In a sidebar, he compares the Chinese baby formula scandal to an American corporate scandal that pretty much everybody has already forgotten about:
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.
See if you can guess which shameful American bit of history he is thinking of.
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88 comments:
Now that you mention it, most of the leftist rage I come across (LinkTV, etc.) involves what the U.S. does overseas. Part of your concentric circles of care and leapfrogging loyalties.
The melamine vs. Vioxx comparison is an apples and oranges comparison. Melamine has no nutritional value, and was there to spoof a test for protein content. Vioxx was an excellent NSAID, and this class of drug has always had problems. Aspirin the original NSAID kills far more people than Vioxx ever did. If aspirin were a new drug undergoing FDA trials it would never be allowed on the market.
FrankC
Sorry but there are major differences in the situations.
All pharmaceuticals have side-effects, many of them very bad.
Going by the wikipedia article, the drug caused 88-140,000 cases of serious heart disease out of 80 million people who ever took the drug. Its reasonable to assume therefore that the vast majority of people who took Vioxx gained pain relief without serious adverse consequences. Hopefully in the future we will have tools to pinpoint who will get adverse reactions to Vioxx (and other drugs) and who will not.
Thanks to the withdrawal of Vioxx people who might benefit from temporary use (such as hospital patients) are being denied access to Vioxx, even though the evidence is that temporary use of Vioxx does not cause damage.
The use of melamine in infant formula helped no one except the manufacturers. There were no, and could not have been any benefits to using melamine in infant formula for the babies.
The differences between the way the Melamine Scandal and the Vioxx incident were covered boil down to two factors, I think.
First, (and isn't it always?) money. Our media can't rip pharma too hard because pharma pays their bills. All of those ads buy more than public awareness. They also buy consideration in the newsroom. It might not be about spiking stories, but it's certainly about taking spokesmen at their word, and echoing what they say. Anyone who's ever lived in a small town gets it; don't poop where you eat.
Second, our fascination with experts. In the Melamine case, some schmucks let the wrong stuff get into the wrong jar. That's a logistical failure, and we (rightly) have very little sympathy. We look down on managers, we think their jobs are easy, and when they fail, we think they need fired. End of story. In the Vioxx case, though, it was about experts. Experts failed to foresee certain circumstances (or at least that's the way it played on the news, see #1). As a nation, we adore experts. We feel that we can't do what they do. If they fail, it's only because they're attempting something nearly impossible, so punishment (we think) makes no sense.
sounds more like wall street and its toxic derivatives that was sold as sweet medicine for america.
Unz has another good piece on China vs USA here:
http://www.theamericanconservative.com/blog/chinas-rise-americas-fall/
I'm currently reading C. Northcote Parkinson's book "East and West". A really remarkable history/geopolitics book written in 1963. In the book he predicts that the East will rise and the West will decline, as has happened in cycles since antiquity.
imagine if vioxx killed mostly blacks than old whites. we'd never hear the end of it.
Nah. A proper comparison would be American pharma to Chinese pharma, and as far as the Chinese pharma is concerned the Vioxx scandal would be an improvement. Chinese counterfeit medicines -- things like fake antibiotics, fake anti-malaria drugs, etc. -- are responsible for deaths of millions upon millions in China and worldwide. And the Chinese don't even consider this much of a problem, just business as usual.
An interesting article by Mr. Unz. It mentioned that Vioxx was often used as a replacement for aspirin. I wonder - was the increased likelihood of heart attack and stroke due to some positive effect of the vioxx, or just because people stopped taking aspirin.
OT,
The nonsensical slander of President Obama being both anti-American and anti-White has absolutely no foundation whatsoever, as this new information, which will not fail to be widely disseminated, will prove.
OT: Barack Obama Sr., 1959, implicated as "anti-American and anti-white" (along with other Kenyan students) by British Foreign Office secret memorandum.
http://www.bbc.co.uk/news/uk-17734735
"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."
That just seems incredibly damning. I'm jealous of the Chinese system to get results in these kinds of cases.
What crap. Vioxx was a disaster: it more than doubled the rate of heart attacks in users. Killed something like 45,000 Americans. Aspirin is enormously safer.
I keep seeing people defending Merck. I have to wonder why. Let me guess: this is the right-wing equivalent of that old Jewish couple in Annie Hall, saying "She's got a right to steal from us!" only switched from blacks to to big business. They've got a right to kill people. Gotcha.
The bit about 'temporary use' of Vioxx being safe is a lie, one Merck made up for legal defense. Vioxx increases clotting risk: as soon as the drug gets to the equilibrium level in the bloodstream, you're at full risk.
I didn't have to guess. I remember very well RKU's comment on some blog comparing MSM's response to melamine and Vioxx scandals. Too bad about Vioxx, really. It really did work wonders on arthritis pain.
I am Lugash.
OT: LAUSD backs down on College4Everyone!!!
http://www.latimes.com/news/local/la-me-lausd-college-20120418,0,1437173.story
I am Lugash.
In the typical trees-for-forest way Unz misses the prime mover of American media attention to Chinese scandals. The interest in PRC PR debacles stems from their being Topic A stories, i.e. fundamentally about media. They lapped up the SARS outbreak once it allowed them to wax narrativesque on the sorry government drones of China's press, so lacking the 1960s Woodwardian virtues of our own. Eventually the nomenklatura story dwarfed the mere medical story and lingers on in such forms as recent Walmart 99-cent movie "Contagion"
imagine if vioxx killed mostly blacks than old whites. we'd never hear the end of it.
Not sure if there are enough stats to prove it but, as a general statement, there is absolutely no doubt that there was some disparate impact in Vioxx action, given how many genes involved in inflammatory response are different.
The thing is, all NSAIDs are a trade-off and all of them have adverse potential. It's your choice: no pain now vs higher risk of heart attack later. Even ibuprofen.
I dunno about this Obama Sr. "anti-white" jazz--haven't you seen all the recent stories about his son's '12 campaign HQ? They're scrambling around at threat level Orange trying to hire people who AREN'T white
Easy to explain. Chinese scandals are of the circa 1900 variety, the early stages of a market economy with a big dollop of atheism to make sure no one gets a conscience. Western media can't pass up an actual scandal that fits the template of their biased minds.
In the U.S., when was the last genuine corporate scandal? NBC blowing up Ford trucks for a story or NBC editing Zimmerman tapes? When was the last time an American corporation intentionally increased the risk of their product (since the melamine scandal goes beyond a Ford Pinto type scenario where damages will be less than the safety improvement) in order to boost profits? The Goldman Sachs Paulson deal comes close, but even then, they created the product for the customer, and the other side of the trade were well heeled investors. The financial crisis is bad, but the "victims" did receive big piles of free money and a free house. When was the last time an American corporation intentionally harmed average consumers?
Actually, all the media brouhaha about China is specifically to divert the attention of Americans from troubles at home caused by the Jewish elite. Unz may see it as hypocrisy, but it's really more of a grand plan. Though the lower orders of the media running dogs don't know what's up, the owners of the media know exactly what they're doing.
But then, Chinese elite use the media to stir up a lot of hostility against America and Japan to divert the attention of Chinese masses from the rotten ways of the Communist Party Elite.
"a big dollop of atheism to make sure no one gets a conscience."
Because Christians and followers of other Abrahamic religions both now and throughout history have always been such wonderful people?
Excellent article by Ron Unz, I'd like to give him my praise and congratulations for a job well done.
IMHO America has suffered due to an obsession with economic dogma, rather than a pragmatic and flexible approach to economic and social policy, it is ironic because usually the man in the street associates dogma with China.
The dogma that gutted America was so-called 'neo-liberalism' that has formed the orthodoxy since the Reagan administration, open borders immigration, free trade, low taxes on the supper wealthy etc. The chiefist advocates of this policy were the WSJ and 'The Economist' magazine.
A sober analysis of history will ajudge Reagan (an ill-educated clown of a politician) as the man who inflicted the coup-de-grace on America, white America at least with his insane immigration 'amnesty'.
Extremely stupid post by Unz. This is the same man who tells you falsehoods about things we know well, such as doing all kinds of legerdemain to lowball the crime rate among Mexican immigrants. So why do you take him at his word among things you do not know well?
For starters:
1. The FDA is pure evil. Watch this video for starters:
www.youtube.com/watch?v=YI-m2Cucdoo
Then this:
http://farmageddonmovie.com/
2. The reason Vioxx was prescribed so heavily for arthritis is that IT WORKED and was intensely popular among people with arthritis. Many people who took the drug were willing to take an increased risk for the guarantee of decreased pain.
3. Let's say you take the study by Graham at face value:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)17864-7/fulltext
During 2 302 029 person-years of follow-up, 8143 cases of serious coronary heart disease occurred, of which 2210 (27·1%) were fatal. Multivariate adjusted odds ratios versus celecoxib were: for rofecoxib (all doses), 1·59 (95% CI 1·10—2·32, p=0·015); for rofecoxib 25 mg/day or less, 1·47 (0·99—2·17, p=0·054); and for rofecoxib greater than 25 mg/day, 3·58 (1·27—10·11, p=0·016). For naproxen versus remote NSAID use the adjusted odds ratio was 1·14 (1·00—1·30, p=0·05).
In other words, the normal chance of having a fatal heart attack is 2210/2302029 or about 1 in 10000. The use of Vioxx aka rofecoxib increases that risk to about 3.58 in 10000.
Many people would take that kind of increased risk for vastly improved quality of life. They should have at least been offered the choice, given that we have the choice to bungee jump, to skydive, or to drink ourselves into a stupor.
Instead the drug was summarily taken off the market by our betters. As for the "55,000" number, can we play that game for other things?
For starters, as La Griffe has calculated (http://lagriffedulion.f2s.com/hood.htm), living in a neighborhood with many NAMs increases your risk of a nasty event well beyond 4 in 10000. Who's responsible for that? In part, those who contend that NAM immigration isn't deadly: like Ron Unz.
Unz's characterization of China (locally flawed, but globally sound) happens to describe his own article as well. I can point out numerous overstatements and misrepresentations within the article--Unz is not someone who can be blindly trusted. But he is always interesting, and I cannot disagree with his main thesis.
I keep seeing people defending Merck. I have to wonder why.
Because the drug worked really well for arthritis, and I will be damned if I let the FDA tell me what risks I can and cannot take.
The FDA sues to prevent cancer patients from trying experimental drugs near the end of life. It sues to prevent people from trying experimental implants or devices. It sues to prevent anyone on US soil, buyer or seller, from opting out of their tender embrace. And as its budget has recently doubled, even more than the current 25% of the economy will come into that tender embrace.
Is the FDA preventing people from living near concentrations of NAMs? Is the FDA preventing HUD from locating NAMs near you via Section 8 vouchers? The government has less than zero concern for your health, it is only concerned with its own power.
This part is interesting and paints a gloomy picture:
"Ironically enough, there is actually one major category in which American expansion still easily tops that of China, both today and for the indefinite future: population growth. The rate of America’s demographic increase passed that of China over 20 years ago and has been greater every year since, sometimes by as much as a factor of two. According to standard projections, China’s population in 2050 will be almost exactly what it was in 2000, with the country having achieved the population stability typical of advanced, prosperous societies. But during that same half-century, the number of America’s inhabitants will have grown by almost 50 percent, a rate totally unprecedented in the developed world and actually greater than that found in numerous Third World countries such as Colombia, Algeria, Thailand, Mexico, or Indonesia. A combination of very rapid population growth and doubtful prospects for equally rapid economic growth does not bode well for the likely quality of the 2050 American Dream."
Steve Sailer: ...the American press seems to do a better job of covering Chinese scandals than American scandals...
Ron Unz: 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.
Hmmm...
Let's see here...
Any commonality we can notice?
Any pattern we can recognize?!?
[*COUGH* scots-irish *COUGH*]
Good piece by Unz. I think he might be a bit too sanguine about China, but his criticisms of America's terrible elites are spot on.
In the US Vioxx scandal the wrongdoers were a handful of elite decision makers: big pharma executives and MSM advertising managers passing bad or incomplete information down to their employees and operatives. The China melamine scandal spread from the bottom up: local distributors were doing this to increase their profits, having already heavily diluted their milk with water.
The US Vioxx scandal shows the immorality of the high IQ, Ivy League elite who have little empathy for the masses and constantly self justify their harmful actions by assuming what what is good for them on a personal level probably results in a benefit for everyone (think lobbying for more H1B visas, green cards, and mass immigration). The Chinese melamine scandal is illustrative of widespread amoral familism in Chinese culture and society where the general attitude is, anything for a yuan, provided it doesn't harm ones family or close associates.
Needless to say the task of punishing an arrogant elite is easier than reforming a 5000 year old cultural tradition.
How about the harm caused (allegedly) by some of the psycho-active drugs without (allegedly) much compensating advantage. How about the harm allegedly caused by statins without, for many categories of patients, extending life?
It seems odd to me that so many people fret about trivial or nonexistent environmental risks while gulping down pharma products for decades when there is, often, no evidence of what harm they might do if taken for decades.
Criticism of the powerful in your own country is riskier than criticism of the powerful in some other country. When the Abu Girab photos came out, I recall foreign media being a *lot* harder hitting and less deferential to official US spokesmen than US media, presumably for the same reason.
A friend with rheumatoid arthritis took Vioxx for 3 years, and would take it again in a heartbeat. Nothing else worked for him like Vioxx.
Like Jim Bouton wrote in Ball Four, if you offered a pitcher a pill that assured 20 wins per year but took 10 years off his life, he'd take it in a heartbeat. So it is with a chronic pain sufferers and Vioxx.
I would demur a bit on Unz’s point about the callousness of America law and forgetfulness of American media. We are now so accustomed to false scares about drugs, foods and other environmental dangers, that the serious pubic may not take real scandals too seriously. And FDA review of new drugs, which after all have been the biggest life savers of modern medicine, is so elaborate, that it may, both legally and practically, be replacing the ordinary responsibilities of individuals and companies to ensure that products are safe.
In this field as in others, we have adopted a regulatory regime and system of stiff civil penalties that seek to prevent unnecessary deaths, in place of a criminal system to punish business mistakes that have caused them. In general, that is a better policy, as shown by extended lives and fewer accidents and fatalities in America than in China. But it doesn’t always work. And sometimes the old reflexes are best, at least for individuals. Both my 95-year-old Hungarian grandmother and my now 92-year-old mother followed a simple rule with respect to drugs. Take as few as possible and always argue with the doctor who prescribes them.
The dogma that gutted America was so-called 'neo-liberalism' that has formed the orthodoxy since the Reagan administration, open borders immigration, free trade, low taxes on the supper wealthy etc. The chiefist advocates of this policy were the WSJ and 'The Economist' magazine.
A sober analysis of history will ajudge Reagan (an ill-educated clown of a politician) as the man who inflicted the coup-de-grace on America, white America at least with his insane immigration 'amnesty'.
Blame Reagan? Why not also blame all his many successors who have all followed essentially the same policies? The pols really seem to have this stuff internalized given the evidence of Bammy's infamous "they cling to their guns and bibles" pro-free trade gaffe at Billionaire's Row in San Francisco in 2008.
http://youtu.be/FHgg_cliDSk
Off-topic, but Slate's "Dear Prudie" section has a person who received a scholarship for hispanics, but isn't really hispanic. Unless they decide to say they are, as Prudie notes citing the same web site as you.
This reminds me of the people of the Soviet Union complaining that they heard every detail of the Challenger explosion immediately, but never heard about Chernobyl until days after its explosion.
Because Christians and followers of other Abrahamic religions both now and throughout history have always been such wonderful people?
People don't always live up to a standard, but the Abrahamic and Buddhist, Confucian, Daoist, Islamic religions all have standards. The Communist government is pushing a "spirit of Lei Feng" propaganda campaign because they recognize the lack of morality in society, which they helped bring about by systematically attacking religion and Confucian teachings.
Who has the more parasitical ruling elite: China or America?
I don't think this is a discussion reasonable people would be having 20 years ago. Something has changed.
"What crap. Vioxx was a disaster: it more than doubled the rate of heart attacks in users. Killed something like 45,000 Americans. Aspirin is enormously safer."
And much, much cheaper too. Aspirin is also very cheap when compared to Plavix.
Big Pharma is a racket--
http://theincidentaleconomist.com/wordpress/heres-some-waste-we-can-cut/
Rotting From Within
Investigating the massive corruption of the Chinese military.
Apparently 'six Nobel laureates in economics' (actually there has never been -rightfully- a real Nobel prize in economics), endorsed 'Why Nations Fail'.
Cynical old me thinks this - if six 'nobel laureates in economics' unanimously endorse any given position, why, that's the most surefire dead certainty in life, if you are a betting man, that the diametrically opposite position is in fact true.You couldn't get a better oracle on this Earth.Ever. Not the gods who handed down to mankind the Sibylline Books, the I Ching or the great oracle of Delphi could ever give you a better prognostication. Bet your hose on the anti-economics proposition right now if you wish to be the 'superior man'.
Such is my opinion of the entire economics profession.
Remember Long Term Capital Management?
The media pretty much ignored the OWS protest in the beginning of it...
'The poster child here is Walmart, a business that once eschewed political involvement since, as Walmart's people naïvely believed, who could complain about just selling cheap, humdrum stuff? They soon discovered otherwise. Walmart may not have been interested in Washington, but Washington was very much interested in Walmart. Between 1998 and 2011, their lobbying expenditures went from nearly zero to $11 million. A parallel huge increase occurred in campaign spending. Walmart's newly discovered political interests include unionization, employee health insurance, duties on Chinese imports, laws dealing with sexual discrimination, and the employment of illegal workers, among other once strictly internal corporate matters. Countless other businesses, including higher education, have received identical wake-up calls, so be proactive and pay in advance. Build an ambitious federal bureaucracy, and the campaign contributions will come.'
The issue is not Somalis per se or, for that matter, the success or failure of any other recent immigrant group. It is axiomatic that, as in the past, some will outperform others. What has changed, however, is the downside risk. Nineteenth-century immigrants from Ireland and Italy, for example, only slowly moved up the economic ladder, but -- and here's the key point -- the cost of modest progress was not a public burden. A struggling Irish family of the 1850s relied on family, friends, private charities, and the Catholic Church, not government-supplied food stamps, subsidized housing, free school meals, Medicaid, government-paid vocational training, Supplemental Social Income (SSI), or preferences in college admission for a "historically under-served" minority. If an immigrant back then suffered from, say, alcoholism or mental illness, he or she might turn to the a priest, not a government-paid therapist. (Technically, today's immigrants who are judged likely to become public charges should be denied visas, but in practice this requirement is easily circumvented. See here.)"
Speaking of the Chinese business practices in the pharma industry or elsewhere, here is a case very similar to the baby formula scandal. Chinese manufacturer deliberately replaced the active ingredient for the drug Heparin with another, cheaper ingredient which could fool the tests. At least 81 Americans died and hundreds were seriously hurt. Strangely, no one ever heard about this.
Our media are not dependent on ads from Chinese Corporations for their survival. The Vioxx scandal was the concealment of the risks associated with Vioxx use. Without a reasonably accurate estimate of risk, no risk vs. benefit analysis can be made and thus rational drug therapy decisions are impossible. The FDA revolving-door bureaucracy is a chronic scandal producer.
White people fear China's rise, thus they will ham up any bad news they can find. This happened to Japan to until their economy collapsed. Then it was nothing but love for Japan.
This kind of schadenfreude is common when someone, or a country, is on the decline and possesses no ability to improve their own standing except to keep others down.
"What fueled my paranoia, however, was how these data were interpreted and it is here that I smelled a vast cyber-attack conceivably originating in Shanghai or Moscow. The first tip-off was a "shocked" reaction off Education Secretary Arne Duncan who then called for educators and community leaders to join forces to eliminate this gap. I can only imagine the newly enlightened Mr. Duncan who, despite eight years heading up the violence-plagued, largely minority Chicago public schools, saying to his advisors, "Why didn't you tell me this before!"
that's a dumb piece.
The situations are not comparable, in that Vioxx helped many people even though it had terrible side effects for some.
Secondly, U.S. media covered Vioxx extensively...
“Certainly America has experienced an enormous growth of officially tolerated corruption as our political system has increasingly consolidated into a one-party state controlled by a unified media-plutocracy.”
In a nutshell.
Did the melamine scandal really get lots of media coverage? I have no memory of it - that could be my fault, of course. I would say the Vioxx controversy was more publicized, although still perhaps less than it merited.
A diet drug, fen-phen, was on the market for a year in the 1990s and caused numerous health problems ( including deaths) without doing anything for obesity
http://en.wikipedia.org/wiki/Fen-phen
The drug was only approved by the FDA because of studies showing how harmful obesity was.
These studies were conducted by scientists working for pharmaceutical companies
"Because Christians and followers of other Abrahamic religions both now and throughout history have always been such wonderful people?"
Why lump all "Abrahamic religions" together? The religions falling under this umbrella - and there are thousands of them, if you count all the subdivisions - are incredibly diverse, and don't necessarily een share the same scriptures.
Anyway, people are inclined to be selfish shits by default. The measure of a religion isn't whether it makes them perfect, but whether it makes them better.
Also, I wonder if the crimes of Verna McClain will attract as much attention from Reverends Al and Jesse as that of George Zimmerman?
McClain? With a name like that she must be white.
Frm the article on Obama's dad:
"He also said that the students had been personally selected by the scheme's sponsors, who had picked candidates almost entirely from their own tribal groups."
Ah, another Obama family member benefitting from discrimination. Discrimination got his dad to Hawai'i. AA got Michelle Obama to Princeton, Barack to Columbia, and both of them to Harvard.
Has the Obama family ever actually suffered from the discrimination he eternally bitches about?
"China’s Rise, America’s Fall", or where Ron Unz tries to wake up the American people that there is a parasitical elite.
"However, although American micro-corruption is rare, we seem to suffer from appalling levels of macro-corruption, situations in which our various ruling elites squander or misappropriate tens or even hundreds of billions of dollars of our national wealth..."
Are the American people capable of seeing the danger? And if so, do they want to do something about? Healthy people and societies put up a fight. My guess is that the same loss of some of the virtues that led to the entrenchment of such evil-doers, due much to great wealth and the vicious cycle it sets off, will prevent a defense.
Perhaps they are too smart for us. Then they could, and would, have been a problem for us at any time. No, they are like vultures to a soon-to-be corpse.
At least we're still honest with others.
The height of our civilization was the Renaissance. A couple of centuries later the first proposition nation was formed as safety and wealth led to Christian heresies, none probably more evil than answering negative to the question, "Am I my brother's keeper?"
(A very visible application of this is in the importing of slaves, indentured servants, and cheaper foreign labor. Lowering wages for your fellow man and disrupting the community and its culture is unadulterated greed. Rome is famous for its population being so dramatically different at the end than it was in the beginning.)
---------------------
1 Timothy 6:10.
For the love of money is a root of all kinds of evil. Some people, eager for money, have wandered from the faith and pierced themselves with many griefs.
Unz writes:
Ironically enough, there is actually one major category in which American expansion still easily tops that of China, both today and for the indefinite future: population growth. The rate of America’s demographic increase passed that of China over 20 years ago and has been greater every year since, sometimes by as much as a factor of two. According to standard projections, China’s population in 2050 will be almost exactly what it was in 2000, with the country having achieved the population stability typical of advanced, prosperous societies. But during that same half-century, the number of America’s inhabitants will have grown by almost 50 percent, a rate totally unprecedented in the developed world and actually greater than that found in numerous Third World countries such as Colombia, Algeria, Thailand, Mexico, or Indonesia.
This highlights how the "demographic transition" myth is just that, a myth.
Promoters of the myth point to the fecundity trends of industrialized countries as evidence that the demographic transition is inevitable. But this totally ignores the fact that due to changing racial composition due to immigration, the US fertility rate is now higher than the other developed countries and is increasing.
Waiting for superho.
California School Board Votes To Fire Science Teacher Who Appeared In X-Rated Videos
http://www.thesmokinggun.com/buster/porn-star-teacher-fired-7893412
http://www.freefuckvidz.com/free-porn/6277.html
Let me just add: God bless Ron Unz and keep doing what you're doing. Some of us are listening.
It's always a delight to read you.
"If aspirin were a new drug undergoing FDA trials it would never be allowed on the market."
That must be why UK doctors are advising people to take one a day to prevent stroke and heart attacks.
Aspirin the original NSAID kills far more people than Vioxx ever did.
No it doesn't.
"The drug was only approved by the FDA because of studies showing how harmful obesity was"
Ha, back in the 1960s there was a diet pill that actually worked called Obetrol.
http://en.wikipedia.org/wiki/File:Obetrol-resized.jpg
Alas, doctors began to stop prescribing it because of its cardiovascular side effects. (it was quite the stimulant you see). So the manufacturer did what any smart businessman would do, change the name (to Adderall) and marketing strategy. As for their new target market--- you don't need to be a transplant surgeon to realize kids usually have pretty healthy hearts.
Of the more than 2 million children prescribed ADHD drugs, Adderall users represent about a quarter of the market."
http://dissidentvoice.org/Mar06/Pringle03.htm
The American elite was actually fairly pro-American as recently as the late 1980s. Some of that can probably be attribute to Ronald Reagan making patriotism cool again.
From the 1990s onward, especially in the last decade, it seems like our elite have turned against us and gone globalist-neoliberal-neoconservative. The same trend can be seen in the cool Brittania of Tony Blair vs the Rule Brittania of Margaret Thatcher.
I lay some of the blame on the doorstep of the Scotch-Irish, who've come to dominate both parties.... but there's got to be something else at work. Perhaps there's been a generational change as Boomers have taken power from previous more culturally patriotic pre-WWII generation, of which Reagan and Thatcher came from. Now, as even more liberal Gen Xers step up into positions of power, the PC and anti-Americanism is getting even stronger among our elites.
@anonymous@4:58 4/19
Rereading Ball Four & saw that amazingly prescient 1970 Jim Bouton quote:
"Baseball players will take anything. If you had a pill that would guarantee a pitcher 20 wins but might take 5 years off his life, he'd take it." (pg 45)
I read that & immediately thought "STEROIDS! Roger Clemons!"
Is just me or the article it's a veiled critic to the post-WASP American elite, "those you shall not name"?
Look at "conservatives" in these here comments lining up to defend a pharmaceutical company that actively suppressed evidence that its drug was more dangerous than advertised.
Keep up the good work!
There is nothing fundamentally wrong with Vioxx. It worked extremely well and, hopefully, will be on the market again some day (I'd buy it from India). Yes, it increases risk of dying. So do MANY other things in life I do. But it decreases suffering (arthritis pain can totally ruin every minute of conscious life). Make your own informed choice.
The REAL problem was that Merck tried to prevent you from making that choice. Lying about the drug's effects - that's what the scandal was about.
Regardless, Ron is right about elites. Ron, if you are reading this, do you think part of the difference is that in one case the elites don't identify with the rest of the country (USA) while in another the elites feel that they are still part of it (China) and must therefore try to act benevolently?
"although India is often paired with China in the Western media, a large fraction of Indians have actually grown poorer over time. The bottom half of India’s still rapidly growing population has seen its daily caloric intake steadily decline for the last 30 years, with half of all children under five now being malnourished."
That is from Ron Unz's excellent article. India is what happens when a selfish, callous, corrupt class/caste is given free reign to run the show.
http://youtu.be/YeG4EMmqfag
From the Unz article:
Sweden is among the cleanest societies in Europe, while Sicily is perhaps the most corrupt. But suppose a large clan of ruthless Sicilian Mafiosi moved to Sweden and somehow managed to gain control of its government. On a day-to-day basis, little would change, with Swedish traffic policemen and building inspectors performing their duties with the same sort of incorruptible efficiency as before, and I suspect that Sweden’s Transparency International rankings would scarcely decline. But meanwhile, a large fraction of Sweden’s accumulated national wealth might gradually be stolen and transferred to secret Cayman Islands bank accounts, or invested in Latin American drug cartels, and eventually the entire plundered economy would collapse.
Wait, is the parasitic elite composed of Scots-Irishmen or Sicilians? I'm confused.
Wait, is the parasitic elite composed of Scots-Irishmen or Sicilians? I'm confused.
Don't be. Ron is only human and cannot not be above the cardinal rule #1: "You shall not name Scots-Irish". So, you supposed to suppose that they are Sicilians.
>suppose a large clan of ruthless Sicilian Mafiosi moved to Sweden and somehow managed to gain control of its government.[...]the entire plundered economy would collapse.<
This already happened to Iceland (not Sicilains, though). Here is an orientation article; here is one more detailed.
A friend with rheumatoid arthritis took Vioxx for 3 years, and would take it again in a heartbeat. Nothing else worked for him like Vioxx.
Like Jim Bouton wrote in Ball Four, if you offered a pitcher a pill that assured 20 wins per year but took 10 years off his life, he'd take it in a heartbeat. So it is with a chronic pain sufferers and Vioxx.
And what's wrong with that?
The very idea that the state, based on "morality", has the right to dictate what drugs not to take hardly seems moral. If they want to ban killer drugs, why not do for tobacco, which has no health benefits at all.
Culture of pain, anyone?
"Is just me or the article it's a veiled critic to the post-WASP American elite, "those you shall not name"?"
Yeah I had the same impression.
Michelle Wie's life changed in a Korean show. She appeared in a Korean show featuring various entertainers. The strength of their golf swings were compared to her swing, and she beat every male entertainer in that show.
However, the last one to try was Kang Hodong, who is arguably the best show host of Korea. He also used to be a Yokozuna of Korean-style sumo.
Kang Hodong, who at that time didn't play too much golf, swung stronger than Michele.
She should have learned at that moment that she couldn't beat men in a men's game, but that worked the opposite way; she wasted years to get into PGA tours and missed her best days.
Kang Hodong, who is now playing lots of golf after a scandal forced him to stop working last year, must have been very relieved about what happened to her.
http://youtu.be/qsirF1WeE54
Serious leapfrogging.
http://youtu.be/2tHAlCSTEL8
http://youtu.be/rrKCWJ1dFQA
http://youtu.be/JHr9brUblHE
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.
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.
Continued,
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.
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.
Continued,
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.
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 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.
Continued,
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.
Continued,
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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