Now, Nepal challenges India on Medical Tourism - what protectionism brings!

A few days ago, I wrote about India's Medical Device Market: http://chaaraka.blogspot.com/2017/04/indias-bizarre-medical-device-market.html

And then, today, I came across an article that makes things even more interesting. Turns out, Nepal is, as one should, taking advantage of the Indian Government's narrow minded attempts at making medical devices available to the market. While India's ominously named NPPA (National Pharmaceutical Pricing Authority - "Authority", puts a nice Democratic spin to things indeed) has decided to control stent prices (especially for drug eluting ones!) at ridiculous rates, at least two companies, Abbott and Medtronic proposed withdrawing from the market. And, it is possible, Boston Scientific wants/wanted to follow suit.

To further wrinkle matters, the NPPA apparently rejected requests by Abbott and Medtronic to pull out of the Indian market! Yes, and apparently so, because, there is no provision in the law to allow a company to withdraw its products from the Indian Market. Well, if companies did not hesitate about bringing their products to India, now they sure as hell will!

Getting back to Nepal, apparently, not only are Nepali Hospitals accommodating Indian patients, but also the Indian doctors that want to operate on them. In my last post, I had lamented about India losing out on medical tourism, and even I hadn't imagined the problem to be as deep as it is. Doctors from India already have lucrative opportunities to do small stints in the US and Europe, when local doctors, especially specialists, go away on vacation, or are unavailable otherwise. This, apparently extends to regions such as Dubai, Singapore, etc. and that is good for them. I am sure, exchanges happen the other way too, but when talent is displaced due to protectionism, it results in a loss of competitiveness. I assume Nepal is even cheaper than India. So, if you didn't have the price controls in place, even with the cost of the stents on market, and the travel expenses, Indian patients, and patients from around the world can only benefit from going to Nepal, not to say anything about the winning local economy.

Confounding Issues and the Ultimate Losers!

I know I keep saying bizarre, but what shocks me is, apparently the NPPA, egged on by a court decision, and at least one organization, All India Drug Action Network, believes that price control is the way to police, regulate and prevent abuse of stents by hospitals, in their search for profits. Before we jump into further arguments on this, it is puzzling enough that the NPPA also wants the Cardiological Society of India to regulate and police itself, to prevent over-use of stents.

So what does the NPPA believe then? Price control works, but is not enough? Or do they doubt that price control would work? The whole thing looks like a mess, and I can tell you one thing - the ultimate and severe losses appear to be that of India's patients.

We'll keep watching the Indian Government and the industry and see what shakes out. It looks like the road ahead is long and bumpy.

References:

1. The article (loading issues and spelling errors lie ahead): http://www.firstpost.com/india/nepal-cashes-on-as-indias-price-cap-send-stents-disappearing-from-country-3427822.html

2. Image, courtesy Pexels: https://www.pexels.com/photo/glacier-snow-mountains-sunny-199/

India's bizarre medical device market

The Indian Government regulates the Indian Medical Device Industry, that are perplexing to say the least. I just came across this news that Abbott is pulling out a couple of their drug eluting stents from India, because of the price ceilings set by regulation (story linked below). Of course, the stents themselves might have issues, including a European Union safety warning.

That said, I still have a few observations here:

1. The drug eluting stent price limits set by the Indian Government appear to be quite low, for any drug eluting stent manufacturer to sell the devices in India. Safety Warning from the EU or not, Abbott appears to be pulling out the stents from the market.

2. Actually, Abbott has "applied" to pull the two stents off the Indian market claiming "commercial unsustainability". They don't say! Apparently, you have to go through a process, simply to stop selling devices in India! Because, of course, if the Indian Government decides that the stents are needed in India to treat patients, they can force you to sell them anyway!! Yeah, it is not just you. I am Indian, and I am a bit shocked myself. Mind you, all this craziness happening, while on the other end, the Prime Minister's Office (PMO) is claiming it wants to aid Foreign Direct Investment (FDI) and a Make in India initiative simultaneously. Honestly, I feel there are very few things out there that could be more conflicting.

If you force people to make their products in India, and then sell it at a price set by the Government's illogical vagaries, how do you expect enthusiasm from foreigners to invest in India. This is quite puzzling.

3. The other thing of interest here is, what of medical tourism. India's cheap medical care with well trained personnel fluent in English has seemed to make it possible for many people to travel from across the world to obtain cost-effective treatment in India. However, if medical devices and other therapies are simply unavailable, India loses leadership and significant revenue and employment in this arena.

4. I am all for Government intervention in healthcare, especially in developing nations. However, these price ceilings appear less to do with patient care. These are but two examples, the drug eluting stents. I am sure there are other devices that face the same sort of excision from the marketplace. Ultimately, Indian patients appear to lose the most here. The Indian Government should strive first to make most, if not all treatments available to Indians, first, before focusing on cost effectiveness. However, cost cutting is a low hanging fruit that politicians cannot resist, and therefore, this appears to be setting a rather dangerous precedent. For those who know the UK's NICE guidelines, know what a slippery slope government control over treatments can be.

5. In relation to all this, I have recently read several articles that lament about Indians' out of pocket costs outweighing subsidies, about the lack of momentum in spending increases by the Government, in comparison to, say defense spending, which is well above healthcare spending.

Conclusion

It is safe to say, India is still not taking a 360 approach to healthcare, and choppy, shortsighted decisions make healthcare investments, be it in medical devices or therapeutics/diagnostics quite challenging for the foreseeable future. We now await new regulatory announcements from the PMO, aimed at improving FDI. I eagerly await to see if any of the proposed changes make FDI, patient access and other aspects of healthcare in India exciting in the near term!

References:

1. Abbott proposes withdrawing drug eluting stents: http://health.economictimes.indiatimes.com/news/medical-devices/now-abbott-withdraws-2-stents-from-indian-market/58308578

2. Blog Image, courtesy, Pexels.com: https://www.pexels.com/photo/architecture-india-agra-delhi-62348/

Abbott the innocent fires Harrison the unrepentent? ...And some very disappointingly minimal actions by Obama

[Click on Post Title for Link to External Article]

If I were the lion from Narnia, I would name Abbott, "Abbott the innocent", that is, if my taxonomy went solely on the basis of companies' ostensible acts. Of course, I am not the lion of Narnia, and no one else should be buying this load of Humira either...

One classic political strategy used in many situations is - assuming the one to yell out loud and clear first is the one to blame.

Except, ahem, we understand politics. And it is "classic" which means old. How many Lucille Ball show endings surprise you anymore?

Here are some questions someone might have to put to the innocents here:

1. Do you review the ads that get put out for $70 million on your behalf?

If not, you are either too rich or, well you are you.

2. If you did review the ads, did you not check for the most fundamental aspect of what approval conditions the ad hints at? Examine this - you don't really get people with science education working for ad companies much. I would imagine not...

So, how did the decision to leave the final proofing for an ad to be displayed in a medical journal get left in the hands of an ad agency? Was the expectation that the ad agency would go hire some outside consultant that would clarify the language on FDA approvals?

If so, who thought that this was a great idea?

3. So, are we to assume, the ad agency, acting on its own poorly conceived cognizance decided to make the fine print, so fine that it is a blur at best, that even if, as suggested by bnet.com, you were to zoom in to 100% or more, the pink vs. white would nearly blind you?

May the cat-belling ceremonies begin

Alright, as another cliche goes, enough beating around the proverbial bush. What responsibility, if any is Abbott going to presume? What punishment if any, is the FDA going to dole out? I mean, the damage is done - right? People have already viewed the ad right? (This presuming those who read journals are incredibly stupid and will trust everything at face value - just ask those who invested in Wall Street).

An analysis

1. The Politics

So, for the last 8 years or so, we can argue, for certain inexplicable reasons (The Bush Presidency if that's what you want to call it), the FDA has been "Deadbeat Central". And now, we have hope and change.

Except it is coming at such a deliberate pace that our hoping and changing seems to need some "extreme enema". The FDA is headless (as of Saturday morning, it has a prospective head and a deputy, provided they have managed to pay taxes, something that Obama nominees have a chronic problem dealing with). Only the God (and not evolution because every alternate opinion, however incredible needs support) knows how much tax-paying and withdrawing drama the nominees will finally bring before they start at the FDA.

2. The Supreme Court

Meanwhile in a far, far galaxy, unkown to Obama and Pelosi (because they are too busy organizing Healthcare summits - because talking rather than doing your job is indeed the best way to get the job done!), the Supreme Court and other agents of spontaneous change will continue to constrict us. How did they figure that pre-emption works only for devices and not drugs?

Is the intention to demonstrate the FDA is good enough only for devices and not drugs? Or did they decided to demonstrate that they are so far removed from the lofty quanta of intellect and depth of understanding required for being at a minimum, a district court judge? Don't they have the responsibility to explain this mess they are leaving us in?

Or did I miss the memo that they don't have to? Looks Cheney-istic, n'est pas?

3. The joke FDA

To pre-empt or not pre-empt - is not the question. In every single way possible, the FDA has demonstrated its incapability at administering anything.

Wait, didn't they just yell at Yaz and Abbott?

Heard of too little, too late?

If no one remembers (and given our short term memory, no one does), here are a few things that the FDA has done to win accolades in the recent past, read my previous post here:

1. The website that the FDA put together on DTC ads to "inform" consumers was designed by a "non-profit" (which of course helps put all the good non-profits to shame) that is a front for the mob, er, pharmaceutical companies. This just makes me sound like one of those Area 51 conspiracy freaks, but this is real! :

http://www.pharmalot.com/2008/09/fda-tapped-pharma-consultant-for-dtc-web-site/

2. They have been so ineffective that companies openly disrespect them - before warning Bayer, the FDA did indicate to them that there was trouble brewing. Bayer didn't care. Take a look at the DTC ads by "Dr." Jarvik and how much pain even Congress had to go through to take him off air (yes, I was one of the folks duped by the ads with him as well, and I am still smarting!).

This is new:

3. Bayer misled customers on Yaz and it's capabilities. The FDA entered into an "agreement" with Bayer asking for a minor correction in the ad - something that appeared fleetingly and is nowhere to be seen. Of course, after the initial celebration of a watered down, ineffective response, no one is talking about it anymore:

http://www.medicalnewstoday.com/articles/138729.php

So, where does this all lead? It goes back to the same topic - the FDA, it's inherent weakness and the unwillingness of lawmakers to do anything about it.

Should we simply complain or come up with a strategy?

Yes, there are several strategies that can be employed - the least effective of which is the one President Obama wishes to employ: blindly continue the same course for the FDA and simply hope that dumping cash and new leadership on a dead mechanism will somehow fix things. Which, is exactly what he has done today. Given the level of promise for change, disappointment and frustration are on the rise.

Here are a few things Obama and Congress can do, at least in the future:

1. Stop thinking linearly as far as the FDA goes. In today's speech, Obama's primary focus was on food, probably motivated by the salmonella outbreaks. However, the FDA regulates much more - drugs, devices, food and a whole array of things. Today's speech confirms that even the President has a poor grasp of the FDA's reach and the necessity to stem it.

One single organization cannot regulate so many aspects of health anymore. Yes, yes, we all know they have subdivisions, but we also know that has basically done nothing. Food administration has to be separated from drug and device administration.

Given the fact that drugs and devices have to be regulated together, one organization should do it. However, they should be distinguished by separate administrations with distinct leadership and separate teams.

2. "Warning letters" and "agreements"

The FDA's business is regulation, not officious groveling to businesses. This is the key point missing in how the FDA is run and how it acts today. In the case of Dr. Jarvik, the Bayer Aspirin ads or even in the case of Yaz, there should have been stricter punishments handed out.

The FDA has failed to act appropriately on all counts. They did not identify the issues at all in some cases - Dr. Jarvik was a fall out of Congress begging and groveling in front of Pfizer for information. The ads kept running for a whole while before Pfizer removed them, almost as an act of condescension, not repentance. The same goes for Bayer with their "dietary supplement nonsense".

This is why the FDA has absolutely no standing anymore. Organizations continually paint outside the boxes and sometimes the paper itself, and they have very, very little to answer for.

How is simply appointing a new head of the FDA actually going to change this? A simple change in leadership is not going to eliminate the regulatory cancer we suffer from.

The solution exists. The strategy exists. However, a lot more action is needed for implementation, bold and quick and unfortunately the President does not seem to be up to it...

Well, Joe the plumber, I mean stent maker, I mean emancipated plumber, listen up...

[Click on Post Title for Link to External Article]

The Premise
The link up here refers to an article from The Canadian Press telling a grim tale of Angiotech's bleak future stemming from its inability to raise much needed funds.

And no, it has nothing to do with the "financial crisis" caused by banks that tried to make "something out of nothing". This has something to do with "drug eluting stents" which I also believe has a lot to do with the words something and nothing...

I have long lamented the lack of definitive proof that drug eluting stents, or for that matter if stents really work at all. The same question and lament goes to the "pioneers" of "balloon, bell and whistle angioplasty" who are labeling themselves experts and innovators quite generously.

Well, let's comeback to the stents beeswax anyway..

Not only have stents not performed in the market, they have also failed to perform inside the human body. Angiotech is just another proof of organizations that overtly stressed and counted on an unproven "technology", in this case Taxus.

What intrigues me is that the FDA has failed to question any of the drug eluting stents and their effectiveness. Our darling, the beautiful baby called "preemption" that the lovely Supreme Court handed us, allows us to theoretically assume that an FDA approval precludes "high levels of performance strictly in accordance with product labeling and marketing for which the device has been approved", how come reality seems to differ?

(Well, we all know accepting preemption is like stepping on horse do and continuing to stand on it, pretending the odor will just go away...well, if the device was put inside you and someone claimed preemption, how will you feel? Ever thought of that amigos?)

This is the last call for passengers of the "reality express" to dismount from the plumbing, er, stenting train.

Here are somethings to think about:

1. A nexus proof, large scale study on drug eluting stents. NIH should be dumping money on this, if at all to stop the money bleeding and waste on health care costs.

2. Companies, especially startups, (you know the ones that don't have too much money to throw away on full page ads, sponsorship of TCT and so on...) should really, really ask themselves if they want to go down the elusive, I mean eluting stent business?

3. VCs should really question further investment in stent companies. Let's see - where did Taxus get BSC and now Angiotech? What has Endavor done to Medtronic? And Xience, well its just Taxus (in case you don't know the whole Guidant story - which means a large portion of this rant makes no sense to you).

And no, I am not buying the bio-resorbable theory either..till I see scientific proof.

4. There seem to be so many companies with the -stent suffix, ThisStent, ThatStent and the NewNewStent..that soon we won't have "-stent" name combinations left...at least somebody stop it for that sake please!

5. Somebody should ask the FDA if it remembers what "post market followup" means. And they should also ask the FDA if they remember having something to do with enforcing something called "post market approvals and follow up".

People who advocate drug eluting stents to me right now look like people propounding all those "weight loss" drugs on TV.

Don't believe me? - I will give you a list of companies. Go look at their current status with reference to stents - BSC, Medtronic, Xtent, Angiotech...

A few random FEA runs on stent designs do not make for fundamental, analytical, scientific proof, without which we should rather be advocating healthier lifestyles and medical treatment.