Waves available now on the Kindle!

February 8, 2009 by ogangurel

Inspired by Goethe’s Faust and described as a cross between Michael Crichton and Umberto Eco, Waves weaves together action, drama, romance, and science in a global setting where the melding of good and evil results in shocking consequences. A technothriller, a psychological drama, a scientific dialogue: there’s something in Waves for everyone and, yes, there’s something of everyone in Waves.
 

Waves – The Trilogy  The Trilogy includes three books: the Melody, which goes forward into the future as a fast-paced technothriller, the Harmony, traveling backwards in time, exploring characters and their fateful decisions, and the Rhythm, fashioned as a scientific dialogue in which the technological secrets are systematically revealed—the reader discovering by the end that all this may not necessarily be fantasy.

“An extraordinary book.”

“… powerfully imaginative …”

Waves – The Novel (Melody)  The technothriller part of the Waves Trilogy. The story recounts the adventures of Tomas, a doctor turned entrepreneur. He’s invented a new technology with both medical and military applications, but has to make a deal with a hedge fund manager, Maximilian Iblis. Adventures ensue that span the globe, including Munich, Paris, Bogotá, Singapore, Kuala Lumpur, Maui, Vienna, and other settings. Max turns out to be quite human and the true devil lies elsewhere. It is left to the reader to contemplate this. The Melody is a fully self-contained novel but reading the Trilogy provides the full story.

“Beautifully written!”

“Absolutely fascinating.”

Waves – The Novella (Harmony)   The psychological drama / Bildungsroman part of Waves. Corruption in Chicago, 9/11, schizophrenia, surgical dramas, romantic escapades, betrayal, loss, elation, discovery, good and evil are all themes explored. The Harmony is a self-contained novella but in order to appreciate the full extent of the story, reading the Trilogy is recommended.

“[Waves] is provocative, engaging, and very believable full of color and texture.”

“… a work of profound expression of human conditionlove, suffering, joy, intrigue, frailty, jealousy, anger, evil, truth, hope, good, mysterytold with incredible knowledge, intellect, rigor, pace and humanity. Its scope and depth will allow every single reader to readily identify and explore herself/himself in this book.”

Waves – The Dialogue (Rhythm)   The scientific dialogue portion of the Waves Trilogy. The Rhythm—a series of twelve dialogues taking place in one day—covers topics such as proteins, cell biology, waves, electromagnetic radiation, thermodynamics and kinetics, biological signal transduction, Newton’s Laws, the brain, evolution, spectroscopy, and cosmology. The technical topics, adapted for general, recreational reader with its own plot line, interweaves with the Melody and Harmony so reading the complete Trilogy is recommended.

“The novel is … an intellectual tour de forceof literature, music, medicine, life sciences, languagesall woven together in triple architectural helix of Melody, Harmony and Rhythm, defining and elaborating secrets of life and the mystery of human condition. It is not just a great fiction, but also a great science-in-fiction.”

“Waves is a completely hip page-turner, yet it is also a literary novel in the grand Western tradition. People from diverse backgrounds and educational levels should be able to connect with [Waves] from wherever they arewhether they’re seeking a great escape, an exciting read, or a profound encounter with a novel of ideas.”

“Rarely does a novel with such ambitious scope succeed. This one does.”

Excerpt from the Prologue

Faust is within all of us. Infinity beckons: whether it be infinite knowledge, everlasting love, limitless wealth, ageless beauty, eternal fame, infinite jest, and whatever else—known or unknown—that motivates.

Life however is finite.

Imagination and reality meet in mystery: between the infinite and the finite, this is our present, boundless struggle. In quest of the infinite, within us all is Tomas.

New Facebook group for Waves!

January 15, 2009 by ogangurel

There’s a new Facebook group for Waves!  Join by clicking here.  Or cut and paste the following link:

http://www.facebook.com/group.php?gid=45715403303

Lots of interesting photos, videos, and discussion topics. Hope you can join!

Global and Historical Perspectives on Invention & Innovation

November 13, 2008 by ogangurel

The distinction between invention and innovation was discussed previously in a series of three articles published earlier:

Part I: Concepts of Innovation, Invention Should Now Be Regarded Differently

Part II: Invention Needs to Be Left Free; Innovation Must Be Managed

Part III: Innovation vs. Invention: Accelerating Development

Having spent the past few days in Rome, I’ve had the chance to reflect upon the rise and fall of empires, the invention/innovation concepts described in the above articles and the relation between these and the fate of nations. 

Reading today’s New York Times sober headlines (5/24/08) about teens unable to find a job (“Toughest Summer Job This Year Is Finding One”) and Wall Street bankers pondering their irrelevancy (“Wall Street Exodus: Fear, Panic and Anger”), makes it seem a Prosecco sipping luxury to consider questions of invention vs. innovation.

It should be clear, however, that the central story of the rise and fall of nations – which certainly does impact us personally – more often than not invokes the ebb and flow of inventive people and innovative societies.  While prominent commentators (such as Thomas Friedman in “Imbalances of Power”) depressingly note the triple storm of fiscal deficit, trade deficit and geopolitical deficit traumatizing America from one shining sea of vanishing strip mall jobs to the opposite shining sea of imploding investment houses, these deficits are but signs and symptoms of a deeper disconnect underlying civilizational decline.  Invention and innovation is the key to both understanding and solving such challenges.

I am writing at the tail end of the Pharma Finance 2008 conference organized here in Rome by the regional authorities – mainly Sviluppo (Development) Lazio, Filas S.p.A and the Italian Institute for Foreign Trade.  As with any business gathering, the 300 plus participants did the usual: sharing ideas and exchanging business cards.  However, this was no ordinary conference along the lines of the usual rituals of industry extravaganzas, investment bank deal-making retreats or government-sponsored foreign direct investment plays.  Pharma Finance 2008 was a very different affair.  This special conference – I will explain its uniqueness further below – combined with a very personal opportunity to contemplate the ruins of an ancient Roman aqueduct just outside my hotel window here in the historic Esquilino district taught me some important and timeless lessons.


Invention vs. Innovation

Invention and innovation are concepts that are often incorrectly conglomerated and confused.  Understanding the distinction will explain the unique importance of the Pharma Finance 2008 conference.

Invention refers to the discovery or creation of a new idea.  It is usually the work of an individual.  Invention is, by definition, outside of reality.  Inventions deviate far enough from reality so as to mark the inventor as being, let us say, a little crazy.  Insane genius is not an oxymoron.

Innovation refers to the combination of inventions and/or institution of processes around a core invention.  Innovation is typically the work of groups – not individuals – since a variety of capabilities and resources are required.  Innovation, by definition, takes invention into reality.  Innovation makes what would have been considered slightly crazy into what is routine.

An innovative product; no invention

A salient example is the IBM Personal Computer (PC) of 1981 – named, as some may remember, Time Magazine’sMan of the Year” in 1982.  The PC was devoid of invention yet it was most certainly one of the most revolutionary innovations of the 20th century.

The IBM engineers sent off to secluded Boca Raton to work their magic were specifically instructed not to invent anything new but simply to take off-the-shelf components and bring to market whatever it was to be within 18 months.

American Ascendency

The PC exerts its influence not only prosaically on everyday lives but also shapes the geopolitics of our era from Iraq and beyond.  For example: we speak wistfully now of the extraordinary economic growth of the US in the late 1990’s.  The influential work of the Harvard economist Dale Jorgenson attributed much of that success to the “…acceleration of productivity growth, driven by information technology, [as] the most remarkable feature of the US growth resurgence.”  Innovation was the major driver of this – what the Dutch economist Luc Soete called the – “historically unique … pulling away of the leading technology country.”

This renewed US economic power – enabled by a remarkable spurt of desktop computing based innovation – has had profound implications since then.  With this power in hand, President Bush was able to write in the preamble to the well-known US National Security Strategy document of 2002:

“Today, the United States enjoys a position of unparalleled military strength and great economic and political influence.”

Powerful words indeed … made possible – quite literally – by a Word processor on a PC.  It is sobering to think how unaware the Bush strategy architects must have been of what is now a completely different economic situation marked by a triad of fiscal, trade and geopolitical deficits.

The Rise & Fall of the Roman Empire

The fall of the Roman Empire is perennially fascinating.  Edward Gibbon’s History of The Decline and Fall of the Roman Empire and his thesis that Rome fell because of a loss of “civic virtue” was more or less required reading for generations of 19th century English Eton and Harrow school boys prepping for their day in the sun as leaders of a British empire upon which the sun never sets … but eventually did.

There has been no shortage of theories to explain the fall of Rome. The still graceful half-ruin of my aqueduct neighbor beckons me to imagine less of the many insults dealt it – “death by a thousand cuts” – and more about the creativity that built it.   This alternative explanatory perspective – looking at the rise rather than the fall – is substantiated by a simple appeal to the laws of thermodynamics – specifically the 2nd Law which mandates that in the absence of specific organizing forces, systems inexorably devolve into complete disorder.  Maximum entropy is the technical term for this state.

Take a sugar cube, for example.  There are only a few conditions of temperature and concentration that lead to the formation of homemade rock candy.  There are zillions of reasons, however – a veritable Avogadro’s number to be precise – for a sugar crystal to dissolve and disappear.  Since disorder is more probable than order, the factors driving an empire’s rise should more simply help to explain its demise.

Duodecim Tabulae and the jus Latii

Two unique “inventions” distinguished Rome from the multitude of other neighboring Latin villages during the 5th and 4th centuries BCE.  The first invention – established around 450 BCE – was the written codification of Roman law – specifically the Twelve Tables (Duodecim Tabulae); a far reaching “bill of rights” for that time.

This potent ability to depersonalize legal relationships, that is to say, to separate them from the particulars of ethnic or family ties enabled the second, even more significant, invention: the unique Roman institution of the Latin Right (jus Latii).  The Latin Right was a form of civic status in between that of full citizenship and non-citizenship (e.g. alien standing) which carried no legal rights.  The Latin Right allowed Rome, in contrast its neighboring states, to productively assimilate foreigners.  Likewise visitors of all origins flowed into a sleepy village which was rapidly transformed into a cosmopolitan city.  Rome became a powerful engine of innovation, tapping into individual inventions from all quarters of the known world, perfecting these and rapidly implementing them throughout the growing Republic. 

Ancient Rome: An Engine for Innovation

The ancient Romans were not known for being a particularly inventive people.  We may never know how much of the astounding variety of Roman innovation was natively developed or assimilated via foreign ferment.  It is safe to say though that for what was once a minor city-state to rapidly acquire the trappings and capabilities of empire could only have been possible through substantial cross-fertilization with other cultures combined with systematic technological improvement.  We know, for example, that the archetypical arch – which made possible the aqueduct still standing before me which, in turn, enabled the aqueous sustenance of large urban populations – was perfected from Etruscan influences.  Likewise, glassblowing came from Syria, a variety of inventions were most definitely imported from the ancient Greeks and even Roman numerals were adapted from Etruscan predecessors.  The Roman engineering corps (praefectus fabrum) was itself an innovation instituted to leverage advanced materials, water power and other inventions to build and sustain Roman military supremacy.

The stunning sophistication of Roman technology was highlighted by Prof. Hamlin Jennings of Northwestern University in a recent Nanotech Today interview “The Nanostructure of Portland Cement – New Approaches to Studying an Old Material.”  Jennings discussed the remarkable properties of the Pantheon – a nearly 2,000 year old domed structure still standing in Rome. In building the Pantheon and its dome, Pozzolana cement – a revolutionary invention in its own right – was applied in a unique layered fashion by which the upper sections of the dome were constructed from successively less dense concrete.  This innovation significantly reduced the Pantheon dome’s overall architectural stresses making possible its soaring grace.

Republican Rome and the early phase of the Empire was built on innovation.  However, notwithstanding the proximal environmental forces that Jared Diamond and others ascribe to civilizational decline, it was the loss of creative forces and the shift to acquisitional conquest as a source of growth rather than material invention that led ultimately to the decline of Empire.  And so, with the dissipation of innovative energies, empires – as do all things – ultimately (and sometimes rapidly) succumb to their thermodynamic endpoint – entropic death.

All roads ultimately lead to disorder; entropy, in the end, rules.

Pharma Finance 2008 and Italian “Malessere”

Reflecting upon Pharma Finance 2008, I have come to realize that this conference was designed to address a very peculiar and important problem for the Italian life sciences community: namely the frustration in transforming the extraordinary inventiveness of the Italian scientific enterprise into productive and effective innovation.

Indeed, it could be said that this problem pertains to Italy more generally – not just the biotechnology sector.  Invention without innovation may be central to the deep “malessere,” or “malaise” felt by many Italians today.  This feeling was well described by Ian Fisher’s article last December in the New York TimesIn a Funk, Italy Sings an Aria of Disappointment.”  His observations received mostly affirmative recognition here in Italy.  As Fisher writes:

“… these days, for all the outside adoration and all of its innate strengths, Italy seems not to love itself. The word here is “malessere,” or “malaise”; it implies a collective funk — economic, political and social — summed up in a recent poll: Italians, despite their claim to have mastered the art of living, say they are the least happy people in Western Europe.”

The article goes on further about the usual topics of economic hardship and political brittleness.  But these – like the traumas now afflicting America – are simply symptoms of a deeper problem.

Disappointment typically arises from a mismatch between reality and expectations.  Italians know they should be doing better but when their gains do not match their talents, these can be perceived as losses.  For Americans, “malessere” may soon arise from the increasing elusiveness of the American dream – and worse still its transmogrification into a nightmare of stranded SUVs languishing among suburban albatross McMansions abandoned with each mortgage readjustment.

Modern Italy: Inventive but not Innovative?

Since the Renaissance (which, by the way, was invented here – Florence to be exact), Italy has been an extraordinarily inventive nation; Italians are among the most original and creative people on this planet.  As is well appreciated, “Made in Italy” is a mark of quality and style.  More significantly “Invented in Italy” could well be the moniker for much of what we take for granted in our modern world.  Radio communication (Guglielmo Marconi), the atom bomb (Enrico Fermi), double-entry bookkeeping (Luca Pacioli), opera and many more remarkable yet now routine ideas were invented by Italians.

Indeed, Italians have not uncommonly been described by their fellow Europeans as being “slightly crazy” in deference to the very Italian ability to think just a bit differently than others.  The invention of a New World is what only an Italian such Christopher Columbus could do.

This uniquely Italian problem – invention without innovation – has two major consequences: economic stagnation and psychic disappointment.  It has also given rise to the significant emigration of inventive talent out of Italy.  There is a reason why Marconi, for example, went to England; Fermi went to the US and Columbus reached America via Ferdinand and Isabella of Spain.

There is profound irony, then, in realizing that a Roman heritage marked by a high degree of innovation (with invention provided by foreign assimilation) being replaced by a modern Italy with its nearly limitless culture of invention (but not necessarily innovation).


Pharma Finance 2008: Fostering Innovation Partnerships

Pharma Finance 2008 was arranged not necessarily to showcase Italian ingenuity and invention – of which there is plenty – but more to foster the partnerships and collaborations necessary for innovation.  Government sponsored business gatherings are often premised by: “look at our great stuff … now give us funding.” Here in Rome the goal was more imaginatively along the lines of “we have great ingenuity here … how can we work together to make it happen?”

The conference was also about opening up local entrepreneurs to the possibilities of partnership.  A senior conference organizer told me:

“Italians are very proud of their discoveries.  It is very personal for them and they hold their ideas quite close to their heart.  Such an attitude can make it difficult to form the necessary collaborations – for example giving up majority control to a venture capitalist – or other partnerships that are necessary for success.”

Another conference official summed it up pithily when he noted that:

“In Italy it is not impossible to have someone like a Michelangelo or even several Michelangelos.  But, how do you innovate around or commercialize something so precious? That is the challenge.”

Scrambler Therapy: An Example of Cross-Border Innovation

Prof. Giuseppe Marineo of the “Tor Vergata” University in Rome was frustrated.  Marineo had invented a new approach to treating visceral pain – the sort of intractable, deep neuropathic pain that arises, for example, from abdominal cancers.  His frustration stemmed from an inability to bring this revolutionary technology, which he called “scrambler therapy” to market.

“Scrambler therapy,” instead of using conventional pharmacological pain-killers or interventional surgery such as neurolysis, uses externally applied electromagnetic signals to confuse endogenous pain pathways into transmitting a signal of “non-pain” rather than “pain” to the brain.  This represents a biophysical approach to treatment rather than a chemical (medical) or mechanical (surgical) one.

Having written before on bioelectromagnetic therapies “Bioelectromagnetic Therapies: Science Fiction or Reality?” the potential of such revolutionary approaches to medicine is not surprising.  Invention can be crazy but rarely is it insane.

Prof. Marineo’s frustration – “malessere” if you will – was not to last long.  During last year’s Pharma Finance 2007 conference the goal of bringing Italian invention to market was, in fact, amply realized.  At that time, Leonardo Zangani (of the Zangani Investor Community) introduced Prof. Marineo and his work to John Nano, Chairman of Competitive Technologies, Inc. (CTT.AMEX) – a technology holding company based in the US CTT took up the technique forming a partnership with GEOMC – a South Korean radio and television manufacturing company for the device’s fabrication.  The Hong Kong-based company Lee’s Pharmaceutical Holdings Ltd. was further enlisted to help with its Asian distribution.

The successful trans-national marriage of Prof. Marineo’s invention with industrial production and worldwide distribution embodied true innovation – a direct result of Pharma Finance 2007.  The hope is that Pharma Finance 2008 will do the same.

America: Land of Immigrants?

The United States is a nation of immigrants and like ancient Rome it has derived nearly all of its inventive creativity from new ideas and cultures outside its borders.  America, however, is now consumed by anti-immigration rhetoric and enforcement.  Consider a recent New York Times report “Italian’s Detention Illustrates Dangers Foreign Visitors Face” describing the travails of an Italian tourist Domenico Salerno – the son of a wealthy contractor – who was detained in a Virginia jail for more than 10 days.  He was locked up, as the New York Times describes it “without charges or legal recourse while Ms. Cooper [his American girlfriend], her parents and their well-connected neighbors tried everything to get him out.”  This criminalization of immigration – not the only such example – portends a tragic societal shift that may substantially accelerate America’s decline more than any combination of its fiscal, trade or geopolitical deficits.

Mr. Salerno – apart from any real or perceived immigration violation – was not a criminal.  It is also unclear whether such draconian enforcement would prevent terrorism as it has been well documented that the 9/11 conspirators had no known criminal records and apparently complied with then-standing immigration requirements.  Ironically, it also should be noted that the ancient Roman Latin Right was not infrequently accorded to foreigners who were otherwise undesirables in their own lands.  Indeed, a grateful and energetic peoples helped drive the Roman innovation engine still impacting our lives today.

Immigration was also essential to America’s scientific and technological ascendency in the wake of World War II.  Legions of talented émigrés escaping war-torn Europe and specifically Nazi persecution were eagerly accepted by the US.  During the succeeding Cold War, the eventual US victory over the Soviet Union was not necessarily an obvious conclusion.  Without these formidable immigrant talents the outcome could very well have been different.

America and Invention

To be sure, invention and innovation cannot in separation drive economic growth and progress.  Invention and innovation work together.  Balancing these two is the essential – one may say existential – challenge which only the most successful societies resolve.

Among the two, invention is the more difficult to cultivate as it requires a culture of freedom, a respect for new ideas and an ability to tolerate a certain degree of “craziness.”  Innovation on the other hand can (and should be) managed and hence a process that may be actively developed.

Clearly, Italy already has substantial innate inventiveness.  In this regard, then, Italy – despite its perceived failings – possesses a tremendous advantage over other nations.  In the absence of such indigenous creativity, it is extraordinarily difficult to create an inventive society as this is a function of deep-seated cultural mores. Indeed, the only remedy to rapidly correct an invention deficit is to encourage selective immigration.

Education, of course, has always been regarded as a powerful and long-term mechanism for increasing a nation’s inventiveness. Education does have its limits.  Invention requires a certain ability to think unconventionally; overly proscriptive educational systems can certainly suppress individual inventiveness.  It should be noted that Leonardo da Vinci – an Italian and arguably history’s most inventive individual – had virtually no formal education; he was also known to have expressed a deep contempt for formalized learning.

Another problem for America is its high cost of education.  Students encumbered by oppressive loans have not the liberty, literally, to be inventive.  Education without freedom – true freedom – only serves to stifle invention.

Is the U.S. inventive enough?

While Italy may be struggling with an innovation deficit, America may very well be facing an invention deficit.  Five factors come to mind:

  • Constraints on immigration (watch, for example the internet TV interview with Dr. Norbert Riedel – Chief Scientific Officer of Baxter International),
  • the regimentation of American education via the “No Child Left Behind” law,
  • a manufacturing sector increasingly crowded out by a service-based (and non-goods producing) economy that is fast approaching 80% of the US gross domestic product (GDP),
  • a foreshortened investment cycle driven by the necessary expectations of increasingly powerful private equity firms and hedge funds, and
  • the exaltation of mediocrity and ignorance that spans resurgent American social and political movements that embrace the status quo rather than change.

Each of these factors alone and certainly all in combination may make it increasingly difficult for America to invent new ideas.  The last point, while admittedly somewhat broad in scope, is particularly concerning.  The injection of political ideology into scientific discovery is bound to be fraught with unintended consequences.

For example, the Marxist-Leninist ideological rejection of cybernetics caused the Soviet Union – despite its tremendous sophistication in mathematics and engineering – to substantially lag behind the US in terms of advanced information technology and computer software capabilities.  Because of the relatively primitive state of Soviet software capabilities, President Reagan’s 1983 Strategic Defense Initiative proposal – the space-based anti-missile program colloquially called “Star Wars” – profoundly frightened the Soviet leadership.  They acutely realized that such an initiative relied heavily on strengths in artificial intelligence and other complex software technologies that the Soviets, at least that time, could not match.  By analogy, the ideologically driven prohibition against embryonic stem cell research here in the US may very well result in similar unintended and insalubrious consequences.

It also becomes nearly impossible for inventive people to apply their talents, find work and survive.  In America, not matching a computer-driven resume scanning system or being inconveniently overly inventive to one’s employers can be a fate worse than having a felony conviction on one’s record.  Leonardo da Vinci would likely have been unemployed and homeless had he lived in America today.  This is unfortunate since the US, more than ever before, needs a modern-day da Vinci to provide creative solutions to its crippling addiction to foreign oil.

Innovation without Invention and is Consequences

Despite the growing invention deficit, innovation is actually quite strong here in the US.  In fact, one of Wall Street’s most recent innovations substantiates the profound problems that emerge from a system of innovation without invention.

Mortgage-backed securitization (MBS) was created – foisted, if you will, on a world eager for higher returns – as a means of expanding home ownership.  Not necessarily a bad thing but without the requisite supporting economic fundamentals this has become, above all, the essence of the current credit crisis.

The mortgage-backed securitization innovation (and its problems) was multi-fold: an appeal to global greed, the opacification of risk, the arbitrage of discrete credit ratings and again the leveraging of information technology capable of crunching voluminous masses of numbers regardless of whether they made any sense.  In this case, innovation occurred in the absence of invention.  True improvements in building design, safety features, energy efficiency or aesthetics did not underlie the increase in home prices.  As is well known, real estate price appreciation was sustained largely as a result of speculative froth (Bernanke’s “irrational exuberance” redux) enabled by complex (and “innovative”) financial reengineering.

Consider another innovation: the SUV where nothing new was created but rather market value (now crashing) was built around combining several “innovations”.  These include:

  • refashioning trucks as personal vehicles,
  • a sophisticated marketing pitch appealing to the emotional sense that “bigger is better,”
  • inexpensive gasoline enabled by artificially low crude oil prices during the late 1980’s,
  • leveraging a suburban culture made possible by a lack of inventive approaches to high-speed rail, light rail or other transportation projects.

As a final example, I can relate my recent experience as a judge for a business plan competition at a leading American business school. Among the several excellent plans that were presented I saw nothing – again nothing – that was particularly inventive.  Proposing a new social networking site, or yet another “fast casual” restaurant concept or an e-mail data-mining capability does little, in my estimation, to create new economic value.  Unmanaged innovation can have rather surprising – and not so salutary – consequences.  More on this shortly.

Pharma Finance 2008: Building upon Invention

Pharma Finance 2008 highlighted some truly inventive approaches to important human problems.  Prof. Marineo presented yet another idea – Entropy Variation System Delta (Delta-S).  The Delta-S technology utilizes organized electromagnetic fields to deliver information to biological systems in order to create desired therapeutic results.  In this way a diseased tissue may be systematically coaxed by external influences to undergo a proper repair process much like the miracle of a developing fetus under the influence of growth factor gradients in tissues and calcium gradients within cells.  Current applications of this revolutionary technology are being developed, for example, to treat liver cirrhosis.

Economic Growth and Anti-Entropy

Prof. Marineo’s “Delta-S: Entropy Variation System” was only one of several Italian inventions showcased here at Pharma Finance 2008.  The reason it is mentioned here, even more than its unusual creativity, is that it specifically relates to the main theme of this article which can be summed up in one phrase:

Value is created by invention converted into reality by innovation.

Modern US style capitalism is predicated on a very simple concept: the supremacy of free-markets.  But herein lays a profound logical and practical fallacy.  The supply-and-demand clearing paradigm of free-markets is based, in practical terms, on the mathematics of market equilibrium.  At the same time the core principle of capitalist success is predicated on the expectation of continual growth which, by definition, implies an ongoing state of non-equilibrium.

Equilibrium – characterized by a state of maximum entropy – leads inexorably towards dissipation and disorder.  If and only if valuable information enters into the growing system can successful enterprises be created and sustained.  This valuable information – the anti-entropy factor – is nothing other than invention. 

Non-equilibrium systems, such as life itself, are characterized by sustained growth and increasing degrees of order.  The success of a capitalist system, then, relies in fostering invention (via freedom) and enabling innovation (via management).  Freedom applies to invention; management applies to innovation.

The distinction between invention and innovation can now be seen to be a categorically essential difference.  Confusing the two and thus misappropriating freedom and management between these can lead to very undesirable consequences.  Excessive management of immigration or education stifles invention.  Unmitigated freedom of innovation leads to monstrosities such as mortgage backed securitization and SUVs.

This is why, in my estimation, Pharma Finance 2008 was such an exciting conference; indeed, an exciting concept speaking more generally.  The concept that Italy’s extraordinary ingenuity benefits from active management of its innovation.

Value is created by free invention converted into reality by managed innovation.

That, I believe, is what Pharma Finance 2008, here in Rome, was all about.  The Italians, evidently, are not so crazy after all.


This distinction has also been discussed by several authors including Bill Buxton, Lewis Branscomb and Philip Auerswald, John Hagel and John Seely Brown, Larry Dignan, Michael Schrage and others who mostly discuss this topic in the context of information technologies.  The purpose of this article is to (1) apply some of these concepts to the life sciences and (2) present a global and historical perspective on the issue all in the context of the recent Pharma Finance 2008 conference.

These are both articles from today’s New York Times (24 May  2008).

Also from today’s New York Times (24 May 2008).

The inventor Dr. Fred McBagonluri provided me with a witty and apt analogy:

A man arrived at the hospital, where his wife just had a baby. As he walked in, he noticed the pediatric nurse cleaning the baby. He walked past his wife without saying anything to her. He congratulates the nurse for cleaning the baby. His wife is mad and raging. Why? Because the baby was her invention and the nurse was simply the innovator. Invention is an uncleaned baby; innovation is when that baby is cleaned up enough to make money!

The idea of taking off-the-shelf components and combining them also has tremendous potential for medical technologies.  See, for example, the articles Convergent Medical Technology: Part I – What is it?, Convergent Medical Technology: Part II – Why is it important? and Patent Reform Act of 2007: Innovation, Implications and the American Inventor.

To be clear, the argument here refers more specifically to the rise of the Roman Republic – relative to the other Latin city-states in the area which it gradually assimilated – resulting in the conquest of Italy and subsequent consolidation of Latium thus creating the framework by which the later Roman Empire emerged.  These are the fundamental reasons for the Empire’s rise rather than the oft-quoted proximal reasons such as the political ambitions of Julius Caesar, the resulting civil wars and other military-political events.

On December 2nd, 1942, Arthur Compton, director of the “Metallurgical Laboratory” at the University of Chicago telephoned James B. Conant, President of Harvard University with the news “The Italian Navigator has just landed in the New World.”  That cryptic message was meant to indicate that controlled and sustained nuclear fission – under the direction of Enrico Fermi – had been achieved.  This was a critical first step towards the development of the atomic bomb.

These are generalizations and not meant, of course, to imply that innovation is absolutely non-existent in modern Italy.  The statement should to be interpreted in terms of a comparative analysis over time (e.g. modern Italy as compared to ancient Rome) and over societies (Italy as compared to other nations that might be considered to be more innovative).

Untreatable Pain Resulting from Abdominal Cancer: New Hope from Biophysics?” Journal of the Pancreas, 4(1): 1-10, 2003.  Click here for a video interview (in Italian) with Prof. Marineo and another video here (also in Italian) demonstrating an early version of the device.

In reading today’s New York Times, another article “270 Illegal Immigrants Sent to Prison in Federal Push” stood out – more concerning than the teenage unemployment or I-banker redundancy reports noted above.  The article writes:

“In temporary courtrooms at a fairgrounds here [in Iowa], 270 illegal [mostly Guatemalan] immigrants were sentenced this week to five months in prison for working at a meatpacking plant with false documents.”

Juliet Stumpf – an immigration law professor at Lewis & Clark Law School – commented on the inauspicious action as being “… a startling intensification of the criminalization of immigration law.”

As described further in the 2nd article (Part II: Invention Needs to Be Left Free; Innovation Must Be Managed) in the previously described three-part series.

It is important to note that I am not at all referring to one people being more “intelligent” than another.  Inventiveness – while typically a result of individual work – results more from cultural attitudes than necessarily innate abilities.  One could say it is an epigenetic rather than genetic factor.

See the work of the Task Force on the Future of American Innovation (http://www.futureofinnovation.org/) whose recommendations – namely to increase government research funding – while important but somewhat different from the one’s discussed in this article.

See, for example, Susan Jacoby’s recent book The Age of American Unreason which was featured in a New York Times article “Dumb and Dumber: Are Americans Hostile to Knowledge?” commenting more generally the decline of American intellectual culture. See also another Op-Ed piece by Jacoby: “Best is the New Worst.”

This statement should not be construed as a generalized indictment against conservatives.  David Brooks in his commentary “The Conservative Revival” writes convincingly about thoughtful conservative movements that are able to, and indeed, thrive under conditions of change.

See: “Software Seen As Obstacle In Developing ‘Star Wars’” which points out that the software requirements represent probably the critical component to the success of any such system.

Russian software engineers have since – now unfettered by Marxist restrictions – proven themselves extremely capable so the Soviet weakness did not reflect some fatal lack of talent in this area.

Low oil prices in the mid-to-late 1980’s (e.g. the 1986 crude oil price collapse) and then largely propagated through the 1990’s were driven by geopolitical considerations, namely as a primary means of burying (to use a phrase borrowed from Khrushchev) the Soviet Union.  In this regard, it is quite disturbing to see President Bush’s recent inability to convince the Saudis to increase their production as it speaks to a profound geopolitical weakness of the United States today.  This was – despite concerns about the rise of Japan in the 1980s – not the case twenty years ago.

See Paul Krugman’s piece “Stranded in Suburbia.”  While Krugman emphasizes the development of fuel-efficient cars, he also points out (not at all the only one to comment as such) on the appalling lack of urban public transit options.

Out of respect for the school and the participants this shall remain nameless.

For a more direct (if somewhat abstruse) summary of Prof. Marineo’s idea:

… the basic Delta-S system is composed of a sophisticated dedicated parallel architecture computer controlled by an expert system which has the task of constructing, instant by instant, the energy forms required in order to achieve a high selectivity vis-à-vis the desired biological target, to evaluate the safety parameters, by means of suitable electromagnetic fields in a feedback loop with the biological system being treated (self-guidance) in order to introduce the energy required with a suitable information content so as to achieve the desired biocompatibility within the process with which it is desired to interact.

It should be noted that the critique described here is not at all the same as the classical Marxist critique of capitalism which emphasizes the historically determined conflict between capitalist growth and social stability.  Nor is this critique the same as the Club of Rome concerns regarding sustainability and the “limits to growth.” The paradox noted in this article points out that successful capitalist enterprises are required to simultaneously straddle both equilibrium and non-equilibrium status.  This is obviously – from both a mathematical and practical sense – a highly problematic situation which, as is briefly argued here, can be resolved in a sustained manner only through the continual input of inventive ideas.

The term “if and only if” is meant to be interpreted in its strict Boolean logic sense.

Waves – a 21st century version of Faust

December 29, 2008 by ogangurel

You can find Waves — a 21st century version of Faust in the spirit of Goethe, Mann, Bulgakov and Melville — at the following links:

Comments (positive or negative) are very much appreciated. I am keen to have this book published so any suggestions and contacts along these lines are also welcome.

Thanks!

Ogan

Convergent Medical Technology: Part II – Why is it important?

November 16, 2008 by ogangurel

The first article – “Convergent Medical Technology: Part I – What is it?” – in this two-part series on convergent medical technologies (CMT), defined what CMT is … and what it isn’t.  This second article presents some reasons why CMT is important and why there will be a crescendo of such applications flowing forth.  The third and last part in the series – later this week – will address some implications of this technology convergence and how it will impact medicine and healthcare.  But first: a musical interlude …

via Thinking about Life Sciences: Convergent Medical Technology: Part II – Why is it important?

Medical Diplomacy: A Brief Outline

November 16, 2008 by ogangurel

In a Boston Globe Op-Ed piece – “The cure for tyranny” (10/24/2005) the former governor of Wisconsin governor Secretary of Health and Human Services Tommy Thompson described medical diplomacy as being:

“the winning of hearts and minds of people … by exporting medical care, expertise, and personnel to help those who need it most.”

While medical diplomacy has an intuitive meaning for most people, for the purposes of this discussion medical diplomacy can be defined as follows:

Medical diplomacy is a form of international relations in which medical and healthcare assets and resources are used to encourage positive relations between nations and/or exchange specific benefits between nations.

This should be contrasted with health diplomacy which refers to “diplomatic efforts to enact international health measures.” Health diplomacy overlaps with but is not necessarily the same as medical diplomacy. The World Health Organization (WHO) is an example of health diplomacy while specific U.S. support of the WHO may be regarded as an expression of U.S. medical diplomacy.

via Thinking about Life Sciences: Medical Diplomacy: A Brief Outline

Emerging Technologies for Nano-Engineered Medicine – Part I On The A to Z of Nanotechnology

November 14, 2008 by ogangurel

Dr. Ogan Gurel interviews Dr. Dean Ho (Assistant Professor of Biomedical & Mechanical Engineering at Northwestern University) discusses ” Emerging Technologies for Nano-Engineered Medicine ” In this first excerpt, Dr. Ho discusses some of the interesting challenges an opportunities involved in the intrinsically interdisciplinary work required for nanotechnology.

via Emerging Technologies for Nano-Engineered Medicine – Part I

Biotech Med Tech Business Models: Investors, Patients Deserve Better

November 14, 2008 by ogangurel

On several occasions, I have commented on the importance of developing new business and financing models for the rapidly evolving areas of medical technology and biotech. These have included:

So Far, Venture Capital Relatively Unsuccessful in Biopharma (November 14, 2006)

A Time to Make Friends: More Partnerships in Biotech, Med Tech? (July 12, 2006)

Tech Convergence a Key Theme at Orthopedics Conference in Chicago (April 3, 2006)

via Thinking about Life Sciences: Biotech Med Tech Business Models: Investors, Patients Deserve Better

Subtle But Powerful, Publication Bias Goes Beyond Financial Incentives

November 14, 2008 by ogangurel

Many of you are aware of the phenomenon of “publication bias” in the scientific literature. This most commonly refers to the fact that “negative” results find their way into publication much less commonly than “positive” results.

Human Nature and Bias

Given human nature, rarely does one want to publicly show their own hypothesis being disproved. While scientists are certainly a competitive sort, the profession finds it more dignified to go about constructively proving one’s own hypotheses than necessarily trashing others.  The lack of public disclosure about negative results is a shame since one of the most important scientific experiments of all time – the Michelson-Morley experiment of 1887 – utterly failed to prove the hypothesis of the stationary ether. This would have experimentally implied that the speed of light would vary according to its orientation with respect to the earth’s movement through space. The hypothesis of the stationary ether, which buttressed the careers of nearly all professional physicists at the time, was trashed. Forward thinkers needed to entertain the concept that the speed of light was a fixed constant. The negative Michelson-Morley result made possible the more radical, positive steps that Einstein took with his theory of relativity. Human nature was not enough to suppress publication of the Michelson-Morley experiment. In fact, this result was so important (albeit negative) that Michelson and Morley gained worldwide renown (and Albert Michelson a Nobel Prize in 1907) for their work. That’s not typically the case.

In our less-innocent modern age where money often rules science more than gentility, there are additional forces influencing publication bias. Who knows what would have happened if International Ether, Inc. had sponsored the experiment. Would the publication have been suppressed? Would the conclusions have been made sufficiently obtuse that proper interpretation was not possible? For the price to maintain International Ether’s stock, the world – with no nuclear power, no atom bomb and no advanced wireless technology, which are all dependent on relativity – would have been strikingly different.

via Thinking about Life Sciences: Subtle But Powerful, Publication Bias Goes Beyond Financial Incentives

Lance Armstrong and the Future of Cancer Care

November 14, 2008 by ogangurel

Lance Armstrong is a unique phenomenon. He’s a talented athlete, a cancer survivor and a political activist. He is in a league by himself. Or is he?  As many people know, survivors of cancer are much more common today. A recent National Center for Health Statistics report released by the American Cancer Society showed a drop in cancer deaths for the second year in a row. Cancer patients as political and even business activists are also increasingly common. In a Dec. 2006 column on MidwestBusiness.com, I wrote about this growing phenomenon:

  • Various disease-oriented non-profit groups, charities and government groups are actively providing venture financing to new biotech start-ups.

  • If the trend of socially driven popularization of biotech investment continues, investors would be looking not just at financial returns but also at social returns.

  • Ultimately, this is what most patients want. Though it is not yet clear whether or not this will require new legal frameworks, it is clear that it would involve new paradigms.

For example, it may imply regulations that make it easier for smaller companies to access the public or semi-public financial markets. Let’s first discuss more about the increasing numbers of cancer survivors, the reasons for that and the implications for future technologies.

via Thinking about Life Sciences: Lance Armstrong and the Future of Cancer Care

What’s More Important in Medicine: Diagnostics, Therapeutics or Prognosis?

November 14, 2008 by ogangurel

What is more important: diagnostics, therapeutics or prognosis? While all are important, we will in this column see how past history has addressed this question and also how recent events (such as the GE acquisition of Abbott Diagnostics) shed light on this fundamental issue.

It is all too easy to take modern medicine for granted, to not delve too deeply into its assumptions and to regard it as having “simply just appeared”. However, considering the historical origins of Western medicine, reference is made to Hippocrates who is often called the “father of Western medicine”. This is not entirely true.

Medical Models

In ancient Greek times, there were two schools of thought in medicine: the Knidian, which focused on diagnosis, and the Hippocratic (or Koan) school, which focused on patient care and prognosis rather than diagnosis.  With the limited knowledge and techniques available then, the Hippocratic approach – with its emphasis on passive treatment and more generalized diagnosis – was more successful. Therefore, we have been handed down the “legend” of Hippocrates as founder of our current medical culture.

via Thinking about Life Sciences: What’s More Important in Medicine: Diagnostics, Therapeutics or Prognosis?

Medical Design Excellence Awards Offer Decisive Glimpse Into Future of Health Care

November 14, 2008 by ogangurel

I’ve just returned from Los Angeles where I served as a judge for an industry award contest. It wasn’t the Oscars.

Instead, I and 14 other jurors were locked in a conference room at the Sheraton outside of LAX. Over three days, we carefully and diligently selected the winners of this year’s Medical Design Excellence Awards (MDEA).  While the Academy Awards get much more recognition, the MDEA winners may very well save your life some day.

The actual results are confidential with the overall winners to be revealed in the April issue of Medical Device & Diagnostic Industry (MDDI). The gold and silver awardees will be announced at the annual Medical Design & Manufacturing East (MD&M East) conference from June 11 to 14 in New York City.  Unfortunately, this column will not tell you who won. Without giving specific examples, I do think it would be of interest to see what caught the judge’s eyes and what it takes to be an MDEA winner. Such considerations have important implications for future trends in the medical device industry.

via Thinking about Life Sciences: Medical Design Excellence Awards Offer Decisive Glimpse Into Future of Health Care

Is Gov. Blagojevich’s new plan to cover the uninsured in Illinois a good or bad idea?

November 14, 2008 by ogangurel

Over the past year, this column and blog has concerned itself mostly with the business of health care. Today, the tables will be turned and we will discuss – albeit only briefly in this short space – the health care of business.

Following the lead of California and Massachusetts, Illinois Gov. Rod Blagojevich has called health insurance a “fundamental civil right” and announced on Sunday an ambitious new plan called IllinoisCovered to cover the estimated 1.4 million uninsured as well as underinsured adults in the state.  Of course, this will cost money – an estimated at $2.1 billion yearly – and the Chicago Tribune also reported on Sunday that “the proposal relies on a new gross-receipts tax, which would require businesses to pay the state each time they got paid for a product or service”.  It is estimated that this new tax would generate $3 billion in the first year and $6 billion yearly when fully operational with most of the receipts going to fund IllinoisCovered and the rest going toward education funding.

via Thinking about Life Sciences: Is Gov. Blagojevich’s new plan to cover the uninsured in Illinois a good or bad idea?

What Patients Want: A Story of Choice, Trials, Evidence-Based Medicine

November 14, 2008 by ogangurel

Clinical trials are serious business. In addition to being big business (e.g. untold billions of dollars every year), they also involve serious ethical issues and choices.

Most of us are aware of the fundamental ethical principle of informed consent underlying all clinical trials. What is less obvious is that conducting a clinical trial carries with it the responsibility to obtain and share its results (whether positive or negative and even if the clinical trial is a failure). It is a failure – indeed a tragedy – when the lessons learned from such studies are not fully appreciated.

Clinical trials involving surgery are especially problematic. While placebo-controlled trials for pharmaceuticals are accepted from a statistical, practical and ethical standpoint, the same cannot be said for controlled trials for surgery involving sham procedures (e.g. surgeries in which the patient is “opened” but no actual therapeutic intervention takes place). Instead, such trials are often designed to compare surgery with some other, non-surgical treatment.

via Thinking about Life Sciences: What Patients Want: A Story of Choice, Trials, Evidence-Based Medicine

KKR Buys First Data: On Private Equity, Pipelines, Development

November 14, 2008 by ogangurel

It
was announced on Monday that First Data, which is one the nation’s
major credit-card processing companies, agreed to be bought out by the
huge private equity firm, Kohlberg Kravis Roberts & Co (KKR) for $29 billion.  As the New York Times reported:

“The
deal ranks among the 10 largest buyouts ever and signals the continued
might of private equity firms, aided by a flood of cheap debt and eager
institutional investors like pension funds.”

What does this and other such mega-deals have to do with pharmaceutical drug pipelines?

The Rise of Private Equity

As many know, we are currently “basking” in an era of low interest rates.  Many would regard this as a good thing.  Indeed, I don’t mind the relatively low mortgage rates now; certainly as compared to the 70’s and 80’s.  But, as with everything, there is no free lunch and there is a price to low interest rates.

There
are the usual macroeconomic theories that point to overheated economies
leading to higher inflation. Some would also say that the current
housing meltdown is related to easier money policies.  And
while not necessarily a “price to be paid” one implication of the low
cost of debt financing is the current boom in private equity – as
evidenced by today’s KKR – First Data deal.

But there is also another price to be paid for an economy that is tilted in favor of debt rather than equity.  Roughly speaking, debt is a conservative financing instrument.  While not inimical to innovation it is generally not the currency that lubricates revolutions.  While
private equity firms can provide great value to the economy they, too,
would acknowledge their efforts essentially make incremental
improvements to an existing company’s operations.

Impact on Innovation

To be sure, this can sometimes create stupendous value and certainly why else would pension funds risk their capital otherwise.  Private
equity, though, exacts value through mechanisms such as management
changes, business process improvements, new market developments, etc.  While this adds value it is not innovation in any substantial sense.

One can counter by saying that innovation is the job of universities and venture capital.  However, despite high levels of liquidity, the world does not have unlimited money.  The
$29 billion for First Data means that much money that doesn’t go to
venture capital or other forms of more equity-based innovation
financing.  Let’s say it costs $1 billion to bring a new drug to market (more on this later).  That
means we could have 29 new drugs being financed instead of having your
Visa or Mastercard processed with slightly more efficiency.  I am simplifying, of course, but the same argument has been held for growing government debt crowding out private investment.  Within the private sector, there are also such “crowding out” phenomena and this is one of them.

Note that these points do not constitute a value judgment.  I have nothing against private equity and truly believe that value creation is a good thing.  Even the much maligned Gordon Gekko – glaring out at the top-heavy phalanx of vice presidents at the Teldar Paper shareholder’s meeting – had a valid point.  We
as a society though should not kid ourselves that these debt-financed
investments will be directed towards fostering innovation.  It would be irresponsible of KKR and of its investors to think otherwise.  [Here's the YouTube video of that famous "Greed is Good" speech.]

So
why doesn’t this money go towards more research and development – in
particular to medical technology or pharmaceutical discovery?  As many have noted (including the Economist this past March), corporate R&D has decidedly shifted more towards the “Development” side and indeed largely away from R&D in general.  To
many firms, the returns on capital from R&D (especially in the
context of this bias towards debt financing) have simply not been great
enough to justify more effort.  The KKR – First Data deal is simply an acknowledgement of that on a grand scale.


via Thinking about Life Sciences: KKR Buys First Data: On Private Equity, Pipelines, Development

Personalized Medicine and Technology Convergence: Decisive Trends

November 14, 2008 by ogangurel

An Unfolding Tragedy: Balancing Act between Innovation and Access

November 14, 2008 by ogangurel

The Diabetes Divide: Is Diabetes a Surgical or Medical Disease?

November 14, 2008 by ogangurel

The ‘Innovation Gap’: Preventing Ideas From Untimely Deaths

November 14, 2008 by ogangurel

FDA: Tortoise, Hare or Something Else

November 14, 2008 by ogangurel

FDA Reform Redux: On Business Models, Regulatory Reform and Safety

November 14, 2008 by ogangurel

The Many Surprising Implications of Hip Resurfacing Implants

November 14, 2008 by ogangurel

Chief Partnership Officer: An Idea Whose Time Has Come?

November 14, 2008 by ogangurel

Convergent Medical Technology: Part I – What is it?

November 14, 2008 by ogangurel

How Doctors Think: Implications for Life Science Business & Finance

November 14, 2008 by ogangurel

GE Healthcare acquisition of Abbott Diagnostics deal scrapped: Who could be the next buyer in line?

November 14, 2008 by ogangurel

Financial Incentives Can Drive New Pharmaceutical & Medical Technology Adoption: What are the Implications?

November 14, 2008 by ogangurel

Bleeding stents … Is the drug-eluting stent era over?

November 14, 2008 by ogangurel

Patent Reform Act of 2007: Innovation, Implications and the American Inventor

November 14, 2008 by ogangurel

Avandia, the Drug Safety Debate and How to Get a Nobel Prize

November 14, 2008 by ogangurel

Boston Scientific, Medtronic settle some defibrillator suits; is the device safety storm over?

November 14, 2008 by ogangurel

Recent postings, including this morning’s “Avandia, the Drug Safety Debate and How to Get a Nobel Prize” have focused on drug safety but the same premises hold true for the device market as well.  Back in 2005 and continuing on through last, we saw some very prominent headlines around Guidant and its massive defibrillator recall.   The topic is still quite timely (despite being overshadowed by Vioxx and Avandia) since just last week it was reported that Boston Scientific settled about $195M of the lawsuits related to the issue as part of its acquisition of Guidant.  Medtronic likewise just settled several lawsuits related to its defibrillators.

via Thinking about Life Sciences: Boston Scientific, Medtronic settle some defibrillator suits; is the device safety storm over?

FDA Report on Avandia: Implications and a “critique” of the critique

November 14, 2008 by ogangurel

FDA panel votes to retain Avandia on the market: DrugWonks celebrate; Prince Hal rails against Falstaff …

November 14, 2008 by ogangurel

An FDA panel voted 22 to 1 on Monday (7/30) to keep Avandia on the market; the vote on the heart attack risk was 20 to 3. 

 

This “result” has been touted as a “victory” by certain pro-pharma groups while my position has not so much been to take sides but rather to highlight these Avandia (and Vioxx) debates as springboards for the greater issues of the growing importance of safety, the evolving risk-benefit balance in “post-modern” medicine, the impacts on FDA reform and the “deconstruction” of the pharmaceutical business model. 

 

Unfortunately others have made this into a highly personal issue which is fine for sandbox politics but not for a topic that demands the highest rigors of scientific discourse and the deepest levels of human compassion.  We are dealing with lives here and fragile egos and statistical minutiae are ultimately only minimally pertinent. 

 

I am not here to defend Dr. Steven Nissen (whom I have never met though I have expressed admiration in the abstract for at least taking a position, however precarious, on safety) nor am I here to defend particular pharmaceutical company interests.  This is an independent blog and as such harbors no agendas, no stock and values logical thought and open, transparent discourse.  Having stepped into the debate, however, I have seen how scientific rigor and medical professionalism can unfortunately play less of a role in shaping public opinion than would be hoped. 

via Thinking about Life Sciences: FDA panel votes to retain Avandia on the market: DrugWonks celebrate; Prince Hal rails against Falstaff …

Thinking about Life Sciences: Is Healthcare too Personalized for Personalized Medicine?

November 14, 2008 by ogangurel

The Deconstruction of Amgen (original blog entry)

November 14, 2008 by ogangurel

As some of you may be aware, Amgen announced last week an unprecedented set of layoffs numbering almost 2,600 employees (or about 14% of its overall workforce).

“We are a company and a management group that faces reality [italics added] and deals with it, and we have a new reality to face today compared to when we planned this year …”

Amgen CEO Kevin Sharer said in an investor conference call as quoted in Andrew Pollack’s New York Times article.

via Thinking about Life Sciences: The Deconstruction of Amgen

Diabetes: Looking Past Blood Sugar …

November 14, 2008 by ogangurel

A Pharmaceutical Addiction

November 14, 2008 by ogangurel

The New York Times
reported earlier this week on an interesting phenomenon in the medical
and pharmaceutical world – namely online advertising by pharmaceutical
companies.  Milt Freudenheim’s article “
A Medical Publisher’s Unusual Prescription: Online Ads” describes how the “medical publishing world [is meeting] the Internet.”  There are yet even more interesting implications to this trend.

via Thinking about Life Sciences: A Pharmaceutical Addiction

On Innovation Part I: Innovation is Not the Same as Invention

November 14, 2008 by ogangurel

Expanding Health Coverage to the Uninsured: How to Pay for it – the Health Impact Tax

November 14, 2008 by ogangurel

As everyone knows – from Michael Moore to President Bush and all the various presidential candidates in between – our nation has a huge problem with the roughly 46 million who lack basic health insurance.  This is both a humanitarian and economic problem which affects all of us.  The basic premises of this proposal cover the following points:

  1. Government covers the aged (Medicare) or poor (Medicaid) and to some extent children (SCHIP).
  2. Business typically covers the working population
  3. Of course, many of the uninsured are among the working public and the consensus is that somehow business should cover the cost of the uninsured
  4. Proposals for a gross-receipts tax (such as recently done in Illinois) have failed in this regard
  5. Instead, it is proposed that a health impact tax (apportioned to different businesses according to a general estimate of the overall impact – positive or negative – of their operations on the health of the population)
  6. This tax would be similar to a carbon tax that is assessed on the basis of a businesses projected environmental impact
  7. This proposal would apportion responsibility for coverage of the uninsured fairly
  8. The program would be nationally based in order to enable freedom of movement and administered by the federal government as an extension of the Federal Employees’ Health Benefits Program (FEHBP)

Most of these points are pretty well accepted with the exception of the major problem – namely how one will pay for such a program.  This is outlined in points #5 though #7 above and discussed in more detail below.

via Thinking about Life Sciences: Expanding Health Coverage to the Uninsured: How to Pay for it – the Health Impact Tax

On Innovation Part II: Fostering Innovation

November 14, 2008 by ogangurel

The previous installment of this series explored three basic points:

1.      Innovation is different from invention

2.      Innovation is the realization of invention

3.      Innovation often results from a combination of inventions

In this regard, fostering invention – which is often done in places like basement university labs and garages – involves creating an environment of relatively unbridled freedom.  To some extent relative isolation from the exigencies of the real world (and hence influence from conventional paradigms) is also beneficial.  Ironically – as the phrase “necessity is the mother of invention” would indicate – globs of money are not required, and can actually inhibit, the process of invention.  Because innovation involves the integration of multiple inventions and interdisciplinary combinations the factors involved in fostering innovation are quite different and in some ways almost opposite those that stimulate invention.

Obviously this is a complex topic, but here are a few high points.

via Thinking about Life Sciences: On Innovation Part II: Fostering Innovation

Fostering innovation doesn’t occur in a vacuum (WTN News)

November 14, 2008 by ogangurel

In this second part of a three-part series on innovation, we discuss the key elements involved in fostering innovation. The third part will focus more on accelerating development.

The previous installment of this series explored three basic points:

• Innovation is different from invention.

• Innovation is the realization of invention.

• Innovation often results from a combination of inventions.

via Fostering innovation doesn’t occur in a vacuum (WTN News)

A prognosis for GE and Abbott Diagnostics (WTN News)

November 14, 2008 by ogangurel

What is more important: diagnostics, therapeutics, or prognosis? While all are important, we will in this column see how past history has addressed this question and also how recent events, such as GE’s acquisition of Abbott’s diagnostics units, shed light on this fundamental issue.

It is all too easy to take modern medicine for granted, to not delve too deeply into its assumptions and to regard it as having “simply just appeared.” However, considering the historical origins of Western medicine, reference is made to Hippocrates, who is often called the “father of Western medicine.” This is not entirely true.

via A prognosis for GE and Abbott Diagnostics (WTN News)

Abbott, GE agree call off their diagnostic acquisition deal (WTN News)

November 14, 2008 by ogangurel

Abbott and General Electric Co. have agreed to terminate their contract for the sale of Abbott’s core laboratory and point-of-care diagnostics businesses, the two companies announced today.

The only explanation given was that the two companies were unable to agree on final terms and conditions of the proposed sale. No specifics were provided by either organization.

via Abbott, GE agree call off their diagnostic acquisition deal (WTN News)

Lance Armstrong and the future of cancer care (WTN News)

November 14, 2008 by ogangurel

Lance Armstrong is a unique phenomenon. He’s a talented athlete, a cancer survivor, and a political activist. He is in a league by himself. Or is he?

As many people know, survivors of cancer are much more common today. A recent National Center for Health Statistics report released by the American Cancer Society showed a drop in cancer deaths for the second year in a row.

Cancer patients as political and even business activists are also increasingly common. In a Dec. 2006 column on MidwestBusiness.com, I wrote the following about this growing phenomenon:

Various disease-oriented non-profit groups, charities and government groups are actively providing venture financing to new biotech start-ups.

If the trend of socially driven popularization of biotech investment continues, investors would be looking not just at financial returns but also at social returns.

via Lance Armstrong and the future of cancer care (WTN News)

Lessons from the deconstruction of Amgen (WTN News)

November 14, 2008 by ogangurel

As some of you may be aware, Amgen announced last week an unprecedented (at least for that charmed firm) set of layoffs numbering almost 2,600 employees or about 14 percent of its overall workforce. As Kevin Sharer, Amgen’s CEO, said in an investor conference call: “We are a company and a management group that faces reality and deals with it, and we have a new reality to face today compared to when we planned this year.”

via Lessons from the deconstruction of Amgen (WTN News)

Crazy like a Google? With GE-Abbott deal scrapped, could Google be next buyer? (WTN News)

November 14, 2008 by ogangurel

Innovation vs. invention: Knowing the difference makes a difference (WTN News)

November 14, 2008 by ogangurel

Consonant with the etymological origin of the word, “innovation” implies the creation of something new. In this regard, innovation is often equated with invention. However, the two definitions – innovation and invention – have been evolving.

Only recently has an appreciation for the difference, and the need to regard them differently, emerged. As Jan Fagerberg wrote in his 2004 article:

“An important distinction is normally made between invention and innovation. Invention is the first occurrence of an idea for a new product or process while innovation is the first attempt to carry it out into practice.”

via Innovation vs. invention: Knowing the difference makes a difference (WTN News)

Reforming FDA: Focus on safety, let market judge efficacy (WTN News)

November 14, 2008 by ogangurel

The primacy of efficacy over safety seems to be so deeply integral to the system that it might be helpful to realize that this has not always been the case. For much of its history, the Food and Drug Administration’s primary mandate was to protect the public’s safety.

via Reforming FDA: Focus on safety, let market judge efficacy (WTN News)

FDA: Tortoise, hare, or something else? (WTN News)

November 14, 2008 by ogangurel

Last year, this column highlighted the debate around drug and device safety. At that time, I expected that the controversy would continue to grow.

Indeed, the Avandia issue splashed across the headlines this past month. One consequence was the congressional hearings lambasting the Food and Drug Administration and its Commissioner, Andrew von Eschenbach, for what Rep. Henry Waxman, chairman of the Committee on Oversight and Government Reform, called “a major failure of our system.”

via FDA: Tortoise, hare, or something else? (WTN News)

Who is minding the Innovation Gap? (WTN News)

November 14, 2008 by ogangurel

I hope you had a restful holiday weekend. The Memorial Day holiday is a paradox. It honors those who have fallen in military service to their country. With fluttering flags at gravestones and taps in the air, it is the most solemn of holidays.

Unofficially, it starts the summer season and with sparkling weather framing joyous graduates, family picnics, the Indy 500, and heated up baseball pennant races, the holiday holds its own festive note as well. I don’t think anyone has figured out how to greet people after the holiday. “Did you enjoy the weekend” doesn’t quite sound appropriate. “Did you have a reflective weekend” sounds overly somber and presumptuous. “I hope you had a restful holiday weekend” seems to me to strike the right tone.

via Who is minding the Innovation Gap? (WTN News)

Barriers will not stop convergence of medical technologies (WTN News)

November 14, 2008 by ogangurel

When a patient presents to a doctor, many assessments have to be made leading to complex “decision trees” throughout the process of what is unglamorously called “managing the patient.”

During residency, which is not the free-for-all carnival that “Gray’s Anatomy” would have us believe, one of the most important judgment calls that is learned is whether the patient is “sick” or not. This is not in the sense that the patient is faking illness but rather the concept that young doctors gradually learn from experience, whether a patient is on the uptrend or downtrend towards recovery.

via Barriers will not stop convergence of medical technologies (WTN News)

Abbott vs. Thailand has implications for innovation and access (WTN News)

November 14, 2008 by ogangurel

Many of you have been following the Abbott Laboratories story regarding its Kaletra AIDS drug and the conflict with the government of Thailand over patent protection and drug pricing. Some of you may regard this as a relatively isolated tiff between a single drug company and another developing country. Others consider this to be a central – if not the central – problem facing the pharmaceutical industry. And a few – myself included – regard this to be one of the most important issues for our society in general.

At stake is – as Tommy Thompson, the former Governor of Wisconsin and former U.S. Secretary of Health and Human Services wrote – “the balancing act between innovation and access.”

via Abbott vs. Thailand has implications for innovation and access (WTN News)

Personalized medicine and technology convergence (WTN News)

November 14, 2008 by ogangurel

It’s been one year since the debut of MedTech Futures and it has been a pleasure and a privilege to have the opportunity to share ideas with through this forum. As this column enters its second year, I wanted to take an opportunity to briefly summarize some of the perspectives over the past year and also discuss a topic of great timeliness and importance – namely personalized medicine.

via Personalized medicine and technology convergence (WTN News)

Of private equity, research, and drug development (WTN News)

November 14, 2008 by ogangurel

Yesterday it was announced that First Data, one the nation’s major credit-card processing companies, agreed to be bought out by the huge private equity firm, Kohlberg Kravis Roberts & Co., for $29 billion. The New York Times reported:

“The deal ranks among the 10 largest buyouts ever and signals the continued might of private-equity firms, aided by a flood of cheap debt and eager institutional investors like pension funds.”

What does this mega deal have to do with pharmaceutical drug pipelines?

via Of private equity, research, and drug development (WTN News)

Healthcare of business: Universal coverage plan includes new business taxes (WTN News)

November 14, 2008 by ogangurel

Over the past year, MedTech Futures has concerned itself mostly with the business of healthcare. Today, the tables will be turned and we will discuss – albeit only briefly in this short space – the healthcare of business.

Following the lead of California and Massachusetts, Illinois Gov. Rod Blagojevich has called health insurance a “fundamental civil right” and announced on Sunday an ambitious new plan called IllinoisCovered to cover the estimated 1.4 million uninsured as well as underinsured adults in the state.

Of course, this will cost money – an estimated at $2.1 billion annually – and the Chicago Tribune also reported on Sunday that “the proposal relies on a new gross-receipts tax, which would require businesses to pay the state each time they got paid for a product or service.”

via Healthcare of business: Universal coverage plan includes new business taxes (WTN News)

What patients want: A story of choice, clinical trials & evidence-based medicine (WTN News)

November 14, 2008 by ogangurel

Clinical trials are serious business. In addition to being big business (untold billions of dollars every year), they also involve serious ethical issues and choices. We are all aware of the fundamental ethical principle of informed consent underlying all clinical trials.

What is less obvious is that conducting a clinical trial carries with it the responsibility to obtain and share results – whether they are positive or negative or even if the clinical trial is a “failure.” It is a failure – indeed a tragedy – when the lessons learned from such studies are not fully appreciated.

via What patients want: A story of choice, clinical trials & evidence-based medicine (WTN News)

And the winners in medical design are… (WTN News)

November 14, 2008 by ogangurel

I just returned from Los Angeles, where I served as a judge for an industry award contest. It wasn’t the Oscars.

Instead, 14 other jurors and I were locked in a conference room at the Sheraton at Los Angeles International Airport. Over three days, we carefully and diligently selected the winners of this year’s Medical Design Excellence Awards (MDEA).

While the Academy Awards get much more recognition, the MDEA winners may very well save your life some day.

The actual results are confidential, and the overall winners will be revealed in the April issue of Medical Device & Diagnostic Industry (MDDI). The gold and silver awardees will be announced at the annual Medical Design & Manufacturing East (MD&M East) conference from June 11 to 14 in New York City.

via And the winners in medical design are… (WTN News)

Innovation and Invention – Similar Words, Different Concepts

November 14, 2008 by ogangurel

Consonant with the etymological origin of the word, “innovation” implies the creation of something new. In this regard, innovation is often equated with invention. However, the two definitions – innovation and invention – have been evolving.

It has been recently appreciated that these two should in fact be regarded differently. As Jan Fagerberg wrote in his 2004 article:

An important distinction is normally made between invention and innovation. Invention is the first occurrence of an idea for a new product or process while innovation is the first attempt to carry it out into practice

via Innovation and Invention – Similar Words, Different Concepts

InTimeTV – NanoTech Today: Biologically Inspired Strategies for New Biomaterials | Zangani

November 14, 2008 by ogangurel

Welcome to Nanotech Today at InTimeTV.com. Nanotech Today is hosted by Ogan Gurel, MD/MPhil and combines two 21st century technologies – internet TV and nanotech – to communicate globally advances and trends in Nanotechnology worldwide.

This week’s episode of Nanotech Today features Phillip Messersmith PhD Professor of Biomedical Engineering at Northwestern University.

via InTimeTV – NanoTech Today: Biologically Inspired Strategies for New Biomaterials | Zangani

InTimeTV: Advanced Care Planning – Legal, Practical, & Clinical Aspects | Zangani

November 14, 2008 by ogangurel

Dr. Ogan Gurel interviews Linda Emanuel MD PhD, Director of the Buehler Center on Aging (Northwestern University).

via InTimeTV: Advanced Care Planning – Legal, Practical, & Clinical Aspects | Zangani

InTimeTV: Medical Devices, Pharmaceuticals and Biotechnology – Bringing it All Together | Zangani

November 14, 2008 by ogangurel

InTimeTV features Dr. Norbert Riedel, Chief Scientific Officer of Baxter International.

via InTimeTV: Medical Devices, Pharmaceuticals and Biotechnology – Bringing it All Together | Zangani

Nanotech Today Internet TV Talk Show Debuts | Zangani

November 14, 2008 by ogangurel

InTimeTV is very pleased to announce a new internet TV talk show for professionals: Nanotech Today. Nanotech Today, which is hosted by Dr. Ogan Gurel, is a truly global venue by which nanotechnology professionals can share ideas, trends and perspectives worldwide.

Guests on the programs include leading researchers, academicians, industry specialists, investment analysts, government officials and other professionals involved in the ever changing world of nanotechnology.

via Nanotech Today Internet TV Talk Show Debuts | Zangani

Hospital Diagnostics – Bioinspired Nanomaterials

November 14, 2008 by ogangurel

Dr. Ogan Gurel interviews Chad Mirkin PhD – Professor of Chemistry and Director of the Institute for Nanotechnology at Northwestern University.

Dr. Ogan Gurel is chairman of the Aesis Group which provides consulting services in the life sciences and healthcare sectors to clients that have included biopharma/medtech companies, hospitals & health systems, private equity firms, venture capital groups and hedge funds. Dr. Gurel is also Medical Producer at InTimeTV – one of the world’s only peer-to-peer professional internet TV talk show networks. At InTimeTV, he is host to three shows – Insights in Medicine, Eye on Harvard and Nanotech Today which broadcast worldwide.

via Hospital Diagnostics – Bioinspired Nanomaterials

Innovation versus invention: Why accelerating development makes sense (WTN News)

November 14, 2008 by ogangurel

This is the last part of a three-part series on innovation. The first part (“Concepts of Innovation, Invention Should Now Be Regarded Differently”) explored three basic points:

1. Innovation is different from invention.

2. Innovation is the realization of invention.

3. Innovation often results from a combination of inventions.

via Innovation versus invention: Why accelerating development makes sense (WTN News)

Innovations galore at the 2008 Medical Design Excellence Awards (WTN News)

November 14, 2008 by ogangurel

I’m here now in Los Angeles serving as a judge in the 2008 Medical Design Excellence Awards (MDEA), which is a premier competition for medical products, devices and technologies. I also published a column on 2007’s competition.

We actually haven’t finished our deliberations yet, and even if we had, I wouldn’t be able to tell you about the winners.

via Innovations galore at the 2008 Medical Design Excellence Awards (WTN News)

Socialized risk not confined to subprime mess; healthcare impacted (WTN News)

November 14, 2008 by ogangurel

Ben Stein, the noted New York Times columnist cum economist, has written an interesting piece titled “Wall Street, Run Amok.” At the time of this writing, it had become the “most popular” among business articles being e-mailed. In this Web 2.0 era, most popular either means there is something valuable and substantive, or enormously entertaining or crazy. In the past, Stein has satisfied both criteria, so I’ll let you be the judge.

via Socialized risk not confined to subprime mess; healthcare impacted (WTN News)

Italian view on invention and innovation (WTN News)

November 14, 2008 by ogangurel

Since the Renaissance (which, by the way, started in Florence), Italy has been an extraordinarily inventive nation. Italians are among the most original and creative people on this planet. As is well appreciated, “Made in Italy” is a mark of quality and style.

More significantly, “invented in Italy” could well be the moniker for much of what we take for granted in our modern world. Radio communication (Guglielmo Marconi), the atom bomb (Enrico Fermi), double-entry bookkeeping (Luca Pacioli), opera and many more remarkable yet now routine ideas were invented by Italians.

via Italian view on invention and innovation (WTN News)

Where are the secrets of everyday life, in proteins or DNA? (WTN News)

November 14, 2008 by ogangurel

There has been much excitement about the promise of molecular genetics and in particular the Human Genome Project in curing various diseases. Ever since the double-helical structure of DNA was published by James Watson and Francis Crick in 1953, DNA has been billed as the repository of the secrets of life.

via Where are the secrets of everyday life, in proteins or DNA? (WTN News)

Counterdetailing: A Cure for A Pharmaceutical Addiction?

November 14, 2008 by ogangurel

In a little known but very significant development, a Senate Special Committee on Aging held a hearing last Wednesday to hear from industry experts on pharmaceutical marketing tactics and entertain “counterdetailing” proposals.   Sen. Herb Kohl (D-WI) who chairs the committee said:

“Pharmaceutical reps often confuse educating with selling, and evidence shows that doctors’ prescribing patterns can be heavily influenced by these sales representatives.”

I’ve written in some detail on pharmaceutical marketing and a blog entry from last Fall “A Pharmaceutical Addiction” which summarizes what has become a spiraling “arms race” among pharmaceutical firms in building and sustaining vast armies of sales reps who call upon physicians.  In that article I point out how the pharma drug rep model has come under increasing attack due to a number of factors and concerns such as:

·         Unsustainable high cost.  Hence the massive layoffs that Pfizer announced last year.

·         Concerns that marketing costs add to the cost of drugs passed on to patients.

·         Ethical concerns about inappropriate pressures being made on physicians with respect to gifts and other benefits being distributed by drug reps

·         The banning of pharmaceutical drug reps from some medical campuses including Stanford, Henry Ford and Rush University medical centers.

Another article sums up many of the ethical and practical aspects relating to what one commentator described as the “monster [created by] the pharma industry.” It’s a big problem.  It has been estimated that the pharmaceutical industry spends nearly $20 billion annually on marketing to physicians in the form of gifts, lunches, drug samples and sponsorship of education programs.  The number of pharmaceutical sales representatives calling on physicians has more than doubled within less than a decade to over 100,000 now [Source: Pipal Research].

Many individuals and groups – both those in the industry and outside – would like to change the model.  Despite the attractiveness of free lunches and golf junkets, physicians generally resent the impositions on their time, pharma executives groan under the spiraling costs and, of course, patient advocacy groups and regulatory agencies express concern about the ethical challenges.  Yet, it’s a hard nut to crack and calling it an “addiction” – metaphor as it is – may be quite apt.

Last week’s Senate committee hearings were quite interesting in this regard as Sen. Kohl also indicated that he along with Sen. Richard Durbin (D-IL) would introduce legislation that would encourage “counterdetailing” programs.   According to the Kaiser Daily Health Policy Report:

“Kohl said that one grant program would help create training material to inform physicians about safety elements and comparative effectiveness of different medications, and a second program would send trained health care professionals to physician offices to provide the information to physicians.”

Apart from the details of such proposals, it is interesting to see the Senator’s approach to the problem.  Some have cynically lambasted “big pharma” for creating and sustaining the “marketing monster” but from direct personal experience I know that many top pharmaceutical executives are keenly interested in solutions to the problem rather than sustaining what is ultimately an unsustainable “arms race.”  Of course, the term “addiction” has quite pejorative connotations but to the extent that “big pharma” wants to get back to the business of bringing innovative medicines to the public rather than sustaining massive sales teams, the “external” help suggested by Senators Durbin and Kohl should be welcome.  These – as well as some proposals outlined in my previous article – will help, rather than hinder, the pharmaceutical industry.

In this regard, I would think the pharmaceutical firms would embrace rather than counter these “counterdetailing” proposals.   

Ogan Gurel, MD, MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

Proteins or DNA?

June 9, 2008 by ogangurel

There has been much excitement about the promise of molecular genetics and the Human Genome project, in particular, in curing myriad diseases.  Ever since the double-helical structure of DNA was published by Watson & Crick in 1953, DNA has been billed as the repository of the secrets of life. Within DNA resides the genetic instructions driving life itself.  Countless scientists and billions of dollars expended worldwide to cracking that secret.  The code has, indeed, been cracked and we know now – as announced in 2003, a half-century after the double helix was first revealed – the complete sequence of a human genome.

Yet progress has been slow to convert that overwhelming volume of information – three billion base-pairs spread over 46 chromosomes of human DNA – into useful knowledge.  The War on Disease continues and diseases remain uncured, many still incurable.  And so, with the continued emphasis on the genetics of disease, these shall remain largely incurable.

Why is this so?  Conventional military strategy holds that decapitation of central targets, the command and control centers or better yet the highest level leaders of the enemy is the most effective means towards achieving victory.  Surely, a cell’s DNA – a command & control center like none other – would be the ideal target for therapy.  What better than to strike at, or manipulate the very secrets of life.  But the secret of life, embodied in DNA is not the same as the secret to life which resides in the proteins.  Proteins are where the action is.

Prior to 1953, there was still considerable debate as to whether deoxy-ribonucleic acid (DNA) was actually the genetic material of cells.  Many scientists, in fact, believed that only proteins – composed of twenty different amino acids in all sorts of configurations – had the necessary “information content” and “information complexity” to store the massive amounts of genetic data that would be required, for example, to build an entire human being from scratch.  Mind boggling as it seemed for mere molecules to give rise to such complexity, in the absence of religious miracles, molecules it had to be and proteins were a more likely candidate than any other intracellular substance. 

DNA on the other hand was a rather bland molecule.  A DNA molecule, when broken down into its constituents was composed of only four (not twenty as in proteins) subunits.  These four substituents – termed nucleotides – were adenine, thymine, guanine and cytosine.  The apparent paucity of information content was further exacerbated by the fact that in all chromosomal DNA isolated to date, the stoichiometric (that is to say, numerical) quantity of adenine was absolutely identical to that of thymine and likewise the quantity of guanine was identical to that of cytosine.  It was difficult to imagine such a blandly appearing molecule as being capable of holding so much information.  Many regarded it as biological “filler material” or fulfilling some other obscure role.  Like Aristotle before who had used his brain to theorize that the brain was merely a cooling mechanism for the blood, many scientists believed that DNA served only a mundane role within the cell.

This view was to change with the famous Hershey-Chase “blender” experiment of 1952 which used extracts of viruses to demonstrate that genetic traits were propagated through DNA, not proteins.  1953 and the double helix confirmed that, of course, on a biophysical and mechanistic level.  People could see that despite the blandness of the constituents of DNA, infinite variety would result from a different sequence of nucleotides and perfect replication would be assured through a double-helical copying mechanism.

The excitement over DNA and the sudden reversal of its fortunes was infectious.  Proteins became the more staid characters on the stage of life.  They carried no information and were simply dutiful workhorses, produced and dictated by the magical genetic codes emanating from the cell’s nucleus.  They did their jobs, no questions asked.  And while the action of life took place at the level of proteins, the action of laboratory biology took place at the level of genes.  For a time, cloning a gene was enough to publish a major paper or earn a PhD.  Elucidating a set of genetic mechanisms or regulatory pathways was a sure step to a Nobel Prize.

This is a simplification, of course.  Major work has been done around proteins.  Sequencing proteins – insulin for example – or solving the three-dimensional structure of a protein – myoglobin, for example – have led to substantial accolades, including Nobel Prizes and, most importantly, significant progress.  The point, however, is two-fold.  First, is to emphasize the natural bias in favor of DNA.  DNA captures the imagination and still excites scientists and lay public alike.  The combination of utter uniformity and infinite variety makes DNA both relatively easy to study and impossibly mysterious to fathom.  It is a potent, emotional combination.  Proteins on the other hand are both more prosaic and more complex.  They do not extend, near infinitely, in a single double-helical structure but rather manifest in a myriad of shapes, some more or less spherical (like hemoglobin), others elongated (like myosin), yet others thin as cables (like collagen) and others a mix of the globular and extended (like antibodies and the other immunoglobulins).  To study a single protein molecule could be a life’s work.  To study DNA could be the work of life which explains, in a nutshell, the appeal of genetic research and its expansive outlook over its more single-minded partner – protein chemistry. To be sure, proteins are more dynamic creatures than the staid drones that described above.

Whatever the case may be, proteins are truly where the action is.  Nearly all drugs act on proteins.  Aspirin binds to a protein (cyclooxygenase).  Penicillin binds to a protein (transpeptidase).  Morphine binds to a protein (the μ-opioid receptor).  Most congenital diseases result from the presence of abnormal proteins.  Cystic fibrosis results from a mutation in the CFTR protein involved in chloride transport across cell membranes.  Sickle cell anemia results from a mutation in the hemoglobin gene.  Hemophilia results from any number of disrupted coagulation factor proteins.  While it is the DNA of these patients that harbor (and transmit) the mutations, it is the resultant proteins that create disease and hence represent the potential targets for intervention.

If one can fix the CFTR protein, one has fixed cystic fibrosis even without addressing the fundamental mutation at the genetic level.  This therapy, moreover, would not simply be a palliative treatment but would, in fact, be truly curative.  One does not need to completely fix the DNA to cure the disease.  It is like making concrete.  One does not have to apply nanotechnology techniques in moving about the constituents of concrete molecule-by-molecule in order to attain the desired strength and weight.  The Romans did it in ways that match – in terms of the result – the sophistication of modern methods. The Pantheon, still standing in Rome after nearly 2,000 years, is simple evidence of that.

While not perhaps as fundamental as DNA, nor as glamorously simple, aiming at proteins, however, is likely to be the most fruitful approach to winning the war on disease.  This has been the case, after all, for many millenia as medicines using salicylic acid (the core ingredient of aspirin) have been used since antiquity.  In the long run, then, the heyday of genetics will likely be a sideshow to where the real action lies.  The study of DNA, ironically, will be but a supplement to the main feature, an important one to be sure, providing further insight into proteins and a richer and deeper list of the products of these genes, namely the proteins that have for the longest time past and future been the targets of our Promethean desire to manipulate life and death.

Proteins are also the target for more sinister applications.  Other than applying massive physical destruction (e.g. overwhelming flames, a large explosion or a bullet through the head for example), there are limited ways in which a life can be rapidly extinguished.  It is virtually impossible to do this through DNA.  DNA, after all, is just sitting there waiting for its information to be decoded and translated into proteins.  The victims of Hiroshima and Nagasaki who survived the initial blast (e.g. the massive physical destruction noted above) died days and weeks, even after the gamma radiation flowing about them caused catastrophic damage to their DNA.  Many died, but it was not at all quick.  Plutonium is considered the most toxic substance – weight for weight – known.  Its effects, however, take days and weeks to exert.

Apart from physical destruction – which is obvious – other methods of rapid killing involve the pharmacological manipulation of proteins, specifically those involved in critical functions such as breathing and circulation and the neurologic circuits that support these functions.  Curare, for example, relaxes muscle and hence makes breathing impossible by binding to and blocking the nicotinic acetylcholine receptor.  This protein transmits the signal for muscle cells to contract.  No signal, no contraction.  The rapidity of paralysis depends on the mode of administration.  Intravenous injection (as used by anesthesiologists) results in paralysis within half a minute.  If breathing is not artificially supported, death will occur a few minutes afterwards.  Of course, medical anesthesia combines muscle paralysis with artificial ventilation along with agents that induce sedation and unconsciousness.  Whether one saves a life or kills one, the target is the same – the nicotinic acetylcholine receptor.  The end result all depends, in a technical sense, on how that target is attacked and, in a moral sense, on the intentions of the attacker.

Botulinum toxin is another example – and a protein itself.  It is one of the most toxic naturally occurring substances though, as is well known (Botox) it is used in near homeopathic concentrations for wrinkle effacing, cosmetic treatments.  The botulinum toxin (of which there are several subtypes) is a multi-chain protein that binds to a protein at the neuromuscular junction.  The neuromuscular junction is the nexus between nerve and muscle in which the signal for the muscle to contract is transmitted via acetylcholine molecules that flow from one side (the nerve side) to the other, muscle side of the junction.  The botulinum toxin binds to a fusion protein, a protein that would otherwise allow acetylcholine containing vesicles on the nerve side to fuse with the membrane releasing their contents into the cleft between nerve and muscle.  With botulinum toxin in the mix, there is no fusion of these vesicles.  No fusion, no acetylcholine released.  No acetylcholine, no signal and hence no contraction.  The end result is similar to that of curare though somewhat slower in effect.

One might think that interfering directly with the muscle proteins – for example the myosin-binding protein in cardiac muscle might be a good target.  In terms of conventional pharmaceutical approaches, there are two problems with this strategy.  First, the intracellular location of such proteins limits the possibilities for drugs to reach these targets quickly and efficiently.  Among other functions, the cell membrane is protective and allows foreign elements to enter only sparingly.  Second, interfering with only a fraction of muscle proteins is likely to have only an attenuated effect.  An absolute flood of drugs need to wash over nearly all of the muscle constituents and this, too, is neither practical nor quick.  Neuromuscular junction elements, therefore, represent effective drug targets.  They are extracellular and the binding to just a few targets amplifies the effect by virtue of the signaling function at such junctions.

Electromagnetic radiation, however, is not constrained by the same limits as pharmaceutical methods face.  Many forms of radiation pass through the body (and into cells) fairly easily.  Certainly ionizing radiation such as gamma rays and x-rays do and even much lower energy electromagnetic radiation such as radio waves likewise traverse easily into cells.  Finally a ray of electromagnetic energy can easily wash over all the constituents of a cell and, of course, an organ.  If such radiation could incapacitate critical protein functions then potent medical (and military) applications could easily be conceived.  Whether the technology is used for life or death depends on the mode of application as well as the intentions and moral constitution of the operator.

 

Ogan Gurel, MD, MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

 

The Persistent Socialized Risk Problem: Gas Tax, Health Care Insurance

May 12, 2008 by ogangurel

The previous Medtech Futures column “Connection Between the Subprime Mess and the Uninsured: Socialized Risk” highlighted a relationship between the ongoing subprime mortgage crisis (now generalized “credit crunch”) and the growing ranks of healthcare uninsured.  I wasn’t talking about the impact of unemployment but rather the concept of socialized risk.

 

Paraphrasing the hedge fund manager David Einhorn from Ben Stein’s New York Times article: “the subprime mess was large a result of a system in which there were private profits and socialized risk.  If things go well, I win; if everything goes south, society pays.”

 

Although healthcare insurance remains a coveted – and in many cases necessary – employment benefit, there are certainly quite a few firms that have either dropped insurance or significantly underinsured their employees.  The New York Times ran another article last week in which even the employer-based insured were feeling the squeeze.

 

Many of the 158 million people covered by employer health insurance are struggling to meet medical expenses that are much higher than they used to be — often because of some combination of higher premiums, less extensive coverage, and bigger out-of-pocket deductibles and co-payments.

 

Since World War II and more concretely since the 1960’s there’s been an implicitly understood system – in part law, in part tradition which is as follows:

 

  • government pays the healthcare of all non-wage earning individuals (Medicare for retirees or the disabled, Medicaid for the deeply poor and SCHIP for children) while
  • employers pay for the earning public. 

 

That’s the logic of the American system.  And logical it is with one exception.  To the extent that some employers skip playing within this system (it is not legally required to provide health insurance) then we indeed have a system of private profits and socialized risk.  Everybody gets sick someday; everybody eventually dies whatever company one works for so when XYZ Corp. decides not to cover its employees somebody will eventually have to pay.  And to the extent that delayed healthcare is often more expensive healthcare that cost is not likely to be cheap.

 

That’s the illogic of the American system.

 

So, what’s the connection to the gas tax?  As everyone knows, instead of proposing truly innovative and beneficial policies (such as a health impact tax as outlined below and previous articles), Sen. Clinton and Sen. McCain proposed a gas tax holiday – basically eliminating the federal excise tax of about 18 cents per gallon between Memorial Day and Labor Day this summer.  The plan was ridiculed by economists and most notably by Sen. Obama as simply a political ploy.

 

Here’s the interesting thing about the gas tax.  Revenues from the gas tax go 100% into the Highway Trust Fund which pays for building, maintenance and upkeep of the nation’s roads – in particular the interstate highway system.  Other roads – such as North Lake Shore Drive in Chicago – which are notoriously in need of repair are funded through state or local coffers.

 

Regarding the gas tax holiday most economists (and Sen. Obama) pointed out that this would result in very little savings for the average consumer, would undermine highway construction projects (even resulting in relatively significant job losses) and actually stimulate demand which would further increase emissions into the environment and bring prices back up.  All these are reasonable arguments.

 

What is important to consider (especially for a health impact tax) is that the gas tax is specifically earmarked (I know that’s a bad word) for high construction.  It is a way of getting around the socialized risk problem.  In other words, let’s say you use the highway a lot (ergo you use a lot of gasoline as well).  You both benefit from the highway usage (presumably you’re driving somewhere that you’d like to go) and also you are actually, physically wearing down the highway.  Your use of the highway is ultimately related to the need to repair and maintain the highway.  Hence in the absence of a gas tax (which is really a highway usage tax) or tolls then your use of the highway essentially amounts to private profits, socialized risk.  I win.  You pay.

 

Lot’s of people would, no doubt, like such a system which is one reason why Sen. Clinton was accused of appealing to our baser instincts.  It is not sustainable, however.  Hence the subprime mess … and hence the problem with the healthcare uninsured.

 

As this column has suggested, a health impact tax – namely a tax related to a companies estimated healthcare impact on society – is really in the long-run the only solution to a problem in which there are private profits and socialized risk. The other solution – socialized, government healthcare – does not fit into the logic of the American system, or the American way.  A health impact tax does.

 

Ogan Gurel, MD, MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

The connection between the subprime mess and the healthcare uninsured: Socialized Risk

April 28, 2008 by ogangurel

Ben Stein – the noted New York Times columnist cum Economist wrote an interesting piece “Wall Street, Run Amok” this weekend which at the time of this writing has become the “most popular” among business articles being e-mailed.  In this Web 2.0 era, most popular either means there is something valuable and substantive or that it is enormously entertaining or crazy.  Ben Stein has – in the past – satisfied both criteria and I’ll leave to you to decide between the two in this respect.

 

In actuality, though, in this article, Mr. Stein is less a promulgator of ideas than a transmitter.  He quotes a fascinating speech by the hedge fund manager David Einhorn (who runs Greenlight Capital) who – according to Mr. Stein – has put his finger on the underlying cause of the subprime mess.  Many of us are aware of the reasons but the quote below (paraphrased by Stein) seems to encapsulate it nicely which is probably why the speech was so compelling to begin with:

 

“The owners, employees and creditors of these institutions are rewarded when they succeed, but it is all of us, the taxpayers, who are left on the hook if they fail. This is called private profits and socialized risk. Heads, I win. Tails you lose. It is a reverse-Robin Hood system.”

 

This is also – in essence – a key component behind the major problem of the uninsured – namely the 47 million or so Americans estimated to not have health insurance.  Prior to the subprime mess, the main domestic problem crowding the electoral airwaves was that of healthcare and specifically that of the uninsured problem.  The subprime crisis, morphing into a credit crisis and then morphing into a recession (or not depending on your convenience) has supplanted that.  Granted that was bound to be the case anyway.  Healthcare is a tough problem and the credit crisis, however complex it may be, has at least obvious and simple solutions.  Lower an interest rate here, tweak another one there, sprinkle a little sugar and hopefully that should do the trick.  I don’t mean this facetiously, of course, as the rather unprecedented efforts of the Fed – not to be downplayed – may have, if some of the tea leaves are correct, indeed set the stage for recovery.

 

This MedTech Futures column has occasionally written about healthcare reform and this concept of “socialized risk” – not to be confused with socialized medicine – is also central to some of the themes written here.  For some of these previous articles see:

 

The Logic of Health Care in Wake of New Obama, Clinton Reform Plans
(2/5/08)

 

Gov. Blagojevich Announces IllinoisCovered to Insure 1.4 Million in Illinois
(3/5/07)

 

You might be asking why electronic ink is being expended on healthcare reform in a MedTech Future’s column.  Two reasons: one, the ideas presented here are sufficiently different yet not crazy to hopefully contribute meaningfully to the debate and two, nearly everytime I discuss medical technology and the prospects thereof, often the “conclusions” strongly depend on projections on what our future healthcare system will look like.  What’s your view on medical tourism?  What’s your view on the future of drug-eluting stents?  Where is orthopedic surgery headed?  I am  often asked.  I provide my most reasoned answer but in many cases the largest unknown (the 800 pound gorilla as the cliché goes) is that of healthcare reform.  It’ll have a big impact and for something that has such an impact it seemed to make little sense and just have the gorilla walk over you silly.  Hence the interest in helping to fashion at least some small part of that debate.  It makes it easier for me to answer the questions clients and colleagues ask of me.

 

So, back to socialized risk.  In the February article I pointed out how – despite superficial appearances – there’s a strange logic to our healthcare system that specifically addresses the different stages of “socialized risk” – namely the risk of getting ill.  A brief quote from that article makes the point:

 

As a consequence of the wage and price controls instituted during World War II, employer-sponsored health care insurance has become – at least until recently – the avenue by which the employed have obtained health care coverage. With the 1960s and the Great Society programs, Medicare and Medicaid were enacted to cover the well-recognized gap that developed among the non-working elderly and poor (respectively).

 

More recently during the 1990s, the State Children’s Health Insurance Program (SCHIP) was brought on board to cover the last apparent gap (namely that of children).

 

In short, our system is actually quite logical and simple. It consists of two parts: businesses pay for the health insurance for the employed public while government pays for everyone else.

 

The problem arises that certain groups – both businesses and individuals alike – choose to “opt-out” of the system.  Their risk becomes socialized.  Hence the statement above needs to be rephrased – in the current situation – to:

 

It consists of two parts: some businesses pay for the health insurance for the employed public while government pays for everyone else.

 

The operative term is “some” which encapsulates a complex situation in which younger individuals choose not to get health insurance (thus socializing their risk) and more broadly and significantly certain companies (such as the well-publicized Wall-Mart) either do not provide health insurance or significantly underinsure their employees.  It is a rational decision for both of these parties and whether it is right or not, the bottom line is that risk has become socialized.  Eventually someone must pay.

 

In the wake of the tragic CTA accident last Friday here in Chicago, I was struck by one statement taken here from the Chicago Tribune article of Saturday.

 

“[Truck driver Don] Wells refused the doctor’s advice and asked to be released, in part because he didn’t have health insurance, Howard said. He was handcuffed and escorted by police to a waiting police wagon.”

 

It’s a fact that Wells killed two people on Friday.  Whether he is at fault or not is up to others to determine.  It is also a fact that his healthcare status has now entered the realm of social cost.  What if Wells had a small subdural hematoma which over the coming days would expand?  What if he had a heart problem that had him take aspirin which in the absence of medical advice would accelerate the projection of this small bleed?  All conjecture, of course, but it should be noted that he did not leave the hospital treated, he left – as the formal phrase is called – AMA, or “Against Medical Advice.”   So, in a few days, he could grow increasingly somnolent and then end up in an emergency room.  Several tens of thousands of dollars later – which taxpayers will pay, perhaps a couple of brain surgeries he may or may not even be in a state to show up in a court room or inform the authorities of what happened on that tragic Friday rush hour.

 

Of course, this is purely hypothetical.  But with nearly 47 million uninsured out there, the hypothetical can become very real.  Statistics do not hide personal tragedies – just ask anyone who’s being forced into foreclosure.  March is over, but beware the Ides of Socialized Risk.  It is not just confined to the subprime mortgage sector.

 

Ogan Gurel, MD, MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

 

A Proposal for Healthcare Cost Containment

April 14, 2008 by ogangurel

The 4P’s of marketing for drug and device companies

April 14, 2008 by ogangurel

Today’s New York Times has an article by Gina Kolata on the increasing cost of drug co-payments incurred by patients – even those with good health insurance.  Here in Midwestbusiness.com, this column has made considerable note of the unsustainable marketing “arms race” that contributes significantly to the cost of drugs. 

 

“With the new pricing system, insurers abandoned the traditional arrangement that has patients pay a fixed amount, like $10, $20 or $30 for a prescription, no matter what the drug’s actual cost. Instead, they are charging patients a percentage of the cost of certain high-priced drugs, usually 20 to 33 percent, which can amount to thousands of dollars a month.”

 

As noted, drug companies spend nearly $20 billion worldwide (mostly in the U.S., of course) on direct-to-physician marketing.  This does not include the billions spent on direct-to-consumer marketing which is yet another massive cost drain on the system and another subject for discussion.

 

We focus here on direct-to-physician marketing.  Just roughly dividing this $20 billion by the U.S. population gives a cost of $66 for every man, woman and child in this country.  Of course, this amount is mostly borne by the sick – hence the thousands of dollars it may cost for some patients per year and even per month.  For some patients, these co-payments are greater than their monthly mortgage and even more than their monthly income.  This $20 billion in marketing costs is ultimately borne by the consumer.

 

Where does this $20 billion go?  Direct-to-physician marketing includes all the “free lunches” (there is no such thing as a free lunch), salaries of good looking physician detailing reps, drug samples and outright bribes to physicians.  Mind you, it is important for pharmaceutical (and device) companies to update physicians on the latest in developments.  In fact, one could say that their obligation to do this goes beyond just building up the top-line.  The ethically questionable (dare I say criminal) component, however, is not a fringe elements but rather a deeply ingrained practice.  Feel free to refer to Barnaby Feder’s article (also in the New York Times) which describes the recent $310 million settlement reached between the government and five major orthopedic device manufacturers –Stryker, Biomet, J&J (DuPuy) Smith & Nephew and Zimmer – many of whom are based here in the Midwest.  And, of course, there’s the notorious Lupron case right here in the Chicago area where Abbott Labs and Takeda Pharmaceuticals paid a $875 million fine back in 2001 to settle criminal and civil charges stemming from a scheme to distribute free samples to doctors who then charged Medicare thousands of dollars for each dose.  I tried finding the article in the Chicago Tribune but for some reason that’s been suppressed.  Instead, you may find a description of that case in the New York Times.  And if you’re still not convinced, check out this juicy article.

 

But there’s a greater cost to all this.  The 4P’s of marketing – as any 1st year MBA student will tell you – are Product, Placement, Promotion and Price.  In the race to build market share – which I have termed a Pharmaceutical Addiction – promotion has taken over the normal balance of marketing.  As any salesman knows – from a gang-banger heroin peddler to the Chief Marketing Officer of Pfizer – poor product will, in the long run, not sell.  However, “smart people” can stave off the inevitable by pouring more resources into promotion especially when you feel that your supply (whether it be from the Colombian rain forest or from your research pipeline) is constrained.  And subconsciously, when the prospect of going to jail looms over your shoulder, short-term solutions may be – for lack of a better term – more “convenient.”

 

It has been estimated that it costs $1 billion to bring a new drug to market.  Think about that.  $20 billion – a fair portion of which distorts (to put it mildly) the fiduciary responsibility of doctors to their patients – could go towards developing 20 new drugs.  The pipeline – in terms of blockbuster drugs – for the world’s largest pharmaceutical company Pfizer can probably be counted with the fingers of one hand. 

 

Ultimately that means that these patients paying thousands of dollars in co-payments like Ms. Steinwand quoted in Gina Kolata’s article “I charged it, then got into my car and burst into tears …” are not getting their money’s worth.

 

Ogan Gurel, MD MPhil
gurel@aesisgroup.com
http://blog.aesisgroup.com/

 

Innovations Galore Spawning From 2008 Medical Design Excellence Awards

February 18, 2008 by ogangurel

 I’m here now in Los Angeles serving as a judge in the 2008 Medical Design Excellence Awards (MDEA), which is a premier competition for medical products, devices and technologies. I also published a column on 2007’s competition.

We actually haven’t finished our deliberations yet, and even if we had, I wouldn’t be able to tell you about the winners.

Winning products will be announced in the April edition of Medical Device & Diagnostic Industry (MD&DI) magazine. The winners will also be presented with gold- or silver-level MDEA trophies at the competition’s ceremony in June, which will be held in conjunction with the Medical Design & Manufacturing (MD&M) East Conference & Exposition being held in New York City.

Suppliers to MDEA-winning products are also named as official suppliers to 2008 MDEA winners and are permitted to use a special logo in association with their products.

We have observed some significant and accelerating trends among the technologies we’re seeing. While we see these trends embodied in individual products, they also represent significant changes that we’re seeing in how medicine is being practiced and how health care is being delivered. Among these trends, we see: 

  • Increasing use of wireless technologies
  • More point of care and home-based technologies
  • Close integration of diagnostics and therapeutics
  • ”Disintermediation”
  • Less WiresThere’s no surprise here. Wireless technologies (including Bluetooth in selected cases) are being increasingly implemented among medical technologies. As a consequence we are going to see less and less wires strung about the hospital, the OR and the doctor’s office.Again, without giving away details, we are seeing wireless patient monitors, wireless cardiac monitors, wireless sensors of various sorts. This is not a new trend but nevertheless one that is accelerating. In addition, we have seen with some of the products submitted an emphasis on reliability and seamlessness in the wireless connections which appears to have been a problem in first generation products.More Point of Care, Home-Based TechnologiesWe are seeing more and more products that bring care directly to the patient instead of requiring transportation of the patient or the blood/tissue sample, etc. to a centralized, separate facility. We have seen, for example, a truly portable CT scanner that can literally be pushed around like a frankfurter cart (without the umbrella, of course) around the streets of New York.

    Another (not to be underestimated) advantage of such technology is that it effectively “disintermediates” (see below) some processes in health care. In other words, the ability to have an intraoperative CT obviates in some cases the need for a follow-up CT scan and then a potential second operation.

    Miniaturization has been the major enabling force behind this trend. Another example we have seen is a handheld ultrasound machine that makes possible the closer integration of ultrasound into the physical examination of the patient rather than relegating the ultrasound study to a later time at a different facility.

    We also saw another device, for example, that allows clinicians at the bedside to ascertain with a handheld device (that’s connected to a PDA) the presence of a brain hematoma (bleeding around the brain) without having to transport the patient to a CT scanner.

    Closing the Loop Between Diagnostics, Therapeutics

    We saw a surprisingly large number of products that bring the diagnostic and therapeutic process closer together and (in some cases) deliver diagnostic and therapeutic capability in one package.

    One example was a very sophisticated dental device for producing dental implants in which one component of the device digitally scans an image of the teeth and the other – as a computer console – designs the implant. The last component actually fabricates the final implant.

    This is one seamless system that truly integrates the evaluation (diagnostic) process with the final therapeutic implementation. The portable CT scanner mentioned above is yet another example of technology enabling a closer integration between diagnosis and therapy.

    Another example product we saw was a system that allowed brachytherapy (radiation therapy) “seeds” to be produced directly as a result of the initial ultrasound evaluation. This enables those seeds to be surgically implanted at the same sitting.

    Disintermediation

    Many processes in health care involve a fairly involved sequence of steps. “Disintermediation” is a business term in which one or more of those steps is taken away, rendered irrelevant and/or otherwise substituted.

    For example, brachytherapy often involves an initial diagnostic step (utilizing, for example, ultrasound to map out the diseased tissue) followed by a fabrication step in which the radioactive seeds are fabricated and then an implantation step in which the seeds are surgically implanted in the cancerous tissues. Having a device enable all those steps in one seamless operation is an example of disintermediation.

    We have seen other examples of this as well. The dental implant scanning, design and fabrication device noted above also disintermediates several steps in the dental implant process. While having a handheld ultrasound machine certainly will not eliminate all conventional ultrasound exams, it will certainly substitute for some of those studies while enhancing the traditional physical exam of the patient.

    We saw quite a few other developments: an increased number of home-based medical devices, further proliferation of “smart” devices and software-driven devices that enhance safety and capabilities. We were somewhat dismayed at some devices that continued to propagate proprietary technologies rather than fostering standardization and interoperability.

    We were also concerned at some products that didn’t incorporate enough aesthetic design. A very small number of products also seemed be wildly expensive, and while we recognize the substantial costs involved in product development and cost is not our leading criteria for prize worthiness, these examples did raise some concern with respect to their impact on medical cost inflation.

    Overall, though, this was an exceptionally strong year for medical design excellence and innovation. The industry will be very pleased to learn of the winners later this spring.

    Iraq, Afghanistan

    What does Iraq and Afghanistan have to do with the MDEA? As one famous surgeon once said, the one indisputable “benefit” of war was in the training of young surgeons.

    Indeed, a number of products were brought to the table that have emerged out of combat experience with injuries and trauma. Without trying to be political, it can be said that at least some good things have come out of that very difficult and challenging situation.

    Ogan Gurel, MPhil
    gurel@aesisgroup.com
    http://blog.aesisgroup.com/

    The Logic of American Healthcare

    February 5, 2008 by ogangurel

    On primary election day here in Illinois, it would be of interest to discuss healthcare reform – an issue that goes head-to-head with the Economy and Iraq as the number one issue facing voters this political season.  One sentiment that appears to unite nearly all the candidates is the claim that our healthcare system is “broken.”  Everybody has a healthcare reform package with the hope – among the Democrats in particular – to solve the huge problem of covering the nation’s 46 million uninsured.

    It would be helpful to review – in broad strokes – how are healthcare system works (or as many have stated doesn’t work).  Despite the claim that it is an irrational system there is, in fact, a logic that has evolved over the past sixty years.  It is a logic that points to why the 1993 Clinton reform plan failed and why both the Obama and “new” Clinton proposals are also potentially doomed. 

    As a consequence of the wage and price controls instituted during World War II, employer-sponsored healthcare insurance has become – at least until recently – the avenue by which the employed have obtained healthcare coverage.  With the 1960’s and the Great Society programs, Medicare and Medicaid were enacted to cover the well recognized gap that developed among the non-working elderly and poor respectively.  More recently during the 1990’s SCHIP was brought on board to cover the last apparent gap – namely that of children. 

    In short, our system is actually quite logical and simple and consists of two parts:

    ·         businesses pay for the health insurance for the employed public while

    ·         government pays for everyone else. 

    Obviously this is a simplification as taxpayers and businesses, of course, pay into Social Security and Medicare.  Nevertheless it is useful to look at the system broadly along these lines.

    There are many reasons why the 1993 healthcare reform effort failed but it would seem that the core reason was that it would upend a system that had evolved through fits and starts (and occasional bursts) over the past sixty years.  In essence, the proposal at that time was that government would pay for (and run) everything. Beyond all the usual complaints against “socialized medicine” such a framework was simply too radical for the logic that was firmly in place.

    Using this framework and fast forwarding to the present we can see that both the Clinton and Obama plans (as summarized very nicely in Paul Krugman’s New York Times column from today) while less radical than that proposed in ’93 likewise complicate the logic and thus run an equal risk of failing.

    Given the premise that there is a large population of uninsured among the working public, a proposal that would fit with this logic would propose that businesses in some form would actually fund healthcare insurance for the uninsured working public.  In essence, both the Clinton and Obama plans would ask (and in the case of the Clinton plan “mandate) uninsured individuals to pay for their healthcare insurance.  Notwithstanding the subsidies that would be involved to make this more-or-less affordable (as the candidates claim), this would create a more complex – and in a certain sense less logical – system of three parts. Namely:

    ·         some businesses pay for the health insurance for the employed public while

    ·         uninsured working people (some in the case of the Obama plan) pay for their own insurance and then

    ·         government pays for everyone else. 

     

    This three-part system – with the operative terms “some” as indicated – strikes me as an inherently unstable system.  The “some” businesses may become more, government gets mixed in with the working public and the problems that we lament over now may look like a party compared to the chaos of the future.

    The concept of having businesses pay for the health insurance of the uninsured working public is not a new one.  Gov. Blagojevich tried that – though in a rather crude way – with the proposed “gross receipts tax” which was roundly defeated and likewise Gov. Schwarzenegger has attempted that in California.  In the latter case, an amalgam of business taxes including those on hospitals and doctors sent his proposal to failure as well.

    So what’s the answer?  Last year, this column – in the wake of the Blagojevich plan proposed a new form of business tax – the health impact tax – that was expressly designed to:

    1.      fit with the existing logic of our healthcare system; namely acknowledging that businesses should continue their role in paying for healthcare insurance for the working population, and

    2.      be fair with respect to the actual healthcare burden that different businesses create on society and hence also proportional to how much they should pay for the uninsured funding pool, and, in fact,

    3.      also provide direct tax incentives for encouraging healthier businesses

     

    It is important to note that this proposal is not “anti-business” but rather consonant with the established principles of our healthcare system over the past half-century.  While it aims to preserve the balance that we have created over these years, it is neither a “conservative” plan as it proposes a 21st century health impact tax (akin to a “carbon tax”) that fully and fairly apportions the externality costs created within our society. 

    If you are interested in more details, I would encourage you to read the Midwestbusiness.com column or my follow blog article.  The bottom line is that while we are voting for what appears to be set positions by the various candidates, the debate isn’t over yet.   We can do better.

     

    Ogan Gurel, MPhil
    gurel@aesisgroup.com
    http://blog.aesisgroup.com/

     

     

    Innovation vs. Invention – Part III: Accelerating Development

    January 21, 2008 by ogangurel

    This is the last part of a three-part series on innovation.  The first part “Concepts of Innovation, Invention Should Now Be Regarded Differently” explored three basic points:

    1.      Innovation is different from invention

    2.      Innovation is the realization of invention

    3.      Innovation often results from a combination of inventions

    The second part focused on fostering innovation and outlined the following three major points:

    1.      Invention needs to be left free; innovation needs to be managed

    2.      Invention is often isolated; innovation is connected

    3.      Marketing: For invention product is key; for innovation product, placement, and promotion all need to be brought together

    This last point – namely the importance of marketing – is crucial.  As folklore would have it, invention is the product of the mad genius, innovation, however, is really the result of the even crazier market.  G. Pascal Zachary wrote an interesting column “The Risk of Innovation: Will Anyone Embrace It’ in yesterday’s New York Times on just this very topic.  One quote from that article suffices to make the point:

    Whether humans will embrace or resist an innovation is the billion-dollar question facing designers of novel products and services. Why do people adapt to some new technologies and not to others? Fortunes are made and lost on the answer.

    Why Accelerate?

    This last part of the series raises a few points about accelerating development. Namely, once we’ve started to innovate and have mechanisms to foster innovation, how do we go about accelerating development of that innovation?

    Why accelerate development?  This may seem like an obvious question with an obvious answer.  However, a development that is innovative enough to be accepted by the market may still be relatively valueless if it reaches the market too late.  The phenomenon of rapidly accelerating technology development and increasingly compressed product life cycles was the topic of a previous column “Intellectual Property: Does it Matter?” which pointed out that a strong a particular intellectual property portfolio means nothing in the context of looming technological obsolescence. 

    Clearly, then, integrating the extracted value over the life cycle means “front-loading” more market penetration in the front end rather than over expending efforts towards patent protection on the product life cycle “back-end.”

    VC Financing A Barrier to Accelerating Development?

    Although simplified for the purposes of this short column, there are two basic barriers to accelerating development.  These are:

    1.      Rigid Startups

    2.      The Innovation Gap

     

    Ogan Gurel, MD MPhil
    gurel@aesisgroup.com
    http://blog.aesisgroup.com/