Category: History of Vaccines

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

So you likely know that there were a bunch of lawsuits against manufacturers of the DPT vaccine in the early and mid 1980s.

“As the number of lawsuits grew to hundreds during the early 1980s, the pharmaceutical companies making vaccines saw their liability insurance bills soar. Worried not only about multimillion-dollar settlements, but also even the legal costs of defending themselves successfully, several companies simply stopped making vaccine.”

How a Media Scare On Vaccine Started a ‘near-Epidemic’

That’s why the National Vaccine Injury Compensation Act passed in 1986, creating the National Vaccine Injury Compensation Program and the Vaccine Court.

About Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

But did those DPT vaccine lawsuits prove that vaccines aren’t safe?

Is that why vaccine manufacturers needed help to limit their liability?

“The total amount claimed in 1984 DTP vaccine suits ($1.3 billion) is more than 20 times the total value of 1984 sales of DTP vaccine at the market price of $2.80 per dose.”

Hinman on DTP Vaccine Litigation

Of course not!

While the older DPT vaccine did cause more local reactions, pain, and fever than the newer DTaP vaccine that replaced it, all of the serious reactions that triggered the lawsuits were later found to not be caused by the vaccine.

Most of the DPT lawsuits were thought to be frivolous.

That’s not surprising, as the same vaccine lawsuits that were succeeding in driving vaccine manufacturers out of business in the United States were failing in the UK and Canada!

This included the Loveday judgment in Great Britain’s High Court of Justice, Queen’s Bench Division and the Rothwell judgment in the Supreme Court of Ontario, Canada, both decided in 1988, with justices ruling that there was “insufficient evidence to demonstrate that pertussis vaccine can cause permanent brain damage in children.”

Similar cases were succeeding in the US though..

“The number (and dollar value) of suits increased in 1982, a year when broadcast and print media began to devote considerable attention to the alleged hazards associated with the use of pertussis-containing vaccines. Most of the media coverage has emphasized alleged risks of pertussis vaccines and has given relatively little attention to the benefits of their use.”

Hinman on DTP Vaccine Litigation

Most experts knew that most of the lawsuits were frivolous, but they weren’t able to stop the damage that was to come, as:

  • the DPT: Vaccine Roulette special aired on TV
  • Barbara Loe Fisher, believing that her child was damaged by the DPT vaccine, formed the Dissatisfied Parents Together organization and wrote the book DPT: A Shot in the Dark, which later influenced Bob Sears
  • there were temporary shortages of DTP vaccine in 1984, as “two of the three American manufacturers of the product decided to halt or restrict its sales.”

What else happened? I mean besides all of the studies proving the DPT vaccine was safe?

Parents who had been scared by the DPT controversy were ready and primed when Andy Wakefield showed up and told them that they had something new to worry about – the MMR vaccine and autism.

And of course, pertussis is now returning, as more parents are scared to vaccinate their kids and the newer DTaP vaccine isn’t as effective as DPT.

More on Those Lawsuits That Almost Put Vaccine Manufacturers out of Business

What Did Thomas Jefferson Say About Vaccines?

A lot of folks are quoting the Founding Fathers these days when they talk about vaccines.

“Thomas Jefferson has a quote, he says ‘He who sacrifices Liberty for security deserves neither.’ And I think that’s really important and fundamentally true.”

Isaac Lindenberger

Wait, that quote sounds familiar.

“Those who would give up essential Liberty, to purchase a little temporary Safety, deserve neither Liberty nor Safety.”

Benjamin Franklin

Sen. Rand Paul used it during the Senate hearing that featured Isaac’s brother Ethan Lindenberger. Only Rand Paul correctly attributed the quote to Benjamin Franklin, even though the quote doesn’t really mean what he thinks it means…

What Did Thomas Jefferson Say About Vaccines?

So what about Thomas Jefferson, did he have anything to say about vaccines?

“I have received a copy of the evidence at large respecting the discovery of the vaccine inoculation which you have been pleased to send me, and for which I return you my thanks. Having been among the early converts, in this part of the globe, to its efficiency, I took an early part in recommending it to my countrymen.  I avail myself of this occasion of rendering you a portion of the tribute of gratitude due to you from the whole human family.  Medicine has never before produced any single improvement of such utility.  Harvey’s discovery of the circulation of the blood was a beautiful addition to our knowledge of the animal economy, but on a review of the practice of medicine before and since that epoch, I do not see any great amelioration which has been derived from that discovery.  You have erased from the calendar of human afflictions one of its greatest.  Yours is the comfortable reflection that mankind can never forget that you have lived.  Future nations will know by history only that the loathsome small-pox has existed and by you has been extirpated.

Accept my fervent wishes for your health and happiness and assurances of the greatest respect and consideration.”

Thomas Jefferson

While anti-vaccine folks shouldn’t be invoking the name of Benjamin Franklin, they certainly shouldn’t be throwing Thomas Jefferson’s name around.

Not only did he support and praise Edward Jenner, Jefferson did his own smallpox vaccine trials!

What Did Thomas Jefferson Say About Vaccines?

The History of Vaccine Exemptions

As we are starting to see some states get rid of their exemptions with new vaccine laws, it is important to understand that many non-medical exemptions came on the scene relatively recently.

After vaccine mandates to start school helped eliminate measles in the United States, over just a few years, from 1998 to 2000, 15 states added personal belief vaccine exemptions. Texas and Arkansas added theirs a little later, during the 2003-04 school year.

The History of Vaccine Exemptions

What happened in 1998 that made state lawmakers in 15 states allow parents to use personal belief vaccine exemptions to opt out of vaccinating and protecting their kids?

Andrew Wakefield happened in 1998...
Andrew Wakefield happened in 1998…

Oh yeah, that’s when Andrew Wakefield published his infamous paper in Lancet that was later retracted.

That’s right, these exemptions had their origins in perhaps the biggest anti-vaccine myth of them all!

Not that there weren’t warnings. Many of us knew adding the exemptions was a bad idea at the time…

The Austin American Statesman published an editorial in 2003 urging Legislators to fix the mess they had just created.
The Austin American Statesman published an editorial in 2003 urging Legislators to fix the mess they had just created.

And now, here we are with rising rates of vaccine-preventable disease as folks use and abuse their exemptions.

So while you are thinking about whether or not your state legislators should be taking away your personal belief vaccine exemption, a better question would likely be why they added them in the first place.

More on the History of Vaccine Exemptions

Do You Remember Sabin Sundays?

You may have heard of the Polio Pioneers, the kids who got Jonas Salk‘s original inactivated polio vaccine in 1954.

They were part of a large clinical trial, getting either the polio shot or a saline placebo, and helped prove that the vaccine was safe and effective.

Do You Remember Sabin Sundays?

Of course, that wasn’t the end of the story though.

After the Cutter Incident, Albert Sabin soon proved that his live, oral polio vaccine was better than Salk’s inactivated polio vaccine.

And it was first given in the United States on April 24, 1960 – the first Sabin Sunday, when 20,000 children came to Cincinnati Children’s to receive his sugar cube vaccine.

“On three consecutive Sundays — “Sabin Sundays” — in 1960, millions of families lined up at churches and schools across the country to swallow a spoonful of pink syrup or a sugar cube treated with a life-saving polio vaccine, developed by UC researcher Albert Sabin.”

Sabin Sunday, 1960

Sabin Oral Sunday immunization programs continued over the next few years all over the country as kids got caught up on their polio vaccines.

Several Sabin Sundays were held in Arizona in 1962.

Can you imagine taking your kids to school to get them vaccinated on a Sunday?

Millions of parents did it!

Newspapers urged folks to attend the Sabin on Sunday clinics to help end the threat of "crippling poliomyelitis."
Newspapers urged folks to attend the Sabin on Sunday clinics to help end the threat of “crippling poliomyelitis.”

They lined up to get their kids vaccinated and protected.

More on Sabin Sundays

Milestones Towards the Eradication of Polio

There is a lot more interest in polio these days, but not because we are close to eradicating this deadly disease, but rather because of the emergence of cases of acute flaccid myelitis (AFM).

Although the cases have a different cause, the symptoms of AFM are the same that we used to see during the outbreaks of polio that used to hit each summer in the pre-vaccine era.

Polio

Surprisingly, in most people, the poliovirus doesn’t actually cause any symptoms. They simply have an asymptomatic infection.

In some others, the poliovirus causes flu-like symptoms, including a fever, sore throat, nausea, and a headache – symptoms that last about 3 to 5 days.

Much more rarely, the poliovirus causes meningitis or paralysis.

It is these cases of paralytic polio that most people are aware of and that panicked parents during summers in the 1940s and 50s.

In addition to respiratory problems (think iron lungs), polio causes muscle atrophy.
In addition to respiratory problems (think iron lungs), polio causes muscle atrophy. (CC BY-NC 4.0)

After having flu-like symptoms, those kids who would develop paralytic polio can develop pain and then flaccid paralysis.

“The most severe form, paralytic poliomyelitis, which is seen in less than 1% of patients, presents as excruciating episodes of pain in back and lower limbs. In children, the disease may present in biphasic form—a period of prodrome followed by a brief symptom-free period of 7 to 10 days and then appearance of asymmetrical paralysis of limbs. Flaccid paralysis is the hallmark with loss of deep tendon reflexes eventually.”

Mehndirattta et al on Poliomyelitis Historical Facts, Epidemiology, and Current Challenges in Eradication

Of course, polio wasn’t always called polio.

Other names have included infantile spinal paralysis, infantile paralysis, Heine-Medin disease, poliomyelitis anterior acuta, and acute anterior poliomyelitis.

The first use of the name “polio” came from Adolph Kussmaul, with his use of the term poliomyelitis anterior acuta, which was derived from the Greek polios “grey” and myelos “marrow” and itis “inflammation.” It was because he knew that it was caused by inflammation of the spinal cord gray matter, even if he didn’t know why.

Polio History

Polio didn’t just suddenly appear in the middle of the 20th century though, it was likely around for ages.

That this Ancient Egyptian priest's leg is smaller than the other and he uses a staff to walk suggests that he could have had polio.
That one of this Ancient Egyptian priest’s legs is smaller than the other and he uses a staff to walk could suggest that he had polio.

In addition to an Egyptian funeral stele (a stone slab used as a monument) portraying Roma the Doorkeeper from 1500 BCE that suggests he had paralytic polio, archeologists have found evidence of polio in skeletons as far back as the Neolithic period.

A medical book from 1789 likely describes people with polio.
A medical book from 1789 likely describes people with polio.

Still, we don’t really know how long polio has been around and we don’t know why we began to see more cases in the mid-20th Century, although there are theories, including, ironically, about hygiene. While we often credit improved sanitation and hygiene for helping to reduce mortality from many diseases, some think that this actually set us up for polio outbreaks, as we were no longer exposed as infants, when we still had some maternal immunity.

The one thing that we do know is that we are on the verge of eradicating polio, as there are very cases now, in just a few countries.

Polio Timeline and Milestones

In addition to the more ancient discoveries about polio, there is a lot to learn about vaccines and vaccine-preventable diseases if we look at the major milestones of this important disease.

Although in the end it is a success story, the road to figuring out what caused polio symptoms and how polio could be prevented was very long.

  • Michael Underwood describes what is thought to be paralytic polio in his book A Treatise on the Diseases of Children, with General Directions for the Management of Infants from Birth  in a section on “Debility of the Lower Extremities” (1789)
  • first reported outbreak of polio in Worksop, England (1835)
  • Jacob von Heine, head of an orthopedic hospital in Germany, publishes a monograph that describes 29 cases of paralytic polio, and actually attributes the condition to inflammation of the anterior horns of the spinal cord, although the cause was still not known (1840)
  • first use of the term poliomyelitis by Adolph Kussmaul (1874)
  • Nils August Bergenholtz reports on an outbreak of paralytic polio in Sweden (1881)
  • Karl-Oskar Medin, a pediatrician who reported on a polio epidemic in Sweden (1887), later presents his findings at the Tenth International Conference in Berlin (1890)
  • the first major outbreak in the United States is documented in Rutland County, Vermont and causes 132 cases of paralysis and 18 deaths (1894)
  • Ivar Wickman tracks cases of polio during an epidemic in Sweden in 1905 and was the first to suggest that polio was contagious and that you could get it from “those afflicted with the abortive type” (1907)
  • although they don’t actually identify the poliovirus, Dr. Karl Landsteiner and Dr. Erwin Popper  identify that a virus causes polio when they inject material from the spinal cord of a child who had recently died with polio into the peritoneum of two monkeys, both of which soon developed paralytic polio (1908)
  • Simon Flexner, first discovers polio antibodies (1911), but unlike other researchers at the time, pushes the theory that polio was spread by the olfactory route, instead of the fecal-oral route, which was why we saw the development of nose sprays, etc., to try and prevent polio, none of which worked of course
  • a large polio epidemic in the United States causes at least 27,000 cases and 6,000 deaths (1916)
  • Philip Drinker and Louis Agassiz Shaw invent the first iron lung, the Drinker respirator (1929)
  • Frank M. Burnet and Jean Macnamara proposed that there were antigenically different strains of poliovirus (1931)
  • John R. Paul and James D. Trask help figure out how polio was spread by identifying the polio virus in human waste and sewage samples (1932)
  • Maurice Brodie and John Kolmer have unsuccessful field trials of early polio vaccines, including allergic reactions and vaccine induced polio because of poor attenuation (1935)
  • Sister Elizabeth Kenny establishes a clinic in Australia to treat polio survivors (1932) and later publishes her treatment recommendations, Infantile Paralysis and Cerebral Diplegia (1937)
  • the National Foundation for Infantile Paralysis is founded by FDR to stop polio (1937)
  • the first March of Dimes fundraisers to stop polio (1938)
  • Carl Kling found traces of the poliovirus in the Stockholm sewage system (1942)
  • the Sister Kenny Institute is built in Minneapolis, as her treatment methods become widely accepted after years of controversy (1942)
  • the U.S. Army Neurotropic Virus Commission, including Albert Sabin, gets a grant from the NFIP to study polio in North Africa (1943)
  • Isabel Morgan actually developed the first inactivated polio vaccine, but only tested it on monkeys (1949)
  • John Enders, with T. H. Weller and F. C. Robbins, received the Nobel Prize in 1954 for their work on the cultivation of the poliomyelitis viruses (1949)
  • David Bodian creates the monkey model using field isolates of poliovirus and with Jonas Salk, identifies the three poliovirus serotyes (1950s)
  • Hilary Koprowki develops the first oral, live polio vaccine, (1950) although Sabin’s vaccine eventually gets licensed because it is thought to be less neurovirulent in monkeys and undergoes more testing
  • there are 58,000 cases of paralytic polio in the United States (1952)
  • Renato Dulbecco, with Marguerite Vogt, successfully grows and purifies polio virus (1952)
  • the Polio Pioneers vaccine field trial, led by Thomas Francis Jr.,  that proves that Jonas Salk’s polio vaccine is safe and effective begins (1954)
  • Jonas Salk gets approval for his polio vaccine (1955)
  • improperly inactivated polio vaccine from Cutter Laboratories (Cutter Incident) causes 40,000 cases of polio, 200 cases of paralysis, and kills ten people (1955)
  • Albert Sabin develops the first live, oral polio vaccine, which replaced Jonas Salk’s inactivated polio vaccine (1961)
  • that polio survivors can develop new, late complications or post-polio syndrome begins to get reported (1969)
  • last endemic case of polio in the United States (1979)
  • the National Foundation for Infantile Paralysis officially changes its name to the March of Dimes Birth Defects Foundation (1979)
  • the World Health Assembly adopts a resolution for the worldwide eradication of polio by 2000 and the the Global Polio Eradication Initiative is launched (1988)
  • last imported case of polio in the United States (1993)
  • the WHO Region of the Americas is declared polio free (1994)
  • “last” case of VAPP that was acquired in the United States (1999)
  • last case of wild poliovirus type 2 (1999)
  • the WHO Western Pacific Region is declared polio free (2000)
  • the United States switches back to using the an inactivated polio vaccine because of concerns over VAPP (2000)
  • the WHO European Region is declared polio free (2002)
  • outbreak of vaccine derived polio among a group of unvaccinated Amish in Minnesota (2005)
  • last case of VAPP that was acquired outside the United States, an unvaccinated 22-year-old U.S. college student who became infected with polio vaccine virus while traveling in Costa Rica in a university-sponsored study-abroad program (2005)
  • last case of VAPP in the United States, a patient with a long-standing combined immunodeficiency who was probably infected in the late 1990s (2009)
  • last case of type 3 poliovirus (2012)
  • seasonal reports of acute flaccid myelitis in the late summer and early fall, which might be caused by a non-polio enterovirus, are reminiscent of polio epidemics in the early part of the 20th century (2014)
  • type 2 poliovirus eradicated (2015)
  • Bob Sears says that it is okay to delay the polio vaccine on his alternative vaccine schedule because “we don’t have polio in the United States” (2015)
  • a global switch from trivalent OPV to bivalent OPV in routine immunization programs (2016)
  • polio remains endemic in just two countries, Afghanistan and Pakistan (2018)

So it should be clear, that despite what some folks think, polio wasn’t conquered overnight. And Salk and Sabin obviously had a lot of help, although those are the names we most commonly hear connected with polio eradication.

“Until poliovirus transmission is interrupted in these countries, all countries remain at risk of importation of polio, especially vulnerable countries with weak public health and immunization services and travel or trade links to endemic countries.”

Global Polio Eradication Initiative on Endemic Countries

And to be clear, polio hasn’t yet been conquered.

There is still some work to do unless we want to see cases of polio and paralytic polio return.

That’s why it is important that you don’t skip your child’s vaccines, even for diseases that we don’t have in the United States anymore.

More on the History of Polio

Recognizing Old Vaccine Scars

Do you have a scar on your arm and you aren’t sure why it is there?

Having a smallpox vaccine scar makes you a part of history.
Having a smallpox vaccine scar makes you a part of history.

Is it from the smallpox vaccine?

Recognizing Old Vaccine Scars

Classically, there are two vaccines that can leave a scar – the ones that protect us against smallpox and tuberculosis.

“BCG scar is a surrogate marker of vaccination and an important index in the vaccination program.”

Dhanawade et al on Scar formation and tuberculin conversion following BCG vaccination in infants: A prospective cohort study

And there are a few easy ways to tell if you have a smallpox scar.

When were you born? Remember, the smallpox vaccine hasn’t been used in the United States since the early 1970s and its use stopped everywhere in 1986.

And where were you born?

The BCG (bacille Calmette-Guerin) vaccine, on the other hand, is still in use in many countries, and is given at birth to prevent tuberculosis disease, including meningitis and disseminated tuberculosis. It isn’t routinely used in the United States though “because of the low risk of infection with Mycobacterium tuberculosis, the variable effectiveness of the vaccine against adult pulmonary TB, and the vaccine’s potential interference with tuberculin skin test reactivity.”

Do you have a vaccine scar on your arm?
Do you have a vaccine scar on your arm? Photo by Earl Hershfield

In general though:

  • the BCG vaccine scar has a raised center
  • the smallpox vaccine scar is depressed, with lines that radiate to the edges

Complicating matters is the fact that you can have multiple scars from each vaccine…

“In 1972, the National Advisory Committee on Immunization in Canada recommended that routine immunization of infants for smallpox be stopped. Very few Canadians born after 1972 have been immunized against smallpox. Those, like me, who were immunized prior to that date have little or no immunity left. Nothing, but a small scar as testimony to a grand global achievement.”

Diane Kelsall on A Small Scar

Do you have any vaccine scars?

More on Recognizing Old Vaccine Scars

What Ever Happened to the Lyme Disease Vaccine?

A Lyme disease vaccine, LYMErix, was approved by the FDA in 1998.

Unfortunately, the manufacturer stopped making it a few years later.

What Ever Happened to the Lyme Disease Vaccine?

Although Lyme disease is caused by a bacterial infection, the bacteria is transmitted to people through tick bites. Not surprisingly, the original Lyme disease vaccine didn’t attack ticks, it attacked the Borrelia burgdorferi bacteria in those ticks, before they could cause an infection.

A new Lyme disease vaccine would be welcomed in the 14 states where the majority of Lyme disease cases are reported.
A new Lyme disease vaccine would be welcomed in the 14 states where the majority of Lyme disease cases are reported.

After three doses, LYMErix was found to be 78% effective at preventing Lyme disease.

Unfortunately, unverified reports of vaccine side effects, especially arthritis, were hyped by the media and anti-vaccine groups and led folks to avoid the vaccine.

In their article, “Concerns Grow Over Reactions To Lyme Shots,” The New York Times even gave equal time to doctors from the International Lyme and Associated Diseases Society, who push the idea that folks need treatment for chronic Lyme disease.

Another vaccine, ImuLyme, didn’t even bother applying for FDA licensure at the time.

“In 2002, in response to low vaccine uptake, public concern about adverse effects, and class action lawsuits, SmithKline Beecham withdrew the vaccine from the market despite the fact that both pre- and post-licensure safety data showed no difference in the incidence of chronic arthritis between those who received the vaccine and those who had not.”

The History of the Lyme Disease Vaccine

Interestingly, a more current article in The New York Times, “Lyme Disease Is Spreading Fast. Why Isn’t There a Vaccine?,” doesn’t mention the media’s role in bringing down the vaccine.

“But the company took it off the market less than four years later, citing low sales, amid lawsuits from patients who said the vaccine caused severe arthritis and other symptoms… The high cost of the vaccine and confusion over who should get it and how many doses were needed didn’t help its prospects.”

Lyme Disease Is Spreading Fast. Why Isn’t There a Vaccine?

And that’s likely why we continue to see false balance in their reporting, as we see them interview a group who is “skeptical about the new vaccine.”

A new vaccine that hasn’t even made it into phase II trials yet!

“Whatever you think about Andrew Wakefield, the real villains of the MMR scandal are the media.”

Ben Goldacre on The MMR story that wasn’t

The media’s role in scaring folks about vaccines isn’t new.

Unfortunately, the impact of the media on the anti-vaccine movement has been felt far beyond Andrew Wakefield, the MMR vaccine and measles outbreaks.

“As we ask how to weigh public health benefits of interventions against potential risks (notably incurred by identifiable individuals), the LYMErix case illustrates that media focus and swings of public opinion can pre-empt the scientific weighing of risks and benefits in determining success or failure.”

The Lyme vaccine: a cautionary tale

Hopefully, folks have learned their lesson though. How many people have developed Lyme disease since LYMErix was withdrawn from the market? After all, Lyme disease should still be a vaccine-preventable disease.

More on the Lyme Disease Vaccine