October 30, 2005


By John Hanchette

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

October 28, 2005

Press Release: Emergent Biosolutions (Biport) Announces Appointment of Jay Coupe to Board of Directors

Kim Brennen Root

Coupe brings extensive military experience, international relationships as areas of expertise.

Emergent BioSolutions Inc. today announced appointment of Jay Coupe to its Board of Directors. Mr. Coupe is the president of Coupe Associates, an international public policy and marketing consulting firm with clients in the United States, Europe and Asia. He graduated from Princeton University with a B.A. in English literature and received a Master's Degree in International Communications from Boston University. His association with Emergent BioSolutions and its subsidiary, BioPort Corporation, extends back to 1998, when BioPort was formed.

“Jay’s extensive military background and his solid relationships internationally
make him a strong addition to our Board of Directors,” said Fuad El-Hibri, Emergent’s
Chairman and Chief Executive Officer. “His perspectives with regard to the strategic
direction of our company are unique, providing diversity that makes for stronger
decision-making overall.”

During his 26-year naval career, Mr. Coupe specialized in public and political
affairs, working in major Washington agencies and joint and Allied commands in
Vietnam, the Republic of China, the Federal Republic of Germany and Italy. He retired
as a Captain in 1988 and formed Coupe Associates.

“My association with BioPort and its parent firm, Emergent BioSolutions, extends
back to the establishment of BioPort in 1998,” Coupe said. “I am proud of the fine work that the company has done in protecting our Armed Forces from biological attacks and believe that this excellent track record will expand and continue long into the future."

Mr. Coupe holds decorations from several countries, including the Republic of
Vietnam and the Republic of China. He was awarded the Ehrenkreuz in Silber by the
Federal Republic of Germany. In 1983, he was knighted by the President of Italy and
named a "Cavaliere della Repubblica Italiana." Among his 22 American decorations, Mr.
Coupe holds the Defense Superior Service Medal, the Bronze Star Medal and the Combat
Action Ribbon. On his retirement from active service, Mr. Coupe was awarded the
nation's highest peacetime military honor, the Defense Distinguished Service Medal.
In 1998-99, Mr. Coupe served as Chief of Staff of the State Department Commission investigating the American Embassy bombings in East Africa. In January, 2001, he became a Special Advisor to Secretary of Defense Donald Rumsfeld. Mr. Coupe interacts on a regular basis with leading industry leaders and government officials.

Mr. Coupe serves on the Board of Trustees of John Cabot University in Rome and
on the Board of Directors of ETI Engineering, a leading producer of intelligence intercept equipment. He is on the Advisory Board of the Fulbright Commission and the Temple Bar Foundation. Among his languages are Italian, Spanish, German, Vietnamese and Chinese (Mandarin).

October 27, 2005

Anthrax treatment may be deadly

By STEVE MITCHELL, Senior Medical Correspondent

WASHINGTON, Oct. 27 (UPI) -- Preliminary studies obtained by United Press International show serious and potential life-threatening problems with a potential anthrax treatment the U.S. government is developing.

Anthrax immune globulin, which the government is developing as a possible treatment in the event of a bioterror attack, protects animals from death if given prior to exposure to toxins from Bacillus anthracis, the anthrax bacterium, but if the compound is formulated incorrectly it can be fatal and it did not prevent death when given after exposure.

Some anthrax immune globulin, or AIG, already may have been placed in the Strategic National Stockpile for emergency use, but at least one expert warned that the research data show the compound does not appear to be effective and actually could kill people.

The Centers for Disease Control and Prevention in Atlanta initiated the animal studies last year, and the Department of Health and Human Services recently awarded a contract to Cangene, a Canadian biotech company, for approximately $428,000 to supply 10 grams of AIG for further testing. HHS researchers have been given a year to finish the studies and decide if the government should order up to 100,000 doses.

The government is interested in developing AIG as an alternative anthrax treatment due to the high mortality rate from the 2001 anthrax letters that killed five people. The death rate was 45 percent, even when intensive-care treatment and antibiotics were administered, and future bioterror attacks could involve anthrax that has been genetically engineered to evade current antibiotics, the CDC noted in its report on the animal studies.

The CDC published a notice in June in the Federal Register that the results of the studies were available, but the agency, for reasons it has not explained, delayed sending the results to UPI until this week -- more than four months after the Federal Register notice and several weeks after HHS awarded the contract to Cangene. The biotech firm, based in Winnipeg, Manitoba, said it was not involved in the animal studies and would not be involved in the additional studies being conducted by HHS.

CDC spokesman Dave Daigle requested that UPI e-mail him questions about the studies, but then did not respond with comment.

"Obviously they can't use this stuff," said Dr. Meryl Nass, an anthrax expert and a physician in Bar Harbor, Maine, adding she would become concerned if officials tried to use it on an emergency basis in the event of another anthrax attack.

"It might kill people," Nass told UPI.

AIG is obtained from the plasma of soldiers who have been inoculated with the anthrax vaccine, which has had a controversial history. The military requires all servicemen to receive the vaccination, but some have objected because they claimed it caused chronic health problems, including dizziness, muscle and joint pain and sleep disruption. Others have said the vaccine may have played a role in causing Gulf War Syndrome. Federal officials, including some in the military, have insisted the vaccine is safe.

In the AIG studies, rats that received a high-enough dose of the compound prior to being injected with anthrax "were completely protected," concluded the CDC report -- which does not cite the names of the researchers who wrote it. The animals survived until the end of the study, which lasted 48 hours.

AIG administered after exposure to anthrax may not confer much protection, however. Rats that received the compound 5, 10 or 20 minutes after being injected with anthrax died within approximately three hours. Only those given AIG immediately after the anthrax injection survived the entire 48-hour study period.

Nass said a study period of 48 hours was short and "very odd." With most animals, it takes a few days before they die from anthrax, so this raises the question whether the rats that were alive after 48 hours would have continued to survive if the study had gone on longer, she said.

Nass also questioned the rationale for administering AIG only up until 20 minutes after the anthrax exposure.

"That means it doesn't work," she said. "You're never going to give it to a human that fast."

Under real-life conditions, a person probably would not become aware of the exposure and the need for treatment lasting a day or two, she said.

The CDC studies also indicate AIG can be deadly under certain circumstances. A separate experiment in rabbits found that a high dose was fatal in all the animals the received it.

"Since there were deaths among 100 percent of rabbits receiving 40 mg/kg AIG intravenously ... a thorough safety evaluation has been initiated," the report stated.

The investigators determined the likely problem was a change in formulation of AIG. The concentration had been doubled from 5 percent to 10 percent for the rabbit study. This was done to increase the potency of the compound and to reduce the amount needed to protect the animals.

"Evidence suggests that this likely clogged the renal tubules, causing an acute toxic nephropathy (acute tubular necrosis) that was seen on necropsy in the dead rabbits," the CDC team concluded in the study.

The problem appeared to be the higher concentration of AIG combined with the fact that it was prepared in a freeze-dried formulation meant it required more time to dissolve into solution.

A less-concentrated dose of AIG still may cause problems, however. In one study, all four animals that received a less-concentrated formula "experienced rapid breathing and (one of the four) experienced diarrhea," the report noted.

The final sentence of the report said the CDC decided that switching the AIG formulation to a 5 percent liquid version may avert some of the dangers of the compound, and the agency "is currently planning animal studies to evaluate AIG dosage and efficacy."

The report does not mention whether those studies ever were conducted or what the results were.

John Langstaff, president of Cangene, told UPI his company recently shipped a supply of AIG to the CDC, which "still has some ongoing activities."

The HHS studies of AIG involve "testing to see if it's safe," Langstaff said.

Cangene was not participating in those studies, but the company would be involved in human clinical trials if HHS elects to pursue development of AIG, he said.

Measure Eases Vaccine Rules - Would Shield Manufacturers

Hartford Courant Staff

Congress is considering a bill that would allow the government to order that vaccines be given to every U.S. citizen in a national emergency, even if a vaccine has previously harmed some people.

The bill would also make it almost impossible for anyone harmed by these substances to sue the manufacturer or drug researchers.

Supporters say protecting producers from potential liability would bring more drug makers to the table. Opponents warn the proposal would render everyone little more than a "guinea pig" for the drug industry.

"[This new] legislation provides liability protection for individuals and entities who engage in countermeasure or pandemic/epidemic technology development, manufacturing or administration," said Michael B. Enzi He is an official with the Biotechnology Industry Organization that represents more than 1,100 biotechnology companies, academic institutions and related organizations.

"Current law," he said, "provides inadequate protections; thus companies have been reluctant to enter the bio-defense market."

"This is a drug company stockholder's dream and a consumer's worst nightmare," said Barbara Loe Fisher, director of the National Vaccine Information Center. "It is 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."

These contrasting views are helping to shape the next phase of the nation's bio-defense program in which seven federal agencies appropriated or spent nearly $25 million between 2003 and 2005.

The measure would give the secretary of health and human services power over what information, if any, the public can know about what drugs people could be made to take against their will. It would also shield manufacturers, universities and other drug research institutions against liability when drug products lead to illness, disability or death.

Had this proposed bill been in place, the six deaths linked to BioThrax, the controversial vaccine the Defense Department bought to protect soldiers against an attack by anyone using airborne anthrax spores, and ordered them to take, might never have been disclosed publicly. The HHS secretary could have decided that the information could harm national security.

The U.S. Food and Drug Administration has been reviewing the deaths of five other service members to determine whether their deaths were also linked to the vaccine.

Information about the drugs' effectiveness or its potential to do harm could not be obtained through normal federal Freedom of Information channels. Manufacturers would be immune from lawsuits arising out of negligence claims in cases where people have been made sick or have died.

Since the public would have trouble obtaining documents proving a drug is causing adverse reactions, Fisher said, there is little chance of challenging a drug company in court.

"The last resort for ordinary Americans who are victims of corporate negligence, is the civil justice system. So, we are against any proposal that leaves people without a just remedy [like this one]," said Erin Mayton, deputy director and counsel of communications for the American Trial Lawyers of America.

The new bill's controversial provisions were discussed over several days inside and outside the Senate Health, Education, Labor & Pensions Committee, which approved the bill.

Doug Heye, a spokesman for U.S. Sen. Richard Burr [R-N.C.], the bill's sponsor, said initial language that would have barred all public access to information has been eliminated. The newer version allows the secretary of HHS to block the release of any information that would hurt national security, he said.

"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," Burr said.

If the bill passes in the Senate, it goes to the House for further action, and if approved there, would need President Bush's signature.

"We feel it is very important to have liability protection for the companies as part of any bio-defense bill," said Allen Abney, a Bush spokesman, who declined to comment on the bill's public information restrictions.

Despite this presidential approval, some doctors believe this bill would turn U.S. citizens into guinea pigs.

"The concept of streamlining product development is left very loose, potentially allowing for any safety requirement to be bypassed," said Dr. Meryl Nass, a Maine physician who has studied experimental vaccines and testified before Congress and in the courts about them.

"This [bill] ignores the Nuremberg Code," said Nass, "in essence requiring American civilians to become guinea pigs for untested products for which their manufacturers have little incentive to assure optimal safety."

Nass said she sees a conflict in the HHS secretary's reviewing of complaints about drugs whose use the secretary authorized by declaring a national emergency. Furthermore, if a drug company disagrees with the secretary's ruling, it could immediately appeal to the federal court.

Connecticut's two Democratic senators have differing opinions on the proposal.

Rob Sawicki, a spokesman for U.S. Sen. Joseph Lieberman, D-Conn., said Lieberman supports Burr's bill and its restrictions on the release of information to protect national security.

Last spring, Lieberman favored passage of legislation giving drug companies protection from lawsuits, tax incentives, drug patent protections and fast track government drug licensing approvals.

"There is no market for these [drugs and vaccines]," said Lieberman, "unless there is a national disaster, so there is no normal market to encourage drug development in this bio-threat area."

The state's other Democratic senator, Chris Dodd, said although the new legislation is sound in attempting to prepare the public for a biological attack, he will not support it in its present form.

"Sadly," Dodd said, "the need for legislation to protect people from biological threats has in crucial respects been placed as a secondary priority behind special protections for special interests in the drug and health care industries. Some limited liability protection is reasonable, but it must be done in a way that doesn't unfairly hurt people affected by potential health crises - or by potential treatments for those crises.

"The bill also gives drug companies exclusive rights to manufacture drugs and vaccines that could increase prices just when people need these drugs most," he said.

Already former HHS Secretary Tommy Thompson has used his emergency powers, created by initial Bioshield legislation, to force voluntary use of BioThrax vaccine for service members. He did so after a federal judge enjoined its mandatory use last April. The vaccine supposedly protects soldiers from enemy attacks by airborne anthrax spores.

BioThrax is manufactured by BioPort Corp. of Lansing Mich. Federal inquiries of its adverse effects show the vaccine can cause lymphoma, lupus, multiple sclerosis, seizures and even death.

U.S. District Judge Emmet Sullivan, acting on complaints that the vaccine was not properly licensed, said the law requires that service members give their consent to be vaccinated.

But Sullivan said he did not have the power to overrule Thompson's emergency vaccine use authorization even though it was issued following Sullivan's ruling. Defense Department lawyers would not tell Sullivan the factual details about the department's basis for asking for Thompson's emergency order saying the details are classified secret. They were, however, able to convince Thompson there is an imminent threat of a biological anthrax spore attack.

In 1998, former Secretary of Defense William S. Cohen ordered forced anthrax vaccine inoculations of all 2.4 million service members. Since then, disputes over its licensing, its safety and the need for its use have been a constant source of public debate.

BioPort's vaccine is utilized almost exclusively for soldiers, has already demonstrated an adverse reaction rate 100 times the figure initially stated on the label. Adverse reactions include immune disorders, muscle and joint pain, headaches, rashes, fatigue, nausea, diarrhea, chills and fever. At least half a dozen deaths and a number of birth defects have been attributed to its use. BioPort is shielded from lawsuits over adverse reactions through a defense department authorization.

Now the HHS is stockpiling the vaccine and other developing drug products, not yet approved, to use on civilians in the event of a terrorist anthrax spore attack. Under initial Bioshield acts passed by Congress in the past two years, HHS and other federal agencies are working on still other new unlicensed drugs and vaccines that in theory will protect the public in the event of a biological attack.

October 20, 2005

The (really scary) soldier of the future

The illegal mandatory DoD anthrax vaccine program was just the start...this article explains a major reason for the Pentagon's war on informed consent...

By Alan H. Goldstein, Salon

Vast government contracts have corrupted the American university system, turning off the fountainhead of unfettered ideas and scientific discovery. Multibillion-dollar federal R&D budgets have replaced the solitary inventor with veritable armies of scientists and engineers in laboratories across the country. Public policy itself has become the captive of a scientific-technological elite.

2005? Try 1961. The paragraph above was taken with only minor changes from President Dwight Eisenhower's famous farewell address.

Things have only gotten worse in 44 years. If Eisenhower was worried about the power and influence of what he called "the military-industrial complex" then, he'd be catatonic now. The risks -- and opportunities -- posed by today's corporate-academic-military behemoth are exponentially greater than in his day. So is the money: Total military spending on basic R&D is probably somewhere between $15 billion and $20 billion per year and rising. Scientists funded by this bottomless war chest are working on mind-blowingly powerful devices that threaten to plunge the world into a deadly new arms race. Oh sure, this stuff could also revolutionize medicine, communications, transportation and every other aspect of human life: the shopworn "spinoff" argument honed for decades by NASA's P.R. machine. But whether humanity will get to use the awesome power of these new technologies -- in particular nanotechnology -- for good rather than ill is one of the key questions of the 21st century.

As a five-star general and the commander of Allied forces in Europe during WWII, Eisenhower was front-row center when the Manhattan Project transformed our reality. He watched a small group of the world's brightest scientists and engineers, with access to the enormous financial resources of the federal government, creating blueprints for machines capable of tearing apart the very fabric of the universe -- followed, in short order, by the conversion of those blueprints into enormous production facilities operated by corporate contractors with even more government funding. The result: a gargantuan arsenal of thermonuclear weapons capable of destroying the world many times over -- a capability previously unknown in the history of war and warriors.

But the insanity of the Cold War pales by comparison to what the military-industrial complex and the scientific-technological elite have in the pipeline for the 21st century. Nuclear war is terrifying but, technologically, it's a one-trick pony. The weapons of the future will be infinitely more diverse and creative. And the driving force behind them, the technological cutting edge, will be nanotechnology.

There has never been anything like nanotechnology. It draws on our accumulated scientific knowledge about how to measure, modify and manipulate the very building blocks of our world: atoms and molecules (see accompanying article). Homo sapiens, the animal world's most skillful toolmaker, has finally begun to create the ultimate toolkit, one that will someday be capable of breaking the world down into its smallest parts (or creating new parts) and putting them back together again in new ways.

For the past five years, unknown to most Americans, the United States has been buying tools for this kit via a strategic program called the National Nanotechnology Initiative. (Full disclosure: I am on a National Research Council committee charged with evaluating the NNI.) One of the NNI's chief purposes is to revolutionize military equipment. In 2003, MIT and the U.S. Army officially opened the flagship nanotech R&D facility, theInstitute for Soldier Nanotechnologies.

This 28,000-square-foot facility in Cambridge, Mass., underwritten by a $50 million grant from the U.S. Army, may very well be the world's most exclusive R&D club. Its members include bluebloods of the old military-industrial complex like Raytheon and DuPont, along with new blood like Zyvex ("providing nanotechnology solutions -- today") and Carbon Nanotechnologies.

According to the original press release, the ISN "combines basic and applied research to create an expansive array of innovations in nanoscience and nanotechnology that will dramatically improve the survivability of soldiers. Current ISN research focuses on several key soldier capabilities, including protection from bullets, blasts and chem/bio threats; automated medical monitoring and treatment; improved performance; and reduced load weight."

This description of research projects -- "protection" from bullets and blasts -- makes them sound purely defensive, but there is simply no way that can be true. Our military knows very well that, ultimately, the best way to "improve the survivability" of a soldier is to eliminate the enemy. If a revolutionary ultra-light nanofabricated material can stop today's bullets, why not use this same material to make tomorrow's bullets? But for real war gamers this logic is only a trivial beginning. It is incumbent upon them to assume that, if we don't make these nanofabricated bullets, somebody else will. And if somebody else can have them, it is further incumbent upon serious war gamers to recommend that a further round of R&D is necessary to protect our soldiers from the nanomaterials initially designed to protect them. These games get much, much deeper ... and they get there really fast. Plus, the most amazing things these folks are factoring into their games undoubtedly remain classified

And so it goes, the endless upward spiral of theoretical escalation driving a downward spiral of research into the small, smaller and, finally, smallest. Research that, enabled by the latest breakthroughs in nanofabrication, will bring imaginary terrors into being. It is exactly this circular logic that has led America to initiate the next global arms race in recombinant DNA-based, nanotechnology-enabled bioweapons.

In two previous articles, this author has reported on the vicious cycle of paranoia that has made "biodefense" the top priority across all federal R&D laboratories. (The biggest untold science and technology story in America is that one-third of all basic research at NIH is now on biodefense. The Federal Biodefense Research conference for fiscal year 2006 will be held at the end of this month.) There is a profound and dangerous Catch-22 clause involving high-technology "biodefense" research, one that we ignore at our own peril.

Put simply, the whole world knows that you can't separate biodefense from biowarfare. This concept was clearly enunciated in the 1972 Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction (signed by the United States on April 10, 1972). Yet, 35 years later, the second Bush administration has given us a policy based on these same two fatally flawed assumptions explicitly recognized in the Bioweapons Convention. Logic error 1: that a defensive bioweapons program differs fundamentally from an offensive program. And logic error 2: that it is possible to defend against biowarfare agents. (Shades of Reagan and Bush's dreams of a defense against ballistic missiles.) The community of nations has universally rejected these assumptions as unfounded and completely incorrect. But as we know, when it comes to deciding the fate of the world there is a higher authority than the community of nations. Or even the American people.

Our bioweapons research programs, enabled by recombinant DNA technology, were frightening enough. But the danger is about to increase exponentially, as "biodefense" research meets nanotechnology.

In high-technology incubators around the world, biotechnology and nanotechnology together are spawning. With the literary imagination for which engineers are famous, the offspring of this union has already been named nanobiotechnology. The overt goal of nanobiotechnology is to completely break down the borders between living and nonliving materials. This goal has the most profound implications for every aspect of human endeavor, but in warfare the consequences of integrating our most powerful technologies are almost beyond comprehension. The fusion of nanotechnology and biotechnology will erase any distinction between chemical, biological, and conventional weapons, altering the face of war (and life) forever.

The key thing to remember is that every military application also has a non-military one: tomorrow's sword will be next week's plowshare (and vice versa). In the nano age, if you aren't very afraid and very excited at the same time, you aren't paying attention.

So just what kinds of military devices are in store for us? We can get an idea simply by examining what the ISN is currently advertising, translating it into English, then extrapolating out another ten years or so.

Energy-absorbing materials

Nanosoldierspeak: "ISN researchers are developing energy-absorbing nanomaterials that will be part of the future soldier's battle suit. These new materials will provide the soldier with protection against ballistics and directed energy, thereby enhancing the soldier's survivability."

Translation: Humans have been seeking "protection against ballistics and directed energy" since the first time someone got hit over the head with a bone, which means we have been seeking this technology since before we were Homo sapiens. Up until now, we have had to drag around a shield or wear heavy armor. But nanotechnology will deliver protection in a way that enhances the performance of our naturally evolved body rather than weighing us down. In fact, when combined with properties like "mechanical actuation and dynamic stiffness," discussed below, people wearing body armor will be moving far faster than those of us relegated to Levis or even Gucci.

Mechanically active materials and devices

Nanosoldierspeak: "ISN researchers are developing nanomaterials that are capable of mechanical actuation and dynamic stiffness. As part of the soldier's battle suit, these adaptive multifunctional materials will improve soldier performance and may provide medical assistance in the field."

Translation: Artificial muscles! Clothing or ultra-lightweight body armor that provides superhuman strength, integrated within the impregnable (sorry, energy-absorbing) body armor under development above. Let's tell it like it is: The ISN wants to build (sorry, nanofabricate), an ultra-light, ultra-strong and ultra-powerful exoskeleton. But the real super-soldier is far more than a human wearing an exoskeleton that imparts inhuman speed, strength and endurance. This nano-enabled exoskeleton will be made of molecular "smart materials" that also create the type of super-sensor powers described below.

Sensors and chemical/biological protection

Nanosoldierspeak: "ISN researchers are developing protective measures that will enable the future soldier to detect and respond to chemical and biological threats. Research is taking place on the development of highly sensitive sensors as well as protective fiber and fabric coatings that can be integrated in the battle suit. These external systems will enhance the soldier's awareness of environmental toxins, thereby providing the soldier with initial protection against chemical and biological agents."

Translation: Evolution has already provided biological life with a "sensorium" capable of detecting individual molecules. That is, the biomolecules inside our bodies can "see" the individual molecules in our environment. Our eyes, for example, can "see" a single photon of light. When we are not distracted, or overwhelmed by the ambient noise of life, all our senses can operate with this type of resolution. But how is such a thing possible? Each atom transmits a unique electromagnetic signature into nearby space. A molecule is a unique group of atoms, so that the space around a molecule has an even more complex signature field. Molecules see and recognize each other via the interaction of these force fields. Sometimes molecular signals merge into a powerful force-field beam that breaks the surface of our macroscopic world. (When uranium undergoes radioactive decay, it emits a beam that's hard for us to miss.) But individual molecules can sense each other every time, all the time -- so that single molecule detection provides near-perfect sensitivity to almost anything that can happen in the physical world.

The ISN will create artificial molecular nanosensors based on the schematics originally built by evolution. Working backward from a successful design is called reverse engineering. So the nanofabricated super-soldier exoskeleton will have an array of reverse-engineered artificial molecular sensors built directly into it. These artificial sensors will be wired into the biological "sensorium" of the soldier. As a result, the nano-enabled combatant will be able to see or sense almost everything in his or her environment. Artificial molecule-scale sensors may start off as external systems to "enhance the soldier's awareness of environmental toxins" or other signals, but this technology can be used to create a whole new set of superhuman senses for anyone, not just soldiers. Someone, somewhere, will soon be able to "sense" almost anything, anywhere in the physical world. Without entering your home, I can know what you are eating, drinking, smoking, wearing, or not wearing. Who gets to have these senses? Will they be installed as passive or active?

Biomaterials and nanodevices for soldier medical technology

Nanosoldierspeak: "ISN researchers are looking at ways to use nanotechnology to improve the way we detect and treat life-threatening injuries such as hemorrhage, fracture, or infection. With new approaches to soldier triage and with automatic first aid for a wounded or disabled soldier, the ISN's goal is to at least begin, if not complete, recovery while the patient is still on the battlefield by developing ways to monitor patient physiology as well as novel materials for wound healing."

Translation: Your camouflage suit is going to sense your metabolic condition and know when you are hurt or wounded. It is going to melt into your wound to stop the bleeding, set your bones, and give you a shot of morphine. To do this, your nanofabricated suit had better have the ability to speak the same language as your living tissue. So using nanotechnology to provide "automatic first aid" ultimately means using molecular sensor systems to detect and respond to the presence of blood cells, serum or antibodies. Basically, the idea is to hack into the CPU of life and interface our biological systems to artificial ones. Make no mistake, we are talking about the ability to hardwire the delivery of medical procedures, drugs or chemicals directly into things worn in or on the body in response to remote signals or sensations. This will undoubtedly save lives on the battlefield, but it also opens up mind-boggling possibilities for behavior modification and control. Instead of an injection when you are wounded, how about an injection when you act in an antisocial manner? Will we have the wisdom to control the machines we have created, especially when they have been built to operate autonomously? In the years ahead, that question will no longer be merely philosophical.
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So, let's take stock. Based simply on the projects posted for public consumption, the ISN is busy creating a soldier of the future who will be protected by an impregnable exoskeleton. This 21st century armor will also impart superhuman strength, reflexes and endurance. It will sense its environment with molecular precision and administer chemicals, pharmaceuticals and other potions directly to the human inside based on pre-programmed stimuli or other command and control signals (global satellite phone link to headquarters ... a battle computer in geosynchronous orbit ... HAL?). It kind of makes one long for the old "mineshaft gap" of the Cold War.

October 19, 2005

A nation of sheeple

Dr. Walter E. Williams
John M. Olin Distinguished Professor of Economics at George Mason University

President Bush informed the nation, during a press conference, that he might seek to use the U.S. military to quarantine parts of the nation should there be a serious outbreak of the deadly avian flu that has killed millions of chickens and 60-some people in Southeast Asia. That's the second time Bush has expressed a desire to use the military for local policing. The first was in the wake of Hurricane Katrina.

The Posse Comitatus Act (18 U.S.C. 1385) generally prohibits federal military personnel and units of the U.S. National Guard under federal authority from acting in a law enforcement capacity within the United States, except where expressly authorized by the U.S. Constitution or Congress.

Enacted during Reconstruction, the purpose of the Posse Comitatus Act was to severely limit the powers of the federal government to use the military for local law enforcement. Would Americans tolerate such a gigantic leap in the federalization of law enforcement? I'm guessing the answer is yes. In the name of safety, we've undergone decades of softening up to accept just about any government edict that our predecessors would have found offensive. Let's look at some of it.

The anti-smoking movement might be the beginning of the softening up process. They started out calling for reasonable actions like no-smoking sections on airplanes. Then it progressed to no smoking on airplanes altogether, then private establishments such as restaurants and businesses. Emboldened by the timidity of smokers, in some jurisdictions there are ordinances banning smoking in outdoor places such as beaches and parks.

Then there are seatbelt and helmet laws that have sometimes been zealously enforced through the use of night vision goggles. On top of this, Americans accept government edicts on where your child may ride in your car. Americans sheepishly accepted all sorts of Transportation Security Administration nonsense. In the name of security, we've allowed fingernail clippers, eyeglass screwdrivers and toy soldiers to be taken from us prior to boarding a plane.

We've accepted federal intrusion in our financial privacy through the Bank Secrecy Act. Rep. Ron Paul, R-Texas, says, "More than 99.999 percent of those [who] had their privacy invaded were law-abiding citizens going about their own personal financial business." Most recently, there's the U.S. Supreme Court Kelo decision, where the court held that local governments can take a private person's house and turn it over to another private person. Politicians have learned and become comfortable with the fact that today's Americans will docilely accept just about any legalized restraint on their behavior.

You say, "Hey, Williams, but it's the law!" In the late-1700s, the British Parliament enacted the Sugar Act, the Stamp Act and the Townshend Acts, and imposed other grievances that are enumerated in our Declaration of Independence. I'm happy that we didn't have today's Americans around at the time to bow before King George III and say, "It's the law." Respectful of the Posse Comitatus Act, President Bush has suggested that he'll ask Congress to amend the law to allow for the use of the U.S. military to enforce regional quarantines. Whether Congress amends the law or not, Bush has no constitutional authority to deploy military troops across the land. Why?

The U.S. Constitution's Article IV, Section 4 reads, "The United States shall guarantee to every State in this Union a Republican Form of Government, and shall protect each of them against Invasion; and on Application of the Legislature, or of the Executive (when the Legislature cannot be convened), against domestic Violence." Coupled with the Tenth Amendment, "The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people," this means short of an insurrection, the U.S. military must be invited by a state legislature or executive. Any federal law that violates these constitutional provisions is null and void and can only be enforced through fear, intimidation and brute military force.

U.S. Senate Committee Approves Vaccine Promotion Legislation

By David Ruppe
Global Security Newswire

WASHINGTON - A key Senate committee yesterday approved legislation that would create a new agency to direct government biological defense research and provide several new types of incentives that proponents say would encourage more private sector investment into countermeasure production (see GSN, Oct. 17).

The Health, Education, Labor and Pensions Committee approved by voice vote the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 despite Democratic objections. A Senate floor vote could come next week. There is no such legislation in the House.

"We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," the legislation's author, Senator Richard Burr (R-N.C.), said in a statement after the vote.

Enacting the bill would mean "that we as a nation are prepared for a variety of threats that include natural, deliberate and accidental threats," said committee Chairman Mike Enzi (R-Wyo.).

The bill is intended to add incentives beyond those approved in the "Project Bioshield" law passed last year, which was designed to encourage the private sector to invest in drug and vaccine production where the U.S. government would probably be the only buyer. Burr and others have said the law did not go far enough to encourage private sector investment.

Burr, who chairs the committee's Bioterrorism and Public Health Preparedness Subcommittee, said potential liability exposure and other factors have left companies reluctant to invest in new biodefense and flu countermeasures.

Critics say the new bill would do nothing to address the potential near-term threat of a deadly avian flu outbreak and that its provisions could drive up the cost of certain drugs and vaccines and greatly reduce the public's legal recourse for defective products.

"I hope . that people don't think that this is going to solve the problem of the possible avian flu pandemic that is on our doorstep," Senator Tom Harkin (D-Iowa) said.

New Agency, Industry Incentives

The bill specifically would create a "Biomedical Advanced Research and Development Agency" within the Health and Human Services Department.

The new agency would act "as the single point of authority" within the federal government for research and development of medical countermeasures against bioterrorism and natural disease outbreaks.

Burr's legislation would also provide incentives that proponents said are needed to encourage the biotech and pharmaceutical industries to invest more for drugs and vaccines for biological defense and naturally occurring disease protections.

For instance, the bill would allow Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product. It would forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures.

The bill would also provide companies with liability protections for new countermeasures not yet licensed by the Food and Drug Administration, so that a company producing products for epidemics or biodefense could only be sued if the Health and Human Services secretary finds clear and convincing evidence it willfully engaged in misconduct that caused the injury.

The bill would provide rebates or grants to encourage companies to manufacture vaccines, medical countermeasures, and pandemic or epidemic products within the United States and would allow the government to help pay the costs of establishing domestic manufacturing facilities.

Burr's proposal would provide a "limited antitrust exemption" for the Health and Human Services secretary and the BARDA director that would allow them to collaborate and consult with industry on developing new countermeasures.

It also would exempt the new agency from standard Freedom of Information Act and Federal Advisory Committee Act requirements for public transparency and would exempt certain federal cost oversight requirements.

Less controversially, the bill also would compensate first responders for countermeasures they purchase and would provide money to encourage development of animal models on which countermeasures could be tested against diseases too dangerous to test on humans.

Doesn't Address Flu Threat, Democrats Say

Committee Democrats said they support the general aims of the bill and many of its provisions, including creating the new agency.

Democrats said, though, that the bill - targeted at longer-term research and development - does little to improve the country's near-term preparedness for responding to an avian flu outbreak. That would include funding the stockpile of antibiotic drugs and improving the public health infrastructure and surge capacity.

"Congress may wait for regular ordeals to deal with the pandemic flu, but the flu virus will not wait while we delay," said Senator Edward Kennedy (D-Mass.).

"We need the capacity to develop the vaccines now. We need to appropriate money now," Harkin said. "We need emergency funding right now, probably to the tune of several billion dollars to begin to get grants out there right now . to build the vaccine manufacturing facilities for flu vaccines. . We need to get these facilities built in the next six or seven months."

Burr said including such provisions in the bill would have greatly delayed the measure. He said there is "ample time" to prepare such legislation and that the committee would soon begin work on it for passage next year.

Other Objections

Democrats said they also objected to how the liability provisions were written. Company liability protections should only apply when a product is used in an emergency, and not for other situations, Harkin said.

Kennedy said the liability protections should be accompanied by a "strong [federal] compensation program" in the bill, because "the rules should not be stacked against patients."

Senator Hillary Clinton (D-N.Y.) criticized the market exclusivity provision for preventing public sale of generic versions of new drugs and vaccines for use as countermeasures against dangerous diseases.

Clinton praised the proposed agency creation as "a good idea," but asked how it, as a coordinating agency, would "have more direct control than all the other coordinating positions have had."

Chairman Enzi said the committee would try to address Democrats' concerns by possibly amending the bill, but said mutually agreed upon changes would be made by Thursday at the latest.

There remain "fundamental differences" between Republicans and Democrats "that we have to work out," Burr said.

Democrats said they might seek to amend the bill on the Senate floor.

Some nongovernmental organizations have taken a harsher view of the bill's implications than the committee Democrats.

It "basically eradicates regulatory safeguards against the production of unsafe vaccines, drugs and devices that the government determines to be for pandemic, epidemic or bioterrorism/security countermeasure use, and then wipes out liability for any drug company or health care provider that makes or dispenses them," the Center for Justice and Democracy in New York said in a recent press release.

As a result of the liability provision, the advocacy group said, families or victims of defective countermeasures could "have no recourse, no ability to file a claim or lawsuit, no way to collect any compensation even if the drug company or health care provider was negligent, reckless or in some cases intentionally harmful."

Congress Set to Pass Law Eliminating Liability For Vaccine Injuries

The National Vaccine Information

Center (NVIC) is calling the "Biodefense and Pandemic Vaccine and Drug Development Act of 2005"(S. 1873), which passed out of the U.S. Senate HELP Committee one day after it was introduced "a drug company stockholder's dream and a consumer's worst nightmare." The proposed legislation will strip Americans of the right to a trial by jury if harmed by an experimental or licensed drug or vaccine that they are forced by government to take whenever federal health officials declare a public health emergency.

The legislation's architect, Senator Richard Burr (R-NC), Chairman of the HELP Subcommittee on Bioterrorism and Public Health Preparedness, told the full HELP Committee yesterday that the legislation "creates a true partnership" between the federal government, the pharmaceutical industry and academia to walk the drug companies "through the Valley of Death" in bringing a new vaccine or drug to market. Burr said it will give the Department of Health and Human Services "additional authority and resources to partner with the private sector to rapidly develop drugs and vaccines." The Burr bill gives the Secretary of DHHS the sole authority to decide whether a manufacturer violated laws mandating drug safety and bans citizens from challenging his decision in the civil court system.

The bill establishes the Biomedical Advanced Research and Development Agency (BARDA), as the single point of authority within the government for the advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks such as the flu. BARDA will operate in secret, exempt from the Freedom of Information Act and the Federal Advisory Committee Act, insuring that no evidence of injuries or deaths caused by drugs and vaccines labeled as "countermeasures" will become public.

Nicknamed "Bioshield Two," the legislation is being pushed rapidly through Congress without time for voters to make their voices heard by their elected representatives. Co-sponsored by Republican Senate Majority Leader Bill Frist (R-TN), Senate Health, Education, Labor and Pensions Committee Chairman Mike Enzi (R-WY), and Senate Budget Committee Chairman Judd Gregg (R-NH), the legislation will eliminate both regulatory and legal safeguards applied to vaccines as well as take away the right of children and adults harmed by vaccines and drugs to present their case in front of a jury in a civil court of law.

"It is 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," said Barbara Loe Fisher, president of NVIC. "This proposed legislation, 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 the government can force all citizens to use while absolving everyone connected from any responsibility for injuries and deaths which occur. It means 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."

The federal Food and Drug Administration (FDA) is legally responsible for regulating the pharmaceutical industry and ensuring that drugs and vaccines released to the public are safe and effective. Drug companies marketing painkillers, like Vioxx, and anti-depressants, which have resulted in the deaths and injuries of thousands of children and adults, are being held accountable in civil court while the FDA has come under intense criticism for withholding information about the drugs' dangers from the public. Since 1986, vaccine makers have been protected from most liability in civil court through the National Childhood Vaccine Injury Act in which Congress created a federal vaccine injury compensation program (VICP) that offers vaccine victims an alternative to the court system. Even though the program has awarded nearly $2 billion to victims of mandated vaccines, two out of three plaintiffs are
turned away.

"The drug companies and doctors got all the liability protection they needed in 1986 but they are greedy and want more," said Fisher. "And the federal health agencies want more power to force citizens to use vaccines without having to worry about properly regulating them. If the Burr bill passes, all economic incentives to insure mandated vaccines are safe will be removed and the American people are facing a future where government can force them to take poorly regulated experimental drugs and vaccines labeled as "countermeasures" or go to jail. The only recourse for citizens will be to strike down mandatory vaccination laws so vaccines will be subject to the law of supply and demand in the marketplace. The health care consumer's cry will be: No liability? No mandates."

The National Vaccine Information Center (NVIC) was founded by parents of vaccine injured children in 1982 and co-founders worked with Congress on the National Childhood Vaccine Injury Act of 1986. For more information, go to http://www.nvic.org./

October 18, 2005

Biological alarm in Washington -- Did terrorists attack Washington with a deadly pathogen?

By Mark Benjamin

On Sept. 24, 2005, tens of thousands of protesters marched past the White House and flooded the National Mall near 17th Street and Constitution Avenue. They had arrived from all over the country for a day of speeches and concerts to protest the war in Iraq. It may have been the biggest antiwar rally since Vietnam. A light rain fell early in the day and most of the afternoon was cool and overcast.

Unknown to the crowd, biological-weapons sensors, scattered for miles across Washington by the Department of Homeland Security, were quietly doing their work. The machines are designed to detect killer pathogens. Sometime between 10 a.m. on Sept. 24 and 10 a.m. on Sept. 25, six of those machines sucked in trace amounts of deadly bacteria called Francisella tularensis. The government fears it is one of six biological weapons most likely to be used against the United States.

It was an alarming reading. The biological-weapons detection system in Washington had never set off any alarms before. There are more than 150 sensors spread across 30 of the most populated cities in America. But this was the first time that six sensors in any one place had detected a toxin at the same time. The sensors are also located miles from one another, suggesting that the pathogen was airborne and probably not limited to a local environmental source.

William Stanhope, associate director for special projects at the St. Louis University School of Public Health's Institute for Biosecurity, has been closely following scattered government and news reports about the incident. He's convinced it was a botched terrorist attack. "I think we were lucky and the terrorists were not good," he says. "I am stunned that this has not been more of a story."

The DHS scrambled for three days to confirm just what may have been in the air that day. On Sept. 27, it turned for help to the Centers for Disease Control and Prevention. The CDC did its own tests, and on Sept. 30 -- six days after the deadly pathogens set off the sensors and well into the incubation period for Tularemia -- alerted public health officials across the country to be on the lookout for Tularemia, the deadly disease caused by F. tularensis.

"It is alarming that health officials ... were only notified six days after the bacteria was first detected," House Government Reform chairman Tom Davis, R-Va., wrote in an Oct. 3 letter to Homeland Security Secretary Michael Chertoff. "Have DHS and CDC analysts been able to determine if the pathogen detected was naturally occurring or the result of a terrorist attack?"

Government officials say the sensors detected a natural event. "There is no known nexus to terror or criminal behavior," Russ Knocke, spokesman for the Department of Homeland Security, told the Washington Post. "We believe this to be environmental." "It is not unreasonable that this is a natural occurrence," says Von Roebuck, spokesman for the CDC. "There are still no cases of Tularemia."

However, Salon has spoken to numerous people who were at the Washington Mall on Sept. 24. Four say they got sick days later with symptoms that mirror Tularemia.

Relatively speaking, F. tularensis is an effective biological weapon. A little bit goes a long, deadly way. A tiny amount -- 10 microscopic organisms -- can cause Tularemia. After an incubation period of three to five days (it can range from one to 14 days), Tularemia attacks the lymph nodes, lungs, spleen, liver and kidneys. Symptoms include fever, chills, headache, muscle aches, joint pain, dry cough and progressive weakness. Left untreated, Tularemia can kill 50 percent of those who've contacted it. Conventional strains of the bacteria do respond to antibiotics, reducing death rates to as low as 2 percent.

As with anthrax, the U.S. military weaponized and stockpiled F. tularensis in the 1960s. The Soviets are said to have engineered strains to be resistant to antibiotics and vaccines. A World Health Organization Committee in 1969 estimated that dispersal of 110 pounds of F. tularensis over a city of 5 million would incapacitate 250,000 people and 19,000 of them would die.

"The biggest concern is that a terrorist would use the organism because it has such a high infectivity rate with a low number of organisms," says Dr. Steven Hinrichs, director of the University of Nebraska Center for Biosecurity.

Scientists have long said that if terrorists use Tularemia in an attack, it will look like this: The bacteria will show up in the air in a city, rather than the country, and perhaps at a major event.

"If Francisella tularensis were used as a bioweapon, the bacteria would likely be made airborne so they could be inhaled," the CDC warns in an information sheet on Tularemia. In a June 2001 consensus statement titled "Tularemia as a Biological Weapon," the American Medical Association warned an attack would come in "an aerosol release" in "a densely populated area."

There is no evidence that terrorists have ever used Tularemia as a biological weapon before, but it may have been used by the Soviets against German troops during the 1942 Battle of Stalingrad, according to a report by the Council on Foreign Relations. The report adds that microbe stocks in Russia, Kazakhstan, Georgia and Uzbekistan are insecure and terrorists could potentially steal weaponized strains of Tularemia from them.

So far, there are no signs of a Tularemia outbreak in the U.S. But because it comes on like the flu, it is unclear if the government would even know if a few people from the Mall that day scattered across the United States had Tularemia. The amount detected in the sensors suggests a very small amount was in the air.

"Clinicians don't often think of it, and it has a non-specific presentation," says Jeff Bender, an infectious disease epidemiologist at the University of Minnesota. "It is basically flu-like symptoms that sound like every other disease you can get."

Like anthrax, F. tularensis is a naturally occurring bacteria. It is typically found in small mammals like squirrels, water rats and rabbits, which is why Tularemia has also been called rabbit fever. Those critters get it mostly from bites by ticks, flies and mosquitoes. People have contacted Tularemia from insect bites or from handling or eating infected material or skinning dead animals. F. tularensis is a concern mostly in central and Western states, particularly Missouri, Arkansas, Oklahoma, South Dakota and Montana. Nearly all cases occur in rural areas, according to the CDC. Around 125 people in the United States get Tularemia each year. Most cases in the United States appear to have come from insect bites or handling animals.

Although insects mostly transmit the disease, there have been cases where the bacteria appears to have become aerosolized in the natural environment. Bacteria from a dead animal could contaminate some soil. In the right conditions, the bacteria might stay viable in the environment for weeks. The soil might then get stirred up and cause the bacteria to be airborne. Fifteen cases of Tularemia were reported in Martha's Vineyard in 2000, apparently after lawn mowers or brush cutters stirred up contaminated material into the air. One person died. Public officials have theorized something similar happened in Washington: The bacteria got into the soil on the mall and it was the marchers themselves who kicked it up into the air.

It is unclear if such a scenario explains what happened on Sept. 24. "The fact that it happened in six locations would have supported an attack scenario," says Hinrichs from the University of Nebraska Center for Biosecurity. Hinrichs has not seen any test results proving that what was in the air that day was a deadly pathogen. Still, he says that government officials would have to consider the incident as more than a natural event. "To have found it in all six would have raised their level of suspicion," says Hinrichs. "It could be a failed attack."

The sensors that picked up on the pathogen are part of the Department of Homeland Security's Bio Watch program. Since Sept. 11, sensors have been placed in 30 of the most populated cities in the United States. Most cities have roughly 12 sensors, although Washington is thought to have more.

The exact locations of the sensors are a secret. Some are piggybacked onto existing air monitoring stations, used by the EPA to measure pollution. The sensors look for signs of the six pathogens scientists consider most likely to be used as biological weapons by terrorists, including F. tularensis. (Other pathogens include anthrax, smallpox and plague.)

Sept. 24 was not the first time the Bio Watch sensors had detected possible biological weapons pathogens. Since the system was deployed, sensors around the United States have identified pathogens that could be used as biological weapons on five separate occasions, Jeffrey Stiefel, program manager for Bio Watch chemical countermeasures, said at an open lecture at the National Institutes of Health on Oct. 6. In all of those cases, the detections were apparently the result of natural phenomena. Indeed, some critics have long worried that one weakness of the Bio Watch program might be the difficulty of distinguishing between natural events and terrorism.

In 2003, two Bio Watch sensors detected F. tularensis near Houston in what the government later determined was a natural event, though the environmental source was never identified. But this was the first time anything popped up in Washington. "This is the first time we have had a situation there that I am aware of," says the CDC's Roebuck. It is also the first time six sensors simultaneously picked up on the same thing. "It has never happened that way before -- that many," Stiefel of the DHS said in his lecture.

Just after the antiwar rally, DHS officials faced a perplexing situation. While the six sensors detected something, at first it was not clear what it was.

Filters are removed from the sensors usually every 24 hours. A laboratory then performs a preliminary test to look for signs of a deadly pathogen. Six filters from the Mall showed the existence of a possible pathogen during that first round of tests.

A second round of tests could confirm the presence of F. tularensis using polymerase chain reaction techniques, which detect DNA signatures. The second round of tests was conducted sometime between Sept. 25 and Sept. 27. But in the second round of tests, none of the samples from the filters was a full DNA confirmation that what was floating around Washington that day was definitely F. tularensis. But it looked like it could be.

"The collectors were concentrated along the Mall," Stiefel said in his lecture. "That starts to say, 'Something looks a little funny here. The bottom line here is that there is something out there."

This posed a quandary for department officials. Under the Bio Watch program, substances detected that are not confirmed positive pathogens can be ignored. But six sensors had detected the same thing in Washington during the biggest peace march in a generation. And Washington, D.C., is not exactly Tularemia country.

There was another troubling thing. One of the sensors that went off was located at the Lincoln Memorial on the far western end of the Mall. Another was located near Judiciary Square, roughly two miles to the east and two blocks north of the Mall. A third was at the Army's Fort McNair, more than two miles from the Lincoln Memorial down the Potomac River past the Mall, on the point of land where the Washington Channel and Anacostia River meet. The locations of the other three sensors have not been disclosed.

This makes a natural event on Sept. 24 more difficult to imagine. Under the government's scenario, soil on or near the Mall somehow became contaminated with the bacteria, perhaps from the body or blood of a dead or injured small rabbit or squirrel. That soil then got stirred up -- possibly by the marchers themselves -- and floated across the Mall and beyond. Marchers and book festival attendees contacted by Salon say it was dusty on the Mall in the morning. But it rained early that day and stayed moist, making the dust theory perhaps less likely, at least after that rain.

"One sensor, I'd say maybe," says biosecurity expert Stanhope of the dust theory. "Two sensors is a stretch. Six sensors? I'm sorry, you don't have enough money to buy enough martinis to make me believe that it is naturally occurring at six different sites. I don't think you could get me that drunk to believe that."

As for how the bacteria may have erupted through natural processes, says Hinrichs of the University of Nebraska Center, "I can't imagine how it could have happened." Asked if he could imagine a scenario whereby F. tularensis could float around the Mall in the dust, Bender, an infectious disease epidemiologist, says, "Theoretically, it is possible." Asked if it could have been an attack, he says, "The question you are asking, 'Was this real or not?' That is a very valid question."

Another possibility is that somebody was testing U.S. biological weapons defenses. How sensitive are the sensors? How quickly and effectively can the government react?

"The Department of Homeland Security would have to consider the possibility that it was neither natural nor an attack, but that it was a testing of the system," says Alan Pearson, a former DHS official, who is now the biological and chemical weapons director at the Center for Arms Control and Non-Proliferation, a nonpartisan organization. "Was somebody trying to see what would happen?"

Regardless of the source, Pearson says, he was troubled that it took the government nearly a week to alert the public. "It points out that the system is still not working fast enough," he says. "If it turned out to be something that really affected people, which it turned out not to be, the system was too slow."

The federal government says that the most compelling argument against a terrorist attack is that nobody got Tularemia. That may be true. But some people say they caught something that day.

Mike Phelps, 45, says he attended the rally in Washington that day, traveling round trip by bus from Raleigh, N.C. On Sept. 27, he came down with a fever, sore throat and headache. Within days, he was coughing up dark phlegm. When he blew his nose, it would bleed. "It was gross," he says. "I literally vomited out cup loads of phlegm. Most of it was dark-colored. I've never had anything like this before."

Phelps' doctor said he had pneumonia and prescribed antibiotics. A few days later, Phelps read about the Tularemia scare and called his doctor. His doctor told him that if it was Tularemia, he would have prescribed him the same antibiotics. Phelps says he called the CDC but was transferred to an automated system. Frustrated, he hung up.

Several members of the women's peace group, Code Pink, also from North Carolina, who attended the march, say they got sick afterward. Stephanie Eriksen, a 46-year-old network engineer for AT&T, says she developed swollen glands and cold symptoms in her throat and chest. She developed a persistent cough that still lingers. "My throat has still not recovered completely," she says. Eriksen says her 14-year-old daughter marched in Washington and got sick. She was tested for strep throat. Eriksen said the results were negative.

Aimee Schmidt, a Code Pink member and student at North Carolina State, says that she developed flu-like symptoms and a raging headache that lasted three days after the march. She says her eyes hurt and her whole body ached. She never went to the doctor. "I made a choice, wise or not, to just deal with it," she says.

Of course, there are countless benign explanations for these symptoms. And it could be true that nobody got sick from F. tularensis on Sept. 24. But bioterror experts say that doesn't prove it wasn't a terrorist attack. The Japanese cult Aum Shinrikyo, they point out, made several unsuccessful biological weapons attacks before the sarin attack in the Tokyo subway system on March 20, 1995. Previous efforts by the cult to release a botulin toxin from a vehicle in 1990, and anthrax spores from a building in 1993, apparently failed to sicken or kill anyone because of faulty dispersal methods.

Terrorists may have made a similar screw-up in Washington on Sept. 24. "One of my working hypotheses is that there was an attack and they failed in their dispersion system," says Stanhope. "They dispersed an incredibly low concentration."

Government assurances that there is "nothing to see here" are reminiscent of the federal government's initial response to the infamous anthrax attacks in fall of 2001. In an Oct. 4, 2001, press conference, then-Department of Health and Human Services Secretary Tommy Thompson emphasized that anthrax occurs naturally in the environment and that "there's no evidence of terrorism."

"I want everyone to understand that sporadic cases of anthrax do [naturally] occur in the United States," Thompson said. Thompson said the first victim to fall ill, a Florida man, was an "outdoorsman" and that investigators were looking into a stream he may have drank from in North Carolina. That man, Bob Stevens, 63, died the next day from inhaling weaponized anthrax that was apparently sent to the offices of American Media Inc. in Boca Raton, Fla.

Soon after, anthrax was sent to the office of Sen. Tom Daschle, D-S.D. Government officials claimed it was a "common variety" and not the weaponized agent most feared. Of course, further investigation proved otherwise.

Currently, the investigation into what happened on Sept. 24 is ongoing. Government officials have apparently been taking soil samples around the Mall, attempting to pinpoint a natural source for F. tularensis. In the meantime, on Oct. 5, the National Institutes of Health announced it would award two contracts worth a total of $60 million to develop new Tularemia vaccine candidates. The announcement said nothing of the events 11 days earlier.

October 17, 2005

Critics See Higher Drug Prices in Bioshield II

By Emily Heil

WASHINGTON - A coalition including employers and generic drug makers on Friday launched a pre-emptive strike against the "Bioshield II" bill that Senator Richard Burr (R-N.C.) is slated to introduce this week, saying the patent extensions it would grant to prescription drugs could suppress generics and raise costs for employers, consumers and the government (see GSN, June 10).

The bill, which is in draft form, would allow brand drug makers to classify a broad range of drugs as "countermeasures" to potential bioterrorism attacks, a category that would allow them to extend patents for drugs that have little to do with biodefense, according to members of the Coalition for a Competitive Pharmaceutical Market, which includes generic drug makers, employers, manufacturers and pharmacy benefit managers. That in turn would raise costs for employers who provide drug benefits to employees, government programs such as Medicare, and to consumers who would be denied access to generic versions of pricey brand drugs, they said.

"Hopefully, senators concerned about the federal budget deficit and about the ability of the federal government to provide drug benefits will appreciate the direct and significant impact this will have on drug costs," said Kathleen Jaeger, president of the Generic Pharmaceutical Association.

The legislation is still being negotiated, a Burr spokesman said.

"It's premature to criticize legislation that hasn't been introduced," he said. "But Senator Burr has made clear that whatever bill is introduced, it will provide for more and better countermeasures to market faster - that's his No. 1 priority."

The Bioshield bill might be marked up in the Senate Health, Education, Labor and Pensions Committee as soon as this week. Project Bioshield is the administration's effort to develop and secure commercial countermeasures to bioterrorism threats.

Under the program, the Health and Human Services Department is to identify threats and encourage industry to produce medical countermeasures. The theory is companies will develop vaccines and other products for which the government would be the only likely purchaser, as long as they know the demand exists. Without incentives, the government might lack a sufficient supply of treatments or vaccines for bioterrorism threats such as anthrax, botulism and Ebola.

In this second installment of Bioshield legislation, Burr is planning to expand the program and ease liability for the makers of bioterror countermeasures. In the latest draft of the bill, Jaeger said, the committee dropped the "wild card" exclusivity that previous drafts of the bill had included, which she called "the most egregious" patent extension. Under the wild-card provision, companies that develop countermeasures could receive additional patent life for any product they chose.

October 13, 2005

Capitol Hill Flu Briefing Was No Trick, and No Treat

By Dana Milbank

Note: "....This was difficult to top, but Poland tried. "I want to emphasize the certainty that a pandemic will occur," he began. "When this happens, time will be described, for those left living, as before and after the pandemic."
"The key to our survival, in my opinion, and to the continuity of government," he said, is vaccination. And "we do not have a licensed or approved vaccine." "

Halloween came early to the Capitol yesterday, as disease experts lined up to scare the dickens out of lawmakers in a "congressional briefing" on the coming flu pandemic.

The elected representatives missed their briefing, because they were home for their Columbus Day recess, trick-or-treating for campaign checks. But a roomful of staffers, pharmaceutical lobbyists and reporters toured a medical house of horrors in the Hart Senate Office Building.

"This is a nation-busting event!" warned Tara O'Toole, CEO of the University of Pittsburgh Medical Center's Center for Biosecurity. Speculating that 40 million Americans could die -- that's about one in eight -- she warned: "We must act now."

"We and the entire world remain unprepared for what could arguably be the most horrific disaster in modern history," inveighed Gregory A. Poland of the Mayo Clinic and the Infectious Diseases Society of America. Somebody in the audience sneezed, and Poland added: "The clock is ticking. We've been warned."

It was hard to top that, but Constance Hanna, an occupational health specialist, tried. "Let me paint you a little picture," she began. "Twenty to 30 percent of your employees don't show up to work . . . schools are closed . . . transportation systems are curtailed or shut down . . . Critical infrastructure will or may fail: food, water, power, gas, electricity."

"This picture," Hanna added, redundantly, "is pretty scary."

Even before the start, there wasn't much doubt about the answer posed in the briefing's title, "Are we prepared for a Pandemic Flu Outbreak?" After Hurricane Katrina, the answer to any question beginning with "are we prepared" is an emphatic negative.

Attendees were greeted by an ominous poster of a man wearing a mask, followed by welcoming tables piled with boxed lunches of cookies, chips and sandwiches (smoked chicken -- at an avian flu briefing?). Those who did not eat quickly would soon lose their appetites.

O'Toole, a medical doctor and public health specialist, said the bird flu of concern is potentially worse than the 1918 pandemic that killed 675,000 Americans. And this time, she said, the mortality rate might not be 1 or 2 percent, but 40 or 50 percent. "You can do the arithmetic," O'Toole said.

For those keeping score, that's 40 million to 42.5 million dead. And O'Toole's ghost story was not over.

"Suppose the pandemic comes next year," she said, and "a year and a half from now, next winter, you're thinking about today. You were one of the lucky ones: You got sick but you recovered and now you have immunity against the pandemic strain. But one out of four Americans was infected, one of four people sitting here today, and half of them died." Some people looked around: There were about 200 in the room, so about 50 would get the bug, and 25 would die.

On the positive side, this level of mortality would have left enough chicken sandwiches for everybody at the event.

Public-health types are always warning of doom and asking for more government spending, $5 billion to $16 billion in this case. It's possible that the virus will not learn to spread easily among humans, and it's likely the virus will grow less lethal if it does. But the medical experts, well-credentialed all, were alarmingly unified in their alarm. Their dire warnings proved gripping enough to silence the usual back-of-the-room chatter.

"This is real," said Shelley A. Hearne, executive director of the Trust for America's Health, as she kicked off the event.

"Death rates approaching this order of magnitude are unprecedented for any epidemic disease," contributed O'Toole.

This was difficult to top, but Poland tried. "I want to emphasize the certainty that a pandemic will occur," he began. "When this happens, time will be described, for those left living, as before and after the pandemic."

"The key to our survival, in my opinion, and to the continuity of government," he said, is vaccination. And "we do not have a licensed or approved vaccine."

Up next, Isaac Weisfuse, the New York City deputy health commissioner, provided some logistical fears to add to the medical ones. "We'll be inundated," he said. "We have no [antiviral] Tamiflu. We have no vaccine. . . . There is no cache of respirators."

There was little left unsaid for speakers lower in the program. Jeffrey Levi of George Washington University prophesied a panic of "millions and millions of people" trying to get antiviral prescriptions filled. Hanna struggled for superlatives: "We haven't even begun to conceive of, to understand, to comprehend what that may mean for our workplace."

That was ominous, but it did not approach O'Toole's apocalyptic fervor: "uniquely virulent . . . hospitals will be quickly overwhelmed . . . this time of peril . . . quarantine is not going to work."

O'Toole's speech quieted the room. People stopped munching on their smoked chicken. Moderator Hearne took the microphone: "And have a good day, right?"

October 12, 2005

Throw Out the Playbook: A New Plan Arrives

Red Flags Daily
By Red Flags Columnist, Sherri Tenpenny, DO

Every winter, it is reported that millions of people in the world get the flu. Coworkers and classmates are home, sick and miserable, for about a week. A few - mostly the elderly and infirm - die. We're told the annual death toll exceeds 36,000 in the United States and a few hundred thousand around the globe.

This computer-generated number has gaping holes in its credibility, however, because medical authorities don't separate and verify those who actually died of influenza from those who died of a "flu-like illness" or of flu-complications, such as pneumonia. (1)

As a general rule, people think of the flu season as a nuisance. Even major controversies - like last year's contaminated vaccine supply that cut the number of doses by 50 percent - barely made a blip on the radar screen. For a few weeks, the media hyped the shortages with images of people standing in line to be vaccinated. But by January, a vaccine shortage turned into a vaccine glut. Authorities abandoned the rationing and started to urge everyone once again to get in line. After all that hoopla, we ended up with a very mild flu season.

In addition, the CDC (Centers for Disease Control and Prevention) has a media plan in place. Referred to as a "Seven-Step Recipe for Generating Interest in, and Demand for, Flu (or any other) Vaccination," it was engineered to ensure the economic success of the season's flu vaccine campaign. The program is designed to methodically manipulate the general public through the use of major media (newswires, television). The scheduled, fear-based messages are aimed at convincing the unsuspecting public that not only is the flu shot necessary, but people should be
demanding it. This results in millions of dollars of free advertising for vaccine manufacturers. (2)

The "recipe" is ramping up all over again with the approach of fall: The annual flu vaccine push is about to begin. "Make a plan, then work the plan," comes to mind. But the plan may be wearing thin. The general public has come to understand that the flu isn't a catastrophic illness. Like the sparrows to Capistrano, it arrives at about the same time every year. Most people are showing the same ho-hum attitude to the frenzied reports of the avian flu virus, H5N1, also referred to as "bird flu."

Predictably, officials don't like it one bit. They are finding it difficult to get people really worried about avian influenza no matter how many articles of "catastrophic concern" they have published. But this time, they need to walk a tight line. They saw the economic consequences caused by "epidemic hype" in 2003, when the world was focused on the SARS (severe acute respiratory syndrome) outbreak.

The SARS virus was thought to spread from humans after infected animals were sold and slaughtered in unsanitary and crowded markets in China's Guangdong province. Over a period of five months, 8,049 people were reported to be infected by what turned out to be a novel human coronavirus. The vast majority of those (7,248) were in China, Hong Kong and Taiwan. Even though there were 774 deaths, or close to 10 percent of known cases, SARS didn't become "the new pandemic," killing millions as feared. (3)

The SARS experience, however, taught officials a critically important lesson about overestimating the staying power of an infection. The economic impact on the Asia-Pacific region of the six-month SARS outbreak was nearly $40 billion.

In Canada, 251 people were infected and 43 died. (4) The Canadian Tourism Board estimated that the epidemic cost the nation's economy $419 million. The Ontario health minister estimated that the cost to the province's health-care system, including money spent on special SARS clinics and supplies to protect healthcare workers, was about $763 million. That's more than $1.18 billion spent on one disease during one season in just one country.

The SARS outbreak also had a substantial impact on the global airline industry. Flights to Asia and the Pacific Rim decreased by 45 percent and the number of flights between Hong Kong and the United States fell 69 percent. (5)

Undeniably, there is a genuine downside to issuing warnings that turn out to be unnecessary hype. Unfortunately, the way that the H5N1 avian flu infection is being handled is starting to inflict a similar economic impact. Since 2003, more than 160 million domestic ducks, chickens and geese have been killed in eight countries. The cost to various local economies is already estimated in the tens of millions. And based on information freely available on the Internet, bird flu is predicted to cause the "Great Global Depression," 40 percent of the world's population to be infected, an unimaginable number of deaths and, in Western civilization, "the end of
life, as we know it." (6,7)

But, if the apocalypse is coming, the general public does not seem overly concerned. The old playbook isn't working this time. No one seems to be paying much attention to the scenarios being portrayed by the CDC and the World Health Organization (WHO). Officials need a new plan.

Enter risk communication.

The field of risk communication is relatively new. Dating from the early 1980s, it evolved from several different fields of study: health education, public relations, psychology, risk perception and risk assessment. The CDC needed a new plan to get people to take bird flu seriously and to move government health officials to earmark massive amounts of money for the planning process.

a.. A new 10-step "recipe" crafted by risk communication experts, Peter M. Sandman, Ph.D., and Jody Lanard, MD, based in Princeton, New Jersey, has arrived on the scene. Their plan will serve to guide people through serious hazards when they are appropriately upset (or even in denial). (8) Here's the "new and improved" version of the "Seven-Step Recipe" for the flu shot:

Step 1: Start where your audience is

Fair enough. For most educational processes, this is a good place to begin. Officials are advised to start with empathy. Instead of "berating" people for their lack of concern about bird flu, make "common cause with the public" . and then talk about how "horrific the next flu pandemic may be compared with the annual flu."

Don't tell them the answer; lead them to the conclusion.

Step 2: Don't be afraid to frighten people

That's right, the new plan advocates the use of fear. "Fear appeals have had a bad press, but the research evidence that they work is overwhelming.. We can't scare people enough about H5N1. WHO has been trying for over a year, with evermore-dramatic appeals to the media, the public and member states."

This is the reason the "same old recipe" isn't working: fear is an over-played card. At every turn is a doomsday message about something coming from the CDC and the WHO. The "Chicken Little" approach has played itself out, even though the press and the government seem to push that same button over and over again.

Step 3: Acknowledge uncertainty

Uncertainty is the name of the game - and it is the very uncertainty of this infection that feeds the fear. The plan encourages officials to admit, "There is so much that we don't know about H5N1."

In spite of encouraging uncertainty, there has been a noticeable change in the language surrounding the arrival of the pandemic from "if the pandemic comes" to "when the pandemic arrives." (9) I suspect we may see more of this "certainty" once the new pandemic vaccine becomes available worldwide.

Step 4: Share dilemmas

In crisis communication, the goal of dilemma sharing is "to humanize theorganization" making the decision, "reducing the outrage if you turn out to bewrong." In addition, this practice will let the public think that it is helping to make decisions, leading to "better buy-in" of the decisions being made.

I wonder if the farmers in Vietnam, China and Thailand are feeling any sense of "dilemma sharing" when their birds - infected or not - are confiscated by the government and killed, leading to a complete loss of income and food production for their families?

Step 5: Give people something to do

In January 2005, Canadian infectious diseases expert Richard Schabas told The Wall Street Journal, "Scaring people about avian influenza accomplishes nothing because we're not asking people to do anything about it." The authors of the new playbook recommend that we start planning how to handle catastrophic business disruptions. They even suggest "cognitive and emotional rehearsal - learning about H5N1 and thinking about what a pandemic might be like and how you'd cope."

Nearly every religious tradition and many researchers, including Depak Chopra, Larry Dossey and Wayne Dyer, have given us a clear message: "You get what you think about." Could global cognitive and emotional rehearsals make the situation worse? Perhaps we should visualize, instead, a safe, clean healthy world, free of viral illnesses for all, humans, birds and animals.

Step 6. Be willing to speculate - responsibly

Step 7: Don't get caught in the numbers game

Step 8: Stress magnitude more than probability

Step 9: Guide the adjustment reaction

All four of these steps serve to accentuate Step 2: Don't be afraid to frighten people. Get people revved up and worried. Get them motivated to fear that the pandemic is coming. Stockpile drugs, frantically push for vaccines, store water and food. We didn't see a disaster at the millennium, but one is just around the corner. At any minute. Soon. We're due.

Step 10: Inform the public early and aim for total candor and transparency

The American government has collaborated with its many agencies to hide so many things from its citizens - from vaccine cover-ups about thimerosal to Vioxx - that it has lost all sense of trustworthiness. Do government officials still have the ability to be "transparent"?

Now that we have seen the new playbook, start watching for the rhetoric. The bird flu vaccine to "protect" the public from the H5N1 virus is more than a year away from release. Nonetheless, watch for the 2005/06 "normal" flu season to be the launching pad for a new form of information sharing called "risk communication." See the plays unfold, paving the way for the arrival of a new "bird flu" shot. A global mass vaccination program plan is about to unfold.


1. "Annual number of flu deaths: It's a guess" can be read by RedFlags's members at

2. "The Flu Season Campaign Begins" can be read by RedFlags' members at http://www.redflagsdaily.com/conferences/vaccines/2004_aug30.php or CDC powerpoint can be accessed at http://www.ama-assn.org/ama1/pub/upload/mm/36/2004_flu_nowak.pdf

3. SARS fatalities. NationMaster.com at http://www.nationmaster.com/graph-T/hea_sar_fat

4. SARS fatalities. NationMaster.com at http://www.nationmaster.com/graph-T/hea_sar_fat

5. Preparing for the Next Pandemic by Michael T. Osterholm. Foreign Affairs, July/August 2005. www.foreignaffairs.org

6. Ibid. Osterholm. Also see:

7. The Next Pandemic? By Laurie Garrett. Foreign Affairs. July/August 2005. www.foreignaffairs.org

8. Bird Flu: Communicating the Risks, by Peter Sandman and Jody Lanard. Perspectives in Health, Vol 10, No 2. 2005. http://www.paho.org/english/DD/PIN/Number22_article1.htm

9. Monto, A.S. The role of antivirals in the control of influenza. Vaccine. 2003 May 1:21(16) 796-800 PMID: 12686