Winter/Spring 2005
O'Shaughnessy's
Journal of the California Cannabis Research Medical
Group
|
Vioxx Deaths = 55,000
(19 times more than 9/11)
Slightly fewer than 2,900 Americans died in the attack
on the World Trade Center and the Pentagon September 11, 2001. Some
55,000 Americans have died from strokes and heart attacks brought on
by Vioxx according to the best estimate of David Graham, MD, of the
Food & Drug Administration. Many more have been disabled.G
To put it bluntly: Merck killed 19 times as manyAmericans with its pills than
the 9/11 attackers did with their hijacked planes.
Why isn’t the President denouncing Merck, Inc., as a terrorist organization?
Didn’t Merck kill many more American civilians Al Qaeda? Why isn’t Gilmartin
wanted, dead or alive? Why does the government continue to do business with
Merck?
Some may argue that Merck’s bosses didn’t wreak
death and destruction intentionally. But that’s not true.
Some may argue that Merck’s bosses didn’t wreak death and destruction
intentionally. But that’s not true; an early clinical trial alerted
Merck executives to the fact that Vioxx caused coronary damage. Their
response was to exclude from future trials anyone with a history of
heart trouble!
Once the drug was on the market, Merck intentionally suppressed indications
that it was causing strokes and heart attacks at twice the normal rate, and
they intentionally spent $8.5 million a month advertising it. “It’s a beautiful
morning” lilted from every TV in the land as Merck pushed a drug that Gilmartin
and the other top bosses knew would kill people.
In the end, 140,000 Americans who went for the Vioxx pitch wound up suffering
heart attacks or strokes as a result. Because heart attacks and strokes are
common causes of death and disability, those induced by Vioxx, in a nation
of 280 million, did not present an immediate red flag. And because several
million people had taken or were taking the drug, the victims were isolated
geographically, one collapsing here, one there, over three years —whereas the
World Trade Center victims died together, in an instant, in a televised inferno.
Public outrage over the Vioxx deaths would have been fostered if the men who
run the corporate state and media identified with the victims rather than with
the perpetrators. Day after day, night after night we would have been bombarded
with feature stories about the families that lost a dad at 39, a mom at 42.
We would be hearing from stroke victims, paralyzed, slurring their words, telling
how long they had been on Vioxx and why. (Two-thirds of the people who took
it were lured by ads and had no need for an easier-on-the-stomach painkiller.)
The President would have called for an investigation and the FBI would have
immediately seized all Merck’s records relating to the approval of Vioxx. They
would have seized the financial records of every M.D. involved in its approval.
Each detail of the conspiracy to market Vioxx would have been played as headline
news. We would learn as much about rigged clinical trials as we did about Scott
Peterson disposing of his poor wife’s body. The American people would know
the name and face of Heartless Ray Gilmartin as well as we know Osama Bin Laden’s.
Instead, the Vioxx story was down-played and still is being downplayed, given
its enormity. We get fed a steady diet of junk news —distant psychopaths, kidnappers— instead
of getting information and learning about events that directly affect us.
Today the Vioxx story is mainly covered as business news —the effect on Merck’s
stock, how much money the impending lawsuits might cost the company, how much
will be covered by insurance, etc. When the trials begin, Merck will undoubtedly
challenge the honesty of the victims. Those who don’t have a valid claim (inevitably
there will be some) will be publicized and ridiculed on Fox, with the rest
of the corporate media snapping at their heels. TV viewers will get a sense
that yes, some people died from taking Vioxx, but many others employed venal
trial lawyers to “game the system...” The intentional murder of 55,000 innocent
America by corporate conspirators will have been erased. Such is the power
of television when controlled by (five other) corporate conspirators.
Merck announced a “voluntary recall” in late September (knowing full well that
Graham had submitted his findings to the Lancet). Pfizer decided to keep its
Cox 2 inhibitors, Celebrex and Bextra, on the market although Graham’s data
suggested they also cause harm (only less frequently.)
An FDA advisory committee met February 17 to review safety data on Cox inhibitors.
They voted 17-15 to allow Vioxx to remain on the market (with a black box warning).
Two days later the New York Times reported that 10 of the 32 advisers had consulted
in recent years for Merck, Pfizer and Novartis. If they had declared their
conflicts of interest, the committee would have nixed Vioxx by 14-8 and Bextra
by 12-8.
No one refuted Graham’s findings that Vioxx at high doses does more cardiovascular
damage than smoking, diabetes, or high blood pressure. But its “unique benefits” were
found to outweigh its adverse effects!
There would have been no need for Vioxx and the other
Cox-2 inhibitors if the DEA allowed U.S. doctors to prescribe codeine
readily —not to mention cannabis.
There would have been no need for Vioxx and the other
Cox-2 inhibitors if the DEA allowed U.S. doctors to prescribe codeine
readily —not to mention cannabis.
“Safety” was the rationale for developing Vioxx (and Celebrex, now made by Pfizer
but developed by G.D. Searle, a Monsanto subsidiary). Aspirin and other non-steroidal
inflammatories such as ibuprofen (Motrin, Advil) and naproxen (Aleve) are effective,
but large doses can cause gastrointestinal bleeding and peptic ulcers in some
people. (Tylenol isn’t anti-inflammatory at all. It reduces pain and fever while
damaging the liver.) So the drug companies saw an “easier-on-the-stomach” marketing
niche that, given the prevalence of arthritis and chronic pain —and the rationing
of codeine and prohibition of cannabis— could prove lucrative.
As explained by Dr. Melamede in this issue, aspirin and the other NSAIDs work
by inhibiting an enzyme called cyclooxygenase (Cox), that helps make compounds
called prostaglandins that facilitate the inflammatory response and have other
important functions, including protecting the stomach lining and maintaining
kidney function. Because the NSAIDS inhibited Cox-1 more than Cox-2, and because
Cox-2 was more prevalent in damaged tissues associated with arthritis, it was
hoped that a drug that inhibited only Cox-2 production would reduce inflammation
without gastric side effects. So, hundreds of millions were invested in research
and development, and the Cox-2 inhibitors were pushed towards the market.
One of Merck’s early studies showed that patients on Vioxx suffered more heart
attacks than patients on naproxen, but the company claimed, without evidence,
that this was due to some protective effect of naproxen, and the FDA bought
it. (Aspirin reduces heart attacks; naproxen doesn’t.) People with heart problems
were excluded from subsequent clinical trials of Vioxx. The goal of the large-scale
study that revealed a 200% increase in heart attacks and strokes was to show
that Vioxx reduced polyps in the colon! Merck was looking for an additional
marketing niche, not trying to answer ominous questions about the safety profile
of its #3 bestseller.
According to Marcia Angell, MD, former editor of the New England Journal of
Medicine, “It is likely that many more people had heart attacks and strokes
from Vioxx than were saved from bleeding ulcers, given the high prevalence
of heart disease in the population that uses Vioxx and the deliberate exclusion
of those people in the trial... Cox 2 inhibitors like Vioxx are no better than
over-the-counter drugs for relieving arthritis symptoms (they do not enable
you to skate like Dorothy Hamill), far more expensive and of only limited effectiveness
in preventing gastrointestinal complications.”
And yet it may up to Merck whether or not to market it again!
David Graham, the doctor who blew the whistle on Vioxx, also warned the Senate
Finance Committee on 11/19 about five drugs he thought should be pulled off
the market or severely restricted. Graham’s warning was reported by Marc Kaufman
of the Washington Post (and almost no one else): “AstraZeneca’s Crestor poses
risks of kidney failure and a rare muscle disease; Abbott Laboratories’ Meridia
is of little use and has cardiovascular side effects; Roche’s Accutane can
cause birth defects if used by pregnant women; Pfizer’s Bextra carries cardiovascular
risks similar to those linked to Vioxx; and GlaxoSmithKline’s Serevent increases
the risk of dying of asthma.”
Dr. David Graham is an epidemiologist whose research is straightforward. He
and his colleagues conducted their Vioxx study by reviewing the files of 1.4
milion California Kaiser Permanente members age 18-84 over a three-year period,
1999-2001, and comparing the rates at which those who took various non-steroidal
anti-inflammatories suffered heart attacks and sudden cardiac deaths. Higher-ups
at the FDA pressured him not to report his findings about Vioxx. “I didn’t
set out to be a whistleblower,” he says. “The FDA made me a whistleblower.”
Graham appeared before the FDA advisory committee that met Feb. 17 and reiterated
his warnings in vain. He questioned the evidence that Cox 2 inhibitors cause
fewer ulcers than the older NSAIDS. Some 40 percent of those who suffered Vioxx-induced
heart attacks died, he said, compared to 5 percent of those who suffer NSAID-induced
ulcers. He threw in a warning about Indocin (endomethacin), which nearly doubled
the risks of heart attacks in a study he had conducted, and Mobic, which increases
the risk of heart attack and stroke by 37 percent, Dr. Graham’s study showed.
According to the New York Times, “Several panel members expressed skepticism
because the findings were derived from observational studies, which are not
completely trustworthy.”
Unlike the randomized, placebo-controlled, double-blinded study, the “gold-standard” of
corporate-state science.