatric trainee was simple – she wasn’t just clueless, but grossly negligent. With the power of hindsight, Jack’s case was dissected to the hilt. Sepsis, the deadly deceiver, became a diagnosis which any half competent pediatrician should casually be able to detect. Jack’s care was meticulously decomposed. The delay in getting chest x-ray, the delay in reading the x-ray read, the delay in prescribing the antibiotics. Unwittingly, the court was exposing system failures, but Dr. Bawa-Garba was being held responsible for each failed component. It was as if she was all of NHS and all of NHS was her on February 18th. Expert witnesses opined that had Jack received antibiotics within 30 minutes, rather than 6 hours, his chances of survival would have increased dramatically. There was tremendous certainty in the counterfactual. Diagnostic medicine is a fog of uncertainty until you know what the patient had. Dr. Bawa-Garba was found guilty of manslaughter – the jury returned the verdict 10:2. Throwing the apprentice under the bus Guilty of homicide for mistaking normalizing pH after a fluid bolus for hypovolemic rather than septic shock. The difference between jail and exoneration in Britain for a trainee physician is a multiple-choice question about a medical emergency. The problem with the law isn’t that that the law is an ass, it is that the law is an inconsistent ass. Jack’s blood gases were deemed characteristic of sepsis. If they were so characteristic, why did Dr. O’ Riordan, the peripatetic consultant of the day, and Dr. Bawa-Garba’s supervisor, not instantly diagnose sepsis when he saw the blood gases? It was Friday, 430 pm – the weekend was nigh. Why did he not immediately see Jack, and transfer him to the intensive care unit? If a trainee, an apprentice, who was doing the work of three registrars, can be found guilty of homicide for not understanding acid-base physiology, what does it say about the competence of her supervisor? How can she be criminally negligent and not he? This is neither scientific nor logical. Dr. O’ Riordan was either incompetent or lazy. Or there’s another explanation – perhaps sepsis in a child is difficult to diagnose, even for a seasoned consultant pediatrician. Dr. O’ Riordan was not on trial, it was Dr. Bawa-Garba. When asked why he did not see Jack, Dr. O’ Riordan said that Dr. Bawa-Garba had not asked him to, she had not impressed upon him Jack’s clinical urgency. This is deeply disingenuous. Every consultant must recall being a junior doctor – recall that trainees don’t not ask for help because of their pride, but because they’re hesitant to ask for help, and they’re hesitant not because they’re afraid, but because there’s a culture of hesitancy, and that culture of hesitancy is a corollary to a culture in which apprentices are expected to make decisions independently, without which hospital medicine would abruptly halt. The onus is on the consultant to sniff out trouble. And Dr. O’ Riordan should have sniffed out trouble. He knew she was new to Leicester Royal Infirmary. He knew, or should have known, that she had been away from clinical medicine for over a year, so probably wasn’t at the top of her clinical game. He knew she was working the work of three registrars. Why did the jury not consider these mitigating factors? Why could they not see that an apprentice had been thrown under the bus? Had Dr. Bawa-Garba prescribed the fatal dose of enalapril, she ought to have been found guilty of manslaughter – that error is egregious. But she did not. And here, too, a failing, a mysterious failing, was internalized by the apprentice. It was deemed her fault for not anticipating that Jack would receive enalapril, even though it was not on his drug chart. She was guilty for not thinking about all the contingencies. The jury heard how about Jack’s delayed treatment. But they did not hear about the other patients who were receiving care in the same hospital from Dr. Bawa-Garba. No patient is an island, least of all in the severely resource-constrained NHS. She was not surfing on the web whilst, unbeknownst to her, Jack’s organs were being attacked by streptococcus – she was performing lumbar punctures, attending to codes, taking referrals from GPs, managing several wards, all by herself. The most unfortunate part of the whole episode was when Dr. Bawa-Garba called off the code confusing Jack for another patient whose code call she attended that morning. The mistake was picked up by another junior doctor. The resuscitation was interrupted by a minute though, sadly, it was too late for Jack by then. Justice Nichol, the sentencing judge, said of that episode that it indicated how far from Jack’s care she had departed. I don’t know how long it had been since his last meal when the Justice opined. But, with a bit of thoughtfulness, he might have arrived at an alternative interpretation. That Dr. Bawa-Garba, hungry, exhausted, and overwhelmed, was at the end of her tethers. That doing the work of three registrars, which is difficult on any day, was particularly challenging in a new hospital after a year’s break for a young mother who probably got little respite at home. That her mistakenly stopping the resuscitation wasn’t a sign of her incompetence, but a sign she was decompensating despite a Herculean effort to stay together on that fateful day. That it had not, for a second, occurred to her that it was Jack who had coded because she felt that Jack’s clinical situation was on the mend. The most merciless expert witness was none other than Dr. Bawa-Garba herself. Her electronic portfolio became her confession. She erred because she had confessed to erring. Her reflections on how she could be a better doctor became proof that she was a bad doctor. Her remorse, the cornerstone of being a compassionate doctor, was evidence that she should be behind bars. It was a scene from confessions in a medieval torture chamber. It was worse than a court for kangaroos. It was literally a case of “we find you guilty because you said you were guilty.” The hyenas in the General Medical Council The law, for all its failings, is the law. One can’t expect jurors to understand how trainees prop up the NHS, how any trainee could have been Dr. Bawa-Garba that day. But one does expect the General Medical Council (GMC), the regulatory body for physicians, to understand how the NHS works. GMC comprises physicians who were once junior doctors in the trenches. Like hyenas drawn to a carcass, the GMC began circling Dr. Bawa-Garba. It was not enough that she was wrongly convicted of manslaughter. It was not enough that Health Education England withdrew her training number – i.e. annulled her residency position. They wanted to make sure she could never practice medicine again. They wanted to erase her name from the medical register. In stead of rescuing the wounded soldier, they wanted to stab her whilst she was exsanguinating. It is easy to run out of adjectives which can be used in polite company for the GMC. But it is worth understanding this organization. To label them as “corrupt” misses the point – sure, power corrupts, but GMC’s pathology isn’t “power corrupts absolutely.” Though they seem as cold-hearted as a serial killer lack of empathy isn’t the issue. Though the GMC’s purpose is to protect patients and guide doctors, it’s an organization which takes an uncompromising stance towards its own reputation, and the reputation of doctors in general in the public sphere. It has long taken the reputation of the medical profession personally. Meaning, if there is a chance that a physician, who has been investigated for fitness to practice, will bring the profession into disrepute, the GMC axes them from the register. The GMC knows it can’t monitor quality in physicians, ex ante. So, it signals its own quality and purpose by taking a ruthless stance against the doctors. The GMC investigations are known to cause night terrors – many doctors have committed suicide whilst being investigated by the GMC. For the GMC, Dr. Bawa-Garba was irresistable fodder. She had already been found guilty of manslaughter by a public court which led the GMC to apply elementary logic – “found guilty therefore guilty.” Here are excerpts from a tribunal which summarizes the thoughts of Mr. Denney – the counsel on behalf of the GMC. “Mr. Denney submitted that your performance on 18 February 2011 was so poor that, regrettably, regardless of the remediation that you have undertaken, there remains a risk that there would be a further collapse of standards in the future with an inevitable risk to patient safety. He acknowledged, however, that you had done all you could to remediate the specific failings identified. He further submitted that, given the fact that you have been convicted of manslaughter and received a custodial sentence, a finding of impairment is also required in the public interest.” To save face in the public eye, the GMC had to make sure she could never practice medicine again. The GMC wanted to stay internally consistent. The law was an ass so, for the sake of consistency, the GMC had to be an even bigger ass. The GMC seemed uninterested in the truth. They seemed uninterested in the mitigating factors of Dr. Bawa-Garba, of system errors, of absent consultants, of triple workloads, of a clinical hiatus. They seemed uninterested in making sure that another Jack doesn’t die from sepsis. If they truly cared about public interest, one wonders why they didn’t conclude that it wasn’t in public interest, and it was a waste of taxpayer’s money, depriving the public of a competent pediatrician? How did they not see that their actions might deprive pediatrics of even more doctors? The GMC side stepped cognitive dissonance deftly – by convincing themselves that Dr. Bawa-Garba was a dangerous pediatrician, who would remain a threat to public safety. And they ignored all evidence which pointed in the opposite direction. The GMC’s plans were thwarted by the Medical Practitioners Tribunal. An independent panel concluded that Dr. Bawa-Garba had indeed erred, and had made a grievous error. But, given her exemplary record before, and after Jack’s death (she worked for nearly four years after the incident, and only stopped working when convicted of manslaughter), given the testimonies of her seniors – who vouched that she was an excellent physician, she was in the top third of her class – the tribunal concluded that suspending her medical license for a year, until the end of her suspended sentence, was reasonable – removing her from the medical register was disproportionate. The GMC wasn’t happy with mere suspension of Dr. Bawa-Garba’s medical license. They wanted her removed from their register. The GMC continued to pursue Dr. Bawa-Garba’s expulsion with extraordinary zeal. Finally, the high court sided with them, which opened the flood gates of the national angst of doctors in Britain. The tribunal believed that Dr. Bawa-Garba was remediable. The GMC did not. How was the GMC able to reason away the compelling evidence attesting to her competence? How did the GMC convince itself that she was a perennial threat to the public? What goes on behind the scenes at the GMC? I ask these questions not rhetorically but with incredulity – is the prime regulatory body of doctors in Britain no longer fit to regulate? Who regulates the regulator? If the GMC genuinely can’t see any mitigation in Dr. Bawa-Garba’s circumstances that fateful day, they are beyond redemption. My concern isn’t that the GMC is dishonest or corrupt – these can be remedied by the right leadership. My concern is that the GMC does not understand clinical medicine. The GMC’s tenuous grip with reality is best expressed in Mr. Denney’s submission that “wholesale collapse of the standard of care provided by you (Dr. Bawa-Garba) came out of the blue and for no apparent reason. He submitted that it was therefore impossible to have any confidence that this would not happen again.” And this is the crux of the problem. The GMC can’t see that when a physician with an unblemished track record fails to make a diagnosis then perhaps, just perhaps, there may be something tricky about the diagnosis. The GMC can’t see that to err is to be a doctor. The GMC is out of touch with clinical medicine in the NHS. It is not evil – it is profoundly ignorant and is playing a dangerous popularity contest in the public. This isn’t good for either doctors or patients. It is hard to see how paying annual dues to the GMC can be considered ethical. Respondeat superior Many have suggested that had Dr. Bawa-Garba been a white female doctor with a posh accent she would not have been found guilty of manslaughter. The press would have been kinder to her, and not labelled her as a “child killer.” I’m not one to patronize racial accusations easily. And even if there is structural racism, this case illustrates a problem far deeper than structural racism. Britain’s junior doctors need to understand the nature of the problem they face. Junior doctors run the NHS, the extent to which is difficult to explain to people who haven’t worked in the NHS. As I mentioned before, Dr. Bawa-Garba was doing the job of both an apprentice and a consultant. This state of affairs is not without dividends. By relying so heavily on junior doctors, the NHS is able to employ fewer consultants. Consultants aren’t cheap – once you factor their salary and benefits, particularly the pensions. Thus, the NHS saves money but, and this is the crucial point, so does the taxpayer. So, junior doctors are workhorses but when the shit hits the fan they can’t take advantage of a legal doctrine known as “respondeat superior” – which basically means that the employer assumes responsibility for their actions. This is a win-win situation for hospitals and lose-lose situation for junior doctors – not only must they make tough clinical decisions, but if they screw up, and unsupervised apprentices will screw up, they’ll be thrown under the bus. How this situation became palatable baffles me to no end. But it gets worse. When a junior doctor complains about being unsupported, i.e. whistle blows, they lose their job, as Dr. Chris Day, an aspiring emergency physician, did. Thus, junior doctors must choose between the devil and the deep blue sea – risk jail if they work unsupported or risk unemployment if they complain about being unsupported. To emphasize, the problem isn’t just that junior doctors work unsupervised – to a large extent, this is unavoidable. The problem is that junior doctors work unsupervised AND are fried for errors of judgment inevitably made because they are not supervised. It is extreme cowardice court marshalling the foot soldiers for making decisions their generals were too busy to make. Trainees should be remediated by their teachers, not prisons. Moving forward Dr. Bawa-Garba’s case has sent a chill down the junior doctors. Instilling a fear of prison for an error of judgment isn’t the best way to raise the morale of the foot soldiers. Dr. Segun Olusanya, a colleague of Dr. Bawa-Garba from medical school, recalls her as a fellow Nigerian student who hardly partied and spent her time reading. Dr. Olusanya is a registrar in intensive care medicine, and isn’t one to be easily scared by medical emergencies. He’s the sort of doctor you want sitting next to you if you’re planning to have a cardiac arrest on a long-haul flight. Dr. Olusanya hasn’t slept well since hearing about his old medical school friend. He is, for the first time in his life, frightened to work in the NHS. It is important for junior doctors not to lose their moral capital on this issue. It’ll be tempting to politicize Dr. Bawa-Garba – but this isn’t about Jeremy Hunt, or austerity, or Brexit. This problem has existed for a long time, and has become more pernicious recently. The solution is clearly more funding but this is a long-term solution. In the short term, junior doctors must, without compromise, be protected from manslaughter charges. This has to be built into the employment contract. The principle of respondeat superior must be installed. The hospital must assume complete responsibility for the actions of junior doctors, contractually. This’ll put more skin in the game for the trusts, who will apply downward pressures on consultants. The British public can’t have it both ways. They can’t simultaneously enjoy the thrift of a healthcare system with a tab of only 9 % of the GDP, yet demand a structure needed to catch outliers. Such a structure costs. It’d have taken a village to save Jack. Jack died not because the village failed him, but because the village did not exist. As the Americans have discovered, if you want zero deaths from sepsis, you need a sepsis protocol – if you want antibiotics to be delivered in 30 minutes, you need chest x-rays to be performed and read in 30 minutes, which means more technologists, more radiologists, more x-ray machines. You need beds in intensive care units, which means you need more intensive care units, and trained physicians to run them. Infrastructure costs. To have a high index of suspicion for sepsis you need to invest in structure and people. If the British public insist on thrift, they must also accept the errors which come with thrift. A competent doctor’s career was torn by a virulent entity which has a mortality as high as 80 %, and against which the NHS is neither any safer nor any wiser, though its life blood, the junior doctors, will have coagulated a bit. In prosecuting Dr. Bawa-Garba and the agency nurse who, sadly, was struck off the register, too, attention has been diverted from the shortcomings of the NHS. The General Medical Council has contributed to the grand public deception. The actions of the General Medical Council will outlive them. Further Reading http://www.manslaughterandhealthcare.org.uk/ https://www.mpts-uk.org/static/documents/content/Dr_Hadiza_BAWA-GARBA_13_June_2017.pdf https://www.ncbi.nlm.nih.gov/books/NBK333425/ https://www.ncbi.nlm.nih.gov/books/NBK333425/ About the author Saurabh Jha is a British-trained medic who worked in the NHS for four years. He can be reached on Twitter @RogueRad
To Err is Homicide in Britain – the case of Dr. Hadiza Bawa-Garba syndicated from https://storeseapharmacy.wordpress.com via Tumblr To Err is Homicide in Britain – the case of Dr. Hadiza Bawa-Garba By TIMOTHY HOFF The recent news that U.S. retail giant CVS Health will purchase insurance giant Aetna, in part to gain millions of new customers for its prescription drug and primary care businesses, is another ominous sign for patients. Patients should worry about all the continued consolidation in the health care industry, whether it is Walgreens buying Rite-Aid to increase their pharmacy clout; Anthem’s ill-fated attempt to purchase Cigna to become an insurance monopoly; or hospital systems like Partners Healthcare in Boston trying to buy the hospitals and physician networks in and around its service area to control patient flow and increase market share. Consolidation often limits competition, and when that happens in market-based systems especially the result, says good research, is often that the cost of health care goes up. This does not benefit patients, who increasingly are paying more out of pocket for their insurance and for the services they receive from doctors, hospitals, labs, and drug companies. The Affordable Care Act did little to encourage greater competition in the health care marketplace. That was probably by design, since those creating the legislation held an implicit assumption that the bigger players in each of the different industry areas like insurance, pharmacy, and hospital care could deliver given the size of the insurance expansion the ACA would promote. As we see from the existing premium inflation on the exchanges across the country and with prescription drugs, and the continued long delays in people’s ability to access care, this assumption was not accurate. To the contrary, the ACA’s focus on new and unproven structures like accountable care organizations; new payment models that reward scale and resource investment in things like information technology; and rewarding those organizations that have the most comprehensive performance measurement infrastructures has encouraged the kind of profit-oriented consolidation in the industry that does less to improve the overall system. Also, given the increased squeeze by payers like Medicare on payments to hospitals, for example, mergers and acquisitions are a natural yet dysfunctional corporate response to higher levels of uncertainty in the external health care environment.
What does this all mean on the ground for patients? First, it means less choice from everything to where they get their medications from which doctors and hospitals they can go to. For example, the Boston metro area is dominated by two very large delivery systems available to patients: Partners or Beth Israel, the latter which intends to merge with Lahey Clinic, creating another care delivery giant in Boston region. Once you are in these systems of care, increasingly they don’t let you out. They need to capitalize on the investments made in getting bigger by forcing patients to see only their doctors, labs, and surgical centers. Once choice is limited, prices can be increased, and without a lot of competitive pressure, for example, exerted on care quality or patient satisfaction, the systems may underinvest in these things. Health care costs in Massachusetts are among the highest in the nation, and this reality is one reason why. A second everyday implication of consolidation is that it makes the health care experience feel more transactional rather than relational. A transactional experience is impersonal, standardized, and organization- rather than professional-driven. The focus is on efficiency and the organization’s interest in turning over volume rather than the patient’s interest in tailored service delivery. In this way, patient contact with the system becomes a maze of 800 numbers, call centers, automated replies, and web-based clicks that move us through standard templates. Consolidation produces large, bureaucratic organizations that have a harder time seeing us as unique individuals, and catering to our parochial preferences and needs, which in health care is important for keeping patients healthy. This often produces a generic and substandard experience for many patients; causes many to lower their expectations for what they will get for their investment of time and money; and makes us all too reliant on “the company” for taking care of us, rather than the clinician. Should we take the waves of consolidation in all parts of the health care system more seriously in terms of its direct impact on patients? We sure should. Closer regulatory scrutiny would help. Often this scrutiny is watered down in the face of specious arguments about consolidation in health care “saving jobs” and contributing positively in terms of economic impact to a given locale. The paradoxical rationale that consolidation will reduce health care costs and improve care quality also gets put forth, even in the face of evidence to the contrary. In a health care industry that remains beholden to market-based principles for doing business, state and federal governments must do a better job of enforcing existing anti-trust laws, certificate of need requirements, and other tools available to ensure health care competition and protect patient interests. That said in some geographic locales and parts of the industry, it may already be too late. Timothy Hoff, PhD is Professor of Management, Healthcare Systems, and Health Policy at Northeastern University in Boston, A Visiting Associate Fellow and Visiting Scholar at Oxford University, and author of the new book, “Next in Line: Lowered Care Expectations in the Age of Retail- and Value-Based Health”, published by Oxford University Press. Bigger is Not Always Better: How Consolidation in Health Care Hurts Patients syndicated from https://storeseapharmacy.wordpress.com via Tumblr Bigger is Not Always Better: How Consolidation in Health Care Hurts Patients |
HealthBotics
I run this blog to share my view on all topics relating to health and happiness. My principal aim is to explore spirituality from a scientific point of view and help people think about life, happiness, and themselves in ways they never have before. Check my new posts everyday, follow it and stay healthy. Personal Links |