In the 1980’s, the American Academy of Pediatrics (AAP) lobbied Congress for the passage of the National Childhood Vaccine Injury Act of 1986. According to the AAP, liability protection for the vaccine manufacturers was the best way to protect the childhood vaccine supply. Under this law, vaccine manufacturers have a duty to warn of vaccine side effects only to pediatricians. This duty does not extend to parents who bring their children to pediatricians for well-child checkups. Once pediatricians receive vaccine side-effect warnings from the vaccine manufacturer, pediatricians should make an individual determination of the medical risks depending on the child’s medical and family history. Like vaccine manufacturers, pediatricians have significant liability protection from medical malpractice under this law due to the AAP’s lobbying efforts in the 1980’s.
The 1986 law requires parents to receive written information about the risks and benefits of vaccines prior to vaccination. The CDC produces these vaccine information statements, but many CDC officials have significant financial relationships with pharmaceutical companies that are poorly disclosed to the public. As a result of the conflict of interests, these statements can conceivably underrepresent the extent and seriousness of the risks as well as exclude chronic side effects.
Another kind of written information available to pediatricians and parents about vaccine safety is the vaccine manufacturer’s package inserts. As a result of vaccine injury lawsuits, U.S. vaccine manufacturers began producing package inserts containing contraindications and side-effects information. The benefit of vaccine injury litigation is that it serves a regulatory purpose by providing better consumer protection. The risk of lawsuits forces vaccine manufacturers to disclose vaccine safety information.
In the 1970’s, disclosure of medical information contained in the DTP vaccine package inserts was thirty years behind available medical literature. Additionally, the contraindications found in the package inserts are narrowing, confusing, contradictory or unknown. Reasons for possibly inaccurate information contained in package inserts are low priorities for vaccine safety and perverse incentives for vaccine safety. With the 1986 law, however, the risk of lawsuits against vaccine manufacturers is extremely low. Furthermore, the 1986 law presumes proper warning is given when the warning labels in the package inserts comply with low government safety standards. For many reasons, the quality of the warning is deficient. In the case of determining a vaccine injury compensation award involving the Gardasil vaccine, however, a special master deemed the package insert information sufficient and denied the petitioner access to vaccine safety information from the vaccine manufacturer.
Besides the duty to warn extending only to pediatricians and their liability protection, a major problem is incomplete knowledge about vaccine side effects. In 2013, the Institute of Medicine acknowledged vaccine safety research gaps including the lack of studies examining the number, frequency, timing, order of vaccines and age at the time of vaccination in the current CDC immunization schedule. There are no scientific studies examining the relationship between cumulative and/or simultaneous doses of vaccines of the entire CDC immunization schedule and health outcomes, yet school entry requires proof of immunization for U.S. schoolchildren. U.S. children are receiving more vaccines at earlier ages under the current CDC immunization schedule. Furthermore, many pediatricians may not know what is a vaccine side effect since their medical education and practice is heavily influenced by the pharmaceutical industry. Because of a pediatrician’s lack of complete knowledge of contraindications and side effects coupled with liability protection, parents may not receive adequate and complete warnings about a vaccine’s side effects. Think about how many times pharmaceutical representatives visit pediatrician offices and leave their imprint, whether it be informational brochures, samples of pharmaceutical products, or invitations to wine and dine.
Historically, the AAP does not favor passing along information about vaccine side effects to parents. In the 1950’s there was clear evidence the DTP vaccine was causing serious adverse neurological effects; however, the AAP continued to give the public message that the vaccine was safe and effective. Instead of warning parents about the risk, the AAP engaged in scare tactics to mislead the public about the actual number of pertussis outbreaks and stressed the danger of pertussis. At the same time, the AAP ignored or denied the risks of the DTP vaccine until finally the FDA approved a safer vaccine for all five doses for U.S. children in 1996.
In 1974, in Reyes v. Wyeth Laboratories, the AAP adopted the position that side-effect warnings were not important and should not be required since they served no useful purpose. In the famous Reyes case, two-week old Anita Reyes received the oral polio vaccine in a Texas department of health clinic in 1970. A nurse gave Anita the vaccine without providing any warning about the vaccine’s side effects to Mrs. Reyes. About two weeks later, Anita was diagnosed with polio. At eight months of age, her father filed a lawsuit under the belief that the vaccine caused Anita’s polio. The Fifth Circuit court awarded Mr. Reyes $200,000. The court held that Wyeth had a duty to warn Anita’s parents directly. The AAP, on the other hand, took the position that warnings only encouraged vaccine injury lawsuits and that these lawsuits threatened efforts to increase immunization rates by frightening or confusing parents. Similarly, in 1982 the AAP rejected the proposal to require pediatricians to inform parents about the risks and benefits of vaccination and risks of vaccine preventable diseases.
Given the AAP’s history, the next time a pediatrician tries to coerce you into vaccinating your child or does not respond to your concerns about why your child is sick or complaining of pain after receiving a vaccine, please keep in mind that pharmaceutical companies have donated millions of dollars to the AAP for years. There are warnings to beware of holistic and alternative health care options as medical quackery; however, it would behoove parents to seek out health care professionals whose livelihoods are not dependent on the pharmaceutical industry. Recognize and research other ways to prevent and treat infectious diseases with less serious side effects; they do exist and are effective and are more widely embraced in other countries not gripped by the clutches of the pharmaceutical industry. Vaccines are not the one and only answer. The holistic and alternative health care professions (whether it be functional medicine, energy medicine, homeopathy, naturopathy, acupuncture, chiropractic, etc.) have become an endangered industry in the U.S. due to the profession’s inability to gain legitimate recognition or licensure by the FDA and other government and medical organizations saturated by the influence of the pharmaceutical industry. The real warning is to beware of the AAP and its allies.
~ Susan Lee
Susan Lee is a legal advocate for vaccine-injured children and their families. She assisted with an amicus brief to the United States Court of Appeals for the Federal Circuit in Carson v. Secretary of Health and Human Services. This entry is from her article “Sacrificing Children’s Safety for Vaccine Supply: Nonexistent Safeguards for Remedying Mandatory Defectively Designed Vaccines” available at http://papers.ssrn.com/abstract=2364071.