Thursday, November 03, 2005

The Coming Health Tyranny II: Forced Innoculations On the Way

This is continued from the last post, so scroll down and read that first. This could conceivably get serious, and in the very near future! I am working feverishly on some autobiographical materials (under the working title Intellectual Nomad) and preparing to get them into final form in case things come unraveled, when I and others who plan to refuse to obey Federal orders to get untested flu vaccines for a non-pandemic that has yet to affect a single American, in a situation in which we cannot sue anyone if we are seriously harmed, have to disappear. This could well mean not posting here or anywhere else for some time to come.

Two articles follow, dated exactly one week apart, bringing us up to date on the situation vis-a-vis the Bush Administration's ploy to use the bird flu non-event as a means of declaring martial law in the United States. I have reproduced the entire articles, because the subject matter is of the first importance!

By John Hanchette
Niagara Falls Reporter
October 25, 2005

OLEAN -- The current U.S. Congress has many qualities that are not endearing, but one of the worst is its addiction to hidden agendas. Case in point:

In the middle of last week, one short day after the bill had been introduced, the powerful Senate Health, Education, Labor and Pensions Committee -- by a quick, simple voice vote of the full panel -- passed something called the "Biodefense and Pandemic Vaccine and Drug Development Act of 2005."

It will probably hit the Senate floor this week for a full vote of that august chamber (and may have already done so by the time you read this). A similar companion bill is expected to be introduced in the House of Representatives before week's end. The lobbying lubrication needed in that conservative chamber to ram it through passage will be even less than in the Senate.

The Senate proposal (S.1873) -- authored and filed by North Carolina Republican senator Richard Burr, an obedient favorite of the current Bush administration -- sounds innocent and altruistic enough, right?

It would establish an efficient-sounding Biomedical Advanced Research and Development Agency (BARDA) to speed up and "provide incentives and protections" for the "domestic manufacture of medical countermeasures" -- vaccines and drugs -- that would help stop pandemic or epidemic sickness within the United States.

Burr said in introducing the bill that it will simply give the Cabinet-level Department of Health and Human Services (HHS) the "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines."

So, who could be against such a lofty goal? Well, I could, for one. This bill is a slavering wolverine masquerading as a furry little lab rat.

First of all, whenever you -- as consumers, taxpayers and citizens -- hear any federal government source saying it wants "to partner with the private sector," you should grab your wallet with both hands and hold on tight. In this case, you should also take your children into your arms. I'm not the only one who's noticed the danger in this proposal.

Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC) -- a private, non-governmental advocacy group pushing for safer vaccines -- calls the Senate bill "a drug company stockholder's dream and a consumer's worst nightmare."

It is, simply put, a legislative genuflection to Big Pharma -- the steamroller-powerful drug-making sector of the economy. The pharmaceutical mega-firms contribute millions to the coffers of congressional members, but if this is signed into law, they potentially could save billions.

That's because this proposed legislation will strip Americans of the right to a trial by jury if they are harmed by either an experimental or licensed drug or vaccine they are forced by the government to take whenever federal health officials declare a public health emergency.

This bill gives the HHS secretary the sole authority to decide if a drug manufacturer violated laws that mandate drug safety, and it bans any citizen from challenging the HHS head's decision in the civil court system. Big Pharma has been pushing for protection like this for several years. In this millennium, the angst and sense of loss following 9/11 was manipulated to produce similar legislative efforts designed to protect drug and vaccine makers even if they manufactured products that were not properly tested, nor clinically proven safe.

"This proposed legislation," said NVIC's Fisher, "like the power and money grab by federal health officials and industry in the Homeland Security Act of 2002 and the Project Bioshield Act of 2004, is an unconstitutional attempt by some in Congress to give a taxpayer-funded handout to pharmaceutical companies for drugs and vaccines."

Further, Fisher points out, the government, under this bill, "could force all citizens to use these drugs and vaccines while absolving everyone connected from any responsibility for injuries and deaths which occur" in their wake.

Sen. Burr is himself the chairman of the Senate Subcommittee on Bioterrorism and Public Health Preparedness. In his bill, BARDA -- the new R and D agency mentioned above -- would be established as the single point of authority in the federal system for the advanced research and development of vaccines and drugs in response to bioterrorism and outbreaks of natural disease.

And BARDA would operate in secret.

The agency would be exempt from the Freedom of Information Act and from the Federal Advisory Committee Act, which requires public public transparency -- making it almost certain that no evidence of injuries or deaths caused by drugs and vaccines labeled as "countermeasures" to bioterrorism or new disease epidemics would ever become public. The bill would not only provide Big Pharma impenetrable cover, it would exempt lots of federal cost oversight requirements, and would forbid government purchases of generic versions of such new drugs or vaccines, a current practice that saves taxpayers millions of dollars.

The Burr bill means, notes vaccine safety advocate Fisher, "that if an American is injured by an experimental flu or anthrax vaccine he or she is mandated to take, that citizen will be banned from exercising the constitutional right to a jury trial even if it is revealed that the vaccine maker engaged in criminal fraud and negligence in the manufacture of the vaccine."

Burr himself has acknowledged that "liability exposure" is one of the factors that has left drug firms "reluctant to invest" in biodefense and influenza countermeasures.

The timing of the new attempt at congressional protection for Big Pharma -- the Burr bill -- is exquisite.

The wording "natural outbreaks" of disease and "pandemics" mentioned by Sen. Burr in his call for support of the bill are designed to make citizens and fellow senators alike think of one thing -- avian flu.

This new biological "threat" is increasingly on the minds of Americans and is reaching near-panic level in terms of public perception.

David Daigle, a spokesman for the federal Centers for Disease Control and Prevention, said the CDC has been experiencing an incredible average of 447,000 hits a day on its bird flu information Web site. He pegged the Internet traffic level "insane."

Americans are avalanching health officials, newspapers, TV stations, their doctors and other public information sources with anxious questions about keeping bird-feeders in their back yards, whether they can eat turkey this Thanksgiving, and whether they should report sightings of dead birds along the roadside. (You can, you can, you don't have to.)Worried patients are asking their doctors for Tamiflu, designed to treat ordinary human flu -- not bird flu.

And guess the number of Americans who have died of avian flu already? Zero.

How many human cases of the bird flu have been reported in the United States? Zero.

That's right, none. The bird flu, which originated in South Korea more than two years ago, rarely spreads from birds to humans, and hasn't even been shown to affect poultry yet in this country. Only 120 or so humans have ever come down with this rare viral strain of influenza -- H5N1 -- and all of them in Asia. Most of the 60 deaths so far -- 43 -- have occurred in Vietnam. Thailand has the next largest number of deaths, 13.

The disease in birds is just now reaching eastern Europe through avian migration. Turkey, Romania, and European Russia have cataloged the dangerous strain.

The virus might be an eventual threat to the flocks of poultry farmers here, but many scientists seem to think H5N1 influenza won't sicken or kill humans on a mass basis unless its mutating properties change dramatically.

Can Senate Democrats stop the passage of Burr's bill? Not bloody likely.

Several Democrats in that chamber have criticized the Burr bill, but mostly from the perspective that it would do little to provide any response to an avian flu outbreak.

"I hope that people don't think this is going to solve the problem of the possible avian flu pandemic that is on our doorstep," warned Sen. Tom Harkin, an Iowa Democrat.

This legislation is obviously fast-tracked. Senate Majority Leader Bill Frist, the Tennessee Republican, is a co-sponsor, as is Senate Budget Committee Chairman Judd Gregg, a Republican from New Hampshire.

They obviously don't care that if signed into law, this proposal would eliminate both legal and regulatory safeguards, applied to vaccines and drugs, that need strengthening, not weakening or elimination. They obviously don't care if children or adults harmed by vaccines and drugs will have to forfeit their right to present a case in front of a jury in a civil court of law.

Don't think this never happens. The Food and Drug Administration is legally responsible at present for regulating Big Pharma, and for ensuring that vaccines and drugs released to the public are safe and effective. Drug companies marketing pain-killer and anti-depressants that have injured thousands are being held accountable in civil courts all the time. And the FDA has come under intense criticism for keeping information from the American public about drug dangers.

For almost two decades, vaccine makers have already been protected from most liability in civil courts through the National Childhood Vaccine Injury Act of 1986 and a concurrent compensation program that offers victims an alternative to civil courts. That program has already awarded almost $2 billion to injured victims of mandated vaccines -- yet two-thirds of the plaintiffs are turned away from such compensation through vigorous defense of the manufacturers by Justice Department lawyers.

"The drug companies and doctors got all the liability protection they needed in 1986," says Fisher of the NVIC, "but they are greedy and want more."

She continues: "It's a sad day for this nation when Congress is frightened and bullied into allowing one profit-making industry to destroy the Seventh Amendment to the Constitution guaranteeing citizens their day in court in front of a jury of their peers."

Amen to that.

John Hanchette, a professor of journalism at St. Bonaventure University, is a former editor of the Niagara Gazette and a Pulitzer Prize-winning national correspondent. He was a founding editor of USA Today and was recently named by Gannett as one of the Top 10 reporters of the past 25 years. He can be contacted via e-mail at

By John Hanchette
Niagara Falls Reporter
Nov. 1, 2005

OLEAN -- Last week's column warned of imminent federal legislation that would toss powerful pharmaceutical companies billions of dollars and complete protection from liability suits in case untested and experimental bird flu vaccines damage American recipients. It drew heavy response.

The bill (S. 1873) -- a big congressional wet kiss to the drug industry -- is dressed up in a noble-sounding title: "Biodefense and Pandemic Vaccine and Drug Development Act."

In essence, however, it would force Americans to receive inoculations against a disease that has yet to kill one of them, while removing their constitutional right to seek redress in our courts in case of injury or death from the shots because of company negligence. The proposal, now moving its way through the Senate, would also ban citizens from using the Freedom of Information Act and other popular informational laws to discover whether the new vaccine (when it is finally produced) was effective and safe, and even whether anyone had suffered adverse reactions to it.

Some of the e-mails and letters were laudatory, but sadly and predictably, many readers missed the point.

One wrote that I could only have reached my conclusions if I started from the position that the pharmaceutical companies were "evil" and that the World Health Organization, the Centers for Disease Control, and "practically every virologist and epidemiologist in the world is part of a conspiracy." Or was I saying that I have "some sort of privileged information that H5N1 influenza will never mutate and begin to infect humans and even if it does, it won't reach the USA?"

He ended by quoting some venerable Chinese philosopher's advice to "plan for what is difficult while it is easy, do what is great while it is small."

Well, yes, point taken on the aphorism -- but that's exactly the philosophical tack I'm following here: identifying a cancerous piece of federal business and dissecting it while it is still an undivided cell. If this bill -- which is absolutely laden with hidden agendas -- metastasizes into actual law, Senate 1873 could further ruin an already devastated national health care system.

Sure, the bird influenza that has killed 62 Asians may mutate into easily contractible flu for humans. I acknowledge that. It may soon reach the United States. I acknowledge that. But my beef is the thematic hidden agenda in this dangerous Senate bill that is designed to protect wealthy corporate contributors from any consequences of money-motivated, irresponsible scientific research and development. The legal precedent would be ruinous and take decades to set right.

One thing the bill-backer friends of Big Pharma are trying to slip through with this legislation is a market exclusivity provision that would extend patents on hugely profitable drugs that are about to evolve into the category of cheaper generic medicines.

Further, it would prohibit federal drug buyers from contracting with generic medicine makers to save taxpayers billions of dollars -- a current admirable practice.

Further, it would allow federal health officials to purchase medicines, vaccines and other palliatives by simple fiat without taking bids.

Further, and most onerously, the bill would vastly broaden the definition of products eligible to be characterized as "countermeasures" to terrorism -- in other words, potentially classifying commonly purchased substances like ibuprofen and aspirin as terrorist-fighting devices.

I'm not the only one who's noticed the exclusivity aspect of this legislative turkey.

The Coalition for a Competitive Pharmaceutical Market (CCPM) is an unusually broad-based national coalition of organizations powerful on Capitol Hill in representing employers, health insurers, chain drugstores, generic drug makers and pharmacy benefit managers.

Last week, this huge group urged the Senate to revise the "biodefense" bill to remove the broadened definition of terrorism "countermeasures" because the proposal allows it to be done "in a way that could grant existing everyday medicines -- rather than novel products related to (defense) against bioterrorism -- multiple years of additional market exclusivity."

This, contends CCPM chairman Annette Guarisco, "would unnecessarily drive up prescription drug costs for private and public payers without advancing our nation's bioterrorism preparedness."

Even the big health insurance companies and pharmaceutical management lobbyists were startled by the brazen provisions at the expense of common citizens Senate 1873 portends.

Mark J. Rubino, chief pharmacy officer for Aetna Inc., states, "For private and public purchasers seeking to provide consumers with therapeutically equivalent, but more cost-efficient generic drugs, the market exclusivity provision included in the Biodefense bill takes us in exactly the wrong direction."

Mark Merritt, president of the Pharmaceutical Care Management Association, said, "This drug monopoly extension proposal is a sweeping and unprecedented measure that would rewrite drug-patenting and force working families, the disabled, and seniors to pay more for their prescription drugs. Perhaps most troubling of all, this measure has moved forward without any regard to the cost (effects) it would have on on Medicare, Medicaid, and private payers. America's working families, seniors, and small businesses deserve better."

Some who read the column accused me of overstating the liability protections for Big Pharma contained in the bill. Surely, they wrote, I was guilty of hyperbole or making things up. Surely, federal legislators wouldn't remove the cherished American right to redress wrongs or seek compensation for uninvited injury.

Oh, yeah? The language seems pretty clear to me. It provides incredibly broad and iron-clad protection from any American seeking legal remedy from Big Pharma and just about everyone else involved in protecting against bird flu. Look up the draft bill's Section 319F-3 (a) if you don't believe me.

"Authority -- As provided in subsection (b), and subject to subsection (b) (1) C, a manufacturer, distributor, or administrator of a security countermeasure, or a qualified pandemic and epidemic product, or a health care provider shall be immune from suit or liability caused by or arising out of the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of a countermeasure, or a qualified pandemic and epidemic product, described in subsection (b) (1) (a)."

That just about covers the waterfront, as they say. The only avenue of relief an injured vaccine or medicine recipient or survivor could follow is requesting an investigation of their allegation by the Secretary of Health and Human Services -- who would have to find "clear and convincing evidence" of "willful misconduct" that "caused the product to present a significant or unreasonable risk to human health and proximately caused the injury alleged by the party."

There are at least seven tough legal tests contained in that one paragraph. And if the HHS Secretary refuses to even investigate the complaint of injury or death, such decision is completely "within the Secretary's discretion and shall not be subject to judicial review."

If the secretary does find for the complaining injured party -- which is extremely unlikely -- the drugmaker or distributor or health care provider named in the determination can petition the federal court in the District of Columbia for "judicial review" of the HHS ruling. But no subpoenas shall be issued, "nor shall other compulsory process apply," and no third parties can intervene. The drug company appeal "shall automatically stay the Secretary's determination for the duration of the judicial proceeding."

There are six more pages of legal gobbledygook backing this up, one of them defining the scope of protection from lawsuit as extending to allegations "relating to, or resulting from the design, development, clinical testing and investigation, manufacture, labeling, distribution, sale, purchase, donation, dispensing, prescribing, administration, or use of product" defined as measures against pandemics or terrorism. There, is that specific enough for you? Is that an imaginative figment?

Interpretation of this congressional language: Pigs will fly backwards and upside down before the common citizen gets any redress or compensation for injury or death resulting from a bird flu vaccine or medicine.

Why are vaccine safety advocates so adamant that John Q. Public might get screwed by all this protect-Big Pharma bird flu legislation? Because it has happened before.

In the 1970s, the panic over swine flu led to an ill-advised vaccine push that crippled many recipients and cost the drug makers millions.

In the 1980s, a dangerously reactive vaccine against whooping cough injured and killed thousands when a safer foreign alternative was already available but stubbornly unapproved by the FDA.

In the 1990s, the federal health establishment insisted -- and still insists -- there is no connection between toxic mercury preservatives in mandated childhood vaccines and the astounding increase in autism (from 1 in 10,000 births to 1 in 166 births), despite ample scientific evidence to the contrary.

Experimental anthrax vaccine is still being tested on troops without informed consent, and was almost tested on infants until a big public fuss erupted.

The yearly hoohah over getting your flu shots to protect against contractible human flu results in less than desired protection because the scientists are always fighting the previous year's struggle that has already mutated or died out.

Both the federal government and big pharmaceutical firms will go to almost any length to protect themselves from blame when vaccines are involved.

Now we read the government experts and private researchers are predicting a minimum of 200,000 deaths and perhaps as many as 2 million deaths if the Asian bird flu mutates into a disease that can be passed from bird to human and then human to human.

"This is shoddy science at best and beyond belief that any reputable scientist could get away with such nonsense," writes Dr. Joseph Mercola, an alternative health physician and author of the popular Total Health Program. "Most of the people (in Asia) who acquired this infection were bird handlers who were in continuous contact with these sick birds. Does anyone in their right mind envision similar circumstances in the United States?"

The issue is certainly timely. This column's date of publication (Tuesday, Nov. 1) will see President George W. Bush go to the National Institutes of Health to tell us how he will spend -- at his executive discretion -- nearly $8 billion that was quickly added to the 2006 funding bill for HHS last Thursday in light of the concern over bird flu. He is expected to devote much of it to stockpiling vaccines once they are developed. The federal government has already committed to buying $162.5 million worth of experimental vaccines against the bird flu strain -- doses which may or may not protect humans -- from Chiron Corp. and Sanofi-Aventis. The feds are also ordering millions of doses of Relenza and Tamiflu, two human anti-flu drugs that seem to slow down the advance of bird flu but not completely halt it.

Meanwhile, the best possible outcome -- that the H5N1 bird flu strain fizzles out or never mutates to threaten humans -- is triggering a new concern among federal officials: that all the frantic warnings so far may have created a sense of public cynicism (or at least skepticism) over global health admonitions about pandemics.

"Will critics say we have been crying wolf?" worried HHS Secretary Michael Leavitt at the end of last week. Will the public "lose the sense of urgency we feel about this issue?"

Well, maybe, Mr. Secretary. But Americans would lend you a lot more credence if you ensured they were treated fairly.

John Hanchette, a professor of journalism at St. Bonaventure University, is a former editor of the Niagara Gazette and a Pulitzer Prize-winning national correspondent. He was a founding editor of USA Today and was recently named by Gannett as one of the Top 10 reporters of the past 25 years. He can be contacted via e-mail at

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