----- Original Message -----
From: "PROVE" <newsletter@...>
Sent: Monday, August 30, 2004 22:58
Subject: [PROVE] Cross Over Point and MMR, Problems at Chiron and Tainted
Flu Shot


[PROVE Note: Thanks to Gary Krasner of CFIC for finding and forwarding this
commentary by Michelle Malkin posted on one of her blogs. She is a widely
respected syndicated columnist - if you have a chance, write to her and
thank her for this piece at malkin@.... As Gary pointed out, we
need good people who have the courage to question the status quo and
encouraging journalists who aren't afraid to speak out against vaccine
policies that hurt people, is a good thing. Additionally, read below to see
the article she is referencing and below that to read about 50 million doses
of this years' flu vaccine made by Chiron being contaminated. It is
interesting to note that Chiron was one of the vaccine manufacturers
fighting legislation in California that would ban mercury in vaccines for
pregnant women and children.]


http://michellemalkin.com/archives/000454.htm

MMR VACCINE PROBLEMS IN BRAZIL
By Michelle Malkin • August 28, 2004 05:01 AM

Lawrence Altman of the New York Times reports that Brazilian health
officials have stopped using Chiron's vaccine against measles, mumps and
rubella after "an unexpectedly high number of children who received it
experienced serious allergic reactions in an immunization program last week.
The reactions included rashes and anaphylactic shock, a potentially fatal
allergic condition." At least 125 children experienced the reactions.

The experience in Brazil offers lessons here in the U.S. While scientific
studies have not established a link between MMR and autism, other side
effects from MMR are well documented. Even pro-vaccination organizations
acknowledge this. Meanwhile, measles, mumps and rubella are extremely rare
in the U.S. These diseases usually do not lead to horrible adverse health
outcomes.

Of course, vaccination is primarily responsible for the low incidence rates.
There is no question that it is in society's interest to have a high
vaccination rate. Any parent who is interested in doing what is best for
society should make sure his or her child gets the MMR vaccine. But the
interests of society and the individual sometimes diverge.

Dr. Eugene Robin, who before his death was a professor at Stanford
University's School of Medicine, provided some reflections on the vaccine
benefit/risk tradeoff here. An excerpt:

[I]n the case of vaccines, there is another problem, the shifting of the
ratio of number of cases of the given disease to the complications caused by
the vaccine. This process can be called the cross-over point and can be
illustrated as follows. Consider that a highly effective vaccine becomes
available and as a result, with the passage of time, there is a progressive
decrease in the incidence of the disease and, thus, in the mortality and
other complications associated with the disease. However, all things being
equal, the percent of adverse events (complications) associated with the
vaccine remains constant.

A point will be reached, the cross over point, where the complication rate
of the vaccine for individual patients will be higher than the adverse
effects of the disease. At this point, for individuals, the wise thing might
be to refuse the vaccine.

I can't speak to the risk/benefit tradeoff in Brazil, but if you live in the
U.S., the risk of experiencing serious side effects from MMR exceeds the
risk of a serious adverse health outcome from mumps, measles, or rubella.

============================
http://www.nytimes.com/2004/08/28/national/28flu.html

August 28, 2004
Company Is Investigating Possible Vaccine Problems in Brazil
By LAWRENCE K. ALTMAN
New York Times

A day after the Chiron Corporation said it was delaying release of its
influenza vaccine in this country because some lots were contaminated, the
company confirmed that it was investigating possible problems with use of a
different vaccine in Brazil.

Brazilian health officials stopped the use of Chiron's triple vaccine
against measles, mumps and rubella, often referred to as MMR, after an
unexpectedly high number of children who received it experienced serious
allergic reactions in an immunization program last week. The reactions
included rashes and anaphylactic shock, a potentially fatal allergic
condition. There were no deaths reported.

Chiron and Brazilian health officials are investigating the cases of at
least 125 children who experienced the reactions.

The vaccine problems raise concern because Chiron, the world's fifth-largest
vaccine manufacturer, is under contract with the United States government to
produce pilot supplies of human vaccines against two strains of avian
influenza, which has spread widely in Asia. The pilot vaccines are needed
because health officials around the world have expressed fears that in a
worst-case scenario, the avian strains could mutate to cause a human
pandemic.

The rates of adverse reactions were significantly higher among the children
receiving the Chiron vaccine, which is made in Italy, than among children
who received a vaccine made by another company, the Brazilian representative
of the Pan American Health Organization said. The organization, part of the
World Health Organization, supplies the vaccine.

"But the situation remains unclear," said a spokeswoman for Chiron, Alison
Marquiss, because full information was not available to determine whether
the reactions were due to the vaccine, to monitoring or to other issues.

Chiron's vaccine against the three childhood diseases is sold in Italy, Asia
and South America, but not in the United States, said Ms. Marquiss. She said
the episode in Brazil was the first time any problems had been reported from
Chiron's MMR vaccine.

Although a link between Chiron's vaccine and the reactions has not been
proved, Ms. Marquiss said that "generally speaking, when a vaccine is
quarantined in this fashion it is unlikely to return to the Brazilian
market."

In recent years, health officials in the United States and elsewhere have
had to deal with delays in distributing influenza vaccines and shortages in
the amount that could be manufactured because of production problems.

Safety tests of the pilot human avian flu vaccines are expected to begin in
this country next winter, said Dr. Anthony S. Fauci, the director of the
National Institute of Allergy and Infectious Diseases, the federal agency in
Bethesda, Md. It has contracted with Chiron, which is based in Emeryville,
Calif., and another company, Aventis, for the pilot vaccines.

Making vaccines "is a very tenuous field and these kinds of things come up
all the time," Dr. Fauci said.

How the company involved responds in such situations is crucial, Dr. Fauci
said, adding that he believes Chiron "is one of the groups that can respond"
because they are forthcoming and have the technological and scientific
skills to overcome such obstacles.

================================
http://www.nytimes.com/aponline/national/AP-Tainted-Flu-Vaccine.html
The New York Times
August 27, 2004

A Big Maker of Flu Shots Finds Some Contaminated By LAWRENCE K. ALTMAN

The Chiron Corporation, a major manufacturer of influenza vaccine, said
yesterday that it had detected a contamination problem in its new supply and
was delaying release of nearly 50 million doses until scientists could
determine the cause.

Chiron makes about half the 100-million-dose supply that federal health
officials expected to be used this flu season. Its chief executive, Howard
Pien, said in a telephone interview that it informed the Food and Drug
Administration and the Centers for Disease Control and Prevention about the
problem on Wednesday. Other than a relatively small amount sent to
distributors in July, Mr. Pien said, the company will probably not begin
issuing the vaccine until mid-October, about a month later than expected.

Chiron's disclosure to the government agencies came on the very day the Bush
administration released the nation's first plan of preparation and response
involving the next pandemic of influenza. In that plan, still in draft form,
the government underscores a need to help industry improve the production of
influenza vaccines for the ordinary seasonal outbreaks as well as for a
pandemic.

Dr. Julie L. Gerberding, the director of the disease control centers, said
Chiron's contamination problem was "not good news," in part because the
usual October flu immunization clinics may need to be postponed until
November.

But given what Chiron has told her, Dr. Gerberding said in a phone
interview, "at this point we don't anticipate an overall shortage.'' As a
result of that expectation, she added, the C.D.C. is not now changing its
recommendations as to who should be immunized.

There are 185 million Americans who ought to be immunized under this year's
recommendations, which, for the first time, advocate giving the vaccine -
two doses, in fact - to all infants from 6 months to 23 months.

In a usual flu vaccination season, most shots are given by Thanksgiving. But
a number of public health experts expressed concern yesterday that the delay
caused by the Chiron problem would complicate such efforts, because they
require considerable planning. The experts said they worried that Chiron was
offering a best case.

"It's a mess," said Dr. William Schaffner, chief of preventive medicine at
Vanderbilt University. "This will lead to striking disparities in flu
vaccine availability around Your Town, U.S.A.''

"If anything,'' Dr. Schaffner said, "this emphasizes the importance of the
pandemic plan and the need for more vaccine manufacturers and new
immunization techniques.''

Mr. Pien, Chiron's chief executive, said he did not foresee a widespread
problem for his company's product, Fluvirin, because, he said, only 8 of 60
batches tested so far have failed to meet the manufacturer's sterility
specifications.

"This should have a minimum impact on the American population," he said.

Nevertheless, "no assurances can be given that additional tests on Fluvirin
will yield satisfactory results or that Chiron will be able to release
Fluvirin this season," the company said in a news release.

Chiron (pronounced KY-rohn), based in Emeryville, Calif., outside Oakland,
manufactures the vaccine in Liverpool, England. Its quality controls cover a
wide range of tests, said Mr. Pien, who declined to specify which of those
the eight contaminated Fluvirin batches had failed. He said the
contamination was biological in nature and possibly due to human error, but
again would not be more specific.

The four million doses in the eight batches will be destroyed, Mr. Pien
said. He said that though Chiron shipped the first one million doses of
Fluvirin to distributors in July, they had not been distributed to doctors
and clinics.

Mr. Pien said he thought the company would be able to release the rest of
its full complement - from 46 million to 48 million doses - by mid-October.
Though that would be about a month later than expected, he said, it would
still be in time to meet public health needs for this influenza season.

Chiron is manufacturing about 25 percent more vaccine than it produced last
season.

A second major manufacturer, Aventis, said it was ahead of schedule in
producing more than 50 million doses. A spokesman for the company said it
was surprised by Chiron's announcement and planned to determine whether
Aventis could make more vaccine and, if so, how soon.

A third manufacturer, Medimmune, plans to manufacture from one million to
two million doses of its FluMist, an influenza vaccine that is sprayed into
the nose.

Denise Grady contributed reporting for this article.


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