FW: vaccine article -Money magazine (part 1)

[Guest guest]

>

>SPECIAL REPORT/YOUR HEALTH: 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 F

>

>

>

> 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. "

>

______________________________________________________

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