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:




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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/

It is high time the FDA considers taking down DTC ads rather than confounding them further

Word is out that the FDA is trying to curtail the number of side-effects stated in Direct-To-Consumer (DTC) pharmaceutical advertisements, in an apparent effort to try and get consumers to understand the key side effects and remember them. This is apparently considered a benefit to the consumer. How? Don't ask me. I think this is a bad idea, and the focus should be to de-emphasize DTC, so that prescribing medicine goes back in the practitioners' courts and pharmaceutical companies can focus on R&D and Translational Research spending. For years now, I have advocated AGAINST DTC ads.

1. Why am I against DTC ads?

The United States is one of the few countries that actually allows DTC ads of this nature. And I have a few critical reasons why many of us, and not just me, are against DTC ads.

1.1 An uninformed public is either given unnecessary hope, with some advertisements. Advertisements have a misleading way of sounding positive, and appear to offer a single point solution, that is quite effective. Needless to say, we don't know how age, sex, gender and other factors differentiate the effectiveness of treatments for many conditions in various patient groups. And where, we do know the effects, the advertisements simply ignore to state such information. Sure, there too, we could be like the FDA and pretend that information overload is the problem. However, when the Doctor finally informs the patient that the drug wont work on them (or tell them so after a few courses of treatment and the associated side effects take their toll), there are the 5 stages of grief, the second opinions, the ensuing loss of trust, the negative effects are too numerous to recount.

1.2 Confusion is the next problem. As the old joke in many television situation comedies (which run the advertisements they mock) that a simple headache medicine could include side-effects ranging from death to, yes, you guessed it, headaches.

Now, let us say that you found a headache medicine or allergy medicine that did indeed have side effects ranging from death to headaches. If you mentioned death only, does that make the patient feel relieved or better prepared? Or, if you leave out the headaches, and the Doctor only mentions them in passing, does the patient take that side-effect seriously? Do they decide to take the medicine? And if they are indeed plagued by headaches from taking the medication, then what?

1.3 Unnecessary Fear is the next problem. Imagine watching a cholesterol ad that warns you of cancer, heart disease or rectal bleeding? This is why the solution is not to MAGNIFY the main side effects. That somehow just makes the problem worse, not better.

1.4 The drug ads are also comically nightmarish. First of all, who in real life walks around telling people they have "moderate to severe Crohn's disease". If they did, it would actually be indicative that they need help of a different kind. And some of the so-called patients appear so deliriously happy after medicating themselves, it almost appears that something else is being advertised. Are you surprised at all that the United States is suffering from an opioid crisis?

Then there are the ads that are downright creepy. While the FDA has agonized over the presence of dogs, I would be more worried about ads that show a patient wandering through some ghoulish cartoon world, right out of the mind of someone who has consumed quite a quantity of hallucinogenic mushrooms.

Now, let me dismantle the reasoning behind this misguided effort at distilling DTC ads to accentuate fear, confusion and misinformation:

2.1. It is based on a study conducted with almost no rigor. The FDA asked 1500 people to watch a few advertisements, asked a few questions and mixed up a cocktail of street-side psychology and came to conclusions. This makes absolutely no sense at all. And this somehow took them years to get to.

2.2. Who decided information retention is the problem? This is what perplexes me. The problem here is patients who probably don't even understand what they ail from fully well, walking into the Doctor's office, demanding to be prescribed WEIRDCONSONANTFILLEDNAMEERASTUMINALIBAB because they watched an ad, that, sure, told them they could have nasal bleeding or brain cancer and something something, but that woman was up the next day smelling flowers and high-five-ing strangers. You see, if we get past all that distraction - the basic problem is - patients should not be making any decisions on their prescription (why have Doctors go through medical school at all then?) and should really leave this to professionals.

2.3. When was the last time a practitioner said, "Phew, I almost forgot about, but I am glad Patient X brought up EASYTOFORGETEXA for his moderate to severe such and such"? (Yes, the "moderate to severe" thing PISSES ME OFF, and to be clear, there is nothing moderate about how much it pisses me off.)

The Solution

This is one of several favorite quotes from one of the shows I love the most, House M.D. :

Dr. Gregory House: You wake up in the morning, your paint's peeling, your curtains are gone, and the water is boiling. Which problem do you deal with first?
Dr. Eric Foreman: House!
Dr. Gregory House: None of them! The building's on fire!

See, the problem is not that there is too much information in DTC ads, or that the amount of side effects retained is the problem. The dog running around in the ad is most certainly NOT the problem.

The problem is the burning house, that is, the fact that we unleash ads about NEARXIGA on people till 11PM, after which the "Non-Attorney Spokesperson" shows up and scares the living lights out of you and does not leave before letting you know that the FDA knows NEARXIGA kills, and equipped with this information, should you notice you've just died, call them.

What the FDA needs to do is to advice pharmaceutical companies to advertise as less of their drugs as possible and focus on spending money over new and more effective therapies. It is that simple. And in fact, that is exactly what a "business friendly" FDA ought to do.

And everyone should watch Dr. House.

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References:

1. The Forbes Article: https://www.forbes.com/sites/arleneweintraub/2017/08/29/fdas-gottlieb-wants-to-rein-in-risk-info-in-drug-ads-but-will-he-succeed/#74f9bf7e2042

2. Dr. House Quotes: http://www.imdb.com/title/tt0774238/quotes

3. Image Courtesy, Pexels: https://www.pexels.com/photo/colors-colours-health-medicine-143654/

Musings on the future of the medical devices industry - start-ups, M&A, funding and so on..

This past Friday, I had dinner with my graduate school roommate. We'd met after nearly 11 years and still, we were able to pick up where we left off. While I have been in Engineering since, he moved on through Engineering in memory chips to M&A, an Executive MBA and is now doing Equity Research focused on the Semiconductor Industry. Therefore, our conversation drifted towards industry comparisons. He related how the semiconductor industry is more or less consolidated, and there is very little left by way of M&A left. Then, we both agreed that there are not going to be many, if any, "start ups" in the semiconductor industry. This is why he moved on to Equity Research. It all made sense.

Then, this weekend, I went away on one of my usual solitary camping trips to the Sequoia and Kings Canyon Parks, and I started thinking about the conversation and the industry and I have a few thoughts that I will share here. Of course, I could be wrong over the long run, but we'll wait and watch. These ideas or thoughts are not in chronological order, and I am not going to try too hard to pin down specific timelines, not the least because of how difficult that would be.

1. Consolidation - Mergers and Acquisitions

Consolidation is what killed off creativity and entrepreneurship largely, in the semiconductor industry. Sure, here and there something crops up, but the sense of revolution, that is missing. A cooling start up here or there doesn't get you much far. I am sure, upstarts will always shake up every industry, but successful industries need a healthy supply of start ups - the breakthroughs and the incremental innovations. You might say, well, anyone can start up, right, so why would consolidation matter?

Most, but not all start ups exit through acquisition, when successful, and also when at least moderately successful. To set this up, you need as many competing buyers as you can get. If you have one Medtronic-Covidien in the place of two, and one Abbott-St. Jude in the place of two, and eventually, as has been guessed, one Boston Scientific-J&J instead of two, you have start ups and their investors left with fewer options. Already, many investors balk at the regulatory environments the start-ups face, now they have to settle for smaller marginal returns and fewer buyers.

There really is no way around this. This happens in every industry. Pharma was already there a while ago, and medical devices will get there.

2. Start-Up Costs

One reason you wont see too many semiconductor start ups or pharma start ups popping up all over the place is that, you can't just make the next Gallium Arsenide replacement or the next CRISPR in your garage that easily anymore. Never say never, but this is an issue that is also unavoidable when industries reach a certain level of maturity.

Now, surely, you will note, medical devices don't have this problem. You CAN build a start up in a garage, and go a long way. In fact, my brother and I or an a mission to demonstrate this vividly, and publish some research work soon. However, there will come a point when even parts of the industry become so complex, that innovation and breakthroughs will, of necessity become harder and slower to get to.

I see that at least as far as this factor goes, we are about 10 years or so away, but the time factor is wrinkled by other causes as well, as we shall see.

3. Funding for Start-Ups

This happened to pharma. Despite spending years in academy to identify molecules and then running up second mortgages, company founders were having a hard time staying put past a point. Because of the 4-phase process and the high risks of failures all along the way, many times companies would be really close to success and then fail.

To apparently avoid this, and in the name of innovation, Venture Capital Funds took to condensing the funding rounds, in many cases A through D, to provide anywhere from $50mn to $150mn or more in funding for an entity at the very start. Of course, they are very selective about who gets funded.

Then, there are the instances where, big pharma pre-selects start-ups for "collaboration" and does milestone based investments.

The underlying theme in all of this is control, and pseudo-random selection. None of which is good for the industry, the start-ups or anyone in general. Will the devices industry come to this? I think, for the large part, yes. But it will again, probably be a while before we get there. So, far I have seen examples where, unsure of the chances of success of a given device start-up, the buyers provided milestone based payments.

However, it is only after medical devices themselves become quite complex will we see the real need for such funding models to take over and become predominant. Although, devices that can no longer depend on the 510(k) model and require an IDE with an extensive clinical trial would be the first ones to fall victim to such models. This has already happened, though maybe not for the reason I have stated, as in the case of Ardian.

4. Standardization - Boon or Bane?

Standardization has always been a part of industries, be it semiconductor, pharmaceuticals or medical devices. In many ways, this factor itself leads to a lot of success. For example, if you are vending a catheter product, you'd have to tell your potential customers, the surgeons for instance, the French size of your catheter. In fact, you'd probably use it as a differentiating factor. This is great. Also, standardization means, getting cheaper components, easier training and so many other benefits. These are the boons.

However, consider this. Standardization also means conforming to a specific size, or category and so on. This can also limit you. It already does. If you ever order anything non-standard, just by virtue of that, you pay more. And not only that, by having to standardize your products, you lose out on innovation and freedom to operate. This is a double-edged sword. For right now, besides the IEC Standards and certain other aspects, this has only helped and certainly has not taken over the industry. However, a time will come when this wont remain as it is.

5. Will the Medical Device Industry fall in with High Technology (and the hype)?

So, the Technology industry is riding its next hype cycle - AI. Even though IBM's Watson and Google's DeepMind maybe the closest we have come to AI, most companies are using mere Machine Learning, most of it in its misshapen infantile stage as a substitute for AI. This has slowly started creeping into medical devices as well. However, the industry is still behind on the IoT wave itself, and therefore, it seems like a good and a bad thing that the devices industry is not in lock-step with high technology.

Because, the bad thing about hype cycles is that most of the craze doesn't amount to any success, and much by way of investment is lost in an effort to create success at any cost. Then, the technology industry crashes and burns gloriously, further scorching the Earth for otherwise promising start ups with incremental or even disruptive potential. This is not to say that the medical devices industry does not have its own hype cycles and the concomitant problems, but I hope that the industry doesn't fall in lock-step with the other, for the benefit of everyone.

6. Conclusion

This post is a collection of a few thoughts that came to my mind, comparing the medical devices industry, a maturing one, to two mature ones, semiconductors and pharmaceuticals. As I mentioned before, I don't expect all of my predictions to pan out, or pan out the way I think they would, nor would the timelines probably get to fruition as proposed. However, the medical devices industry appears to be inescapably sailing along to maturity much like others have, and some of the stops are going to be the same.

For innovation, funding and success, the lessons others learned along the way could prove to be very insightful, and that, is something, all of us, entrepreneurs, managers, engineers and others alike should focus on.

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Reference:

1. Image, courtesy, Pexels: https://www.pexels.com/photo/black-and-white-blackboard-business-chalkboard-356043/