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/

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

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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.

Update: Stent Startup facing difficulty with IPO..

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Here is my post from yesterday:

http://chaaraka.blogspot.com/2007/12/drug-eluting-stents-what-very-proactive.html

So, I talked about the FDA and their much delayed, yet knee-jerk reaction on DES. I also talked about how stent companies do keep popping up, regardless of several issues with perception. To sum it up, I defined how the major stent players are more worried about litigation on defective products than in actually trying to understand (I am pretty sure - no one has a clue) if stents are actually effective and proving it medically and scientifically.

Referring back to the article on VentureBeat, it is a little bothersome to me that they didn't react quickly. What is it that they were doing from May all the way through December? Yes, and what is with all the secrecy?

Well, it maybe that Devax has other issues to deal with. But they are venture funded. So aren't their investors interested in making sure Devax doesn't raise unwanted suspicions?

Maybe we will hear from them soon....

It is interesting though that Venture Capitalists do continue to fund stent companies. Only time will tell if these "new" stent companies will revive the market or if the whole thing will unravel. One thing we would not expect to see as much is the kind of mania that surrounded DES when they were first introduced.



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Drug Eluting Stents - what a very proactive, caring FDA has decided to do

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It seems like dinosaurs were converted to fuel faster. How long drawn out is the drug eluting stent story going to be? Are DES actually effective? If they are, what is happening with all those deaths and increases in mortality risk?

Is the problem with the drugs? Because stents work don't they? Or do stents work either?

While you may think these don't fall under the gamut of the FDA....they do have a responsibility to patients, companies and stock holders of publicly traded medical device companies.

The essential problem is that the device industry has not always paid a lot of attention to thorough analysis. To date, effective analysis has not been performed on what stents actually do.

Wasn't it one hell of a shocker to find out that angioplasty for all the hue and cry it created and made rich folks out of a handful few is actually not that effective when you compare it to drugs?

So, expert one day, lucky guy another....no one is an expert anymore.

Our only way to find out whether or not something works is to build it, build a hype around it, bring the FDA into the hype-building exercise and then when patients die...overreact!

Indeed, it is the stone ages of medical devices today. We hit something over the head and if it survives..it works!

Trying out unproven treatments on a whole lot of people based on a slim history to pass judgements is veritably not the right way to device use.

Where lies the solution? Definitely not with the FDA. The FDA has proven itself quite ineffective and gullible to industry pressure.

The solution lies in smart companies and in University laboratories. Instead of "teaching" people how to make devices, some of these schools would benefit from spending research effort and energy on building appropriate models of the human body, with respect to both anatomy and physiology and then study the interaction of the device with the body, and the long term effects of the device. The NIH will also benefit the industry by jumping in with grants..

Of course, data generated from devices should still not be ignored. It is a very critical source for further analysis wherever the models would become inaccurate.

Will it slow down product development? Not really. The current model for developing devices and bringing them to the market is fairly successful. No one is asking for an "overhaul" of the very basics of the industry. (Imagine suggesting that - boy would the bubble burst!)

A sound analytical background should be built around the device development process. That is already being done by the really good companies that spare no expense to ensure that they are actually building effective devices. But two things have to happen:

1. Extend the analysis, way into the post-market process without any slow down.

2. Bring more companies in-line with these efforts and make long-term device and device-body interaction studies an industry standard. After all, this is one heck of an industry where rituals and ritualistic folks make constant hay....

Will it be expensive? I ask you to spend a few seconds imagining your company, the company you built with your very hands on a stock market free fall....now does it sound expensive?

As to the FDA? Instead of restating the obvious, the organization would benefit from learning to act responsibly and instilling a sense of responsibility in device companies.

Didn't we all know that stricter guidelines and more studies were needed for drug eluting stents? Did we ever hear of any efforts by the companies involved to design appropriate research projects to understand drug eluting stents and their effect on the body?

No, instead they are merrily carrying on over a patent tussle on a product that doesn't work!

And more stent companies are popping up...everywhere!

Who do you think is responsible for all this?


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