ATS: Merck and Vioxx: A Twisted Tale of Cover-ups, Pork and Profits, page 1

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.

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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 months.�

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 death.

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 stand alone.

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 ourselves.


Related News Links:
www.medscape.com
www.jbc.org
www.emedicine.com

heart.bmjjournals.com

Related AboveTopSecret.com Discussion Threads:
www.medforum.com...
www.wramc.amedd.army.mil...
www.atsnn.com...
www.atsnn.com...

[edit on 21-10-2004 by soficrow]

[edit on 21-10-2004 by Nerdling]

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UPDATE:

Merck Should Have Pulled Vioxx in 2000 -Study
www.reuters.co.uk...

Study: Merck should have pulled Vioxx in 2000
Company knew of data showing heart risks, scientists say
www.msnbc.msn.com...

Drug-Safety Reviewer Says F.D.A. Delayed Vioxx Study
www.nytimes.com...



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UPDATE November 14, 2004:

From Reuters: "Top executives at pharmaceutical giant Merck & Co. Inc. decided in May 2000 against developing a study to test directly whether its Vioxx painkiller drug might pose a heart risk, The New York Times reported on Saturday. Just two months after results from a clinical trial suggested concerns the popular anti-arthritis drug might cause a higher risk of heart attacks, company scientists questioned whether a focused trial was possible and marketing executives apparently feared one would undermine sales..."

DANGEROUS DATA:
Despite Warnings, Drug Giant Took Long Path to Vioxx Recall
www.nytimes.com...

The Vioxx debacle continues to highlight the 'dangers to people' inherent in the current system, which is designed to protect corporate profits. The safety of numerous drugs, not just COX-2 inhibitors like Vioxx, is increasingly in question.



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UPDATE


Arthritis drugs linked to hardened arteries:
Study shows how painkillers may cause fatal heart disease
www.msnbc.msn.com...

"...The drugs, known as COX-2 inhibitors, include Merck and Co.�s Vioxx, which earned the company $2.55 billion a year but was pulled off the market Sept. 30 after a study showed it doubled the risk of heart attack and stroke.
...The research, published in Friday�s issue of the journal Science, also supports the theory that there could be a �class effect,� meaning that all brands of COX-2 inhibitors could raise the risk of heart disease.
...�I believe the evidence is very strong that we have a class effect to deal with here,� said Dr. Garret FitzGerald, a cardiologist and pharmacologist at the University of Pennsylvania who led the study.
...His team found that a fatty acid made by the cyclooxygenase-2, or COX-2, enzyme protects female mice from hardening of the arteries. Shutting down COX-2 long term may actually kick-start the process, known as atherosclerosis..."


Earlier Merck Study Indicated Risks of Vioxx
"Nearly a year before Merck received results from the clinical trial that prompted the company to withdraw its painkiller Vioxx from the market, the company received preliminary results from a separate study of patient records that also apparently indicated that the drug posed cardiovascular risks."

www.nytimes.com...



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Originally posted by jholden
I'm confused. I did extensive research on FMD statistics after your initial response. Many authorities suggest a U.S. frequency of 1% of the population, while the latest larger studies show a lower frequency, on the order of 0.02%. Am I looking in the wrong places? Can you direct me to any studies or websites which suggest, as you've said, that it occurs at a higher frequency. Don't misunderstand me, I believe my father and another good friend both died from Vioxx. I am trying to support your article, not denounce it.

Your confusion may be in your understanding of the term "incidence" or frequency. Incidence refers to the number of new cases diagnosed each year.

...Also, many incidence stats are skewed because they only look at a particular body part.

...FMD is seldom diagnosed before a life threatening “event” occurs, and 65% of reported cases in the USA are diagnosed in autopsy, with an incidence rate of 1.1% in adults. ...Living adult patients are diagnosed at an incidence rate of 0.6%, by angiography.

www.emedicine.com...

“FMD frequency in the USA: incidence of new cases in adults diagnosed by angiography – 0.6%; diagnosed in autopsy – 1.1%.”

NOTE: Incidence means new cases found yearly, presented as a % of the total population.
Also see Puri, PMID: 10334397.

Here's a table that puts together the stats for FMD incidence in autopsy with reported death stats:

YEAR - DEATHS - TOTAL POP - EST ADULT POP (75%) - 1.1% ADULT POP: FMD incid in autopsy

1999 - 2,391,399 - 279,295,000 - 209,471,250 - 2,304,184
1998 - 2,337,256 - 276,115,000 - 207,086,250 - 2,277,949
1997 - 2,314,245 - 272,912,000 - 204,684,000 - 2,251,524
1996 - 2,314,690 - 269,667,000 - 202,250,250 - 2,224,750
1995 - 2,312,132 - 266,557,000 - 199,917,750 - 2,199,095

Source: Population: Census; Reported Deaths; World Health Organization.

As you can see, nearly all of the reported deaths also are diagnosed with FMD in autopsy – so the obvious conclusion is that nearly 100% of the American population is infected with FMD by adulthood.


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Originally posted by soficrow
The system is set up to benefit multinational corporations, at the expense of ordinary people and their lives.

I wish to see the system fixed, and the situation improved. ...You think this is a problem?

I too believe this is a disgrace.The FDA's drug approval system has become as toxic as the poisons it conceals.I seriously am thinking they should adopt the skull & crossbones as their logo.

A veteran scientist at the Food and Drug Administration said Monday he had decided against presenting new data on the heart risk of pain relievers at a highly anticipated meeting later this week, saying he felt intimidated by FDA officials.

The way this CNN article is handled sends further alarms,it is openly stating Dr. Graham is under witness intimidation,showing FDA intentional collusion with PharmCo to suppress data.

But Graham told Reuters in an interview that an e-mail from his supervisor Paul Seligman said that if he continued to press for inclusion of the new data he would be doing so at his own risk.

"The tone of it is (that) I'm being insubordinate," he said.

Their taking it very personal by this odvious veiled threat.This Seligman should be subpoenaed.

An FDA spokeswoman said agency officials told Graham it was his choice as to whether he wanted to present. "We just prefer that published literature be presented," she said.

Hell-O, Dr. Graham is the associate director for science and medicine at the FDA's Office of Drug Safety - that's his JOB!

But Graham said it was not a real choice. "Because I feel so threatened by management, it's not worth taking the risk," he said he told his supervisors.

Amazing...this is the agency that is supposed to be protecting us?

"Our findings are important to the safety of a number of marketed pain relievers," he said.

Really understating that people's lives are on the line!

Are these Senators or PharmCo Puppets?

Sen. Charles Grassley, chairman of the Senate Finance Committee that held the November hearing, said the FDA first told Graham he could not present the study but later, in Seligman's e-mail, said it was Graham's decision to make.

In part of the e-mail quoted by Grassley, Seligman said, "I think we've already articulated our preference that your talk cover the key studies in the published literature. Clearly, you would like to cover more than this which is your call."

Grassley said Graham was "being sent mixed messages."

"Dr. Seligman is clearly saying to Dr. Graham proceed at your own risk," the Iowa Republican wrote in a letter to FDA Acting Commissioner Lester Crawford sent late Monday.

Grassley also questioned the FDA's defense that only published studies should be presented, noting that Graham was reportedly asked to present information from an unpublished Merck study.

Questioned?All signs indicate a full congressional investigation is required. Grassley seems to be a parrot for the FDA rather than taking a more investigative approach as an overseer of its fair practice regarding the health & safety of the American public - His Job

It's a sad state of affairs when the sincere concerns for public safety by researchers like Dr. Graham are met with odvious contempt = disregard to the risk of consumers lives in favor of profits.Seems this FDA would rather quarantine the findings than the disease,sending an intimidating message to future drug researchers that disclosing/publishing alarming findings might put them at risk like the 'russian-roulette' pill-takers themselves.Their should be more of a public outcry demanding for a more in-depth congressional investigation into FDA's drug approval process,but I guess it's when a loved one falls victim to the next shielded 'silent' killer when it will finally hit home,by then too late.

Alarming Full Article

Hehe, yes I substituted the rather odd -hydra instead of -mole for a lack of a better analogy,since it takes more than a mole to perform the collusion tango. lol
The fates of noble informers of the madcow cover-up is also highly disturbing to hear,their practically the equivolent modern-day saints.
It also reminds me of a program I saw a while back about the Canadian Nexia Biotechnologies marketing BioSteelJ silk they extract from goats implanted with a spider gene.Seems that too could have some frightening effects on consumers of goats milk.Dr Frankenstein has nothing on these folks..LOL

Yum Yum - Not

Canadian scientists have implanted spider genes in a herd of goats, resulting in the production of silky strands in goat milk that can be used for sutures and other applications.

"We have combined the old and the new," Turner told UPI in a recent interview. "The old is represented by the goats and their milk, which is used to make cheese. The new is genetic engineering."

Truly Freaky

Beyond spider silk in goat's milk - Nexia has a new product called Protexia - for treating exposure to organophosphate based nerve agents. ...What do you make of it?....

Nexia Biotechnologies Inc. (TSE: NXB) develops and manufactures
complex recombinant proteins in the form of biomaterial and
biopharmaceutical products with industrial and medical
applications. The Company’s most advanced performance fiber
product under development, BioSteel®, is based on spider silk
proteins. BioSteel® products will include medical devices (wound
closure systems) and advanced industrial performance products
(military and aerospace applications). The Company’s lead
biopharmaceutical product under development is a version of
human tissue plasminogen activator (“htPA”), a commercially
available thrombolytic protein drug used to treat heart attacks
and ischemic strokes.


Nexia

Nexia Biotechnologies Inc. develops and manufactures complex recombinant proteins for military and civilian applications. Protexia™, Nexia's lead pharmaceutical product, is being developed as a military battlefield protection system and a medical countermeasure (rescue therapy) for civilian homeland security.

Protexia Fact Sheet
(pdf)


MONTREAL, Dec. 14 /CNW Telbec/ - Nexia Biotechnologies Inc. (TSX:NXB)
announced today that their US & Canadian military biodefense partnerships have
yielded early but promising results for the use of Protexia(R) (recombinant
human butyrylcholinesterase - BChE) to treat civilian casualties resulting
from a terrorist chemical weapon attack.

www.newswire.ca...

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