[Ip-health] Vioxx and the Mortality Paradox

Riaz K Tayob riaz.tayob at gmail.com
Wed Jun 6 06:24:41 PDT 2012


[Will WHO not make a statement about substandard medicines...]

June 05, 2012
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The Health Benefits of Cyanide
Vioxx and the Mortality Paradox
by RON UNZ

In recent weeks my description of the possible scale of the Vioxx 
Disaster has begun getting a little coverage on the web and in the 
British press, leading to some strong “push back” by people who say I 
can’t possibly be right. They may certainly be correct in their opinion, 
but I think their reasoning is mistaken, so I thought I’d briefly 
summarize the analysis once more, emphasizing again that the evidence is 
purely circumstantial.

I realize most readers may be growing increasingly weary of Vioxx 
mortality disputes—I certainly am—but given the tens or more likely 
hundreds of thousands of American deaths at issue, adding a few short 
paragraphs of text seem not totally unwarranted.

(*) In 1999, Vioxx was marketed to the American people by Merck as a 
particularly effective anti-pain medication with minimal side-effects, a 
sort of super-aspirin substitute targeted at arthritis sufferers in the 
over-65 category. Backed by an eventual half-billion dollars of 
advertising, it soon became one of the most widely popular—and 
lucrative—drugs in this country and the world, with some twenty-five 
million total American prescriptions. As a consequence, it also became 
one of Merck’s most important revenue sources.

(*) In 2004, a detailed published FDA study proved that Vioxx had deadly 
consequences in its patients, greatly increasing the risk of sudden 
cardiovascular death, and had probably killed at least 30,000-60,000 
Americans since its introduction. Learning of the pending publication of 
this study, Merck immediately pulled the drug from the market. The media 
later discovered that Merck had apparently been aware of these huge 
cardiovascular health risks from the very beginning, but had decided to 
ignore them, presumably because the drug was so lucrative. Merck 
eventually paid some $8 billion dollars in total government fines, legal 
expenses, and damages for Vioxx-related deaths.

(*) As it happened, the 2004 American death rate unexpectedly dropped by 
50,000, the greatest such national decline in sixty years, a decline 
whose cause completely mystified American health authorities, who 
searched in vain for some possible logical explanation. This decline was 
almost entirely due to fewer deaths in 65+ age range, mostly due to a 
large drop in cardiovascular fatalities.

(*) Interestingly enough, an examination of the American mortality data 
freely available on the government CDC website reveals a corresponding 
rise in deaths for Americans 65+ which had previously occurred in 1999, 
the year Vioxx was introduced. This 1999 mortality rise was the largest 
in the past fifteen years, and—perhaps coincidentally—a sharp shift in 
the rate of cardiovascular deaths had once again been the leading factor.

It is completely impossible for me to say whether or not the recall of a 
an extremely popular but deadly drug proven to cause cardiovascular 
deaths among its 65+ target population had any direct connection to the 
huge drop in cardiovascular deaths among Americans 65+ during that same 
year. Similarly, the earlier sharp rise in 65+ cardiovascular deaths the 
year the drug had been introduced may or may not be purely coincidental. 
But one would think these intriguing facts might arouse a bit of 
curiosity within American media and government circles.



Based on these items, I have advanced a speculative hypothesis 
suggesting a much higher Vioxx death-toll than is currently accepted. 
One of the main arguments which various critics have made against my 
hypothesis is that although the American 65+ death rate did undergo 
rather surprising upward and downward shifts during 1999 and 2004, the 
years that Vioxx was introduced and then removed, the behavior of the 
death rate during the intervening years was far less remarkable. A few 
people have argued that the widespread use of a deadly drug during 
2000-2003 would surely have caused large, continuing changes in the 
mortality figures, and their absence tends to completely eliminate the 
possibility.

Unfortunately, this reasoning is incorrect, and confuses an impact upon 
total longevity with an impact upon mortality rates. This can easily be 
understood if we consider an extreme thought-experiment.

Suppose, for example, that the government required everyone aged 65 and 
above to immediately take cyanide tablets, and established this as a 
permanent policy going forward, with mandatory cyanide doses being a 
fixture of every 65th year birthday party.

Obviously, this would lead to many premature American deaths and a very 
substantial change in American lifespans. Indeed, since our current 
life-expectancy is around 78, the vast majority of Americans henceforth 
would be killed by government cyanide, instead of dying naturally. Over 
the next hundred years, the overwhelming majority of all deaths would be 
from cyanide, and the total cyanide death-toll in America might approach 
the half billion mark. Clearly, cyanide would become a very major 
negative health factor in American society.

However, the actual impact upon the annual American death-rate would be 
small or perhaps even favorable during nearly the entire period in 
question, a totally astonishing result. This seeming paradox follows 
from the fact that everyone eventually dies of something, and therefore 
there would automatically be huge drops in cancer, heart attack, 
strokes, and car accident fatalities which would almost exactly balance 
out the rise in cyanide deaths.

Consider, for example, the American population one hundred years from 
now and compare it with a non-cyanide scenario. In the former case, 
there would be no one aged 65+, with that portion of the population 
having succumbed to cyanide; but those would be the *only* differences 
in total net-fatalities compared to the base-case Every other American 
death would have been the same under the two scenarios, though certainly 
with different timing. And if we average that small slice of additional 
deaths over the one hundred years in question, the average annual impact 
is fairly small.

Obviously, the first year of a mandatory-cyanide scenario would see a 
huge die-off of all those 65+. But mortality rates after that would 
generally be pretty ordinary, perhaps even sometimes *lower* than under 
the normal situation, depending upon the shape of the evolving 
age-distribution curve. Indeed, it is quite possible that people just 
looking at the mortality rates for the ninety-nine following years and 
comparing these with current projections might notice they were somewhat 
reduced, and wrongly conclude that mandatory cyanide might have 
significant beneficial properties, since it seemed to cut mortality 
rates. This rather counter-intuitive result might be termed “The 
Mortality Rate Paradox.”

However, if at any point, the mandatory-cyanide policy were 
discontinued, that particular year would see a remarkable *drop* in the 
annual death rate, followed by smaller changes in subsequent years, 
until eventually a new age-mortality equilibrium was established. Thus, 
the only significant signals of a mandatory cyanide policy found in the 
annual mortality rates would come at the beginning and at the end of the 
policy.

Obviously, Vioxx did not remotely have the lethality of cyanide, nor was 
its use universal among the elderly. Moreover, any Vioxx-related 
mortality shifts were substantially masked by much larger directional 
mortality trends due to the aging of the population, improvements in 
life-saving and other medical technology, and all sorts of other 
factors. Distinguishing signal from noise is not as trivial as examining 
the slope of a curve.

But it does seem a bit intriguing that the mortality-curve for Americans 
65+ followed a very similar trajectory to that of the extreme 
thought-experiment: a sharp rise in the year of introduction, a few 
years of relative stability, and then a very sharp drop in the year of 
recall.

Most of the Vioxx defenders put the total six-year death toll perhaps 
around 33,000, or roughly 6,000 additional deaths per year. But the 
actual shifts we find at the crucial starting and stopping points are 
far higher than this. For example, elderly deaths actually rose 35,000 
in the year Vioxx was introduced, a figure several times larger than the 
average for the preceding few years, and dropped by 67,000 in the year 
it was withdrawn, which was similarly anomalous and remarkable, many 
times higher than the recent average change. Both these mortality shifts 
were heavily driven by the cardiovascular category.

It seems to me that a Vioxx-induced premature American death toll which 
was well into the hundreds of thousands is the most parsimonious 
explanation of these surprising mortality statistics.

Ron Unz can be reached at his website.






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