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CHIRON CORPORATION GAMBLES ITS OLD EMERYVILLE CHIPS TO WIN
THE POT AND BEAT THE RAP

(Part 1 in a series)
by Kathryn Joanne Dixon 

Serratia marscescens bacteria ate patented 7 to 12 day old chicken embryos and surrounding fluids in the eggs delivered to the Liverpool plant to make influenza vaccine.  Technicians employed by Chiron Corporation used machines to inject through a tiny hole in each eggshell one of the three different influenza seed viruses selected by the Food and Drug Administration advisory panel. The influenza virus mutates so every year the FDA selects three existing mutations, hoping one of them will constitute the type of flu mostly likely to hit the United States. Injections completed, the technicians re-sealed the eggshells and the influenza viruses multiplied in them for about three days.(1)(2) 

Then the technicians broke the eggshells.  They extracted the fluids around the embryo chicks--- fluids flush with flourishing viruses. Yet bacteria were eating the fluids and some still traveled with the vaccine as it flowed through sterilization filters that strained contaminants from the vaccine.(3)  Outside the eggs, they ate a dessert of organic matter not cleansed from equipment. Some munched their way out from any breakages in the equipment into the eggs. How? Bacteria still elude detection by people and some kill people. Bacteria on this earth at this time are not conquered by Homo sapiens, a salient political and scientific potential tipping point. Neither are viruses conquered. But back to the prevailing existing procedure in 2004 of making influenza vaccine despite bacteria, such as serratia. Next, technicians inactivated (killed) the viruses in the fluids by adding formaldehyde.  Then a machine spun down the fluids to separate out the part containing the viruses. The virus-laden fluids were injected into eggs again and were tested to ensure the viruses were dead. (2)

Why are dead viruses important?

When the influenza vaccine (the dead viruses) is injected into human beings, it stimulates their immune systems to produce antibodies to fight infection by these dead viruses as though they are fighting a genuine infection by live viruses. However, those injected do not develop full-blown influenza because dead viruses are too weakened to cause it. It is one of the most important life-saving medical principles ever, which was discovered in essence by Edward Jenner in 1797 and bears repeating:  If human beings who are injected with a dead virus encounter the same influenza virus which is living, the antibodies formed to fight the dead viruses help the body recognize and kill the live viruses by neutralizing them before they enter cells and by destroying infected cells before the virus can multiply in vast numbers.(4),(5)

Thus Chiron’s technicians made sure there were no living viruses growing among the dead viruses in the egg fluids.  If all were dead, thus suitable to make safe vaccine, they were extracted and the fluids were processed into several hundred thousand doses of each single strain called a lot or batch.(2)  Before the batches of the inactivated viruses against all three strains were combined and poured into vials as finished vaccine, the technicians applied the mercury-containing organic compound Thimerosal to kill all minute life forms, such as the bacteria, and to act as a preservative of the vaccine.  Yet some serratia probably survived it.(3),(6),(7)  How?  Serratia survived it all by the habit of dining well.  In minute spaces and time intervals, time after time, serratia had made enzymes within their own single cells, and then pushed them out through the cell walls onto their meals. These enzymes chopped the food into subunits and took them back into the cells by osmosis, that is, by diffusion through their semipermeable membranes or by active transport, that is, by grabbing a molecule of food and pulling it through the cell wall.  Consequently, in time serratia feasted on the finished Fluvirin vaccine inside the sealed vials ready for shipment. Mobbed there, the telltale reddish-brown mass of serratia would try to spread into the tissues of people and eat their cells like egg whites if they had the chance to leave the vials and be injected into people.(8)

These were the Serratia marscescens, the tough little life forms Chiron considered to be less than pawns in the high-risk game it played for one of the highest stakes – mastery of the world’s biotechnology – of “life”, itself.  In this particular game, the competitors re-define ruthless moves moment by moment. No risk seems too great.  

For starters, Chiron Corporation actually gambled its very existence by deciding to manufacture Fluvirin, its anticipated first sale of influenza vaccine to Americans, in an old plant contaminated with this bacteria in its plant in Liverpool England without first cleaning the plant completely.  Why?  Chiron knew the situation was dirty.  Before Chiron initiated the process of purchasing the plant in May 2003, British and FDA inspectors cited two prior owners, licensed to manufacture vaccine in England, for failing to take all the steps needed to keep bacteria out of the plant.(9)  Immediately after Chiron purchased the plant, the FDA requested Chiron find the “root cause” of the bacterial contamination.  Chiron did not do so.  It never paid the price to clean the plant completely so as to eliminate bacteria.  Was the price of cleaning the plant so high in Chiron’s calculations that it was a profit-killer? If so, did Chiron’s executives actually think they could get away with selling vaccine contaminated to a certain degree with bacteria?  Or did Chiron execute a scheme directed by someone’s sinister futuristic intelligence?  It is persistently rumored that there are a few people who are 25, 50, maybe 100 years ahead of the current knowable frontier of science, as that frontier is believed to be known or even sensed by those the world acknowledges as the best scientists.    

To live, the serratia ate Chiron’s vaccine, and it reproduced too.  Using the process biologists call “binary fission”, each single cell of bacterium divided into two identical cells.  In optimal conditions this division can occur every fifteen minutes.  Biologists estimate that under ideal conditions a single bacterium with a mass of ten millionth of a gram could produce millions of bacteria with a mass of 8 billion tons in just 24 hours.(10)

Could anyone beat these tiny fast breeding super gluttons at their ultimate game – to ride into the tissues of human beings via vaccine injections and eat the cells in and about their vital organs?  Could Chiron?

Without control of all possible outcomes, a game may be lost so long before it starts. Once Chiron decided to gamble on Fluvirin being the flu vaccine for millions of Americans in the fall of 2004, it used the tightest controls it could fashion, to win. Chiron’s first move was to control the bioburden, i.e. the bacterial level.  Chiron’s executives and scientists planned to control the bioburden in the plant without finding the “root cause” and rooting it out as the FDA requested in its June 2003 inspection.  In fact, in June 2003, the FDA made a “request for voluntary action”. It requested such voluntary action as Chiron cleaning the aseptic connections between tanks in the formulation area and properly handling the curtains separating sterile from nonsterile areas and that it engage in other sanitary practices at the plant.  Chiron did not take these actions.  For Chiron, “control” was not a matter of spending money to satisfy the FDA’s request – after all Chiron anticipated the FDA would probably not inspect the plant after June 2003 anyway.  And in fact, the FDA did not inspect after the process of making vaccine began in June 2003 until it ended in the fall of 2004 (11).

Chiron’s second move was to add Thimerosal to the vaccine to kill off most or virtually all bacteria and to preserve it. However, serratia can survive Thimerosal.  According to the FDA’s Center for Biologics Evaluation and Research(12):

Preservatives cannot completely eliminate the risk of contamination of vaccines. The literature contains several reports of bacterial contamination of vaccines despite the presence of a preservative, emphasizing the need for meticulous attention to technique in withdrawing vaccines from multi-dose vials. (Bernier et al 1981; Simon et al. 1993).

The FDA further stated:

In September 2001 Chiron/Evans was approved for manufacturing a preservative-free formulation of their influenza vaccine, Fluvirin.(12) 

Despite the controversy about the health effects of mercury, a component of Thimerosal – did it cause autism or not? —Chiron’s executives chose to add Thimerosal to the Fluvirin vaccine it intended to sell in the United States in the fall 2004.(7)  Chiron was authorized by the FDA to make a preservative-free vaccine, but health issues pushed aside, Chiron hedged its bets against too much bacterial contamination and just added Thimerosal to the mix. 

Chiron’s third move, its grand finale, was to control testing.  To control the rules of the game which test its integrity is to win the game.  If the bioburden continued to increase, Chiron would try to keep the level in its Fluvirin influenza vaccine contained or limited to certain lots so that the 4.8 million doses produced at the plant would pass the tests for contamination.  All first and primary tests would be conducted by Chiron’s own staff at the plant. Then the FDA would test some samples. The key words – “some” and “samples”.(2)  Chiron would have the last word in testing. Its final tests would be conducted after the finished Fluvirin doses were shipped to the United States, and before their final release to medical distributors and providers.(13)  A grand finale in a final test tube.  The British authority, the Medical and Healthcare products Regulatory Agency, the MHRA, was not expected to perform sterility tests on the vaccine, even though Chiron’s influenza manufacturing plant was located in Liverpool, because this particular batch of Fluvirin vaccine was not to be made available on the UK market, but in the United States.(14)  Having its own tests results in hand, a sure pass, Chiron anticipated selling Fluvirin in the United States starting in the fall of 2004.  Profits would be enormous -- $400 million in sales, 25% of Chiron’s total annual sales.(15)  After almost five million doses of Fluvirin were injected into Americans, and especially if Fluvirin was proven efficacious in preventing influenza or at least seemed to work well enough, it would be too late for anyone to do anything about any bacteria problem and Chiron’s profits would already be snug in the bank. 

The downside? Of course, if people were injured by contaminated vaccinations, they could sue, and/or complain to the FDA or the Department of Justice.  If Chiron stockholders claimed an adverse impact upon their Chiron stock they could sue and/or complain to the SEC or the Department of Justice.  The FDA, SEC, Congress and Department of Justice deploying its FBI agents and/or calling a grand jury could investigate. After the investigations?  Business as usual or indictments?  A trial?  Big legal judgments, fat fines and even jail – these were the doomsday scenarios.  Stock prices could dive, a doom worse than doom.  Perhaps the government would be reluctant to buy Chiron vaccines in the future?  It seemed Chiron’s game plan had to include controlling not just the bacteria but the FDA, the SEC, the Department of Justice and a federal judge or two. The problem is no problem to some people.  In fact, Chiron, utilizing its Emeryville connections, had already identified one of the ultimate controlling factors in American business  – control of the local United States Attorney’s office and the federal judge handling the case, providing, of course, that the judge had the legal finesse to write a decision the Ninth Circuit Court of Appeals could not overturn, and which would result in the Supreme Court’s denial of a petitioner’s writ of certiorari.

Chiron eyeballed the hand it was dealt and figured hard.  Did it project, perhaps, its calculators whirring, that the economic and political fallout from any future complaints and lawsuits about contaminated vaccine would be negligible in comparison to its profits?  Besides, in the small venue where Chiron played its game, a couple of federal judges and the office of the United States Attorney and its FBI agents had been known to play along.

So why not up the ante! 

Chiron decided to make 12 million more doses of Fluvirin vaccine that it had made the year before.(16)  The old contaminated plant in Liverpool would be humming, serratia or no serratia. 

To gamble by risking bacterial contamination was easy and natural for an outfit out of Emeryville, California, where gambling is one of the old “kings” and where, more importantly to Chiron, such Emeryville “kings” are above the law. 

In 1859 Joseph S. Emery, “king” of the quarry business, having quarrying rock on Angel and Goat Islands to build the spectacular buildings that constitute San Francisco's skyline,  purchased 185 acres for $8,000 situated between Berkeley and Oakland, the “Emery Tract”.  He built a Victorian mansion for himself at the corner of Park and San Pablo Avenues, then subdivided and leased the remaining land to settlers to make a buck.  Recreation for these settlers in the neighborhoods known as the old Golden Gate district, the Temescal district, Klinknerville and Butchertown consisted of drinking, womanizing and betting on horses at the Oakland Trotting Park located on the north side of Park Avenue.  This is where the Chiron’s and Pixar Animation Studio’s campuses are now located.  In the 1920’s Chinese settlers introduced the lotteries all up and down Park Avenue and at 65th and Hollis.(17)  The first lotteries were called “Pak kop pie (“white pigeon ticket”) because “pigeons were used to carry the tickets and winning numbers.”(18)  Nowadays Emeryville’s modern day gambling clubs, at least the “legal” ones, include the Oaks Card Club, the King Midas Club and “The Bank”. The red light district flourishes around the clubs all the way to the dock with its ramp to the Bay and big money is passed for anything from drug deals to corporate acquisitions.  Emeryville’s law enforcement is traditionally absent at all critical times when the deals go down for any of the “kings” of Emeryville

Where is Emeryville, California and why should anyone care?  What does Chiron, one of the most eminent biotechnology corporations in the world, have to do with a nook and cranny called Emeryville, known in San Pablo street slang as E-town or E-ville?

It is important to note that Chiron Corporation in fact operates its worldwide headquarters at 4560 Horton Street, Emeryville, California. Why?  Some say Chiron made Emeryville.  Wiser heads say Emeryville made Chiron.  The Chiron Emeryville connection even drew Presidential attention or inattention.  In the October 13, 2004 presidential debate, moderator Bob Schieffer asked President Bush, “Suddenly we find ourselves with a severe shortage of flu vaccine. How did that happen?"

"Bob,” Bush responded, “We relied upon a company out of England to provide about half of the flu vaccines 
for the United States citizens and it turned out that the vaccine they were producing was contaminated. 
And so we took the right action and didn't allow contaminated medicine into our country."(19)

During that early fall of 2004, while the Presidential debates slithered on, disabled persons and parents carrying children waited on sore feet, leaned on canes, crutches and walkers or sat in wheelchairs in the long lines on the streets outside clinics waiting for flu shots. Chiron’s Fluvirin vaccine, which was to constitute half of the nation’s supply, had been banned from sale in the United States.  People were turned away after waiting hours for a shot manufactured by the French firm Aventis-Pasteur (now Sanofi Pasteur) which supplied some vaccine. The public was enraged and scared.  Chiron’s brass may have breathed a sigh of relief when the President pointed to an unnamed company out of England (in fact a division of Chiron, known as "Chiron Vaccines") as having created the flu vaccine shortage, rather than Chiron Corporation of Emeryville.  But the relief didn’t last.  A few facts were oozing out from between the cracks in the offices and labs filled with number crunchers and scientists, expeditiously located near the cages of monkeys, cats and pigs, all awaiting martyrdom for the sake of scientific experimentation and profit at Chiron’s worldwide headquarters in Emeryville.

A review of a few facts waving like red capes for raging bulls on the timeline of public events shows the intentions of the players.  They will show Chiron fully intended to sell its contaminated vaccine, knowing it could make some people sicken or die.  Furthermore, they will show Chiron got to the point of covering up its cover-ups as it squirmed to the last minute to try to convince the FDA to give it a sweetheart pass on its contaminated product.  Chiron had but one goal – profits in the short-term and more profits in the long-term especially for the production of its new experimental influenza vaccine.(20)

Old timers downing the daily news with doubles at the Townhouse Bar & Grill, 5862 Doyle Street, Emeryville weren’t at all surprised. Just amused.

Such cynical business ploys were not out-of-character for Chiron  – rather they constitute its deepest albeit secret character.  Profiteering from contamination and exploiting a vulnerable population are two tricks straight out of the same black portfolio of tricks Chiron played in Emeryville, California in the late 1990s.  And these old tricks paid off big time -- Chiron established its worldwide headquarters and laboratories in Emeryville for the lowest price possible.  From that bargain basement albeit contaminated platform, Chiron then marched on to become the second largest biotechnology firm in the world.  One must respect pure skill.  Chiron became masterful at playing national and international politics by utilizing its secure base in Emeryville to exert influence with certain judges and the district attorney in Alameda County and with certain judges in U.S. District Court, Northern District.  From the tiny Emeryville venue, it reached out to conquer the biotechnological/political world, so to speak.  To Chiron, a little bacterial infection of some human beings in the grand scheme of things, if discovered, if ever, is just a cost of doing business?  After all in Emeryville and in England, Chiron executives, turned a blind eye to illegal human experimentation, a not-so-well-hidden fact noted by interested parties.

In order to understand Chiron Corporation, it is necessary to survey the international and American laws against human experimentation and to know the real loopholes, the expected future loopholes and the minefields in between.

Today, some people may still be nostalgic for the days when people were shocked by such perversions as the Tuskegee Syphilis Study or by the horrific evidence of human experimentation by the Nazis adduced by the prosecutors at the Nuremberg trials.  On the other hand, today some American scientists almost frankly express their dream of experimenting upon human beings again without any governmental controls – such experimenters could outpace all others in developing pharmaceuticals and other products without going through years of FDA controlled tests and hurdles.  They argue privately that if American scientists don’t do this, scientists outside the U.S., or some, as lawless rogues, within the U.S., will do so, and in fact, are doing so covertly.  Scientists, free of constraints against human experimentation, will stage preemptive strikes to beat U.S. scientists in the race to develop new biological products. Will some of these scientists or their paymasters be materially aligned with foreign organizations on the list of Foreign Terrorist Organizations as designated by the Secretary of State in accordance with section 219 of the Immigration and Nationality Act as amended by the Patriot Act of 2001 which set forth legal criteria for designation of foreign terrorist organizations?(21)

However, even if these scientists are not on the list, their role on shore or off shore, regarding human experimentation may violate the Nuremberg Code which set forth ten principles including informed consent, lack of coercion and human rights of the subject as a prerequisite regarding human experimentation

Why is the Nuremberg Code one of the most important laws on the books, the one, along with the American Constitution, fascists wish to burn most?

After the Allies defeated Nazi Germany in World War II and after the Holocaust, the Nuremberg trials took place at the Nuremberg Palace of Justice. The Nuremberg trials consisted of two groups of trials. The Trial of the Major War Criminals Before the International Military Tribunal before judges from allied nations, convened on November 20, 1945 and indicted and tried twenty-four major Nazi leaders, including Goring, von Ribbentrop, Hess, and Speer and six criminal organizations, such as the SS and Gestapo, for war crimes.  Twelve men were found guilty and sentenced to death, seven were imprisoned, three acquitted and two did not go to trial.(22)  The trials resulted in a document entitled The Charter of the Nuremberg Tribunal and the judgment of the Tribunal set forth the Nuremberg Principles which define what constitutes “war crimes”, “crimes against peace” and “crimes against humanity”.  In 1949 a convention of nations created and later ratified the Fourth Geneva Conventions, which were heavily influenced by the Nuremberg Principles. The Fourth Geneva Conventions of 1949 set forth rules of the treatment of civilians during wartime in enemy hands. The prior conventions covering the treatment of battlefield casualties, casualties at sea and prisoners of war were revised.(23)

After the International Military Tribunal concluded, two more trials convened before United States judges only – the trials of lesser war criminals called the Nuremberg Military Tribunals and the “Doctors’ trial”.(24)  On October 25, 1946, twenty-three German physicians and scientists were accused of membership in a criminal organization, the SS, and of “war crimes” and “crimes against humanity” regarding inmates in the concentration camps and vulnerable populations.(25)  Witnesses described atrocious and vile human experimentation upon them.  Judges in the Doctors’ Trial found ffifteen defendants guilty, seven were sentenced to death and eight imprisoned.  Seven were acquitted. 

The Doctors’ Trial judges added to the Nuremberg Principles a document called the Nuremberg Code which defines the physician’s duty to the subject of research. 

Jennifer Leaning, in an article entitled War Crimes and Medical Science, in the British Medical Journal of December 7, 1996 explained the application and reach of the Nuremberg Code:(22)

It was written to apply to subjects of experimental or non-therapeutic research--where the information sought will not directly benefit the subjects of the research. These subjects must be healthy, competent volunteers who have freely and with full information consented to participate. Thus prisoners, members of vulnerable populations, and all those who feel that they might bear a cost by refusing are not suitable subjects for research. Although the term "informed consent" was not employed in the statement, its core elements were defined at Nuremberg.

The judges did not consider what we now call therapeutic research, which is conducted in the course of providing care. Rare in 1946-7, this now constitutes the majority of all medical research involving human subjects. The judges also dealt only with consent from adult and competent subjects. They did not address the complex questions surrounding subjects who are incompetent to make informed judgments.

These issues were taken up in the Helsinki declaration of 1964 (see p 1448), drafted by the World Medical Association. This document spells out in more detail, in medical language specific to the scientific understanding that had evolved since Nuremberg, the nature of the arguments that must be weighed before asking a patient (not a healthy, competent volunteer) to consent to participate in diagnostic or therapeutic research. It does not contain an absolute requirement that informed consent be obtained in the setting of therapeutic research and introduces the notion of guardianship as a means of obtaining consent from incompetent subjects

The United States is voluntarily subjected to the Nuremburg Code and the Helsinki Declaration, and eventually enacted laws to implement their principles.  Arthur L. Caplan and Glenn McGee briefly explained the evolution of the law regarding human experimentation up to the present time, in Bioethics for Beginners:(26)

Concerns about research ethics were further heightened by a research project called the Tuskegee Study, sponsored by the United States Public Health Service to assess the clinical course of syphilis. Public health researchers conducting the study, which began in 1932 and was ended at the direction of the Congress of the United States in 1972, withheld both diagnostic information and effective treatment from black men enrolled in the study in order to retain their ongoing participation. The abuses of the Tuskegee Study prompted the formulation of a national commission to examine ethical issues in research, and eventually led Congress to enact regulations requiring informed consent from participants and the review of all federally funded health research by appointed review boards. In 1997 United States President Bill Clinton issued a formal apology to the survivors of the Tuskegee Study and their families.

The United States National Institute of Health now requires that human experiments supported by the Department of Health and Human Services (though not other agencies) be approved by Institutional Review Boards. The NIH sets forth an applicable model of legal reasoning, in Sheet 3, Criteria For Institutional Review Board (IRB) Approval Of Research Involving Human Subjects:(27)

1. ROLE OF THE NIH'S IRBs

All domestic and foreign institutions or sites where research involving human subjects is conducted or supported by the Department of Health and Human Services (DHHS) are required to perform this research in keeping with Federal regulations, Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects (45 CFR 46).  Said 45 CFR 46 requires prospective and continuing review and approval of human subjects research activities by a committee, usually called an Institutional Review Board (IRB).

2. IRB REVIEW OF RESEARCH ACTIVITIES INVOLVING HUMAN SUBJECTS

An IRB may approve research only after it has determined that all of the following requirements are satisfied

(a) Risks to subjects are minimized by using procedures that are consistent with sound research design, and that do not unnecessarily expose subjects to risk. Whenever appropriate, researchers should employ procedures that are being performed on subjects for diagnostic or treatment purposes.

(b) Risks to subjects are reasonable relative to (1) anticipated benefits, if any, to subjects, and (2) the importance of the knowledge that may reasonably be expected to result.

(c) The selection of subjects is equitable. In making this assessment the IRB must take into account the purposes of the research and the setting in which it will be conducted. The IRB must be particularly attentive to the special problems that may arise when research involves vulnerable populations, such as children, pregnant women, prisoners, mentally disabled persons, or economically or educationally disadvantaged persons. If any of the subjects is likely to be susceptible to undue influence or coercion, the IRB may require additional safeguards in the study to protect such subjects.

(d) Informed consent will be sought from each prospective subject, or the subject's legally authorized representative, generally by means of a written consent document. The IRB will carefully review these documents to assure that they contain the required elements of informed consent (see 45 CFR 46.116, or NIH MPA III.b.9, 10) and that they are understandable to a layperson.

(e) The research plan makes adequate provisions for ensuring the safety of subjects.

(f) There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

A reading of the laws of the United States and international law, such as the Nuremberg Code and the Helsinki convention pertaining to human experimentation seem clear, elegant and good. But is the law -- so good, so clear, so elegant, only rarely applied?  Finally, the law is only as good as its enforcers and whistleblowers and they fight each other. 

Some physicians and scientists and Nazi leaders escaped prosecution at Nuremberg, and in some cases the United States declined to prosecute Nazi scientists and spies who were useful to the United States.  Some were escorted to the United States and given citizenship, housing, a comfortable living standard and high positions in scientific research.  Clare Lasby’s book Operation Paperclip elucidates this phenomena and names some names.  More names and details may be forthcoming in about two years – 2007.  According to Reuters, on March 25, 2005, President Bush signed legislation into law “extending by two years the life of a government panel charged with declassifying CIA documents that detail the spy agency's ties to former Nazis and war criminals”.(28)  The importedNazi scientists will be nonogenarians, if they are lucky not to be dead, when the facts about their lives in Germany and America are finally released.

In truth, America didn’t need Nazi scientists within its borders after WWII in order to engage in violations of the Nuremberg Code.  Without the Nazi’s expertise, the American government engaged in monstrous experiments such as the Tuskegee Syphilis Studies and radiation experiments upon its own civilian populations, let alone upon the military enlisted.

Why hasn’t anyone tried to destroy the Nuremberg Code, given the huge amount of money corporations or individuals can make if they can do human experiments without government controls?  Or has anyone been able to punch loopholes in the Nuremberg Code?

Enter President George Walker Bush!  He did not directly punch loopholes in the Nuremberg Code, but he punched a significant loophole in the Nuremberg Principles and the Geneva Convention. In February 2002(29), President Bush said the U.S. would not apply the Geneva Convention to Al Qaeda and Taliban fighters it held as prisoners, called “enemy combatants”.

Attorney General Alberto Gonzales, in his capacity then as White Housel Counsel to President George W. Bush, stated in an August 2002 memo, regarding the interrogation of prisoners suspected of torture:  "In my judgment, this new paradigm renders obsolete Geneva's strict limitations on questioning of enemy prisoners and renders quaint some of its provisions."(29)

Although Attorney General Gonzales didn’t comment about the Nuremburg Code regarding human experimentation, he derided the letter and spirit of the Nuremberg Principles and Geneva Convention regarding “war crimes”. All three laws were born from the verdicts of the trials conducted in Nuremberg to address the horrific abuses of human beings by the Nazis. All three stand together.

President Bush and his Attorney General Alberto Gonzales may have created a slippery slope moving away from the Nuremburg Code and Geneva Convention.  In April 2004, photographs revealed that some U.S. military personnel were torturing prisoners at Abu Ghraib who were not deemed to be Al Qaeda and Taliban enemy combatants, but who were former Iraqi soldiers and civilians Some of the American soldiers abusing prisoners have since been prosecuted for violating U.S. military codes based upon the Nuremberg Code and Geneva Convention. The Lancet, a British medical journal reported in August 2004 that doctors working for the US military collaborated with interrogators in the abuse of detainees at Abu Ghraib.(30)  If proven, these charges would violate the Nuremberg Code Would these alleged abuses have occurred if the President’s then White House counsel had not put out the word that "In my judgment, this new paradigm renders obsolete Geneva's strict limitations on questioning of enemy prisoners and renders quaint some of its provisions."(29)

If a person puts too many loopholes in it the law starts looking like Swiss cheese and the rats can’t resist it.

Chiron’s scientists and executives were and are aware of the Nuremberg Codes, the Helsinki Convention and the relevant laws and above all the loopholes contained therein. But can these be rendered quaint and obsolete?  That is the question. 

What can happen if people plow roughshod over the Nuremberg Code and do rogue illegal biological experimentation?  The products produced by this experimentation can be deposited in containers almost anywhere in any country.  Couple that with the constant public relations telling all the elderly in America that they must have the flu vaccine in order to survive, and your government in America has created a very vulnerable population who will clamor, wait in line in freezing temperatures and desperately seek a vaccine that may well be more dangerous then the influenza it is supposed to cure.  Simply, people don’t know what is in the vaccines.  And someone out there is able to open those containers full of the products of illegal rogue experiments.  These new viruses or bacteria take flight by air or infiltrate food or water or pools of vaccine or just become somehow hidden within envelopes circulated through the United States Post office until they reach the desks of Senators, as happened in the weeks after 9/11.  On March 18, 2005, the Associated Press reported that the anthrax has yet to be traced to any one experiment or experimenter although the FBI believes the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick in Frederick, Maryland, housed the strain of anthrax found in the mail.(31)

It must be noted:  Biological experimentation by nature of its sophistication and the equipment required to produce it, is not the easy realm of the hallucinating lone nut.

In December 2004, Ben Fenton, in The Telegraph newspaper reported that an ex-KGB spymaster Alexander Kouzminov disclosed that “covert Soviet sabotage agents prepared secret sites where phials of lethal bacteria would be left, ready to poison western military establishments, civilian settlements and even assassinate political leaders in the event of war with the Soviet Union.”(32).

The Telegraph article further stated, “
His disclosures about the use of `dead drops’ to hide biological weapons of mass destruction in the event of a global war will send shudders down the spine of the western defense community.”  Kouzminov said, “I was asked to carry out analysis of the suitability and effectiveness of the places selected for the potential clandestine storage of containers with dangerous biological materials and toxins so that when needed they could be used to disable or destroy objectives.”(32)

Kouzminov’s work was “clandestine”, a type of cloak and dagger operation, unknown or so his principal(s) fondly believed, to the enemy or the public. 

Does Chiron engage in any “clandestine” experimentation?  The United States government usually labels clandestine work by government employees as “classified”, although some matters fly under or over the radar of classification.  One concept of strict highest levels of classification is that the public will never know what really happened, at least in their lifetimes.  For example, on September 30, 1998, Laura A. Denck, Executive Director of the Assassinations Record Review Board issued a Notice  in the Federal Register entitled Formal Determinations, Additional Releases and Corrections.  It stated that many records regarding the assassination of President John F. Kennedy on November 22, 1963 will not be released until 2017.(33)  The Final Report of the Assassination Records Review Board, Chapter 1, published in September 1998 explains the torturous labyrinthine pattern of the withholding of these records since the Warren Commission Report of 1964 first released some of them.(34)  In 2017, all those who were of the age of majority,18, on the date of the assassination, will be 72 years old.  Almost all the witnesses to the assassination will be dead. The government’s withholding vital information about major events which shape Americans’ daily lives throughout their lifetimes, has forced them to live in shadowy ignorance, which fuels fear, anger and a justified suspicion of all things governmental.

Does the United States government conduct classified human experiments on its citizens today?  Is Chiron Corporation involved in conducting them?  Is consent of the subjects of these classified experiments obtained in accordance with the Nuremburg Code?  The short answer: Americans do not know and may not in their lifetimes.  During the Clinton administration, rules were not formulated regarding classified human experiments. After 9/11, President George W. Bush gave the Secretary of Health and Human Services the power to classify such information.

Peter Hardin, in the his article, The ethics of experiments; Scholars fear post-attack secrecy, Richmond Times Dispatch, March 3, 2002 wrote, in part:(35):

Reckoning with a biological attack at home and the war on terrorism overseas, the U.S. government has invoked new tools for secrecy.

In this climate, the government is likely in the future to conduct secret, classified research on human subjects, a Virginia scholar warned last week, and not all the proper protections are in place.

"It borders on the scandalous that we still don't have rules in place that would at least begin to protect the people who are in those trials," cautioned Jonathan D. Moreno, director of the Center for Biomedical Ethics at the University of Virginia.

At a forum on bioterrorism and bioethics in the wake of the Sept. 11 terrorist attacks, officials highlighted a World War II-era hepatitis study on children and adults at a Virginia asylum.

The research was carried out by federal scientists at the Lynchburg State Colony in order to fix a flawed vaccine given to soldiers. That study involved tough ethical questions worthy of review today, said Paul A. Lombardo, director of the U. Va. center's program in law and medicine.

The conference, with an audience from government, industry and academia, was sponsored by the U. Va. center and the Center for Bioethics at the University of Pennsylvania.

Moreno pointed to a December news report that President Bush had given the secretary of health and human services the authority to classify information as secret. Moreno said that could allow the Defense Department or CIA to undertake secret human experiments with the HHS.

In 1995, President Clinton's Advisory Committee on Human Radiation Experiments recommended conditions for the rare circumstances in which the government conducts classified human experiments, but the rules still are not in place, said Moreno, who was a senior staff aide to the panel.

New priorities for the nation might dampen the public challenging of research practices, he said in an academic paper.

Federal scientists justified experimentation on patients at the Lynchburg Colony in 1942 because they judged the search for a safe yellow fever vaccine "of utmost national urgency," Lombardo noted. He drew from a November article in The Richmond Times-Dispatch.

A flawed vaccine had been contaminated with the hepatitis B virus. It sickened tens of thousands of soldiers and killed 100. At Lynchburg, the researchers used the faulty vaccine and other material to inoculate patients in what Lombardo called an "absolutely secret" study with an "absolutely vulnerable" group of people.

Such research, shielded from public view and obscured by "the fog of war, inevitably reminds us of the sometimes troubling combinations of a vulnerable population, official secrecy, terror of war and fear of disease, all happening at the same time," he said….

The fact that there is no law inhibiting the United State government itself from conducting classified human experiments on its citizens, shows the power of the web of nightmares woven by the practitioners of quasi-legal, illegal, and outright Nazi-type human experimentation.  This is the web spun by the spider of biological terrorism and her mother, the mother of all wars, profiteering, and this spider is friend to no one and has no friends.  That spider makes supper of the Nuremberg Code, let alone any persons or population craves, any chance she gets.

Is Chiron such a spider?

First a test tube sample of Chiron’s current dilemma must be obtained. How did a couple of bugs in England almost take down a corporation?  The sample obtained must be analyzed a little in order to answer questions falling like bombs all around Chiron.  Will its stock hold up or dive?  Will it continue to make vaccines? Can its executives escape the big house?  Will the U.S. government buy its Fluvirin vaccine for the next flu season or the one after that or even buy its new experimental influenza vaccine grown by a method that grows strains within clones of a 1980s-era dog kidney cell?(20)  Will the U.S. continue to buy other Chiron vaccines and any of its new vaccines?  It seems the specimen in this test tube straight from Chiron is an opaque dilemma!  Perhaps a deep dig into Chiron’s deep shadowy past in Emeryville will reveal the formation of its true corporate character which made it what it is today.  In particular, Chiron’s machinations in the United States District Court, Northern District of California, the San Francisco and Oakland divisions, are telling.  Finally, Chiron executives’ experience with illegal human experimentation must be noted with due diligence.

by Kathryn Joanne Dixon © 4/11/05


FOOTNOTES

1.  Stephen Spotswood, NIAID Researching, Predicting The Future Of Flu, U.S. Medicine, December 2004, Url: http://www.usmedicine.com/article.cfm?articleID=996&issueID=69

2.  Marilynn Marchione, “Flu-shot factory operates with biological precision” Associated Press, October 24, 2004.

3.  Jeannie Whalen, Pui-Wing Tam of the San Francisco Chronicle and  Sarah Lueck of the Wall Street Journal, Betsy McKay,  “Behind flu-vaccine shortage: Struggle to police drug industry globally,” Associated Press, San Francisco Chronicle, November 5, 2005, Url:
http://sfgate.com/cgi-in/article.cgi?file=/news/archive/2004/11/05/financial0931EST0037.DTL

4.  Netdoctor.co.uk,  “Fluvirin. How does it work?”  Url: http://www.netdoctor.co.uk/medicines/100003068.html

5.  David V. Cohn, Ph.D. University of Louisville,  “An Inquiry Into the Causes and Effects of the Variolae Vaccine (Jenner - 1798)”, Foundersofsicence.net, Url: http://www.foundersofscience.net/jenner.htm

6.  Food and Drug Administration, “Thimerosol in vaccines,” FDA website, 2005, Url: http://www.fda.gov/cber/vaccine/thimerosal.htm

7.  Chiron Corporation, “Important Safety Information for Fluvirin® Influenza Virus Vaccine Chiron Corporation website, 2005,
Url: http://www.chiron.com/products/vaccines/fluvaccines/fluvirin.html

8.  Harold Eddleman, Ph.D., Microbiology - The Study of Microbes. What Are Bacteria? Indiana Biolab, January 23, 1988, Url: http://www.disknet.com/indiana_biolab/b003.htm

9.  Paul Jacobs, “How Flu Vaccine Was Contaminated” and “What Chiron Knew”, San Jose Mercury News, November 20, 2004, Url: http://www.mercurynews.com/mld/mercurynews/business/10231662.htm

10.  Curriculumonline, “People and Medicine. Bacteria”, School Science, 2005
Url: http://www.schoolscience.co.uk/content/4/biology/glaxo/pm2inf1.html

11.  Rep. Henry A. Waxman, “Letter to Democratic Members of the Government Reform Committee re: Summary of FDA Documents”, November 17, 2004.

12.  FDA Center for Biologics Evaluation and research (updated March 21, 2005), “Thimerosal, Mercury in Plasma Derived Products” FDA website, Url: http://www.fda.gov/cber/vaccine/thimerosal.htm

13.  Sabin Russell, “6 million Doses of Suspected Vaccine in U.S. Warehouses Quarantined since August Pending Tests”, San Francisco Chronicle, October 7, 2004
Url: http://sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/10/07/MNG31952VC1.DTL

14.  Medicine and Healthcare Products Regulatory Agency, “Monitoring the safety and quality of medicines: Vaccine safety.”, MHRA website, 2005, Url: http://medicines.mhra.gov.uk/ourwork/monitorsafequalmed/vaccinesafety/vaccinesafety.htm

15.  Orange County Register News Service, “Vaccine maker slices profit forecast in half”, Orange County Register, October 6, 2004, Url: http://www.ocregister.com/ocr/2004/10/06/sections/business/business/article_265078.php

16.  Paul Jacobs, Deborah Lohse, Llisas Krieger, “Vaccine plant had history of problems”, San Jose Mercury News, November 7, 2004.

17.  Donald Hausler, “The Incorporation of Emeryville”, Journal of the Emeryville Historical Society, Volume VII, Number 4,  Winter 1996, pps. 4-8.

18.  Nancy Smith, “Emeryville’s ‘Chinese Lotteries’, Journal of the Emeryville Historical Society, Volume III, Number 1,  March 1992, pps. 10-11.

19.  Fred Gardner, “The flu vaccine question”, Counterpunch, October 16, 2004, Url: http://www.counterpunch.org/gardner10162004.html

20.  Zina Moukheiber, “Broken Eggs”, Forbes, November 1, 2004, Url: http://www.forbes.com/global/2004/1101/032_print.html

21.  U.S. State Department, “Fact sheet” dated July 31, 2002, website immigrationlinks.com Url: http://www.immigrationlinks.com/news/news1498.htm

22.  Jennifer Leaning,  “War Crimes and Medical Science”, British Medical Journal, December 7, 1996, 313:1413-1415. Url: http://bmj.bmjjournals.com/cgi/content/full/313/7070/1413

23.  Principles of the Nuremberg Tribunal, Source: Url: http://deoxy.org/wc/wc-nurem.htm

24.  Wikipedia, “The Geneva Convention”, March 5, 2005, Url: http://en.wikipedia.org/wiki/Geneva_Convention

25.  From the Indictment, [from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. Nuremberg, October 1946–April 1949. Washington, D.C.: U.S. G.P.O,
1949–1953, Source United States Holocaust Museum,
Url: http://www.ushmm.org/research/doctors/indict.htm

26.  Arthur L. Caplan, Glenn McGee, “Bioethics for Beginners”, Bioethicsnet, 2005,
Url:
http://www.bioethics.net/articles.php?viewCat=3&articleId=6

27.  National Institute of Health, “Role of the NIH’s IRBs”,  NIH Website, 2005,
Url:
http://ohsr.od.nih.gov/info/sheet3.html

28.  Reuters, “Bush Signs Law on Release of CIA-Nazi Documents”, Wired.com, March 25, 2005 Url: http://wireservice.wired.com/wired/story.asp?section=Breaking&storyId=1009706&tw=wn_wire_story

29.  Michael Isikoff, “Memos Reveal Crimes Warnings”, Newsweek, May 19, 2004, Url:  http://msnbc.msn.com/id/4999734/site/newsweek/

30.  Associated Press, “Doctors a part of Iraq abuse”, August 20, 2004, Url: http://www.military.com/NewsContent/0,13319,FL_doctors_082004,00.html

31. Mark Sherman, “Anthrax attacks still unsolved years later”, Associated Press, March 18, 2005 Url: http://abcnews.go.com/US/wireStory?id=593906&page=1

32.  Ben Fenton, “The Russians knew West’s germ warfare secrets”, The Telegraph, December 2, 2005 Url: http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2005/02/12/nspies12.xml

33.  Assassinations Record Review Board, “Formal Determinations, Additional Releases and Corrections”, 
Federal Register: October 6, 1998 (Volume 63, Number 193, Notices, Pages 53640-53641, 
Federal Register Online, Url: wais.access.gpo.gov.

34.  Final Report of the Assassination Records Review Board,, Chapter 1, the Problem of Secrecy and the JFK Act, September 1998, Url: http://www.fas.org/sgp/advisory/arrb98/part01.htm

35.  Peter Hardin, “The ethics of experiments; Scholars fear post-attack secrecy”, Richmond Times Dispatch, March 3, 2002. 

The End