Vioxx manufacturer Merck and Co. Inc. used its power as a leading medical publisher to bury critical information about an epidemic cardiovascular
disease called fibromuscular dysplasia (FMD). In turn, the FMD cover-up concealed evidence that COX-2 inhibitors like Vioxx block the body’s COX-2
immune response to the disease and so, rapidly accelerate its progression. FMD is incurable, eventually resulting in stroke, heart attack, ruptured
aneurysms, dissected arteries or kidney failure.
“According to Dr. Wolfe, the COX-2 enzyme has important functions throughout the body, including bone healing, repair of tendon rupture, circulation
to the heart, and other protective and restorative roles, especially in emergency situations. “The body needs to be able to produce [the COX-2 enzyme]
and use it as part of the healing process,” Dr. Wolfe said. “By inhibiting it as the COX-2 inhibitors do, more so than the older NSAIDs, you're
asking for trouble.... I think the safe way to go is really not to use any of the drugs in this class…”
Please visit the link provided for the complete story.
All three of the approved COX-2 inhibitors have the same action and create the same problems, says Dr. Garret A. FitzGerald of the University of
Pennsylvania in Philadelphia. Dr. Eric J. Topol, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio, supports a full Congressional
review into this issue.
The science is simple. FMD causes stem cells and then smooth muscle cells to mutate and create cold-sore-like lesions inside the walls of blood and
lymph vessels. The lesions are classified as dysplasia, fibroplasia or hyperplasia. COX-2 is part of the body’s immune response designed to heal the
lesions. The downside is that COX-2 often causes secondary headaches, or joint or other pain. COX-2 inhibitors treat these secondary symptoms by
blocking COX-2 production.
Over 3.5 million new cases of FMD in adults were reported in the USA in 2003, based on the last published US incidence rate of 1.7% reported in
Britain’s online eMedicine Journal. In the USA, 65% of reported cases are diagnosed in autopsy – nearly 7,000 every day, on average in 2003.
The disease can be acquired, sporadic or transmitted congenitally. It is infectious, but likely not contagious. About 10% of FMD cases found in France
are familial, according to the current French national Orphanet health database FMD entry. By comparison, Rushton’s 1980 landmark study found 60% of
FMD cases to be familial in the USA, while the latest US Medline entry reports that FMD in the USA is now always congenital.
FMD is chronically progressive but until recently, usually took decades to become disabling or life threatening. “All forms of fibromuscular dysplasia
are progressive and have variable rates of progression,” reported Goncharenko et al in 1981. These findings were confirmed as recently as 1999, by
Ogawa and his associates at the Hokkaido University School of Medicine in Japan, who pointed out that “some cases progress rapidly in a few
Disease progression is individual and varied, partly because FMD is not just a cardiovascular disease. It is also a “systemic angiopathy,” a disease
of both the lymph and blood vessels, observe researchers like Italy's Fisicaro and colleagues (1994) and the USA’s Julian (1980). “All forms of FMD
represent a single process in the morphogenesis of which the leading role is played by fibroblast-like transformation of SMC (smooth muscle cells),”
scientists Bragin and Cherkasov reported as early as 1979.
As it progresses and spreads through the lymph and blood vessels, FMD damages the immune, nervous and hormonal systems, and the metabolism – as well
as slowly destroying vessel walls, tissues and organs. Progression is accelerated by many medications and exposure to common contaminants in food, air
and water. For example, the effects of ergot and toxic oil on FMD were well investigated between the 1970’s and 1990’s.
FMD’s effects on the heart were described thoroughly in the 1970’s and 1980’s, notably by leading cardiologist Dr. T. N. James of the World Health
Organization. In 2000, Lee and his team at the UK’s Southampton General Hospital wrote, “Fibromuscular dysplasia is best recognized in the renal
arteries and can affect the epicardial coronary arteries. Fibromuscular dysplasia of small coronary arteries has been described in several conditions:
hypertrophic cardiomyopathy, Friedreich's ataxia, scleroderma, prolonged QT interval, Marfan's syndrome, progressive muscular dystrophy, tunnel
aortic stenosis, mitral valve prolapse, and in the sinus node artery in sudden death. …The abnormal vessels are often seen in areas of fibrosis and
have been identified in infants. It is likely that the fibrosis is secondary to (rather than a cause of) the abnormal vessels.”
So, FMD causes stroke, heart attack and kidney failure. The body produces COX-2 to fight FMD. COX-2 inhibitors shut down COX-2 production, thus
causing stroke, heart attack and kidney failure. Most significant, the road to fatality is marked frequently by progressive dysfunction and early
disability. Victims are completely uninformed, and blind-sided by mounting bills and decreased earning power. Personal bankruptcy often precedes
FMD is seldom diagnosed before it is life threatening. Most cases are found ‘incidentally’ and are not required to be reported. Early diagnosis is
possible with a simple skin scraping to test for COX-2 and a protein called a-smooth muscle actin (a-SMA), which are markers for myofibroblasts
(mutated stem cells); a-SMA and myofibroblasts are markers for fibromuscular dysplasia (FMD). However, early diagnostic tests and preventive
treatments are not covered by public or private insurance and consequently, are neither offered nor provided.
Under the circumstances, it was easy for Merck to cover up the link between COX-2 inhibitors and FMD progression – simply by hiding the disease a bit
more systematically. Following reports of Vioxx’ fatal effects on the kidney and heart, Merck began ‘revising’ FMD entries and references in its Merck
Medical Manuals and various patient and professional publications. The company funded studies that brought earlier FMD research into question,
creating entirely synthetic medical controversies. By these and other means, Merck re-defined, minimized and finally, disappeared FMD like a third
world refugee. It happened quickly. By 2004, FMD was off the radar, thanks mainly to Merck.
Merck’s FMD cover-up can be tracked step-by-step in the Merck Medical Manual’s printed editions between 1999 and 2004. Just the home edition tells the
tale; by 2004, Merck no longer listed FMD as a disease. Other Merck medical publications, and corporate-funded studies and organizations now describe
FMD inaccurately as rare, genetic, most often benign or even, a ‘natural consequence of aging’ – if they mention it at all.
Numerous respected sources contradict Merck’s position on FMD – like the National Institute of Health’s (NIH) OMIM entry # 135580 for “Fibromuscular
dysplasia of the arteries,” France’s Orphanet, Europe’s award-winning “Health on the Net” and literally millions of medical articles written by
independent researchers, peer reviewed ad infinitum and listed on the NIH PubMed database.
Unfortunately, Merck is the leading medical publisher in the USA. Most other medical publishers simply quote Merck as definitive, and few American
doctors go beyond Merck’s quick profiles. So things happen. 65% of reported cases are diagnosed in autopsy; 35% are diagnosed before death. Sara’s
story is sadly typical:
“I just lost my mother to an Aortic Dissection Type B caused by fibromuscular dysplasia (news to us!). Mom had severe abdominal pain and was
misdiagnosed with irritable bowel and gall bladder problems, and had her gall bladder out. Her back was hurting her for months, a low dull back pain
that was constant for a couple of days and then gone and then back yet again. August 30th we thought she was having a heart attack. They life-flighted
her to our closest heart hospital. AFTER two attempts and failures to stent the artery they found the fibromuscular dysplasia. Her kidneys started to
fail. On the 7th of September, they tried a last ditch stent and finally an open heart bypass. She arrested twice. We were looking at having her with
brain damage, and dialysis, and paralysis. She was 49 and died on Sept 8, 2002 at 5:50 am. We let her go. Mom played golf everyday, ate a decent diet
and enjoyed life. She never smoked or drank, never had high blood pressure. Why wasn’t the FMD diagnosed? When we look back she had EVERY sign, not
just one or two but all of them!!! WHY!!!”
Source: Posts 650 and 655 at the Global Health Network’s support group for FMD.
Why indeed. Well, Merck bought four years on the free market for Vioxx. In 2003, the blockbuster pulled in $2.5 billion, in the US alone. According to
IMS Health and Forbes, COX-2 inhibitors and arthritis drugs have a market of $5.4 billion per year in the United States, with Celebrex accounting for
$2.6 billion of those sales. The Department of Defense contracted with Merck-Medco Managed Care to provide military personnel mail order service for
maintenance prescriptions in 2001, but military Vioxx sales figures are not available. Suffice to say - even bad drugs are incredibly profitable.
Most people staunchly defend ‘profit’ as the sole rationale for conducting business, ethics be dammed and devil take the hindmost. Merck does not
Bush advisor and Merck CEO Raymond Gilmartin plans to release a new COX-2 inhibitor called Arcoxia, as soon as FDA approval can be arranged. Then,
Merck stocks will rebound and the world will be Right again.
It’s not a conspiracy, just good business.
NOTE: The COX-2 inhibitor scandal and cover-up should not have happened, and would not have – if we had Open Access to publicly funded medical and
scientific research. We need access to ‘privately owned’ hidden information on drug trials and studies to make informed decisions, and protect
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[edit on 21-10-2004 by soficrow]
[edit on 21-10-2004 by Nerdling]