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/

Blog Brief: Medical Technology Funding - relaying good news

I first saw this posted on the sfmedengineers group, and on searching, found out that Mediligence had this blog on medical technology funding. It appears that amidst all the bad news and coerced good news, medical device companies seem to be enjoying the cliched "green shoots".

Amidst shying VCs and dried up funding wells, $300mn for a month appears to be quite a sum for 2009. Hopefully, this also means there is some sanity to the ideas that are being funded. A cursory glance does show that it is not a bunch of stent companies that received money.

So, here's to hoping we are in for a period of rationality. One easy way to find out if irrationality has returned, obviously would be a good count of highly ambiguous device ideas, companies that don't even have device ideas, ideas or even an i, and of course, my favorite, stent companies.

Till then, let's hope we see some real medical needs be solved, as opposed to the future Madit-CRT in waitings. (Madit CRT - the act of "If at first you don't succeed or obtain a large population size, simply say everyone has a disease and implant a potentially volatile shock device close to their hearts".)

Here is the link to the companies that received funding in the past month:

http://mediligence.com/blog/2009/06/30/medtech-financings-total-300-million-in-june/

Comparative Effectiveness - why are some so afraid?

[Click on Post Title for Link to External Article]

The Premise
One of the main reasons why I used to be an avid supporter of Hillary Clinton's Presidential Campaign was her Healthcare policy. Among other ideas, she was an early champion of comparative effectiveness and now President Obama has solidified that into the final version of the signed stimulus bill.

My Proposal
The first study I would propose to the HHS/NIH fund is comparing the effectiveness of medical treatment Vs. stents, drug eluting, bioresorbable or otherwise...

Why?

I am almost at the point where I am ready to conclude stenting is an ineffective, expensive treatment. I am not there yet, but everything I read and analyze, seems to take me in that direction.

For almost every study that involves stenting, there's a ruse - a blame is placed on something external. The real ugliness is hidden - it is almost proven now that in almost every situation stents are useless when compared to good old medical management.

And now device manufacturers and the coating manufacturers are in nexus trying to "study" and "prove" the effectiveness of the stents and the drugs they "elute".

They could be no farther from what appears elsewhere:

Here is one that demonstrates that "late stage stenting", that is doing the procedure several days after the patient has had an attack is not effective:

http://uk.reuters.com/article/healthNewsMolt/idUKTRE51H7D020090218

I am betting, and you can count on it, that the stent manufacturers are going to come out and blame patients for "waiting" before getting treatment. We all know that this is not the case - not when we just looked at the results from 447 patients.

Why are device and drug manufacturers scared?
It is not simply because they are scared that their particular device/drug would be named the expensive and ineffective one.

Testing comparative effectiveness was their responsibility and they chafed on it - with the FDA's obsequious assistance.

Remember, and understand, in case you didn't know - comparative effectiveness studies are only new to the United States, since lobbyists have effectively (this, they are effective at) blocked efforts to launch such studies. Elsewhere it has been practiced for quite a while. Look at the UK for example.

Yes, one of the folks quoted in NY Times states rightfully that none of the other countries that have performed comparative analysis for years haven't figured out an effective mechanism yet. Okay, all I am saying is that it is a great opportunity for US leadership in this area then, now that we have $1.1 bn to spend on it.

What is the current state of studies on approved treatments and devices?
The current state of the union, er, comparative effectiveness or even stand-alone effectiveness of devices/drugs is terrible.

Here is what happens:

Evidence to support effectiveness of a certain therapy/drug is primary to CE/FDA certification. So, yes, companies sponsor them quite happily.

However, post-market approval studies are weak - more so for devices than the drugs. This is because of effective policy oversight on the part of who else, your friendly neighborhood FDA.

Whither ethics?
There is no question that ethically every device manufacturer should be invested in post-market follow-up at much higher levels of diligence.

At the detriment of profits? Isn't this just expensive?

NO!

After all, every device manufacturer wants to keep expanding device use, refining the device, fight for and retain reimbursement codes and rates.

All of this should be based on sponsored studies, monitoring and so on - which costs money yes.

Instead, they spend it on lobbyists, firing off workers and buying up competitors and smaller players - simultaneously (oh you know I am taking another dig at 'you know who').

So, when they won't even study the effectiveness of their own drugs/devices, do you think these masters of the universe will succumb to comparative studies voluntarily?

"Rationing Treatments" and "Government Intrusion"
Yes, I am sure ideologically you have a problem with the government deciding what you deem to be necessary treatment - except it was already proven ineffective and expensive.

Why, then should you still vote for that treatment?

This is where the drivel sounded off by idiots like Rush Limbaugh doesn't hold. Large government may not be your thing. You may love being Conservative.

Good, pay for your own treatments.

The vast majority of the public on the other hand simply doesn't know. If you quizzed them many of them would probably be surprised that comparative effectiveness studies are not being done right now. They would have assumed that.

They (me included) needed for Obama to do this.

Still Not Convinced?

Here is a real-world example. A certain subset (large) of breast cancer patients that do not respond effectively to chemotherapy. Following chemotherapy, there is a huge risk that "chemo brain" effects may lead patients to suffer from reduced mental alertness and other consequences.

Now add on top of this the fact that many patients will not even benefit from chemotherapy!

Genetic studies are being developed to find out which patients will respond to chemo and which ones wont. This will help patients who don't respond well to this treatment save themselves from the treatment. This is a subset of the type of results comparative studies would result in.

In the absence of these types of studies, drug and device manufacturers can keep merrily entreating Doctors to keep prescribing treatments that may be not only useless but harmful treatments.

Combine this with unscrupulous DTC ads, and the FDA's uselessness (aka, instead of banning the YAZ ads outright, they added a very confusing layer of message to customers), and you have yourself a lot of wasted money and unhealthy, dissatisfied patients.

Are Comparative Studies Risk-Free for the consumer?

No. Here are some risks I have thought of. I am sure there are more I am missing:

1. Is $1.1bn enough? How will it be distributed? We haven't seen a plan. Will NIH ensure that grantees will not have any ties to companies that make the drugs/devices they study?

2. Apparently the money is available for "many years". How many years? What will happen when the money runs out?

3. How will treatments and drugs that require studying be prioritized? We know the HHS will have authority over this. But who specifically? And what will be their logical course to action?

4. A certain portion (again we don't know how much) of the money available will be used to review data from studies previously conducted - well, what with the problems we have had with greedy study leaders having issues with disclosing "conflicts of interest", how do we know how many of them are reliable? Even without these issues, how many studies will have reliable data that can be used to make effective analyses?

Trust me, I am no fan of meta-analysis. Just do one on half a dozen of the "coffee does this to your body" studies out there..

So, yes, the current plan for Obama's proposal is virtually non-existent.

Comparative Effectiveness - why are some so afraid?

[Click on Post Title for Link to External Article]

The Premise
One of the main reasons why I used to be an avid supporter of Hillary Clinton's Presidential Campaign was her Healthcare policy. She was an early champion of comparative effectiveness and now President Obama has solidified that into the final version of the signed stimulus bill.

My Proposal
The first study I would propose the HHS/NIH fund is comparing the effectiveness of medical treatment Vs. stents, drug eluting, bioresorbable or otherwise...

Why?

I am almost at the point where I am ready to conclude stenting is an ineffective, inexpensive treatment. I am not there yet, but everything I read and analyze, seems to take me in that direction.

For almost every study that involves stenting, there's a ruse - a blame is placed on something external. The real ugliness is hidden - it is almost proven now that in almost every situation stents are useless when compared to good old medical management.

And now device manufacturers and the coating manufacturers are in nexus trying to "study" and "prove" the effectiveness.

They could be no farther from what appears elsewhere:

Here is one that demonstrates that "late stage stenting", that is doing the procedure several days after the patient has had an attack is not effective:

http://uk.reuters.com/article/healthNewsMolt/idUKTRE51H7D020090218

I am betting, and you can count on it, that the stent manufacturers are going to come out and blame patients for "waiting" before getting treatment. We all know that this is not the case - not when we just looked at the results from 447 patients.

Why are device and drug manufacturers scared?
It is not simply because they are scared that their particular device/drug would be named the expensive and ineffective one.

Testing comparative effectiveness was their responsibility and they chafed on it - with the FDA's obsequious assistance.

Remember, and understand, in case you didn't know - comparative effectiveness studies are only new to the United States, since lobbyists have effectively (this, they are effective at) blocked efforts to launch such studies. Elsewhere it has been practiced for quite a while. Look at the UK for example.

Yes, one of the folks quoted in NY Times states rightfully that none of the other countries that have performed comparative analysis for years haven't figured out an effective mechanism yet. Okay, all I am saying is that it is a great opportunity for US leadership in this area then, now that we have $1.1 bn to spend on it.

What is the current state of studies on approved treatments and devices?
The current state of the union, er, comparative effectiveness or even stand-alone effectiveness of devices/drugs is terrible.

Here is what happens:

Evidence to support effectiveness of a certain therapy/drug is primary to CE/FDA certification. So, yes, companies sponsor them quite happily.

However, post-market approval studies are weak - more so for devices than the drugs. This is because of effective policy oversight on the part of who else, your friendly neighborhood FDA.

Whither ethics?
There is no question that ethically every device manufacturer should be invested in post-market follow-up at much higher levels of diligence.

At the detriment of profits? Isn't this just expensive?

NO!

After all, every device manufacturer wants to keep expanding device use, refining the device, fight for and retain reimbursement codes and rates.

All of this should be based on sponsored studies, monitoring and so on - which costs money yes.

Instead, they spend it on lobbyists, firing off workers and buying up competitors and smaller players - simultaneously (oh you know I am taking another dig at 'you know who').

So, when they won't even study the effectiveness of their own drugs/devices, do you think these masters of the universe will succumb to comparative studies voluntarily?

"Rationing Treatments" and "Government Intrusion"
Yes, I am sure ideologically you have a problem with the government deciding what you deem to be necessary treatment - except it was already proven ineffective and expensive.

Why, then should you still vote for that treatment?

This is where the drivel sounded off by idiots like Rush Limbaugh doesn't hold. Large government may not be your thing. You may love being Conservative.

Good, pay for your own treatments.

The vast majority of the public on the other hand simply doesn't know. If you quizzed them many of them would probably be surprised that comparative effectiveness studies are not being done right now. They would have assumed that.

They (me included) needed for Obama to do this.

Still Not Convinced?

Here is a real-world example. A certain subset (large) of breast cancer patients that do not respond effectively to chemotherapy. Following chemotherapy, there is a huge risk that "chemo brain" effects may lead patients to suffer from reduced mental alertness and other consequences.

Now add on top of this the fact that many patients will not even benefit from chemotherapy!

Genetic studies are being developed to find out which patients will respond to chemo and which ones wont. This will help patients who don't respond well to this treatment save themselves from the treatment. This is a subset of the type of results comparative studies would result in.

In the absence of these types of studies, drug and device manufacturers can keep merrily entreating Doctors to keep prescribing treatments that may be not only useless but harmful treatments.

Combine this with unscrupulous DTC ads, and the FDA's uselessness (aka, instead of banning the YAZ ads outright, they added a very confusing layer of message to customers), and you have yourself a lot of wasted money and unhealthy, dissatisfied patients.

Are Comparative Studies Risk-Free for the consumer?

No. Here are some risks I have thought of. I am sure there are more I am missing:

1. Is $1.1bn enough? How will it be distributed? We haven't seen a plan. Will NIH ensure that grantees will not have any ties to companies that make the drugs/devices they study?

2. Apparently the money is available for "many years". How many years? What will happen when the money runs out?

3. How will treatments and drugs that require studying be prioritized? We know the HHS will have authority over this. But who specifically? And what will be their logical course to action?

4. A certain portion (again we don't know how much) of the money available will be used to review data from studies previously conducted - well, what with the problems we have had with greedy study leaders having issues with disclosing "conflicts of interest", how do we know how many of them are reliable? Even without these issues, how many studies will have reliable data that can be used to make effective analyses?

Trust me, I am no fan of meta-analysis. Just do one on half a dozen of the "coffee does this to your body" studies out there..

So, yes, the current plan for Obama's proposal is virtually non-existent.