Don't Rely on High-Tech Medicine for Your Health

Do you put your trust in modern medicine? Do you rely on their high-tech equipment -- part of the so-called "modern marvel"? If so, then you may be just too trusting for your own good. Did you know that official records reveal that every year tens of thoudands of people in the US alone are killed by mistakes in the medical system? That's just the official data, I can assure you the real figure is far higher. If that many people were killed by any other means there would be a massive public outcry. So, where is your voice when it matters?

Here are the two most recent failures in medical technical equipment. If these products had been used on you or on someone you love, too bad, it would just be a case of "oops, sorry... next please" as the system moved on.

Class 1 Medical Device Recalls - Welch Allyn PIC 50™ Automated External Defibrillators

Date Recall Initiated: June 30, 2006

Product: Welch Allyn PIC 50™ Automated External Defibrillators, catalog #97108X manufactured from March 2002 through October 2004.

Use: This device is an automated external defibrillator (AED) that is intended for use by emergency or medical personnel to monitor and treat patients with symptoms of cardiac dysfunction. The device monitors patient vital signs and delivers an electrical shock (defibrillation) to the heart if needed to restore normal heart rhythm.

Recalling Firm: MRL, Inc., A Welch Allyn Company

Reason for Recall: An electrical contact problem may result in the device’s failure to provide a defibrillation shock, which could result in delay or failure to resuscitate the patient. This failure may be accompanied by various error messages on the display panel, including the “Defib Comm” error message.

Public Contact: Consumers with questions may contact the company at (800) 462-0777 or (847) 520-0300 for more information.

FDA Comments: MRL, Inc sent Urgent Medical Device Recall letters dated 7/05/06 to its customers who purchased PIC 50™ AEDs, which contained a list of the affected units' parts/serial numbers and requested that customers inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing.

The recall letters instructed customers to respond by fax or mail to the notification within 5 working days if the unit has displayed the “Defib Comm” error, and within 30 days if it has not displayed the “Defib Comm” error.

Within 10 days of receiving a response to the recall notice, MRL, Inc. will provide PIC 50 owners with a loaner PIC 50 while their unit is being serviced, with instructions on how to return their unit for correction.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Updated July 7, 2006

And on just the day before...

Baxter Healthcare Corp. Signs Consent Decree with FDA; Agrees to Correct Manufacturing Deficiencies

The U.S. Food and Drug Administration (FDA) today announced that Baxter Healthcare Corp. (Baxter) and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices.

Infusion pumps are electronic devices intended to control delivery of solutions and medications to patients. They are used in situations where medication must be administered intravenously or through other routes, in a continuous or intermittent manner, for a prolonged period of time.

"Infusion pumps deliver life-saving drugs and nutrition to thousands of critically ill patients. But if they don't work properly, patients are put at risk," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "Baxter has clearly had significant problems with some its infusion pumps. With this action today, Baxter has agreed to correct those problems. FDA's goal is to see that the necessary corrections are made, that the public health is protected and that users have access to safe and effective pumps."

Under the terms of the consent decree, signed by Baxter's Chairman and Chief Executive Officer, Robert L. Parkinson, Jr., and its Corporate Vice President and President of Medication Delivery Services, Peter J. Arduini, the company has agreed to take necessary measures to ensure compliance with the CGMP and QS requirements by all of its facilities that manufacture, process, pack, label, hold or distribute the Colleague and Syndeo Pumps. The decree also requires Baxter to retain an independent expert consultant to conduct inspections of its infusion pump facilities and certify to FDA that corrections have been made. FDA will continue to monitor these activities through its inspections.

Under the consent decree, FDA will allow the firm to continue to provide routine service maintenance, or to replace components, parts, or accessories for the Colleague and Syndeo Infusion Pumps that were already in the hands of customers before October 12, 2005. Baxter is also required to submit to FDA an acceptable detailed corrective action plan to bring the Colleague and Syndeo Infusion Pumps currently in use in the United States into compliance with the Federal Food, Drug, and Cosmetic Act (the Act). The agency recently issued a Preliminary Public Health Notification dated April 28, 2006 with recommendations for users, titled "Important Safety Recommendations for Baxter's COLLEAGUE Infusion Pumps" (see http://www.fda.gov/cdrh/safety/042806-baxter.html).

If corrective action under the decree is completed and Baxter has been allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its domestic infusion pump facilities at least once a year for at least four years. Results of these audit inspections will be reported directly to FDA. If Baxter fails to comply with any provision of the decree, or violates the Act or FDA regulations, FDA may order the firm to again stop manufacturing and distributing, recall the products or take other action.

The most recent FDA inspection of Baxter's Round Lake Facility, conducted on June 20-30, 2005, revealed deficiencies with the CGMP and QS requirements for devices, including the firm's failure to implement adequate management controls over its quality system operations and corrective and preventive actions (CAPA) procedures. During this inspection, design defects relating to the reliability of both the Colleague and the Syndeo Infusion Pumps were also revealed.

During the course of FDA's June inspection, Baxter initiated a voluntary world-wide hold on all Syndeo Infusion Pumps due to design defects that can cause the device to stop functioning. Also during the June inspection, Baxter initiated a voluntary world-wide hold on all Colleague Infusion Pumps due to a product design defect relating to a temperature sensitive component of the device's timing circuit, known as the Y2A crystal, which causes the timing circuit to fail.

Before the June 2005 inspection, FDA conducted two previous inspections of Baxter's medication delivery systems facility in Round Lake, Illinois, in September 2000 and June 2002, all of which revealed lack of management controls over the firm’s quality system operations and inadequacy of its CAPA and complaint handling systems. These deficiencies undermined Baxter's ability to assure the quality of the devices manufactured at its Singapore plant. In September 1999, FDA issued a Warning Letter to the firm addressing its lack of CAPA procedures. In August 2001, another Warning Letter was issued to Baxter addressing deficiencies in its CAPA procedures.

The consent decree also resolves the disposition of Colleague and Syndeo Infusion Pumps that were seized by the Department of Justice on behalf of FDA in October 2005. The consent decree was entered today by the U.S. District Court for the Northern District of Illinois.

Now if you find these alerts reassuring, as the FDA intends, then I have this to say to you: Wake Up!

Don't be lulled into complacency. Start thinking for yourself. Consider the fact that it takes time, reporting, investigation, multiple failure incidents, suffering and loss before the FDA decides to act on your behalf. From my observation, there is a tendency for the FDA to put some drug and equipment manufacturers ahead of your protection anyway. You are unwise to rely on the medical system. Start taking action to ensure your own health.

Americans Obsessed with Killing & Death

As I said recently in The Health Gazette...

While every nation must face the tragic realities of homicides and suicides there is no doubt that the US has some serious issues to face in these areas. These data strongly suggest some significant problems in and affecting the American population. It may be helpful for bureaucrats to count the events and to nicely tabulate the data and to talk of dealing with it as part of the "public health agenda" but who are they kidding? This is a very serious problem and it is time, surely, for some serious self-examination, diagnoses and effective treatments. The following report is from the CDC.

I was referring to a recent report on homicide and suicide rates in the US released by the CDC. It begins like this.

Violent deaths claimed 49,639 lives in the United States during 2003, and the prevention of violent deaths is an integral part of the public health agenda (1). In 2003, CDC launched the National Violent Death Reporting System (NVDRS) to provide detailed information on the circumstances of violent deaths. The system can be used to develop and evaluate prevention policies, programs, and strategies at the national, state, and local levels (2). This report describes the analysis of violent deaths from seven states that participated in NVDRS in 2003, plus six additional states that participated in 2004.

Homicide circumstance information revealed that most victims knew the suspects involved and that intimate partner conflicts continued to be among the most important contributing factors. Suicide circumstance information indicated that mental health disorders and intimate partner problems had important roles. These findings underscore the value of NVDRS data for effective planning and targeting of violence-prevention programs.

The report goes on with the following remarks. Frankly, they just as worrying as the death rates. Why? Because they are so cold, dispassionate, bureaucratic, scientific. These people are talkin about homicides and suicides of staggering incidences yet they hide withing their emotionless world making it appear that something is being done. In truth, there is scant evidence that any initiative or program yet instituted has done any good at all in dealing with this dark side of the American psyche.

NVDRS is an active, state-based surveillance system that collects information on homicides, suicides, deaths of undetermined intent (i.e., those for which available information is insufficient to enable a medical or legal authority to make a distinction among unintentional injury, self-harm, or assault*), deaths from legal intervention (e.g., involving a person killed by an on-duty police officer), and unintentional firearm deaths. Seven states provided data in 2003 (Alaska, Maryland, Massachusetts, New Jersey, Oregon, South Carolina, and Virginia), and six additional states contributed in 2004 (Colorado, Georgia, North Carolina, Oklahoma, Rhode Island, and Wisconsin). NVDRS uses a multisource approach (i.e., death certificates, coroner/medical examiner reports, law enforcement records, and crime laboratory data) for analysis of violent deaths.

Using information from all of these sources, data abstractors in each state assign a manner of death (i.e., suicide, homicide, unintentional firearm deaths, legal interventions, and undetermined deaths) to each case. NVDRS also collects the International Classification of Diseases, 10th Revision (ICD-10) code for underlying cause of death (UCOD), circumstances contributing to the death, and characteristics of the death, including victim-suspect relationship and victim toxicology results. The UCOD is categorized as suicide or homicide using standard definitions from the National Vital Statistics System (NVSS) (3--5).

You can read the report on the Health Gazette via the link above if you wish. Can someone please explain what this American obsession with killing and death is all about?

Health Consequences of Involuntary Exposure to Tobacco Smoke

The US Surgeon General's report, The Health Consequences of Involuntary Exposure to Tobacco Smoke (1), was released on June 27, 2006. The report is an evaluation and synthesis of evidence regarding the health effects of exposure to secondhand smoke. An update of the 1986 report, The Health Consequences of Involuntary Smoking, the report also adds information regarding secondhand smoke to the smoking and health database developed for the 2004 report, The Health Consequences of Smoking; the database is available at http://www.cdc.gov/tobacco.

The six major conclusions of the latest report are as follows:

1. Secondhand smoke causes premature death and disease in children and in adults who do not smoke.
2. Children exposed to secondhand smoke are at an increased risk for sudden infant death syndrome (SIDS), acute respiratory infections, ear problems, and more severe asthma. Smoking by parents causes respiratory symptoms and slows lung growth in their children.
3. Exposure of adults to secondhand smoke has immediate adverse effects on the cardiovascular system and causes coronary heart disease and lung cancer.
4. The scientific evidence indicates that there is no risk-free level of exposure to secondhand smoke.
5. Many millions of Americans, both children and adults, are still exposed to secondhand smoke in their homes and workplaces despite substantial progress in tobacco control.
6. Eliminating smoking in indoor spaces fully protects nonsmokers from exposure to secondhand smoke. Separating smokers from nonsmokers, cleaning the air, and ventilating buildings cannot eliminate exposures of nonsmokers to secondhand smoke.

Copies of the full report (stock no. 017-024-01685-3) can be purchased from the Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, Pennsylvania 15250-7954; via telephone, 866-512-1800; or at http://bookstore.gpo.gov. The full report, the executive summary, and the consumer-oriented publication, The Health Consequences of Secondhand Smoke --- What It Means To You, also can be downloaded at http://www.cdc.gov/tobacco. Single, free copies of these three publications can be ordered at http://apps.nccd.cdc.gov/osh_pub_catalog.

FDA Agenda Bigger than Terrorist Threat

June 30, 2006 is a day that will be long remembered as a dark milestone in the history of FDA and its campaign against health consumers. On June 30, an FDA "Final Rule" goes into effect, establishing a regulatory power grab of such scale and scope that it attempts to bypass all laws, the will of Congress and fundamental protections for consumers. This "Final Rule," which may as well be called a "Final Solution" for drug consumers, claims that consumers can no longer sue drug companies for the harm caused by any FDA-approved drug, even if the drug's manufacturer intentionally misled the FDA by hiding or fabricating clinical trial data.

In one blatantly illegal act, the FDA is attempting to pull off the greatest Big Pharma coup of all: The outright elimination of any responsibility whatsoever for the suffering and death caused by deadly pharmaceuticals.

In the preamble of the FDA's new "Final Rule" to take effect on June 30, the agency asserts that FDA approval of prescription drugs -- and their implied safety -- may no longer be second-guessed by consumers or organizations of any kind. The FDA's stamp of approval, the agency claims, is an absolute declaration of safety of all such drugs, for any use whatsoever, including off-label use (the use of drugs on health conditions that were never tested in clinical trials).

But such a position has no basis in law. During a June 6, 2006 hearing, a New Jersey state court judge Carol E. Higbee characterized the FDA's preamble as, "a political statement by the FDA" and explained that the ploy has, "...nothing to do with science. ...It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption. ... In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States."

The FDA is dangerous to America

That this outrageous assertion by the FDA would take place at a time when so many Americans are routinely killed by the harmful side effects of prescription drugs only contributes to the arrogance and absurdity of this rogue agency that has now become the No. 1 threat to the health and safety of the American people. Even a terrorist nuclear attack on a major U.S. city would not equal the number of Americans who have already been killed by the negligent actions of the FDA. Related article

FDA-approved prescription drugs injure 2.2 million and kill approximately 100,000 Americans each year, according to peer-reviewed published studies, and more realistic estimates put the number of deaths at over 200,000 people annually in the United States alone (see Death By Medicine for detailed statistics). Vioxx, according to senior FDA drug safety researcher Dr. David Graham, appears responsible for the deaths of over 60,000 Americans, and further deaths due to beta blockers, antidepressant drugs, statins and other medications continue to mount by the hour.

The resulting FDA body count of American casualties makes the casualties of war look small in comparison. The Vietnam War claimed the lives of approximately 50,000 Americans (plus many more Vietnamese), and a memorial in Washington D.C. honors those who died. But FDA-approved prescription drugs have killed well over a million Americans, yet no memorial will be built, no honors bestowed, and now the FDA would deny the families of those victims their legal right to fight for any sort of compensation.

It's not like these consumers were killed by enemy gunfire in a foreign land; they were killed by American companies, on American soil, with the full permission and approval of an American regulatory agency! The enemy from within is, indeed, far more dangerous than any foreign threat to the lives of American citizens. Not since World War II have so many Americans died from a single, common, preventable cause, and it almost seems that the FDA has declared war on the American people and is using chemical weapons to win that war.

The scourge of dangerous prescription drugs, combined with willful collusion at the FDA, has now created a chemical holocaust on U.S. soil that will continue to claim the lives of mothers, fathers, daughters and sons until the American people demand that justice be served and that the FDA / pharmaceutical industrial complex be dismantled and condemned through some modern-day equivalent of the Nuremberg Trials. How many millions more have to die from this chemical holocaust before this reign of medical terror is brought to an end?

The ramifications of the FDA's Final Rule

The FDA's new "Final Rule" would allow drug companies to operate with impunity, shouldering absolutely no responsibility for the harmful (even fatal) side effects of their prescription drugs, many of which we are now learning were only approved under highly suspicious circumstances that smack of fraud, corruption and outright criminal intent. Consumers harmed or killed by toxic prescription drugs -- even drugs that their manufacturers knew were extremely dangerous -- would have no recourse whatsoever.

If such a rule were to go unchallenged, the degree of profiteering by Big Pharma would be unprecedented. Free to charge monopoly prices thanks to the FDA-enforced domestic drug racket that outlaws international competition, and unburdened by the financial risk of lawsuits from consumers harmed by their drugs, Big Pharma would be emboldened to unleash a dystopian era of unprecedented disease mongering, bribery of doctors, false advertising and the mass drugging of children, adults and seniors alike... with absolutely nothing to hold them in check.

This result may, in fact, have been the intention all along. This "Final Rule" appears to be little more than a thinly-veiled attempt to establish wide-ranging authority where none exists by burying it in the language of a drug labeling rule. A more detailed legal criticism is offered by Karen Barth Menzies, an attorney at Baum Hedlund in Los Angeles:

On Wednesday, Jan.18, 2006, the Food and Drug Administration issued new regulations regarding the labeling of prescription drugs, including regulations aimed at providing doctors and patients with clearer information about the risks associated with prescription drugs. However, in the preamble to these new regulations, the FDA inserted conclusory and legally unsupported statements that tort lawsuits alleging a failure to warn of known or reasonably knowable safety risks are preempted by federal law. This attempted power-grab by the FDA wholly ignores the prerogative of Congress, contradicts both statutory and case law precedent, disregards the parallel but distinct roles played by FDA and tort liability law, fails to provide an avenue through which consumers may be compensated for drug-induced injury, neglects any federal replacement of applicable state policing and enforcement procedures, and shirks constitutionally established principles of federalism which protect the jurisdiction granted to states in matters involving public safety and health. By inserting preemption language into the Final Rule without an official consultation with state and local government groups concerning the preemption language, the FDA also violated Executive Order (E.O.)13132. (When an Executive department or agency proposes to act through adjudication or rule-making to preempt State law, the department or agency shall provide all affected States notice and an opportunity for appropriate participation in the proceedings. Exec. Order No. 13132, [[4(e), 64 Fed.Reg. 43255, 43257 (1999). According to the National Conference of State Legislatures (NCSL), the preemption language inserted into the preamble of the Final Rule is a thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute and does not have by way of judicial ruling. The NCSL called FDA s action an abuse of agency process and a complete disregard for our dual system of government.

The fallout of the FDA's "Final Solution"

The ramifications of this "Final Rule" action by the FDA cannot be overstated. If this rule is allowed to stand, it represents the end of health justice, the end of the power of Congress, and the surrender of absolute power to an agency of such arrogance and evil that it has conducted armed raids on vitamin clinics, organized the raid of a church, and even ordered the destruction of recipe books it didn't want to see published. (Supporting documents are available for all of these statements).

The FDA, through its willful negligence, is indirectly responsible for the deaths of more Americans than all terrorists, murderers and drunk drivers combined. As the deaths continue to mount, and drug companies become even more aggressive with outlandish disease mongering and advertising efforts, the FDA rears up to unleash a new wave of corporate terrorism upon the American people by emboldening drug companies to care even less about the safety of their synthetic chemical products, most of which cause harm by their very nature of being foreign to the human body.

As Menzies explains:

Pharmaceutical industry lobbying efforts and zealot tort reformers have sired a new wave of brazen attempts to shield drug manufacturers from tort liability. The preemption language in the preamble to the Final Rule is but the latest attempt. Preemption has become the argument du jour and politically appointed regulatory officials the mouthpieces. The crafty messages sound of consumer protection, but are just the opposite. Limiting the liability of drug companies will not improve public safety. The FDA's purported position on preemption assumes that the FDA is infallible and that negligent misconduct by pharmaceutical companies should be the sole purview of FDA. Recent regulatory failures demonstrate that FDA is neither infallible nor does it have the capability of policing drug manufacturers negligent misconduct.

Want to see the real FDA at work? Read the story of Rezulin, and you'll be shocked to learn the truth about the real agenda that drives this rogue agency.

The end is near for the Big Pharma / FDA racket

Why would the FDA engage in such an obviously unlawful power grab? Because Big Pharma co-conspirators have realized that lawsuits threaten to bankrupt the drug companies. The products of these companies are so universally harmful, and their ability to hide this truth is slipping away so rapidly, that the financial burden of settling lawsuits (or defending them in court) threatens to crush the entire pharmaceutical empire.

Merck alone is defending itself against literally thousands of lawsuits from just one drug: Vioxx. As the truth emerges about the dangerous side effects from the long-term use of other widely-prescribed drugs, class action lawsuits will reach a momentum that will make the Big Tobacco settlements seem like a friendly game of Friday-night poker.

Truth be told, there is not enough money in the world to pay for all the pain, suffering and death that has already been caused by prescription drugs, and if drug companies are held responsible for even a small fraction of the patients their products have harmed and killed, they will rapidly fall from the most wealthy corporations in the world to the most bankrupt, both financially and morally.

And so the FDA is jumping in with one last, desperate attempt to cast a spell of immunity over all drug companies in order to preempt the coming flood of class action lawsuits. But even this effort will fail, as the truth about the dangers of prescription drugs can no longer be censored. Through a tidal wave of new books, documentaries and health websites, consumers are learning the shocking truth about Big Pharma and the FDA, and the beginning of the end of the age of chemical medicine is already under way.

Reading suggestions: The Truth About the Drug Companies by Marcia Angell, M.D., Psyched Out by Kelly Patricia O'Meara, or Death by Prescription by Ray Strand.

You see, the arrogance and greed of drug companies will ultimately be their downfall. They have pushed too hard, too far, and they have landed themselves in a realm of such obvious scientific fraud and criminal negligence that the backlash is inevitable. The rampant disease mongering, the mass drugging of schoolchildren with amphetamines, the false claims of drug ads, the bribery of doctors, the collusion at the FDA... it's all coming to the surface now, and by the time this house of cards comes tumbling down, the resulting criminal trials against drug company executives and FDA officials will make the Enron trials sound like a high school debate.

It is not only inevitable that drug company executives and FDA senior officials will do prison time for their crimes against humanity, it is important that they be loudly condemned via such punishments for knowingly defrauding, harming and ultimately killing countless Americans in exchange for one thing: Corporate profits.

American medicine is now the shame of the world, and the conduct of senior officials at the FDA is nothing less than criminal. There is now no greater threat to the health and safety of the American people than the U.S. Food and Drug Administration.

"As currently configured, the FDA is not able to adequately protect the American public. It's more interested in protecting the interests of industry. It views industry as its client, and the client is someone whose interest you represent."

- Dr. David Graham, senior drug safety researcher at the Food and Drug Administration, and Vioxx whistleblower

Source: http://www.NewsTarget.com/019497.html