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Interesting AI & Immune System Initiative by Microsoft and Adaptive Biotechnologies that leaves behind some questions

It is no secret that the larger technology companies including Google, Microsoft, nVidia, IBM, Apple and others want to dominate AI, as well as healthcare, in an ever expanding competitive landscape. While it is anyone’s guess if they will succeed, or get upstaged by smaller, nimbler firms in either arena, the moves they make are definitely interesting to watch. A lot of the moves appear benign, but could lead to cannibalization, such as the “AI Contests” some of the organizations put up (more posts to come on this).

Partnerships can go both ways I suppose, and are probably a strategic way to externalize any risk of failure. In that sense, in the current example, both Microsoft and Adaptive Biotechnologies appear to want to play up their strengths. The premise of what they want to do with the partnership is also quite intriguing. You can read it from the horses’ mouths in the links provided below. I will summarize them and lay out a couple of thoughts that come to my mind.

Essentially, the project would turn the body’s immune system itself into the data source for diagnosis. Because every time the immune system responds to a disease, T-Cell receptor (TCR) proteins are expressed to combat antigens. Mapping the TCRs, through a simple blood test, as Microsoft and Adaptive postulate, can go a long way in early diagnoses of an array of diseases. To say the least, the project is ambitious, and here are a few thoughts:

  1. Accurate diagnosis and personalized therapy require knowledge of the state of the human body and its disease. Simply mapping the genetics of a person, and considering their epigenetics and their lifestyles, etc. is complex enough, but it still might not be enough! Thus, TCRs could be mapped and allow for quicker diagnoses, if the theory pans out on a large-scale. It is yet unclear to me that mapped TCRs can actually yield the necessary diagnostic clues, machine learning or not, for a larger variety of diseases. However, it might supplement diagnostic efforts alongside genetics, epigenetics and other health data sources.
  2. From a business angle, I also find this to be intriguingly different from the general bedlam of text processing a la Watson, and all the algorithms rushing to read and reinterpret imaging as with nVidia and others. Microsoft has appeared to have looked for and found a partner with a unique approach to the application of machine learning in healthcare.
  3. Any large set of unknown targets, powered by data might appear to be a classic problem for machine learning to solve. However, Microsoft and Adaptive (Microsoft has invested in them now, apparently) might have joined a Kool-Aid club that bridles the horses behind carts. What I mean when I array out those cliches is this: medicine already has a problem of knowledge paucity when it comes to diagnoses, until more clarity becomes available, by way of a progressed disease. This is fundamentally because disease precursors are poorly understood, from want of clinical research, not lack of intelligence. What is to say the TCRs won’t just set off an array of false and confounding alarms? Yes, with liquid biopsy and other such hyped up methods out there, the industry is in a rush for quick fixes. It might well turn out that this is much harder to resolve, with clinical studies and protocols that will require to demonstrate that TCR expression, their proportional presence, etc., do truly indicate the preliminary stages of a disease being present in the body. I am not convinced yet.
  4. There is also a maddening rush out the gate to define universal tests with pinpricks of blood. While I am not suggesting we practice good old, barbaric bloodletting (although there are all kinds of people out there “thirsting” for a comeback to this practice), I think this is an unnecessarily over-constrained problem definition, perhaps making titillating fodder for press releases and blog posts. There might also be an urge to combine these pinprick tests with diabetes monitoring and such. While it is tempting to fantasize about such possibilities, and at some point, these might come to fruition, there is no need to go to such extremes before solving fundamental problems in medicineaccurate diagnosis and targeted therapy. For example, when should a person’s blood be drawn? How frequently? Would the frequency vary when a certain set of TCRs are observed? There are so many things to worry about here. I would think companies would stop using overly broad terms such as “universal”.
  5. In my posts here, in my talks, daily discussions and so on, I always come back to a few bugaboos. Who will own the TCR mappings? Who owns the product of the machine learning algorithms? Will they be patented and bridled off? How will such diagnostic methods be regulated? Validated? Will Explainable AI, something I expect to be a fundamental principle that should be applied to healthcare be required (see explanation from DARPA linked below) and used judiciously? And on and on we go.
  6. Data has been walled off quite well in the healthcare industry up to this point. Yes, we got the human genome, but much much more sits behind curtains and masks and other cliches you can think off, that every new technology that promises to expose and dig through data always concerns me, surrounding ownership.
  7. The “Theranos” Effect: If you are like me, and know about the story of Theranos, you are still sitting up at nights, jaws dropped, wondering how in the hell, the company is still in vogue (I have written about this on my medical devices blog, in fact, using the same Pixabay image! See link below). I have also linked, one of several dozen well-written write ups that offer us a tale of caution, and I plan to call this, as I have named it, the “Theranos” Effect. In summary, this company went into the “over promise, and extreme under-delivery” (or never delivery, to date..) business. They engaged in egregious and unethical business practices, fooling the industry, investors, partners and more, along the way. How do we make sure that with all the promise of AI, companies don’t make such ugly incidents repeat themselves? Mind you, this is not me pointing fingers at Microsoft. I think this is indeed a great effort. I am just offering this up as an important tale of caution, for people in healthcare, and in any industry for that matter. I understand, as much as anyone else that businesses need hype to push their products. However, it would behoove you to make sure you don’t push things off a cliff…

CONCLUSION

In mankind’s march towards the goal of a healthy future for all, we have many strides to make. Naturally, we want to be as accurate and as thorough, yet economic as we can. Therefore, we rely on technological breakthroughs on one end, such as anything ranging from improvements in basic science, to sensors and AI, and on the economics of lower thresholds for test materials consumed, time to diagnosis and other aspects on the other end. What Microsoft and Adaptive aim to do with their (investment based) symbiotic looking partnership is commendable. It may take us one step closer to our goal, but it may not be the one to take us there at all. Only time can tell, and in the meanwhile, I hope commonsense and ethics prevail over hype and fantastic marketing materials.

Should you have something to add, please leave a comment below.

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References:

  1. The Microsoft Blog Post: https://blogs.microsoft.com/blog/2018/01/04/microsoft-adaptive-biotechnologies-announce-partnership-using-ai-decode-immune-system-diagnose-treat-disease/?imm_mid=0fa701&cmp=em-data-na-na-newsltr_ai_20180115
  2. Adaptive’s Press Release: https://www.businesswire.com/news/home/20180104005464/en/Adaptive-Biotechnologies-Announces-Partnership-Microsoft-Decode-Human
  3. DARPA, on Explainable AI: https://www.darpa.mil/program/explainable-artificial-intelligence
  4. Vanity Fair on Theranos: https://www.vanityfair.com/news/2016/09/elizabeth-holmes-theranos-exclusive
  5. Myself, writing with incredulity on Theranos’s longevity: http://chaaraka.blogspot.com/2017/12/theranos-lives-to-die-another-day.html
  6. Image, Courtesy, Pexels+Pixabay: https://www.pexels.com/photo/white-and-clear-glass-syringe-161628/

The FDA Designates an Eye-Diagnostic System as a “Breakthrough Device”

 

Last year, in my talk at the San Jose BIOMEDevice Conference, I had postulated that one of the key factors in the rate and level of adoption of AI based devices and systems would depend on how the FDA would act on such submissions. It is good to see that one company seems have to have proceeded with taking the FDA to task. The result is positive, and good news for companies pushing AI based systems, but also carries a tale of caution, for the road ahead for everyone involved. I will lay out the case briefly in this blog, but this is not the last time you will hear me talk about the effect of regulatory agency response to such device submissions and their long-term implications.

I just reviewed news that IDx, a company that designed what is being described as “an AI based autonomous diabetic retinopathy” detection system has been given “breakthrough” status by the FDA for their system. This provides the system with an expedited review, and potentially quick approval. This is very encouraging, not only for the organization with the retinopathy system, but also for all companies vending AI systems.

Here are a couple of key thoughts I have on this:

  1. A very promising outlook: I am not aware of how much Scott Gottlieb had, in terms of a personal hand in this decision, but I am sure his leadership had a measurable impact on the decision to expedite review. He has taken a stance of modernizing some of the approval processes, especially in the area of Digital Health. The FDA’s backing for AI based systems, is a very positive thing for companies with an AI focus on healthcare.
  2. Good for competition in the healthcare industry: Once the FDA sets AI based apps and systems on the path to commercialization, there will be no excuse for organizations that do not adopt Machine Learning and Neural Networks. Of course watch for a good spike in M&A activity in this regard.
  3. The Hype Cycle is around the corner: While companies with real ML/DL products and services will be out there, helping patients, there will also be the fakes and the wannabes that we will have to contend with. And it is quite possible that the rotten apples will ruin it for everyone. This is something to watch for.
  4. Unrealistic expectations and unintended consequences: I know this is closely related to the point about the hype cycle, but I want to make a refined point here. Even the companies with good AI based tools might push the envelope on hyping up the utility and efficiency of their products. Over-promise and under-delivery lead to angry and disappointed customers and eventually will create problems for everyone in the industry.
  5. How will CMS and private insurance companies handle reimbursement? This is a big question and can be the topic (and probably will be) of several blog posts. However, I just wanted to highlight that while AI might improve efficiency and automate diagnoses and treatments, companies have to resolve how and where the reimbursement will come from.
  6. A word of caution on regulation: While it is commendable that the FDA is moving forward with initiatives on things such as AI. However, I do not always agree they are doing a great job on things. I was irked by the craze with which the orphan applications were being reviewed by the FDA. The FDA, in the past, has gotten too cozy with the industry and Congress, with terrible consequences. Those who remember the Menaflex incident (reference below) remember how quickly the public’s trust in the FDA eroded, and how the organization took years to recover from that. Therefore, there is cause for concern here, and one hopes there will be a balancing act in making sure that the approval processes remain rigorous enough.

Conclusion: The current “breakthrough” designation and fast track review show great promise, but one hopes the FDA will balance it out with an equal dose of caution.

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Did you enjoy this post? Please subscribe for more updates, using the sidebar. Have ideas or blog posts you’d like to see here? Contact me at yamanoor at gmail dot com.

References:

  1. The Press Release on IDx: https://www.eyediagnosis.net/single-post/2018/02/05/FDA-to-expedite-review-of-IDx-DR-a-breakthrough-AI-diagnostic-system?lipi=urn%3Ali%3Apage%3Ad_flagship3_feed%3B6Bf9xSfCRQSJXa4nvXjScA%3D%3D
  2. On what happened with Menaflex: https://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM183642.pdf
  3. Image, Courtesy, Pexels: https://www.pexels.com/photo/people-face-child-eye-32267/