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Money Magazine expose on
Billion Dollar Vaccine Business
The Lethal Dangers of the Billion-Dollar
Vaccine Business
by Andrea Rock
Money Magazine December
1996
Your Health by ANDREA ROCK
WHEN MIRIAM SILVERMINTZ OF FAIR LAWN. N.J.
TOOK HER SEVEN
month old son Nathan to the pediatrician for his third series of
vaccinations on Feb. 18,1991, she was
thrilled to hear the doctor say her
baby was growing beautifully. Just five
hours later, as Nathan lay in his
crib, he shrieked in pain. Terrified.
Miriam ran in and cradled her baby in
her arms. Nathan collapsed, his eyes rolling
back in his head, as he
suffered a severe seizure. “We called
911, and they worked on him for 45
minutes,” says Miriam. “but I knew when
I held him in my arms that he was
dying.” What killed Nathan? “When I first
called the pediatrician after the
ambulance arrived, he said Nathan probably
was just having a reaction to
his DPT shot,” Miriam recalls. “But when
Nathan died, the doctor did an
about-face and said it had nothing to
do with the vaccine.” Nathan’s death
was officially attributed to a congenital
heart defect. But Miriam, now 36,
and her husband Steven. 37 (pictured on
page 151). couldn’t shake the
feeling that Nathan’s death was somehow
linked to the shot. They began to
search for details on DPT which prevents
diphtheria, pertussis (formerly
known as whooping cough and tetanus.
The search led them to the National Vaccine
Information Center of Vienna, Va.. a 14-year-old
nonprofit educational and
support group for parents whose children
have been harmed by vaccines.
There, the Silvermintzes learned that
a DPT shot can indeed cause death-as
well as adverse reactions ranging from
fever and irritability to the
permanent brain damage suffered by Joshua
Reed, now 13 (pictured opposite),
of Great Bend, Pa. They also discovered
that some batches of the vaccine
cause more problems than others. In fact,
because of lax federal recall
regulations, Nathan appears to be the
first of nine children who died
shortly after getting a shot from the
same DPT lot. Finally, the
Silvermintzes were confronted by the most
painful discovery of all. “We
learned,” says Miriam “that there were
safer ways to manufacture DPT that
weren’t being used in this country. In
1994, the U.S. Court of Federal
Claims awarded damages to the Silvermintzes
under the National Childhood
Vaccine Injury Act of 1986. “It was bad
enough suspecting that Nathan’s
death was caused by a vaccine,” says Miriam,
“but still I had believed it
was one of those one-in-a-million things.
When I learned that his death was
followed within three weeks by another
in New Jersey and then another in
Illinois and another in Pennsylvania and
five more after that while this
batch of vaccine stayed on the market
for an entire year, it broke my
heart. I feel betrayed by the drug companies
who make vaccines and by the
doctors and government agencies I’d always
trusted to protect us.
Your Health VACCINES ARE INDISPENSABLE. THEY SAVE
lives, cutting the number of U.S. pertussis
deaths to about five last year,
for example, from 1,118 in 1950 before
state governments made the
vaccination mandatory for school admission.
No one is suggesting that your
kids skip their shots. However, shouldn’t
your doctor always alert you to
the danger signs-before and after immunization-that
you should watch for to
prevent tragedy? Neither is the case now.
A MONEY investigation of the
booming vaccine industry (estimated revenues
of more then $1 billion a year
in the U.S. alone, up from $500 million
in 1990) and of its federal
regulatory agencies reveals severe violations
of public trust. In probing
the politics and economics of the two
vaccined that have been used longer
than any others in this country, DPT and
polio, MONEY found that health
officials publicly down-play the lethal
risks. In addition, medical experts
with financial ties to vaccine manufacturers
heavily influence government
decisions that have endangered the health
of immunized kids while enhancing
the bottom line of drug companies.
Among MONEY’S disturbing findings we learned that
DPT shots caused brain damage at the rate
of one case for every 62,000
fully immunized kids. The shots also kill
at least two to four people a
year, according to a federally funded
Institute of Medicine study and
perhaps as many as 900 a year- including
a great number misclassifed as
victims of sudden infant death syndrome-
according to the independent
National Vaccine Information Center. What’s
worse these tragedies can be
virtually eliminated by a current product.
Who wouldn’t pay $9 more than
the current product. Who wouldn’t pay
$9 to protect their child even from a
one-in-62000 risk of severe illness, let
alone death? Sound like a simple
solution? Don’t count on it. Although
they are now making some small moves
the government and the drug industry have
an appalling record of facing up
to vaccine problems. For example, MONEY
has learned that: Ø For decades,
American pharmaceutical companies have
known how to produce the safer DPT
vaccine but decided not to bring it to
market because it would increase
production costs and lower the drug’s
50% or higher profit margins. Ø The
only cause of polio in the U.S. for the
past 17 years has been the oral
version of the vaccine itself, and though
the Food and Drug Administration
has finally recommended a reduction of
the oral product’s use, there are no
plans to take it off the market. The twice-as-costly
vaccine administered
by injection does not cause polio.
Ø The oral polio vaccine and the injected variety
are commonly made using monkey tissues
which contain viruses that can be
harmful to humans. A safer injected vaccine
using human tissue is available
in Canada but not in the U.S. event though
it is made by the same company
that produces all U.S. injected polio
vaccine. Ø Federal regulators have
stymied many efforts to investigate the
impact of those monkey viruses but
are now paying attention to particularly
disturbing research by a Chicago
molecular pathologist linking one to human
cancer. This is the same monkey
virus that a new Italian study suggests
is being passed on sexually by
people throughout the world and from mothers
to babies in the womb.
How a safer DPT shot has been delayed Manufacturers
put profits ahead of vaccine safety with
impunity. A 1986 law promoted by
the drug industry dramatically limits
vaccine manufacturers’ legal
liability in cases where their products
cause injury or death. The law was
enacted to help prevent vaccine manufacturers
from being driven out of
business by rising liability costs. That
was a worthy goal. But in practice
the reform effectively removed one of
the drug industry’s most compelling
incentives to ensure that its products
are as safe as possible. Rather than
filing lawsuits against drug companies
or against physicians, victims or
their families now must first file claims
under a federal vaccine injury
compensation program. Also the damages
awarded are not paid by drug
companies: they are paid by you-in the
form of a user tax tacked onto the
price of the each vaccination. The tax
totals $33 for a child fully
immunized-five vaccinations for DPT, four
for polio and two for measles,
mumps and rubella-in accordance with federal
requirements. To date, the
users taxes have been spent to compensate
more than 1,000 people, including
the Silvermintzes, at a cost to taxpayers
half a billion dollars. Meanwhile
manufacturer’s’ profits have risen as
the average cost to fully immunize a
child at a private physician’s office
has climbed 243% since 1986, from
$107 to $367. The most prominent beneficiaries
have been the two producers
who dominate the U.S. market for DPT and
polio vaccines. Connaught
Laboratories ($300 million in U.S. sales
last year) and Wyeth-Lederle
Vaccines & Pediatrics ($350 million).
U.S. revenues for both companies have
increased 300% since 1986, estimates David
Molowa, international
pharmaceutical analyst at the Wall Street
investment firm Bear Stearns.
While the drug companies’ revenues have
soared people have needlessly
suffered. For example, though most kids
develop only minor reactions such
as fever and irritability following a
DPT vaccination. About one in 310.000
injections result in permanent brain damage,
according to a 1993 British
Study that followed children over a 10-year
period. Since they can occur
with anyone of the full series of five
DPT shots the odds of suffering
brain damage for a child receiving all
five 4; vaccine works out to one in
62,000. Additionally, based on a large
study conducted jointly by the FDA
and UCLA researchers, the National Vaccine
Information Center calculates
that DPT deaths could exceed 900 per year.
And while a 1979 Study may seem
outdated, consider that in the U.S. the
pertussis portion of the vaccine,
the component that causes the damage,
is little changed from the original
crude formula introduced in the 1920’s.
At the same time, the safer vaccine costing
$9 more a dose has been used in
Japan since l98l. Patented there by scientist
Yuji Sato, it has wiped out
83% of minor reactions such as fever and
swelling and virtually eliminated
seizures, brain damage and death. The
reason: The Japanese use an acellular
vaccine, extracting only the portion of
the pertussis bug that will trigger
the body’s immune response to protect
against the disease. They remove or
neutralize poisons that are by-products
of the bacteria, including
endotoxin, a substance scientists say
can cause serious afflictions, such
as Joshua Reed’s brain damage. By contrast,
until recently, the two
licensed U.S. DPT manufacturers. Wyeth,
Lederle and Connaught
Lab-oratories, used only the whole bacteria,
toxins and all, yielding a
whole-cell vaccine that former FDA researcher
Charles Manclark has
described as being “crude and impure.”
What’s more, tests completed in
Italy and Sweden in 1995 indicated that
the purified acellular vaccine was
not only safer than the whole-cell vaccine
but was up to twice as effective
in preventing pertussis. Ironically, Sato
was merely applying technology
developed-but then abandoned-by American
manufacturers.
By 1972, six U.S. pharmaceutical companies had
worked up some purified form of the pertussis
vaccine that was safer than
the whole cell. One of the companies,
Eli Lilley marketed its vaccine,
Trisolgen, for 19 years before getting
out of the vaccine business in 1976
and selling the rights to Wyeth. Internal
Lilly documents reveal that
reported adverse reactions to Trisolgen
were only a fifth of those to their
whole-cell product and that “severe reactions
virtually do not occur.”
Nevertheless, Wyeth and other manufacturers
initially rejected this
process. According to a 1977 Wyeth document,
it’s scientists analyzed the
Lilly formula and found that the purification
process would yield 80% less
of the component that fights pertussis
than the whole-cell formula, which
would result in “a very large increase
in the cost of manufacture.”
Wyeth-Lederle told MONEY that clinical
studies did not show that Wyeth’s
version of Trisolgen was safer than the
whole-cell vaccine. Accordingly.
Wyeth-Lederle says. Wyeth began looking
into developing an acellular vaccine.
They still don’t get it “SURE, YOU CAN PRODUCE A
MUCH LESS toxic product in very low yields.
And anyone who has worked on
pertussis knows this,” Dennis Stainer,
an assistant director of production
and development at Connaught Medical Research
laboratories in Canada, told
a 1982 symposium sponsored by U.S. Government
health officials. “What we
are really faced with, I think now is
going from a vaccine that costs
literally cents to produce to one that
I believe is going to cost dollars
to produce.” Connaught began research
into acellular vaccine in 1979 and in
1996 obtained an FDA license to sell it.
“To criticize as slow, scientists
who achieved the first U.S. license for
infant use of Tripedia, an
acellular pertussis vaccine, is like criticizing
gold-medal hurdler for not
having started the race or cleared the
hurdles as early as you think she
should have,” Christine Grant Connaught’s
vice president for public policy.
told MONEY. Since July. Connaught’s infant
DPT vaccine with a Japanese
acellular pertussis component has been
on the market. Nevertheless, whole
cell continues to be used in about 9O%’
of all U.S. vaccinations. “The FDA
needs to pull the license on whole-cell
vaccine, as Japan did, and get it
off the market.” says Mark Geier. A physician
and geneticist who worked for
nine years at the National institutes
of Health researching toxins and
other vaccine contaminants.
But the medical community continues to
defend the old vaccine, for example.
Neal Ilalsey chairman of the committee
that makes vaccine recommendations
at the American Academy of Pediatrics,
says, “While acellular does cause
lower rates of minor problems, it doesn’t
mean whole cell is all bad or
shouldn’t be used.” Halsey’s view is shared
by many doctors. Says Geier:
“The fact that a lot of pediatricians
think whole-cell pertussis vaccines
doesn’t cause brain damage shows what
a lot of money can do. Drug companies
have paid a lot of money to people like
James Cherry to put forth that
image.” Cherry a physician and professor
of pediatrics at the University of
California at Los Angeles is a widely
recognized pertussis expert who has
been a leader on advisory committees that
help frame immunization policy
for the American Academy of Pediatrics
and the Centers for Disease Control.
Back in 1979, at a symposium he said,
“All physicians are aware that
pertussis vaccine occasionally produces
severe reactions and that these may
be associated with permanent sequellae
[complications caused by the
vaccine] or even death.” But by 1990,
Cherry had changed his mind,
proclaiming in the Journal of the American
Medical Association that severe
brain damage caused by pertussis vaccine
was nothing but “a myth.” From
1980 through 1988. Cherry got about $400,000
in unrestricted grants that he
termed “gifts” from Lederle. From 1988
through 1993, he was given $146,000
by Lederle for pertussis research, and
from 1986 through 1992, UCLA
received $654,418 from Lederle for pertussis
research. Additionally, drug
manufacturers paid Cherry and UCLA $34,058
for his testimony as an expert
witness. in 15 DPT lawsuits brought against
the companies. The National
Vaccine Information Center, among other
consumer groups, protested that
because of possible conflicts of interest
Cherry should not be allowed on
vaccine policy committees at the Centers
for Disease Control. When asked
whether his acceptance of funding and
payments from Lederle created a
conflict of interest, Cherry told MONEY,
“I got nothing out of it, If
having a feeling for children is the charge,
then I’m guilty. None of this
was done for the companies.” The CDC no
longer permits members of vaccine
advisory committee t vote on issues involving
any company with whom they ha
a financial relationship. But they can
participate in discussions-which
allows them to continue influencing policy
Minutes of a June 1995 CDC
advisory committee meeting, at which members
‘voted to delay recommending
use of a safer polio vaccine, show that
five of the nine members present
had financial ties to vaccine manufacturers.
The hidden Risks of Polio Vaccine In October of 1988
LENITA SCHAFER brought her three month
old daughter Melissa for her first
oral polio vaccination. A month later,
while fixing ‘Thanksgiving dinner at
her New England home, Lenita began feeling
severe back pain. Within 48
hours she was unable to move her legs:
13 weeks after that, she was told
she would be in a wheelchair the rest
of lest of her life. Lenita had
contracted polio by changing her daughter’s
diaper. Lenita had not been
given the federally required warning that
the oral vaccine contains live
polio virus that can cause polio in some
babies or in the people who come
in contact with live virus shed in the
babies’ stool and body fluids. But
even if Lenita had been given the current
two-page CDC information sheet on
the risks and benefits of polio vaccine,
she would not have had a picture
of the danger she faced. The CDC sheet
that doctors are required by law to
give to parents still states that so-called
contact polio is a risk for
people who never have been vaccinated
against the disease. Yet Lienita, 44,
was immunized as a child The CDC knows
better. Minutes from a June meeting
of the
CDC’s advisory committee on immunizations show the
organization realizes that people who
vaccinated are susceptible to contact
polio: “The previous belief…has not been
borne out by experience.” Says
Walter Kyle, a Hingham, Mass. Attorney
who represented Lenita and other
contact polio victims: “The CDC’s job
is to give people the truth.”
Furthermore, going beyond that the CDC
info sheet is outdated and
inaccurate, Lenita would not have contracted
polio if her baby had simply
received an injection of inactive polio
vaccine (IPV”) rather than an oral
dose vaccine (OPV). The injection protects
against the disease but can’t
cause it because the polio virus has the
“killed-inactivated with chemicals
that it is not infectious. In addition,
federal health policy contributed
to Lenita’s paralysis. Although the injection
was an available option
doctor was following government PC when
he automatically gave Ileni
daughter the oral vaccine. For 30 years
until this September, one of the
reasons that CDC officials recommended
vaccine was precisely because the
virus shed in a recently vaccinated babies
body fluids could immunize more
people through contact than it threatened
albeit without their knowledge or
consent. Federal health officials were
~ that, each year, about 10 children
their caregivers might actually get polio
from the oral vaccine. But the
feds considered these human sacrifices
acceptable able for the greater
public health goal preventing polio outbreaks.
The policy may well have
made sense at the height of the polio
epidemic in the 1950s, but since 1979
the only cases of polio in the U.S. have
been caused by the oral vaccine
itself-a total of 119 casualties from
1980 to 1994 alone in the name of
federal public health policy. What’s more,
in 1994 the World Health
Organization declared in a public statement
that so -called wild polio
(transmitted by any means not related
to the vaccine) had been eradicated
in the entire Western Hemisphere. “In
a polio-free nation, in a polio-free
hemisphere, we cannot have eight to 10
individuals paralyzed every year
when there are alternatives,” says Samuel
Katz, a pediatric infectious
disease specialist at Duke University.
So why is the oral vaccine still in
use in 98% of the 20 million annual polio
vaccinations in the U.S.? John
Salamone of Oakton, Va., whose son David,
now 6, has polio as the result of
an oral immunization, says “The answer
is that it all comes down to MONEY.
A physician put it in perspective for
me when he said I had to understand I
was fighting a $200 million industry.
A $230 million industry, to be exact, embodied in
one company, Wyeth-Lederle, the sole supplier
of oral polio vaccine in the
U.S. A year ago, the CDC’s Advisory Committee
on Immunization Practices
recommended that the government advise
pediatricians to use injected
vaccine for the first two polio vaccinations
and oral for the final two.
The new program, according to CDC reasoning,
would reduce
vaccine-associated polio to one to five
cases a year while still passively
immunizing a portion of the U.S. population
until wild polio is eradicated
in the Third World-a goal health officials
expect to reach in the next five
years. The committee’s recommendation
signaled a victory for Connaught, the
sole marketer of injected polio vaccine
in the U.S. But the CDC did not
formally act on the committee’s recommendation
until two months ago, in
part because Wyeth-Lederle launched an
intensive lobbying effort to hold on
to its own $230 million oral polio vaccine
business. Ronald Saldarini,
president of Wyeth-Lederle Vaccines &
Pediatrics, told MONEY that his
objection to the policy change had nothing
to do with loss of market share
but was based on several factors, including
“compliance, systemic immunity,
and lack of data and experience with the
recommended schedule,” as well as
the public health risks using a vaccine
that does not passively immunize
people. “Wild polio is just a plane ride
away,” he said. Wyeth-Lederle’s
lobbying paid off. CDC director David
Satcher announced in September that
the agency would recommend two doses of
injected vaccine followed by two
doses of oral. But he also said that the
alternatives of giving four doses
of oral or four of injected would be acceptable.
“Unless patients
specifically request injected vaccine,”
says John Salamone. Doctors are
inclined to do the easy thing, which is
continuing to give the familiar
oral polio vaccine.” Cost may also be
factor in what is offered, especially
at public health clinics. The federal
government currently buys oral
vaccine for $2.32 a dose. compared with
$5.40 for injected.
A deadly new worry
HERE IS ANOTHER POLIO VACCINE RISK-”A
ticking time bomb,” according to
Harvard Medica School Professor Ronald
Desrosier-that public health
officials are reluctant to discuss frankly
What is it? The polio virus that
is used in both Wyeth-Lederle’s oral vaccine
and Connaught’s injected
version is grown on monkeys’ kidney tissue.
“The danger in using monkey
tissue to produce human vaccines,” says
Desrosier, “is that some viruses
produced by monkeys may be transferred
to humans in the vaccine, with very
bad health consequences.” Desrosier acknowledges
that you can test monkeys
before using their tissue and screen out
those carrying harmful viruses.
But he warns that you can test only for
those viruses you know about-and
that our knowledge is limited to perhaps
“2% of existing monkey viruses.”
The danger is not hypothetical. In 1959,
Ben Sweet, a 35-year-old scientist
at Merck, the pharmaceutical giant, discovered
that a previously undetected
monkey virus called SV-40 had contaminated
oral polio vaccines given to
Americans for the prior five years. When
testing revealed that SV-40 was a
cancer-causing agent, producing tumors
in hamsters, the FDA and
manufacturers agreed that rhesus monkeys
would no longer be used in vaccine
production. Instead, the manufacturers
would use African green monkeys, in
whom the virus was easier to detect and
screen out. But federal health
officials knew the potential problem was
enormous because, by then, as many
as 30 million Americans had received both
injectable and oral polio
vaccines contaminated with SV-40. “Seeing
that viruses could jump species
really opened our eyes.” says Sweet. “Merck
stopped all polio vaccine
development cold.”
Even though SV-40 was being screened out,
scientists such as John Martin, a
professor of pathology at the’ University
of Southern California, warned
that other monkey viruses could be dangerous.
But government officials
rebuffed Martin’s attempt to research
those risks back in 1978 and again in
l995 when he was denied federal funding
and vaccine samples he needed to
investigate the effects of simian cytomegalovirus
(SCMV), an organism that
his studies indicate causes neurological
disorders in the human brain. The
virus has been found in monkeys used for
polio vaccine production.
Similarly, Cecil H. Fox was also rebuffed
when, as a senior scientist at
the National Institutes of Health in 1988,
he asked to examine archived
lots of polio vaccine to learn whether
they contained simian
immunodeficiency virus (SIV), which has
been screened out of polio vaccines
since 1987 because of potential human
impact. “The resistance of those in
authority to face the issue of prior vaccine
contamination is particularly
unfortunate,” says Martin, “because research
establishing a viral cause for
neurological disorders or cancers can
lead to effective antiviral treatments.
Beginning in 1992, scientific evidence
supporting fears about prior
contamination began to mount. Studies
suggested that SV-40 was a catalyst
for many types of cancer, not only in
people who had received polio vaccine
containing the virus but in their children
as well.
In a series of papers published from 1992 through
1996, Michele Carbone, a molecular pathologist
at Chicago’s Loyola
University Medical Center, examined the
same types of tumors in humans that
were known to develop in hamsters exposed
to SV-40. He discovered SV-40
genes and proteins in 60% of patients
with mesothelioma, a particularly
deadly form of lung cancer, and in 38%
of those with bone cancer. His most
recent research, presented at a medical
conference in July, connects SV-40
and these cancers even more clearly by
describing the mechanism through
which SV-40 turns a cell cancerous. Carbone’s
research shows that SV-40
switches off a protein that protects cells
from becoming malignant. Not
everyone who is infected with SV40 gets
cancer for the same reason that not
every smoker gets lung cancer: A variety
of assaults on the immune system
usually combine to trigger malignancy
But SV-40 could be a factor that
predisposes some people to develop tumor
of the brain bone and tissue that
surrounds the lung.
Now, in what could be a crucial piece of the puzzle,
a study by Italian researchers published
in October in the U.S.. Medical
Journal Cancer Research suggests that
the reason all three cancers are on
the rise is that the SV-40, originally
introduced to humans through polio
vaccine, is now being spread sexually
and from mother to child in the womb.
The study found SV-40 present in the blood
and semen of 25% of healthy
study subjects. According to one of the
study’s authors, biology and
genetics professor Mauro Tognon of Italy’s
University of Ferrara’s School
of Medicine, this would explain why SV-40
was detected from 1992 on in the
brain tumors of children who were born
after 1965 and therefore presumably
did not receive vaccine containing SV-40.
Tognon also points to SV-40 as
one possible reason for the 30% increase
in U.S. brain tumors over the past
20 years.
Howard Strickler, senior clinical investigator at
the National Institutes of Health’s National
Cancer Institute, told MONEY
that the federal government is taking
recent reports about SV-40 very
seriously “They are plausible, but it’s
not a done deal,” Strickler said.
The accumulating body of evidence from
research around the world has
heightened the fears many scientists have
expressed for years about the
dangers of using monkey tissue in vaccine
production, particularly when
there are safer alternatives available.
“There’s no question that our polio
vaccines should be made exclusively with
killed viruses grown on human
diploid tissue,” says Howard Urnovitz,
a microbiologist in Berkeley.
Connaught uses human diploid cells (from
aborted fetal tissue) to produce
Poliovax, the inactivated polio vaccine
it manufactures and markets in
Canada. The company is licensed to sell
Poliovax in the
U.S. but now markets Ipol here, a vaccine grown on
monkey tissue. “Ipol is the more widely
used vaccine, and it was a company
decision [to continue selling it here
based on what best meets the needs of
the U.S. market,” Connaught’s Christine
Grant told MONEY.
The FDA is equally dismissive of the potential
dangers. Peter Patriarca, deputy director
of the division of viral products
at the FDA, says he sees no need to stop
producing polio vaccines with
monkey tissue. Government thinking is
best summed up by Neal Halsey, who is
a member of advisory committees on immunization
practices at both the CDC
and the American Academy of Pediatrics.
Halsey cautioned MONEY against
“raising a hypothetical concern that could
jeopardize vaccine supply. If it
were a real concern, the FDA wouldn’t
allow the production of vaccine on
monkey tissue.” That viewpoint, of course,
overlooks the fact that the FDA
allowed the production of polio vaccine
that contained SVAO, SlV and SCMV
with human health consequences that are
just beginning to be understood.
Moves that must be made right now EVALUATING THE
SAFETY RECORD OF VACCINES such as DPT
and polio is especially important in
light of the vaccine industry’s explosive
growth. According to Frost &
Sullivan, a technology market research
firm in Mountain View, Calif.,
current worldwide revenues o nearly $3
billion are expected to more than
double to $7 billion over the next five
years as scores of new vaccines
come to market. The industry is no longer
focused primarily on
life-threatening diseases, or on children
but wants to introduce adult
vaccines like those in the research ‘pipeline
to fight herpes and other
sexually transmitted diseases.
What can be done in our interest? Much
of the necessary change involves
reforms in public health policy In a joint
effort with doctors and
scientists the government should:
* Ban dangerous products. To immediately
improve the safety of existing
vaccines, we must use only acellular DPT
vaccines and inactivated polio
vaccines. And, we must discontinue use
of monkey tissue in the production
of all vaccines. Cost should not be a
factor. “To avoid even a small risk
of brain damage or death, what mother
wouldn’t pay even $50 more for a
safer vaccine,” says Victor Harding, a
Milwaukee attorney who has
represented parents of children harmed
by vaccines.
* Expand research. “We want to see scientific
proof that you know precisely
what is happening in the human body when
you give vaccines to our babies,”
says Barbara Loe Fisher, co-founder and
president of the National Vaccine
Information Center. She and other experts
recommend that the NIH take half
of the $415 million spent on promoting
immunization and new vaccine
research and allocate it to studies investigating
the cause-and-effect
relationship between existing vaccines
and immune and neurological
disorders suspected to result from their
use. An Institute of Medicine
committee appointed to evaluate vaccine
safety in ~994 noted that its
analysis had been hampered by lack of
such studies. Out of 59 health
problems suspected to be associated with
a variety of vaccines, the
committee found that no scientific studies
had been conducted on 40 of them
(see the table on page 157 for a list
of the key risks). To aid such
evaluations, experts want the FDA and
manufacturers to provide samples of
current and archived vaccines to independent
researchers.
* Stop hiding facts. When federal health
officials and pediatricians
refrain from warning the public about
risks out of fear that parents will
stop immunizing their children, they insult
parent’s intelligence and
endanger the public’s health. Parents
deserve the facts so they can make
informed choices. Geneticist and former
NIH researcher Mark Geier says that
when he speaks out publicly about vaccine
risks or testifies on behalf of
vaccine-damaged children, he is frequently
criticized by other physicians.
Says Geier: “They agree privately that
what I say is accurate but warn that
if I’m not careful, I’ll scare people
away from taking vaccines. That’s
certainly not my goal-my own kids are
vaccinated. But if you operate on the
premise that you can’t tell the public
about problems with vaccines because
you’ll scare them away, then unfortunately
the problems don’t get fixed.
HOW TO KEEP YOUR CHILDREN SAFE: To ensure that your
child gets the benefits of immunization
while minimizing the risk, follow
these steps ~BE ASSERTIVE. Request that
your child receive the inactivated
polio vaccine, which is given as a shot
rather than orally, and the
acellular form of DPT. Tell your doctor
what you want well before you come
in for your appointment so he or she can
get the vaccines In stock ~ BE
INFORMED. Ask to see government “benefit/risk
information” on each vaccine
before your child is immunized. And discuss
with your doctor any reason
your child might be at particular risk
possible risk factors: a personal or
family history of seizures or neurological
disorders, Immune system
disorders or previous bad reactions to
vaccines. Also, if your child has a
cold or other illness, immunization should
be delayed because the risk of
an adverse reaction is higher when the
immune system is already under
assault from another virus or bacterium.
~ BE CAUTIOUS. Your doctor should
explain what symptoms to watch for-such
as high fever or high.pitched
screaming-that might indicate a serious
reaction. Monitor your child
closely after vaccination, and call your
doctor if you suspect a problem.
“If your doctor is not concerned and you
still are, take the child to an
emergency room,” advises Barbara Loe Fisher
of the National Vaccine
Information Center, a nonprofit organization
in Vienna, Va. that provides
vaccine safety information to consumers
and assists those who have suffered
adverse reactions. For more safety tips,
or to learn your legal rights if
your child is injured by a vaccine, you
can call the organization at
8oo-909-SHOT.
A-~R.
MORE VACCINE HEALTH RISKS THAT MUST BE CHECKED OUT:
In addition to the vaccine-related problems
disclosed in the accompanying
article, may other risks have been discovered
through lab experiments and
random cases reported by victims or doctors.
The government and the medical
community, however, have failed to follow
up these findings with the
comprehensive studies that could prove
a definite causal link between the
vaccine and the disease. A “controlled
clinical trial” is considered the
gold standard of scientific inquiry, and
“controlled observational studies”
rank as the next best. According to the
Institute of Medicine, a private,
nonprofit organization for the examination
of health policy matters,
neither method of inquiry has been used
to check out any definitive
connection between the medical problems
listed in the table and the
vaccines that preliminary scientific researc
suggests can cause them.
Vaccine Problem DPT Encephalopathy (inflammation of
the brain resulting in loss of consciousness
that can range from stupor to
coma); demyelinating diseases of the central
nervou system (infections of
linings around nerve cells that can cause
problems such as muscle weakness
and blurred vision); Guillain-Barré
syndrome; (nerve condition
characterized by numbness and weakness
of the limbs); anaphylaxis (severe
and sometimes fatal allergic reaction)
Measles Epilepsy; optic neuritis (inflammation of
the optic nerve that causes blurred vision
and can be an early sign of
multiple sclerosis); transverse myelitis
(spina cord disease);
Gulliain-Barré syndrome; death
from vaccine strain viral infection
Mumps Encephalopathy; aseptic meningitis
(inflammation of the membranes covering
the brain, causing fever,
headaches, stiffness in the neck, drowsiness
and sometimes loss of
consciousness); sensorineural deafness;
sterility; thrombocytopenia a
reduction in the number of platelets in
the blood, manifested by a rash,
nosebleeds, a tendency to bruise easily
and prolonged bleeding from cuts)
Oral polio Transverse myelitis; death from vaccine
strain viral infection Hepatitis B Guillain-Barré
syndrome; demyelinating
diseases of the central nervous system;
arthritis
Deceptive Numbers and Dangeroud Decisions: Since
1990, doctors have been required by law
to report all adverse vaccine
through a centralized federal system overseen
by the Food and Drug
Administration and the Centers fur Disease
Control But they frequently fail
to do so-either because they don’t recognize
that a subsequent health
problem Is related to a vaccination, or
they consider it relatively
harmless. From 1991 through August 1996,
48,743 adverse reactions were
reported. Unfortunately, those figures
represent only a small portion of
the dangers. For example, a 1995 CDC study
found that reporting rates were
less than 1% for serious reactions such
as loss of consciousness after a
DPT’ shot A 1994 survey of doctors’ offices
in seen states, conducted by
the National Vaccine information Center
found that only 28 of 159 offices
said they file a report after a patient
has an adverse reaction to a
vaccine Underreporting is an important
problem because those figures are
what the FDA relies on to identify exceptionally
dangerous lots of vaccine.
When doctors don’t repor harmful effects
there is little chance a “hot lot”
can be Identified early in its market
life and recalled before more
children are hurt What’s more, unfortunately,
even with timely reporting,
the FDA is reluctant to act. For example
the lot that killed Nathan
Sllvermintz produced exactly 70 adverse
reactions, including nine
deaths-yet was never taken off the market.
Why? “This lot did have a
relatively large reporting rate for serious
and fatal reactions,” Marcel
Salive, chief of the FDA’s epidemiology
branch, told MONEY, “but there were
other lots of vaccine of smaller size
that had higher numbers of reports in
those categories, so it was felt no action
was needed.” What does it take
to get action? No horror is enough, apparently.
Salive confirms that no lot
has been recalled because of adverse effects
since the centralized
reporting system was set in place six
years ago. A.R.
Any information obtained here is not to be construed as medical or
legal advice. The decision to
vaccinate and how you implement that decision is yours and yours alone. |
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