We Don’t Need to Keep Repeating Anti-Vax Junk Science
We Don’t Need RFK, Jr. and His Anti-Vax Rhetoric. We Can and MUST Remember The Pertussis Vaccine Chaos
The anti-vaxxers have been out in force since Rober F. Kennedy, Jr. spoke at Hillsdale College recently, followed by his announcement to run for the nomination for Democratic candidate for the US Presidency. I’m deliberately not providing any links, as he deserves no promotion of his baseless, conspiracy-laden theories around vaccines.
Here is my only political statement. RFK, Jr. has no viable niche within the US population other than the anti-vax niche. Few responsible Democrats or moderate Republicans would vote for him based on his conspiracy ideas of vaccines and pharma. Even his family tells us that they disagree with his views on vaccines.
– End of politics.
Let’s go to the science of the DTP vaccine fiasco. I’ll demonstrate how RFK, Jr lies and obfuscates. He routinely takes things out of context and picks and chooses his “history” (as do all good anti-vaxxers).
I’m going to take you readers to the 1980’s, and show you what it was like when the rise of anti-vaxxers nearly ruined the vaccine business leaving children without vaccines. Why am I qualified to do this? Because I was there as a mother vaccinating her kids. But I was also there as an employee of Lederle Laboratories, one of the three vaccine manufacturers at the time.
I was there. . in the thick of the total disruption
of the vaccine marketplace
RFK, Jr. was not.
I know the truth of what transpired.
RFK, Jr. focuses only on Wyeth, one of the three manufacturers involved in this. He speaks recklessly. He is blatantly disparaging the vaccine manufacturers, sowing doubt in the minds of new moms needing to vaccinate their kids. He is destructive and does not speak to the truth.
His book is the worst “academic” endeavor I’ve ever seen. Extraordinarily biased, he is all over the place providing no complete picture of events. I urge you to watch the videos done by “Debunk the Funk”, Dr. Dan Wilson for his reviews on RFK’s book “The Real Anthony Fauci”. Listen to a scientist, not a conspiracy theorist. I’ve provided a couple of links to many of Dr. Wilson’s videos.
Let’s go back in time to 1982. I had been employed by Lederle Laboratories for six years. On April 19, 1982, Lea Thompson, an investigative reporter, aired a documentary on NBC: DPT: Vaccine Roulette. She claimed she was providing accurate information on the dangers of the DTP vaccine.
Nothing could have been further from the truth. Literally, overnight, panicked mothers were flooding the pediatricians’ offices with phone calls. I was in the field at the time. I also had one toddler, with one on the way (I was 2 months pregnant). I was to have another pregnancy during the next few years, while all this insanity over the DTP vaccine was reaping havoc in the medical community.
Interestingly, the “documentary” did not show an infant or toddler suffering with whooping cough. If you’ve ever seen the disease, you would sit in tears knowing there was little you could do to help your child. I’ve seen horrible videos, where an infant cannot stop the coughing, the “whooping”, with slobber and mucus running down his chin, turning blue as he cannot catch his breath.
A documentary on the “dangers” of the pertussis vaccine, but no dangers from the disease? Biased, to say the least.
Please click on this link to hear what a child sounds like with whooping cough: https://www.babycenter.com/health/illness-and-infection/sounds-of-whooping-cough_10316927
There were three companies in this marketplace at this time. Lederle Laboratories, Wyeth Laboratories and Connaught Laboratories.
Tri-Immunol, Lederle Laboratories
May 7, 1982, the Senate convened a meeting to hear testimonies from stakeholders in the DPT vaccine debate.(1) In the following years, the DPT hysteria set the stage for a much more dangerous problem – as lawsuits against vaccine manufacturers increased, rises in vaccine prices and drops in vaccine production threatened the immunity of the entire country. (1)
The American public was angry. But it was perception, not fact that drove this anger. They lashed out at the three manufacturers. By June 1984, both Wyeth and Connaught stopped the distribution of the vaccine due to hundreds of lawsuits that threatened to put both companies out of business. Lederle was the SOLE provider of the vaccine. . .never a good place to be for the American public. By December, there was a shortage of vaccine – never seen before in recent vaccine history.
Lederle also had one or two batch failures. . . not a common thing to occur in those days of vaccine manufacturing. But it serves as a testament to the testing of product at multiple steps of the manufacturing process and before the vaccine goes out to patients.
The vaccine industry was in total chaos. “It was no longer economically or politically beneficial for manufacturer to be in the vaccine business.” All three of the manufacturers had made state-of-the-art batches of vaccine – a product that was made true to specs, but carried inherent risks, and mandated by the government for public health reasons. I know that Lederle was already working on a safer pertussis vaccine, but it was not yet ready to come to market. The manufacturers were targeted for making the safest vaccine known by the science at that time, albeit with risks (as with ANY pharmaceutical product). The government was ill equipped to respond to the public health crisis.
Initially the juries found in favor of the families and the three companies faced millions of dollars in settlements. It was argued in several lawsuits that the manufacturer failed to make a safer vaccine and that the companies failed to report all the risks involved. Sorry folks, there was no safer vaccine at that point within medical science that could be approved and manufactured. And false, the companies provided the packing labeling with every vial that went out, along with patient education materials. HCW’s knew how to answer questions from their patients.
It was not proven in most cases that the vaccine had been the culprit of the plaintiff’s condition. “The record reflected, ‘for the purposes of this motion, the court will ASSUME the plaintiff’s condition was caused by the pertussis vaccine.’”
In June 1984, the cost “of the lawsuits had overtaken Wyeth, and Wyeth had decided to stop manufacturing the DPT vaccine. Connaught Labs followed with an announcement of its own, stating that the loss of their private insurance made the financial burden too great to continue fighting lawsuits and distributing the vaccine.” Lederle was the ONLY company to “bear the cost of distributing the vaccine and assume liability for its effects.”
Shortages were happening across the company, Lederle had to send out partial shipments to accounts. Pediatricians and physician groups had to delay the 4-6 year old immunization, leaving the kids vulnerable at school. Infants were not receiving their initial 3 dose immunization.
Rationing was happening. The incidence of cases increased during this time. In 1984 and 1985, it was determined that 70% of reported cases were in patients not adequately vaccinated for pertussis.
The nation was facing a possible whooping cough epidemic if the DPT market continued to falter.
Lederle committed to staying in the marketplace. They were self-insured, causing further increases in the 15 dose vial. The price of a 15 dose vial went over time from $4.00 to $420.00 (cost of being self-insured, and lawsuits that were decided not on the science, but on emotion).
In December 1984, Henry Waxman, Chairman of the House Health Sub- Committee, called a hearing. Lederle was the only distributor of DTP. I remember, as an employee, listening to our President of Lederle, Robert Johnson, speak to the crisis: “Increased production costs combined with escalating litigation resulted in a price increase of the vaccine.” The companies also committed to the lowering of the price of the vaccine “if they were relieved of the liability costs.”
The American Academy of Pediatrics spoke: “It is an unfortunate fact of life that as vaccines have been developed for many of our childhood diseases and as their use has become universal with almost complete disappearance of those diseases, the public concern for these once dreaded childhood diseases tends to wane while concern for the rare reactions to the vaccines begins to mount. Those diseases are not so uncommon that the rare reactions are now a source of intolerable proportion.”
I remember visiting my parents during this time. I was sitting after dinner talking with my mother. I was born in 1952. The pertussis vaccine came out in 1948. I told my mother that I just didn’t understand this fear from mothers, and I certainly couldn’t understand the anti-vax mouthpiece that had caused such turbulence in the vaccine marketplace. I remember my mother saying: “Barb, it was not that many years that we had the pertussis vaccine when you girls were born. We mothers were scared to take you outside to go to the pool or other places where you could get either polio or whooping cough. We knew what whooping cough looked like and we were petrified that our children would be infected.”
We have lost our way with preventing horrible diseases that affected the baby boomers’ parents only years before we were born. All because the anti-vax community thinks it can hijack the health and care of all children with lies and manipulations, rather than letting our expert physician community provide the information.
The American Medical Association stated: It is a scientifically established fact that vaccines will cause a certain predictable incidence of adverse reactions. . . even where there is absolutely no negligence in the manufacture and administration of the vaccine.”
Obviously, the few people who had legitimate long-term and disabling sequelae from the vaccines needed to be heard and taken care of. I agree we must provide for those who are hurt legitimately by the administration of a vaccine.
The National Childhood Vaccine Injury Act of 1986 (NCVIA) was created by Federal law. “The bill granted protection measures to vaccine makers in tort lawsuits and made them immune to liability if their vaccines complied with federal standards.”
It took time for this Act to be implemented. During the wait, Lederle was struggling. Connaught came back in the market. They were self-insured and had to consider raising the price again.
Through further research during this time, and after, it has been determined that the DTP vaccine did NOT cause the neurological damage or seizure disorders that many lawsuits claimed it did. There is no association with brain injury, epilepsy, SIDS, infantile spasms, serious neurological illness, no increased risk for encephalopathy. Anti-vaxxers continue to spread fear and panic. They took advantage of the legal system trying to bankrupt the manufacturers and put them out of business. They created a time of rationing the vaccine. They created the sky-high prices for the vaccine. “So no, the DPT vaccine was never really as dangerous as folks said or thought it was, despite what you might read or hear in anti-vaccine books or news reports.” (2)
We are at a similar point with our Covid vaccine. The “perception of risk” is at the forefront of the antivax community. They provide fear through lies, misunderstanding the science, innuendoes, using “memes” that are misleading, etc. The honest science unfortunately is being drowned out.
RFK, Jr. is one of the leaders of this anti-vax community. We cannot have a person in the Office of the Presidency who doesn’t believe in the expertise of our medical scientists. We saw the destruction that DJT did to our pandemic effort. Public health must speak out.
RFK, Jr. said in one of his recent speeches: “Now they (vaccine companies) have this liability shield. No matter how negligent they are, no matter how reckless they are, no matter how grievous your injury is, no matter how toxic and unnecessary the product is. No matter how ineffective the vaccine. You cannot sue them. And these are the companies that are not good companies. They are the same companies that gave us the opioid economic epidemic.”
No, Mr. Kennedy, the vaccine manufacturers had nothing to do with creating the opioid crisis. This is pure fear-mongering and we simply cannot have a president spitting out incendiary falsehoods. Look up who was involved in the opioid crisis. . . and yes those few companies, along with national pharmacy chains, PBM’s and a minority of physicians running opioid pill offices were ALL to blame.
No, sir, pharma is NOT reckless. We do not seek approval for products whose possible benefit is overwhelmed by toxicities. We do not put unnecessary products on the market. We do not put ineffective vaccines on the market.
In the lawsuit brought to the US Court of Appeals, Ninth Circuit, Jan 7, 1986, the Judge wrote:
“The fact that the consumer’s injuries were proximately caused by the manufacturer’s product does not in and of itself constitute a sufficient basis upon which to predicate the manufacturer’s liability. When the cause action sounds in negligence, a manufacturer’s duty to additionally test and investigate the propensities of its product is dependent upon the foreseeable risk of harm to potential users in light of then-current scientific or medical knowledge and discoveries. . . . that the marketing of some drugs is fully justified to prevent disease despite risk inherent in their use. ” (10)
To end this story, Lederle was able to bring to market a new acellular DTP vaccine, followed by several other companies. Medical science has done its work and will continue to do so.
I must add that in RFK Jr’s talk, he misspoke. The acellular pertussis vaccine is NOT attenuated, as RFK Jr. said. The acellular pertussis vaccine, as its name implies, takes portions of pertussis outside the cell, rather than the whole cell pertussis vaccine and it is inactivated, not attenuated. While the product may provide fewer side effects, it also does not have the degree of immunogenicity that the whole cell did. Realize pertussis is still a tough bacteria from which to make an excellent vaccine.
I have never seen or heard RFK, Jr. speak to any of this history in the vaccine marketplace. Biased? I think so. He certainly does NOT give full disclosure, nor full context to the real issues that the vaccine marketplace experiences.
The anti-vax movement caused this chaos in our vaccine industry. It did not have to happen this way. The vaccine manufacturers were looking for a better pertussis vaccine. It would come to market in due time, with proper medical scientific data to support its approval.
The anti vaxxers wreaked havoc on our vaccine market, almost leading manufacturers to bail out entirely. We cannot allow that. It is time to become educated on the damage that anti-vaxxers do to our opportunities to keep ourselves healthy. Let’s not repeat what happened in the pertussis chaos of the 1980s.. . .ever. . . again. We must learn from prior experience.
References:
You can read an excellent synopsis of what transpired during this time, documenting my comments. I providing a wide list of further references, hoping you become more educated on the topic. I also include information on the newer versions of the pertussis vaccine.
https://casetext.com/case/toner-for-toner-v-lederle-laboratories
https://www.sciencedirect.com/topics/medicine-and-dentistry/pertussis-vaccine
42 U.S.C. Section 300aa-22 (§22) provides:
(a) General Rule. Except as provided in subsections (b), (c), and (e) State law shall apply to a civil action brought for damages for vaccine-related injury or death.
(b) Unavoidable adverse side effects; warnings
(1) No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings. (emphasis added)
(2) For purposes of paragraph (1), a vaccine shall be presumed to be accompanied by proper directions and warnings if the vaccine manufacturer shows that it complied in all material respects with all requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. §§ 301 et seq] and section 262 of this title (including regulations issued under such provisions) applicable to the vaccine and related to vaccine-related injury or death for which the civil action was brought unless the plaintiff shows—
(A) that the manufacturer engaged in the conduct set forth in subparagraph (A) or (B) of section 300aa- 23(d)(2) of this title, or
(B) by clear and convincing evidence that the manufacturer failed to exercise due care notwithstanding its compliance with such Act and section (and regulations issued under such provisions).
(c) Direct Warnings. No vaccine manufacturer shall be liable for civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, solely due to the manufacturer’s failure to provide direct warnings to the injured party (or the injured party’s legal representative) of the potential dangers resulting from the administration of the vaccine manufactured by the manufacturer.
(d) Construction.—[omitted]
(e) Preemption. No State may establish or enforce a law which prohibits an individual from bringing a civil action against a vaccine manufacturer for damages for a vaccine-related injury or death if such civil action is not barred by this part.