Wow - Vioxx effect on death rates was incredible - I took it for a couple years, was the only drug that helped my arthritic big toes, but I stopped needing meds for them several years ago after intense alternative PT and knowledge of what actually caused the pain, doing things to avoid inflammation in the toes, resolved the problem for the most part - hint: the pain was actually "referred pain" caused by problems elsewhere in my body - and V has dramatically reduced the swelling as well.
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rates occurred in 1999, the year Vioxx was introduced, while the largest drop occurred in 2004, the year it was withdrawn," says Unz.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 , 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."
BTW, Merck was prosecuted for promoting Vioxx off-label - this ties directly into the current AMRN case, although in reverse - the FDA is killing people by limiting distribution of V, instead of killing people by allowing them access - article also mentions something that's been discussed on this board recently, the questionable scientific validity of a large number of research being published in medical journals:
What would you say if you knew someone had killed 60,000 people? Would you call it a felony of the worst kind, times 60,000? If you totaled up the value of all those lives in criminal court, what would you say they're worth?
Billions? Trillions?
Or—how about a measly $321 million in exchange for a guilty plea to a misdemeanor? When you consider that this involves the second-largest drug maker in the U.S.—Merck—and its deadly drug Vioxx, then you'll probably agree that a misdemeanor and a $321 million fine amounts to nothing more than a slap on the wrist.
Business analysts were estimating a $25 billion judgment when the drug was taken off the market, but even when combined with the $4.85 billion in payouts to patients who suffered heart attacks and strokesi, the final bill is nowhere close to original estimates of the damage.
Yet that's the plea agreement Merck recently made with a federal court in Boston on April 19ii, after being charged with illegal promotion of Vioxx for treatment of rheumatoid arthritis, before it was approved for that use.
The sad tale brings up memories of what I tried to warn readers about in 1999, when I showed that people taking this drug were at a massively increased risk of dying from heart disease and stroke. It's tragic that Vioxx was removed only AFTER 60,000 people died.
It's even more tragic that a court would consider Merck's illegal promotion of the drug a misdemeanor rather than a felony, since this tactic clearly exposed far more people to the dangerous drug than it would have otherwise. And, adding insult to injury, instead of the billions that Merck anticipated paying out, it got away with such a paltry sum.
Hired Writers Responsible for Some of Merck's Vioxx Studies?
Particularly galling is the fact that these deaths could have been so easily avoided, were it not for the deceptive maneuvering of parties who stood to profit handsomely from the success of the drug.
Ghostwriting has become an increasingly troublesome problem in the medical science community, and the Vioxx debacle is a perfect example of why ghostwriting medical research is a devious practice that needs to be rooted out.
Merck has previously acknowledged that it has been known to hire professional writers to develop research-related documents that eventually get published under the name of reputable leaders in the medical community. Critics rightfully doubt the validity of such research, and question the actual involvement of the scientists listed as authors of these ghostwritten papers.
Back in 2008, Dr. Joseph S. Ross of New York's Mount Sinai School of Medicine came across ghostwritten research studies for Vioxx while reviewing documents related to lawsuits filed against Merck.
According to an April 16, 2008 article on MedHeadlinesiii:
"In about 96 journal publications, Ross and his colleagues discovered internal Merck documents and e-mail messages pertaining to clinical study reports and review articles, some of which were developed by the company's marketing department, not its scientific department. In others, there is little evidence that the authors recruited for the report made substantial contribution to the research itself. ... Some of the authors listed in the Merck study reports of concern... question the true nature of ghostwriting. One neurologist originally listed as "External author?" and then listed as Dr. Leon J. Thal, of the University of California, San Diego in the final draft, died a year ago in an airplane crash."
An editorial published in the Journal of the American Medical Association (JAMA)iv that year by Drs. Psaty and Kronmal also questioned whether Merck might have deliberately manipulated dozens of academic documents published in the medical literature, in order to promote Vioxx under false pretenses.
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