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THE LETHAL DANGERS OF THE BILLION-DOLLAR VACCINE BUSINESS

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How about sending reprints of this article to all members of

Congress???

> > Here is an interesting article written in 1996

> >Hope it not too long.

> >Nina

> >

> >THE LETHAL DANGERS OF THE BILLION-DOLLAR VACCINE BUSINESS WITH

GOVERNMENT

> APPROVAL, DRUG COMPANIES SELL VACCINES THAT CAN LEAVE YOUR CHILD

BRAIN

> DAMAGED, CAN SPREAD POLIO FROM YOUR BABY TO YOU--AND CAN EVEN KILL.

SAFER

> STUFF IS AVAILABLE. HERE'S WHY YOU HAVEN'T BEEN GETTING IT.

> >Author: Contributors: ANDREA ROCK Date/Issue: DECEMBER 1996 VOL.

25 NO. 12

> Word Count: 4521 Section: SPECIAL REPORT/YOUR HEALTH

> >

>

> Thanks for posting this - this is the excellent expose in MONEY

magazine of

> all places in 1996!

> --------------------------------------------------------

> Sheri Nakken, R.N., MA

> Vaccination Information & Choice Network, Nevada City CA & Wales UK

> $$ Donations to help in the work - accepted by Paypal account

> vaccineinfo@b... voicemail US 530-740-0561

> (go to http://www.paypal.com) or by mail

> Vaccines - http://www.nccn.net/~wwithin/vaccine.htm

> Homeopathy course - http://www.nccn.net/~wwithin/homeo.htm

> ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL OR LEGAL

ADVICE. THE

> DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

> Well Within's Earth Mysteries & Sacred Site Tours

> http://www.nccn.net/~wwithin

> International Tours, Homestudy Courses, ANTHRAX & OTHER Vaccine

Dangers

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> CEU's for nurses, Books & Multi-Pure Water Filters

> ******

> " Just look at us. Everything is backwards; everything is upside

down.

> Doctors destroy health, lawyers destroy justice, universities

destroy

> knowledge, governments destroy freedom, the major media destroy

information

> and religions destroy spirituality " .... Ellner

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Here is an interesting article written in 1996

Hope it not too long.

Nina

THE LETHAL DANGERS OF THE BILLION-DOLLAR VACCINE BUSINESS WITH GOVERNMENT

APPROVAL, DRUG COMPANIES SELL VACCINES THAT CAN LEAVE YOUR CHILD BRAIN DAMAGED,

CAN SPREAD POLIO FROM YOUR BABY TO YOU--AND CAN EVEN KILL. SAFER STUFF IS

AVAILABLE. HERE'S WHY YOU HAVEN'T BEEN GETTING IT.

Author: Contributors: ANDREA ROCK Date/Issue: DECEMBER 1996 VOL. 25 NO. 12 Word

Count: 4521 Section: SPECIAL REPORT/YOUR HEALTH

When Miriam Silvermintz of Fair Lawn, N.J. took her seven-month-old son

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 lay in his crib, he shrieked in pain. Terrified, Miriam

ran in and cradled her baby in her arms. 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 ? " When I first called the pediatrician after the ambulance

arrived, he said probably was just having a reaction to his DPT shot, "

Miriam recalls. " But when died, the doctor did an about-face and said it

had nothing to do with the vaccine. " 's death was officially attributed to

a congenital heart defect. But Miriam, now 36, and her husband , 37

(pictured on page 151), couldn't shake the feeling that 's death was

somehow linked to the shot.

They began to search for details on DPT, which prevents diphtheria, pertussis

(familiarly 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 , 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,

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 '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. "

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 children

receive the safest vaccines that can be made? And shouldn't your doctors 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 than $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 vaccines that have been used longer than any others in this

country, DPT and polio, MONEY found that health officials publicly downplay 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 cause 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 misclassified 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 vaccine that would cost $19.43 a

dose, just $9 more than the current product. Who wouldn't pay $9 to protect

their child even from a one-in-62,000 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:

--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.

--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.

--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., even

though it is made by the same company that produces all U.S. injected polio

vaccine.

--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 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 of half a billion dollars.

Meanwhile, manufacturers' 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 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

results in permanent brain damage, according to a 1993 British study that

followed children over a 10-year period. Since damage can occur with any one of

the full series of five DPT shots, the odds of suffering brain damage for a

child receiving all five doses of vaccine works out to one in 62,000.

Additionally, based on a 1979 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

1920s.

At the same time, the safer vaccine costing $9 more a dose has been used in

Japan since 1981. 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 byproducts of the bacteria, including endotoxin, a substance

scientists say can cause serious afflictions, such as 's brain

damage. By contrast, until recently, the two licensed U.S. DPT manufacturers,

Wyeth-Lederle and Connaught Laboratories, used only the whole bacteria, toxins

and all, yielding a whole-cell vaccine that former FDA researcher

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

whole cell. One of the companies, Eli Lilly, marketed its vaccine, Trisolgen,

for 15 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, its 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 an 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 a gold-medal hurdler for not having started the race or

cleared the hurdles as early as you think she should have, " 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 90% 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 Halsey,

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 vaccine doesn't cause brain damage

shows what a lot of money can do. Drug companies have paid a lot of money to

people like 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 its vaccine advisory committee to vote on

issues involving any company with whom they have 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 1988, Lenita Schafer (pictured on page 153) brought her

three-month-old daughter 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 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 true 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 only for people who never have been

vaccinated against the disease. Yet Lenita, now 44, was immunized as a child.

The CDC knows better. Minutes from a June 1995 meeting of the CDC's advisory

committee on immunizations show the organization realizes that people who were

vaccinated are susceptible to contact polio: " The previous belief...has not been

borne out by experience. " Says Walter , a Hingham, Mass. attorney who has

represented Lenita and other contact polio victims: " The CDC's job is to give

people the truth. "

Furthermore, going beyond the fact that the CDC info sheet is outdated and

inaccurate, Lenita would not have contracted polio if her baby had simply

received an injection of inactivated polio vaccine (IPV) rather than an oral

dose of live-virus vaccine (OPV). The injection protects against the disease but

can't cause it because the polio virus has been " killed " --inactivated with

chemicals so that it is not infectious.

In addition, federal health policy contributed to Lenita's paralysis. Although

the injection was an available option, the doctor was following government

policy when he automatically gave Lenita's daughter the oral vaccine. For 30

years until this September, one of the reasons that CDC officials recommended

oral vaccine was precisely because the live virus shed in a recently vaccinated

baby's body fluids could immunize more people through contact than it

threatened, albeit without their knowledge or consent.

Federal health officials were aware that, each year, about 10 children or their

caregivers might actually get polio from the oral vaccine. But the feds

considered these human sacrifices acceptable for the greater public health goal

of 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 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.? Salamone of Oakton, Va., whose son , 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.

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 of 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 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 Salamone, " doctors are

inclined to do the easy thing, which is continuing to give the familiar oral

polio vaccine. " Cost may also be a 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

There is another polio vaccine risk-- " a ticking time bomb, " according to Harvard

Medical School professor 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 , a

professor of pathology at the University of Southern California, warned that

other monkey viruses could be dangerous. But government officials rebuffed

's attempt to research those risks back in 1978 and again in 1995 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 , " 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 SV-40 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 tumors 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.

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

Urnovitz, a microbiologist in Berkeley.

Connaught uses human diploid cells 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 Grant told MONEY.

The FDA is equally dismissive of the potential dangers. 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 SV-40, SIV 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 of 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

1994 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 parents' 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. "

Sidebar: MORE VACCINE HEALTH RISKS THAT MUST BE CHECKED OUT

MORE VACCINE HEALTH RISKS THAT MUST BE CHECKED OUT

In addition to the vaccine-related problems disclosed in the accompanying

article, many 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 this table and the vaccines that preliminary scientific

research suggests can cause them.

Vaccine DPT

(Problem) Encephalopathy (inflammation of the brain resulting in loss of

consciousness that can range from stupor to coma); demyelinating diseases of the

central nervous system (infections of linings around nerve cells that can cause

problems such as muscle weakness and blurred vision); Guillain-Barre syndrome

(nerve condition characterized by numbness and weakness of the limbs);

anaphylaxis (severe and sometimes fatal allergic reaction)

(Vaccine) Measles

(Problem) Epilepsy; optic neuritis (inflammation of the optic nerve that causes

blurred vision and can be an early sign of multiple sclerosis); transverse

myelitis (spinal cord disease); Guillain-Barre syndrome; death from vaccine

strain viral infection

(Vaccine) Mumps

(Problem) Encephalopathy; aseptic meningitis (inflammation of 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)

(Vaccine) Oral polio

(Problem) Transverse myelitis; death from vaccine strain viral infection

(Vaccine) Hepatitis B

(Problem) Guillain-Barre syndrome; demyelinating diseases of the central nervous

system; arthritis

Sidebar: DECEPTIVE NUMBERS AND DANGEROUS DECISIONS

DECEPTIVE NUMBERS AND DANGEROUS DECISIONS

Since 1990, doctors have been required by law to report all adverse vaccine

reactions through a centralized federal system overseen by the Food and Drug

Administration and the Centers for 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 seven 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 report 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 Silvermintz 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 year -AR

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