Is the Vaccine Injury Compensation Program Evidence of Vaccine Safety?

by Jul 1, 2019Health & Vaccines9 comments

The Department of Health and Human Services, Washington, DC (Sarah Stierch/CC BY 4.0)

The New York Times’ argument that the government’s Vaccine Injury Compensation Program is evidence of vaccine safety rests on falsehoods and deceptions.

On June 18, the New York Times published an article titled “Vaccine Injury Claims are Few and Far Between”, which argues that data from the government’s Vaccine Injury Compensation Program (VICP) shows that vaccines are extraordinarily safe. However, the argument presented is fallacious, and, furthermore, the Times attempts to support it by grossly deceiving its readers.

Mainstream media articles related to the topic of vaccines almost never mention the VICP, so on one hand, it’s refreshing to see an article focused on it. On the other hand, the Times in this case serves its typical function of manufacturing consent for government policy rather than properly educating people so they’re able to make a truly informed choice about whether to vaccinate.

Protecting Vaccine Manufacturers at Public Expense

As happens frequently in Times articles, some of the most important information is placed way down the page (if included at all). In this case, it’s only at the very end of the article that the Times comes around to pointing out that the Vaccine Injury Compensation Program was established under a 1986 law that granted broad legal immunity to the pharmaceutical industry against vaccine injury lawsuits. The National Childhood Vaccine Injury Act was passed in the face of lawsuits that were putting vaccine manufacturers out of business, the purpose being to preserve existing public vaccine policy by ensuring a steady supply of vaccines.

According to the Times (emphasis added):

A 1986 law established the compensation fund, financed by a tax paid by vaccine manufacturers of 75 cents per dose. The law acts as a liability shield for drug companies: People claiming injury are required to seek redress first with the vaccine program in the United States Court of Federal Claims and with the Department of Health and Human Services before they can sue a manufacturer.

The next paragraph repeats that, if the petitioners reject compensation or their claim is dismissed, “they can sue the vaccine manufacturer”.

The Times cites a lawyer who represents people filing claims suggesting, however, that it would be hard to win a lawsuit against the manufacturer because the VICP requires “a lower burden of proof” than civil court.[1]

The Times is deceiving its readers on two counts here. First, while it’s true that the excise tax that funds the VICP is nominally paid by the manufacturers, the cost is ultimately born by the consumers because the tax is included in the price charged to purchasers.[2]

This is a key deception by the Times because it has the effect of whitewashing the true purpose and effect of the VICP: to shift the financial burden for vaccine injuries away from the pharmaceutical industry and onto the taxpaying consumers.

Second, it isn’t generally true that if the petitioner rejects or is denied compensation that they can then just sue the manufacturers in civil courts. On the contrary, the legal immunity granted to the pharmaceutical industry under the 1986 law is nearly total. In 2011, the US Supreme Court effectively closed the civil courts as an option except under two narrow conditions, judging that the “unavoidability” of vaccine injuries establishes “a complete defense” against lawsuits, provided that the vaccine was prepared according to specifications and was accompanied with adequate warnings (which are found in the manufacturer’s package inserts). In the Supreme Court’s judgment, uniquely for the vaccine industry, “design defects” are “not a basis for liability.”[3]

This, too, paints a very different picture of vaccine safety than the one the Times wants its readers to take away—as does the fact, noted by the Supreme Court, that vaccine manufacturers, before being granted legal immunity, found it difficult to obtain product liability insurance.[4] This raises the obvious question: if vaccines are really as safe as public health officials claim, why does the vaccine industry uniquely require indemnification from the government in order to stay in business?

Furthermore, as Justices Sonia Sotomayor and Ruth Ginsburg observed in a dissenting opinion, the Court’s decision “leaves a regulatory vacuum in which no one—neither the FDA nor any other federal agency, nor state and federal juries—ensures that vaccine manufacturers adequately take account of scientific and technological advancements. This concern is especially acute with respect to vaccines that have already been released and marketed to the public. Manufacturers, given the lack of robust competition in the vaccine market, will often have little or no incentive to improve the designs of vaccines that are already generating significant profit margins.”[5]

This elimination of market incentives to develop safer products was not an unforeseen consequence of the 1986 law. It was anticipated. For example, in 1984, Jonas Salk, the inventor of the inactivated poliovirus vaccine, expressed “serious concerns” about the proposed legislation in testimony to Congress, primarily “the removal of the incentive for manufacturers and the scientific community to improve existing vaccines”, as well as “the removal of the incentive to change policy” to recommend the use of equally effective but safer vaccines when they exist.[6]

So, to sum up, here is the critical context that the Times article omits in order to persuade its readers that vaccines are extraordinarily safe: The Vaccine Injury Compensation Program was established under a 1986 law that granted vaccine manufacturers near total legal immunity and effectively shifts the financial burden for vaccine injuries away from the pharmaceutical industry and onto the taxpaying consumers while eliminating the incentive for manufacturers to develop safer and more effective means of disease prevention.

The Times’ Erroneous Risk-Benefit Analysis

Beyond omitting that crucial context, the Times’ argument rests on a simplistic risk-benefit analysis that ignores relevant facts and depends upon numerous false assumptions—including the totally baseless assumption that the number of claims filed under the VICP is representative of the true rate of vaccine injuries relative to the number of doses administered.

Returning to the beginning of the article, the Times asserts that data from the VICP “offers one way to gauge the safety of vaccines.” It informs that in the past twelve years or so, about 126 million doses of measles vaccine have been administered in the US. Whereas in the pre-vaccine era there were 400 to 500 measles-related deaths each year, only 284 people have filed injury claims from those millions of vaccinations, and of those only 143 received compensation under the VICP. “A total of $4.15 billion in compensation has been paid out since the program’s inception.”

These numbers, the Times would have you believe, demonstrate that getting the vaccine is far safer than getting measles. Continuing, the Times asserts (emphasis added):

The likelihood of serious harm if a person contracts measles is much greater than the chance of being injured from the measles vaccine, data shows. About one of four people who get measles are likely to be hospitalized, and one to two of every 1,000 people who get it are likely to die from the disease, according to the C.D.C. In comparison, claims of harm have been filed for about two out of every million doses of the measles vaccine.

All you need to do, though, to see that both the Times and the CDC are lying to you about the risks from measles is to click the link that the Times conveniently provides and look at the actual data.

Lying about the Risks from Measles

The data presented in the Times’s source, a CDC document, does not show that one to two out of every thousand people infected with measles died from it in the pre-vaccine era; it rather shows that measles only resulted in about one or two deaths out every ten thousand cases.

The document does state that measles results in hospitalization in “1 out of 4 cases”, in encephalitis (brain inflammation) in “1 per 1,000 cases” and in death in “1-2 per 1,000 cases”, and the CDC repeats these claims on its website.[7]

However, what the CDC and the Times are really presenting with the “1-2 per 1,000” statistic is the ratio of deaths per reported cases. That is not at all the same thing as the number of deaths that occurred in relation to the total number of people who were infected with measles. The CDC certainly knows this, and the Times reporters should have recognized this, too, assuming they bothered to read their own source and are capable of independent thought.

Each year, according to the Times’ own source, there were 450 to 500 deaths and about 500,000 reported cases. But as the document also explicitly clarifies, most cases were not reported. Rather, the estimated number of measles cases each year was about three to four million.[8]

Hence the Times has misreported the number of deaths per measles cases too high by an order of magnitude.

In case you’re incredulous and have a hard time believing your own eyes over the word of the CDC and the New York Times, you can have it from no less authoritative a source than the Institute of Medicine (IOM), which in a 1994 report stated that data from the pre-vaccine era shows that in industrialized countries like the US, “the measles fatality rate is 1 per 10,000 cases”—not one per one thousand.[9]

Likewise, the data presented in the Times’ own source does not show that one out of four people who get measles are hospitalized. Rather, 48,000 hospitalizations per four million cases annually is a hospitalization rate of only one out of every eighty-three cases of measles.[10] And the rate of measles encephalitis was more like one in 10,000, as we’ll come to.

Ignoring Vaccine Failure and the Shifted Risk Burden

Apart from lying to its readers about the measles hospitalization and death rates, the Times fails to inform the public that measles vaccination has actually increased the ratio of deaths per reported cases.

By 1990, this rate had risen “dramatically” to 3.2 deaths per 1,000 reported cases, according to a study by two leading experts published in the Archives of Internal Medicine (now JAMA Internal Medicine).[11]

According to data from a public database on the CDC’s website, from 1999 through 2017, there were twelve measles-related deaths. Although we’re constantly told by the media that measles outbreaks are occurring because parents are choosing not to vaccinate their children, only two of the twelve measles deaths were in school-aged children. Two others were in infants under one year old (and hence too young to be vaccinated), and the remaining two-thirds were in adults aged twenty-five or older.[12]

During the same time period, according to CDC data, there were 2,393 reported cases of measles in the US.[13]

That’s five deaths per 1,000 reported cases, a significant increase since the pre-vaccine era.

This increase is an unintended but predictable consequence of mass vaccination having shifted the risk burden in the event of exposure away from children, in whom measles is generally a benign illness, and onto those for whom it poses a greater risk of potentially deadly complications: infants and adults.[14]

Adults are at a relatively higher risk today because the immunity conferred by the vaccine is inferior to that acquired by infection, and because, before the vaccine, reexposure to the still-circulating virus served as a natural booster, keeping immunity strong generally throughout a person’s lifetime.

The waning of vaccine-conferred immunity is known in the medical literature as “secondary vaccine failure”.

When the vaccine fails to stimulate a protective level of antibodies in the first place, it’s called “primary vaccine failure”.[15] This has been estimated to occur in anywhere from 2 percent to 10 percent of vaccinated individuals.[16]

The reason infants are at relatively higher risk today is because mothers are less well able to confer passive maternal immunity to their babies than mothers were during the pre-vaccine era. Back then, infants were generally protected by antibodies transferred from their mothers prenatally through the placenta and postnatally through breastmilk. Vaccinated mothers today, by contrast, have lost the opportunity during childhood to acquire the superior immunity gained from natural infection and have also been denied the natural boosting effect of frequent reexposure, which is known as exogenous boosting.[17]

Hence mass vaccination has undermined the natural herd immunity that the US population was already well into developing in the pre-vaccine era, which served to protect the most vulnerable members of the population.

A related salient fact the Times declines to inform its readers is that most of the dramatic decline in measles mortality witnessed during the twentieth century occurred prior to the introduction of the vaccine in 1963.[18]

This was true generally for infectious diseases, not just measles. As noted in a paper published in Pediatrics, the journal of the American Academy of Pediatrics (AAP), “nearly 90% of the decline in infectious disease mortality among US children occurred before 1940, when few antibiotics or vaccines were available.” Hence “vaccination does not account for the impressive declines in mortality seen in the first half of the century.”[19]

This decline was instead due to an increasing standard of living, including improved nutritional status generally among the population. Vitamin A deficiency, in particular, is a known risk factor for complications from measles, and the World Health Organization (WHO) uses high dose vitamin A supplementation in developing countries as a treatment for measles infection.[20]

Moreover, despite the public constantly being told that high vaccination rates are required to maintain “herd immunity” against measles, due to the phenomenon of vaccine failure, outbreaks can still occur even in highly vaccinated populations. As stated by Gregory A. Poland and Robert M. Jacobson, the authors of the Archives of Internal Medicine study, “outbreaks can continue to occur unless the vaccine is virtually 100% effective and virtually 100% of the population is immunized.” They acknowledged that vaccine-conferred “herd immunity does not appear to operate as a protective mechanism until nearly 100% of the population undergoes seroconversion.”[21]

In other words, the theory that mass vaccination can stop outbreaks from happening through “herd immunity” is known to be false. Since (a) certain members of the population cannot be vaccinated, including infants under age one; (b) the vaccine fails to confer a protective level of antibodies among a certain percentage of the population; (c) the protective effect of vaccination wanes over time; and (d) vaccination has resulted in a loss of exogenous boosting, therefore measles outbreaks can continue to occur even if public health officials manage to maintain as high a vaccination rate as possible.

And since the risk to infants and adults in the event of exposure is higher today than it was during the pre-vaccine era due to mass vaccination, when measles deaths do occur in these age groups, the deaths could just as well be attributed to public vaccine policy as to the virus.

Ignoring the Opportunity Costs of Vaccination

The lost opportunity to gain the superior immunity conferred by infection and the loss of exogenous boosting are two examples of opportunity costs of vaccination, which simply are not taken into consideration by public health officials or policymakers, just as the New York Times ignores the opportunity costs in its simplistic and unscientific risk-benefit analysis.

Another consideration that the Times completely ignores is that studies have found measles infection during childhood to be associated with numerous health benefits.

For example, measles infection has been observed to cause regression of cancer in children and has been associated with a decreased risk of numerous diseases later in life, including degenerative bone disease, certain tumors, Parkinson’s disease, allergic disease, chronic lymphoid leukemia, both non-Hodgkin lymphoma and Hodgkin lymphoma, and cardiovascular disease.[22]

Hence it is reasonable for parents today to inquire whether, by mass vaccinating, we are trading a generally benign childhood illness for an increased risk of other much more serious diseases later in life.

Ignoring the Extremely Low Risk of Getting Measles in the First Place

Furthermore, contrary to the argument presented by the New York Times, the risk-benefit analysis that parents must do today isn’t to compare the risk of permanent injury or death from the vaccine with that from measles if infected. Parents living in the US need to also consider the fact that the chance that their child will be exposed to measles in the first place is close to zero.

What the Times fails to acknowledge is that it is reasonable for parents to judge that the risk of their child being permanently injured or killed by measles must be less than that from the vaccine. The fact is that, even assuming an extraordinarily safe vaccine, the risks from a vaccine that is effective at eliminating viral transmission will inevitably at some point become greater than the risks from the disease it is designed to prevent.

That is precisely why the live oral polio vaccine, for example, is no longer used in the United States. As the CDC has acknowledged, every domestic case of polio that occurred after 1979 was caused not by the wild virus, but by the vaccine.[23] (Only the inactivated poliovirus vaccine is used in the US now.)

This reality about the risks from vaccines that are effective at reducing incidence of the target disease was acknowledged in an article published in Clinical Infectious Diseases in 2011. It is perfectly rational for individuals to conduct their own “complex cost-benefit analyses”, its authors conceded, in order to determine what’s in their own or their child’s best interest; and it’s “not surprising” that many arrive logically at the conclusion that it’s best to avoid the risk of vaccination when “the chance of contracting an infection is close to 0.”[24]

The Times’ failure to take this reality into account alone renders its risk-benefit analysis totally invalid.

Falsely Assuming That the Risks of Vaccination Are Known

Another error the Times makes in its argument relates to its false claim that one to two people die per every thousand infected with measles. Since the true case-fatality rate for measles was one per ten thousand, prospective studies designed to determine whether the risk of permanent injury or death from the vaccine is lower than the risk from measles would have to be very large. Yet no such large controlled studies have ever been done. The only clinical safety studies in children mentioned by the manufacturer of the measles, mumps, and rubella (MMR) vaccine in its package insert included a total of only 284 children. Hence these studies had statistical power to detect only very frequently occurring adverse events.

The manufacturer, Merck, says these studies showed that the vaccine was “generally well tolerated”, but the inclusion of a control group receiving an inert placebo is optional and not a requirement for vaccine manufacturers to obtain licensure from the Food and Drug Administration (FDA), and there’s no indication in the insert that Merck’s safety studies included a placebo control group from which to compare rates of adverse events.[25] Indeed, documents obtained by the Informed Consent Action Network (ICAN) through the Freedom of Information Act (FOIA) show that in none of the clinical trials used by Merck to obtain FDA approval for its combination MMR vaccine were rates of adverse events compared between recipients of the vaccine and children who instead received an inert placebo.

The clinical trial summaries also call into question Merck’s characterization of how well tolerated its vaccine is, showing that substantial numbers of subjects suffered either from upper respiratory or gastrointestinal illness after vaccination. One trial, for example, included 194 children who received either a varying dose of the combination MMR vaccine or the single rubella vaccine, and among these children, 55 percent reported developing upper respiratory illness and 40 percent gastrointestinal illness.[26]

Referring to postmarketing surveillance, Merck’s package insert also states that encephalopathy or encephalitis have been reported following vaccination at a rate of about one per every three million doses administered. But it asserts that this “risk of serious neurological disorder following live measles virus vaccine administration remains less than the risk of encephalitis and encephalopathy following infection with wild-type measles (1 per 1000 reported cases).”[27]

But, again, the number of reported cases during the pre-vaccine era represented only a fraction of total measles cases. According to the CDC, “Before measles vaccine was available, more than 400,000 measles cases were reported each year in the United States. However, since virtually all children acquired measles, the true number of cases probably exceeded 4 million per year (i.e., the entire birth cohort).”[28] Hence the true number of cases was ten times the number reported, or one case of encephalitis for every 10,000 cases of measles, assuming that unreported cases were more likely to be benign and that few cases of measles encephalitis escaped detection.

And, again, parents today need to consider that the chance of their child getting measles—much less developing measles encephalitis or dying from it—is extremely low. It is not unreasonable for parents to judge that this near-zero risk must be lower than the risk of encephalitis associated with the measles vaccine, even assuming this adverse event is as rare as Merck says it is.

Furthermore, as we’ll come to momentarily, the rate of one per three million doses could very well be a significant underestimate; we really have no idea how frequently this adverse event occurs after vaccination.

Falsely Assuming That VICP Claims Represent the Rate of Vaccine Injuries

This brings us to yet another fundamental error in the analysis presented to us by the New York Times. The authors’ argument additionally rests on the assumption that the number of claims filed under the VICP—about two per every million doses administered—is representative of the number of people who are permanently harmed or killed by vaccines. But there is absolutely no basis for that assumption whatsoever.

The Times attempts to support its assumption, upon which its argument depends, with the remark, “The rarity of claims is especially notable because the program aims to make it easy to file a petition.” The Times also points out that the CDC includes information about the VICP in its vaccine information statements that are handed out to parents at pediatricians’ offices.

Curiously, though, nowhere in the article does the Times mention the Vaccine Adverse Event Reporting System, or VAERS, even though it was also created under the 1986 law granting legal immunity to the vaccine industry specifically in order to be able to detect harms from vaccines that weren’t detected during prelicensure trials.

VAERS, too, ostensibly aims to make it easy to report potentially related adverse events following vaccination. Yet severe underreporting is a known problem with this passive postmarketing surveillance system. CDC researchers have acknowledged that VAERS is “subject to underreporting”.[29] The US Congress has also been informed by the FDA that VAERS reports “represent only a fraction of the serious adverse events” associated with vaccination.[30]

Thus, the reality is that we don’t really have any good idea what the true rate of serious adverse events are following measles vaccination. To determine that would require large randomized placebo-controlled studies with long-term follow up, which neither the manufacturers nor the government have shown any interest in doing.

And while there were twelve measles-related deaths between 1999 and 2017, according to CDC data, during the same period, there were 160 reports of death to VAERS following vaccination with Merck’s MMR vaccine.[31]

This does not mean that the vaccine caused these deaths. We don’t know that, and VAERS data cannot tell us. But even if only a fraction of this number represents vaccine-caused deaths, it could still indicate that the risk of death from the vaccine is greater than from the virus—and there is also the possibility that deaths reported to VAERS represent only a fraction of deaths occurring post-vaccination for which the vaccine could potentially have been the cause.

Ignoring the Recognized Failures of the VICP

Additionally, while the Times characterizes the VICP as though it operates as supposedly intended, the truth is that it has largely failed in its stated aims. An Associated Press investigation in 2014 found that, although ostensibly intended “to speed help to Americans harmed by vaccines”, the VICP “has instead heaped additional suffering on thousands of families”.

Among the problems is that “the government fights legitimate claims and fails its obligation to publicize the court, worried that if they concede a vaccine caused harm, the public will react by skipping shots.”

That is to say, the government has an inherent conflict of interest in administering the program since it is also responsible for recommending vaccines with a goal of attaining high vaccination rates.

Another problem is that, while cases were supposed to be resolved within a year (240 days), more than 95 percent took longer, with an “average case length more than three years”.[32]

The AP’s findings were bolstered by a 2014 report of the US Government Accountability Office (GAO) that found that, since 2009, the average time to adjudicate claims was about 3.5 years.

Moreover, while the CDC had added numerous additional vaccines to its routine childhood schedule, its parent agency, the Department of Health and Human Services (HHS), had failed to add covered injuries for them to the VICP’s “Vaccine Injury Table”, which lists injuries associated with childhood vaccines that are presumed to be caused by the vaccine if occurring within a given period of time after vaccination, absent another more probable cause. At the time of the GAO report, there were sixteen vaccines covered by the VICP, but only half had associated covered injuries on the table.

If an injury isn’t listed on the table, the petitioners must prove with the preponderance of evidence that the vaccine more likely than not caused the injury. If HHS concedes, the petitioner is awarded compensation. If the government contests the claim, a special master weighs the evidence and issues a decision. However, a third possible outcome is a settlement negotiated between the petitioner and the government. As the GAO reported, for claims filed since 2006, “most compensated claims were adjudicated through negotiated settlement”, which enables the government to award compensation for injuries while at the same time maintaining that it was not demonstrated that vaccination was the cause.[33]

The New York Times article mischaracterizes this by stating, “About 70 percent of the awards have been settlements in cases in which program officials did not find sufficient evidence that vaccines were at fault.” What this characterization conceals is that the government has an incentive to settle rather than concede claims since it can then claim that it was not proven that the vaccine caused the injury, regardless of whether the preponderance of evidence might have supported that conclusion had petitioners chosen to pursue their case without settling.

As the GAO reported, complaints about the VICP included dissatisfied petitioners who felt that the program placed too great a burden on them and their family. About half of petitioners surveyed said that the amount received in compensation “was inadequate to cover past and future medical care” resulting from the vaccine injury. There was also a “perception of an adversarial or unfriendly environment throughout the process”.

Another problem was that, even though information about the VICP is included in the CDC’s vaccine information statements, HHS has acknowledged that “many parents, the general public, attorneys, and health care professionals were not aware VICP existed.” Consequently, as one stakeholder informed the GAO, “the public is largely unaware of the program”, resulting in “individuals being denied the opportunity for compensation.”[34]

Stanford law professor Nora Freeman Engstrom pointed out in a 2015 article that the idea behind the VICP was that, compared to suing a vaccine manufacturer in civil court, “compensation would be more quickly, more easily, more consistently and more simply delivered, without long delays or adversarial process.” Yet to say that the VICP had “failed to live up to these high hopes” was “putting it charitably”. The average time it took for claims to be adjudicated under the program “is substantially longer than similar claims resolved by court judgment or trial verdict within the traditional tort system”, and the process was “frequently antagonistic” toward petitioners.[35]

Furthermore, unlike the civil court system, in the so-called “vaccine court”, claimants are barred from the discovery process, the proceedings are not public, and there is no jury.[36]

There’s no doubt that this system well serves the financial interests of the vaccine manufacturers. But, contrary to the Times’ characterization, it has quite different implications with respect to the interests of the general public.

Conclusion

In sum, the Times claims that the Vaccine Injury Compensation Program provides us with evidence of how extraordinarily safe vaccines are, and to support that assertion, it claims that “data shows” that the risks of vaccination are far less than the risks to children living in the US today from measles. The Times attempts to support that claim by asserting that one in four people with measles are hospitalized and one or two out of every thousand die, but both of those assertions are false.

In truth, complications and deaths from measles were far rarer during the pre-vaccine era because most cases were benign and not reported. Consequently, we do not have the data necessary to be able to conclude that the risks of vaccination are less than the risks of measles infection. Prelicensure clinical trials were simply not large enough to be able to determine this. Nor were any large, randomized, placebo-controlled studies with long-term follow up ever conducted post-licensure to be able to determine the true rate of adverse events associated with the measles vaccine.

Additionally, the ratio of deaths per reported cases has actually increased as a result of mass vaccination shifting the risk burden in the event of exposure away from children, in whom it is generally a benign illness, and onto infants and adults, who are at greater risk of potentially deadly complications.

The Times’ argument about what “data shows” further depends on the assumption that the number of claims filed under the VICP provides us with an accurate representation—or possibly even an overestimation—of the number of serious vaccine injuries that occur. But that is false.

In truth, we have no idea whatsoever what proportion of vaccine injuries are represented by compensated claims under the VICP. But we do know that injuries reported to the passive surveillance system established under the same law, which is supposed to enable researchers to detect harms cause by vaccines, represent only a fraction of the true number of vaccine-associated adverse events.

Moreover, even if it were true that large clinical trials had demonstrated that the relative risk of permanent injury or death is less from the vaccine than from measles infection, this is simply not the risk-benefit analysis that parents must do today. Rather, the risk-benefit analysis must take into consideration the fact that the vaccine has been effective at reducing incidence of measles so that the likelihood of getting measles in the first place is almost nonexistent. The Times simply ignores the obvious truth that it is reasonable for parents to judge that the risks of vaccination, even assuming a very safe vaccine, must outweigh the risks from measles when the chance of their child getting measles in the first place, much less being permanently harmed or killed by it, is near zero.

Furthermore, to support its argument that the VICP shows us how safe vaccines are, the Times characterizes the program as being an efficient and effective means for families of children injured by vaccines to obtain compensation, but this, too, is false.

On the contrary, the program is recognized even by the government itself as having largely failed in its stated aims. Rather than being efficient, it typically takes several years to adjudicate claims. Rather than eliminating the adversarial nature of civil court cases, the government has simply replaced the pharmaceutical corporations in the role of adversary—which is to be expected given its incentives to deny, to the greatest extent feasible, that vaccine injuries occur.

The Times further mischaracterizes the VICP by stating that petitioners who are denied or who decline compensation can just sue the vaccine manufacturer in civil court, which is false. While the law does contain language to that effect, the Supreme Court in 2011 closed the door to suing manufacturers in the civil court system for design defect claims, leaving this route open only to claims that the pharmaceutical company failed to manufacture the vaccine according to specification or failed to include adequate warnings in its package insert.

Finally, the Times states that the compensation program is funded by the vaccine manufacturers, but that is false.

In truth, the excise tax that funds the program is included in the price of vaccine products charged to purchasers. This deception enables the Times to completely whitewash the true purpose and effect of the 1986 National Childhood Vaccine Injury Act, which is to shift the financial burden for vaccine injuries away from the pharmaceutical industry and onto the taxpaying consumers, with near total legal immunity being upheld for the manufacturers on the grounds that vaccine injuries are unavoidable, and with a further consequence being the elimination of the key incentive for pharmaceutical corporations to develop safer and more effective means of disease prevention.

The reality, of course, is simply irreconcilable with the Times’ argument that the VICP provides us with evidence of how safe vaccines are. Hence the newspaper’s reliance on lies and deceptions to make its case. And this is typical not just for the New York Times, but the mainstream corporate media in general, which have taken it upon themselves to do public policy advocacy rather than journalism.

Our children deserve better.

References

[1] Pam Belluck and Reed Abelson, “Vaccine Injury Claims Are Few and Far Between”, New York Times, June 18, 2019, https://www.nytimes.com/2019/06/18/health/vaccine-injury-claims.html.

[2] Supreme Court of the United States, Brueswitz et al. v. Wyeth LLC, FKA Wyeth, Inc., et al., February 22, 2011, https://www.supremecourt.gov/opinions/10pdf/09-152.pdf. See the footnote on page 24.

[3] Ibid., p. 3, 7.

[4] Ibid., p. 4.

[5] Ibid., “Sotomayor, J., dissenting”, p. 28 (p. 57 of the document).

[6] US Congress, National Childhood Vaccine-Injury Compensation Act, Hearing before the Committee on Labor and Human Resources, United States Senate, May 3, 1984, https://files.eric.ed.gov/fulltext/ED255480.pdf.

  1. 166

[7] Centers for Disease Control and Prevention, “Measles Data and Statistics”, CDC.gov, February 16, 2018, p. 4, https://www.cdc.gov/measles/downloads/MeaslesDataAndStatsSlideSet.pdf. Centers for Disease Control and Prevention, “Complications of Measles”, CDC.gov, last reviewed June 13, 2019, accessed July 1, 2019, https://www.cdc.gov/measles/symptoms/complications.html.

[8] CDC, “Measles Data and Statistics”, op. cit.

[9] Institute of Medicine, “Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality” (Washington, DC: The National Academies Press, 1994), p. 118, https://doi.org/10.17226/2138.

[10] CDC, “Measles Data and Statistics”, op. cit.

[11] Gregory A. Poland and Robert M. Jacobson, “Apparent Paradox of Measles Infections in Immunized Persons”, Archives of Internal Medicine, 1994, https://doi.org/10.1001/archinte.1994.00420160048006.

[12] Centers for Disease Control and Prevention, CDC WONDER, “About Underlying Cause of Death, 1999-2017”, https://wonder.cdc.gov/ucd-icd10.html.

[13] Centers for Disease Control and Prevention, “National Notifiable Infectious Diseases: Weekly Tables”, https://wonder.cdc.gov/nndss/nndss_weekly_tables_menu.asp.

[14] Poland and Jacobson, “Apparent Paradox of Measles Infections”, op. cit.

[15] Ibid.

[16] Gregory A. Poland and Robert M. Jacobson, “The Re-Emergence of Measles in Developed Countries: Time to Develop the Next-Generation Measles Vaccines?” Vaccine, January 5, 2012, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3905323/.

[17] This phenomenon is well-recognized in the medical literature. See for instance: Inácio M. Mandomando et al., “Measles-specific Neutralizing Antibodies in Rural Mozambique: Seroprevalence and Presence in Breast Milk”, American Journal of Tropical Medicine and Hygiene, November 1, 2008, https://doi.org/10.4269/ajtmh.2008.79.787. Sandra Waaijenborg et al., “Waning of Maternal Antibodies Against Measles, Mumps, Rubella, and Varicella in Communities With Contrasting Vaccination Coverage”, Journal of Infectious Diseases, May 8, 2013, https://doi.org/10.1093/infdis/jit143. Mark Papania, “Increased Susceptibility to Measles in Infants in the United States”, Pediatrics, November 1, 1999, https://doi.org/10.1542/peds.104.5.e59.

[18] Robert D. Grove and Alice M. Hetzel, Vital Statistics Rates in the United States, 1940–1960 (Washington, DC: US Government Printing Office, 1968), p. 85, https://www.cdc.gov/nchs/data/vsus/vsrates1940_60.pdf.

[19] Bernard Guyer et al., “Annual Summary of Vital Statistics: Trends in the Health of Americans During the 20th Century”, Pediatrics, December 2000, https://doi.org/10.1542/peds.106.6.1307.

[20] Evan Mayo-Wilson, “Vitamin A supplements for preventing mortality, illness, and blindness in children aged under 5: systematic review and meta-analysis”, BMJ, August 25, 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3162042/.

[21] Poland and Jacobson, “Apparent Paradox of Measles Infections”, op. cit.

[22] “Harnessing The Measles Virus To Attack Cancer”, Science Daily, October 31, 2006, https://www.sciencedaily.com/releases/2006/10/061030143318.htm. Rønne T, “Measles virus infection without rash in childhood is related to disease in adult life”, Lancet, January 5, 1985, https://doi.org/10.1016/S0140-6736(85)90961-4. Annie J. Sasco and Ralph S. Paffenbarger, Jr., “Measles Infection and Parkinson’s Disease”, American Journal of Epidemiology, December 1, 1985, https://doi.org/10.1093/oxfordjournals.aje.a114183. S. O. Shaheen et al., “Measles and atopy in Guinea-Bissau”, Lancet, June 29, 1996, https://doi.org/10.5555/uri:pii:S0140673696916177. Helen Rosenlund et al., “Allergic Disease and Atopic Sensitization in Children in Relation to Measles Vaccination and Measles Infection”, Pediatrics, March 2009, https://doi.org/10.1542/peds.2008-0013. Stefano Parodi, et al., “Childhood infectious diseases and risk of leukaemia in an adult population”, International Journal of Cancer, October 15, 2013, https://www.ncbi.nlm.nih.gov/pubmed/23575988. Maurizio Montella et al., “Do childhood diseases affect NHL and HL risk? A case-control study from northern and southern Italy”, Leukemia Research, August 2006, https://doi.org/10.1016/j.leukres.2005.11.020. Yasuhiko Kubota, Hiroyasu Iso, and Akiko Tamakoshi, “Association of measles and mumps with cardiovascular disease: The Japan Collaborative Cohort (JACC) study”, Atherosclerosis, August 2015, https://doi.org/10.1016/j.atherosclerosis.2015.06.026.

[23] Centers for Disease Control and Prevention, “Polio Disease – Questions and Answers”, CDC.gov, updated August 11, 2014; archived copy available at https://web.archive.org/web/20150103130229/http://www.cdc.gov/vaccines/vpd-vac/polio/dis-faqs.htm.

[24] Paul Fine, Ken Eames, and David L. Heymann, “‘Herd Immunity’: A Rough Guide”, Clinical Infectious Diseases, April 1, 2011, https://doi.org/10.1093/cid/cir007.

[25] Merck & Co., Inc, “Package Insert – Measles, Mumps, and Rubella Virus Vaccine Live”, FDA.gov, accessed June 28, 2019, https://www.fda.gov/media/75191/download. FDA regulations require controlled studies, but pharmaceutical companies aren’t required to include a control group of subjects who receive an inert placebo; this is optional. Food and Drug Administration, “Information Sheet: Drug Study Designs: Guidance for Institutional Review Boards and Clinical Investigators”, January 1998, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-study-designs. Additionally, the FDA doesn’t regulate placebo composition, and frequently, instead of using an inert placebo, pharmaceutical companies use an active comparator. Beatrice A. Golomb et al., “What’s in Placebos: Who Knows? Analysis of Randomized, Controlled Trials”, Annals of Internal Medicine, October 19, 2010, https://doi.org/10.7326/0003-4819-153-8-201010190-00010. In vaccine trials, it is typical for pharmaceutical companies to inject the “control” group with another vaccine or a component of the vaccine such as aluminum adjuvant.

[26] Food and Drug Administration, summary of clinical studies of the combination measles, mumps, and rubella vaccine by Merck to obtain licensure, 1978; obtained via FOIA by Informed Consent Action Network (ICAN) and published April 2, 2019, https://icandecide.org/governments/, https://icandecide.org/government/FDA-Production-FOIA.pdf.

[27] Ibid.

[28] Centers for Disease Control and Prevention, “Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP)”, Morbidity and Mortality Weekly Report, December 29, 1989, https://www.cdc.gov/mmwr/preview/mmwrhtml/00041753.htm.

[29] Penina Haber et al., “Guillain-Barré Syndrome Following Influenza Vaccination”, JAMA, 2004, https://doi.org/10.1001/jama.292.20.2478.

[30]  106th Congress, 2nd Session, House Report 106-977, Sixth Report by the Committee on Government Reform, The Vaccine Injury Compensation Program: Addressing Needs and Improving Practices, October 12, 2000, https://www.congress.gov/106/crpt/hrpt977/CRPT-106hrpt977.pdf.

[31] VAERS data is searchable using the CDC WONDER website: https://wonder.cdc.gov/vaers.html.

[32] Mitch Weiss, Justin Pritchard, and Troy Thibodeaux, “‘Vaccine court’ keeps claimants waiting”, Associated Press, November 17, 2014, https://www.apnews.com/af3ac36a464440858a743ac5c4929bec.

[33] US Government Accountability Office, Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled through Negotiation, Report to the Chairman, Committee on Oversight and Government Reform, House of Representatives, November 2014, https://www.gao.gov/products/GAO-15-142.

[34] Ibid.

[35] Nora Freeman Engstrom, “Federal Program for Vaccine-Injured Children is Failing, Stanford Scholar Says”, Stanford University, July 2, 2015, https://law.stanford.edu/2015/07/02/federal-program-for-vaccine-injured-children-is-failing-stanford-scholar-says/. See also: Nora Freeman Engstrom, “A Dose of Reality for Specialized Courts: Lessons from the VICP”, University of Pennsylvania Law Review, June 28, 2015, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2623756.

[36] Gayle Delong, “Is ‘Delitigation’ Associated with a Change in Product Safety? The Case of Vaccines”, Review of Industrial Organization, June 14, 2017, https://doi.org/10.1007/s11151-017-9579-7.

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9 Comments

  1. Elle

    Thank you for a great article!

    Reply
  2. Jennifer

    Excellent information. The readers of Time would be much better off reading your article. Thank you for your insight!

    Reply
  3. Melissa

    Thanks for an excellent article and doing this work!

    Reply
  4. Rtp

    Thanks for this. If you want to prove how ridiculous the “one in a million” claim for severe vaccine reactions is then all you have to do is ask “what exactly delineates a severe reaction vs a minor one?”

    To illustrate, the CDC freely admits that vaccines cause seizures but ask them how many cases of epilepsy have been caused by vaccination and they will tell you that it is practically none. How? How could vaccines cause seizures – even multiple seizures – but not be a primary cause of a seizure disorder? It makes no sense.

    This is what the CDC does. It freely admits that reactions that parents probably won’t complain about are indeed caused by vaccination but any reactions that parents will complain about are presumed to be caused by something else – even if the latter is just a logical extension of the type of reaction that the CDC freely admits can be caused by vaccines!

    So if I get a headache for two days following vaccines the doctors/CDC will say “Yep. It was the vaccines for sure.” But if the headaches were to then continue for two months the doctors/CDC will say “nope. Can’t have been the vaccines.”

    Any reaction can be severe or minor depending on its intensity or duration and there is no strict way of delineating this. Therefore the CDC simultaneously claiming that “1) Minor reactions are frequent; but 2) severe reactions are rare” is nonsense – there is no way of knowing such a thing and the CDC is clearly lying.

    Reply
  5. Christina

    Thanks for the fabulous article!! Your work really means a lot to so many of us!!

    Reply

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