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UPI Investigates: The vaccine
conflict
By Mark Benjamin
Investigations Editor
Published 7/20/2003 8:45 AM
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WASHINGTON, July 20 (UPI) -- The screaming
started four hours after 8-month-old Chaise Irons received a
vaccination against rotavirus, recommended in June 1998 by the
Centers for Disease Control and Prevention for every infant to
prevent serious diarrhea.
Within a day
he was vomiting and eliminating blood. Doctors performed emergency
surgery, saving him by repairing his intestines, which were folding
in on one another. A doctor later figured out the vaccine caused
Chaise's problem.
In October 1999,
after 15 reports of such incidents, the CDC withdrew its recommendation
for the vaccination -- not because of the problem, the agency
claims, but because bad publicity might give vaccines in general
a bad name.
But a four-month
investigation by United Press International found a pattern of
serious problems linked to vaccines recommended by the CDC --
and a web of close ties between the agency and the companies
that make vaccines.
Critics say
those ties are an unholy alliance in a war against disease where
vaccine side effects have damaged, hurt or killed people, mostly
children.
"The CDC is
a disgrace. It is a corrupt organization," said Stephen A. Sheller,
a Philadelphia attorney who has sued vaccine
makers for what he says were bad vaccines. "The drug companies
have them on their payroll."
The CDC, based
in Atlanta, said it is committed to fighting
disease and balancing vaccine side effects.
"Our goal is
to protect the public health from both disease and from serious
adverse events," said Dr. Walter Orenstein, director of the CDC's
National Immunization Program.
The agency sets
the U.S. childhood immunization schedule,
or the list of shots pediatricians give children. Some states
say kids can't go to public school unless they have had CDC-endorsed
vaccines.
Since the mid-1980s
the agency has doubled the number of vaccines children get, up
to nearly 40 doses before age 2. The CDC also tracks possible
side effects, along with the Food and Drug Administration. This
puts the agency in the awkward position of evaluating the safety
of its own recommendations.
An advisory
committee of outside experts helps the CDC make vaccine recommendations.
UPI found:
-- In two cases
in the past four years, vaccines endorsed by the CDC were pulled
off the market after a number of infants and adults appear to
have suffered devastating side effects, and some died. Critics
now worry about a possible link between vaccines and autism,
diabetes, asthma and sudden infant death syndrome, among other
ailments.
-- Members of
the CDC's Vaccine Advisory Committee get money from vaccine manufacturers.
Relationships have included: sharing a vaccine patent; owning
stock in a vaccine company; payments for research; getting money
to monitor manufacturer vaccine tests; and funding academic departments.
-- The CDC is
in the vaccine business. Under a 1980 law, the CDC currently
has 28 licensing agreements with companies and one university
for vaccines or vaccine-related products. It has eight ongoing
projects to collaborate on new vaccines.
The situation,
while legal, gives critics plenty of reason to worry that vaccine
side effects are worse than CDC officials say.
"When you take
a look at the ever-increasing numbers of doses of vaccines babies
have gotten over the past two decades and you see this corresponding
rise in chronic disease and disability in our children, it is
out of control," said Barbara Loe Fisher, president of the National
Vaccine Information Center, which does not accept money from
vaccine manufacturers.
She worries
that vaccines might be linked to ballooning rates of chronic
illness like autism, which has increased tenfold since the mid-1980s,
and asthma, which has more than doubled since 1980.
Fisher's group
wants to overhaul the mass vaccination system.
"The CDC has
a very hard time investigating in an unbiased way what is happening
to our children because of ideological and financial conflicts
of interest," she said. Fisher believes a vaccine injured her
son in the 1980s.
Developing a
vaccine can cost a half a billion dollars. A recommendation by
the CDC guarantees a market and a 1986 law limits manufacturers'
liability for side effects.
The annual global
market for vaccines is expected to go from $6 billion today to
$10 billion by 2006.
The CDC said
the best vaccine advisers often have ties to the industry, making
potential conflicts unavoidable. Agency officials review possible
conflicts.
"The issue of
safety is critical and you need people extremely knowledgeable
about safety to develop the best policy formulations," said Orenstein.
The agency has to weigh possible side effects against dangerous
disease. "We need to put safety data in context with risk-of-disease
data," he said.
The agency said
ethics officials also review partnerships with companies to make
new vaccines.
"Each one of
those proposed activities is reviewed by the CDC's ethics officials,
by our office of general counsel, and by me to make sure that
there are no conflicts of interest," said Dixie Snider, CDC associate
director for science.
Andrew Watkins,
director of the CDC's Technology Transfer Office, negotiates
licensing agreements with outside companies. He said agency scientists
routinely leave to work with vaccine manufacturers.
"It does happen
that some of our inventors end up working for a manufacturer," Watkins
said. "In fact, we consider that a wonderful tool of technology
transfer, although we do lose a good scientist."
But Watkins
said very little money actually changes hands, making it unlikely
to influence the CDC. He said companies, including vaccine makers,
only gave the CDC around $1 million last year to work on collaborative
projects and the agency only got $150,000 last year in licensing
fees.
"We are a real
cheap date," Watkins said.
Rep. Dan Burton,
R-Ind., who has been investigating vaccines for four years, said
conflicts at the CDC are a problem, particularly on the vaccine
advisory panel. He believes vaccines triggered his grandson's
autism.
"This presents
a real paradox when the CDC routinely allows scientists with
blatant conflicts of interest to serve on influential advisory
committees that make recommendations on new vaccines, as well
as policy matters," Burton told UPI. "All the while these
same scientists have financial ties, academic affiliations, and
other vested interests in the products and companies for which
they are supposed to be providing unbiased oversight."
Because of concern
over vaccine side effects, Congress in 1986 passed a law setting
up a database at the CDC to track reports from doctors, manufacturers
and the public of possible side effects from vaccines that started
in 1991.
As of the end
of last year, the system contained 244,424 total reports of
possible reactions to vaccines, including 99,145 emergency room
visits, 5,149 life-threatening reactions, 27,925 hospitalizations,
5,775 disabilities, and 5,309 deaths, according to data compiled
by Dr. Mark Geier, a vaccine researcher in Silver Spring, Md. The data represents roughly
1 billion doses of vaccines, according to Geier.
The reports
do not necessarily show that a vaccine caused a problem.
The pain of
Rotashield
The CDC's Advisory
Committee on Immunization Practices, ACIP, helps the agency decide
what vaccines are safe enough to recommend. It is made up of
12 experts from hospitals, universities and state health departments.
In June 1998,
the committee recommended that all infants be vaccinated against
rotavirus. The virus causes bad diarrhea that can be fatal.
At the time,
vaccine maker Wyeth had a vaccine called Rotashield. Merck hoped
to soon follow with its own version.
Wyeth ended
up pulling its vaccine off the U.S. market in October 1999 after
it was suspected of causing an excruciating contortion where
a child's large intestine folds over the small one.
Emergency surgery
is sometimes required to prevent death. That was the case with
8-month-old Chaise Irons.
"Chaise was
vomiting blood and blood was coming out of his stool," said his
mother, Jayne Irons, from her home in Malibu, Calif. Doctors performed emergency
surgery to repair Chaise's intestines, saving his life.
Jayne said she
never questioned her doctor's advice to give Chaise the vaccine. "I
had no reason to doubt anybody. I am such a believer in vaccinations," Irons
said.
The Irons' will
get $25,000 for Chaise's injuries from a government compensation
program.
For Rotashield,
the CDC's public database contains 664 total reports possibly
caused by the vaccine, including 288 emergency room visits, 63
life-threatening reactions, 232 hospitalizations, 10 disabilities
and eight deaths.
"Eight deaths," said
Jayne Irons. "You just have to thank God that you are not one
of the deaths."
Republican staff
on the House Government Reform Committee looked into the CDC
panel that recommended the vaccination. Their August 2001 report
found that "four out of eight CDC advisory committee members
who voted to approve guidelines for the rotavirus vaccine in
June 1998 had financial ties to pharmaceutical companies that
were developing different versions of the vaccine."
A transcript
from that June 1998 meeting shows the committee voted down an
effort by one member to phase in the vaccine because of concern
over possible bad side effects. "I'm still a little concerned
about the safety issues," Marie Griffin from Vanderbilt University said before that vote.
When asked,
members of the committee told UPI their potential conflicts do
not affect their judgment.
"I am probably
just the kind of person you are talking about," said Paul Offit,
chief of infectious diseases at the Children's Hospital of Philadelphia, who was a committee member
until last month. At the same time, he shared a patent for another
rotavirus vaccine. Merck has funded Offit's research for 13 years.
"I am a co-holder
of a patent for a (rotavirus) vaccine. If this vaccine were to
become a routinely recommended vaccine, I would make money off
of that," Offit said. "When I review safety data, am I biased?
That answer is really easy: absolutely not."
"Is there an
unholy alliance between the people who make recommendations about
vaccines and the vaccine manufacturers? The answer is no."
Merck bought
and delivers copies of Offit's book, "What Every Parent Should
Know About Vaccines," to American doctors. The book has a list
price of $14.95.
"Merck Vaccine
Division is pleased to present you with a copy of the recent
publication, 'What Every Parent Should Know About Vaccines,'" says
a Dear Doctor letter from Merck. "The authors designed the book
to answer questions parents have about vaccines and to dispel
misinformation about vaccines that sometimes appears in the public
media."
Offit said he
does not know how many copies of his book Merck purchased. "I
don't have any control over that," he said.
The 2001 Government
Reform Committee's investigation noted potential conflicts with
another committee member. The chairman of the CDC's Vaccine Advisory
Committee, Dartmouth Medical School Professor Dr. John Modlin,
owned $26,000 in Merck stock.
In a telephone
interview with UPI, Modlin said he had sold that stock, but that
he had recently agreed to chair a committee to oversee Merck
vaccine clinical trials. Modlin, who was the committee chairman
until last month, said he does not know how much compensation
he receives from that post, but that Merck "pays my expenses" to
attend meetings.
In October 1999,
the committee reversed its recommendation that all infants should
get rotavirus vaccinations. Modlin said the vaccine was safe
enough, but the committee reversed itself out of concern that
bad press over Rotashield might make some people stop getting
vaccinated altogether.
"There could
be some spill-over effects that would have a net negative effect," Modlin
said. "I thought that was the committee's finest hour."
Meeting transcripts
over the past decade showed that at some meetings, half of the
members present had potential conflicts with vaccine manufacturers.
The CDC said
that in October 2002 it adopted new guidelines for participating
on that advisory committee that in the future will preclude people
with conflicts like Offit's from sitting on the committee.
"We learned
from that experience (with rotavirus) and have now put in force
more stringent criteria recently so we do not nominate people
with those kinds of conflicts," said the CDC's Snider.
At the June
2002 committee meeting -- the last meeting for which minutes
are available -- four of the 11 members present acknowledged
conflicts with Wyeth, GlaxoSmithKline, Merck, Pfizer, Bayer and
Aventis Pasteur. Two of the four did research or vaccine trials
for manufacturers. One of the four was a co-holder of a vaccine
patent as well as a consultant to Merck.
At odds over
autism
At 8:05 a.m. on Monday, July 16, 2001,
a vaccine safety committee of the influential Institute of Medicine convened a public meeting
at the Charles Hotel in Cambridge, Mass.
The purpose:
to discuss whether CDC-recommended vaccines might be responsible
for a wave of autism and neurological problems in tens of thousands
of American children during the 1990s.
The concern:
most vaccines contained a mercury-based preservative
called thimerosal. Too much mercury has known toxic effects on
the brain.
Since the mid
1980s, the number of childhood vaccinations recommended by the
CDC had nearly doubled. The agency recommends nearly 40 doses
of vaccines for children today. Also since the mid-1980s the
autism rate in the United States had soared by 10 times to
an astonishing one child in every 300.
Cause and effect
or coincidence?
The vaccine
manufacturers deny any connection, but the Institute of Medicine -- part of the National Academy
of Sciences and a key adviser to the federal government on medical
concerns -- wanted to hear from Dr. Thomas Verstraeten, a CDC
expert on the issue.
When Verstraeten
appeared before the committee, he made a surprise opening statement.
"First, I should
mention that as of 8 a.m. European time I have been
employed by a vaccine manufacturer," Verstraeten told the panel,
according to a transcript. "That means since 2 a.m. American time," just hours
before he spoke on behalf of the CDC.
Verstraeten
had been working at the CDC on a study of 76,659 children to
determine if thimerosal might be causing neurological problems
like autism.
Signs of autism
usually show up around age 2. Sometimes children who had previously
appeared to interact normally will suddenly regress, become withdrawn
and stop responding to their parents and the outside world. They
may perform repetitive motions, like spinning or flapping their
arms, have seizures, scream uncontrollably and resist physical
touch.
Manufacturers
had used thimerosal, which contains ethyl-mercury, as a preservative
in multi-dose vials of vaccine. The vials allow needles to be
inserted repeatedly and the vaccine drawn out. The vials are
cheaper than packaging doses of vaccine separately, without thimerosal.
Depending on
what vaccines a child got during that period, a visit to the
doctor during the 1990's may have exposed some children to 125
times the limit on mercury set by the Environmental Protection
Agency.
A February 2000
draft of Verstraeten's study, obtained by United Press International,
appears to show that thimerosal might cause brain problems.
That draft cites "increasing
risks of neurological developmental disorders with increasing
cumulative exposure to thimerosal."
"We can state
that this analysis does not rule out that receipt of thimerosal-containing vaccine in children under
3 months of age may be related to an increased risk of neurologic
developmental disorders," the study said.
To discuss the
findings in Verstraeten's study, the CDC convened a meeting at
the Simpsonwood Retreat Center in Norcross, Ga., on June 7-8, 2000. The agency invited vaccine
experts and representatives of four vaccine manufacturers.
After discussing
that study, Dr. David Johnson, a Michigan state public health
officer advising the CDC on vaccines, said that the findings
were troubling, according to a transcript.
"My gut feeling?
It worries me enough," said Johnson. "I do not want (my) grandson
to get a thimerosal-containing vaccine until we know
better what is going on."
Later in the
same conversation, CDC officials agreed to keep the study private.
"We have been
privileged so far that given the sensitivity of information,
we have been able to manage to keep it out of, let's say, less
responsible hands," said Bob Chen, head of CDC's Vaccine
Safety and Development unit.
Dr. Roger Bernier,
who was then CDC's associate director for science, responded, "I
think if we will all just consider this embargoed information,
if I can use that term."
The CDC's Walter
Orenstein said the agency wanted to look hard at the study before
discussing it in public, not cover it up. The CDC never published
a study based on the data, but said it would soon.
GlaxoSmithKline
declined UPI's request to interview Verstraeten from Rixensart, Belgium, but Orenstein said Verstraeten
left the CDC to move back to Europe.
For Lara Bono
of Durham, N.C., the connection between vaccines
with thimerosal and her son's autism is obvious.
Bono said her
son Jackson began to change drastically
within days of receiving a group of thimerosal-containing vaccinations.
Bono says that
on Aug.
14, 1990,
four days after receiving the last of a group of shots, 16-month-old
Jackson was becoming withdrawn. Within two weeks he stopped responding
or acknowledging his parents. Two weeks after that Jackson no longer would make eye contact.
It soon became difficult to get Jackson to eat or sleep. He has had
bouts of spinning uncontrollably and seizures.
"Fast forward
another couple of months and he was gone. The mercury was in
his brain," Bono said.
Years later,
Bono discovered that at one point, Jackson's mercury exposure may have
been more than 40 times the limit set by the EPA. Nine years
later, Bono says, Jackson was diagnosed with mercury
poisoning she says came from the vaccines.
Boyd Haley,
chairman of the Chemistry Department at the University of Kentucky, has done studies that he
says show some children with autism do not excrete harmful mercury
from vaccines, but keep it in their bodies. He says the CDC knows
the vaccines the agency recommended may have harmed a generation
of children.
"I know that
they know and that is what bothers me more than anything else," Haley
said. "You can't do a study showing it (thimerosal) is safe.
It is just too damn toxic."
In June of 2000,
the agency's Vaccine Advisory Committee signed on to a statement
calling for the removal of thimerosal from vaccines "because
any potential risk from mercury is of concern."
"However, there
remains no convincing evidence of harm caused by low levels of
thimerosal in vaccines," the statement said.
In October 2001,
the Institute of Medicine panel that heard from Verstraeten
found that it is "biologically plausible" that thimerosal causes
autism, but that, "current scientific evidence neither proves
nor disproves a link."
To avoid any
conflict of interest, that panel specifically excludes "anyone
who had participated in research on vaccine safety, received
funding from vaccine manufacturers or their parent companies,
or served on Vaccine Advisory Committees."
Laid low by
Lyme vaccine
The rotavirus
recommendation is not the only controversial call made by the
CDC. Another involves a vaccine to fight Lyme disease, a tick-borne
illness that can cause profound fatigue, headache, fever and
severe muscle pain.
"It was after
the booster shot that I absolutely collapsed," said Lewis Bull,
a farmer from East
Lyme,
Conn. Bull, now 49, volunteered in 1996 to take shots during
a clinical study for a new vaccine to prevent Lyme disease developed
by SmithKline Beecham, now GlaxoSmithKline. Clinical studies
are tests on humans to make sure vaccines are safe and work before
going on the market.
In the study,
Bull first received placebo shots containing no vaccine and felt fine.
But soon after
his second shot of the real vaccine he began to suffer from debilitating
arthritis, memory loss and fatigue. Some doctors believe the
Lyme vaccine side effects mirror the disease itself.
"For the first
six months I could not get out of bed. The memory loss was incredible.
I've played guitar all my life and I could not remember how to
play guitar. I could not find the town hall and I used to go
there four times a week," he said in a recent telephone interview.
Bull said his
fatigue was so severe he would sleep for stretches of 22 hours
or more. Without medical insurance, Bull was forced to sell his
farm.
On Feb. 18, 1999, the CDC endorsed Lyme disease
vaccine for people age 15-70 who work or recreate in possible
tick-infested areas.
By October of
2000, more than 1.4 million people had received the vaccine,
according to the CDC.
But 19 months
later, in February 2002, SmithKline Beecham pulled the vaccine
off the market because "sales of LYMERIX are insufficient to
justify the continued investment."
The company
also faced hundreds lawsuits by people who said they suffered
side effects, many similar to Lewis Bull's.
Although he
never sued, Bull said he complained to the CDC to report what
he says were obvious side effects from the vaccine, called LYMERIX.
The government's
database of possible side effects for LYMERIX lists 640 emergency
room visits, 34 life-threatening reactions, 77 hospitalizations,
198 disabilities and six deaths after people took the shots since
the CDC endorsed it.
According to
CDC meeting transcripts where the advisory committee weighed
its recommendation, five of 10 committee members disclosed their
financial conflicts of interest with vaccine manufactures. Three
of the five had conflicts of interest with SmithKlineBeecham.
The committee
ignored a plea from a consumer advocate to delay a recommendation
on LYMERIX because it might not be safe, according to a February
1999 transcript.
"We are just
saying there is a wealth of information out there that is different
than the information you have been provided. I think the honorable
thing to do would be to wait," said Karen Vanderhoof-Forschner,
founder of the Lyme Disease Foundation, a patient's advocacy
group that eventually opposed the vaccine.
UPI found that
the CDC and SmithKline Beecham worked together on a Lyme vaccine.
A 1992 CDC activity report obtained by UPI says the agency
had an agreement "with SmithKline Beecham that currently funds
three positions at (the CDC) for the purpose of providing information
of use in developing advanced test methods and vaccine candidates."
In June 2001,
the General Accounting Office delivered a report to Sen. Chris
Dodd, D-Conn., on this issue. It says that CDC employees "are
listed on two Lyme-disease related patents" including "a 1993
joint patent between CDC and SmithKline Beecham Corporation." The
report also said that six of 12 consultants working for the CDC
on Lyme vaccines "reported at least one interest related to a
vaccine firm."
Do babies need
Hep B?
In 1991 the
CDC recommended that all infants get their first Hepatitis B
vaccination just hours after birth. The disease is mostly spread
from dirty needles and unprotected sex. It can create deadly
liver disease.
The vaccine
has been blamed for mysterious deaths following the shots, sometimes
filed as sudden infant death syndrome.
One is the Sept.
16, 1998,
death of Lyla Rose Belkin at age 5 weeks. She died 15 hours after
getting her second Hepatitis B vaccine booster shot.
Michael Belkin
said in a telephone interview from Seattle that his daughter was lively
and alert prior to receiving the shot. She became agitated and
noisy, suddenly fell asleep, and died 15 hours later. Belkin
said the coroner indicated that his daughter's brain was swollen;
a reaction some researchers believe could be caused by the vaccine.
"So in the CDC
and (the Vaccine Advisory Committee's) own words, almost every
newborn U.S. baby is now greeted on its entry into the world
by a vaccine injection against a sexually transmitted disease
for which the baby is not at risk -- because they couldn't get
the junkies, prostitutes, homosexuals and promiscuous heterosexuals
to take the vaccine," Belkin told a congressional panel on May
18, 1999.
"Parents need
to understand that the system providing the vaccines injected
into their children's veins is corrupt and scientifically flawed," Belkin
told UPI. "Parents should do their own homework and investigate
this question: What is the risk of getting a severe neurological
vaccine adverse reaction versus the risk of getting neurological
complications from the disease?"
The CDC's files
contain 32,731 total reports of possible
reactions following Hepatitis B vaccinations since 1991, including
10,915 emergency room visits, 685 life-threatening reactions,
3,700 hospitalizations, 1,200 disabilities and 618 deaths.
In October 2002,
the Institute of Medicine reported that the "evidence
is inadequate" to prove or disprove that some vaccines might
be behind some cases of SIDS, and called for more research.
The CDC says, "There
is no confirmed evidence which indicates that hepatitis B vaccine
can cause chronic illnesses."
Some of the
officials involved in the agency's 1991 decision to recommend
that all infants receive the Hepatitis B vaccine also had close
ties to vaccine manufacturers.
Dr. Sam Katz
was the advisory committee chairman at the time. A professor
at Duke, Katz said 30 percent of children who get the disease
get it from unknown causes, possibly in daycare.
He said the
CDC tried to give the shots to teens, but it was hard to get
them to show up for all three doses.
"So they said,
'Well, we've got a captive audience and we want to give it to
the newborns anyways.'"
Katz developed
a measles vaccine now manufactured by Merck, which also manufactures
a Hepatitis B vaccine. Katz said when he was chairman of the
committee in 1991 he also worked as a paid consultant for Merck,
Wyeth and most major vaccine manufacturers.
He said conflicts
do not pose a real problem.
"I think it
has increasingly become a problem, but it is a perceived problem,
not a real problem," Katz said.
Another member
of the committee in 1991 was Dr. Neal Halsey, director of the
division of disease control at Johns Hopkins University. He continued to advise the
committee throughout the rest of that decade, as did Katz.
Halsey is a
former CDC employee who has done research paid for by most of
the major vaccine manufacturers. When he testified before the
House Government Reform Committee in 1999, he disclosed a salary
at that time for work on a Lyme vaccine.
He also established
the Johns Hopkins Institute for Vaccine Safety, started in part
with "unrestricted educational grants in 1997 from several vaccine
manufacturers and some private donations," according to Halsey.
Congressional investigators said that support included $50,000
in start-up funds from Merck and a payment from Wyeth. Halsey
said vaccine manufacturers do not fund the center's vaccine education
activities.
Halsey said
the CDC needs experts like him to get the best advice.
"In order to
get the people with experience, you need people who have done
the research," Halsey said in a telephone interview. "To do that,
you have to have people who have done research for vaccine manufacturers."
Halsey said,
however, that the CDC should not recommend vaccines and evaluate
safety at the same time.
"I think it
is a problem and I think it would be better if an independent
body evaluated safety," Halsey said.
Copyright © 2001-2003 United
Press International
This article was provided
courtesy of Dr. Leonard G. Horowitz
and Tetrahedron, LLC
206 North 4th Avenue, Suite 147
Sandpoint, Idaho 83864
http://www.tetrahedron.org/
Toll free order line: 888-508-4787;
Office telephone: 208-265-8065;
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See also:
http://www.DrLenHorowitz.com
http://www.miraclesix.com
http://www.c-cure.net/
http://www.originofaids.com/
http://www.healingcelebrations.com/
http://www.3epower.us
http://www.lovetherealdavincicode.com
http://www.liveh2o.org
http://www.lovecodeseminar.com
http://www.inlieswetrust.com
http://www.healthyworldstore.com
Visit also:
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"
Free Your Mind....
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