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September 22, 2019

8/3/2019 7:30:00 AM
Vaccine-reported injuries on the rise, $4B in compensation paid

News analysis



Both vaccine-reported injuries and compensated vaccine injuries are on the rise, according to figures from the federal government, adding fuel to a fire which is already raging across the country about vaccine safety.

What's more, a study performed for the federal government indicates that fewer than 1% of vaccine injuries are ever reported, meaning total incidents of alleged vaccine injury could be vastly understated.

Updated as of July 1, the amount of compensation paid by the federal government for vaccine injuries topped $4 billion. The money is paid by the National Vaccine Injury Compensation Program (VICP) established by Congress in 1986.

Of that amount, $1.1 billion, or 27%, has been paid between fiscal year 2015 and the current fiscal year.

The VICP is a federal no-fault system designed to compensate individuals, or families of individuals, who have been injured by childhood vaccines, whether administered in the private or public sector, the federal government states. The U. S. Court of Federal Claims decides who will be paid, without a jury.

Under the system, parents who believe their children have been injured by a vaccine must file a claim in VICP. In most circumstances, vaccine manufacturers are immune from civil lawsuits filed in state or federal courts.

Indeed, federal law holds that no vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death after Oct. 1, 1988, if the vaccine was properly prepared and was accompanied by proper directions and warnings.

The latest numbers related to such injuries seem dire, and they could be worse than they appear.

As of July 1, 20,808 petitions have been filed with the VICP since 1988, with 6,639 of those determined to be compensable. Total compensation paid over the life of the program is approximately $4 billion, the federal Health Resources and Services Administration reports.

Some 13% of those petitions remain unresolved.

Beyond outright compensation, the number of people filing vaccine injury claims is staggering.

The government monitoring mechanism, the Vaccine Adverse Event Reporting System (VAERS), indicates that approximately 30,000 reports are filed each year. The government says about 85-90% of the reports involve mild side effects such as fever, arm soreness, and crying or mild irritability.

However, 10-15%, or between 3,000 and 4,500 of those claims, are classified as serious, meaning there was an adverse event which resulted in permanent disability, hospitalization, life-threatening illness, or death, the government states. Over 30 years, that would translate into between 90,000 and 135,000 serious injuries.

What's more, the number of reported incidents are picking up speed.

Between 2011 and 2018, for example, there were 3,665 compensable claims, an average of 458 per year for that eight-year period. Compensable claims peaked in 2017 with 706 payable petitions.

Those figures compare with just 781 compensable claims for the previous eight years between 2003 and 2010, or an average of 97 per year.

Besides decisions on compensations, the number of petitions filed claiming vaccine injury is moving steadily higher, too, topping 1,100 petitions for a year in 2016 for the first time. More than 25% of all petitions have been filed in the last five years of the 30-year-old program.



The New York Times: Nothing to see here

According to The New York Times, in a June 18 story entitled "Vaccine Injury Claims Are Few and Far Between," vaccine injury numbers are blown way out of proportion.

For instance, reporters Pam Belluck and Reed Abelson wrote, over roughly the past dozen years in the United States, about 126 million doses of measles vaccines were delivered to Americans, yet only 284 people filed claims of harm from that vaccine during that period, and, of those, about half were dismissed, while 143 were compensated.

"Over the past three decades, when billions of doses of vaccines have been given to hundreds of millions of Americans, the program has compensated about 6,600 people for harm they claimed was caused by vaccines," they wrote. "About 70% of the awards have been settlements in cases in which program officials did not find sufficient evidence that vaccines were at fault."

In other words, those awarded compensation for vaccine injuries are but a literal drop in the bucket of the total number of people vaccinated.

Government data backs up the reporters' analysis. According to the CDC, for every 1 million doses of vaccine that are distributed, only one individual is compensated.

And while there have been 520 compensated death claims, the reporters wrote, about 90 involved the flu shot. Nearly half of compensated death claims involved DTP, an early vaccine against diphtheria, tetanus, and pertussis that was discontinued long ago, they wrote.

In addition, they reported, a growing proportion of recent claims, about half of all petitions since 2017, do not involve the content of vaccines themselves.

"Instead, they refer to shoulder injuries, usually in adults, that occurred because a health provider injected a vaccine too high on the shoulder, or into the joint space instead of into muscle tissue," The Times reported. "That may cause an inflammatory response leading to shoulder pain and limited motion."

The reporters also say the rarity of claims is notable because the program aims to make it easy to file a petition and frequently pays claimants' fees for lawyers and expert witnesses.

The reporters do acknowledge autism is not on a list of compensable claims. That matter, they wrote, was exhaustively evaluated for several years by federal courts, which ultimately ruled that evidence showed that autism is not caused by vaccines and is not a legitimate claim for the injury program.

Thus autism related claims were dismissed and are not now considered.

On balance, the reporters concluded, the data shows just how safe vaccines are, rather than the other way around.

"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 CDC," they wrote. "In comparison, claims of harm have been filed for about two out of every million doses of the measles vaccine."



Enter Robert F. Kennedy, Jr.

Not everyone is so sanguine about the vaccine court, as it is commonly called, especially Robert F. Kennedy, Jr., and his Children's Health Defense (CHD).

For one thing, the CHD states, actual compensation from a government court is a lot different from actual vaccine injury. Indeed, the number of vaccine-injury reports flowing into VAERS each year can hardly be considered few and far between.

"Contrary to what the government and media would like us to believe, vaccine injury in this country is hardly rare," the CHD contends on its website. "More than 30,000 'adverse events' are now reported annually to the official federal monitoring program for vaccine safety, with some 200,000 cases listed since 1990."

But that's only the tip of the iceberg, Kennedy and the CHD believe.

"Many experts, however, believe the injuries are underreported by a factor of ten because the system of collecting adverse events is not required by law," the CHD states. "This means that up to two million Americans may have experienced an adverse event during that time."

Indeed, in a report prepared by Harvard Pilgrim Health Care for the U.S. Department of Health and Human Services, the purpose of which was to "to improve the quality of vaccination programs by improving the quality of physician adverse vaccine event detection and reporting to the national Vaccine Adverse Event Reporting System (VAERS)," very few injuries that do occur are reported at all.

"Adverse events from drugs and vaccines are common, but underreported," the report stated. "Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug events and 1-13% of serious events are reported to the Food and Drug Administration (FDA)."

It was even worse for reporting of adverse vaccine events.

"Likewise, fewer than 1% of vaccine adverse events are reported," the report stated. "Low reporting rates preclude or slow the identification of 'problem' drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed."

That's hardly few and far between, and, if those numbers are accurate, there could be as many as 3 million vaccine-adverse events each year in the United States.

In the study's trials, 1.4 million doses of 45 different vaccines were given to 376,452 individuals between June 2006 and October 2009. Of these doses, the report stated, 35,570 possible reactions (2.6% of vaccinations) were identified.

That represented an average of 890 possible vaccine-adverse reactions per month.

To be sure, as the CDC points out and the CHD acknowledges, most of those adverse events are mild, as also noted by The Times' reporters. But the Kennedy group says that doesn't tell the whole story.

"Thankfully, most events (roughly 85%) were considered mild (localized pain and swelling, low-grade fever, etc.), but the rest were far more serious, including encephalopathy (brain damage), seizure disorders, chronic arthritis and neurodevelopmental disorders including, many parents argue, autistic regression," the CHD stated. "To put it another way, anywhere from 4,500 to perhaps 45,000 serious vaccine injuries occur every year in the United States."

The higher figure of 45,000 is not far-fetched and could be too low. In 2017, the U.S. population of children four and under was about 20 million. According to the CDC, some 98.7% of those children received at least some vaccinations by age 2.

If 2.6% have an adverse reaction, as the government's numbers indicate, that's 513,240 adverse reactions, of which around 51,300 would be serious, if the government's conservative number of 10 percent of adverse events are likely serious.

And that's not all. Another study just published in The Pediatric Infectious Disease Journal in April, by a researcher with the Department of Social and Preventive Medicine at Laval University in Quebec, found not only that adverse events following immunization (AEFI) were frequent but that 16% of those who were re-immunized after an adverse event suffered another adverse event, and one in five of those were more serious than the first one.



As for the formal claims

But what about the formal petitions to the VICP, which - if any of the above numbers are close to accurate - do seem to be few and far between, as The Times correctly reported? If there were so many adverse reactions, wouldn't there be more claims?

No, Kennedy and his group say.

For one thing, as The Times' reporters acknowledged, the program is little-known, even among health care providers. A 2013 study by the CDC of physicians, physician assistants, advanced practice nurses, and nurses found that only 71% were even aware of the VAERS reporting system.

And while 37% of providers - more than a third - had encountered an adverse reaction after administration of a vaccine, only 17% had ever reported an incident to VAERS.

For another, as CHD points out, there is a strict statute of limitations on filing a claim - three years "after the first symptom or manifestation of onset or of the significant aggravation of such injury after the administration of the vaccine."

The time limit is non-negotiable, so many claims are never brought, and many others are dismissed.

Indeed, if a claim is brought beyond 36 months, it will not only be dismissed but it will be barred from further action in any court of law. CHD's executive director, Lyn Redwood, is quoted as saying she learned the hard way.

"Nobody informed me that my son's vaccines contained mercury" the website quotes Redwood. "Unfortunately, by the time we found out and realized he was suffering with autism induced by mercury neurotoxicity, we were outside the statute of limitations."

For Kennedy's group, the implications are obvious.

"If even a small percentage of these unreported and recurrent vaccine injuries were brought forward for compensation, the entire NVICP house of cards - and the CDC's deceptive claims of unassailable vaccine safety - would crumble," CHD states.

As for the number of claims dismissed, about half, there's another reason so many are kicked out of court, Kennedy's group claims: It isn't a court.

"Vaccine Court is not a court of law," the CHD states. "In vaccine court there is no judge, no jury and the most basic rules of law do not apply."

The legal deck is stacked against petitioners from the start, CHD states.

"Attorneys for HHS work for the Justice Department and have at their disposal all the money, power, and access to experts that our government can command," the group states on its website. "Special Masters who hear cases are DOJ employees. Meanwhile, petitioners are denied access to government data that would be provided under normal discovery rules in civil court."

There's another reason why the number of petitions are so low, CHD states. The vaccine court doesn't consider claims of autism. The New York Times' reporters acknowledged that, but say autism claims were exhaustively evaluated for several years by federal courts, which ultimately ruled evidence showed autism is not caused by vaccines and is not a legitimate claim for the injury program.

The reporters were referring to the Omnibus Autism Proceedings of 2002, in which a special master would "determine whether thimerosal containing vaccines and/or MMR vaccines can cause autism or similar disorders and if so under what conditions."

The case involved 5,400 families who had filed claims of vaccine-caused autism with the court, out of which test cases were chosen to serve as proxies for all the others. The potential value of those claims exceeded $100 billion.

Ultimately, the claims of all 5,400 were dismissed, and the vaccine court has since refused to consider autism petitions.

However, last September, Kennedy requested the DOJ inspector general and Congress investigate fraud and obstruction of justice in the Omnibus proceedings by HHS and DOJ officials. Specifically, Kennedy cites recent evidence that he alleges shows that government officials intentionally misrepresented the opinion of their own expert witness and willfully concealed from the vaccine court and petitioners critical material evidence showing how vaccines may cause autism.

While Kennedy's request for an investigation has not been acted upon, The Times' reporters did not mention that a recent challenge to the legitimacy of the omnibus court findings had arisen.

Finally, there is the question of cost-benefit analysis. For The Times' reporters, claims of harm for about two out of every million doses of measles vaccine pales in comparison to the one in four people with measles who are likely to be hospitalized, and to the one to two of every 1,000 measles patients who will die.

But that calculation would change if the number of claims drastically under-represents the actual number of serious adverse events that occur.

And there's yet another consideration. Many vaccination critics say the vaccination schedule has helped to produce the sickest generation of young people in American history.

Since around 1990, these critics says, when the childhood vaccine schedule began to vastly expand, the number of children with chronic health issues also jumped dramatically.

A 2010 study in JAMA showed the prevalence of major chronic conditions in American children and youth more than doubled between 1988 and 2006, for example, and, in a 2007 National Survey of Children's Health, 43% of children had at least one of 20 chronic health conditions.

The Centers for Disease Control (CDC) states one child in six in America suffers with learning and behavior disorders while millions more suffer with asthma, diabetes, and other chronic allergic and autoimmune diseases.

Vaccination skeptics point a correlative finger at vaccinations, pointing out that between 1983 and 2017 the number of recommended vaccines jumped from 24 doses of seven vaccines by the age of 18 years old to 69 does of 16 vaccines by age 18. They back their claims with studies pointing to vaccine roles in the uptick in autoimmune and neurodevelopmental disorders.

To be fair, those correlations draw their own vociferous critics. Suffice it to say that the long-term positive benefits of vaccinations - or lack thereof - probably cannot be settled one way or another by only assessing whether contracting a vaccine preventable disease is worse than the adverse events immediately and directly associated with that vaccine.

To put it another way, a febrile seizure after an MMR might be better than getting the measles, but what other chronic conditions and disorders - such as autism - are possible, if not immediately, then over the course of several years? That debate rages on and is not settled.

For now, the vaccine court has become a ping-pong ball in a contest between two sides. The silver lining is, as the contest gains an ever larger audience, the inner workings of this little-known "court" will become ever more scrutinized.

Richard Moore is the author of the forthcoming "Storyfinding: From the Journey to the Story" and can be reached at richardmoorebooks.com.



Reader Comments

Posted: Monday, August 12, 2019
Article comment by: Rick Burke

Bravo, Mr Paulson. I couldnít have said it better.

Posted: Friday, August 9, 2019
Article comment by: Thomas Paulson

Mr. Walker, the publisher, and Mr. Moore, the columnist, have made it abundantly clear that they donít like government, regulations, taxes, or vaccines. And that is fine Ė they own the paper and therefore have a bully pulpit that allows them to present their opinions to anyone willing to buy a copy. But if they want what they publish to be considered journalism, there are standards that need to be followed. Standards such as not presenting false or misleading titles that are not supported by the facts in the article. Or creating false equivalencies by giving the same weight to arguments from fringe individuals like Robert Kennedy, Jr. as you would from the facts presented by the Centers for Disease Control and from study after peer-reviewed study that find no links between autism and vaccination. Or misleadingly leaving out details like the fact that vaccines prevent tens of thousands of deaths and save billions of dollars in health care expenses each and every year. Because when you donít follow journalistic standards, what you publish isnít journalism, but just another ideological rant, worth little more than the paper it is written on.
Publishing a newspaper carries a minimum level of journalistic responsibility that a story will be well researched and the facts presented truthfully. The publishers have done neither in this case. Promoting the idea that vaccines cause autism and widespread injury, and that the governments of the US and other nations and the vast majority of scientific researchers around the world are actively covering this up may fit in with the world view of the publishers, but it is not one based on objective facts. The people of the Northwoods deserve better than this.

Thomas Paulson, PhD
RHS '84




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