The wsj starts off with a good review on Thalidomide, but later cannot help itself...

 

Any sensible person who reads the wsj knows the publication is a double-edged sword at best. You mostly read it for the financial news and hope they are not lying through their teeth. And, like diamonds in the rough, or other undesirable places, every now and then, they do manage to write about things in a meaningful manner. 

It was with this sort of pleasant surprise that I started to read a review of the book titled "Frances Oldham Kelsey, the FDA, and the Battle Against Thalidomide". It is a poorly kept secret that the FDA was provided with ammunition at the most opportune of times, with which it prevented much death and dismemberment. It is also well-known that in today's political environment, such powers would be quite tough to come by, as this article linked below will demonstrate. 

The earlier part of the review

The earlier part of the review is pretty cool. Thalidomide, prescribed as a sleep aid, would have escaped review were it not for Frances Oldham-Kelsey's keen scientific eye and healthy apprehension for something that appeared too good to be true. Having worked on a drug that had a deleterious effect on fetii, she stepped up at the right time and required William S. Merrell Pharmaceuticals to provide more data. The ensuing saga, even in the short review, reads like a B-movie plot, and I leave all that up to you. I definitely recommend the review, and I personally put the book on my list of must-reads. 

The ignorant whiny part

Just when I was about to fool myself into thinking, "Wow, the wsj is about to become the WSJ in my eyes!", the review slipped into the well-branded, stereotypical, tone deaf part: "Ms. Warsh fails to discuss the tradeoffs of the glacial approval process"

You know what the tradeoff is? STAYING ALIVE and HEALTHY. It is remarkable that in the same review about a book that shows how one scientist stood in the way of unknown thousands of mutilated fetii and a good drug review process and created a revolution that now the world has started to embrace (with the EU pulling ahead of us), the review author irresponsibly caters to wsj's baser instincts. 

Conclusion: How to do approvals right

Drug and device approvals are quite tough to get right, even when the FDA is acting ethically, and not colluding with surgical supplies companies (I will link a post in which I touch upon the bad governance below), things slip by. Thus we end up with bad metal implants, knees, hips, you name it, questionable Azheimer's drugs and much more. 

Then, as with Aduhelm, (story below), the FDA realizes its mistakes, especially in bowing to political pressure from unscrupulous convicted felons, their friends, and others, and overclocks in the other direction. This then results in events like the one from last week, when MDMA was denied for PTSD treatment. Now it will take us forever to find out if the rejection was justified. 

Thus what we need are smarter, scientific reviews that don't arise from undue political pressure and self-destructive book reviews. At the end of the day, I am sure, Califf is not scanning unscrupulous publications for book reviews to worry about the pace at which his agency should approve drugs or devices. At least, I hope he has better things to read. 

Using machine learning techniques, better clinical data, honest reviews, dedicated panels of humans and other commonsense approaches, glacial or not, the FDA can strive to keep patients alive in the decades to come!  There will be plenty of time to discuss these techniques, and for now, I urge you to stick to the "glacial" timelines in an era where the glaciers are melting. 

References:

1. The self-destructive book review on wsj: https://www.wsj.com/arts-culture/books/frances-

oldham-kelsey-the-fda-and-the-battle-against-thalidomide-review-the-noble-bureaucrat-7f1fc379

2. The book:https://www.amazon.com/Frances-Oldham-Kelsey-against-Thalidomide/dp/0197632548

3. The FDA's aduhelm misadventure: https://www.nbcnews.com/health/health-news/fda-broke-protocols-approving-biogen-alzheimers-drug-congressional-rep-rcna63662

4. The FDA colludes with your favorite surgical device manufacturers: https://chaaraka.blogspot.com/2019/04/so-what-will-fdas-secret-hidden.html

5. The FDA's sudden repugnance for MDMA: https://www.nbcnews.com/health/health-news/fda-panel-rejects-first-mdma-treatment-deep-concerns-flawed-trials-rcna155325

6. The cover image for the blog post: https://www.pexels.com/photo/selective-focus-photo-of-pile-of-assorted-title-books-1148399/

On World Mosquito Day (August 20, 2023)

 

It might seem a bit crazy at first scan, to have a World Mosquito Day. That, in and of itself, is not surprising, given that most people are coached to alternatively hate or fear mosquitoes, cockroaches, other insects, lizards, scorpions, snakes, tigers, bears, lions.. you get the picture. 

Now, some fears are acceptable, but many are not. The fear of infection, disease and death are natural, but we have to be careful about taking things too far with any species, including humans, as displayed with the fear associated with many coronaviruses such as HIV and COVID-19. Both virus infections, especially the much-feared and maligned HIV, can be managed effectively with early diagnosis. 

However, mosquitoes do remain something to be worried about. They can spread the following viruses/infections:

1. Malaria
2. Dengue fever
3. Zika virus
4. Chikungunya virus
5. West Nile virus

In addition, mosquito bites hurt a lot, and they have become a nuisance across all the world, regardless of the underlying ecology. For instance, if you visited the Sierra Nevada mountains, or Alaska in summer, or decided to go to South America, Africa or Asia, you would find yourself relentlessly attacked by mosquitoes, except in the cold of the winter. 

In all, that is the purpose of World Mosquito Day. Stay aware of the presence of mosquitoes, not only in and around your work and home environment but also all the places you visit. 

The pregnant, the immunocompromised as well as those with special health circumstances need to be careful about exposure. 

It is also important to try and avoid or at least minimize the use of DEET compounds when trying to protect yourself from mosquitoes. 

Similarly, standing water is one of the main environments in which mosquitoes can thrive It is important to avoid allowing large quantities of unclean water to accumulate. 

Finally, keep up with the latest information such as the WHO malaria vaccine program, and other efforts that will help you and your loved ones. 

References: 

1. Cover Photo: https://www.pexels.com/photo/black-white-mosquito-86722/

2. WHO Malaria Vaccine Program: https://www.who.int/initiatives/malaria-vaccine-implementation-programme

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

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/

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! 

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/

Slides from my AI Presentation at BIOMEDevice 2017 and introducing a new site

If you have been following the blog, you have heard I was presenting at the San Jose BIOMEDevice Conference this week. In connection with this, I have a new site, http://medpund.it/, focused on discussing my research in Artificial Intelligence, as well as to discuss the impact of the field on Medicine and Medical Devices. There will be discussions on technology, business and social aspects as well.

From time to time, I will highlight my posts from there on this blog, but I invite you to support me on that site, as you do here as well, by subscribing to updates using one of the means provided. I am trying to keep my focus areas separated on different sites. I would like to see how this experiment pans out. As always, you will not be bombarded with any advertisements, ever (maybe a couple of plugs here and there, but that's it).

Meanwhile, do head over to the site and download my slides, and provide me some feedback. The slides themselves, prepared in my style of minimal wordiness, do not tell the full story, but I will write posts on the various topics discussed in my presentation. Feedback is welcome.

The link: http://medpund.it/index.php/2017/12/07/slides-how-artificial-intelligence-is-changing-medical-devices/

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.