Cockburn writes: "'Besides,' says Unz laughing, 'it shows the stupidity of our political leaders that they didn't seize upon this great opportunity. They should have just renamed Vioxx the 'Save Social Security Drug,' and distributed it free in very large doses to everyone, starting on their 65th birthday. Maybe they should have even made it mandatory, three times per day.'"
How many people died from Vioxx? (photo: Suresh Anthikad)
When Half a Million Americans Died and Nobody Noticed
12 May 12
Was the US drug Vioxx responsible for far more deaths than has been acknowledged so far?
RE American lives cheaper than those of the Chinese? It's a question raised by Ron Unz, publisher of The American Conservative, who has produced a compelling comparison between the way the Chinese dealt with one of their drug scandals - melamine in baby formula - and how the US handled the Vioxx aspirin-substitute disaster.
The Chinese scandal surfaced in 2008, shortly before the Beijing Olympics. Crooked dairymen diluted their milk products, then added a plastic chemical compound called melamine to raise the apparent protein content back to normal levels. Nearly 300,000 babies across China suffered urinary problems, with many hundreds requiring lengthy hospitalisation for kidney stones. Six died.
Long prison sentences were handed down and a couple of the guiltiest culprits were tried and executed for their role. Throughout these events, American media coverage was extensive, with appropriate sneering about the Chinese leadership's indifference to human life.
Four years earlier, in September 2004, Merck, one of America's largest pharmaceutical companies, issued a sudden recall of Vioxx, its anti-pain medication widely used to treat arthritis-related ailments.
The recall came just days after Merck discovered that a top medical journal was about to publish a study by an FDA (Food and Drug Administration) investigator indicating that the drug in question greatly increased the risk of fatal heart attacks and strokes and had probably been responsible for at least 55,000 American deaths during the five years it had been on the market.
It soon turned out Merck had known of potential lethal side effects even before launching Vioxx in 1999, but had brushed all such disturbing tests under the rug.
With a TV ad budget averaging a hundred million dollars per year, Vioxx swiftly became one of Merck's bestsellers, generating over $2 billion in yearly revenue. Twenty-five million Americans were eventually prescribed Vioxx as an aspirin-substitute thought to produce fewer complications.
There was a fair amount of news coverage after the recall, but pretty slim considering the alleged 55,000 death toll. A class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007.
When the scandal first broke, Merck's stock price collapsed, and many believed that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck's stock price eventually reached new heights in 2008 and today it is just 15 per cent below where it stood before the disaster.
The year after the scandal unfolded, Merck's long-time CEO resigned and was replaced by one of his top lieutenants. But he retained the $50 million in financial compensation he had received over the previous five years. Neither he nor any other Merck executives was charged with corporate malfeasance.
Senior FDA officials apologised for their lack of effective oversight and promised to do better in the future. The Vioxx scandal began to sink into the vast marsh of semi-forgotten international pharmaceutical scandals.
Then in 2005, as he now remembers it, Ron Unz "was reading my morning newspapers, as I always do, and noticed tiny items about an unprecedented drop in the American death rate. Hmm I said, I wonder if that might have anything to do with all those other stories about that deadly drug recently taken off the market and all the resulting lawsuits."
The year after Vioxx was pulled from the market, the New York Times and other media outlets were running minor news items, usually down-column, noting that American death rates had undergone a striking and completely unexpected decline. These were what Unz, a dedicated news browser, was reading.
Typical was the headline on a short article that ran in the 19 April 2005 edition of USA Today: 'USA Records Largest Drop in Annual Deaths in at Least 60 Years.' During that one year, American deaths fell by 50,000 despite the growth in both the size and the age of the nation's population. Government health experts were quoted as being greatly "surprised" and "scratching [their] heads" over this strange anomaly, which was led by a sharp drop in fatal heart attacks.
For his Chinese melamine/Vioxx comparison, Unz went back to those 2005 stories. Quick scrutiny of the most recent 15 years worth of national mortality data provided on the US Government's Centers for Disease Control and Prevention website offered Unz some useful clues.
"We find the largest rise in American mortality rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn," says Unz. "Vioxx was almost entirely marketed to the elderly, and these substantial changes in the national death-rate were completely concentrated within the 65-plus population.
"The FDA studies had proven that use of Vioxx led to deaths from cardiovascular diseases such as heart attacks and strokes, and these were exactly the factors driving the changes in national mortality rates."
The impact of these shifts, Unz points out, was not small. After a decade of remaining roughly constant, the overall American death rate began a substantial decline in 2004, soon falling by approximately five per cent, despite the continued ageing of the population. This drop corresponds to roughly 100,000 fewer deaths per year. The age-adjusted decline in death rates was considerably greater.
"Patterns of cause and effect cannot easily be proven," Unz continues. "But if we hypothesise a direct connection between the recall of a class of very popular drugs proven to cause fatal heart attacks and other deadly illnesses with an immediate drop in the national rate of fatal heart attacks and other deadly illnesses, then the statistical implications are quite serious."
Unz makes the point that the users of Vioxx were almost all elderly, and it was not possible to determine whether a particular victim's heart attack had been caused by Vioxx or other factors. But he concludes: "Perhaps 500,000 or more premature American deaths may have resulted from Vioxx [my italics], a figure substantially larger than the 3,468 deaths of named individuals acknowledged by Merck during the settlement of its lawsuit. And almost no one among our political or media elites seems to know or care about this possibility."
I remarked to Unz that it seemed truly incredible that a greater than expected death rate of this dimension should scarcely have caused a ripple.
"I'm just as astonished," he said. "From 2004 onwards, huge numbers of America's toughest trial lawyers were suing Merck for billions based on Vioxx casualties - didn't they notice the dramatic drop in the national death rate?
"The inescapable conclusion is that in today's world and in the opinion of our own media, American lives are quite cheap, unlike those in China.
"Besides," says Unz laughing, "it shows the stupidity of our political leaders that they didn't seize upon this great opportunity. They should have just renamed Vioxx the 'Save Social Security Drug,' and distributed it free in very large doses to everyone, starting on their 65th birthday. Maybe they should have even made it mandatory, three times per day. At sufficiently large levels of national consumption, Vioxx could have almost singlehandedly eliminated all our serious budget deficit problems. 'Vioxx - The Miracle Anti-Deficit Drug'."
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Comments
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The article states, that, even in the beginning: "the recall came just days after Merck discovered that a top medical journal was about to publish a study by an FDA (Food and Drug Administration) investigator indicating that the drug in question greatly increased the risk of fatal heart attacks and strokes and had probably been responsible for at least 55,000 American deaths during the five years it had been on the market."
For a bit of a "reality check" on the numbers being tossed around here, just compare the facts above with the known 58,000 Americans we lost during the entire course of the Viet Nam War.
55,000 in five years ? Way to go, Merck.
I second Mr. Levy's query regarding the conspicuous absence of all of our "pro-life" homies in the Federal Government
when it came time for the prosecution of Merck on this one. Especially when the casualty rates started getting up into some "real numbers" as the years went passing by.
Too busy the 'pro-lifers' are to work to save the lives of countless/incre dible numbers of God's children of all ages, worldwide, the victim's of constant war, war, war for $$$, and so many slaughtered by today's favorite of Pres. Oh Bomb Ah - drones.
Naive plus for us to ever expect neo-con, erzatz christians, to ever 'boot the money grabbers out of the temple', and follow the example of their beloved man/God, Jesus. Evil greed and power addiction ain't nothin' new in humankind's history, i.e. the cause of the crucifixion of Jesus. And, painful as it is, we of all and no religious and political persuasions must gather together worldwide, and overcome evil wherever it prevails, i.e. in govts., corporation, and yes, in churches.
Indeed, and the term "pro-life" is an oxymoron, too. It also assumes that those who are "pro-choice" are "anti-life."
NOT!
Recently I was prescribed Pradaxa by a Cardiologist for an AFib condition. After reading about the drug I told the Dr. I wouldn’t take it. When he asked why I told him the drug had no antidote. If something did happen to me the excessive bleeding, because of the drug, could not be stopped short of putting me on a dialyses machine and even that probably wouldn’t save me from bleeding out. I found it totally unbelievable that the FDA would have ever approve the release of a drug that had nothing available to counter act its effect.
There is a movie "Thrive" by Foster Gambel (of Proctor & Gambel) that will blow your socks off. He goes against the Banks/Corps/Gov 't that he was groomed to be a part of and created a movie that exposes all of these entities for the criminals they are. Its an important movie and will explain everything about what we are up against.
http://www.thrivemovement.com/the_movie
The other aspect of these drugs is the system at large creating a means of law suits. For every advertised drug, a law company pops up to file suit over damage from the drug. Quite a racket.
I stopped voting in 2006. Suddenly all the illusions disappeared and I was able to see the problems clearly and to understand that our problems are our responsibilitie s, and that it is the height of apathy and irresponsibilit y to continue to delegate our responsibilitie s to people who don't care. I've been urging people to stop voting ever since. But whereas when I first started, I was subjected to vicious attacks by political party operatives, nowadays they can no longer get away with it because most people are tired of their lies.
(1) the research said 55,000 deaths since the drug came on the market. How do we get to half a million in the headline?
(2) if there was an unusual DROP in the death rate due to the withdrawal of the drug, there must have been an unusual RISE in the death rate as the drug was introduced.
I'm not defending the firm, just trying to get good facts
You'll find that in paragraph 15.
The relevent quotes are too long for the limit on comment length, but it's in the middle - that the excess deaths plausibly related to Vioxx may well have actually been 100,000 per year for a 5 year period, from 1999 to 2004. Sharp rise in the death rate when the drug awas introduced, sharp drop in the death rate when it was taken off the market. It is admittedly not clear proof of causation, but seems quite plausible, if the quoted data is accurate, that the total excess deaths may have been that half-million.
Read a bit further down -
This drop corresponds to roughly 100,000 fewer deaths per year. The age-adjusted decline in death rates was considerably greater.
Muliply that by 5 years and you get half a mill, conservatively estimated.
A. Yeah, why didn't the "authorities" catch this sooner?
B. Why isn't anyone in jail at least over the "official" 55,000 dead?
C. What the heck was Tim McVeigh executed for then? Defacing public property?
If people counted actual heads rather than percentages when determining risk or rhetoric, more care would be exercised. At the very least, the board members should have had to physically write out 55,000 apology letters each and hand delivered them to the families.
It seems to me that although drug companies do make mistakes in pushing what turns out to be a dangerous drug onto the market, it is also true that they have come up with many more beneficial drugs without which many more people would die. Our increased life expectancy over the past 50 or so years have been to a large degree due to such drugs.
Drug companies are not always the villains progressive journalists portray them to be. And the FDA are not always the incompetents they are often portrayed to be - they more often do an excellent job of ensuring our drugs and food are safe.
We can be grateful, BUT the point is that they kept selling the drug after they knew of its detrimental affects. THAT'S CRIMINAL.
Do you understand English?
But Americans are as a whole totally terrible at assigning relative risk for anything. We should stop believing that ANY drug lacks side-effect risks or is 100% safe. And if you don't want risk in this case, live with pain. You can't have both, drugs aren't magic bullets. And Americans have to stop believing everything can be solved by taking a pill.
I do not trust many of the pills out on the market and have become less trusting of the entire medical system. I had insurance for my back surgery and they loaded me with so many drugs when I was discharged, I didn't know what to do with them all.
A few years later, I was between jobs and caught pneumonia. I did not have insurance and was not given anything at the hospital except a prescription that cost over $100 which I didn't have but had to buy anyway because I was very close to death already. The emergency room personnel acted as if they didn't care whether I lived or died because I didn't have insurance. Kinda wish I had taken a couple of the Vioxx and sued after the pneumonia experience.
I have an elevated Cholesterol, and my doctor wanted to put me on Libitor, I told him no chance. I am a healthy woman in my late seventies, and I am taking NO medications, except the occasional aspirin aspirin I take vitamins.
I saw my husband loosing muscels. And before he died his legs were sticks. No calves whatsoever.
Several of my friends, who are on statins, complain of muscel cramps and pains
Drug commercials are so obviously manipulative you have to wonder how the hell they influence consumers to use the stuff? Then you read Vioxx sold $2 billion a year, and you realize when it comes to designer drugs (and a long list of other risky, useless products) Americans are as needy and gullible as toddlers. A great mass of ignorant, ill-informed plodders, perpetually angry and frightened lab rats preyed upon by Big Pharma, so defensive about their chronic high anxieties they'll do anything to justify them or simply deny their affects. What better delusional solution than some body and/or mind-altering substance, booze being on top of that pyramid, followed closely by the epidemics of meth and oxycodone abuse, with hearty perennials crack, cocaine and heroin still competing for attention. Compared to these street poisons, designer meds for seniors have an aura of respectable legal purity, as if they're not only life-saving but indespensible, despite the risible littany of often grotesque side effects, required "by law" to be stated aloud, but usually obscured by guitar music while the serene beneficiary of the drug strolls on a beach. "Stop" indeed.
Not everyone has that luxury, but thankfully, when a 'prominent' shoulder specialist (at a major Chicago university hospital) just prescribed Vioxx (like candy) without asking enough questions in his haste to be done and go on to the next patient, I actually READ the insert and threw the Vioxx down the toilet, opting for the lesser evil of two aspirin instead. He also suggested I get a steroid injection [ to MASK the pain] too, but never went after the CAUSE of the pain, in this instance a spur inside the shoulder capsule. THESE DAYS doctors rarely go after the actual CAUSES of ailments or pain, just routinely racking up prescription $$$$ for pharmaceuticals ( or doing surgery). We do NOT have the best system in the world at all, but we do have the costliest, and for seniors and women especially, one of the most dangerous.
This killer drug is but one grain of sand on a very large beach, its sands lethal to so many, in so many ways.
A while back I was talking to a social worker for disabled and elderly people. He said that the ones who use Canibus take fewer pills. That's exactly why Big Pharma fights to keep it illegal.
Just think how many people would not have died needlessly if they used Canibus instead.
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″ (More ... ). Also see some Arizona specific data (“Trends in Age-Adjusted Mortality Rates of Deaths due to Cardiovascular Disease, Arizona and US, 1980-2004″ – More ... ). 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…
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 ” (More ... )
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.
That said, I think the pharma companies are run by greedy sociopaths. I wish they could be replaced by human beings with developed consciences. I'd love to trust that the meds I take have minimal side effects and would be only beneficial.
The same greed culture is here and in China.
Anything that you put on your dog and KILLS fleas (aka Advantage) could kill your dog via cancer when it gets older. The same pesticides, herbicides. You do not need FDA, you need Physiology 101.
We need socialism - community - NOT profit.
Voting is the ONE tool we have that cannot be purchased, threatened, or taken away by money or government. It's all we have. As long as we do the research and find out the truth about these issues, we CAN change this corrupted system.The only reason most of this corruption is in place is because people gave up.
The old addage that "evil exists when good men do nothing"couldn' t be more true than it is today. I would urge you to find out the truth about the huge issues that could very well cripple our nation and vote to insure that doesn't happen.
The alternative is to move to another country you think is doing it better.Which one looks better to you ???
Canada if it weren't so darn cold in the winter.
But I gave you a thumbs up on your post.
Tou made some good points
Evil exists when evil people continue to vote for evil and do nothing to work for change. Wars exist because evil voters delegate war powers to an imperialist government. Fukushima exists because evil voters think that capitalists should have the power to decide whether or not to allow unsafe aging nuclear power plants to be shut down before they melt down, and since capitalist care more about profit than about people, unsafe nuclear reactors in capitalist countries cannot be shut down before they melt down.
As for moving to another country, if I were younger, in better health, and could afford to, I'd choose the 5th happiest country in the world, Venezuela. I have a friend who lives in Caracas and is very happy there. But in reality, I'd settle for any country where the votes actually have to be counted, because any country like that would have to be more democratic than the United States.
lololol.
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?
took it off the market... The AMA is a Eugenics Foundation.
Most of the great gains in life expectancy have come in part or entirely from some very cost-effective public health programs. Unfortunately these programs do not create large profit opportunities for the private sector, so they are more under-funded than ever relative to their need. As long as the "wrecking crew" is allowed to continue to sabotage government for there own ends things like this can happen, and at some threshold we will be unable to determine with any assurance of accuracy that a real outrage even occurred, or didn't occur.
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.
Quinine Sulfate is sold under the brand name Qualaquin. See http://www.rxlist.com/qualaquin-drug.htm for more information.
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.
I've read him for 25 years and was inclined to give Cockburn the benefit of the doubt until reading this week his denial of the reality of global warming and its causes.
I think it would have been a good idea for Alexander to consult with actual epidemiologists or statisticians before uncritically taking a conservative pundit at face value.
I expect that generic drugs have probably extended my life some years, to this point, much to my surprise. They tend to be more effective at maintaining health, on the whole, than buffalo robes and incense censers. That also includes the half aspirin daily.
Cockburn did't write the Vioxx article. He picked it up from http://www.theamericanconservative.com/
It's clear to me there needs to be some kind of education campaign to get people to seriously pay attention to the road when they drive. And yet there is encouragement from every quarter to play with gadgets. The screens of distraction are everywhere now, they are even putting them right there on the windshield of the car, it's incredible to me. Our public radio station takes calls from "Arnie on the 10." The State of California has billboards up urging people to "dial 511" if they're "Stuck on the 10?"
Law enforcement is trying to raise awareness by sponsoring "distracted driving" crackdowns, but it's still daunting. The commercial obsession that says manipulating gadgets is normal/desirabl e behavior at all times (including when driving) is infecting the minds of otherwise rational people to the point where they are unthinkingly promoting behavior that's very harmful, in fact, behavior that kills.
But it makes money for some people and is enjoyed by others, so it's going to take a long time. As far as anyone even beginning to make a fuss about it, that hasn't even happened.
Among other matters, my current column responds to some of the critiques of the analysis here: http://www.ronunz.org/?p=3637
From 2003 to 2004 Vioxx prescriptions fell by 5.965 million and death rates fell. From 2004 to 2004 Vioxx prescriptions fell by 13.994 million (to zero) and death rates rose. Given that the larger change in Vioxx prescriptions was associated with an increase in death rates, this would tend to indicate the Vioxx reduced mortality.
Of course, it is unlikely (but not inconceivable) that Vioxx reduced mortality while it was on the market and the withdrawal of Vioxx increased mortality. A more likely explanation for the observed data is that other factors (much) more than offset the impact of Vioxx either way.
However, it turns out that more sensitive analysis of the data is possible. Vioxx was introduced in late May of 1999 and withdrawn on September 30th of 2004. The CDC publishes monthly mortality statistics that can be used to compare the actual 12 months before and after Vioxx was introduced and the 12 months before and after Vioxx was recalled.
It turns out that the average monthly death rate was almost identical (70.575 versus 70.599) for the 12 months before and after Vioxx was introduced. This is a better test than using calendar years because Vioxx was only sold for 7 months in calendar 1999. By comparing 1998/06 - 1999/05 to 1996/06 - 2000/05 we are testing 12 months of no Vioxx (some Vioxx in late May 1999 is possible) versus 12 months of full marketing.
The same approach can be used to analyze the Vioxx withdrawal. For the period from 2003/10 - 2004/09 the average monthly death rate was 69.444. For the 12 months after Vioxx as recalled, the average monthly death rate was 68.708. Net, the average monthly death rate declined by 0.736. By contrast, the average monthly death rate for calendar 2003 was 70.175 versus 68.107 for calendar 2004 (a net decline of 2.068). Using actual 12 month periods is a better test because Vioxx was prescribed for 9 months in 2004 making comparisons with 2003 difficult. Stated differently the death rate decline, using actual 12 month periods was 35.58% of the decline using calendar year periods.
Was the 0.736 decline in average monthly mortality a consequence of the Vioxx recall? Perhaps, perhaps not. Most of 0.736 decline appears to be related to a large P&I (Pneumonia and Influenza) epidemic in late 2003 / early 2004. Of course, the data is predictably more complex. The monthly death rate in March of 2005 was higher than the death rate in March of 2004. Once again, Vioxx appears to have been a secondary (or lesser) influence on mortality.
Thank you
Peter Schaeffer
From 2003 to 2004 Vioxx prescriptions fell by 5.965 million and death rates fell. From 2004 to 2004 Vioxx prescriptions fell by 13.994 million (to zero) and death rates rose. Given that the larger change in Vioxx prescriptions was associated with an increase in death rates, this would tend to indicate the Vioxx reduced mortality.
Of course, it is unlikely (but not inconceivable) that Vioxx reduced mortality while it was on the market and the withdrawal of Vioxx increased mortality. A more likely explanation for the observed data is that other factors (much) more than offset the impact of Vioxx either way.
However, it turns out that more sensitive analysis of the data is possible. Vioxx was introduced in late May of 1999 and withdrawn on September 30th of 2004. The CDC publishes monthly mortality statistics that can be used to compare the actual 12 months before and after Vioxx was introduced and the 12 months before and after Vioxx was recalled.
It turns out that the average monthly death rate was almost identical (70.575 versus 70.599) for the 12 months before and after Vioxx was introduced. This is a better test than using calendar years because Vioxx was only sold for 7 months in calendar 1999. By comparing 1998/06 – 1999/05 to 1996/06 – 2000/05 we are testing 12 months of no Vioxx (some Vioxx in late May 1999 is possible) versus 12 months of full marketing.
The same approach can be used to analyze the Vioxx withdrawal. For the period from 2003/10 – 2004/09 the average monthly death rate was 69.444. For the 12 months after Vioxx as recalled, the average monthly death rate was 68.708. Net, the average monthly death rate declined by 0.736. By contrast, the average monthly death rate for calendar 2003 was 70.175 versus 68.107 for calendar 2004 (a net decline of 2.068). Using actual 12 month periods is a better test because Vioxx was prescribed for 9 months in 2004 making comparisons with 2003 difficult. Stated differently the death rate decline, using actual 12 month periods was 35.58% of the decline using calendar year periods.
Was the 0.736 decline in average monthly mortality a consequence of the Vioxx recall? Perhaps, perhaps not. Most of 0.736 decline appears to be related to a large P&I (Pneumonia and Influenza) epidemic in late 2003 / early 2004. Of course, the data is predictably more complex. The monthly death rate in March of 2005 was higher than the death rate in March of 2004. Once again, Vioxx appears to have been a secondary (or lesser) influence on mortality.
Thank you
Peter Schaeffer
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