Keep the Iowa Standard Going!
***This is part two in a series of articles on Lindsay Maher’s presentation at Saturday’s Informed Conference 2020 hosted by Informed Choice Iowa. Part one can be found here.***
In the late 1970s, early 1980s, there was about $3 billion worth of claims going against vaccine manufacturers. Most were related to the DTP and polio vaccine.
“Manufacturers were starting to freak out because they have a lot of lawsuits they got to pay out on because of all these vaccines are injuring kids,” Maher said. “And they don’t know what to do.”
They told Congress they’d leave the market and nobody would be left to produce the vaccines unless Congress helped. Families were also spending more than six years in the tort process waiting to be compensated due to injured kids.
The government stepped in and said it would help victims get compensation, stabilize the vaccine market by taking the liability themselves and find safer vaccines while monitoring them to ensure the problem doesn’t continue.
President Ronald Reagan signed the law Nov. 15, 1986.
There were five goals of the program:
- Remove liability from vaccine manufacturers, except for cases of fraud or improper preparation.
- Develop the Vaccine Injury Compensation Program to compensate the victims.
- Develop the Vaccine Information Statement, which was supposed to improve informed consent so parents knew what they needed to know going in.
- Develop Vaccine Adverse Event Reporting System (VAERS) so there was a way to monitor the whole program and whether a vaccine or specific block was causing more injury than others.
- And there was supposed to be a task force created for safety that would report to Congress on what steps they were taking to improve the program and improve vaccine safety. They were supposed to be reporting every two years.
Injury compensation program
The injury compensation program was designed to give money to the injured and remove liability from pharmaceutical companies. However, claims must be filed within three years of symptoms occurring.
It is a court system of its own with a special master or judge, not a traditional courtroom with a jury or discovery. A lone judge examines the claim and compares the claim to a vaccine injury table and then awards compensation.
Maher displayed an example of a vaccine injury table. It lists illness or disability or conditions covered. This particular example from the MMR vaccine listed very severe allergies, swelling of the brain, shoulder injury, vasovagal syncope, thrombocytopenia (bleeding disorder), chronic arthritis, vaccine strain measles or a vaccine strain virus that people get despite being vaccinated.
Tim and Joanna Sarver had a daughter named Erica. At 12 months, Erica was vaccinated for MMR. Within days she started seizing for 45 minutes straight. This happened in Iowa in 2006. Erica ended up in the hospital as they could not get the seizures to stop. She ended up with liver failure and brain swelling, which caused permanent brain damage.
For the next two years, they spent time trying to rehab Erica and provide some basic life skills, but she died in her sleep at three years old. They submitted a claim, but it took two-and-a-half years to be compensated.
In the first year of the program, 92 percent of cases were compensated within months — including for autism.
But in 1995, only 74 percent fell on the table. That year, the Secretary of Health and Human Services (who maintains the table and makes changes to it) was Donna Shalala. Maher said Shalala decided we’d be unable to keep up as the government was paying out record amounts and injuries were increasing.
She erased some things, changed some definitions, some timelines and things have not been the same.
DTP causing brain injury used to be compensated at 25 percent. After Shalala’s changes, it was compensated at 5.4 percent.
By 2015, only 2 percent of cases fell on the in-table category. One out of every three cases is even compensated and it takes on average 2-5 years to receive compensation.
“Not at all within a few months like it was designed for,” Maher said.
The money comes from a trust fund, which is funded by a tax paid every time someone gets a vaccine. Payments for death, though, are still capped at $250,000. That was the limit set in 1986. That $250,000 limit in 1986 would translate to a value of $572,780 today.
“They haven’t changed that amount,” Maher said. “No money can replace a child, but if you spent years medically responsible for that child, you know medicine is not cheap in this day in age. So there could be a lot of debt incurred.”
The program has paid out more than $4.4 billion since 1989. The trajectory is increasing as there was an incredible inflection in 2006. Forty percent of the $4.4 billion has been paid out since 2006.
“The consequences of the National Childhood Vaccine Injury Act are we have no incentive to conduct proper safety studies,” Maher said. “When you remove liability from a product, that company doesn’t have to do everything in its power to make sure that the product works or that product is safe. They just have to do the bare minimum. They now have a liability-free market with 74 million American children.”
Manufacturers are also incentivized to develop more vaccines.
“You just removed the biggest hurdle for them — liability,” she said.
When the act was signed, investment in biologic products (which is what vaccines are labeled under) tripled in three years. It went from $85.6 million in 1986 to $273.7 million in 1989. A litigation study on the safety of the products licensed after 1986 revealed 5.2 more adverse reactions for over 100,000 doses than before.
“That’s not safer,” Maher said. “We’re not improving safety.”
Maher said the only stumbling block for pharmaceutical companies now are regulators and the people.
The vaccine industry since 1986 has exploded. It’s gone from $272 million to $60 billion.
“But there’s no money in vaccines we’re told, right,” Maher said.
Informed consent that isn’t too informative
Initially, there was a strong push for informed consent in the 1986 law with 10 objectives laid out — things like early warning signs, any contraindications that you may not think of, genetic conditions, symptoms or reactions to the vaccine in which they may occur, when should they be brought to the attention, when should they seek legal counsel.
Medical associations, doctors, pharma and HHS lobbied Congress aggressively in 1993 to change it.
“Yes, the vaccine information statement was 12 pages long,” Maher said. “But at that time we only had three vaccines. Now more were being added every year and it took time to develop all this language. But, they went in and they lobbied hard and they changed the act to cut out a majority of the information.”
Now it’s a concise description of benefits, a concise description of the risks, a statement of the National Vaccine Injury Compensation Program and other relevant information as determined by the HHS Secretary.
That statement of the National Vaccine Injury Compensation Program was the only promoting HHS was doing of the program.
“They were supposed to be promoting it so people knew about it,” Maher said. “When in fact they were not because they didn’t want to. They didn’t want to make it seem like our vaccine schedule was hurting people.”
Now the vaccine injury statement is one page, front and back.
Vaccine administrators were not liability-free originally, but during the change in 1993 — which Maher said was part of a huge health omnibus bill — Congress added in all vaccine administrators to protect doctors, nurses, medical associations, etc.
The statement now talks about the benefits of the vaccine, what the disease looks like if you don’t get vaccinated. What you should talk to your health care provider about. On the backside, there is one paragraph on the risks.
Mostly soreness, swelling, fever, maybe bruising. Perhaps some more severe reaction, but the statement says they very rarely happen. These include seizures, pain stiffness in joints, pneumonia, swelling of the brain, spinal cord covering, temporary low platelet count.
People with immune system problems could contract an infection, which could be life-threatening.
It adds, as with any medication, there is a very, very remote chance of the vaccine causing a severe allergic reaction, serious injury or death.
“That is the extent of our informed consent,” Maher said.
The information sheet also says to call 9-1-1 if there is a serious problem. And it lets people know about VAERS. They also talk about the National Vaccine Injury Compensation Program. The statement says there is a time limit, but that time limit is not given.
“I don’t know how many stories I’ve heard where people say they’ve never received this statement at all before they got an injection or it was thrown at them afterward,” Maher said. “Or, it was given to them, five seconds before. It wasn’t gone over. None of this was gone over. It’s like, ‘here, you can read this on your way home.’ Cover-your-butt disclosure is what I call that.”
For many doctors, Maher said they believe that provides enough informed consent. That is because, as she said, doctors spend maybe half of a day talking about vaccines in medical school.
“They don’t know all the specifics, they don’t know all the complications, they don’t know all the adverse events, they don’t know all the ingredients,” Maher said.
Last year, a bill was put forward in Iowa that would codify the various forms. The law would make it mandatory for a health professional in Iowa to report an adverse event if they see it. If they did not, they’d be penalized.
The director of the board of medicine said they would really need to educate medical professionals on what adverse events are and how to report them before anything was legislated.
“Thankfully one of our beautiful souls on our board spoke up and said, ‘Um sorry, you’ve had 34 years that this has been law,’” Maher said. “‘The medical associations know about this law, they helped change the law to get you liability free. It’s past time for you to be educated. You could be doing this already.’”
In VAERS, and in federal law, it is required for vaccine administrators to report, but it is not enforced at the state level or the medical board — those who oversee licenses.
“It is a passive voluntary safety surveillance system,” Maher said. “You can report if your doctor or nurse or whoever witnesses the injury doesn’t. But in all honesty, it’s supposed to be the doctor. They’re supposed to support anything in the reportable events following the vaccination table. They’re supposed to report any adverse event listed on the vaccine insert. See, this is, this is what an actual vaccine insert looks like. Informed consent from the manufacturer itself. If you want to ask for it, it’s in the little box that comes with the vaccine.”
The insert is in about size four font, Maher said. It has everything one needs to know on the clinical trials, clinical studies and what they found out.
“But it’s summarized nicely on one page of the vaccine information statement,” Maher said.
Some of the adverse events witnessed, compensable, reportable and on the vaccine insert include Guillain-Barre Syndrome, transverse myelitis (a form of paralysis), encephalopathy, seizure disorder, death, brachial neuritis, acute disseminated encephalomyelitis (which Maher said took a young boy’s life in the Quad Cities just two years ago because of the HPV vaccine). The list actually continues. It includes chronic inflammatory demyelinating, brain damage, ovarian failure, Bell’s Palsy, juvenile diabetes, Idiopathic Thrombocytopenic Purpura, rheumatoid arthritis, multiple sclerosis, fibromyalgia, infantile spasms, anaphylaxis, ocular myasthenia gravis, hypoxic seizure, autoimmune diseases, food allergies, asthma, eczema, juvenile diabetes, Tics, Tourette’s, ADD/ADHD, Autism, speech delay, neurodevelopment disorders, SIDS, narcolepsy, and epilepsy.
“All these things are considered chronic illnesses, but they are all adverse events or injuries that have been reported and compensated,” Maher said. “Why aren’t we informing people about this?”
Maher blames the passive reporting system and the fact that doctors are not trained. She said that conclusion was confirmed in 2011 after Dr. Ross Lazarus explored automating the VAERS system. He received a million-dollar grant and works for Harvard Pilgrim. He explored and examined 715 medical records and 1.4 million vaccine doses. He found only one percent of injuries are reported.
Maher said that one-in-ten recipients or 2.6 percent of every vaccine given is causing an injury.
“One-in-ten,” she said. “And our children are receiving 69 different doses of them. One-in-ten.”
There was no data on severity and the CDC never responded to test the system. This is a direct quote from the report:
“Unfortunately, there was never an opportunity to perform system performance assessments because the necessary CDC contacts were no longer available and the CDC consultants responsible for receiving data were no longer responsive to our multiple requests to proceed with testing and evaluation.”
“They stopped responding,” Maher said. “HHS, they dropped it.”
There has been more than 5,618 VAERS reports in Iowa since 2018. If that is one percent, then Maher said we’re missing more than half a million injuries that were never reported.
“That’s one in six people in our state,” she said. “How are these products even getting licensed you may ask if this is what is happening. If this could be the outcome, lifelong autoimmune issue or chronic health issue — how is this even being licensed? Well, enter the FDA.”
The Hepatitis B vaccine, which is given on the day of birth, had a safety review prior to licensure was 4-5 days.
“So they tested and watched your kid for 4-5 days before they said OK let’s put it on the schedule,” Maher said. “And, there was no placebo.”
Recombivax is one of those Hep-B vaccines. For that, it was given to 147 healthy infants and children up to age 10. They were monitored for five days.
“One hundred forty-seven,” Maher said. “One of the big challenges of safety studies is the tyranny of small numbers. You are not necessarily going to see injuries in 100 people. You may not necessarily see injuries in 500 people. And they know that.”
Engerix-B, the other Hep-B vaccine, included 5,071 healthy people, but only monitored for four days.
“Not to mention we’re giving it up to an age 10-year old,” Maher said. “We’re giving this to a newborn baby who can’t talk, who can’t report how they feel, whose only way to express itself is inconsolable crying. What kind of adverse events are they experiencing?”
Studies performed on mice by independent researchers around the world have shown Hep-B vaccination alone can cause neurological damage when given this early to children.
For Garadasil, the HPV vaccine, two placebos were used. One was a saline placebo and amorphous aluminum hydroxyphosphate sulfate was the other. But the two groups were combined when results were reported.
“How is that controlled,” Maher asked. “How is that gold standard science when you take two controls and put them together to report them? Why would they do that?”
Potentially, she said, because the increase in new autoimmune conditions would be the same 2.3 percent in the 10,000 and 9,000 people they tried this in.
“I wonder what that baseline would be,” Maher said. “I wish we had autoimmune data from NIH. I wish we had a placebo group so we had a baseline to go on. Why don’t they do that?”
Gardasil 9 is considered safe because it compares to the original Gardasil. It was updated to vaccinate against nine strains instead of the original two — of hundreds of strains of HPV.
There is a new MMR vaccine coming out as well. That was tried in a few thousand volunteers. Adverse events were reported by about half the people. Grade 3 adverse events were six percent, serious adverse events were two percent, adverse events prompting an ER visit was 10 percent and new onset of chronic disease was 3.4 and 3.7 percent in each of them.
The FDA recently approved Remdesivir, Maher said, for coronavirus treatments.
“Despite the fact that the largest clinical trial found zero difference between it and basic standard care,” Maher said.
Dr. Eric Topol tweeted:
“How can Remdesivir get a full FDA approval when there are such mixed data? Not supportive of this decision at all. Does it work early? Does it work late? Does it work anytime? So much unresolved.”
Vaccines on the current childhood schedule have never been tested on a true intersample placebo. Informed Consent Action Network unearthed this fact.
“The cumulative schedule has never been tested for toxicity or synergistic effects,” Maher said. “See, not only are we giving kids one vaccine in the well-child visit, sometimes we’re giving them five. And those ingredients may add up. They may increase the dose and toxicity. They may interfere with each other. We don’t know.
“The schedule has never been tested for mutagenic or carcinogenic potential, or the ability to cause infertility,” Maher said. “I know so many women who battle infertility, and unfortunately, all of us in here have been affected by cancer. It is the second leading cause of death in America and it’s the second leading cause of death in children. In children. That is awful and ridiculous. How can children develop cancer, which is usually damage to their DNA causing tumorigenic cells to form in that short period of time — one year, two years old.
“13.1 on every vaccine insert — this thing — carcinogenic or mutagenic potential and impairment of fertility has not been studied. How is that even allowed? How is that even possible that we are doing this repeatedly when it is the No. 2 cause of death in America?”
Maher highlighted the ingredients list from the CDC website. The Hep-A vaccine includes MRC-5 cellular proteins (celluline from an aborted fetus).
“Yes, you could be putting human DNA cells in your body,” she said. “Whether you have a moral conflict with that, you should definitely have a safety conflict with that.”
Other ingredients include formalin (a derivative of formaldehyde ), aluminum hydroxide, polysorbate 20, neomycin sulfate and aminoglycoside antibiotic.
“Yes, there are small amounts of antibiotics in some of our vaccines,” Maher said. “Yet we say we have superbug issues. We say we have all this MRSA and bacteria that resist our antibiotics. I wonder why. Not only is the rampant over-prescribing of antibiotics a huge issue, but we’re putting them in here as well.”
The HPV vaccine includes amorphous aluminum hydroxyphosphate sulfate — more aluminum, which stimulates the immune system to react. Polysorbate 80 is in Gardasil 9 and has been used since the 1980s in food products and vaccines. It is great at spreading things out, but Maher said it’s also really good at passing barriers like your gut lining and your blood ring barrier.
“What’s it taking with it? Whatever it’s carrying,” she said. “Those lines are meant to protect us. Not when you put that in there.”
Some vaccines still have mercury. The Men-B vaccine was added to Iowa’s schedule a few years ago. That contains more heavy metals, sugar and antibiotics.
“Again, how many of those have been studied synergistic toxicity,” Maher said. “Any of the effects? How much aluminum are we putting in someone when we put five vaccines in them? Is it too much? What’s the legal dose? Apparently, they don’t care.”
***The next part of the series will be the conclusion of Maher’s presentation. It will also include information about conflicts of interest within the agencies tasked with keeping Americans, and vaccines, safe.***