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.
-30-
Thursday, February 20, 2014
Friday, February 7, 2014
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, 4th 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.
-30-
Book Review: My Share of the Task, a Memoir
30 October 2013
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.
-30- Book Review: How to Break a Terrorist
3 January 2014
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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