by Virginia McCullough ©

America is living through a tragedy that has been created by another round of fear and paranoia generated from the Bush White House.  Senior citizens are lining up in hot weather, enduring long lines and dying when they could be waiting in the comfort of their own homes and protecting themselves from the stress generated by the hype in the headlines.  Major newspapers regurgitate the government line stating that death is a real possibility unless senior citizens and the very young submit to flu shots.  The big lie is the best lie and, like robots, the older men and women and parents of the very young line up and allow themselves to be injected with substances they really know nothing about - independent judgment replaced by fear generated by the PR paid for by the United States taxpayers.

What is being injected into their bodies?  Whom does the government rely upon when they urge their most vulnerable citizens to submit to inoculations that prevent a disease whose impact is questionable?   Is there any proof that these trusting senior citizens face a greater risk of illness and death if they do not submit to injections of unknown substances from unreliable companies,  than if they took their chances uninoculated?  In this election year, America's senior citizens and the parents of its youngest citizens, are entrusting their future to the American political leaders.  How are American political leaders protecting the most vulnerable citizens in the United States?  As politicians urge inoculation what responsible oversight have they put in place to protect their constituents?

As the highest elected official in the land, certainly President Bush can supply answers to these questions.  During the last debate moderator Bob Schieffer asked the President the following question, "Suddenly we find ourselves with a severe shortage of flu vaccine.  How did  that happen?"  President Bush, with a staff of thousands of researchers and public relations personnel at his disposal, gave the national audience the following answer, " Bob, we relied upon a company out of England to supply about half of the flu vaccines for the United States citizens and it turned out  the vaccine they were producing was contaminated.  And so we took the right action and didn't allow contaminated medicine into our country." (Click. The Flu Vaccine Question: How Bush Blew It by Fred Gardner, 10/16/04)

Was the President telling his fellow Americans the truth?  No!  His attempt to shift the responsibility for the current scandal from the United States to the United Kingdom was another lie to protect yet another incompetent company trying to peddle an untested, unproven product at the expense of the gullible public. Let's look at facts behind the fiction woven around Chiron, the company responsible for 2004's flu vaccine scandal.

Mr. President, Chiron is NOT "a company out of England."  Chiron  has been headquartered in Emeryville, California since its inception in 1981.  Emeryville is a small, politically powerful town that serves as the east end anchor for the Bay Bridge.  Featuring spectacular views of San Francisco directly across the bay,  Emeryville's history harkens back to California's gold rush days.  During that era Joseph S. Emery came to California.  He was a stone cutter who briefly visited the promising gold mines and then moved to the Bay Area.  He returned to his original profession quarrying rock on Angel and Goat Islands to build the spectacular buildings that constitute San Francisco's skyline.  In 1859 Emery moved his home to the East Bay and purchased 185 acres of land for $8,000.  Emery built San Pablo Avenue Horse Cart Railroad connecting Oakland to Emeryville.  He was also one of the group which organized the California-Nevada Railroad which began in Oakland and terminated in Orinda.

In l896 Emeryville became a full-fledged town, seat of big industrial enterprises and rail terminals.  Joseph Emery lived to see his home acreage grow from a tiny group of dwellings to a city bearing his name before his death in 1909.  He rests in the Mountain View Cemetery in the Oakland hills above his namesake city.

Emeryville was an integral part of the Barbary Coast and still retains its wild west spirit.  It is a city that is never far from the headlines.  If there is scandal  in the headlines, the dateline often reads: "Emeryville, California." (Click. Where is Emeryville, California? Why Should We Care? by Virginia McCullough)

During the 1960's Emeryville tried to clean up its image by beefing up its anti-gambling ordinances.  Exceptions were made, of course, so that gambling continued unabated in its infamous cardrooms where political deals were made behind closely guarded doors.

In the 1960's the Emeryville Peninsula was created by filling shallow water areas with demolition debris and it was sold in 1969, to Lathrop and Matthew H. McCloskey who developed the Watergate complex, a 1,249 unit apartment complex. 

In the mid 1970's Emeryville created parks and a 500 berth marina filling by in 7.8 acres of San Francisco Bay to create a small boat harbor.  During this same time frame multi-story office buildings rose located between the Eastshore Freeway and San Francisco Bay.

In 1976 the Emeryville Redevelopment Plan was adopted.  It was stated at the time that the Plan would enable Emeryville to expand its economic base and house stock while improving its physical environment.  Eleven years later the City of Emeryville adopted a second controversial plan called The Shellmound Park Redevelopment Plan, covering an additional 170 acres.  With these plans,  the growing city attracted big businesses and expanded its industrial base.  Chiron headquarters would eventually be located mostly in the Emeryville Redevelopment Plan with a small portion located in the Shellmound Redevelopment Plan.

Paralleling Emeryville's city expansion were "a series of  scientific discoveries in the mid-1970's that demonstrated that genetic material from two different sources could be spliced together and then continue to function.  Following these discoveries, expanded efforts in molecular biology, biochemistry, and supporting disciplines led several entrepreneurial scientists to view the expanded commercial potential of biology to agriculture, veterinary medicine, and human health care."  (City of  Emeryville, Chiron Development Plan EIR - February 14, 1995.)  This same report states that in response to these discoveries Drs. William Rutter, Edward Penhoet, and Pablo Valenzuela founded Chiron Corporation in 1981.  The company started small with 10 workers and had an initial goal to produce a vaccine against the hepatitis B virus.  Once that goal had been achieved the company  intended to expand to develop other products to diagnose, prevent, and treat human disease.

By 1995 Chiron  was enjoying moderate success with Betaseron, its groundbreaking drug used to treat a type of multiple sclerosis reducing its symptoms.  The drug had gained approval from the Food and Drug Administration (FDA) in July of 1993 and doctors were inundated with calls from patients seeking the drug.  The approval and subsequent demand catapulted Chiron into profitability and made it one of the largest biotechnology companies in the world.   Initially production could not meet demand and when Chiron and Betaseron's developer, Berlex Laboratories of Richmond, staged a lottery to determine which patients would be allowed to start treatment first, the public relations only increased the demand. 

Betaseron was administered through shots every other day and soon patients were complaining about unpleasant side affects.  Many  patients stopped treatment or did not start the shots.  In 1994 Betaseron accounted for $100 million of Chiron's $450 million in sales.  But the repercussions of the side effects dropped sales to $80 million in 1995 and Chiron's stock fell.  Chiron reacted by idling its Puerto Rico and Amsterdam plants because of the lower demand.

In the late summer of 1995 Chiron announced that they would move quickly to seek FDA approval  for a whooping cough vaccine that had been under development since 1983.  Cornelia Dekker, vice president of Chiron's Biocine Research stated that the successful of Chiron's vaccine, "solidifies our position in pediatric vaccines and it is a big part of our future strategy."  The vaccine is given in combination with diphtheria and tetanus vaccines at 2 months, 4 months and 6 months with booster shots given at 18 months and once again before kindergarten.  Chiron officials said that their product is superior to their competitors because it employs genetic engineering to inactivate the pertussis bacterium which the others use a chemical inactivation.

Optimism continued to be followed by pessimism as Chiron found itself in trouble with federal health officials once again.  Just after the first of the year in 1996 the FDA put the brakes on expanded clinical tests of Myotrophin, a drug made by Cephalon and marketed by Chiron.  Safety issues and disputes about the drug's effectiveness arose when a European trial showed much higher mortality rates for those patients taking the drug then for those patients taking a placebo.

Strong supporters of Chiron continued to point out that Chiron was used to these problems.  When other biotech companies would fail to get approval for drugs they had developed, Chiron would buy them out acquiring the technology, and it would continue to pursue FDA approval, often successfully.

So Chiron continued to grow through a series of acquisitions and  in house product development.  But Chiron's own consolidated financial statements  clearly stated  that "continued profitability of the company depends on the successful completion of  clinical trials and subsequent FDA approval for commercialization of additional vaccines, diagnostics and pharmaceuticals under development."

Then on Tuesday, October 5, 2004, came the shocking announcement by British regulators that they had suspended Chiron's license to produce the flu vaccine at its Liverpool plant after it found serratia bacteria in it. Click. "Caution wise if serum is contaminated"  Caught off guard and embarrassed, the FDA announced ten days later that "none of the influenza vaccine manufactured by Chiron is safe for use."  The contamination problem had first been publicized on August 25th.   Chiron's Chief Executive Officer Howard Pien told a congressional committee that the company would still be able to release 46 million to 48 million doses of the vaccine just one week before the British authorities pulled the company's license.  Dr. Lester Crawford, acting commissioner for the United States Food and Drug Administration finally admitted that the FDA had not communicated with British regulators about the contamination problem. The FDA had simply relied on information supplied to it  by Chiron, the company it was supposed to be regulating.

The in-house repercussions at Chiron were many.  Newly-appointed to Chiron's Board of Directors, Richard Wills, 49, Chief Executive Office of highly respected Tektronix Inc., an Oregon technology company, immediately resigned.  The stock market indicated Chiron's stock price dropped more then 28 percent.  Chiron's conduct and its communications with the British regulators and the FDA are now being examined by the Securities and Exchange Commission, a federal grand jury and Chiron's shareholders' attorneys.  It is possible that those involved might face criminal investigation in the future.

The American politicians and the American public deserve, at the very least, the answer to the following question: "What did Chiron and its officers know and when did they know it?"

Virginia McCullough © 20/18/04

Iowa scientist: Caution wise if serum is contaminated

by Tony Leys, staff writer, DesMoines Register, © October 8, 2004

The type of bacteria that reportedly contaminated millions of doses of flu vaccine could have caused serious trouble if spoiled vaccine had been injected into patients' arms, one of Iowa's top scientists said Thursday.

Dr. Mary Gilchrist, director of the University of Iowa Hygienic Laboratory, said she wasn't surprised to hear that Serratia
bacteria were being blamed for the problems. Serratia thrive in liquid, she said, and they are a common problem in hospitals. Some strains have become resistant to antibiotics. That could allow them to overcome precautions taken in the manufacturing and packaging of flu vaccine.

People often ingest Serratia bacteria from tainted food or beverages. That's rarely a major problem, Gilchrist said, because the human digestive system does a good job of flushing the germs out.

"They're not a terribly bad player, but having them injected right into your body is not something you would want to happen," she said. If the germs wound up in muscle tissue, they could cause serious infections.

Gilchrist said that if the serum is tainted with Serratia bacteria, British officials made the right call in withholding millions of doses.

She hopes the problem raises enthusiasm for developing better vaccine production methods.

The old techniques take months, which complicates annual efforts to formulate vaccines that match current flu viruses.

Faster, more modern methods also could be less susceptible to contamination by bacteria

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