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Chinese Melamine and American Vioxx: A Comparison
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TAC-ChinaAmerica In contrasting China and America, pundits often cite our free and independent media as one of our greatest strengths, together with the tremendous importance which our society places upon individual American lives. For us, a single wrongful death can sometimes provoke weeks of massive media coverage and galvanize the nation into corrective action, while life remains cheap in China, a far poorer land of over a billion people, ruled by a ruthless Communist Party eager to bury its mistakes. But an examination of two of the greatest public-health scandals of the last few years casts serious doubt on this widespread belief.

First, consider the details of the Chinese infant formula scandal of 2008. Unscrupulous businessmen had discovered they could save money by greatly diluting their milk products, then adding a plastic chemical compound called melamine to raise the apparent protein content back to normal levels. Nearly 300,000 babies throughout China had suffered urinary problems, with many hundreds requiring lengthy hospitalization for kidney stones. Six died. A wave of popular outrage swept past the controlled media roadblocks and initial government excuses, and soon put enormous pressure on Chinese officials to take forceful action against the wrongdoers.

China’s leaders may not be democratically elected, but they pay close attention to strong popular sentiment. Once pressed, they quickly launched a national police investigation which led to a series of arrests and uncovered evidence that this widespread system of food adulteration had been protected by bribe-taking government officials. Long prison sentences were freely handed out and a couple of the guiltiest culprits were eventually tried and executed for their role, measures that gradually assuaged popular anger. Indeed, the former head of the Chinese FDA had been executed for corruption in late 2007 under similar circumstances.

Throughout these events, American media coverage was extensive, with numerous front-page stories in our leading newspapers. Journalists discovered that similar methods of dangerous chemical adulteration had been used to produce Chinese pet food for export, and many family dogs in America had suffered or died as a result. With heavy coverage on talk radio and cable news shows, phrases such as “Chinese baby formula” or “Chinese pet food” became angry slurs, and there was talk of banning whole categories of imports from a country whose product safety standards were obviously so far below those found in Western societies. The legitimate concerns of ordinary Americans were fanned by local media coverage that sometimes bordered on the hysterical.

However, the American media reaction had been quite different during an earlier health scandal much closer to home.

In September 2004, Merck, one of America’s largest pharmaceutical companies, suddenly announced that it was voluntarily recalling Vioxx, its popular anti-pain medication widely used to treat arthritis-related ailments. This abrupt recall came just days after Merck discovered that a top medical journal was about to publish a massive study by an FDA 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.

Within weeks of the recall, journalists discovered that Merck had found strong evidence of the potentially fatal side-effects of this drug even before its initial 1999 introduction, but had ignored these worrisome indicators and avoided additional testing, while suppressing the concerns of its own scientists. Boosted by a television advertising budget averaging a hundred million dollars per year, Vioxx soon became one of Merck’s most lucrative products, generating over $2 billion in yearly revenue. Merck had also secretly ghostwritten dozens of the published research studies emphasizing the beneficial aspects of the drug and encouraging doctors to widely prescribe it, thus transforming science into marketing support. Twenty-five million Americans were eventually prescribed Vioxx as an aspirin-substitute thought to produce fewer complications.

Although the Vioxx scandal certainly did generate several days of newspaper headlines and intermittently returned to the front pages as the resulting lawsuits gradually moved through our judicial system, the coverage still seemed scanty relative to the number of estimated fatalities, which matched America’s total losses in the Vietnam War. In fact, the media coverage often seemed considerably less than that later accorded to the Chinese infant food scandal, which had caused just a handful of deaths on the other side of the world.

The circumstances of this case were exceptionally egregious, with many tens of thousands of American deaths due to the sale of a highly lucrative but sometimes fatal drug, whose harmful effects had long been known to its manufacturer. But there is no sign that criminal charges were ever considered.

A massive class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007, with almost half the money going to the trial lawyers. Merck shareholders also paid large sums to settle various other lawsuits and government penalties and cover the heavy legal costs of fighting all of these cases. But the loss of continuing Vioxx sales represented the greatest financial penalty of all, which provides a disturbing insight into the cost-benefit calculations behind the company’s original cover-up. When the scandal broke, Merck’s stock price collapsed, and there was a widespread belief 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 is just 15 percent below where it stood just before the disaster.

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Furthermore, individuals make decisions rather than corporate entities, and none of the individuals behind Merck’s deadly decisions apparently suffered any serious consequences. 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, compensation greatly boosted by lucrative Vioxx sales. Senior FDA officials apologized for their lack of effective oversight and promised to do better in the future. American media conglomerates quietly mourned their loss of heavy Vioxx advertising, but continued selling the same airtime to Merck and its rivals for the marketing of other, replacement drugs, while their investigative arms soon focused on the horrors of tainted Chinese infant food and the endemic corruption of Chinese society.

This story of serious corporate malfeasance largely forgiven and forgotten by government and media is depressing enough, but it leaves out a crucial factual detail that seems to have almost totally escaped public notice. The year after Vioxx had been pulled from the market, the New York Times and other major media outlets published a minor news item, generally buried near the bottom of their back pages, which noted that American death rates had suddenly undergone a striking and completely unexpected decline.

The headline of the short article that ran in the April 19, 2005 edition of USA Today was typical: “USA Records Largest Drop in Annual Deaths in at Least 60 Years.” During that one year, American deaths had fallen 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.

On April 24, 2005, the New York Times ran another of its long stories about the continuing Vioxx controversy, disclosing that Merck officials had knowingly concealed evidence that their drug greatly increased the risk of heart-related fatalities. But the Times journalist made no mention of the seemingly inexplicable drop in national mortality rates that had occurred once the drug was taken off the market, although the news had been reported in his own paper just a few days earlier.

A cursory examination of the most recent 15 years worth of national mortality data provided on the Centers for Disease Control and Prevention website offers some intriguing clues to this mystery. 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. Vioxx was almost entirely marketed to the elderly, and these substantial changes in 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 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 5 percent, despite the continued aging 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. But if we hypothesize 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. Perhaps 500,000 or more premature American deaths may have resulted from Vioxx, 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. A recent Wall Street Journal column even called for relaxing FDA restrictions aimed at avoiding “rare adverse events,” which had been imposed after the discovery of “unanticipated side effects of high-profile drugs like Vioxx.”

There are obvious mitigating differences between these two national responses. The Chinese victims were children, and their sufferings from kidney stones and other ailments were directly linked to the harmful compounds that they had ingested. By contrast, the American victims were almost all elderly, and there was no means of determining whether a particular heart attack had been caused by Vioxx or other factors; the evidence implicating the drug was purely statistical, across millions of patients. Furthermore, since most of the victims were anyway nearing the end of their lives, the result was more an acceleration of the inevitable rather than cutting short an entire young life, and sudden fatal heart attacks are hardly the most unpleasant forms of death.

But against these important factors we must consider the raw numbers involved. American journalists seemed to focus more attention on a half-dozen fatalities in China than they did on the premature deaths of as many as 500,000 of their fellow American citizens.

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.

(Reprinted from The American Conservative by permission of author or representative)
 
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  1. Well done. Let’s see what happens next. I’m especially keen on the idea that corporate officers be held personally responsible for criminal corporate behavior under their jurisdiction. Only the boss can police the organization.

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  2. Anonymous says:     Show CommentNext New Comment

    Remember the story where a company sold the remainder of its stock of vaccine that it found out was tainted with Aids, to Asia.
    Big Pharma IS evil.

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  3. There’s a simpler reason, though I won’t deny these guys aren’t pro-American. American corporations own bits of each other, and CEOs sit on each others’ boards. A newspaper might well be afraid of ruffling feathers with someone higher up. But a Chinese corporation? Who cares about them?

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  4. the obvious conclusion:

    US media believes one Chinese infant is more valuable than 80,000 American senior citizens.

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  5. “Remember the story where a company sold the remainder of its stock of vaccine that it found out was tainted with Aids, to Asia.”

    No.

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  6. Merck’s attempt to save taxpayers from the expense of over long lives, and unhealthy ones at that, went too far, like the tobacco industry’s heroic efforts which were almost making 65 an acceptable retirement age when we (in Australia) legislated in ways designed to discourage smoking with the result that the new middle-aged in mid 70s are still working hard to pay for the new longevity of the unhealthy elderly…… Ten years of dementia from 95 ought to just about get me my share…..

    Ron, your interesting and well aimed article raises a collateral question or two that you would be well-equipped
    to handle.

    When McKinsey’s former man-in-Australia, Bob Waterman, got together with Tom Peters to write “In Search of Excellence” (Wow! How time passes) they used a filter to select the companies they looked at but still came up with some, or so Tom Peters says at
    http://www.tompeters.com/dispatches/009406.php ,
    which were not well known at the time. The contrast is made by Peters with Jim Collins’s blank slate start looking at masses of data to unearth his candidates for “Built to Last” and “Good to Great”.

    My interest in all this is prompted by remembering that Merck was one of the Great, or maybe Built to Last, that Collins and his team found in their data and analysis. And also remembering, that corporate culture/ethics was supposed to be a big part of the great companies’ essence.

    The questions become more interesting and worthy of a high-powered Unz attack when one questions much of what passes for great management theory and theorising. My recollection was that Waterman & Peters had nominated praised quite a few duds, as time proved them to be. Delta airlines came to mind. Peters (supra) does not mention it but does say “To be sure, the likes of Wang and Atari and Kmart are today embarrassments. ”

    I was particularly impressed by Collins’s methodology and thoroughness. I don’t remember many particulars in his list but, if he got Merck wrong he did, from memory, get Ford right as a superior performer, late in the day, to GM.

    In economics there are long term changes which the average economist is slow to pick up on, like increased longevity, like the current position on Maslow’s hierarchy of needs of significant parts of the world’s increasingly prosperous population(s), like the beliefs that people have which matter, and which should be compared with the past when, e.g. people did not anticipate and act to protect themselve from over-enthusiastic application of supposedly “Keynesian” policies. I guess the general public only began to believe in the permanency of inflation about the late 1970s…
    What are the equivalent time lags for analysts and advisers in the field of management, private sector and/or public sector? (Both economists and management theorists probably need to have cottoned on early to Mancur Olson’s work and, more recently, the solid evidences of public sector “producer capture” which appears to be ruining the chances of American governments at all levels keeping faith with those they led to believe had binding contracts or undertakings that they would be treated honestly, fairly and even generously).

    With your usual mildness Ron, and only your usual modesty, you might give your readers something considered under a punchy headline such as “Peters v. Collins – did they both get it mostly wrong?”. I would be an avid reader.

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  7. I came from China and now lives in Australia. I can tell you now that there is no land anywhere in the world that is free and clean of evils. We are all done for. The entire human society is now due for another reset! If the people could execute such as an evil act as 9.11 what else will they not do? Reset, reboot, re-start, whatever you call it is the only solution. We are simply too corrupt to correct ourselves.

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  8. Anonymous says:     Show CommentNext New Comment

    For me, the clinchers are

    a. “estimated fatalities, which matched America’s total losses in the Vietnam War”
    b. “there is no sign that criminal charges were ever considered”
    c. “eventually being settled [...] with almost half the money going to the trial lawyers”

    and above all

    d. “there was a widespread belief 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”

    Conclusion: America today is about one thing, and one thing only. $$$$$$$$$$. Deregulate and reduce corporate taxes to zero, or yer a commie!

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  9. i worked for elsevier who helped merck publish their bogus results in fake journals created to advertise the product and the clinical trial results. elsevier made a pretty penny on these. they are criminally complicit and feigned ignorance when the dangers of vioxx broke. first of all ignorance is no excuse. second of all, as an employee (now former) it is next to impossible for me to believe that no one setting up these fake journals had no idea what they were doing. rather the exact opposite. as a publisher you know exactly what your journal “mission” (commonly referred to as aims and scope) is. moreover, you also have to have an idea of where your content/papers are coming from. so when you create your business model for a new journal launch, or even supplement, you have to have a plan as far as acquiring research. elsevier should have also been criminally liable but of course they got off just like the scumbags at merck. the take away is most corporate crime has it’s enablers too and it’s rarely just one corporation involved in things of this nature. i should also mention that as publishers we were given “message training” from PR to deal with the fall out. so upper management knew full well the implications of what they did.

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  10. Anonymous says:     Show CommentNext New Comment

    I’m not a conservative. I found this item through the Occupy Wall Street org. website. I’d like to thank you for this article. I think Obama, Holder, Romney and every member of the Senate and Congress and the media too should find it impossible not to respond to this outrageous scandal.

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  11. Having read much more commentary on Steve Sailer’s blogsite I am (not for the first time) impressed by the shortsighted stupidity of those marketing Vioxx. It is quite clear that the proportion of people who took the drug and suffered heart attacks in consequence is so small that it would be quite reasonable for those who found Vioxx to relieve their pain far better than aspirin or other non-steroidal anti-inflammatory drugs should be content to take the risk (even allowing for unknowns such as the possibility that those who benefited most might be at greater risk….). Why on earth didn’t Merck cover itself with a pitch which even made it seem that those taking Vioxx were highly intelligent people making a considered assessment of benefit against risk? The marketing possibilities are endless as they are also in many cases manipulative.

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  12. Anonymous says:     Show CommentNext New Comment

    Vioxx as an issue in public debate and discourse is dead on arrival.
    How many years has it been since its removal from the market?
    Good Luck getting any recognition of this matter in any venue save for some web and small publishers like this.

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  13. Anonymous says:     Show CommentNext New Comment

    “there is no sign that criminal charges were ever considered”

    Lawyers can’t get as much money from someone who is incarcerated.

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  14. There is a huge difference between the two cases – honestly they are not even comparable. In China, the manufacturers deliberately tampered with their product. In the case of Vioxx, there’s no evidence that Merck tampered with the product or changed anything to it after it OBTAINED FDA APPROVAL, which is another huge factor to consider.

    Yes, Merck might have known the product increased the chances of heart attacks. But guess what – McDonald’s knows it’s cheeseburgers increase the risk of heart attack as well, but no one is suing them. Also what you are not mentioning is that Merck actually WON most of it’s court cases, but ended up settling other cases for billions, because it felt it would have been more expensive to fight them out. You can read more details on these shenanigans here:

    http://washingtonexaminer.com/2011/08/manhattan-moment-win-or-lose-trial-lawyers-get-millions-vioxx-fees/40722

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  15. @James Rohan:

    Such details are minor. Point is, to be free of this system, one must be willing to drop out of it in its entirety. They can take everything own, including your family and those you love, but they can never take your mind or your spirit without your involvement…

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  16. Inre: A cursory examination of … national mortality data provided on the Centers for Disease Control and Prevention website…”

    While it is true, according to CDC that there were ~54,000 more deaths in 1999 from all causes and ages, there were ~698,000 more deaths from circulatory diseases across (45+) ages.

    What miracle of science and medicine reduced all other (non-circulatory disease ) deaths by ~644,000

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  17. … journalists discovered that Merck had found strong evidence of the potentially fatal side-effects of this drug even before its initial 1999 introduction, but had ignored these worrisome indicators and avoided additional testing, while suppressing the concerns of its own scientists.

    Boosted by a television advertising budget averaging a hundred million dollars per year,…Merck had also secretly ghostwritten dozens of the published research studies emphasizing the beneficial aspects of the drug … thus transforming science into marketing support…”

    Can it have escaped Mr. Unz attention that he has just recapitulated not just the Vioxx scandal, but the trajectory of corporately subsidized disinformation in the Climate Wars?

    .

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  18. I see >one< poster has mentioned the forgotten man of this exercise, the arthritis sufferer. When Vioxx left the planet it left me with horrible tendonitis, like red hot nails driven into my heels, as well as arthritis that prevents me from recognizing my own signature. I would accept 10 times the risk Vioxx carried with it to have the quality of life I once had. To be honest, I would take it again no matter what the risk.

    My doctor, who is extremely conservative – and a biochemist – has never disagreed with any medical/political decision except for this one. He considered the risks negligible.

    And where's the black market when you need it? If they can pump out megatons of cocaine, surely they could come up with Vioxx…

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  19. Upon reading the comments from other readers, it appears to me that the point of the article was lost on many. IMO anyway

    In (bad) China, people did bad things that HURT other people. Lots of people. The gov’t finally responded with badly needed heavy handed proceedings and pronouncements.

    In (good) America, people did bad things that KILLED other people. Lots of people. The gov’t response was tepid and minimal. Much of it has been played down and swept under the rug. The outrage squelched. No one paid the price for the deaths of those people. The corporation responsible paid next to nothing as a percentage to sales and the stock (during a bad economy) has rebounded most the way.

    In (bad) China, people where made to be responsible for their actions. In (good) America, people got off scott-free after playing the system, hiding the truth. The top man in charge retired with mega bucks and no consequences.

    Get it?

    Its not about Vioxx, per se. Not about melamine. Its the damn corruption in the US.

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  20. “What miracle of science and medicine reduced all other (non-circulatory disease ) deaths by ~644,000″

    Hygiene.

    In the early 1900s countless lives were saved by hygiene. Both of Dr.’s and at home. I think it can be argued that cleanliness has been the number one advancement in science and medicine that has reduced deaths by many millions over the years.

    The next great advancement in medicine will be nutrition and food health. (Not anything to do with malnutrition, mind you)

    Eventually people will come to realize that most disease is a result of what we eat and how it is grown/raised and handled and preserved. Elimination of toxins, in all the many forms, as they are introduced into our food chain, in all the many ways, will lead to an end to most disease that doesn’t have an infection component.

    Pills are not cures.

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  21. Ron Unz’s misguided attack on Merck over Vioxx…

    In The American Conservative, Ron Unz compares the Vioxx litigation to the Chinese melamine scandal, and finds the American justice system lacking. (Also: Sailer; Roberts; and a plaintiffs’ lawyer who makes the lay mistake of confusing a mass tort wit…

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  22. The TAC needs to do some fact checking before
    publishing something like this. If Vioxx actually resulted in 500,000 premature
    deaths it would have shown up in the overall death rate. It didn’t. See
    “National Vital Statistics Reports” (http://www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_04.pdf). The overall and age-adjusted death rates fell from 1999 to 2005.
    Indeed, the age-adjusted death rate fell faster after 1999 than it did
    before.

     

    If the 500,000 statistic was correct, there
    should have been at least 100,000 incremental deaths in the peak year from
    Vioxx. That’s 33 per 100,000 for the entire U.S. See any blips
    in the data of the magnitude? They don’t stand out…

     

    Of course, the incremental deaths should
    really show up in the CVD (cardiovascular disease) mortality statistics. They
    don’t. See “US Death Rates 1975-2009? (http://seer.cancer.gov/csr/1975_2009_pops09/results_merged/topic_graph_heartdis_cancer.pdf).
    Also see some Arizona specific data (“Trends in Age-Adjusted Mortality Rates of
    Deaths due to Cardiovascular Disease, Arizona and US, 1980-2004? – http://www.azdhs.gov/azcvd/documents/pdf/az-burden-of-cardiovascular-disease.pdf).
    The Arizona data is not by itself particularly important (state level death rate
    variations are huge). However, the Arizona data exactly tracks the U.S. overall
    data.

     

    Is it possible that Vioxx resulted in 50,000
    deaths over the period in question? Sure. I don’t have anything approaching the
    background to evaluate such a claim. I wouldn’t be surprised either way as to
    the truth. For the record, I do have opinions on topics like this. I spent years
    deflating Thiomersal / autism claims…

     

    However, there is a larger issue here.
    NSAIDs (Celebrex, Vioxx, Bextra, etc.) are all associated with incremental
    mortality. Indeed, even Naproxen (also a COX-2 NSAID) has been linked to higher
    death rates. However, these drugs are simply too valuable to give up. Ask the
    people who take them, if anyone has any
    doubts. For many, NSAIDs are the difference between a normal life and ongoing,
    severe pain.

     

    This is why the FDA panel voted 31-1 to keep
    Celebrex on the market. The same panel also voted 17-15 to keep Vioxx for sale.
    Even excluding panelists with industry ties, the vote was 8-14 (losing) to
    approve Vioxx. If Vioxx was really as bad as some allege, why did 8 panelists
    (with no industry ties) favor its continued sale? Why was the vote in favor of
    Celebrex (which is also linked to CVD) almost unanimous? See “10 on FDA Vioxx
    panel had ties to companies ” (http://www.msnbc.msn.com/id/7031927/ns/health-arthritis/t/fda-vioxx-panel-had-ties-companies/#.T6lukFJpe18)

     

    Thank you

     

    Peter Schaeffer

     

    P.S. I have no ties to the drug industry
    (other than as a customer). I was once prescribed Naproxen many years ago. It
    was astonishingly helpful even though I only took it for a week or two. I have
    taken Aleve (OTC Naproxen) from time to time.
     

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  23.  A few more notes.

     

    1. If Vioxx had anything approaching the
    impact  TAC (The American Conservative)
    is suggesting, it would  have shown up in the CVD death statistics first
    and foremost. It doesn’t.

     

    2. Vioxx was withdrawn on September 30th,
    2004. Many folks probably continued to take their pills for a few weeks longer.
    If Vioxx was really so deadly that removing it from the market for the last 3
    months of 2004 had a material effect, then much larger increased in death rates should have shown up
    sooner. Indeed, since it was still on the market for most of 2004, the largest
    impact on death rates should have been from 2004 to 2005. In fact, the crude
    death rate rose from 2004 to 2005. Evidently, removing Vioxx raised death
    rates.

     

    3. The age-adjusted death rates tell a more
    useful story. The age-adjusted (AA) death rate plunged from 2003 (832.7) to 2004
    (800.8). From 2004 (800.8) to 2005 (798.5) it was almost flat. Removing Vioxx
    from the market stopped (for a while) progress in reducing death
    rates.

     

    4. The introduction of Vioxx provides even
    stronger evidence. Vioxx was introduced on May 20th of 1999. However, sales were
    slow at first. Only 4.845 million prescriptions were written in 1999. The number
    of prescriptions rose to 20.630 million in 2000 and 25.406 million in 2001 (the
    peak year). The crude death rate rose from 847.3 in 1998 to 857.0 in 1999.
    However, it fell to 854.0 in 2000, and 848.5. Evidently an extra 15 million
    Vioxx prescriptions in 2000 reduced the death rate as did another 5 million in
    2001.

     

    5. The AA death rates tell an even better
    story. The AA death rate rose from 870.6 in 1998 to 875.6 in 1999. However, the
    extra 15 million Vioxx prescriptions reduced it to 869.0 in 2000 and another 5
    million Vioxx prescriptions reduced it to 854.5 in 2001. As mentioned above, the
    AA death rate falls from 832.7 in 2003 to 800.8 in 2004 (with Vioxx still on the
    market for most of the year). It then essentially flat lines in 2005
    (798.8).

     

    6. The use of crude death rates is
    ultimately misleading. The American population is obviously aging. AA death
    rates make considerably more sense. In a few years, the baby boomers will start
    dying off in large numbers. The crude death might even rise. What does that
    demonstrate other than the pig coming out the other end of the
    Python?

     

    7. 
    Obviously everyone will die
    eventually and that 500,000 is an estimate of premature deaths. Premature by how
    much? A year? A month? One second? If the reduction is material it should show
    up in death rates (AA and crude). It doesn’t.

     

    8. Death rates rise and fall for reasons
    clearly unrelated to Vioxx. The crude death rate rose from 1994 (866.1) to 1995
    (868.3) and from 816.5 in 2004 to 825.9 in 2005.

     

    9. See Table 8 http://www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_08.pdf
    for a comparison of 1998 versus 1999 death rates. The overall death rate fell in
    the 65-74 cohort while rising 75-84 cohort and the 85+ cohort. CVD fell in both
    the 65-74 cohort and the 75-84 cohort from 1998 to 1999. The CVD death rate rose
    for the 85+ cohort from 1998 to 1999.

     

    See also Table 9 in http://www.cdc.gov/nchs/data/nvsr/nvsr50/nvsr50_15.pdf
    for a 1999 to 2000 comparison. As Vioxx prescriptions soared (quadrupling to 20
    million) all 65+ death rates fell. The CVD 65+ death rate also
    fell.

     

    10. In the last pre-Vioxx year the overall
    death rate was 847.3. In 2003 with Vioxx going strong, it was 841.9. In 2004 (14
    million Vioxx prescriptions) it was 816.5. Of course, the age-adjusted data show
    that Vioxx “saved” even more lives. The 1998 AA rate was 870.6. The 2003 rate
    832.7. The 2004 rate was 800.8.

     

    11. The crude death rate was essentially
    flat from 2004 to 2005 when it should have fallen the most. The 65+ data is more
    dramatic. Table 9 of http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_10.pdf
    shows 65+ mortality rates fell every year from 1999 to 2008. So did the CVD
    death rates.

     

    12. Any alleged linkage between Vioxx going
    off the market in 2004 and mortality statistics suffer from a basic flaw. Vioxx
    was recalled on September 30. September 30th isn’t Jan 1.

     

    Thank you

     

    Peter Schaeffer

     

    P.S. I am not claiming that Vioxx was
    harmless. NSAIDs are (apparently) intrinsically dangerous. However, the
    incremental deaths were too few to show up in the overall mortality statistics
    and more decisively, too few to show up in the CVD mortality
    statistics.

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  24.  A few more notes

     

    1. There were rumors that Vioxx was
    dangerous before the recall. Indeed the claims predate FDA approval (clearly
    another story). However, rumors aren’t numbers. There were 19.959 million Vioxx
    prescriptions in 2003 versus 13.994 million in 2004. That’s a fall of 5.965
    million. However, the fall from 2004 to 2005 was 13.994 million. Yet, somehow
    raw (but not AA) death rates fell from 2003 to 2004 and rose from 2004 to 2005.
    2004 Vioxx prescriptions were 70.11% of 2003. That’s only slightly below the
    75% we would expect from the withdrawal
    date. In other words, physician avoidance  (pre-recall) was quite modest at
    best.

     

    2. Total COX-2 sales did not plummet in
    2004. The IMS data shows that they were flat or down slightly. Let me quote from
    “IMS Health, National Sales PerspectivesTM, 2/2005?

     

    “Despite the negative publicity and the
    voluntary withdrawal of Vioxx®, the COX-2 inhibitor class was flat for 2004 with
    sales of over $5.3 billion. Celebrex® remained the largest product with sales of
    $2.7 billion and Vioxx® achieved sales of $1.8 billion in the first nine months
    of the year before being withdrawn on September 29.” The link is http://www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=003a1d3be7a29110VgnVCM10000071812ca2RCRD&vgnextfmt=default

     

    Other sources show Celebrex and Bexta sales
    peaking in 2004. Another report from IMS makes this point and suggests a decline
    in total COX-2 sales. See “Biotech Remains Industry Growth Engine, With 17
    Percent Sales Growth”. The key quotes are

     

    “Merck’s surprise, voluntary withdrawal of
    Vioxx® in September and potential safety concerns associated with other pain
    relief medications resulted in doctors switching patients away from Vioxx or
    starting them on other COX-2 products. Patient volume for the remaining COX-2s
    initially increased by more than 25 percent following the withdrawal, driven by
    a 15 percent increase in new therapy starts and a two-thirds share of all Vioxx
    switches.“Over time, COX-2 usage has declined to below pre-Vioxx withdrawal
    levels, due in part to further safety concerns about this class of drugs,” said
    Lisa Morris, global director, IMS longitudinal services. “By year-end, the
    prescription COX-2 and NSAID market saw a 9 percent decline in total patients.”
    The link is http://www.imshealth.com/portal/site/imshealth/menuitem.a46c6d4df3db4b3d88f611019418c22a/?vgnextoid=933a1d3be7a29110VgnVCM10000071812ca2RCRD&vgnextchannel=41a67900b55a5110VgnVCM10000071812ca2RCRD&vgnextfmt=default.
    The 9% decline may have been versus the third quarter of 2004 which means that
    total COX-2 prescriptions could have easily equaled 2003 (which appears to be
    the case).

     

    See also “Sales rise for Celebrex and Bextra
    after Vioxx withdrawal” (http://www.usatoday.com/news/health/2004-11-30-painkillers_x.htm)

     

    “Pfizer’s Celebrex gained a majority of
    sales for new-generation painkillers in the month after Merck & Co. yanked
    Vioxx due to safety concerns, according to IMS Health, a pharmaceutical
    information company.”

     

    3. 2005 was a very different story. Vioxx
    sales were zero of course. Bexta went off the market on April 7th, 2005. Bextra
    did generate substantial revenues in the first quarter of 2005. However, the
    retail data (not the entire story) show Bextra growing from 2003 to 2004 (to
    over $250 million per quarter) and then falling to $148.370 million for all of
    2005. Once again this is retail only data. Even though Celebrex stayed on the
    market with FDA approval, sales crashed in 2005. See “Sales plummet as cox-2
    miasma vexes consumers” (http://findarticles.com/p/articles/mi_m3374/is_10_27/ai_n15341417/).
    Quote

     

    “According to IMS Health, sales of cox-2
    inhibitors have plummeted 65 percent for the first five months of 2005,
    representing $1.5 billion in lost sales of Bextra, Celebrex and Vioxx. Of those
    three drugs, only Celebrex remains on the market. And now, two other cox-2
    inhibitors that were in the drug development pipeline at the time of the Vioxx
    withdrawal are not expected to make it to market any time soon–if at
    all.”

     

    Another source gives a 48% fall in Celebrex
    sales in 2005. See “Pfizer to resume airing ads for Celebrex” (http://www.usatoday.com/money/industries/health/drugs/2007-04-01-celebrex-usat_N.htm).
    Quote

     

    “The return of Celebrex to TV follows its
    financial comeback. Celebrex sales hit $3.3 billion in 2004 then dropped 48% in
    the year after Vioxx’s withdrawal. Last year, Celebrex sales were $2 billion.
    Still, it ranks behind ibuprofen and naproxen in arthritis prescriptions,
    according to market tracker Verispan. Before the Vioxx recall, Celebrex was
    ahead of naproxen but behind ibuprofen.”

     

    Let’s recap for a moment. COX-2 volumes were
    flat from 2003 to 2004 and death rates fell. COX-2 volumes crashed in 2005 and
    death rates rose. This is not the correlation  the TAC is suggesting.

     

    4. Drug companies do give away samples that
    could impact total consumption in 1999. However, volumes appear to be low
    compared to prescriptions. In 2007, drug companies spent $8.4 billion giving out
    samples. See “Pharma scales back drug samples to physician offices” (http://www.ama-assn.org/amednews/2012/03/26/prl20326.htm).
    Total prescription sales were $286.5 billion (IMS Health).

     

    The notion that Vioxx early adopters were
    more at risk is conceivable, but lacking in any substantiation. Why would
    doctors single out patients with the greatest CVD risk, as the first users of
    Vioxx?  To make such a claim,  the TAC needs facts or at least a mechanism (in my opinion).
    If Vioxx had been the first COX-2 drug on the market this would be a stronger
    thesis.  A person could argue that the
    sickest patients (in general), with the most pain, were the first users.
    However, Celebrex was approved on December 31, 1998.

     

    5. TAC’s  use
    of overall and 65+ death rates suffers from several large problems. The
    biggest problem is that Vioxx apparently caused heart problems (all of Vioxx’s
    critics agree on this point). However, there is nothing in the heart disease
    data to support  the TAC thesis. Online
    data shows that the CVD death rate fell from 1998 to 1999. To be precise the CDC
    has two sets of data from 1998. The standard data shows a fall for all age
    groups except for the 85+ group. Overall the rate falls from 268.2 to 265.9. Row
    44 (the modified data) shows a slight rise overall (from 264.4 to 265.9) and big
    falls for the 65-75 group and the 75-84 group. The 85+ group rises as well. Any
    hint of a spike is absent. The 1999 versus 2000 CVD data show CVD death rates
    falling for everyone (as Vioxx sales quadrupled).

     

    Let’s look at this another way. An
    incremental 100,00 deaths per year is roughly 33 per hundred thousand for the
    entire population. No shifts of that magnitude show up in the CVD
    data.

     

    The NVSS (National Vital Statistics System)
    data makes the same point. The Major cardiovascular death rate fell from 1998 to
    1999 (and kept falling in 2000) for all groups except for the 85+ cohort as
    Vioxx sales soared. Even the 85+ cohort is below 1998 levels in 2000. There is a
    big fall from 2003 to 2004. However, that should have occurred in 2005. The data
    has other big falls as well (1988 to 1989, 1989 to 1990, 2000 to 2001, and 2005
    to 2006).

     

    The subcategories (Heart disease, Heart
    attack, Chronic ischemic heart disease, Atherosclerotic cardiovascular disease,
    Heart failure, and Stroke) show the same pattern. Most fall from 1998 to 1999
    and 2000. Heart failure and Stroke rise slightly. If Vioxx was nearly deadly
    as  TAC’s assert s , it would show up in the NVSS
    CVD data. It doesn’t.

     

    As a check, I graphed CVD mortality from
    1998 to 2007. The Vioxx effect is not apparent. The expected spike from 1999 to
    2000 and crash from 2004 to 2005 are clearly absent.

     

    Thank you

     

    Peter Schaeffer

     

    P.S. David Graham estimates that Vioxx
    might have caused 88,000 to 139,000 additional heart attacks / strokes with a
    30-40% mortality rate. That’s certainly plausible and not contradicted by the
    CVD data. Of course, total COX-2 mortality must have been higher because of the
    side effects of Bextra / Celebrex.  As everyone
    knows, Celebrex remains on the market.

    Read More
  25. A few more notes
     
    1. Vioxx
    volumes declined by 30% from 2003 to 2004. For the entire year of 2003, Vioxx
    was dispensed at a rate of 1.663 million prescriptions per month. For the first
    9 months of 2004, the rate was 1.555 million prescriptions per month. That’s a
    decline of 6.5%. Of course, after 2004-09-30 the prescription rate was zero.
    As the
    reader can see the decline in Vioxx usage, pre-recall was quite small.
    Note that Vioxx volumes peaked in 2001 and declined thereafter. Why is not
    clear. However, Bextra was approved in 2002 and was commercially
    successful.
     
    Stated differently, if Vioxx usage fell significantly before
    the recall it would show up in the prescription numbers. It doesn’t. My data
    does show a 30% fall from 2003 to 2004. However, that is for the entire year.
    You can get similar data by checking http://www.modernmedicine.com, This is a “Voice
    of the Pharmacist” website. The data is retail-only. It very closely matches the
    statistics I have produced so far (ultimately derived from the same sources,
    apparently).
     
    2. Of course, the actual cost of manufacturing brand name
    pharmaceuticals is a small fraction of the price (much less true for biologics).
    However, the $8.4 billion cited below is not the “cost” of making the free
    samples. It’s almost entirely the cost of sending detail agents to doctor
    offices. If you check the link, you will see that the $8.4 expense included 116
    million detail agent visits to doctor offices. At an average cost of $72.41 per
    visit, obviously the money was spent on wages, salaries, and travel expenses,
    not manufacturing samples.
     
    3. It is very unclear if Vioxx caused
    front-end (the most vulnerable first) or back-end mortality (a cumulative
    effect). This is an important issue and contrary indications exist. See
    “Q&A: Vioxx’s Health Risks” (http://www.npr.org/templates/story/story.php?storyId=5415884). Merck tried to claim that there was no adverse impact prior to 18
    months. See Figure 2 from “Cardiovascular Events Associated with Rofecoxib in a
    Colorectal Adenoma Chemoprevention Trial 2005/03/17″ (http://www.nejm.org/doi/full/10.1056/NEJMoa050493). If this claim was/is correct, the entire 1999 / Vioxx thesis is
    falsified. However, it does not appear to be true (which is why I have avoided
    it so far).
     
    Based on additional data and some corrections to the
    methods used in the original paper, the NEJM published a correction. See
    “Correction – Cardiovascular Events Associated with Rofecoxib in a Colorectal
    Adenoma Chemoprevention Trial 2006/07/13″ (http://www.nejm.org/doi/full/10.1056/NEJMx060029). To get a better understanding of the correction, see “Adverse
    Cardiovascular Effects of Rofecoxib 2006/07/13″ (http://www.nejm.org/doi/full/10.1056/NEJMc066260). The letters from Nissen and Furberg (noted Merck critics) are
    instructive. They reject the 18 month thesis and suggest an essentially linear
    cumulative risk model. I quote (from Nissen).
     
    “The original article
    included a post hoc hypothesis that curves for confirmed thrombotic events would
    not begin to diverge until after 18 months of exposure to rofecoxib. However,
    all intention-to-treat analyses in the newly released report show that the event
    curves begin to diverge much earlier, generally within four to six months. The
    most useful Kaplan–Meier curves, involving intention-to-treat analysis of the
    APTC end point, show divergence after only three months of exposure to
    rofecoxib”
     
    At least one author appears to support the 18 month
    hypothesis (maybe). See “Time-to-Event Analyses for Long-Term Treatments — The
    APPROVe Trial 2006/07/13″ (http://www.nejm.org/action/showImage?doi=10.1056%2FNEJMp068137&iid=f02).
     
    Note that none of the NEJM data shows any hint of
    front-loaded risks. The Merck model claims no incremental risk before 18 months.
    The contrary analysis seems to show greater risk much sooner. However, the risk
    is cumulative and linear. The longer a person took Vioxx the more likely they
    were to have some kind of heart failure as a consequence. Stated differently,
    they were at greater risk starting soon after they took Vioxx and eventually the
    risks added up.
     
    As should be clear, this is deeply problematic for any
    effort to blame Vioxx for 1999 mortality. Vioxx was dispensed for 7.33 months in
    1999 at a rate of 661,000 prescriptions per month. In 2000, the rate was 1.719
    million prescriptions per month. It would appear that far more people took Vioxx
    in 2000, than in 1999. However, a person
    could try to argue that Vioxx usage accelerated in 1999 and that the full 2000
    rate was reached late in 1999. Perhaps. However, let’s assume that it is true.
    This means that very few 1999 Vioxx users would have been taking it for 4-6
    months (or even 3 months) in 1999. Let’s go further and drop any risk onset
    delay and assume a purely linear model (incremental risks start on day one).
    That makes the total Vioxx risk equal to the number of prescriptions (which
    quadrupled between 1999 and 2000). This falsifies the 1999 Vioxx thesis
    immediately.
     
    However, let’s go further and assume a very front loaded
    risk profile (you either die quickly or you don’t die at all) and that Vioxx
    prescriptions accelerated to the 2000 rate by the end of 1999. With that
    combination of assumptions, the incremental mortality should have been in 1999.
    However, it also means that in 2004 there was no one left to die. Clearly Vioxx
    wasn’t adding a lot of new users by 2004 (sales had been declining since 2001).
    With a front loaded model, the Vioxx recall should not have reduced 2004
    mortality.
     
    4. Another very important question is whether incremental
    Vioxx mortality persisted after each person stopped taking Vioxx. Of course,
    Merck claimed that the answer was no. However, that may not be true. See “Study:
    Health Risk Remains a Year After Quitting Vioxx” (http://www.npr.org/templates/story/story.php?storyId=5400413&ps=rs). Quote “”It was very surprising to me,” says Steven
    Nissen, acting chief of cardiovascular medicine at Ohio’s Cleveland Clinic. “I
    had always assumed that if you stop taking the drug, the risk would go away.”
    Nissen says this data shows that’s not true.
     
    “What it shows us is that you can stop taking Vioxx, and
    based upon this study, for the next year, you’re still at increased risk. And,
    in fact, the amount of increase is almost exactly the same as we saw during the
    three years that people were actually taking the drug,” Nissen
    said.”
     
    Note also the author (Nissen). Assuming Nissen is correct,
    the 2004 Vioxx recall thesis is wrong.
     
    5. As the reader
    can see, all of the Vioxx mortality models falsify the 1999 / 2004 Vioxx
    thesis. The 18 months to trouble model (See “Vioxx: 18 Months to Trouble? –
    http://pipeline.corante.com/archives/2006/06/26/vioxx_18_months_to_trouble.php) rules out any connection between the introduction of Vioxx in 1999
    and any incremental deaths. The front-loaded model (die now or not at all)
    allows for a major 1999 impact (with sufficiently accelerated Vioxx adoption in
    late 1999), but falsifies the 2004 impact of the recall. The linear cumulative
    risk model (apparently preferred by Merck’s critics) falsifies 1999 and 2004.
    The persistent risk thesis contradicts the front-loaded model and undermines any
    claims related to the recall.
     
    6. The NVSS data and the CDC data show
    declines in CVD mortality from 1998 to 1999. The decline may have been less than
    other years, but a decline is a decline. If Vioxx was really responsible for
    500,000 deaths, the data should have a large spike. No such spike exists. The
    smaller decline in 1999 is certainly interesting and may have been related to
    COX-2 sales. Note that Celebrex was introduced very early in 1999 and reached
    huge volumes in that year (unlike Vioxx). That’s not to say that Celebrex is
    responsible for the lesser decline in CVD mortality in 1999. However, it is a
    better fit.
     
    7. The CDC noted the upsurge in
    mortality in 1999 and analyzed it. See “Deaths: Preliminary Data for 1999″
    (http://www.cdc.gov/nchs/data/nvsr/nvsr49/nvsr49_03.pdf). Quote
     
    “The preliminary number of deaths in
    the United States for 1999 totaled 2,391,630, an increase of 54,374 from the
    1998 total. The crude death rate increased from 864.7 per 100,000 population in
    1998 to 877.0 per 100,000 in 1999. The two influenza outbreaks of 1999
    contributed to the large increase in the number of deaths (10–12), especially
    among the older age groups and for several chronic diseases.”
     
    A later
    report (Deaths: Final Data for 2004 – http://www.cdc.gov/nchs/data/nvsr/nvsr55/nvsr55_19.pdf) makes the same point. Quote
     
    “Since 1980, the age-adjusted
    death rate has decreased every year except 1983, 1985, 1988, 1993, and 1999.
    During these years, influenza outbreaks contributed to increased mortality in
    the United States (14,15).”
     
    See the 1998 – 2001 P&I mortality data
    online (http://www.cdc.gov/flu/weekly/weeklyarchives2001-2002/01-02summary.htm) for additional information. Note that the first 1999 mortality
    spike was in March (two months before Vioxx was introduced). 2004 deaths were
    lower than 2003. Once again, the P&I data provides some insight. Note the
    huge spike in late 2003 and the absence of such a spike in 2004. See http://www.cdc.gov/flu/weekly/weeklyarchives2004-2005/04-05summary.htm for a graph. Thank you Peter
    Schaeffer
     

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  26. Anonymous says: • Website     Show CommentNext New Comment

    Whether the VIOXX statistics are accurate or not, American life has indeed become cheap. 

    The current administration is pushing a medical device for rapid national implementation known to cause injury and death, even partially financing it to the tune of tens of billions of dollars, probably with Chinese money no less. 

    There are financial penalties for medical refuseniks (non-adopters). 

    However, FDA, the Institute of Medicine and others readily admit in publication thay have no idea of the magnitude of the harm because of lack of data collection, impediments to information diffusion and even legal censorship of the harms data.   In effect, we don’t even know if the benefits exceed the harms, and FDA and IOM admit it.  FDA in fact refers to the known injuries and deaths from this device as “likely the tip of the iceberg.”

    Perhaps it’s no longer a big deal if people are injured and/or die in
    data gathering for this medical enterprise.  E.g., see “FDA Internal Memo on
    H-IT Risks” at http://hcrenewal.blogspot.com/2010/08/smoking-gun-internal-fda-memorandum-of.html , and the Inst. of Medicine
    report in the same issues at http://hcrenewal.blogspot.com/2011/11/iom-report-on-health-it-safety-nix-fda.html .It’s all for the greater social
    good.

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  27. I work in the Pharama Industry so from my knowledge, Merck falsified Phase IV reports (which is due after a year or two of drug sale) on efficacy and Adverse Events to FDA which led to FDA continue approval of it. But too many people are dead using it and more cases against Vioxx are coming out. This is why Merck finally withdrew Vioxx before official FDA inquiry into it.

    I believe if a criminal investigation toward manipulation of data against Merck happens, FDA would eventually get blamed for the second approval of Vioxx and lack of good audit on the Phase IV results. FDA saved itself by not starting such investigations. It maybe corruption and it maybe self preservation to avoid a government agency being sued.

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  28. This is a compelling article, but seriously undermined by your back-of-the-envelope death estimate. Since it continues to be linked to (e.g. in your recent “American Pravda” article), I would strongly urge a correction. I’d start by consulting an epidemiologist.

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