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Another decision from the ‘Vaccine Court’
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Several times in the past, I have used this column to bring readers up to date on the workings of the “Vaccine Court” as it works its way through the “Omnibus Autism Bundle.” The background information that follows will serve to remind readers what this is all about and why it might be important to adult infectious disease physicians.
The National Vaccine Injury Compensation Program (VICP) was enacted into law in 1986. It was landmark legislation designed to address the apparent flight of vaccine manufacturers from the marketplace because of enormous judgments for plaintiffs who alleged injury from this or that vaccine. This clearly posed a threat to the U.S. supply of vaccines, particularly vaccines for childhood immunization. The program is funded by a small levy on each dose of vaccine sold; over the years the fund has accumulated several billions of dollars.
Under the VICP, individuals (or their parents or guardians) who may have been injured by a covered vaccine must file a petition for “no-fault” compensation with the United States Court of Federal Claims (USCFC).
The VICP has a vaccine injury table; if a petitioner has a specific injury that appears on the list that occurred within some specified interval after receiving the vaccine, it creates a presumption of causation and compensation can occur forthwith. If, on the other hand, a petitioner’s alleged injury does not appear in the table or occurred outside of the acceptable time frame, then a hearing is held before the appointed “Special Masters” of the U.S. Court of Federal Claims and evidence is presented both by the petitioner and the Secretary of the Department of Health and Human Services (HHS). Both sides may present medical evidence, expert testimony and the like. The term “Vaccine Court,” although it gets the point across, is actually a misnomer; it refers to the Special Masters of the USCFC.
Autism and the court
Of note, autism does not appear in the vaccine injury table. There are about 5,000 cases that allege injury resulting in autism before the court; these have been lumped together into the “Omnibus Autism Bundle.” There are three theories of causation: first, thimerosal and MMR vaccine somehow act in concert to produce autism; second, thimerosal alone causes autism; and third, MMR vaccine alone causes autism. Nine test cases were to be heard, three representing each of the three theories of causation. Subsequently, however, the third theory was dropped, since all of the evidence bearing on MMR vaccine was presented during the hearings on the cases representing the first theory, ie, that MMR vaccine and thimerosal act together to case autism.
In early February, the court rendered its decision about the first three test cases and completely rejected the claims of the petitioners in all three cases. In the language of the court: “It was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive.” This was considered, correctly I believe, to be a victory for science, reason and common sense. Statements issued by officials at HHS, the American Academy of Pediatrics and the American Medical Association were all appropriately low key, all pointing out a vindication of science and reason, but not gloating. All acknowledged the burden that autism places on families and supported the need for more research into the cause(s) of autism.
Hearings on the cases exemplifying the second theory, ie, thimerosal itself is the culprit, started last fall and are currently in post-hearing briefings; a decision will be made later this year or next. One can only speculate whether the decision about the first theory in any way presages the decision about the second. However, the simple fact that autism rates did not change after thimerosal was removed from childhood vaccines surely says something important.
Then, as an outlier, there is the Hannah Poling matter, about which I wrote last May. This case, in which the Court ruled in favor of the petitioners, introduced the possibility of a third factor, eg, a genetic factor, or as in this case, a mitochondrial disorder, that somehow rendered Hannah Poling uniquely susceptible to vaccine injury. The Court was persuaded that this was “plausible,” and therefore awarded her compensation. This came as something of a surprise to the medical experts, who were totally unaware of any scientific basis to support such a claim.
Effect on physicians
Why does all this matter to you, the reader? Some of you practice pediatric infectious disease and will surely get asked about these matters both by parents and pediatricians. Even if you limit practice to adult infectious disease, you will be regarded as “the experts” on vaccines and vaccine reactions by both primary care physicians and the public.
Will any of this dissuade the substantial body of people who firmly believe that MMR vaccine and/or thimerosal caused their child’s autism? It’s doubtful at best. One grandmother of my own acquaintance is convinced beyond any reason that MMR vaccine caused her granddaughter’s autism; she continues to believe it just as firmly today, after the court’s decision. The vigor of the anti-vaccination group will not be diminished and a decision adverse to the petitioners would likely further harden the commonly-held belief that the federal government, the vaccine manufacturers and academia have all colluded together into a vast “Vaccine Establishment.”
When the decision is made on the cases representing the second theory, I will certainly let you know.
Free antibiotics
Briefly an another matter: on page 14 of this issue of Infectious Disease News is a brief article describing IDSA’s response to the decision of several large grocery changes to provide certain popular antibiotics free of charge. Turns out now that the IDSA has been joined in its criticism by none other than the Consumers Union! Consumer Reports notes that “every antibiotic prescribed unnecessarily increases the risk of a future infection from a bacterial mutation that is resistant to antibiotics.” When was the last time that IDSA and Consumers Union were on the same side of a political position?
Strange bedfellows indeed!