The Vaccine Conflict
UPI
Investigates: The vaccine conflict
By Mark Benjamin
Investigations Editor
Published 7/20/2003 8:45 AM
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
The CDC, based in
"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
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,"
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
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
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
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
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
"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
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
Cause and effect or coincidence?
The vaccine manufacturers deny any
connection, but the
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
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
For Lara Bono of
Bono said her son
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
"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,
Boyd Haley, chairman of the Chemistry Department at the
"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
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
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
"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
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
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.
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