Federally "Indict" Merck Executives...
Opinion by Consumer Advocate Tim Bolen
Friday, December 3rd, 2004
We need a health care "Nuremberg..."
Shortly after South Carolina MD Jim Shortt was falsely accused of killing a female Multiple Sclerosis (MS) patient this year, supposedly by applying a Hydrogen Peroxide IV to get rid of viruses and bacteria, armed Federal, State, and local law enforcement agents, in almost a "Waco style" assault team, donned their body armor, their mirrored sunglasses, activated their Public Relations teams, and screamed and battered their way into Shortt's West Columbia, South Carolina clinic. With guns and warrant on hand, they seized everything in sight.
Although medical literature clearly shows that Hydrogen Peroxide IV, to get rid of viruses and bacteria, has been around for over ninety (90) years, and records show that over a million treatments have been made, with NO DEATHS, ever recorded, the mere "allegation" of death, false that it was, and made by an elected official with no medical training, caused a massive assault by US law enforcement.
Now let's get real here. It looks to me that US law enforcement has a "policy" here of "zero tolerance" for death by a faulty health treatment. If that's the case, than I think we should be soon watching a humungous raid of Big Pharma giant Merck. For Merck, by US FDA investigation, has killed over 55,000 people with its Vioxx drug alone..
We learned from the US "Enron scandal," that we must hold industry leaders personally responsible for their actions - and that criminal indictments are an absolute necessity.
Columnist Arriana Huffington wrote an excellent article published in the New York Times November 24th, 2004 called You Want A Moral Issue? How About Drugs That Don’t Kill?.
She was talking about Big Pharma giant Merck's killing of 55,000 people with their deadly drug Vioxx. About that she said "there ought to be a special place in hell for corporations that show such a wanton disregard for human life."
55,000 people died, and I haven't heard a word from Attorney General John Ashcroft's office about raids on Merck's offices, pending arrests, property seizures, warrants, injunctions, seizures of products, bans on products sold in this country, etc.
We lost 3,000 people in the attack on the World Trade Center towers in New York City September 11, 2001. We've lost another three thousand in the counter-attack on terrorism, including the massive assault in Iraq. That's about 6,000 deaths total. Merck knowingly killed 55,000 people with Vioxx alone - and we haven't even looked at what else these drug lords peddle - our FDA is so owned, and disabled, by Big Pharma, that investigations ARE NOT LIKELY.
Using US law enforcement's "guidelines" for "zero tolerance," I fully expect, and DEMAND an immediate raid, guns drawn, body armor in place, mirrored sunglasses nosed, with full media alert, of EVERY Merck office worldwide.
We need immediate seizure of every Merck document ever initiated. We need an immediate seizure of every Merck product offered in the United States. Every Merck executive's home needs a raid. We need to immediately ban every Merck product sold in the United States, pending investigation, and alert the medical profession.
You think I'm jesting? I'm not. Merck knows "the worst" is coming. One of my sources tells me that Merck, a few weeks ago, awarded its top 250 executives "golden parachute" retirement packages that would supersede the financial collapse of Merck.
And, it was those executives who were ultimately responsible for all those deaths. We can't let them head for Argentina with submarines full of Art and gold...
We need a health care "Nuremberg..."
Tim Bolen - Consumer Advocate
This "Millions of Health Freedom Fighters - Newsletter" is about the battle between "Health and Medicine" on Planet Earth. Tim Bolen is an op/ed writer with extensive knowledge of the activities of a subversive organization calling itself the "quackbusters," and that organization's attempts to suppress, and discredit, any, and all health modalities that compete with the allopathic (MD) paradigm for consumer health dollars. The focus of the newsletter is on the ongoing activities, battles, politics, and the victories won by members of the "Health Freedom Movement" against the "quackbusters" It details "who the quackbusters are, what they are, where they are operating, when they appear, and how they operate - and how easy it is to beat them..."
For background information on the "Battle between Health and Medicine" go to: http://www.savedrclark.net/by_whom2.htm. A copy of THIS newsletter, and older ones, are viewable at the website http://www.quackpotwatch.org/default.htm.
For EVEN MORE interesting and related articles go to http://www.bolenreport.com.
FDA "Backs Down(?)" Over Deadly Mercury Amalgams...
Opinion by Consumer Advocate Tim Bolen
Monday, March 19th, 2007
One of the biggest scandals in American health care is coming to a head this March 27th, 2007. In the United States Court of Appeals for the District of Columbia, a case, called "Moms Against Mercury, et al., v. FDA" will get its time in the sunlight, and the Defendant, the United States Food & Drug Administration (FDA) isn't doing well in its Defense.
The case is simple. Citizens are suing the FDA for NOT, during the last THIRTY YEARS, ruling on the safety, or danger, of mercury amalgam tooth fillings. The Plaintiffs want mercury amalgam tooth fillings banned completely, and forever.
And, the FDA has virtually no defense...
The US anti-amalgam movement, an aggressive division of the North American Health Freedom Movement, has for years, chipped away at "official dentistry's" promotion of mercury amalgam tooth fillings, pointing out, correctly, their inherent dangers. But "official dentistry" doesn't listen, and in fact, actively punishes dentists that shy away from, or actively advertise the removal of, mercury amalgam fillings. The war has been active for a long time.
With this legal assault the anti-amalgams have adopted an effective offense. In essence, you might say, the anti-amalgam people, armed with silver bullets, have found the secret entrance to the FDA's dungeon, climbed down into the sanctuary during the daylight hours, opened the coffins of the FDA's sleeping staff dentists, sprinkled holy water over them, and driven wooden stakes through their hearts. So to speak.
This case can be the decisive blow - for the FDA attorneys don't have very good answers. The case reads:
SUMMARY OF ARGUMENT
Thirty years after being directed to classify all devices, 20 years after classifying all other dental fillings materials, 13 years after being mandamused to classify but winning on exhaustion grounds, nine years after specifically promising (in writing) to classify, four years after pleading no excuses to Congress for not classifying, it’s clear that FDA’s policy is not to classify encapsulated mercury amalgam. To say FDA ignores this issue is incorrect: FDA’s public relations machine is has been in high gear, as the Center for Devices bobs and weaves about its duty to classify through three “literature reviews,” three “consumer updates,” one “white paper,” and a plethora of sound bites.
The decision not to classify – a plain violation of the statute – is thus a reviewable decision.
FDA’s choice of cheerleader for amalgam, instead of regulator of amalgam, is not acceptable. FDA otherwise bans, limits, and warns against other products, drugs, or foods containing mercury, while other federal health agencies and the health regulators of other nations condemn mercury amalgam.
FDA not only ducks classifying, but also refuses to do an environmental assessment, which would plainly indicate the need for an environmental impact statement. Nor will FDA seek a timely and valid panel recommendation – the previous one being too old (1994), procedurally invalid (no statement for departing from Class III), and sub silentio overruled in September 2006. The writing is on the wall in both cases: An environmental assessment will plainly indicate the need for an environmental impact statement, which report would show alternatives to toxic mercury can be used in fillings, thereby eliminating the major source of mercury in the nation’s wastewater – amalgam. In September, the FDA panel decisively rejected the FDA staff’s pseudo-science about amalgam (e.g., it is safe because it’s been used for a long time), so FDA ducks asking the panel for formal action.
FDA keeps amalgam on the market via a sham substantial equivalence test, pretending that a powder half-device containing no mercury equates to a full device capsule that is 50% toxic mercury. When asked by Senator Kennedy why this practice is allowed, Commissioner Von Eschenbach in writing denied that FDA considers the two devices to be substantially equivalent. Since the staff has ten times approved amalgam under this test in the past six years (and many times before that), perhaps the Center for Devices is engaged in rogue activity unknown to the Commissioner’s office.
The correct recourse is not a mere order to classify, allowing an unclassified, unregulated device – with 50% mercury and for which substitute materials are legal and available for any dentist to place – to remain in commerce, but to remove it from commerce temporarily until FDA complies with its legal duties.
This Court must direct FDA to start being amalgam’s regulator instead of amalgam’s cheerleader. Whether by intention or lethargy, FDA’s Center for Devices has protected the marketing of mercury fillings by doing none of its regulatory duties – neither classifying nor requiring proof of safety nor doing an environmental assessment nor seeking a valid recommendation from the scientific panel. Since they have ducked and dodged classifying encapsulated amalgam after classifying all other dental filling materials in the 1980s, the mercury apologists at the Center for Devices by now realize that completing any of these tasks will lead straight to the end of mercury in dentistry.
Thus, an order to classify is not enough. The legal prerequisites (environmental impact statement and Panel referral) mean the process will take months; the record of bad faith suggests it will take years. Amalgam is illegally in commerce. It must be removed from commerce forthwith, temporarily, until FDA chooses to complete its regulatory duties.
What was the FDA's response to this legal action?
Charlie Brown, two-time elected Attorney General for the State of West Virginia, and now attorney for the Plaintiffs, says of the case:
Our case, filed April 27, 2006, by 9 petitioners (names below)* charges FDA with illegally allowing the sale of mercury fillings. For thirty years, FDA has defiantly refused to classify amalgam -- even though this step is required as the legal prerequisite to sale of any implants. Even the repudiation of its pseudo-science by two FDA Scientific Panels on September 7, 2006 has not deterred FDA, who is making false and deceptive claims to mask the vote of these Panels.
Faced with standing before a federal court, FDA now departs from its role as chief cheerleader for mercury fillings. In its brief, FDA admits, five times, that it does not know if mercury amalgam is safe or unsafe!
The nine petitioners who sued FDA: Four organizations: Moms Against Mercury (Amy Carson, Angela Medlin), Connecticut Coalition for Environmental Justice (Mark Mitchell, M.D.), Oregonians for Life (Mary Starrett), and California Citizens for Health Freedom (Frank Cuny); two state officials: California Dental Board Public Member Kevin J.Biggers, and Arizona State Senator Karen Johnson; three individuals: Dr. Andy Landerman, Linda Brocato, and Anita Vazquez Tibau.
This is a breakthrough not thought possible a year ago. To repeat, FDA now admits that the evidence is “changing,” thus the safety of mercury fillings is not “definitive” and is “the subject of intense disagreement.” Quotations from FDA’s brief, containing those admissions, are below.**
FDA’s admissions in its brief to the US Court of Appeals: “there is a lack of conclusive evidence regarding the health effects of mercury fillings”; “constantly changing scientific evidence” exists on mercury amalgam; “complex issues and intense disagreement [exist] about the scientific evidence regarding mercury and its potential health effects”; “the complexity of the issue and the lack of conclusive scientific evidence on the health effects of dental amalgams”; “the lack of … definitive scientific evidence.”
Let's see what happens next.
Tim Bolen - Consumer Advocate