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August 30, 2000

Background [Vaccine History]

      [The current Congressional Quarterly Researcher has a collection of
material looking at current vaccine issues and controversies, one of which
is the alleged links to autism.  It is significant that these topics are
being addressed in such a politically prestigious publication. We are
reprinting some of these reports in this newsletter. This article gives a
history of the inoculation movement.]

Background [Vaccine History]

      Early Breakthroughs
      The first vaccine breakthrough in modern times came in 1796, when
Edward Jenner, an English country physician, noticed that dairymaids exposed
to the milder disease cowpox were immune to smallpox. He took some fluid
from a patient's cowpox sore and later introduced it into a scratch in the
arm of an 8-year-old boy. Forty-eight days later, when Jenner exposed him to
smallpox, he resisted the infection. Jenner named his substance "vaccine"
after the Latin word for cow.
      Another breakthrough came in the late 19th century, when Louis
Pasteur, a French chemist, developed chemical techniques to isolate viruses
and weaken their effects so they could be used as vaccines.
      Yet vaccination continued to provoke controversy. Pasteur's first
administration of rabies vaccines to humans was strongly protested by
physicians and the public, and efforts to immunize British troops against
typhoid at the turn of the century were bitterly opposed despite the serious
risk of typhoid faced by troops serving in the Boer War in South Africa.
[12]
      By the turn of the century, other scientists had developed "killed"
vaccines against typhoid, plague, rabies and cholera. By the mid-1920s,
vaccines had been developed against diphtheria -- an often-deadly childhood
disease characterized by a severe inflammation of the throat -- and
pertussis, or whooping cough, another often-fatal childhood disease
characterized by a loud "whooping" sound as the victim struggles to get air
into the lungs after violent fits of coughing.
      Children and parents of the 1940s and '50s especially dreaded
paralytic polio, which could paralyze arms, legs or respiratory muscles.
News stories showed children with metal braces on their legs or encased in
the so-called iron lungs that helped them to breathe.
      Two teams of scientists led by Jonas Salk and Albert Sabin each
developed a polio vaccine. The Salk vaccine, using killed viruses, was
licensed in 1954 and used in mass-immunization campaigns. Within six years,
polio cases dropped 90 percent.
      But the Salk vaccine did not provide complete immunity against all
three polio viruses. By 1961, Sabin had developed an oral vaccine that did,
using a live, attenuated virus. It all but replaced the injectible Salk
version in the United States. But because it used a live virus, about a
dozen persons a year contracted polio from the vaccine or from being exposed
to a recently vaccinated child. Consequently, public health officials
decided last January to phase out the live, oral vaccine.
      By the 1960s, routine vaccination was no longer controversial among
the public and the medical community, and live-virus vaccines had been
developed for measles (1963), rubella/German measles (1966) and mumps
(1968).
      Mandatory Vaccinations
      To be effective, vaccination depends on universal immunization.
Otherwise, anyone who is not immunized can contract a disease and spread it
to others. State laws requiring immunization date from the early 1800s, when
Massachusetts required smallpox vaccinations. Britain established the
principle of universal free vaccination for smallpox three years later. In
recent times in the United States, local immunization laws aimed at schools
and licensed day-care began with efforts to eliminate measles in the 1960s
and '70s.
      Opposition to mandatory vaccinations -- largely based on religious,
legal, medical or safety grounds -- emerged almost as soon as they were
implemented. In 1905, the U.S. Supreme Court upheld compulsory-vaccination
laws, but anti-vaccination sentiment prevailed in some states. [13]
      Nonetheless, the incidence of smallpox continued to decline. The
United States reported its last naturally occurring case in 1949. In 1971,
routine vaccination for smallpox was discontinued.
      By contrast, the polio vaccine resulted in an immediate push for
federal action to make the vaccine widely available. After Salk reported
positive results from his vaccine in 1955, members of Congress from both
parties urged the government to distribute the vaccine itself or help the
states.
      The Republican administration of Dwight D. Eisenhower branded a
Democratic-sponsored bill for universal free vaccines as a form of
socialized medicine. By August, Congress had drafted a compromise measure,
the Poliomyelitis Vaccination Act, which provided $28 million to the states
for free universal polio vaccines.
      Over the next 45 years, the nation would experience a cyclical
pattern: Disease risk would appear to diminish thanks to immunization; then
politicians would cut back on immunization funds; vaccination rates would
drop, followed by disease outbreaks; then there would be an outcry for more
funding for immunizations. [14] For example, polio aid was curtailed in
1957, only to be revived in 1960 after outbreaks of the disease in several
cities. To provide broader assistance, President John F. Kennedy asked
Congress in 1962 to authorize aid to states to buy vaccines against
diphtheria, whooping cough and tetanus, as well as polio.
      DPT Under Attack
      By the early 1980s, infectious epidemics that killed hundreds of
children a year had drifted into distant memory, and some parents were
beginning to start questioning the need for massive inoculations. [15] A
small number of those parents felt that their children had been damaged by
vaccines that were not as safe as they could be -- particularly the DPT
shot.
      Among them was the NVIC's Fisher. In 1980 her toddler Chris suffered a
severe reaction after his fourth dose of DPT and an oral polio vaccine.
After studying the medical literature on vaccine reactions, she learned that
he had suffered convulsions and collapsed shock, a rare, adverse reaction to
a DPT shot.
      After that, Chris was different -- physically, mentally and
emotionally. "He no longer knew his numbers or the alphabet, he had poor
concentration levels, constant ear infections and diarrhea that would not
stop," Fisher says. "He became emaciated and stopped growing."
      Fisher learned that similar adverse events related to the DPT shot in
Japan, Sweden and the United Kingdom had led to drops in immunization rates
in those countries, and subsequent epidemics of pertussis.
      In 1982, Fisher and other mothers founded the advocacy group that
evolved into the NVIC. Their goal: get Congress to demand safer DPT
vaccines.
      By then Japan was already using a safer version of the vaccine,
produced, ironically, with technology developed by the NIH. In fact, a U.S.
company, Eli Lilly, had marketed the safer version in the 1960s and '70s,
but when Wyeth bought Lily in 1976, it discontinued the product. A 1977
Wyeth internal document said producing the safer DPT shot would result in "a
very large increase in the cost of manufacture." [16]



       English physician Edward Jenner (top) coined the term "vaccine" after
discovering how to protect against smallpox. Jonas Salk (center) led the
team that developed the first polio vaccine in 1954 in Pittsburgh. Albert
Sabin (bottom) developed an improved oral polio vaccine in 1961 at his
University of Cincinnati lab. (Sources: Centers for Disease Control and
Prevention, Archive Photos and Corbis-Bettmann Photos.)
      "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.
health officials. "What we are faced with is going from a vaccine that costs
literally cents to produce to one that I believe is going to cost dollars to
produce." [17]
      By the mid-1980s, at least 300 lawsuits had been filed against U.S.
DPT manufacturers. "They knew that the older pertussis vaccine was making
kids sick," recalls Ted Warchafsky, a Milwaukee attorney who represented
parents seeking damages.
      In 1991, Fisher documented the development of the DPT vaccine in A
Shot in the Dark, explaining how the more toxic whole-cell pertussis portion
of the shot was causing so many problems, and why a safer, acellular version
had not been widely marketed in the United States.
      "When word went out that I was writing that book, people started
leaving packages of documents, with transcripts from government meetings, on
my doorstep in the middle of the night," Fisher says. "One physician told
me, 'You are on the right track, but I will never stand up beside you
publicly and say that.' "
      Fisher says "it was all about money," but, in fact, health officials
and drug firms also wanted to keep the price of vaccines low enough for
impoverished Third World governments.
      "It's the same for every . . . vaccine," said Stanley Plotkin, medical
and scientific director for Pasteur-Merieux-Connaught, a Paris-based
pharmaceutical company. "Research costs are recouped in North America and
Europe, and the vaccines are sold in the developing world at much, much
lower margins." [18]
      Stainer went on to ask at the 1982 meeting whether it was right to
switch to the safe DPT vaccine: "Are we . . . going to have two vaccines,
one for the wealthy and one for the rest? I don't think any of us want
that."
      But that is exactly what has happened. The U.S. government stopped
purchasing the whole-cell DPT vaccine in 1996 and recommended that doctors
switch to the acellular DTaP version. Only about 6-7 percent of the
pertussis vaccines in the U.S. still contain the whole-cell DPT. But it is
widely used in the Third World.
      But back in the mid-1980s, faced with increasing lawsuits, one of the
three DPT producers stopped producing it, and the remaining manufacturers
found it was increasingly difficult to obtain liability insurance.
"Shortages of the vaccine occurred in some areas of the country, and prices
escalated dramatically," Duke University's Katz recalled. [19]
      But instead of selling the safer Japanese vaccine, Warchafsky says,
U.S. manufacturers asked Congress to limit their liability for adverse
reactions to any vaccine mandated by the government, hinting they might stop
producing children's vaccines without it.
      "And then the industry started buying up the experts," he contends,
citing the example of James Cherry, a widely recognized pertussis expert who
has served on both the ACIP and the AAP's vaccine advisory committee.
      Cherry was a principal author in a 1978-79 study sponsored by the FDA
and the University of California at Los Angeles (UCLA), which found that an
alarming number of children receiving the DPT shot, one in 1,750, was at
risk of suffering from "collapse shock" and an equal number of having
convulsions.
      Yet by 1990, after having received a $400,000 grant from Lederle, he
declared in the Journal of the American Medical Association (JAMA) that
severe brain damage caused by the vaccine was a "myth." By 1993, Lederle had
given Cherry and UCLA an additional $834,000 for pertussis research and
expert testimony in lawsuits brought by parents of injured children. [20]
      Meanwhile, Congress in 1986 limited the liability of manufacturers of
mandated vaccines and health practitioners who administer them. The National
Childhood Vaccine Injury Compensation Act also:
      Established a "no-fault" system of compensation for injuries or deaths
reasonably associated with the administration of childhood vaccines;
      Ordered CDC to set up a centralized system for reporting adverse
reactions to vaccines; and
      Required periodic independent reviews of the scientific evidence on
adverse events.
      Immunizations Lag
      By the late 1980s, immunization rates were slipping again. Then, in
the first years of George Bush's presidency, the nation got a wake-up call
on the dangers of incomplete immunization: A major measles epidemic in
1989-91 killed at least 132 persons.
      Concentrated in Chicago, Houston, Los Angeles, New York and
Philadelphia, the outbreak had infected 18,000 people by 1989. More than
three-fourths of the cases involved unimmunized preschool children, mostly
blacks and Hispanics.
      "Everyone knows that when immunization levels drop, it is just a
matter of time before you get an epidemic," said Philip A. Brunell, former
chairman of the AAP Committee on Infectious Diseases. [21]

       The U.S. military's push to inoculate all service members against
anthrax spread by germ warfare has been highly controversial. Many service
members quit rather than take the vaccine or were court-martialed for
refusing to take it. (KRT Photo/Kim Foster)
      p>In recent years, concern about vaccines has deepened as officials
have begun adding new vaccines for non-epidemic diseases to the mandatory
schedule, and as enforcement of mandatory vaccinations has begun to tighten.
      Some doctors, rewarded by managed-care companies for achieving high
inoculation rates, won't treat patients who refuse vaccination. States,
which receive federal grants for achieving high inoculation rates, are
pressuring local health departments to improve inoculation rates. And
welfare mothers in some states are having their checks reduced if their kids
don't get vaccinated.
      The Clinton administration has won legislation to extend vaccination
programs to the poor and has recommended new legislation to improve
vaccination levels. Since 1994, the Vaccines for Children program has
allowed the government to provide free pediatric vaccines for low-income
children.
      In addition, the federal government is overseeing establishment of a
network of state electronic vaccine-tracking registries. So far, 22 states
have set up or are in the process of establishing such registries, whereby
all children are enrolled at birth. One state is using the database to
contact parents of children who have not received all their federally
mandated vaccines.

      [12] From Susan S. Ellenberg and Robert T. Chen, "The Complicated Task
of Monitoring Vaccine Safety," Journal of the U.S. Public Health Service,
Public Health Reports, January/February, 1997; Vol. 112, No. 1; pp. 10-20.
      [13] Jacobson v. Massachusetts 197 U.S. 11 (1905).
      [14] For background, see Kenneth Jost, "Childhood Immunizations," The
CQ Researcher, June 18, 1993, pp. 529-552.
      [15] For background, see Mary H. Cooper, "Combating Infectious
Diseases," The CQ Researcher, June 9, 1995, pp. 489-502.
      [16] Rock, op. cit., p. 153.
      [17] Harris L. Coulter and Barbara Loe Fisher, A Shot in the Dark
(1991), p. 209.
      [18] "Industry Perspective: An Interview with Dr. Stanley Plotkin,"
IAVI Report, June 1996. p. 7.
      [19] Katz's comments were made in testimony Aug. 3, 1999, before the
House Government Reform Committee.
      [20] Rock, op. cit., p. 153.
      [21] Jost, op. cit., p. 540.

From the CQ Researcher of Aug 25, 2000
2000 Congressional Quarterly Inc. All Rights Reserved.

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