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The autism and vaccines decision may help curtail pending lawsuits
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In February, the National Vaccine Injury Compensation Program rejected the petition of three test cases alleging that autism spectrum disorders were caused by the measles-mumps-rubella vaccine and/or mercury-containing compounds. This will undoubtedly influence the decision of the more than 5,000 cases pending.
These decisions were based on testimony of 28 medical experts, 50 expert reports and more than 500 pages of transcripts and briefs that cited 9,000 scientific articles. One cannot deny that the hearings were thorough and fair. Appeals have been filed in all three cases. Mechanisms for appeal are prescribed under the VICP.
The mechanism for filing claims is described in the legislation establishing the system. It is designed to provide prompt and fair settlement of claims with minimal or no cost, if unable to afford it, to the party filing the claim. Attorneys may represent the claimant and they are fairly compensated. The judgments are based on the vaccine injury table, which contains known side effects associated with vaccines. Alternatively, as in these cases where they are not in the table, a “preponderance of evidence” can be presented that the vaccine caused the putative injury. These may include generally accepted but unproven theories, expert testimony and other evidence. The cases are heard by “Special Masters” in the Court of Federal Appeals. The VICP prescribes the mechanism of appeal, which is being pursued in all three cases. The details of these decisions can be found in The New England Journal of Medicine (2009; 360:2498-2500 and 2009; 360:2500-2501).
The VICP is included in legislation as part of the National Childhood Vaccine Injury Act (NCVIA) of 1986, passed at a time when our whole immunization system was jeopardized by litigation fueled by the media, by attorneys and by parents, angry mainly with the very reactive wP. In retrospect, there should have been an earlier response instead of allowing these concerns to simmer.
A study by Dr. Baraff and his coworkers under a contract with FDA reported that at the site of injection of wP, swelling, redness and pain occurred in 40%, 37% and 51% of the vaccinees respectively (Pediatrics. 1981; 68:650). In 2.5% of cases, the reactions in these young infants were more than two inches in size. The other reactions included persistent and unusual crying, sometimes lasting as long as 21 hours in one in a 100 vaccinees and a period in which the infants were limp, pale and poorly responsive in one in 1,750 vaccinees.
Fever of greater than 102.2ºF was reported in 6.1% of vaccine recipients. Associated with this was probably the most disturbing reaction — a convulsion — which occurred in one in 1,750 vaccinees. It was not much of a stretch for parents to conclude that this vaccine also caused permanent brain damage, and it was a number of years until it could be determined that this probably was not true. Unfortunately, we can never prove that something will never happen and this fueled parental reactions and distrust.
Reactions to this vaccine had resulted in loss of public confidence in other countries, with a subsequent decline in immunization accompanied by massive increases in cases of pertussis and deaths. It was not our proudest hour.
Fortunately, we were rescued by Japanese manufacturers who developed the aP, which we now use.
American manufacturers were understandably not enthusiastic about pursuing the development of newer vaccines as they were not very profitable and carried with them the risk of litigation. Many vaccine manufacturers left the business altogether at that time. As chair of the Red Book Committee during this time, I was intimately involved in trying to respond to this crisis.
In my new book, I note that “one manufacturer’s representative told me that they had four lawsuits prior to 1980 and 60 in a short period after including nine in one month. The amount for which they were being sued was in the billions of dollars or several hundred times their annual sales from the vaccine. Another shared with me that they were a diverse company in competition with other divisions within their organization for resources. It was pointed out to me that they made as much from the sales of underarm deodorant as from vaccines and did not get sued for the former. The legislation assured that the dwindling number of vaccine manufacturers would not disappear entirely.” It was no surprise then that companies would develop Viagra rather than new vaccines.
In addition to the NVIP, the NCVIA contained provisions for coordination of the activities of the stakeholders and oversight of the ongoing vaccine programs. Perhaps one of the most important provisions, which was designed to maintain public confidence by transparency, was the vaccine information sheets.
Another portion of the bill was designed to assure safety. This included the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink VSD. Both these post marketing surveillance systems were intended to detect rare events, which might not have been found in the earlier clinical trials that involved fewer subjects. These were able to alert us to the problem with the first rotavirus vaccine, ie, intussusceptions, which was found only after millions of doses of vaccine had been given. The VSD follows about 4 million vaccinees annually who receive their care in HMOs.