The Lethal Dangers of the Billion-Dollar Vaccine Business
by Andrea Rock
Money Magazine December 1996
Your Health by ANDREA ROCK
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.
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.
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.
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.
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.