Myths and Timelines
by Barbara Loe Fisher
The National Vaccine Information Center is committed to disseminating information about vaccines and infectious diseases in order to prevent vaccine injuries and deaths through public education and defend the informed consent ethic. Following is information about several myths being perpetuated by those who should know better, as well as a chronology of events between 1982 and 2007 that set the record straight.
MYTH #1: DPT vaccine injury lawsuits in the 1970's and 1980's drove most drug companies making vaccines out of US market; or specifically, as Offit states in the June 3, 2007 Boston Globe Op Ed, " at the beginning of the 1980's, 18 companies made vaccines, by the end of the decade, only four were left."
FACT: In 1982, there were four drug companies making and selling vaccines for children in the U.S.: Merck, Wyeth, Lederle and Connaught. In 2007, after two decades of mergers and acquisitions, there are six drug companies making and selling vaccines for children in the U.S.: Merck, Wyeth, Sanofi Pasteur, GlaxoSmithKline, MedImmune and Novartis. Foreign companies, like Australia's CSL Biotherapies, are poised to enter the lucrative US vaccine market soon. There are more than 200 vaccine trials in various stages worldwide and most vaccines being developed will be targeted by CDC officials and drug company lobbyists for widespread use in order to guarantee stockholder profits for vaccine manufacturers.
MYTH #2: Because DPT vaccine injury lawsuits in the 1970's and 1980's drove drug companies out of the US market, vaccine shortages occurred and continue to occur; specifically, Offit blames "the legacy of pertussis litigation" for shortages of tetanus vaccine "in 1998," pneumococcal (Prevnar) vaccine "beginning in 2000" and influenza vaccine "between 2003- 2004."
FACT: In a 2002 Government Accounting Office (GAO) investigation and report,"Childhood Vaccines: Ensuring an Adequate Supply Poses Continuing Challenges," the threat of vaccine injury lawsuits was not listed among reasons for vaccine shortages in the U.S.. Instead, the GAO identified primary reasons as (1) manufacturing production problems; (2) calls by immunization policy-making bodies to remove a preservative from vaccines as a precautionary measure; (3) a manufacturer's decision to cease production of some vaccines; and (4) greater than- expected demand for a vaccine that had recently been added to the immunization schedule.
Almost all of the vaccine shortages that the U.S. has experienced have been due to vaccine manufacturer production and government regulation compliance problems. Dr Offit should be well aware of reasons for vaccine shortages in the past decade because he was publicly identified as a member of the CDC's Advisory Committee on Immunization Practices (ACIP) from 1998 to 2003.
MYTH #3: DPT vaccine does not cause brain inflammation and permanent brain damage; specifically Offit states that "Subsequent studies of hundreds of thousands of children showed that the risk of permanent brain damage was the same in children who had not received the vaccine as in those who had."
FACT: Of all the vaccines which have been routinely used by children in the past century, the brain damaging effects of the pertussis (whooping cough) portion of DPT vaccine is among the most well documented in the scientific literature. Created in 1912, the crude pertussis vaccine basically consisted of B. pertussis bacteria killed with heat, preserved with formaldehyde, and injected into children. In the early 1940's, aluminum was added as an adjuvant and later the mercury preservative, thimerosal, was added when pertussis was combined with diphtheria and tetanus vaccines to create DPT. Pertussis vaccine was never studied in large clinical trials before being given to children in the first half of the 20th century or after it was combined into DPT and recommended for mass use by the American Academy of Pediatrics in 1947.
The pertussis vaccine's ability to kill was first signaled in 1933 when T. Madsen reported two babies died within minutes of vaccination. In 1947, Matthew Brody gave detailed descriptions of two cases involving brain damage and death after pertussis vaccination. But, it was the 1948 published case study by Byers and Moll that gave the strongest warning that children were suffering brain inflammation within 72 hours of pertussis vaccination and being left with various kinds of brain damage. Forty years later, the prospective UCLA/FDA study published in Pediatrics in 1981 comparing DT and DPT vaccines would find that 1 in 875 DPT shots is followed by either a convulsion or collapse shock episode within 48 hours of vaccination.