Pradaxa: a bid for enrichment

Vincent J. Curtis

15 Feb 14

The report below is in respect to a law suit in which a university located in my hometown is indirectly involved.  The case involves excessive bleeding caused by the use of Pradaxa, a drug said to be superior to warfarin in the control of blood clotting due to irregular heartbeat.  The blood clotting from inrregular heart beat can break free from the heart, travel to the small blood vessels of the brain, and cause a stroke.  Warfarin, pradaxa and other drugs prevent clots from forming to begin with.  This condition has dangers of its own.


I read the excellent report Steve Buist, Investigations Editor of my local newspaper, on the Pradaxa case, presently ongoing in East St. Louis.  Based on what he wrote, there seems to be one or more logically fallacies at the heart of the court case.  The most obvious one may be boiled down to the distinction between the relative and the absolute.

The PHRI study, by which the FDA approved Pradaxa, compared the relative effects of warfarin and two dose levels of Pradaxa.  Among the three, the 150 mg dose of Pradaxa was relatively the best for treating blood coagulation problems.  But that result does not establish that, absolutely, there will be no complications in using the the drug at that concentration.  The case against Boerhringer Ingelheim and PHRI seems to be based upon the belief that Pradaxa was held up to be absolutely safe, when in fact the clinical trials only showed that it was relatively the best treatment among those studied. Moreover, these results are statistical and based upon probabilities; they may not hold in individual cases.

I am a little surprised that the PHRI study did not include a control group of sufferers who were denied any kind of treatment.  A study that included that kind of control group would presumably show that, absolutely, treatment with Pradaxa provided the best of outcomes, again statistically. It would also show that none of the outcomes were as good as perfect health.  These people are suffering a morbidity, after all.  The taking of Pradaxa is to substitute a less bad morbidity for one that is worse.

Thus when people who are being treated with Pradaxa suddenly suffer abnormal bleeding, against what are we to compare that abnormality: relative to a warfarin treatment?  What of the absence of treatment altogether?   Would the patient have suffered a stroke instead of bleeding in that time period?  In individual cases, no one can say what the absolute outcome is going to be.  We know what the statistical average should be in a large number of cases.  We know what we would like it to be in individual cases: to be like the restoration of perfect health; but that ideal is not always possible. And grown people ought to know that.

In addition, when one studies a group of 44,000, as was done in the PHRI study, any outcome which happens six times in a million will not likely be observed.  Thus when jumping to the full population, numbering in the many millions, outcomes are possible which were not observed in clinical trials. Grown-ups ought to know this.

Thus the lawyers for the plaintiffs are going to engage in one or more logical fallacies and are going to try to prove that the scientists at PHRI and at Boerhringer Ingelheim didn't know what they were doing.  The lawyers are going to try to show that they, mere amateurs, are smarter than the scientific experts.  The scientific experts are experts in medicine, not the more obscure realms of logic.  I fear the trial will prove to be a farce of reasoning and argument.

I understand why Boerhringer Ingelheim is dragging its feet.  The plaintiff's lawyers have nothing to go on except the complaints of their clients and the inconclusive FDA report that Buist mentioned in his article.  They are engaging in a fishing expedition so that they can find some statement which in isolation proves to be sensational to their case.  The requirement by the judge that the company provide copies of "any possible derivation of means to document someone's thoughts, words, and deeds short of attaching electrodes to their scalps and electronically downloading what is contained in their minds" is almost inconceivably broad and would likely amount to millions of pages if completely fulfilled.  That is quite a burdensome administrative undertaking, disruptive and costly for the company and of no possible benefit to it.  No doubt some things will be left out, and the failure to deliver some obscure document will be held up as a sign of a guilty conscience and bad faith.  The note taking by the scientists will, in future, be conditioned by the fear that those notes may be subpoenaed as evidence.

Buist's account of the case was excellent.  I fear from his report that the trail will prove to be a farce and will unfairly blacken the reputations of some really good people.  Unfortunately, the lawyers for the plaintiffs will not be made to suffer for their misdeeds, and the trial judge will not be made to suffer for failing to act upon the observation that this case is a farce start to finish.

If you just want new drugs like Viagra, then by all means let trials like that over Pradaxa flourish. But if you want new medicines that treat serious illnesses, then these farce-trials need to be exposed for what they are: a bid for enrichment, first by the lawyers and then by the plaintiffs.
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CCV was never a Good Idea

 

 
Vincent J. Curtis


23 Dec 2013

 

David Pugliese broke the story that the Close Combat Vehicle acquisition project will be cancelled by DND.  The CCV acquisition was plagued with problems from the beginning, and several rounds of requests for proposals were unsatisfactory.

 

Julie DiMambro, spokesperson for MND Rob Nicholoson, was quoted as saying, “…our Government has been living up to our promise to give the Canadian military the tools it needs to get the job done….the Canadian Armed Forces are once again the best in the world.”

 

The real story behind the cancellation of this new CCV tool is not the lack money, not a lack of satisfactory options, but the lack of a warfighting doctrine by the army combined with the lack of money.  The Army brass simply does not know what the next job is going to be, and cannot justify to itself buying an expensive tool designed for a job that may not come up.

 

What army reservists are training for is often a good sign of what DND brass expects the army to have to do should the call go out.  Since the end of field operations in Afghanistan, army reservists have not been doing much of anything specific, and nothing that involves the coordinated movement of several companies at a time.  Training from out of the 1960’s: patrolling, light infantry advance-to-contact, has been the army reservist fare since the wind-down of Afghan style tactical scenarios.

 

Some time in February, 2014, several light infantry units of 31 Brigade, 4^th Canadian Division, are going to be moved to Rankin Inlet, Nunavut, to undertake an exercise there.  Rankin Inlet lies on the western shore of northern Hudson’s Bay.

 

It is expected that the reservists will operate out of the NORAD Forward Operating Location Rankin Inlet facilities at the Rankin Inlet Airport.  What exactly the reservists are going to practice, few involved seem to know.  What the anticipated OPFOR object this exercise is supposed to defeat is met with a chuckle.  No mechanized combat vehicles or artillery are expected to come along.  Light infantry is going to be plunked down in the middle of the Arctic and expected to do something by itself.

 

DND is going to overpay for the nine-day exercise in the high Arctic, and sources suggest that 31 Brigade is looking for the excess cash.  Deploy, freeze, return, collect.  An object of this exercise may be that it demonstrates to the world Canada’s commitment to the high Arctic.  But no one involved seems to know.

 

The army top command has communicated no idea of the next kind of war the army will be called upon to fight.  They have communicated little idea of how they would like to fight.

 

Spending $2 billion on the acquisition of a new vehicle that is designed to fight best on the terrains of Europe could prove to be financially dislocating.  Investing that much money into what could prove to be the wrong thing does not help burnish reputations or help the soldiers who have to risk their lives working with them.

 

DND did have a particular vehicle in mind when the CCV project began, and would likely have bought it had it been offered.  Rheinmetall makes an all-new Puma CCV for the German Army.  It was designed from the ground up to be able to work closely with the Leopard II tank, which the Canadian army now has in good numbers.  What Rheinmetall actually offered DND as a CCV was not the Puma they hoped and expected, but a reworked and upgraded Marder vehicle, which the German army was taking out of service and replacing with the Puma.  DND turned down the offer for used vehicles.

 

Also offered in the CCV category was the new Swedish CV 90 vehicle.  Whether this vehicle would be able to work closely with non-Swedish tanks and on non-Swedish terrain remained questions.

 

Buying a vehicle now that unquestionably could work with the current inventory of Canadian tanks might have justified the CCV acquisition project to go forward.  Lacking such assurance, a good reason to acquire a CCV regardless was lacking.

 

Through the Canada First Defense Strategy, the Canadian government promised the military a stable and predictable level of funding over a twenty year period.  That promise lasted until the first budget crisis.  The cancellation of the CCV project, however, was not the product of the government failing to live up to the promise for the military to buy new equipment.  This was a decision of the military brass, who can’t justify the expenditure to themselves.

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Book Review: My Share of the Task, a Memoir

 

 

Vincent J. Curtis

30 October 2013

 

My Share of the Task: A Memoir By General Stanley McChrystal

 

Portfolio/Penguin
2013
ISBN 978-59184-475-4
452 Pages
Hardcover
$29.95 US

 

This is as much a book about leadership as it is a history.  General Stanley McChrystal was as important as General David Patraeus was in America’s War on Terrorism in the decade from 2001 to 2010.  McChrystal was the one who organized the counterterrorism effort of the U.S. military against al Qaeda in Iraq and Afghanistan.  The death of al Qaeda in Iraq leader Abu Musab al-Zarqawi in 2006 and the destruction of his network were the high achievements of McChrystal’s organization in that decade.  These, combined with the exploitation of the “Anbar Awakening” and the military surge of 2007-8, were what led to an end of the wave of terrorism and civil war that engulfed Iraq in the aftermath of the invasion that brought down Saddam Hussein, and enabled the Coalition to depart Iraq in 2011 with a stable Iraqi government in place.

 

McChrystal spent most of his military career in the Special Operations community of the U.S. military.  He qualified as Airborne, Special Forces, and Ranger and spent most of his development period either in command of units or as the J3 (Operations Officer) of units.  He spent as little time in the Pentagon as he could get away with.  Eventually, the lack of political instincts which would have been developed by a long stay in the Pentagon were to cost him at the end of his career.

 

The military reader can gain on two fronts by reading this book.  The first is on leadership and the second on the development of “industrial counterterrorism.”

 

In taking the reader through his development period, McChrystal enables the student of leadership to gain valuable insights not only into what made McChrystal the General, the Commander, and most importantly the leader he became, but also what makes good military leaders in general in the modern world.  Seeing the finished product in Iraq, the British saw him as a “soldier-monk.”  Supported by his loyal military wife Annie, McChrystal dedicated his life to the war against al Qaeda.  He spent years in Iraq and Afghanistan, living in spare accommodations immersed in the war, and enjoyed next to no down time back home during the prolonged crisis of the war.  McChrystal did not do a “tour”, he fought the war.

 

McChrystal’s great achievement as a leader was the development of Task Force 714.  There was no model for such a thing.  But in order to fight the metastasizing cancer of al Qaeda inspired terrorism in Iraq, McChrystal invented what came to be called “industrial counterterrorism,” and TF714 was the vehicle by which that method of combatting terrorism was deployed.  All the means by which intelligence was gained and analyzed were fused with the means of fighting in TF714, and industrial counterterrorism was the product of a feed-back loop of intelligence and captures run at very high speed.  Based on information provided by intelligence, US and British Special Operators used to go out on several missions a night, capturing terrorists for the further exploitation by the intelligence side.  Without a leader with the man-management skills of McChrystal, industrial counterterrorism would never have come about.  Industrial counterterrorism was only possible because of the vast, but disparate, intelligence and special operations resources of the United States.

 

McChrystal’s downfall came about when he let a trait that made him a great leader – trust – be exploited by people he ought to have been cautious in dealing with.

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Book Review: How to Break a Terrorist

 

 

Vincent J. Curtis


 3 January 2014

 

How to Break A Terrorist by Matthew Alexander With John R. Bruning

 

St. Martin’s Griffin
2008
ISBN 978-0-312-67511-0
287 Pages
Paperback

 

Never trust an interrogator.  That’s the bottom line message of the book.

 

Matthew Alexander is a pseudonym, but the man has appeared on television, which is how he came to my attention.  Alexander was the guy who come up with the clue which led to the killing of Abu Musab al-Zarqawi in 2006 by the U.S. military in Iraq.  Al-Zarqawi was the leader of al Qaeda in Iraq, and was the man responsible not only for a lot of terrorism in Anbar province, but for sparking the civil war between Shiite and Sunni sects that was only broken by the “surge” of 2007-8.

 

What makes the book interesting is the inside look it gives to the methods of “Industrial Counterterrorism” that was developed by U.S. General Stanley McChrystal to combat al Qaeda in Iraq and Afghanistan.  McChrystal’s book, published in 2013 and reviewed previously, gives the official account of the interrogation which led to the vital clue that ultimately led to the killing of al-Zarqawi.  Alexander’s book, published five years before McChrystal’s book, refutes the official account and Alexander claims for himself the success of having “broken the terrorist” that led to Zarqawi.  Since McChrystal does not deal with Alexander’s claim and admits that his book was written with security of operations in mind, one can conclude that Alexander is right, and that several people were decorated for an achievement they did not themselves gain but were nevertheless decorated for reasons of internal politics.  Alexander was shafted, and this book gains a measure of revenge.

 

At the time of the book’s publication, the enhanced interrogation techniques employed by the CIA to break three of the highest value terrorists in al Qaeda had become known and were highly controversial.  Alexander tossed gasoline on that fire.  His book is sub-titled “The U.S. interrogators who used brains, not brutality, to take down the deadliest man in Iraq.”  He spends several mercifully short chapters needlessly to preen about his skills, and otherwise compare himself favorably to the knuckle-dragging brutes in the CIA.

 

While the thrust of his preening was that brutality was not necessary to the breaking of his terrorist, by focussing on his skills he proves that brains in general do not always suffice either.  Alexander writes about how it was his brains, his experience, his knowledge base, his risk-taking, and his insights which led to success and not those of the team of interrogators that had been assigned to breaking the key terrorist.

 

The book does provide lots of detail about the inner workings of Industrial Counterterrorism, and how U.S. interrogators work to break people and find out what they want to know.  Alexander admits that the person he was to a terrorist was false, and the promises he made them were broken.  He can justify this as the way it works in order to achieve a good end.

 

In all, this book is worth a read.

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Virginia Latest State to get screwed over Gay Marriage

Vincent J. Curtis

29 Jan 2014

 

 

Virginia’s newly elected Attorney-General Mark Herring (D-Va) has decided not to defend in court a challenge to a ban on gay marriage in Virginia’s state constitution.  It is his constitutional duty to defend the laws of Virginia in court, and only he has legal standing to do so.  If he refuses to defend the law, no one else can.

 

Republicans in the state called upon newly elected Governor Terry McAuliffe (D-Va) to appoint a special prosecutor to do what the state A-G refuses to do.  McAuliffe declined.

 

Thus we see that not only is the United States constitution being distorted to find a right that did not previously exist in it, but also that constitutional obligations of state officials are being refused in order to facilitate the rape of the Virginia state constitution.

 

Constitutions are put in place to define the offices, political responsibilities, and general structure of an entity’s government.  It is a convenient place to entrench rights because a constitution is so hard to change, and made deliberately so.  The constitutional entrenchment - that marriage was between a man and a woman - surmounted the steep difficulty of the amendment process.  That the declared will of the majority can be overturned by legal gambits has to make one wonder about the value and even validity of other parts of the constitution, and the deal its existence once represented between the people and their government.

 

If the Virginia state A-G can ignore his responsibility to defend the laws of Virginia in court, on what basis does he prosecute people under those laws?  If the elected officials of the state of Virginia hold their offices on account of a law they refuse to uphold, why should the people of Virginia pay any attention to them and their alleged claim to the right to exercise political powers granted under that constitution?  How can they accept office on the one hand, and then decline to perform the office on the other?

 

There are two immediate answers to the second question: the fear of the coercive powers those officials have while they retain the respect of the officials who do the actual coercing; and a general inertia.  The inertia is like that of an aircraft continuing to fly forward even as the cockpit portion tears off.

 

The refusal of the state A-G and the Governor of Virginia to defend that state’s constitution in court undermines the very basis of the offices they hold.  Their refusal undermines the basis of the law by which they hold office.  If the Gov and A-G can ignore their responsibilities of office, why shouldn't the people ignore their responsibilites towards the state, such a paying taxes and obeying state laws?  If the Governor and the Attorney-General do not respect the laws of the state, why should anyone else?

 

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Now Oklahoma Gets Molested by Gay Rights Error

Vincent J. Curtis

 

17 Jan 2014

 

On Wednesday, U.S. Senior Judge Terence Kern, a Tulsa-based federal judge, ruled that Part A of an Amendment to the Oklahoma state constitution, popularly approved in November 2004 and which defined marriage as between a man and a woman, violated the Equal Protection Clause of the 14^th Amendment.

 

The judge had the decency to stay his ruling pending appeals.

 

This is the same ruling based on the same error as in the Utah case.

 

The right of women to vote in the United States was not discovered in the 14^th Amendment by the Supreme Court of the United States.  The right was recognized by the passage of the 19^th Amendment in 1920.  That is the precedent for recognizing rights in law in America.

 

At present, there is nothing in particular in law which prohibits a gay man from marrying a gay woman, and consequently there is no violation of individual rights under the 14^th Amendment by holding that a marriage is a convention between a man and a woman.

 

The judges seem to base their decisions on an assumed equality between homosexuality and heterosexuality.  While there may be a vague equivalence, everyone recognizes that homosexuality is different from heterosexuality.  That is basis enough for holding that they can be treated differently in law.  They may be equivalent, but they are not equal; and consequently the going through the charade of a marriage ceremony between a gay pair cannot be held to be equal to a true marriage.  There is nothing here for the 14^th Amendment to protect.

 

If gay marriage is to be recognized in the United States, the proper method is for a constitutional amendment, as in the case of the right of women to vote.  What gay rights advocates know is that if an Amendment concerning gay marriage were put before the American people, the product would be a definition of marriage as between a man and a woman.  That is why they are using this court gambit.

 

A few years ago, political commentator Mark Levin published a book entitled “Men in Black.”  It was an account of failings of Supreme Court justices and how those failings created bad judgements, bad law, and bad social policy as a result.  Dred Scott and Roe v. Wade are cases in point.  The Dred Scott decision led directly to the Civil War, and Roe v. Wade prevented the United States from coming to a political decision concerning abortion.  Abortion still roils American politics some forty years after the decision.

 

This history of judicial activism ought to inform the U.S federal judiciary that they should to stay out of resolving political issues through legal judgements, especially ones based upon faulty interpretations of the law.  Political problems are best resolved through the political process in America.

Rethinking Renewal in Hamilton: A Response

This is a response to an Op-Ed piece in my hometown newspaper.



Vincent J. Curtis

9 Jan 2014


Sirs;

As a connoisseur of argumentation, I found the article written by P. S. and D. P. to be an interesting specimen.  The rhetoric was superficially very good, but the reasoning of the piece was dogmatic, presumptuous, and ultimately appalling.  Delivered as a speech, it would be rabble-rousing. That means it would work on unthinking people.  But people who are able to think calmly for themselves would dismiss it.

It was presumptuous of them to assert that Hamilton is trying to reinvent itself, rebrand itself, and rebuild after suffering a double whammy.  Hamilton is trying to none of this; it is what they think Hamilton ought to do, but presently is not.

They say that in the next election Hamiltonians can choose to renew their city for the next generation, or be left behind.  A false choice could hardly be more obvious.

Like President Obama, they seek not the tangible aspects of change, but a change in attitudes and political climate, a fundamental change.  Apparently, the natural evolution of the city is not good enough for them.

They say that somebody should be learning from grassroots leadership.  Well, what is city government for? and who, exactly, are the grassroots leadership?  You would think that city councillors constituted the leadership of the grassroots.  That is what their job is, after all.  By grassroots leadership, they seem to mean self-appointed busybodies who can’t get themselves elected.

City Hall needs to be open to everyone, they say.  Well, in general, that sounds reasonable.  But what is one to do when unreasoning stupidity presents itself frequently at city hall?

They want to improve the quality of our streets.  Well, I do too.  They all should be well paved, and they are not.  But what S. and P. want to do is reduce main traffic arteries, streets essential to commerce and life in the city, to the status of residential streets.  They seem to say that kids ought to be able to play road hockey on Upper James, Main Street, Mohawk Road, Cannon,  Rymal Road, and Victoria Avenue.

They want to shaft property developers with new charges, with all the righteousness of the Occupy Wall Streeters.

They want to run an I heart Hamilton campaign to raise the city’s profile internationally.  What this expense was supposed to achieve went unmentioned.

They want us all to be more politically involved in city business than we are at present.  That may mean that we get twice as many political pamphlets from our city councillors as we do at present. Otherwise, that statement is more applicable to the school boards than to city council.

Of course, we have to spend a cool billion upon the LRT - the “game-changer.”  And bike lanes, which are not “social services” and are not “costs” but “investments.”

This rhetoric for the mob: for those already convinced.

By the time the folly in this sort of program is found out, it will be too late.  Kind of like how Obamacare is working out in the United States, of which it was said that you had to pass it in order to find out what was in it.

What this city does not need is a large dose of experimentation by sorcerer’s apprentices.  The city should be left to evolve naturally and with a prudent eye towards the budget and keeping costs low. Often, the less activist the government, the better.  Activist government is mistake-prone and costly.

The city has enough trouble keeping its streets paved.  It does not need to take on large and expensive new endeavors.

Regards;