Monday, August 10, 2020

Update: Newsom does say buck stops with him, as he points fingers outward...

 


This is a quick update to the post I wrote from this morning, regarding the resignation of Angell, California's Public Health Director late on Sunday. On that I mentioned, and I will quote here: 

For a true leader, the buck stops with you. Not a few levels below you! Especially not on scientists and public health officials. 

And of course, he then gave a press conference where he said the following:

“I’m governor, the buck stops with me.” 

Well that is good, and you can read about it in the link below, but here are still some unknowns and bothersome things:

1. Why did she have to resign? We still haven't heard what he has to say about that. 

2. If the state did inherit a bad database system, why did they not try to fix it till it was broken? And if the buck stops with you, then why bother passing it on again, in the same presser?

Conclusion

So, I don't know about you. I am still not impressed. You can't simply say the buck stops with you and then have a trained health professional resign. So, we are still where we were, except Newsom's questionable leadership stands a bit more exposed. 

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References:

1. Title image, pixabay vai pexels: https://www.pexels.com/photo/1-us-bank-note-47344/

2. My original blog post from this AM: http://chaaraka.blogspot.com/2020/08/during-pandemics-we-need-honesty-not.html

3. On Newsom's presser: https://deadline.com/2020/08/california-coronavirus-update-governor-gavin-newsom-ethics-complaint-one-billion-dollars-1203009219/

During Pandemics, we need honesty, not resignations

 


California, my state of never-ending hubris, and chutzpah, is in the midst of a crisis. As with everything else, it is being handled rather poorly. Gavin Newsom, our governor is in a big fight to prove he is a better manager of the crisis than another, more inept leader. Ironically, this has only exposed Newsom's own lack of vision, leadership, and above all, patience. Since I am not beholden to political winds, I am happy to specify criticism every-where it is due! 

First, despite the warnings of Santa Clara County and others, waving evolving science in the face of everyone, the State was reopened in a maddening rush to nowhere. We all know how that has gone for us. 

Second, Newsom, still hasn't learned his lessons, and keeps looking for "outs", including going out and declaring a 21% drop in cases that simply was the result of a flaw in data gathering and analysis. Of course, the end result is, an otherwise capable enough Public Health Director, Sonia Angell, has resigned, as of Sunday evening, rather abruptly. 

The Problem

She is not without blame. Apparently her department knew there were data glitches (links below), and first reported them to the counties, rather than Newsom and State Health and Human Services Secretary Mark Ghaly. 

Hence it would appear Newsom had egg on his face, misreporting a drop in cases. Sure, but if you were he, wouldn't you ask yourself why the sudden drop? I would. Let me draw an analog. 


Tigers in India and Coronavirus in California

As the genius of some politicians in India was employed into feeding chickens to malnourished tigers in Indian zoos, WWF, an organization I grudgingly support, came out in full throated support of an extremely flawed Indian Government tiger census, a few years ago with a "study" that claimed the number of tigers in India had simply doubled! Now, even if Pfizer had dumped barrels of Sildenafil into all the watering holes in India's National Parks that are well poached, I suspected my ferocious feline friends wouldn't have had that much quick success. 

Back then, I was foolish enough to have a fraudbook account (facebook, for the uninitiated), I picked a rather friendly fight with WWF India about the government's count, seriously raising doubts. They assured me, they hadn't counted separate scat deposits, or double paws and what have you, and that this remarkable doubling had indeed happened. Utterly unconvinced, I simply gave up. 

Well, a few months after...

This is all Newsom had to do. Have a healthy dose of skepticism, or any at all. He didn't and now we have to lose an actual, educated officer from public service? 

Pressure in Public Service and Pandemics

It should be clear to anyone that Newsom made a huge mistake. The San Jose Mercury News just had
an editorial about what a mess our non-recovery, recovery has become. This is perhaps why, just as with publications in science, where people fake data to project success, Sonia Angell and her team, or just herself, or whoever she is covering for, probably hid the data problem. 
While Newsom is echelons above Ron DeSata..Desantis, who apparently, simply fired Florida's chief data wrangler for refusing to cook up data, the effect remains. 

1. We have lost an official with education and at least passable competence. If politicians get to keep their jobs, why shouldn't public health officials? In fact, I prefer the latter over the former. 

2. This has now created unwanted talking points for conspiracy nuts, with a view towards debunking the very existence of the pandemic. Sigh!

3. Continuity is VERY important. Yes, hiding data or data problems is bad. Hiding them from your boss is bad, but people should be given an opportunity to repent, express remorse and still do their jobs, which come with the backing of their scientific training. Especially, "at times like this," as cliched and painful as that has become!

Conclusion

In rushing to re-open a state that was not clearly anywhere near ready, and then playing an odd game of Mahjong with the various counties, Newsom ultimately bears the blame, not the officials who pre-date him. Yes, mistakes were made, and it is rather egregious of Angell to have hidden what happened, but Newsom would actually be demonstrating leadership, were he to disallow the resignation and let her continue to serve the public, with revived interest and earnestness. 

Newsom and Ghaly should ask themselves, what in their behavior has caused officials to hide the truth from them, that they were willing to share with the counties involved! 

Apply less pressure on public health officials and subordinates where you have failed, purposefully so. For a true leader, the buck stops with you. Not a few levels below you! Especially not on scientists and public health officials. Leave that to imbeciles like elon musk. 

Alas, that is not to be! A truly failed opportunity. 

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Images, Courtesy of:

1. Cover Image: Kelsey Johnson via pexels: https://www.pexels.com/photo/golden-gate-bridge-2331573/



References:




Sunday, August 02, 2020

India's uncontrolled and corrupt medical supply chain comes to bite back just in time for a pandemic



There is a strong yearning among many Indians, myself included, for our nation to reach the upper echelons, to considered as having arrived, and to be recognized as a developed nation. Sadly, political and societal will is lacking. This is not to be considered a negative post railing against India. I just want to state through at least one more recent story (linked below, Indian sites can drain your GPU through glaring graphics, so buyer beware), that I know adds to a large volume of anecdotes and press articles about the corruption that persists doggedly, at many levels of society, and alas, also in the medical supply chain. 

The Story

Recently, my father shared a story about Remdesivir being sold at approximately 4 times the regulated price in Tamil Nadu, India, our home state. You can say, a curiosity about healthcare runs in the family, so he does keep an eye out on local stories. As the story goes, even as supplies are sufficient, unscrupulous pharmaceutical "agents" are hogging supplies and then reselling them to desperate people at very high prices. There has of course been a complaint from the Medical Association to the local Government and as with all things, nothing tangible is happening.


Why? 

Simply put, the Indian government, while heavy-handed, has a very poor sense of direction or priorities.
They claim that Western companies engage in price gouging, so enforce really odd and incredible controls on the sale of drugs and devices originating from elsewhere (most Allopathic medicine in India originates elsewhere anyway). Despite innovations such as the Jaipur leg, this sort of regulation and control has done nothing to promote innovation at large scales from within India.
Yes, there are some really innovative solutions that come up, and there will be more as Indians realize their potential, but it is not owing to the really bizarre and ultimately useless regulatory environment set up. Why do I keep saying bizarre? Well, if you are an Abbott or a Medtronic for example, if you don't like the government's own price gouging, er, control, you have to apply even to withdraw a product from the market. I have blogged about this in the past. This is at the core of the problem. The real problem. 

The Real Problem

Yes, a significant portion of India still lives in poverty. Yet, list prices are not the problem. This is a
solvable issue. Even in a fair market, India could easily subsidize prices for customers who access public care, and of course, regulate ceiling prices. Instead, they control the prices and have done nothing to battle systemic corruption in every aspect of the healthcare chain. Therefore, hoarding and price gouging has just been transferred to criminals at large. This is now a systemic problem and affects every aspect of healthcare delivery like it has for decades, and the general public suffers. 

The Solution


I am not a free-market buff. I think a healthy dose of regulation is not a bad idea. However, the Indian
Government needs to federate pricing and manage this with maturity. Random, piecemeal pricing controls are not the solution, either. As I have written on this blog before, it destroys competitiveness and companies will shy away from introducing drugs and devices in India, medical tourism, or not. Protectionism can go both ways and really risk innovative products from India finding customers elsewhere in the future. The more urgent solution needs to be immediate control of the supply chain within India. Here are a few thoughts:

1. Prices for important drugs and devices, such as branded stents, or Remdesivir should be on a national database, available publicly, with a ceiling price clearly stated. 

2. If there is price gouging, there should be a separate hotline, that is then responded to when called upon, with swift punishments, which should include jail time. 

3. Modern tracking methods such as RFIDs and others should be used to track lots and quantities and where within the country shipments land. 

4. Suprise secret shoppers should visit online and brick-and-mortar stores and check out what is going on. I mean, it can be that simple, and the government has barely scratched the surface on such possibilities. 

Conclusion

It is clear that the Indian Government lacks the maturity to focus on the correct problems and the right solutions. I believe this transcends political parties as well. The medical profession and the public at large must insist on appropriate solutions that prevent injustices which will really push down the country's progress. India's pride and place in the world are at risk otherwise, as the coronavirus pandemic has shown. 

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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 Times of India Story (please be aware of the graphic-intensive nature of the web page): https://timesofindia.indiatimes.com/city/chennai/rs-3000/vial-remdesivir-sold-for-rs-12000-in-tn/articleshow/77271533.cms

2. An archival post I authored about the medical device market in India: https://chaaraka.blogspot.com/2017/04/indias-bizarre-medical-device-market.html

3. An archival post I authored about the status of Foreign Direct Investments (FDI) in India: https://chaaraka.blogspot.com/2012/08/indias-pharma-fdi-mess.html

Credits: 

1. Cover Image, courtesy Darshak Pandya via Pexels: https://www.pexels.com/photo/architecture-daylight-hand-india-574324/

2. Image of open book with glasses, courtesy Ugurlu via Pexels: https://www.pexels.com/photo/close-up-of-eyeglasses-on-book-336407/

3. Image of question mark, courtesy Pixabay via Pexels: https://www.pexels.com/photo/ask-blackboard-chalk-board-chalkboard-356079/

4. Image of lady with hands on her face, courtesy Kat Jayne via Pexels: https://www.pexels.com/photo/adult-alone-anxious-black-and-white-568027/


Friday, July 24, 2020

International Self-Care Day and what we should do amidst the pandemic


The International Self-Care Day is commemorated on July 24th, annually.

Why?

Well, if you are thinking about self-(health)care, you want to be engaged 24x7. Or, here in the "new" world, 7x24. Get it?

Now that we have that cuteness aside, let us talk about it a bit.

The Pandemic, Self-Care and You

So, dear reader, sorry, it is impossible to hide from the pandemic, or wish it away by the end of a random month in the future, unless you are a despot.

How are you?

Have you been caring for yourself? Self-care includes both physical and mental health care, as well as taking good care of your person. And as the title image postulates, it is not selfish! (Credits below).

I am hoping, even if you weren't doing so right now, with all the craziness going on, that you will, starting now. I am also hoping you would stay with me, as I lay out a personal, DIY, Maker experiment that my brother and I have been engaged in.

Some Self-Care Reminders

We all know these things. Yet, why do we have so much difficulty indulging in them? Well, stop the guilt and stop caring! For yourself. It will put you in a better place to care for others. That should take care of the guilt and be enough of an incentive. So here goes:

1. Grooming. I am very bad at this. I am now trying to improve. I hope you do too!

2. Walking. Yes, just pick yourself up and go for a walk. This is something I am good at.

3. Healthy Eating. I am doing better at this. Cut down gently on the stuff that needs to be eaten less, and start adding more of what needs to get in!

4. Meditation. Well, sigh, ADHD doesn't always allow me to do a good job of this. My daytime walking is also very focused on photography typically, and I tend to use visual and auditory cues as well as that "sixth sense". However, when I do the step-count catch-up at night, I play music and walk feverishly, on my block's sidewalk. Despite forming new friendships and gaining odd, new experiences, I have had the ability to meditate at night, without meaning to. I still suggest bringing a pen and paper because at some point, ideas start flowing!

5. Practice Zen. Having randomly picked Japanese as a language I would never learn, and therefore must, I extended my interest into a Zen class! And it was pleasantly, amazingly life changing and so different from what I thought it was. So read about emptying your mind, and using repetition to de-focus, so you may!

Healthcare Self-Care

For those with chronic health conditions such as diabetes, or the propensity towards diabetes, such as pre-diabetes, which I have self-care in the area of body health comes with some of those aforementioned activities such as walking and healthy eating. Generally speaking, more awareness and education is key. Knowing the important things to focus on is critical. Just about two years ago, for instance, I had my cholesterol tested. While my LDL (Low-Density Lipoproteins) level was low, which is generally considered a good thing, the HDL (High-Density Lipoproteins) level was low as well, and this is a problem. In East Indian men, a cohort I belong to as a cis-man, this is particularly a known issue.

Once I learned of that, I was able to start making dietary modifications to try and assist that process. I am a bit embarrassed to admit, I have not since gotten tested. The COVID-19 pandemic is a convenient excuse, but it does come with a grain of truth in that, I would rather testing resources as well as healthcare practitioners focus their energy on the sick, while giving themselves breathing room to recover. Then I know there is at least a touch of arthritis on my mother's side, and definite cardiovascular disease history on both sides.

The idea here is not to sit around and wait for things to come to me. I try to take, a middle path approach of taking enough care of myself. Of course, it would be very gratifying to do more, but I know that we live in rather contentious times and things will take time to turn in our favor, should they do. So, self-care should not become self-obsession or hypochondria. Of course, that is easier said than done. People who suffer from hypochondria can vouch for that.

This is where I think those who formally work in healthcare can endeavor to foment change.

Promoting Self-Care among the public

1. Keep it simple. The advice, the description of the health condition, the remedies, the consequences of inaction must all be laid out in the simplest terms. Heavy language tends to confuse and tune people out. Doctors should work with nurses, nutritional experts and other professionals to aid the public in a cohesive manner, with unified, simple messaging.

2. Awareness and Education must come with a cost-benefit analysis, laying out economic and familial benefits, as well as other areas where improvements can be beneficial. Painting a wholesome picture of how taking care of yourself helps you and those in your life has a very high chance of long-term success.

3. Update recommendations with care. Recently, blood pressure recommendations were updated to end up being rather confusing even to a trained mind. This is exactly what you want to avoid. Give people a couple of numbers, and a high/low binary classification and/or something simple. This is always the best way to go with these things. Throw in various permutations and combinations and you start losing people.

4. Repetition and reinforcement are key. It takes a while for messages to come through at times. Patience, repetition and reinforcement are important when creating awareness about healthcare in general and self-care in particular.

Our own experiments, Quantified selves and Self-Care

My brother, Sai Yamanoor and I are makers, besides being engineers. Faced with the travails of pre-diabetes the emergence of wearable watches and our own desire to help ourselves as others, we set out to brainstorm things we could do.

The end results are what we call Personal Health Dashboards 1 and 2, named for the first and second generation. Using LEDs, the first generation, PHD 1 highlights your progress towards your daily step goal, with the LEDs from left to right starting to glow, as you walk more, spanning from red to yellow to green.


This was a useful Proof-of-Concept and a prototype. With this, we were able to work on a next generation design and prototype. In this one, the Personal Health Dashboard (PHD) 2, or PHD2, we took our daily step goal, and started counting down the total steps to completion. So, if your daily goal is 10,000 steps and you have walked 2,000 so far, you will see 8,000 displayed and so on. This, another wild experiment in the Quantified Self milieu, turned out to be quite motivational and useful!


We continue to devise and build such tools. All designs are shared through publications and repositories online. We used to display these at Maker Faires in the hopes of inspiring other makers to engage in Self-Care, and of course the care of others.

Conclusion:

There are many forms of self-care. There are many ways to accomplish self-care. Pick your own adventure! Celebrate self-care day, every day, and not just on 7/24. If you wish to add the event to your calendar and remind yourself next year, you may do so!



Reference:

1. Cover Image, Courtesy, Madison Inouye: https://www.pexels.com/photo/self-care-isn-t-selfish-signage-2821823/

2. Some Information on International Self Care Day: https://self-management.eu/compareu-events/international-self-care-day-2020/#:~:text=Jul-,International%20Self%2DCare%20Day%202020,a%20vital%20foundation%20of%20health.

3. Detailed Instructions to construct PHD2: https://www.hackster.io/diychamps/personal-health-dashboard-7ee555

Tuesday, April 07, 2020

Observing World Health Day (April 7) in a momentous year


The World Health Organization has been promoting World Health Day, annually on April 7. In years past, one might have struggled to pick from various health conditions and issues, or cohorts to make observations. This year, we are in a unique position where the carelessness and sloppiness of many years has caught up with us, and here we are, with all of health, as potentially the issue to focus on. Here are a few thoughts on this day:

1. First, all healthcare and public health workers. All of humanity is indebted to you, from the First Responders and Police to Doctors and Nurses, Aides, Policy Makers, Public Health Leaders and Workers and many many more. There are many, many heartening and heartbreaking stories coming out, and many yet to be written whenever we can finally say this is done and over.

2. There has been a surprising lack of leadership across the globe, complemented by a surprising display of leadership to complement it. Leadership in crisis, especially a healthcare crisis deserves several blog posts on its own, and I will see if I can find time to write about this issue in detail. However, I will leave you with this. Don't "rally around a flag". That is useless. Hold elected officials to their tasks, and start acknowledging failures, and start punishing them at the polls. Otherwise, you are doing a disservice to yourself, setting bad examples for future generations and prolonging irresponsible responses to urgent situations.

3. It is incredible the amount of disinformation and ignorance that prevails, even among such danger. Just this Sunday, a neighbor was having a loud conversation with someone over the phone, proclaiming that the CVD was just the flu, and that you are supposed to get it and just power through it. For a good measure, he also threw in his apparent distrust of the news, because they were "trying to scare you". I am not about to start proselytizing willy-nilly, so I just let me jaw drop and started pondering exactly what it would take for humanity to overcome such wanton ignorance.

4. The emergence of idiots masquerading as "social scientists" and other nonsense. This includes Peter Navarro, Dr. Oz and a mix of quacks and other idiots. It is remarkable that such people still have influence, and even a pandemic is unable to stop this travesty. There has to be a forceful effort to prevent people from endangering the population.

5. The general lack of preparedness among many places across the world. This is very inexcusable, because we have recently had several smaller outbreaks such as the recent Ebola outbreak, the H1N1 outbreak and others, which have channeled the need to be better prepared. We have to do extensive analyses to understand how policy failures led to to such remarkable failures, and how they can be fixed going forward.

6. Several organizations have abdicated their responsibility. The WHO is suspect of kowtowing to China. The CDC is directionless. The FDA is approving tests at a questionable pace, and is allowing for unscientific experimentation to proceed, just to satisfy people looking for "quick fixes". This causes extensive damage to ongoing and future efforts without significant changes in leadership.


There are many, many more issues to be considered, and of course, they also have to be looked at with both breadth and depth. The message is clear. We slipped. And now, there is yet another opportunity to come out of this situation with a new perspective on things. The real question is, will we?

For now, stay home, stay safe and stay healthy!

Reference:

Image Source:

https://www.pexels.com/photo/fashion-man-people-sign-3952233/

Friday, March 06, 2020

Simple Innovations: What Comes After Coronavirus - Virtual Interactions


If you, like me are not a participant of the great toilet paper panic of 2020 (seriously, if you get sick, WHAT are you going to do with TP?), you are wondering what it is that we ought to do going forward.

Thinking of the future, one area of weakness that has opened up: virtual interactions

If you think about it, it is pretty ridiculous. Literally thousands of conferences on all manners of futuristic topics have been slow-boating their own toilet paper moment.

Conferences on the future which promise us all kinds of "solutions" are run in quite the old-school way. In reality, technology for virtual conferencing has been available for quite a while now. Greed has been the biggest roadblock up to this point.

Hopefully, when we are done with this, we push for more virtual interactions - virtual classes, virtual conferences and other means of interactions.

It is rather ironic to have to postulate basic steps, that everyone is aware of, but are not being taken!

Image Reference: https://www.pexels.com/photo/internet-technology-computer-pc-193349/

Friday, January 31, 2020

February is Heart Month


In the US, capitalizing on the spirit of Valentine's Day, February is commemorated as Heart Health Month.

So, get moving, get reading and get changing!

Photo Credit, etc. : https://www.pexels.com/photo/hands-heart-love-305530/

Sunday, September 01, 2019

India: Tamil Nadu bans unnecessary intersex pediatric surgeries!


Note: I am from Coimbatore, Tamil Nadu, a very progressive city in a very progressive state. And so, I may not be as objective in writing this, even though, Diversity, LGBT and Women's rights are a top priority for me and I recognize that India has yet to make immense progress.

An Introduction

India is a country steeped in tradition and superstition, both of which cause immeasurable pain to those who don't "belong". And of course, infants have no power to fight the ills they are subjected to. I come from Tamil Nadu, where female infanticide has been a very sad and despicable crime, that the Governments have fought over several years. Female children are seen as a burden, because of the heinous observance of "dowry", which has to be presented to the male side during marriage. This, and the ongoing suppression of women, and other heinous acts against them, extends to transgender and other people who are not perceived as "normal".

In Tamil Nadu, one of the states that is somewhat progressive, right wing forces have yet to fully have an effect. In that environment, transgender folks have been getting some rights and attention in recent times. Hijra, as they are known in India, they are now offered the status of a third gender - a glimmer of hope, given the ostracization and crimes against them.There is an insightful video of transgender issues from Coimbatore, my hometown:


Unnecessary Intersex Surgeries in Children - A Global Problem

If you believe that unnecessary surgeries among intersex children is localized to developing nations, you need a bit of a refresher (See link below). Rest assured, right down from the US, such surgeries are a plague on children, and cause them severe, irreversible physical and emotional trauma. Much awareness, education and regulation is needed to reverse this trend. 

In that sense, this news that under the direction of the High Court, the Tamil Nadu Government has passed an executive order to ban such surgeries, except under conditions where the health of the child is endangered is heartening. They are also claiming to form a committee to prevent abuse of the health condition exception. 

The careful review of exceptions is critical. California knows this the best. Having passed a law to enforce vaccinations, the State learned that the provisions for exceptions are routinely and heavily abused by extremely irresponsible Doctors and Parents. 

The Future

One has to wait and see if future Governments in Tamil Nadu, as well as other Governments in other States, and some day, perhaps the National Government of India will follow this lead. It is very difficult to predict how things will go. Women, and minorities of every kind are in danger in India, and face discrimination and victimization routinely. Add to this caste based crimes, honor killings and other issues, the future is still grim. One can only hope that well-meaning courts and governments can act with care and prudence to help intersex children, transgender people, homosexual people, women and other minorities in India.

Reference:

  1. News on the ban on intersex surgeries: https://www.reuters.com/article/india-lgbt-intersex/indian-state-bans-unnecessary-surgery-on-intersex-babies-idUSL5N25O22X
  2. Unnecessary Intersex Surgeries in the US: https://www.hrw.org/report/2017/07/25/i-want-be-nature-made-me/medically-unnecessary-surgeries-intersex-children-us
  3. California tries to deal with vaccination exemptions: https://www.apnews.com/e82739a3289647d39b0cf1c791628e17
  4. Image, Courtesy, Pexels: https://www.pexels.com/photo/adorable-baby-baby-feet-beautiful-266011/


Wednesday, April 10, 2019

With Microsoft following Google on the way out of EHRs, it is disconcerting that Apple is getting in on the game...


It is official, Microsoft is exiting the Health Records business altogether, shuttering HealthVault completely and sending consumers elsewhere. In lieu of admitting defeat, they are issuing hyperboles about looking at the enterprise and so on. That is just fine. Like Google, they have probably learned that their holier than thou attitude doesn't extend to many areas of healthcare.

Why Apple is worse

I must admit. I have never been a fan of Apple. Most of what they have done involves being second, or third, or fourth in class, slapping pricey labels on things and bully vendors. And their things are getting more expensive all the time. And honestly, while the media hypes about how Apple is the next best thing since sliced bread (pun intended), you have to take a few things into consideration.

First, they said the same thing about Google and while they were "verily" solving blood glucose monitoring on Powerpoint, er, Google Slides. We know how that ended.

Second, Apple is a very controlling company, with closed systems in silos. Unless you are apathetic or ignorant, how can you call that a good thing for healthcare?

Third, they charge well above what their services are worth, and so once again, I repeat, unless you are apathetic or ignorant, how can you call that a good thing for healthcare?

Fourth, and this is stated with quite  bit of pleasure - remember Apple maps? 

So, there is no guarantee that they will succeed, and should they do so, I am almost certain it is not a good thing. 

Some Further Thoughts

EHRs are complex. Patient privacy is involved. Data vulnerability is an ever-present danger. Healthcare is already very expensive - adding unreasonably expensive products and services from vendors does not make any sense. It may be slightly better than giving out fake contracts worth millions of dollars to your friends for PR - paging Seema Verma, but that does not make it a good thing!

Anything related to healthcare needs to be part of the long game. The problems are complex, there is a lot of politics involved, and cost-efficiency is a must. Tech companies, especially of the Google kind think that they can use customers as guinea pigs, releasing products in wishy-washy cycles, and remove features, or shutter products and services on a whim. This is NOT how healthcare problems will be successfully solved. 

Can T. Rex play Ping-Pong? 

Besides the go-it-alone-because-we-know-everything approaches that Apple and Google (although, they now have Verb Surgical) like, there is the approach IBM took with an entirely different problem - using Watson to solve cancer by pairing up with M.D. Anderson. 

I liken that to two T. Rex (the word has no plural, mind you), deciding to play Ping-Pong and then after much agonizing effort, finding out, they have really short forearms, and should have taken the time to consider that first. 

Today, especially when it comes to the Artificial Intelligence hype cycle, "partnerships" are being announced at such a breathtaking pace that it is hard to keep up. Nothing wrong with partnerships, but you have to make sure that it is strategically sound, is actually complementary and clearly steers away from being a partnership, only in name, where one party just dumps their technology and a lot of funds and grants to desperate researchers and practitioners!

So what would drive success with EHRs?

Well thought, secure, planned and executed products, that are iterated in an evolutionary manner through testing and improvement. The approach, whether a solo effort, or a partnership or involving several partners, needs to put patients first and take a humble approach to a problem no one has solved yet! 

There are several experts who have spent their lifetimes thinking about digitization. Playing the game without involving them is just irresponsible. It is also important to play the long game, be respectful of patients and not change features and products on whim. EHRs and emails are completely different. 

Interoperability should be more than a nice bell or whistle, and something you actually strive for. Along with that should come some degree of openness - more the better, so that it is not a dog-eats-dog approach, but rather a co-operative, collaborative one, acknowledging that not everyone wants to be bound by your product or service. 

Subscribe and Support, Please! 

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:

Monday, April 08, 2019

In Boston May 15 - 16? I am giving away a VIP pass to the BIOMEDevice Boston Conference!


I am speaking at the Boston BIOMEDevice Conference and the ESC. As a speaker, I have ONE complimentary pass to give away.

Since most everyone I know in the Boston area, will probably be at the show, I am  giving away the pass.

That's it. No forms to fill, no subscriptions to get into, no feedback, no nothing! Just the desire to soak in all the expertise and industry experience on display for two whole days.

If this strikes you as something you can enjoy, get in touch with me at yamanoor at gmail dot com, or via LinkedIn: https://linkedin.com/in/yamanoor/

I need the following information from you to forward on to the good folks at MDDI:

First and Last Name
Job Title
Company Name
Email Address

That's all for tonight folks! 

Sunday, April 07, 2019

How Healthy are we? Pondering the status quo on World Health Day



The good folks at JDRF woke me up on a lazy Sunday morning with an email about April 7th being World Health Day. As I lay in bed listening to some Carnatic Music renditions (a form of South Indian music), a sometimes-morning routine for me on weekends, I noodled on the topic of health. For a while now, since we heard about the second ever patient to be rid of HIV, I have been thinking about writing a post about how slow progress in medicine has been, and how much progress is yet to be made.

Yes, the post is somber in many ways, but the goal here is not to depress or take away from the progress we have made, but to serve as a yardstick for where we need to go from here.

1. AIDS/HIV

The HIV virus is the most impacting of several that jumped to humans from other animals - a phenomenon termed Zoonosis. Humans have been suffering from HIV infections and its consequence, AIDS, for just about 5 decades now, and we have so far cured TWO patients, and that is, only because of their special circumstances!

Given the fatal consequences, and the innumerable deaths the virus has led to, it stands in stark contrast to other victories of the past, such as against smallpox, another consequence of Zoonosis.

Yes, the HIV virus is very tricky and is ancient (it appears the Chimpanzees fought it off millennia ago). However, it shows that for all our understanding of chemistry, biology, microbiology, virology and genetics, we are as of now, quite unequal to the task.

And as I mentioned above, both patients who are in remission for HIV had special circumstances, and their doctors were courageous, taking more risks than most have. And that is one of several problems I wish to discuss in this post.

2. Cancer


Yes, decades of promises and billions of dollars we have no cure for cancer, except for the most incidental cases. In fact, we don't even understand cancer well enough. Theories have come and gone, resembling fads of yesteryears.

For the most part, cancer therapies resemble what I call "fancy bloodletting"with the rare exception, such as with thyroid cancer. Thyroid cancer, in some cases can be cured by injecting radioactive Iodine, which the thyroid gland laps greedily, as it evolved to (it will take up Iodine, radioactive or otherwise, that is). You then wait as the radioactive Iodine destroys the cancerous thyroid cells.

You may then ask, why we haven't found extended this type of solution to mos types of cancer. Well, we haven't done a good job of understanding genetics, biomarkers and the other aspects of biological science which would provide us with the tools necessary to advance cancer therapy past horrifying drugs or radiation.

I personally find it appalling that it is not illegal to use "inoperable tumor" as an excuse to send a patient home to die!

3. Chronic "Lifestyle" Diseases

Now, we all share the blame for this. As societies prosper, especially in developing countries like India, unhealthy lifestyles are leading to High Blood Pressure, Obesity, Diabetes and other conditions that cause decline in Quality of Life and in some cases, also lead to mortality. In the past couple of decades, there has been some modicum of progress with respect to blood pressure (no, NOT renal denervation, more on that in a minute), diabetes and cardiovascular care, but people are making themselves sicker faster than medicine can catch up. More awareness will get us part of the way, but this is one of those areas of health that can be tackled as a team effort.

4. Barbarism, Renal Denervation and the Poverty of R&D


When I first learned of renal denervation, I was immediately alarmed. It continues to irk me today, that this was not the universal reaction. Maybe I am overly sensitive to such nonsense, which is whata this is, because I have come across this before. I was once an intern at a company that burned millions of dollars (!) on the path to treating migraine with visual aura by closing the inter-atrial septum. Yeah!

Renal Denervation is based on some "research" around the middle of the previous century, in a Mary-Shelley-esque manner, someone toasted renal nerves to notice a drop in blood pressure. Without much further research into the long term effects of doing this, someone dusted this off the basement of some library and turned it into Ardian, which Medtronic then hyped the medical device industry into a frenzy, by ridiculously overpricing Ardian during the acquisition.

I do not buy the theory that Medtronic "botched' the clinical trials. I think humanity is lucky in that pharmaceuticals have progressed enough to be better than the weed-killer approach to blood pressure management.

What we should truly focus on is this - the medical device industry is really behind the curve on basic research. Too much of the focus is on development, some of it quite mindless, like the use of drills to remove arterial plaque!

This poverty of R&D efforts is one of the key reasons why progress in medicine has been so slow. 

5. Private Fraud and other Misbehavior

Elizabeth Holmes and Theranos are but the latest examples of people and organizations behaving badly. History is full of such examples, and this is in fact how the FDA came into existence. That, there is an assault underfoot to water down the FDA will be discussed momentarily.

The way some companies approach regulations is not as the framework to work within, but the dilapidated fencing to test aggressively for weaknesses. The lack of ethics causes problems for medicine and society.

6. Bad Governance


Just a couple of days ago, I posted about the secret database FDA maintained and helped an unknown number of medical devices cover up a further unknown adverse medical device events, masking the true limits of such devices and the harm caused by them. Spanning multiple administrations, this struck a blow to the very heart of why the FDA was created in the first place.

World over, many governments are undermining healthcare, in more ways than one, eventually harming both current and future generations.

7. Medicine Inequality

Under-served populations suffer from many inequalities in medicine. The aged, women, people below the poverty line, entire regions of the planet - several cohorts constitute under-served populations. Pricing is one. Access is another. The deliberate act of making medical devices disposable, fundamental to the chosen business model for many organizations in the industry is another. Patents, regulatory pathways, corporate greed - the factors abound. Suffice it to say, much work remains to be done.


Conclusion - Opportunities abound! 


The aforementioned points can be seen one of two ways. One way would be to be angry and depressed. The more positive approach would be to see all of these as opportunities ripe for innovation to cause true, lasting change.

That is the purpose and spirit with which this post was written.

Rooting out unethical behavior, bad governance, downright criminal behavior, making medicine affordable and equal, causing real technological progress, improving Quality of Life (QoL), reducing morbidity and mortality are all challenges we can take up and whittle down!

So, Happy World Health Day!

As usual, if you want to be reminded of the event annually, here is an event:




Subscribe and Support, Please! 

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. Map of the World: https://www.pexels.com/photo/black-green-brown-continent-87652/

2. Blood Draw Image: https://unsplash.com/photos/Zp7ebyti3MU

3. Image of Breast Cancer Ribbon: https://www.pexels.com/photo/awareness-cancer-design-pink-579474/

4. Image of Blood Testing Equipment: https://www.pexels.com/photo/health-medical-medicine-diet-46173/

5. Image of Broken Glass: https://burst.shopify.com/photos/broken-shards-of-glass-hanging-in-a-boarded-up-window?q=looking+glass

6. Image of Syringe: https://isorepublic.com/photo/syringe-with-blood/

7. Image of Hammer: https://www.pexels.com/photo/close-up-court-courthouse-hammer-534204/

8. Image of Beautiful Old Lady: https://www.pexels.com/photo/grandmother-making-faces-34540/

9. Image of Cheerful Team: https://www.pexels.com/photo/group-of-people-raising-right-hand-1059120/

Friday, April 05, 2019

So, what will the FDA's secret hidden database lay bare?


NOTE: By now, if you haven't heard of the secret database the FDA has been keeping to help companies hide adverse events, I'd say you are not keeping up! I will supply a couple of links for you to peruse to get yourself up to speed.

ON THE ETHICS: It is key to discuss the ethics or rather their absence, in detail. However, I want to focus on something else for now. I am curious about what we will learn, and I want to focus on that. However, I will leave you with a couple of points to ponder:

1. It is typical for controversies to take a political bent. But here is an alarming example of something that started with one administration, and sustained through several.

2. There are something like 780+ federal agencies, that we know of. Just the potential of the spread of this type of bold unethical behavior, that will go unpunished is just jarring!

3. Congress is completely asleep at the wheel!

4. THIS ONE IS KEY: How many company executives know about this, have participated in this, and what are the implications of all this?

What I Expect We Will Learn


1. Just how many medical devices and their manufacturers been accessing the database?

2. What type of adverse events were being hidden?

3. The relationship between adverse events that we were made aware of, previously and what was in the database. Do we get a chance to just sum them up and say, "well, we thought this device had 5 adverse events per year, and now we know it was 25 per year because we found thata on an average, 20 were being hidden per year?"

4. What if certain types of adverse events were hidden from us?  What if injuries were made public, but deaths hidden?

5. What if companies got preferential treatment in terms of access to the database and how was this decided?

6. To what extent can we answer the question: how far was the true harm to patients?

Lost Opportunities

1. Imagine how many start ups could have germinated to solve issues caused by devices that people falsely believed to be better than they are!

2. Imagine how many patients could have chosen alternate treatments or devices. One also has to wonder how many credible lawsuits were not filed owing to the fact that the evidence was hidden!!

3. Doctors could have better cared for their patients, and provided them with adequate warnings, alternates or protection.

4. The FDA is meant to protect us. Medical Device Companies are supposed to be ethical. And now, it is anyone's guess how deep the loss of credibility is going to go!!!



There is more to come

This database raises far more questions and alarms. I am sure in the days, weeks and months to come, we will discuss more of these issues, as details become apparent. Currently, we know something like 3X the data was hidden, in just a year, per Star Tribune. Who knows what the real depth of the problem is.

Subscribe and Support, Please! 

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.Star Tribune: http://www.startribune.com/fda-says-it-will-make-more-info-available-on-medical-device-problems/507788372/

2.The Kaiser Health News Report: https://khn.org/news/hidden-fda-database-medical-device-injuries-malfunctions/

3. Image of Woman: https://www.pexels.com/photo/black-and-white-black-and-white-depressed-depression-568025/

4. Image of Right and Wrong: https://pixabay.com/photos/ethics-right-wrong-ethical-moral-2991600/

5. Image of Seated Person: https://stocksnap.io/photo/95TESM9499

Tuesday, April 02, 2019

World Autism Day and World Autism Month


Just this morning (it is still the 2nd of April as I compose the email) I found out that the UN declared April 2nd and the month of April, Autism awareness day and month. This is obviously one of the best things the UN has done. Autism is a general term for a class of conditions that cause people to be differently able.

I wish I had known earlier, so that I could have alerted you all to it myself, and written about some of the latest research to help people with autism integrate well. Our busy lives keep us all quite occupied and therefore, many moons ago, I created a calendar, to remind myself. I have created two events, if you wish to remind yourself:

World Autism Month:



Note: Unfortunately, Google doesn't allow me to take a monthly block event and repeat it annually. I will try to figure something out for this.

Meanwhile, here is an event that will repeat itself annually and you can set reminders to yourself after importing:




I will try to post more after I have had time to gather my thoughts.

Image: https://pixabay.com/images/id-2377410/

Thursday, March 28, 2019

The Sterigenics Brouhaha: A Teaching Moment


A Note: I have found the people at Sterigenics to be very forthcoming in my previous interactions with them. They are "singled" out here, only because they made the news for all the wrong reasons!

What happened: It appears that Sterigenics was putting out untenable amounts of EtO into the atmosphere surrounding its Willowbrook, IL facility, and after the breakdown of negotiations, the State EPA shut down the facility. Viant in Michigan took a more voluntarily approach once the state level environmental agency started eyeing them.

This has created a gaping hole for many medical device companies - something that could have been totally avoided. The FDA with its highly tenuous and underwhelming leadership, is restating clearly obvious solutions as some sort of a strategy: use other techniques or other facilities. Yes, you can say, "D'uh!".

Bad Precedents: 

1. False Expertise: Thinking all experience is equal, many companies hire the same "experts". This has led to what can be ironically described as "extreme pigeonholing". That is the notion that EtO is the most effective way, Sterigenics is the only vendor to go with, and stupidly enough (any expert who tries to convince you otherwise, is not one, by paradox), a very specific chamber, at a very specific location within that organization.

Of course, this has created all kinds of logistics gymnastics for medical device companies and quite the financial cash-cow for Sterigenics. Instead of basing project planning on device safety and effectiveness, many companies planned it on when they "could get in on the queue for the chamber"! And of course, to jump the queue, you had to pay a fee!

Some smart companies at least got more than one chamber validated for their sterilization needs, but that is where most of it ended!

I have seen contract manufacturers suggest this to start ups, and I saw them agree to this utter, inexcusable madness as SOP! This has been the norm for as long as I have worked in the industry, and I used to sit up and wonder when the chickens will come to roost...well!

2. "Single Source" usually means you have not tried hard enough: Among some insane arguments I have heard, a common one is, "the stuff we want is so complex, only this one shop wants to do it". Yes, that is true, but that just means you have not worked to reduce complexity! And guess what? Sterilizing product, while challenging for some extreme cases, is usually not so.

A lot of irresponsibility abounds in the medical device industry, where again, the same people are recycled across companies as experts, ignorance of the fundamental principles of Supply Chain Management is fairly common!

Single sourcing, the use of unnecessarily obscure materials and processes and the absence of long term risk-mitigation and elimination strategies is plainly flabbergasting!

Now granted, there are exceptions, but it cannot be the norm. Part of your ongoing efforts from the very start has to be the effort to multi-source everything. This will help you mitigate unnecessary risks for your patients, your investors and your organization.

Imagine, if you have a device that works, but you can't use it to treat a loved one, because you didn't do enough! 

What you can learn and do

1. No sterilization technique is perfect. As you can clearly see, neither is EtO. So, in sterilization, as with everything else, look for diversity of options - vendors, methods, all of it!

2. Treat single-sourcing as a critical business risk! Risk mitigation and/or elimination is important for critical business risks, and sterilization is no exception.

3. Rid yourself of false prophets. No, EtO is not the best. No, you don't HAVE to stick with one vendor, and one chamber. No one sane has to!

4. Talk to different vendors. Diversify!

5. If you are the vendor: Don't pollute and cause harm to humans and offer more options and sites to your customers. Yes, every chamber must be validated, but find scientific means to make this more generic. There will always be enough medical devices for you to make money off of sterilization.

References:

1. Sterilizer Shutdown: https://www.mddionline.com/fda-scrambles-prevent-shortages-wake-sterilization-shutdowns?ADTRK=UBM&elq_mid=7944&elq_cid=74447

2. Image of basket filled with poultry eggs: https://www.pexels.com/photo/basket-filled-with-poultry-eggs-1625385/

3. Image of blackboard: https://www.pexels.com/photo/addition-black-and-white-black-and-white-chalk-374918/

4. Image of the number 1: https://www.pexels.com/photo/bike-chain-number-one-1061142/