FEAT DAILY NEWSLETTER
Sacramento, California http://www.feat.org
October 25, 2001
News Morgue Search www.feat.org/search/news.asp
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To WSJ: Haven’t Noticed Any Hysteria
·
To WSJ: Presumption of Safety Without Scientific Study
·
Alternative Therapies Mostly Untested in Children
[This letter to the editor of the Wall Street Journal is
from Sallie Bernard and Lyn Redwood of Safe Minds. (See previous FEAT
Newsletter post.) The organization was singled out for blame on the current
vaccine shortages.
This, plus a following letter from Liz Birt is their
response.]
Your editorial of October 23, 2001, “Immune to Reason”, is
a series of unsupported assertions about the impact of thimerosal removal on childhood
immunizations and reflects a limited understanding of the issue. The topic is important to public health and
deserves a more detailed discussion.
As you noted, Safe Minds is the leading organization
investigating thimerosal’s role in neurodevelopmental disorders. We haven’t
noticed any “hysteria” among the public over thimerosal. We also haven’t
noticed any mass avoidance of childhood immunization by parents as your article
implies. The latest CDC reports show
vaccination rates to be at an all-time high.
What we have seen are parents asking legitimate questions about the
safety of the vaccines they give their babies.
Specifically, parents want to know why a known neurotoxin,
mercury, is in a product that is injected multiple times into infants under 6
months of age. The regulatory agencies,
the CDC and the FDA, have been short on answers. Neither agency - and now the
Institute of Medicine as well - has been able to produce any scientific
evidence which says that the thimerosal in vaccines is safe, despite it having
been used in biological products as a preservative since the 1930s.
Moreover, thimerosal is an unnecessary component of infant
vaccines. Certain DTaP and Hib vaccines
have always been made without thimerosal. The Merck Hepatitis B vaccine was
easily switched to a thimerosal-free version simply by packaging the product in
single dose vials, which obviates the need for a preservative. Our point from the beginning is that it is imprudent
to expose babies to a neurotoxin unnecessarily. The Institute of Medicine has
agreed.
In fact, the premise of your editorial is the wrong
argument, that infants must either forgo vaccines because they contain
thimerosal and thus contract horrible diseases, or they can be protected
against these diseases by receiving thimerosal-containing vaccines. The correct
argument is, should babies have vaccines with a neurotoxin or should they have
vaccines without a neurotoxin? Beginning in the latter part of 1999, some of
the formulations for all routine infant immunizations have been
thimerosal-free. Since that time, the CDC has been presented with several
options by vaccine experts, manufacturers, and ourselves for reducing or
eliminating thimerosal exposure to infants without disruption to the
immunization program. These proposals range from giving infants thimerosal-free
products while using up the thimerosal-containing supplies with older children,
to allowing existing thimerosal—free producers
to ramp up production. Each time, however, the CDC refused to give
consideration to these proposals.
Your assertion that the government’s request for
thimerosal removal is causing a shortage of DTaP vaccine is also unfounded.
Back in June 2000 SmithKline Beecham (now GlaxoSmithKline) informed the CDC
that it had the capacity to produce enough of its thimerosal free DTaP
(Infanrix) to fully immunize all children in the US. The CDC declined the
offer, claiming reluctance to depend on a single supplier. Another DTaP
supplier, Wyeth-Ayerst, a division of American Home Products, pulled out of the
low margin DTaP market earlier this year to focus resources on their highly profitable
Prevnar vaccine. Prevnar raked in $450 million in revenues in its debut year
(2000) and is considered one of AHP’s hottest products. In contrast, when it comes to DTaP vaccines,
it is the CDC which sets the low prices with manufacturers. Equally telling,
there is currently a severe shortage of the tetanus-diphtheria vaccine, which
only contains thimerosal and has not been singled out by FDA or CDC for mercury
removal.
Your editorial insists there is no credible evidence that
thimerosal has caused harm to children. The authors should review the IOM web
site which contains the presentations of scientists to the IOM thimerosal
review committee. There they would find a statement by Dr. George Lucier, a
highly respected toxicologist from NIEHS, which says that thimerosal has likely
caused neurological harm in some children. They could read the presentation by
David Brown, ScD, whose modeling of mercury levels from thimerosal showed elevations
in ranges known to be associated with neurological deficits in other
populations. They could examine an analysis by the CDC itself which found
statistically significant associations between thimerosal exposure and speech/language
delay, attention deficit disorder, and neurodevelopmental disorders in
general. Or, they could review the data
from Jeff Bradstreet, MD, who has found excessive mercury levels in autistic
children with no other known mercury exposure than the thimerosal in their
vaccines.
Certainly, more research is necessary to assess the
effects of multiple thimerosal injections on infants. What is not necessary is
a dismissal of the issue based on insufficient knowledge of the facts.
* * *
[This letter to the WSJ is from Elizabeth Birt of Medical Interventions
for Autism and a member of Safe Minds.]
Your October 23, 2001 Review & Outlook piece, “Immune
to Reason” missed the mark. Parents are not “hysterical” about the fact that a
known neurotoxin has been injected into the bloodstreams of newborn and infant babies;
we are asking this fundamental question “Where are the long term safety studies
on the vaccines we are being forced to give to our children?” The answer from
the CDC and the vaccine industry is there are none because they are too costly.
If a drug manufacturer approached the FDA with this type of pitch they would be
sent to the “reject” application door and told to conduct large scale safety
tests. The CDC’s mantra is universal vaccination is safe because we say so and
if children are not vaccinated thousands will die so therefore it is better to
sacrifice a few (we hope) for the good of the many.
Is this really true? Is it ethical? Infectious disease
deaths plummeted before the introduction of vaccines due to better treatment therapies
and more sanitary environments. Vaccines do save lives and prevent suffering;
however, we have a duty to make them as safe as possible. The CDC has been given a free hand to
mandate a vaccination schedule that has never been tested. Industry has
benefited in the process but has our society?
Do we know how many deaths we are preventing while we are
potentially creating long term chronic illnesses? The answer is no.
Under the Freedom of Information Act, Safe Minds obtained
a 2/29/00 report generated by a CDC researcher who is now employed by Glaxo
Smith Kline, demonstrating a relative risk for autism at a thimerosal exposure greater
than 62.5 micrograms. The results of this report were altered within a four
month period to reflect a 1.69 relative risk at the same thimerosal exposure
with the same database possibly by altering the original study protocol. A
relative risk of over 2.00 is sufficient in a court of law to prove that a vaccine
caused an injury. Safe Minds has
requested that the database used by the CDC to monitor the safety of all
childhood vaccines and these reports be released for independent
epidemiological review. The CDC has steadfastly refused. In addition, Roger
Bernier, Ph.d., the Associate Director for Science of the National Immunization
Program at the CDC is on record under oath as stating that the CDC reported an
“inconclusive” relationship between thimerosal containing vaccines and ADD,
speech and language disorders, tics, unspecified developmental delay and neurodevelopmental
disorders The CDC’s own study which was released reported a “statistically
significant positive correlation” between these outcomes and thimerosal
exposures. Where does the “spin” end and the truth begin?
The CDC’s policy of concealment will be judged as one of
the greatest public health mistakes in our country’s history. Instead of
establishing an atmosphere of openness to parental and scientific concerns, the
CDC’s policy is to deny full access of data for scientific review, paint the
parents of neurologically impaired children as “hysterical”, engage in a
campaign to destroy the scientists engaging in this type of inquiry and to
utilize deceptive propaganda in the media. Before more children are sacrificed
for an unknown, unquantified “greater good”, we are demanding that thorough, uncompromised
science be done on a biological and epidemiological level. Our children deserve
no less.
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* * *
[In addition to more testing of their products, the
manufacturers of
alternative medications would do well in gaining better
acceptance from the
medical associations by providing a competitive supply of
free note pads,
pens and other promotional specialty items at doctor’s
offices. By Melissa
Schorr. -LS]
http://dailynews.yahoo.com/h/nm/20011024/hl/children_3.html
Reuters Health - Giving alternative medications to
children may be dangerous, doctors told an audience at the annual American
Academy of Pediatrics meeting in San Francisco on Tuesday.
Pediatricians warned that that alternative medicines—such
as herbal and nutritional supplements—have not been well tested among children
and may even have dangerous ramifications.
“We are concerned parents self-medicating extends to
medicating their child,” said Dr. Alan D. Woolf, a professor of pediatrics at
Harvard University and head of clinical toxicology at Children’s Hospital in
Boston, Massachusetts. “In some cases, this can be harmful to the child.”
In the same session, Dr. Michael Artman, a professor of
pediatrics at New York University, noted that approximately 20% of children in
the general population report using some form of complementary and alternative
medicine such as hypnosis, acupuncture, homeostasis, herbal or dietary
supplements.
The percentage may be as high as 30% to 40% among children
with chronic diseases such as asthma, cancer and diabetes, Artman said.
However, few tests of such remedies’ safety have been carried out in children.
“There aren’t many studies on how herbs affect children,
we are always extrapolating from adults,” Woolf explained. “This isn’t to raise
the scare factor, but it’s simply an unknown.”
Artman said that compounds that are safe in adults are not
likely to be harmful in children, however, children may need an adjusted dose.
Patients should also be made aware that unlike traditional
medications, there is no US Food and Drug Administration (news - web sites) (FDA)
regulation or quality control on what the products actually contain.
“With herbs and supplements, it’s always buyer beware,”
Woolf said.
Doctors need to ask their patients what alternative
medicines they are using and help counsel them on safety, Woolf added.
“Pediatricians should ask the unasked question: are they
using complementary and alternative medicine for their children?” Woolf said.
“We need to give parents the information they’re seeking whether they should
use these therapies for their children.”
Doctors should be supportive of these measures if the
benefits are based on evidence and the risks are seemingly low, he suggested.
However, doctors should also debunk the myth that because
an herbal medicine is “natural,” it must be safe. For example, the herb
Comfrey, available in some teas, was yanked by the FDA for causing liver
damage, especially in children.
Other seemingly innocuous herbs can interfere with normal
blood clotting and should be discontinued well ahead of any surgery.
“You don’t want a 17-year-old girl going in for...surgery
to be taking ginseng or garlic, because she’ll bleed and bleed,” Artman noted.
“You want to know that ahead of time.”
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