Serratia is normally not harmful to healthy people but it is what is known as
an opportunistic pathogen. Given the opportunity, Serratia can spell trouble.
In people with a compromised (weakened) immune system, Serratia can
cause infection of the blood (sepsis), wound infections, and infections of
the endocardium (of the heart) and the urinary and respiratory tracts.
And part of the problem is that the high-risk groups for the flu who most
need the flu vaccine are precisely those with a weakened immune system.
Another part of the problem is that the finding of Serratia in the vaccine is
a red flag, It is a warning that who knows what else may be contaminating the
vaccine.
NEW YORK - "Everyone is asking how the Chiron shut-down will affect
vaccination rates, but few are asking how this could have happened," says
David Kirby, author of the forthcoming book Evidence of Harm – Mercury
in Vaccines and the Autism Epidemic: A Medical Controversy, from St.
Martin’s Press. Kirby is also a contributor to the health and science
pages of The New York Times and other publications.
This week, Chiron’s Fluvirin vaccine was pulled after the potentially
dangerous serratia bacteria was found in some lots. "Chiron used the
mercury-based preservative thimerosal as a sterilizing agent in making
Fluvirin, to prevent exactly this type of contamination,” says Kirby,
whose book explores the
possibility that thimerosal could have contributed to the rising
numbers of cases of autism, ADD and other childhood disorders.
“Thimerosal is also used as a preservative in multi-dose vials. By
definition, no thimerosal-containing solution should have live bacteria
present in its final formula.”
Thimerosal, Kirby adds, “has never been proven to be 100% safe, and now
we see again that it is not 100% effective either.” A law to ban
thimerosal in childhood vaccines was just signed by California Governor
Arnold Schwarzenegger.
Vaccine making is nasty business, and microorganisms thrive in the warm
egg-based brew used to produce the flu shot. The microbe-rich solution is
treated with thimerosal, as a sterilizing agent, to kill all the bugs. Most
mercury is removed before packaging, though 25 micrograms-per-dose remain in
each 10-dose vial, to avoid contamination from repeated puncture of the
seal by syringes.
This vaccine was contaminated with serratia at the
company’s factory in Liverpool, England. “But with so much thimerosal
in the mix, how was the bacteria able to survive?” Kirby asks.
Thimerosal, it seems, is not a perfect preservative. In 1982, an FDA
panel reported that thimerosal only prevents the growth of new bacteria
rather than killing all the organisms altogether. It said mercury-based
preservatives should be removed from topical products, and proposed
that thimerosal was “not generally recognized as safe and effective.”
In fact, thimerosal was singled out as being “no better than water in
protecting mice from fatal streptococcal infection.” And it was 35.3 times
more toxic for embryonic chick heart tissue than for Staphylococcus aureus.
Other studies found that up to 26 percent of the population was
hypersensitive to thimerosal. Fluvirin’s package insert warns that it should
not be given to “ anyone with a history of hypersensitivity to any component
of the vaccine, including thimerosal.”
“This raises some troubling questions,” Kirby says. “If thimerosal
doesn’t work, why are we using it? And why did it take the British Government
to intervene on behalf of the safety of Americans? Now we face an imminent
flu season with only half the vaccine needed. Millions will go unvaccinated
and
people could die because thimerosal failed to perform its job.
Government and industry must work to develop a safe AND effective way
of making flu vaccine.”
NEW BOOK EXPLORES LINKS BETWEEN MERCURY IN VACCINES AND AUTISM, ADHD
AND
OTHER CHILDHOOD DISORDERS
NEW YORK – Did mercury in vaccines cause an epidemic of autism, ADD,
ADHD, speech delay and other childhood disorders? A new book, to be
released by St. Martin’s Press in Winter, 2005, explores this chilling
possibility -- and the heated controversy swirling around it. The book,
Evidence of Harm, Mercury in Vaccines and the Autism Epidemic: A Medical
Controversy, was written by New York Times contributor David Kirby.
By most accounts, autism is now epidemic in the United States. In the
1990’ s reported autism cases among American children began spiking, from
about 1 in 10,000 children in 1987 to a shocking 1 in 166 today. In this
period, new shots containing a mercury-based preservative called Thimerosal
were added to the nation’s already crowded vaccination schedule. Meanwhile,
some parents noticed that their healthy children were descending into
silent, disturbed, and physically ill behavior after receiving vaccinations.
In 1999, the FDA announced that children were being exposed to mercury at
very young ages at levels far exceeding federal regulations, but the public
health establishment failed to take parental concerns about the impact
seriously.
Evidence of Harm explores both sides of this controversy, which has
pitted families and their allies against the federal government, public
health agencies, medical academies, and powerful pharmaceutical giants. It
examines:
Story of Thimerosal: a mercury-based additive approved by the FDA in
the 1930’s as a vaccine preservative and never subsequently tested by
the Agency Increase in reported autism cases and apparent parallel to the
increase in number and frequency of Thimerosal-containing vaccinations in the
1990s. Private meeting at which FDA, CDC, medical and pharmaceutical
company representatives discussed data on neurological childhood
disorders related to mercury in vaccines
Mysterious rider to the 2002 Homeland Security bill which would free
drug companies of liability in lawsuits regarding Thimerosal State and
federal lawsuits filed by families against the drug makers
seeking compensation for the lifelong care of their ill children
New biological research indicating a direct link between Thimerosal exposure
and neurological disorders Preliminary Federal investigations currently
underway into allegations of fraud, malfeasance, and conflict of interest at
pharmaceutical companies and among officials at the FDA and CDC
Recently discovered CDC data showing a shockingly high correlation between
Thimerosal exposure and autism, ADD and other childhood disorders This
disturbing, important book examines both the personal stories of families and
the unfolding political drama in the courts and halls of Congress.
DAVID KIRBY has been a contributor to The New York Times for seven
years, where he writes science and health articles for Science Times,
among other things, and has been a writer in this field for over fifteen
years. He lives in Brooklyn, New York.
Tainted flu vaccine could have been a health nightmare Bacteria used in 1950
germ-warfare test in Bay Area can be deadly --and target groups for shots
would be most susceptible
Bernadette Tansey, Chronicle Staff Writer
Sunday, October 31, 2004
Americans may never know how close a Bay Area company came to
distributing a bacteria-tainted flu vaccine, or how much of that vaccine was
contaminated. What is known is that the bacteria that ruined the stockpile of
vaccine produced by Chiron Corp. was used in a secret germ-warfare experiment
in the Bay Area conducted by the Army and was tied to three deaths in Contra
Costa County in 2001.
The bacteria -- which tainted about half of the nation's flu vaccine supply
-- was once considered a harmless microbe. But a 1950experiment, in which a
ship off the San Francisco coast let loose clouds of Serratia marcescens to
test whether an enemy could launch a biological warfare attack from a
distance, is now suspected of causing a cluster of hard-to-treat infections.
Experts say the serratia bacteria can trigger a cascade oflife-threatening
illnesses, including heart-valve infections, pneumonia and septic shock when
injected into vulnerable patients. The bacterium was blamed for a
deadly outbreak of meningitis in Contra Costa County in 2001, which was
traced to injected drugs legally mixed by a Walnut Creek pharmacy.
British regulators pulled the license of Chiron's factory in Liverpool on
Oct. 5 after discovering vaccine tainted with serratia. There had been
problems with sterility at the plant, which Chiron insisted were confined to
a small fraction of the vaccine's inventory. The company was preparing to
ship at least 46 million doses of its product, Fluvirin, to U.S.
distributors.
Officials at Chiron, which is based in Emeryville, and the Food and Drug
Administration have yet to provide details about how the bacteria infiltrated
the vaccine at Chiron's British manufacturing plant. Nor have they revealed
how much of the live bacteria or its dangerous toxins were found in the huge
inventory of vaccine doses.
What is known is that serratia can be deadly.
If distributed nationwide, a flu vaccine contaminated withserratia would
become a highly efficient vehicle to deliver thedangerous microbe into the
bodies of people most susceptible to itseffects -- the old, the sick, those
with weakened immune systems andsmall children. That's the very population
most strongly urged byhealth authorities to get a flu shot.
"If you injected it, you'd get bacteremia and sepsis, especially in the
people most likely to get the vaccine, said Mary York, a Walnut Creek
consultant and former director of microbiology at UCSF. "It would be
horrible."
People exposed to the bacteria in the air or water are unlikely to become
ill. But injecting it into fragile patients is a different matter. The
illnesses that could result would be hard to treat because serratia has a
genetic knack for quickly developing resistance to antibiotics, said Dr. Lee
Riley, a professor of infectious disease at UC Berkeley.
The organism is now known to be a frequent culprit behindoutbreaks of
infection in hospital patients, who often undergo invasiveprocedures such as
surgery,
intravenous fluid drips and injections,which could help microbes penetrate
the bloodstream.
How long it would take to discover that a flu vaccine nationally administered
to millions of people was contaminated with serratia -- and how many would
become infected and sickened before the program was stopped -- is a question
that, fortunately, remains unanswered. If the contaminated vaccine had been
shipped and injected, doctors might start to pick up signs like swelling and
redness at the site of the flu shot, said Dr. Suzanne Bradley, an infectious
disease specialist at the University of Michigan Medical School.
"For most of us, we'd probably fight it off and say, 'I'm never going to get
this vaccine again,' " she said.
But in the more vulnerable patients, like the elderly with underlying medical
problems, serratia could multiply in the heart valves and spread to the
lungs, causing pneumonia, said UC Berkeley's Riley. "Such a person could
potentially die," said Riley. "Even if you had one single case like that, it
could be devastating." The aggressive treatment often needed to control a
serratia infection also has its risks, said Riley.
"As a treatment of last resort, you have to use multiple drugs,"Riley said.
But a prolonged course of combined antibiotics would exposepatients to the
further danger of infection by fungal growths, he said."Treatment becomes
very,
very difficult."
How serious and how widespread the health damage might be from such a
contaminated flu vaccine would depend on how many of the live germs, or the
toxins from its cell walls, had managed to infiltrate each vaccine dose, said
the University of Michigan's Dr. Bradley. A sole bacterium might cause no
harm. However, one of serratia's other tricks is that it can keep
multiplying, even if the solution containing it is chilled.
"It grows in the refrigerator," said Mary York.
Flu shot shortageThe American health care system had planned to inoculate a
record100 million people against flu when British drug regulators blocked the
release of the 46 million flu vaccine doses made at the Liverpool plant of
Chiron Corp.
U.S. officials have replaced some of the lost vaccine, boosting available
doses to 61 million, and have attempted to reserve supplies for the most
vulnerable people -- the elderly, the ill and young children. The flu kills
36,000 people a year in the United States, primarily among high-risk groups.
Congress is investigating the quality of oversight of the Chiron plant by the
Food and Drug Administration. The Securities and Exchange Commission and
federal prosecutors also are investigating whether Chiron downplayed its
problem in public statements.
CDC medical ethicists are drafting guidelines for the fair allocation of
crucial drug supplies in case of future shortages --decisions now handled by
local health officials.
| BEIJING, Nov. 27 (Xinhuanet) -- A new set of
regulations taking effect Saturday will prohibit Chinese lab directors
from allowing experiments on risky pathogenic microbes without
approval.
The Chinese cabinet passed the 32-page and
72-item regulations in response to the incident in March when two
people were infected by severe acute respiratory syndrome (SARS) virus
at a lab of the Chinese Center for Disease Control and Prevention. China will grade its pathogenic microbe labs by
four levels. The first and second grades are labs forbidden to conduct
experiments on risky pathogenic microbes, which can cause severe
diseases in human and animals and easily spread, the regulations said.
The third and fourth grade of labs are off limits
for experiments without special certificates from the health and
veterinary medicine administrations, the regulations said. These labs also must get approval from the
administration when they plan to take up the experiments on risky
pathogenic microbe and report the result when the research ends, the
document added.
Early this year, the Diarrhea Virus Laboratory
under the Institute of Virus Diseases of the center did experiments
with the SARS virus without proper qualification and facilities to
prevent the virus from spreading. The administration found that the lab researchers
used an untested method to kill the SARS virus and did not test the
result of the process. This was later confirmed as the source of SARS
outbreak in China this year. The 2004 recurrence of SARS caused nine
people to fall ill and one death.
The director and deputy director of the center
resigned. The head and deputy head of the center's Institute of Virus
Diseases as well as director of the lab were dismissed in July. Now, according to the regulations, the head of
the institution that owns a lab and head of the lab will be dismissed
if a mistake like this happens again. The biosafety regulations were the first and most
authoritative one in China for medical labs, said an official with the
Ministry of Health Saturday.
"The ministries of Health, of Agriculture and of
Science and Technology all issued relevant documents and rules on this
aspect but no standardized one was issued," he said, "We are working on
an plan to implement the regulations." Gao Qiang, executive vice-minister of health,
said early July that strengthening lab biosafety is an important and
urgent task for the national health system. "The March outbreak sounds the alarm for the
nation's lab safety management," Gao said. "The necessary punishment
for some cadres is to help consolidate the responsibility awareness for
relevant officials and establish a responsibility system for
majoraccidents."
The regulations also ask medical labs to set up
special departments or personnel to supervise the facilities. The labs
must report to the superior administration if an accident takes place,
the regulations said. The first outbreak of SARS happened in early
spring 2003 and a total of 5,327 cases were reported that year in 24
provincial areas on the mainland. Nearly 350 people died of the
disease. The Ministry of Health issued a plan to prevent SARS and bird flu this winder and next spring early this month,
promising to send out experts within 24 hours after the first suspected
case is found.
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