Wednesday, August 22, 2012

The Myriad Decision: When commonsense took leave of American Jurisprudence

If you thought America's problems were the first-to-invent vs. first-to-file, or the Apple-Samsung trial or the medical device tax as various golf-playing company executives and clueless Republican Congressmen from Indiana would have you are wrong. The American legal system's problem is...what appears to be a disastrous lack of baseline commonsense! Why would I go ahead and say that?

If like me, you have been reading the real news instead of Taylor Swift and the Kennedy she is dating or why Shia Labeouf and his girlfriend threw a lachrymal part on the streets, you have already heard about the Myriad decision.

Irresponsibility - A systemic problem

From Antonin Scalia to Tom Head, an otherwise inconsequential Judge in Texas who predicts a civil war if Obama is re-elected, the American Judiciary system is full of some very irresponsible individuals. The fact that the country and her future rests in the hands of such people can best be described as appalling. And now the Myriad decision comes as sound proof of what a mix of lack of scientific education, ethical responsibility combined with partisan judges can do for the future of science, technology and ultimately business in this country.

Nature is not an excuse

In the Myriad case, allowing the company to patent BRCA1 and BRCA2 the judge writing the majority opinion wrote - “Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature.”

If you read that as if he was interpreting that breast cancer is man-made. The statement also seems to open the doors for people to patent minor variations on naturally occurring substances. However, the problem is a bit deeper. Somehow a collective majority of judges at an appeals court don't even seem to have the level of scientific background that a 6th grader would be expected to have. 

Dangerous Precedent

This ruling sets a very dangerous precedent! If uninformed judges are allowed to get carried away and make such poor decisions, then the life sciences industry will truly be in shambles. And this is not some conspiratorial warning for the future - it is already here. Unless a full appeals board or the Supreme Court strikes it down, you will have a whole bunch of patented genes. What will this lead to? The answer is blindingly obvious:

1. Research will be stifled. If something as basic as BRCA1 or BRCA2 is patented, then who would want to continue research and drug development that influences either gene? 
2. If someone did want to conduct research, what would they have to do? License the very act of handling, using or talking about the genes from Myriad? How stupid is that?
3. It is not a stretch to conceive that people will start patenting SNPs (Single Nucleotide Polymorphisms) and make even simple diagnoses fall out of the reach of the masses. 

There are several other small and large disturbing possibilities. 

Protecting ourselves from the judges...

Now that we know a bunch of geniuses are stalking the halls of American Justice, we need to find ways to make sure that research and industry make progress despite them and not because of them: 

1. Get Congress to pass specific laws barring naturally occurring genes from being patented.

2. Carefully examine how judges get elected to the various echelons of the judiciary.

3. Establish procedures and guidelines that will quicken the process of censuring runaway judges and if possible, impeach them, or nudge them to retirement.

4. Be vigilant about for-profit companies that would constantly want to find loopholes and exploit them. This one seems so obvious, and yet, it cannot be emphasized too much. 



Thursday, August 09, 2012

India's Pharma FDI Mess...

A note: "Apothecurry" - a blog with a very creative and meaningful name is my favorite blog to get some nifty scoops  on the status of the Indian pharma industry, and I suppose what the Indian Government is doing to it...

You can find the blog linked at the end of  the post.

The question everyone wants to ask: Why is the Indian Government f*ing up the pharma industry?

Among other things they have done:

1. They forced Bayer to license a Cancer drug in a very ambiguous manner. Bayer is no saint, the proposed drug cost and their stance is a direct evidence of either greed or self-loathing inanity - hard to say.

2. They have made a pledge to provide free drugs to India's teeming millions without a proper plan or even the semblance of one...

3. Now, they have threatened Foreign Direct Investments, and, according to Apothecurry, in quite a disparate manner.

Bringing the License Raj back:

Well, not the TBBT Raj, but the much maligned "License Raj", the practice of requiring companies to obtain licenses and burying them in reams of paperwork, promoting corruption, stifling even a whiff of innovation and essentially choking an industry.

Apparently, various arms of the Indian Government have their own plans to stuff their hand in the cookie jar. First apparently the Commerce Ministry wants every foreign investor to go through an intermediary agency called the Foreign Investment Promotion Board (FIPB).

A group of folks from various ministries, on the other hand have suggested that this hell befall only those foreign investors that dare seek more than 49% of a local pharma company. Either way, this is not good news for the Indian pharma industry.

Pharmaceutical Xenophobia

As with everything else, independent India simply misunderstood and maligned Gandhi's "Swadesi" exhortation. Untimely as his death would have ever been, were he to live today, he would pooh-pooh the anti-foreigner sentiment being used to gain popularity and votes while burying real issues.

You would think in a failing economy, the Indian Government, led by none other than Manmohan Singh, famous for bailing India out of the License Raj would not even think of suggesting protectionism.

However, like any other Government, they would like to blame their failings on someone else and thus would have you believe that India's impoverished healthcare system is a consequence of unscrupulous FDI. They may be unscrupulous, yes, but the bulk of the problem, all the way from apathy to lack of vision and corruption rests solely with India.

Whither India?

Someone should tell Sonia Gandhi, Manmohan Singh and their bandwagon of daylight dreamers that the Indian economy is not on a bed of roses. Rather than ease restrictions and make it easy for investor money to flow, the Indian Government is looking to take the country back and plunge it into the same darkness as the energy grids.

If they worry foreign investors would get carried away, they should put forth legal barriers, not imbue some Russian-Venezuelan axis of Xenophobic Hell on Earth.

If this continues, we will see that India's healthcare reach suffers worse than ever, drugs get pulled off the market, or never get into the market and the industry will whither away with stiff external competition.


Thursday, July 12, 2012

The more obvious ACA - India connection: The windfall to Indian IT

If you are unaware of the Supreme Court decision last month, you are either completely disconnected from the US or are a very successful cave-dweller.

There are several groups benefiting from this decision, all the way from insurance-starved Americans to stir-crazy Tea Party loonies, otherwise known as the GOP. And yes, no matter the amount of fake tears that AdvaMed sheds and its senseless parrots mimic, medical device makers and the pharmaceutical industry are also going to benefit immensely. Sensing huge windfalls, the health insurance industry has also reacted with hidden glee.

However, one important connection has not been made very obvious. Of course, in an election year, who would want to tout the fact that a whole host of Indian IT companies would be making money from a successful US bill? I always knew that EHR/EMR start-ups and Indian companies would benefit from the Affordable Care Act (ACA) -  the numbers seem to be surprisingly low, at least if you were to believe Economic Times.

A luke-warm $5.4bn!

In the truly egregious manner in which most Indian newspaper articles espouse information, analysts who are elevated to "experts" (although the article, linked below does dole out some borderline-pertinent comments) mention that the Indian outsourced software and IT industry would see about  1.2 lakh crores (frustrated by the strange units? Well, that is how the rest of the World feels about FPS) or $5.4bn from the ACA. The analysts from Everest Group, apparently also believe that the true "potential" for this market could be $22bn, which still appears low.

If you look at how big the EHR/EMR and other Medical IT market is going to be over the next decade in the US, one wonders if they mean annually? Understandably, NASSCOM, the Indian IT equivalent of AdvaMed (though not so self-involved) predicts that health based BPO only accounts for 4% of the overall industry, and that it can go up to 11-14% of the total outsourcing business. 

Higher Possibilities or Poor Vision?

While a single article does not a trend make, it would appear that the Indian IT industry is still stuck on "serving" rather than "leading". This is probably why the numbers appear too low to me. The companies are still probably stuck in the "Y2K" mode - calculating how many L1 and H1 visas they can snag and how they can benefit from innovation that comes out of the US. It would appear to me that the Indian IT industry and India in general has much farther to go before they can develop leadership in the true sense. 

It is not that Indians lack creativity, innovation, or simply the power to invent. Leadership has a little more to it by way of ingredients, and I believe this is where the Indian industry with its mob mentality, focused on 90-day cycles is giving in. 

An opportunity for the US that the GOP will take away?

Technically, the lack of Indian leadership in IT is an opportunity for entrepreneurs in the US to look past election-year rhetoric. 

34th time is a charm, no the 35th is, or the 36th...

33 times - that is the number of times the GOP in Congress has tried to repeal the healthcare law. Obviously, this creates unnecessary pall over the healthcare industry, ranging from traditional pharma and medical companies to new and innovative Health 2.0 companies. Over the long term, this could only get worse. Surprisingly, having sided with the GOP on the immensely disastrous attempt to repeal the law, now, on the verge of benefiting from all the effects that ACA will have, I am sure, the industry is tearing its hairs apart over all the uncertainties this constant invective on "Obamacare" is causing to future profits and the very fundamentals of growth in the healthcare industry.

Who will win? India, the US or someone else?

India should take a real close look and see how they have managed to water down a major business bonanza into $22bn or worse $5.4bn. True leadership would mean India turning herself into a leader and direct rather than follow world IT by simply serving as the Global IT bellhop. This might mean fostering indigenous entrepreneurship, doing away with the listless Congress Government, giving the BJP a stern warning that they will go the same route if they don't liberalize; importing Indian talent that has left shores, creating an environment where others would like to come and play - look at Start-Up Chile! There is much work to be done, none of which should involve a lengthy, strategic plan to grovel to others.

As for the US, the democrats need to tout their successes over the past four years, get over the election hoopla and look for true action - reforming legal immigration, realizing that low cost outsourcing is here to stay and fostering innovation. The ACA is only the first step. They should work to put a lid on all the nonsensical lobbyists, stop pussyfooting on efforts to strengthen the FDA and enact other laws key to creating a truly lasting, healthcare solution. Otherwise, if it is not India, it will be someone else!

Look out for more posts on the US and India...


Thursday, February 23, 2012

India's drug discovery innovation prognosis is "poor". Is anyone surprised?

I know the last post was also about India. With all the action in India, it is quite tempting to write a lot more India-specific posts. I have saved a few US-specific and generic posts that I hope to roll out in the near future, time permitting.
Outsourcing does not equal innovation

Yes, no blog post on India looks good without a cute image of India's flag. Well, moving on, a research group analyzed patents in the US that originated from India and of over 4,000 patents, found only 20 originated from Indian CROs, and that too were limited to chemistry and shared between two non-US companies that owned the bulk of the IP.

The study and the article based on it (on which this post is based) concludes that India's traditional strength is in chemistry and the whole thing doesn't bode well for the biopharmaceutical industry in India.

Innovation from India - A deeper problem!

India's lack of prowess in drug discovery, or for that matter any field arises from deeper issues.

1. License Raj: Though large portions of this has been eliminated, the damage that the British did and the fact that Indians loved and embraced bureaucracy almost like extremely bored lovers embrace bondage; that too for decades has not helped. Red tape has smothered and choked India quite a bit, and there is no quick way out of this. However, this needs to happen, forming companies, doing research and innovating need to speed up before all of this becomes too expensive to do in India's inflated economy.

2. Geriatric Politicians: Indian politics has devolved into a weird two-party system at the national level and a million party system at the regional levels. It is also scintillated by politicians who are not just physically old, but are also intellectually too old in their world view for the 21st century. Many have no ability to lead India in any positive direction. They lack the ability to take charge and challenge other nations.

3. "Adaptive" Design a.k.a copy the lead: Excepting start ups, and that too the select few that are really good, many companies in India simply copy designs, strategies and everything else. Yes, this disease plagues a lot of companies in the US and China as well, but in India, as a young undergraduate student, I found out that rampant plagiarism was given a cute name - "Adaptive Design" and was being openly discussed and glorified in conferences and even in educational settings.

Of course, there are several other factors, but suffice it to say, the above are among the top handful reasons that prevent India from innovating and truly breaching leadership in drug research, and for that matter any business field.

Car-sharing for prison inmates

Yes, Zipcar may have been original. True differentiation, however does not come from repeatedly copying that one model. Unless companies look for original innovation, and not yet another car-sharing service for prison inmates, philandering priests or people with no driving skills, they will not be able to forge new paths for any vertical - be it a region or nation. Innovation does not equal also-rans. Rather it requires truly disruptive changes.

Easy Money Vs. Longevity 

Indian politicians, economists, policy makers and founders need to understand this. It is easy to work under duress to make money and carve out a space for oneself. There is a need for companies to plan for the long term. It is perfectly alright for companies to make that easy money initially. However, unless they come up with strategic plans, they will be nothing but glorified call centers, CROs or cheap urine-sample analyzers. I kid you not, there are companies in India that can analyze urine-samples flown all the way from Britain at a cost lower than you could get it done in Britain!

What does drug discovery innovation take?

Drug discovery, needless to say is quite challenging. It will take deep knowledge in biological sciences, pharmaceutical sciences, chemistry, biotechnology and not by any small means innovation in software for success. With increasing expenses, most of the big pharma companies face additional challenges that arise from the "patent cliff". Of course, besides being a glorious opportunity for third-grade MBAs doubling as C-level executives that can lay off hardworking scientists, engineers and others, it is truly something that these companies have to grapple with.

While the "what" of drug discovery innovation can fill a few books, it is essential that innovations in science and business need to be combined with good vision and long term focus for drug discovery success, and this is true of the entire world, and not just India. With literate, cheap English-speaking labor in all strata starting from management to science, engineering and manufacturing available in large volumes, India should not lose this opportunity to some other nation.

Conclusion: India, obviously needs someone to take bold steps and move the country forward deliberately into the 21st century. Who will do this? Will it be the politicians? Will it be the start-ups? Or like most things in and about India, will it be spontaneous?

I know, as I write this post, it is much easier to simply criticize, complain and point out the errors. However, a change in psyche is necessary. As stated above, the recipe for success should at least include:

1. A younger generation of nimble entrepreneurs with nimble companies that simply flout the status quo and hierarchy that is loved in India and forge forward with innovative, groundbreaking ideas

2. Academic institutions that break free from the familiar mold and equip students with the right knowledge and incite hunger for innovation among students

3. An awakened nation with policy makers, politicians and others who will not rest till India puts herself in the map, be it through innovation in business models, discovered drugs or tools that lead to any of these endpoints and beyond.






Tuesday, January 31, 2012

India gets her own stem cell hosptial

This was an interesting, albeit expensive tidbit I saw today...India is apparently getting a INR 90 crore hospital, dedicated solely to stem cell treatments. At the outset, it appears to be a cool idea. The plans call for the Government to spend all of the money required to build the hospital, with an initial investment of  INR 30 crores in the first year.

The partner, is Giostar, or Global Institute of Stem-cell Therapy and Research, based in San Diego. Not much information is available, but it appears that quite a number of the founders are of Indian origin.

IMO, the plan itself seems to capitalize on the difference between the dollar and the rupee, the growth in India, its large population with a variety of disease presentations (which yours truly discovered by doing some ear to the ground empirical research in 2006) and of course, looser regulatory infrastructure on the part of the Government. Mind you, this is just my guess work.

However you look at it, this appears to be a good idea and a win-win situation for everyone involved. Of course, given the obscurity of Giostar (at least in my run of the mill attempt at learning more about them), the Government is taking a bigger risk right now. Should it pay off though, Surat and consequentially India will become quite the stem cell research hub though.

The Regulatory Atmosphere: For a young India, unable to grasp its own might, and lacking the leadership, this just might be the break. After all, India has fallen behind and stayed behind China in almost every way. However, unlike China, hopefully the regulatory environment will mature faster than the various "stem cell" hospitals that are about to proliferate.

Unless you have been hiding in some biotech cave, China recently started clawing back on all the fake and ineffective stem cell studies that have showed up there. As of now, most countries have a reactionary philosophy towards regulations. The recent deaths due to contaminated drugs in Pakistan can only serve as a grim reminder!