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June 5, 2019

Why the US government has paid $4B to patients allegedly injured by vaccines

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    Unlike other drug-related injuries, where the drugmaker can be held liable, when it comes to vaccine injuries, the government addresses complaints via a special program—which some say may unintentionally give legitimacy to misinformation that fuels "'vaccine-hesitant' community," James Hamblin writes for The Atlantic.

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    A spate of lawsuits

    The Vaccine Injury Compensation Program (VICP) made its first payment in 1988, but the sentiment that spurred its creation began nearly two decades prior, Hamblin reports.

    One of the first high-profile lawsuits over a vaccine involved a baby girl who became paralyzed in 1970 after receiving the polio vaccine. At the time, the vaccine involved a live virus that in very rare circumstances could cause the disease itself, Hamblin writes.

    The girl's father sued the maker of the vaccine, and a jury awarded the family $200,000 on the grounds that the family had not been adequately warned of the risk the vaccine carried, which was known at the time.

    Following the polio vaccine lawsuit, several other lawsuits against vaccine manufacturers made the news in the 1970s and '80s. In many cases, patients were suing for damages into the tens of millions, according to Hamblin.

    The special program for vaccine injuries

    Public health officials grew concerned that the threats of lawsuits would lead drugmakers to stop pursuing vaccines, so Congress in 1986 passed the Vaccine Act. The Act created the VICP to handle injury claims related to vaccines—and ensure drugmakers' continued interest in making them, Hamblin reports.

    Stanford Law School professor Nora Freeman Engstrom explained, that under the program, patients who might possibly have been harmed by vaccines would give up some legal redress and in exchange, they were to be guaranteed compensation. Under the law, the program was tasked with addressing claims "quickly, easily, and with certainty and generosity."

    However, Engstrom in a 2015 analysis found that the program denied most of the claims it received for the bulk of its history. According to her analysis, about 25% of claims submitted to VICP were compensated.

    An increase in payouts

    But things have changed significantly in the last four years, Hamlin reports. Compared with Engstrom's earlier findings, between 2015 and 2019, the program compensated 77% of claims, according to a report from the Health Resources and Services Administration. In 2017, the program paid 706 claims—up from 57 in 2004.

    Citing those statistics, Hamblin writes, "While this change brings the VICP closer to its initial mission, the sheer amount of money changing hands may also amplify public perception of the risk of vaccines."
    Hamblin notes that the amount of money the program has paid out has increased "steadily" over the past decade, from $54 million in 2006 to $282 million in 2017—with payments on track to surpass that number this year.

    Further, citing a 2018 analysis, Hamblin writes, "This time period has also seen rising public skepticism of the pharmaceutical industry and online conspiracies propagating more readily than ever."

    Moreover, Hamlin suggests that the way the commission determines whether to pay claimants may give a false, inappropriate sense of legitimacy to vaccine skepticism.

    Compared to a criminal case, in which a defendant is presumed innocent until proven guilty, under the VICP, the vaccine is presumed to be the cause of injury—even if causation isn't proven. In fact, VICP's site notes that "being awarded compensation for a petition does not necessarily mean the vaccine caused the alleged injury." The program estimates that roughly 70% of payments are the result of a settlement "in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine caused the alleged injury."

    A tradeoff worth making?

    But while it's possible that the VICP could unduly amplify claims from vaccine skeptics, several public health officials maintain the commission serves an important public health purpose.

    A recent JAMA article written by VICP current and incoming physician leaders states, "Although the establishment of the VICP may support some arguments of those who question the safety of vaccines, its existence promotes wide acceptance of vaccination as a public good that is also humane to those who perceive they have been injured by this public good."

    While recent trends may suggest there's a financial incentive to bring claims, Cody Meissner, the chair of pediatric infectious disease at Tufts University School of Medicine and incoming chair of the commission, said he prefers this setup to one in which it's challenging and costly to bring a claim.

    Narayan Nair, a physician and current head of the VICP, said, "Vaccines are safe. That's the message we need to get out there" (Hamblin, The Atlantic, 5/14).

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