Tag: liability

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

Del Bigtree on the Government’s Plan to Force Inject Stuff into Your Body

Del Bigtree considers himself to be an expert on vaccines.

Bob Sears doesn't consider media talk show hosts to be expert sources of medical information.
Does Bob consider Del an expert source of medical information?

Either Bob Sears disagrees or he really does think that measles is a deadly epidemic…

Del Bigtree on the Government’s Plan to Force Inject Stuff into Your Body

What makes Del Bigtree an expert on vaccines?

Del’s claim to fame is that he “was an Emmy Award-winning producer on the daytime talk show The Doctors, for six years.”

Del Bigtree shared a Daytime Emmy Award with 27 other producers...

So he shared a Daytime Emmy Award with 27 other producers…

And he produced Andrew Wakefield‘s Vaxxed movie. The whistleblower movie that didn’t actually include the whisteblower…

It sounds like pure anti-vaccine propaganda

So what did Del have to say in Washington?

“These crowds are gathering all over the nation because we are talking about having the government force inject free citizens. Think about it. Take vaccines out of it. We are going to force inject children of free parents.

Now there are people that are really worried about Donald Trump. He is forcing a wall to be built on the border of this country, but now we are not worried about a forced injection by the government?

If someone worse than Trump, someone more dangerous, more controlling… This person puts in the CDC, the head of the CDC, the head of the FBI, the head of the NIH, the head of the EPA… Do we really want to give the government power over our bodies where we have no say on what it injects into us? This isn’t an issue about vaccines. This is an issue about the last thing we can control in a free country which is our bodies.”

Del Bigtree

Of course, no one is talking about forcing anyone to vaccinate their kids. That’s not what a vaccine mandate to go to school does.

But that’s not all…

Alex Jones Del included a lot of standard anti-vaccine misinformation that we hear over and over again:

He also mentioned his lawsuits against the HHS and FDA which he thinks “proves that none of this science is really there.”

“I actually want my children to have the measles. This is a disease that only affected killed 1 in 500,000 in 1960 before the vaccine ever arrived. You’ll hear 1 in 1,000, that’s a lie. Technically, 1 in 10,000 people who get the disease could die from it. Those are tiny numbers. That’s the same number that autism used to be.”

Del Bigtree

Tiny numbers?

Just remember that in 1960, there were 434 measles deaths in the United States.

And while the great majority of people did indeed survive having measles, it was hardly a walk in the park. Most people describe kids with measles as being miserable, with a high fever for a week, a cough, and other symptoms, which is why they often end up going to the ER several times before they finally get diagnosed.

Which brings me to perhaps the only time I might ever agree with Bob Sears – folks like this should not be considered medical experts!

“But I would think when you have a child with autism, you know, or on the spectrum, you have no reference point. You have no…

I don’t want this to sound wrong, but it’s a little bit more like having a dog or a Doberman or something that you don’t understand how it thinks, you don’t know. I mean, I mean a better figure than animal reference except… you don’t have their brain.

Or you hear about stories of people that bring home of exotic you know of chimpanzee or something where they can’t, and this is not sounding right.”

Del Bigtree

Not about vaccines, and certainly not about autism.

More on Del Bigtree

Why Aren’t Vaccines Regulated like Drugs?

Have you ever heard the argument that vaccines aren’t held to the same standards as drugs, food, or other products?

“Vaccines are not held to the same double blind gold standard of clinical testing as other pharmaceutical drugs because they are considered biological products under the Public Health Federal Food, Drug and Cosmetic Act. They meet the same standards as cosmetics.”

20 VACCINE “FACTS” you need to know to make an informed decision

Placebos, liability, testing – these are all arguments that anti-vaccine folks try to use to scare parents into thinking that vaccine development isn’t well regulated and vaccines aren’t held to the same standard as drugs.

Why Aren’t Vaccines Regulated like Drugs?

Would you be surprised to learn that part of their argument is true?

Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.
Even after approval by the FDA, a vaccine still has to be reviewed by the ACIP before it is put on the immunization schedule.

No, not the part that vaccine development isn’t well regulated!

“Current authority for the regulation of vaccines resides primarily in Section 351 of the Public Health Service Act and specific sections of the Federal Food, Drug and Cosmetic Act.”

Vaccine Product Approval Process

Federal regulations and rules ensure that our vaccines are safe.

  • Public Health Service Act (42 USC 262-63) §351
  • Food, Drug, and Cosmetic Act (21 USC 301-392)
  • Title 21 Code of Federal Regulations (CFR) 600-680 – standards for biological products
  • Title 21 CFR 314 (21 CFR 601.25[d][2], specific to biologicals – ensures adequate and well-controlled clinical trials
  • Title 21 CFR 312 – investigational new drug application (IND)
  • Title 21 CFR 210-211 – good manufacturing practices
  • Title 21 CFR 58 – good laboratory practices
  • Title 21 CFR 56 – institutional review boards
  • Title 21 CFR 50 – protection of human subjects
  • Prescription Drug User Fee Act (PDUFA) of 1992, 2002, and 2007
  • Food and Drug Agency Modernization Act (FDAMA) of 1997
  • Food and Drug Agency Amendments Act (FDAAA) of 2007

I meant the part that vaccines aren’t regulated like drugs.

While both vaccines and prescription drugs are regulated by the FDA, that work occurs within two different centers of the FDA:

  • Center for Biologics Evaluation and Research (CBER) – vaccines
  • Center for Drug Evaluation and Research (CDER) – over-the-counter and prescription drugs

Both centers work to make sure we have safe and effective vaccines and drugs to keep us healthy, even if there are some differences in how they do it.

“Vaccine clinical development follows the same general pathway as for drugs and other biologics.”

Vaccine Product Approval Process

That’s right, vaccines and drugs go through the same types of clinical trials.

After completing the three phases though, vaccine developers must then apply for a Biologics License Application (BLA), which is reviewed by a multidisciplinary FDA reviewer team. This is also when their manufacturing facility gets inspected.

“Following FDA’s review of a license application for a new indication, the sponsor and the FDA may present their findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). This non-FDA expert committee (scientists, physicians, biostatisticians, and a consumer representative) provides advice to the Agency regarding the safety and efficacy of the vaccine for the proposed indication.”

Vaccine Product Approval Process

Once approved and licensed, the FDA and CDC continue to work to make sure the vaccine is safe, including having some vaccines undergo undergo Phase 4 studies and monitoring for side effects through VAERS and the Vaccine Safety Datalink.

And then, even after approval by the FDA, new vaccines aren’t put on the immunization schedule until a review and approval by the Advisory Committee on Immunization Practices (ACIP).

“Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.”

The Regulation of Vaccines for Human Use in Canada

It is also important to keep in mind that this process doesn’t just happen in the United States.

Still wondering why vaccines aren’t regulated like drugs?

“Vaccine development differs from drug development in several important ways. First, because vaccines are preventive and are given to healthy individuals – often children – they require very large clinical trials, leading to increased research and development costs. Second, vaccines are biological products that can be very complex to manufacture and are subject to stringent quality control standards, resulting in much higher capital costs. Third, unlike drugs, vaccines have no secondary markets, making it unlikely that manufacturers will generate additional profits beyond the initial target markets. Finally, unlike generic drugs, which only need to demonstrate adherence to a pre-established development process, vaccines are biologicals that require full re-development to demonstrate their equivalence. (World Health Organization, 2014). Each manufacturer is required to invest in the full regulatory approval process for their vaccine products.

Myths and Facts about Vaccine Product Price and Procurement

It’s only because vaccines are more strictly regulated than drugs and other products.

Vaccines are safe and necessary.

More on Vaccine Regulation

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

There is a new meme going around suggesting that folks have no business telling anyone to vaccinate and protect their kids unless they can answer a series of questions.

I bet answers from anti-vaccine folks aren't the same as the answers from the rest of us...
I bet answers from anti-vaccine folks aren’t the same as the answers from the rest of us…

While it is certainly good to be educated about vaccines, their questions seem rather loaded.

Anti-Vaxxers Should Be Able to Answer These Questions Correctly

Since it is immoral and dangerous to push misinformation that scares parents away from vaccinating and protecting their kids, it would be nice if anti-vaccine folks would answer these questions before they tried to persuade anyone to not get vaccinated:

  1. Name 5 vaccine ingredients that you think are toxic and how exactly they can be toxic at the amounts present in vaccines.
  2. Name 5 possible complications of a vaccine-preventable disease.
  3. Are doctors and alternative health care providers who push non-standard, parent-selected, delayed protection vaccine schedules able to be held liable if their intentionally unvaccinated child suffers a vaccine-preventable disease or starts an outbreak, infecting other people?
  4. How many children died of vaccine-preventable diseases in the early 1980s, before the vaccine schedule grew to include the new vaccines we give today?
  5. Is it true that no one can force you to get vaccinated?
  6. What percentage of reports to VAERS are actually caused by vaccine reactions?
  7. How many doses of vaccines have been given since the Vaccine Court began paying for vaccine injury cases?
  8. Which vaccines must be avoided because of shedding or other concerns if you have a child with an immunodeficiency in your home?
  9. Why do some folks think that many vaccines still contain thimerosal?
  10. If today’s vaccines already contain far fewer antigens than they did in the old days, what would be the extra benefit of splitting them up even further into separate shots for each vaccine-preventable disease?
  11. Have you read all of studies on the safety and effectiveness of combination vaccines, including those that are double-blinded and placebo controlled, and the current vaccine schedule?
  12. Can you give me one other interesting fact about vaccines or vaccine-preventable diseases that was not already asked or discussed?

What’s my interesting fact?

Many on-the-fence and vaccine hesitant parents do change their mind about vaccines and decide to make the right choice and get their kids vaccinated and protected.

More Things Anti-Vaxxers Should Know