Vaccine research: let’s perform a little thought experiment. Don’t worry, it won’t hurt and you’ll be back before morning. Let’s make believe you own a drug company. You’ve got a new vaccine and you’d like to market it. The potential profits are enormous but first you need to show that it is safe. Why? Because you care about the people who will be using your product and also because the federal government requires (through the Food and Drug Administration [FDA]) that these things be approved before they’re put on the market. So, how would you do that?
Vaccine research: the process
Theoretically, the process is really quite simple. You would take two groups of more or less similar children or adults (taking age, weight, ethnicity, health, etc. into account) and you’d vaccinate half of them – the vaccinated group – and not vaccinate the other half – the control group.
Then you’d watch them all. You would look for any physical or mental changes – after all, the vaccine goes through the entire body and may affect any organ, system or body function. And you’d compare both groups.
You would watch the children (or adults) for weeks, months and even years since adverse drug/vaccine reactions may take a long time to surface. And then you’d ask and, of course, try to answer as best you could the following:
- Is one group developing differently than the other?
- Does one group have more allergies than the other?
- Is there more asthma in one group than the other?
- Does one group have more autism than the other?
- Are there more hearing or vision problems in one group than in the other?
- Does one group have more neurological disorders than the other?
- How about psychological problems? Does one group have more than the other?
- Does one group have more tics? Seizures? Tourette’s? Stuttering? Cancer?
- And how about infertility? Dyslexia? ADD? Does one group have more than the other?
- Overall, is one group healthier or sicker than the other?
You get the idea
You get the idea; you’d want to know if there is any difference between the vaccinated and the non-vaccinated. This has been referred to as “a fishing expedition,” because you don’t know what will turn up. Ideally, the vaccine research study would include future generations to see if the children of the vaccinated group show any health issues.
Of course, it’d be a long and expensive study if you waited for future generations of humans to discover if a vaccine (or any drug) is safe and effective. If and when they do these multigenerational or longitudinal studies, researchers use animals that have a shorter period of reproduction. After all, a cat can have kittens when it’s a year old – a lot younger than humans. That’s a lot cheaper than waiting decades for a child to grow up and have children, and that doesn’t include hiring a band, a caterer, a hall – ok, you get the point.
Ultimately, you wish to show that those given your vaccine will be stronger, healthier in mind and body and happier than those not given your vaccine. You’d also keep the data and over time, to see if there is any difference as they grow older. Wouldn’t it be nice to know if 20 or 30 or 40 years later one group came up with conditions those in the other group did not?
Would you do this kind of vaccine research?
Would you do this research? You would? Well, now you know why you don’t own a drug company. That is precisely the research you do not want done.
Let’s see how a vaccine safety test is really done
If you want to get your vaccine approved, learn from the experts who have been getting their vaccines approved as safe and effective (and compulsory) for years. Here is a wonderful example of a vaccine study that appeared in the highly respected New England Journal of Medicine with the catchy title “The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenza type b polysaccharide and Neissereia meningitidis outer-membrane protein complex.”
Santosham M, Wolff M, Reid R et al. The efficacy in Navajo infants of a conjugate vaccine consisting of Haemophilus influenza type b polysaccharide and Neissereia meningitidis outer-membrane protein complex. NEJM. 1991;324(25):1767-1772.
Stay with me, and if you do decide to go into the vaccine business you’ll thank me for it.
The researchers were supposed to be testing the safety of the Hib (Haemophilus influenza b) vaccine. How did they do it? Simple, they took two groups of infants. One group was vaccinated with the vaccine and they compared these infants to a similarly sized group of what they referred to as “non-vaccinated” or “placebo” infants.
The “non-vaccinated” group
Aha! – caught you. And you thought you were paying attention. If you actually bothered to read the study (who does?) you’d discover that all the infants in the “non-vaccinated” were vaccinated! That’s true, but how could that be? This is how they did it: both groups were vaccinated with lots of vaccines but one group – the vaccinated group – got an extra vaccine: they were vaccinated with the test vaccine (Hib).
Here’s how it was done (and this is done in nearly all vaccine research):
• The vaccine group (2,588 Navajo infants) was injected with Hib, DPT (diphtheria, pertussis, tetanus) and OPV (oral polio vaccine). They received five vaccines at one time.
• The “non-vaccinated” or “placebo” group (2,602 Navajo infants) was injected with DPT, OPV and lactose!
Yes, you read that correctly. The so-called non-vaccinated group was vaccinated!
Deaths and injuries from a placebo?
This study was ended early because of a large number of deaths and injuries in both groups. How did they explain that the so-called “non-vaccinated” or “placebo” group had deaths and injuries? They didn’t and no one asked.
Now comes the punch line
The vaccine was approved! Why? The logic goes like this: since both groups of children have a similar amount of neurological disorders, seizures, shock and deaths then the experimental vaccine is no worse than what’s already been approved so it’s safe. I am not making this up.
It is a pretty bad habit of vaccine researchers to give several vaccines simultaneously where the effect of only one of them has to be studied and evaluated. Obviously, this leads to confounding results … side-effects in most studies was restricted to 48 to 72 hours. Needless to say, that many serious adverse effects show up long after that time span; by definition they could never be mentioned in those studies. Nevertheless, most of these studies pretend to prove the safety of the vaccine. – Kris Gaublomme, M.D., The International Vaccination Newsletter, March 1998
Now it’s given to babies …
According to the National Vaccine Information Center (NVIC), there have been more than 15,000 serious adverse events following the Hib vaccine reported to the U.S. Vaccine Adverse Events Reporting System (VAERS), including more than 2,250 deaths.
In 2011, Japan ordered doctors to stop giving Hib and pneumococcal vaccines after 4 babies died. At the same time, more than 2,250 babies died in the U.S. And what did the U.S. government agencies do? Nothing!
What about the Irish and the Jews, and the Africans….?
A big problem with many vaccine studies is that they are done on one ethnic group. For example, the above study was done on Navajo babies. Would we find the same results for Irish, Italian, Korean, Japanese, Chinese, German, African, French, African, Polish, Jewish, Russian or other children? No one knows.
Vaccine research: the small print
In small print, the study cited above reveals the problem permeating nearly all vaccine research: the researchers are financially tied to pharmaceutical companies. The researchers aren’t paid to do objective research – they are paid to find this vaccine is safe. What about the FDA? The FDA does not do any research of its own; it is completely dependent on the honesty and integrity of the pharmaceutical company’s researchers.
Don’t forget that many people in the FDA will, when they leave the organization, work for the pharmaceutical companies they have been “regulating.” Who wants to risk upsetting their future employers?
Vaccine research: what we really need
We need vaccine research studies comparing vaccinated with truly non-vaccinated children done by independent researchers using a placebo that is a real placebo – such as saline or better still, nothing at all.
In the meantime, no vaccine has been tested according to the scientific gold standard: a double-blind, placebo-controlled study. There is no scientific study which can confirm the long-term safety and effectiveness of any vaccine.
Dr. Tedd Koren is the author of Childhood Vaccination: Questions All Parents Should Ask.