When half a million Americans died and nobody noticed

Was the US drug Vioxx responsible for far more deaths than has been acknowledged so far?

Column LAST UPDATED AT 10:03 ON Fri 27 Apr 2012
Alexander Cockburn

ARE American lives cheaper than those of the Chinese? It's a question raised by Ron Unz, publisher of The American Conservative, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals – melamine in baby formula - and how the US handled the Vioxx aspirin-substitute disaster.
 
The Chinese scandal surfaced in 2008, shortly before the Beijing Olympics. Crooked dairymen diluted their milk products, then added a plastic chemical compound called melamine to raise the apparent protein content back to normal levels. Nearly 300,000 babies across China suffered urinary problems, with many hundreds requiring lengthy hospitalisation for kidney stones. Six died.

Long prison sentences were handed down and a couple of the guiltiest culprits were tried and executed for their role. Throughout these events, American media coverage was extensive, with appropriate sneering about the Chinese leadership's indifference to human life.
 
Four years earlier, in September 2004, Merck, one of America's largest pharmaceutical companies, issued a sudden recall of Vioxx, its anti-pain medication widely used to treat arthritis-related ailments.

The recall came just days after Merck discovered that a top medical journal was about to publish a study by an FDA (Food and Drug Administration) investigator indicating that the drug in question greatly increased the risk of fatal heart attacks and strokes and had probably been responsible for at least 55,000 American deaths during the five years it had been on the market.
 
It soon turned out Merck had known of potential lethal side effects even before launching Vioxx in 1999, but had brushed all such disturbing tests under the rug.

With a TV ad budget averaging a hundred million dollars per year, Vioxx swiftly became one of Merck's bestsellers, generating over $2 billion in yearly revenue. Twenty-five million Americans were eventually prescribed Vioxx as an aspirin-substitute thought to produce fewer complications.
 
There was a fair amount of news coverage after the recall, but pretty slim considering the alleged 55,000 death toll. A class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007.

When the scandal first broke, Merck's stock price collapsed, and many believed that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck's stock price eventually reached new heights in 2008 and today it is just 15 per cent below where it stood before the disaster.
 
The year after the scandal unfolded, Merck's long-time CEO resigned and was replaced by one of his top lieutenants. But he retained the $50 million in financial compensation he had received over the previous five years. Neither he nor any other Merck executives was charged with corporate malfeasance.

Senior FDA officials apologised for their lack of effective oversight and promised to do better in the future. The Vioxx scandal began to sink into the vast marsh of semi-forgotten international pharmaceutical scandals.

Then in 2005, as he now remembers it, Ron Unz "was reading my morning newspapers, as I always do, and noticed tiny items about an unprecedented drop in the American death rate. Hmm I said, I wonder if that might have anything to do with all those other stories about that deadly drug recently taken off the market and all the resulting lawsuits."
 
The year after Vioxx was pulled from the market, the New York Times and other media outlets were running minor news items, usually down-column, noting that American death rates had undergone a striking and completely unexpected decline. These were what Unz, a dedicated news browser, was reading.
 
Typical was the headline on a short article that ran in the 19 April 2005 edition of USA Today: 'USA Records Largest Drop in Annual Deaths in at Least 60 Years.' During that one year, American deaths fell by 50,000 despite the growth in both the size and the age of the nation's population. Government health experts were quoted as being greatly "surprised" and "scratching [their] heads" over this strange anomaly, which was led by a sharp drop in fatal heart attacks.

For his Chinese melamine/Vioxx comparison, Unz went back to those 2005 stories. Quick scrutiny of the most recent 15 years worth of national mortality data provided on the US Government's Centers for Disease Control and Prevention website offered Unz some useful clues.

"We find the largest rise in American mortality rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn," says Unz. "Vioxx was almost entirely marketed to the elderly, and these substantial changes in the national death-rate were completely concentrated within the 65-plus population.

"The FDA studies had proven that use of Vioxx led to deaths from cardiovascular diseases such as heart attacks and strokes, and these were exactly the factors driving the changes in national mortality rates."
 
The impact of these shifts, Unz points out, was not small. After a decade of remaining roughly constant, the overall American death rate began a substantial decline in 2004, soon falling by approximately five per cent, despite the continued ageing of the population. This drop corresponds to roughly 100,000 fewer deaths per year. The age-adjusted decline in death rates was considerably greater.
 
"Patterns of cause and effect cannot easily be proven," Unz continues. "But if we hypothesise a direct connection between the recall of a class of very popular drugs proven to cause fatal heart attacks and other deadly illnesses with an immediate drop in the national rate of fatal heart attacks and other deadly illnesses, then the statistical implications are quite serious."

Unz makes the point that the users of Vioxx were almost all elderly, and it was not possible to determine whether a particular victim's heart attack had been caused by Vioxx or other factors. But he concludes: "Perhaps 500,000 or more premature American deaths may have resulted from Vioxx [my italics], a figure substantially larger than the 3,468 deaths of named individuals acknowledged by Merck during the settlement of its lawsuit. And almost no one among our political or media elites seems to know or care about this possibility."
 
I remarked to Unz that it seemed truly incredible that a greater than expected death rate of this dimension should scarcely have caused a ripple.
 
"I'm just as astonished," he said. "From 2004 onwards, huge numbers of America's toughest trial lawyers were suing Merck for billions based on Vioxx casualties - didn't they notice the dramatic drop in the national death rate?

"The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China.
 
"Besides," says Unz laughing, "it shows the stupidity of our political leaders that they didn't seize upon this great opportunity.  They should have just renamed Vioxx the 'Save Social Security Drug,' and distributed it free in very large doses to everyone, starting on their 65th birthday. Maybe they should have even made it mandatory, three times per day. At sufficiently large levels of national consumption, Vioxx could have almost singlehandedly eliminated all our serious budget deficit problems. 'Vioxx - The Miracle Anti-Deficit Drug'." · 

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The Chinese executed some at the top of corporate companies that cause death we & America give them a scolding, a slap on the hand, a derisory fine & they walk away scott free.
Another sign that politicians & corporate  business are in bed together

Great article, but 55,000 is not half a million, is it? Wrong by a factor of 10.

Think of all the fuss over 9/11, just a drop in the ocean compared with the terrorism carried out by so called 'free enterprise' drug companies. No memorial? No tacky parade and wreaths laid? No address by the President from the White House? No war on capitalist terrorists?

 Did you read the article ?

 55 k is the figure proposed at the beginning by the FDA,

 the 500 K is the putative figure recently arrived at by looking at the sudden rise and then later fall in the US death rate and  calculating the net difference over the time that Vioxx was "available".

And nobody noticed all these old people dying ??

And no one from Merck served a day in jail.   Sad. 

Mr Cockburn, the American media is well known for their willingness and readiness to castigate other countries/ governments in the world while being blind to the numerous problems present here in the US. Friends were surprised when I said recently that of all the countries in which I have lived, in all continents, the one whose health service I have the least confidence in is the USA's. The reason- because it is too money and profit driven. I fear that these will be uppermost in the minds of most of the health professionals who treat me or whose advice I seek.

Ah the famous insurance based, 'we don't want a socialist NHS here', American health system , fails again.  What a surprise.  I wonder how many American politicians got their campaign funds greased by Merck?

According to this Cockburn interpretation of reality, Chinese Military Controlled and Bureaucrat Supervised Collective Farms intentionally poisoning 300,000 babies in their drive to meet PRC Central Committee's quotas is a perfect moral equivalent to a private enterprise in the West ignoring some research that probably resulted 11,000/year deaths, over 5 years, of people over 65?  Yeah, Exactly The Same Thing.   Oh, and not to trouble you too much with math, but the report says deaths went up by 50,000 Per Year, and that the drug may have contributed to the death of  11,000 Per Year (55,000 over 5 years).  So, what caused the other 39,000 deaths in the increase?  Some other evil corporate plot to murder their paying customers?   Panic mongering marxist drivel.  Of course Merck should be punished, and probably more than they were, but we don't live in the PRC where scape-goats are publicly convicted in kangaroo courts and are then taken out and shot in the head, and their families charged for the bullets.

..not entirely true - we slash their $8 mil annual bonuses by 20%

So, the entire article is just a farce?

I don't think you read your chart properly.  There's a big increase from '98 to '99 and an equally large decrease from '03 to '04

I suspect this is true, although after reading the article, I am under the impression that Unz did not rigorously analyze his statistical data using confidence tests.

Given the significance of this issue, I think it would be important to compute those confidence intervals.

 Your link is broken.

The statistics you are citing are general death rates not those associated with heart attacks. I want to see the data used for this as well, but if your going to cry foul, at least get YOUR stats right.

turning a blind eye allowed a very effective population control.  

Yeah; it’s a shame that we pay the FDA, not only in money
but also our liberties, which puts up a guise of safety and then protects the
company from punishment. (Very similar to the cigarette cartels set up by the
U.S.  govt) The tax revenue is too much
to say no… and you are right we should let the markets decide which companies
can survive, instead of setting up crony capitalism... which in turn puts and
end to competitiveness and innovation… removes accountability and makes it for
faulty products to stay on the market… 
no company would put shit on the market if the government was not there
to protect them from lawsuits, and keep the prices sky high.

If this were true, someone else would have noticed it...sounds too good to check...

Correct me if I am wrong here on the Math in this article. Basically its states that over the life time that the drug was out Merck made 10 Billion dollars...and the lawsuit payed out 4.85 billion...they killed this many people are still in business AND made more than 5 Billion.  In a just world ALL of their money they ever made should have been taken and distributed to the victims families. And the company taken over by the US government and dismantled/sold to other companies. Oh and those who knew about it...should have been hung.

To all the conservative politicians who enabled this to happen: Have fun in Hell.

Psuedoscience at it's worst.  You have NO IDEA as to the source of reduced deaths!

At least make some secondary correlation with an increase of deaths when it was introduced; otherwise, your accusation is groundless.

SO WHAT!!?? Marijuana and cocaine kill more Americans than that EVERY DAY! That is why they are ILLEGAL!  Please get it through your heads that no matter how many people get killed by prescription drugs, they are SAFE!  They have been approved by the GOVERNMENT!

 Wow, someone has stolen my ID and is writing some craaaazy stuff.

You can't trust the government, any government, to do anything right!

Very well-done review of the Vioxx disaster. I attended the FDA advisory meeting in Gaithersburg, MD and was sitting in the first row as the Merck personnel testified. This was the only hearing I attended where the audience laughed at some of the Merck responses to questioning. Many in the audience had access to internal Merck documents which detailed their cover-up. Why are these people not in jail? The simple answer is that like in the "second-generation" anti-psychotic drug disaster, money trumps ethics in  Big Pharma.  Sad to say.

I can't help but reflect on 9/11, and how Americans still get in a tizzy and to this day cry into their cornflakes and find jokes about it distasteful.

And here we have as many as 100 times more people dying, and nobody gives a shit and the head of the organization who did it lectures at Harvard and is on the board of Microsoft.

 It ain't over until the fat lady sings..........Ray Gilmarting is now teaching at Harvard....and, on the board at Microsoft and sleeping very well at night. The only thing I can say is that Karma is a bitch. He may not know what is coming and when it is coming, but...mark my word....It will come.

what a joke, they are still operating.

Yep, and we have one political party that works overtime to stop lawsuits from happening. Tort reform is all about protecting the hiney of the most powerful.