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News 8 Investigates: Vaccine Safety Part 2
Reporter: Valeri Williams
Updated: Feb 23, 2001 at 12:57AM
DALLAS - Most parents trust the government to ensure that the vaccines we
inject into our children are safe.
A News 8 Investigation focused on what some call the questionable science
behind getting vaccines licensed in this country.
As we've said before and we want to stress again: traditional childhood
vaccinations have been a good thing.
But what we've chosen to do with this is take a closer look at how some of the
newer vaccines are coming on to the market, and to ask why parents aren't being
told more.
"I feel like I took him to the doctor's office and I paid them to poison
my son -- and I didn't know any better," said Melynda Slay.
In June 1999, Slay had her newborn son inoculated with the new RotaShield
vaccine.
Vaccine ads from that time promised that RotoShield would help prevent
childhood diarrhea. But within days, Harrison's bowels were dangerously
obstructed to the point of possibly rupturing.
"That probably was the worst week I've ever had in my life because I
wasn't sure if my son was going to live or die," Slay recalled.
Federal regulators from the Centers for Disease Control soon discovered that
more than 100 other infants had suffered the same problem.
RotoShield was pulled off the U.S. market in less than 15 months and some are
now questioning how the drug ever received government approval.
"These committees have become the rubber stamp committees for the drug
companies to push their product in the market," said Dr. Erdem Cantekin, a
medical researcher.
Cantekin has long been concerned about the financial links between the
pharmaceutical industry and many doctors and scientists who sit on vaccine
approval committees.
He is not alone.
Last summer Rep. Dan Burton (R-Ind.) held Congressional hearings which revealed
that at least half the members of vaccine committees at both the Food and Drug
Administration and the Centers for Disease Control had financial ties to drug
companies developing different versions of the Rotavirus vaccine.
"We have had people who are head of advisory panels who own stock in
pharmaceutical companies," Burton said.
The report found others who received grants or contracts worth hundreds of
thousands of dollars, yet all were granted waivers which let them vote on the
vaccine's approval.
"If you own stock in a pharmaceutical company, and you are on an advisory
panel that will be approving or disapproving a vaccine by that pharmaceutical
company and you know it could have an adverse impact on the stock that you hold
in that company, it just might taint your judgment," Burton said.
On the very same day that the CDC's Vaccine Advisory Committee pulled the plug
on RotoShield, it drafted a recommendation for another vaccine called Prevnar.
News 8's investigation found that out of 12 committee members, four had
financial ties to the drug company making Prevnar.
At the FDA, three out of 12 committee members received waivers for conflicts of
interest so they could vote on Prevnar's license.
Among them was Dr. Robert Daum, the newly-elected chairman of the
committee. He said his conflict
amounted to research on another vaccine for children at another company.
"You have to understand I still drive my 1989 Toyota, and the door on the
right side still doesn't open. Nothing good happened to me," Dr. Daum
said. "They're still selling
God-knows how many million doses a year now for American Home Products. I don't
benefit from that. Nothing has changed in my life."
Daum admitted, however, that his role is "a very fine line."
Daum and others argue that there is a very limited list of experts within the
world of vaccine research. They say that in order to have the best
professionals on the committees, there must be acceptance of conflicts of
interest.
"No man can serve two masters," Cantekin countered. "I could
find 100 competent scientists and doctors to put on these committees which are
better than they have. All of whom don't have any conflict of interest and have
not taken a single dollar from anybody."
He and others claim all this chumminess has made government committees
unwilling to challenge poor testing procedures in studies of a proposed
vaccine's safety.
For example, here are the results of a clinical trial of Prevnar in 38,000
California children:
According to the drug company's own documentation, children receiving Prevnar
with other vaccines had more seizures, more rashes, higher fevers and other
side effects than children who received the control vaccine.
And the real surprise? The control vaccine in the testing was not a placebo,
but another experimental vaccine that was still being tested.
Dr. Daum defended the testing procedure. "I think it makes for better
parent compliance and more willingness to participate to have a control that
would actually benefit from receiving something, and not saline. I wouldn't
want to submit my child to an experimental protocol where there was a chance he
just going to get a dummy shot."
Barbara Fisher is the only member of the FDA's Vaccine Committee who is not a
doctor or a scientist; she's a consumer advocate and the only committee member
to have voted against issuing a license for Prevnar.
Fisher said the study leading up to the license fails to measure up -- ethically,
morally or scientifically.
"What's scientific about that? That every time something bad happens after
vaccination it's 'coincidence'? That's not science, that's politics," said
Fisher.
Prevnar was licensed to vaccinate infants against certain strains of
meningitis, pneumonia and bacteremia -- horrible diseases which combined affect
fewer than 150,000 children each year.
Weighing the risks of vaccination versus the risks of disease is a tough
decision for any parent, but what many parents have told us upsets them is that
they were surprised -- and scared -- by how much information they did not know.
Rep. Burton said he is calling for another Congressional hearing on the
approval of Prevnar this spring.
FOR MORE INFORMATION
Prevnar: Official Web Site
Prevnar Q & A
House Committee Critical of Vaccine Approval Process
Pediatrics Group Recommends Prevnar
Parents Requesting Open Vaccine Education
Texas Vaccine Schedule
Vaccine Averse Event Reporting System
CDC: Overview of Vaccine Safety
More Information About Earaches
The Centers for Disease Control and Prevention
New Childhood Vaccine Targets Meningitis
Report a Vaccine Reaction
Eight Questions Parents Should Ask
National Vaccine Information Center
Note: These sites are not part of WFAA.COM website. WFAA.COM has no
control
over their content or availability.
Copyright: 2001 by WFAA-TV Co. All Rights Reserved.
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Dawn Richardson
PROVE(Parents Requesting Open Vaccine Education)
prove@vaccineinfo.net (email)
http://vaccineinfo.net/ (web site)
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PROVE provides information on vaccines, and immunization policies and
practices that affect the children and adults of Texas. Our mission is to
prevent vaccine injury and death and to promote and protect the right of
every person to make informed independent vaccination decisions for
themselves and their family.
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Breaking News Archives - each day's breaking news from December 1, 2003 (check here for breaking news you might have missed and breaking news that didn't ever hit the "front page")
More News - all the news most recently posted on this website
All the News - a running tab of everything posted on this website since October 29, 2003
Top Stories Archives - daily breaking and other important news stories
Daily News Archives - all the news posted on this website each day (from April 2001)
Hot Topics - selected stories, by category
Return to Vaccination News Home Page (for best results, right click to "open in new window")
DISCLAIMER: All information, data, and material contained, presented, or provided here is for general information purposes only and is not to be construed as reflecting the knowledge or opinions of the publisher, and is not to be construed or intended as providing medical or legal advice. The decision whether or not to vaccinate is an important and complex issue and should be made by you, and you alone, in consultation with your health care provider.