Explain the rare side effect victims in layman's terms?

You can read how 00.6% of those getting a normally safe dose of a drug, or vaccine have a bizarre negative and sometimes fatal result.

What are these exactly? Is it really that 1 in 100 million people will have a fatal reaction to Tums? Or are these bizarre intersections of not healthy person/vulnerable and some kind of interaction with something else?

I mean if you told me 1 in 100 million healthy people will have a fatal reaction to say pudding I would refuse to believe it, and would not be shocked to find the fatality was say 98 years old or something unrelated.

When researchers are conducting clinical trials of new treatments, they are required to record every “adverse event” that subjects report to them. These can range from a headache to rashes to cancer. It’s up to the study clinician(s) to decide whether the event is related to the study treatment. In some cases, it’s obvious (a car wreck causing muscle soreness). In others, it isn’t so clear.

When those treatments go to market, all of the adverse events that can’t be ruled to be not related to the treatment are included as possible side effects. So, if in your study of a vaccine with 1000 subjects, one person dies with no obvious cause, you end up with a reported risk of death of 0.1%.

I should add that sometimes these strange adverse events end up being related to the treatment and very important. The best example I know of is the the first rotavirus vaccine and intussesception. It was unexpected, rare, and thought to be unrelated to vaccination. However, careful studies showed that it was associated with the vaccine, resulting in the original formulation RotaShield being pulled from the market.

The current rotavirus vaccines (Rotarix and Rotateq) have not shown any associations with intussusception.

Also note that drug side effect charts usually list a comparison with a placebo and list the “side effects” from the placebo, which are usually non-zero. If someone takes a pill and later feels nauseous and reports it, it gets recorded, even if he had a big shellfish dinner that night.


Exactly. I am being a paid guinea pig for either an ebola vaccine or a placebo over the next 6 months - I get a booklet to fill out daily where I take my temp, look at the innoculation site, and write down how I feel and if there are any side effects for the first month, then I go in for a monthly checkup and then a final blood titre checking for antibodies at the 6 month point, and for some things [the MMR one I did last year] I might have a titre check after 1 year.

[it isn’t a lot of money, but I get free vaccinations or medications or whatever I am guinea pigging for and it is interesting.]

The decimal point is a typo, and my math was off.

How do you get into this type of thing? And more importantly, do you find out if you were given the ebola vaccine at the end of the trial?

Way back in the mid 90s I saw an announcement on a bulletin board over on the Submarine base, they were looking for people to work in the sound lab listening for sounds embedded in pink and white noise to improve sonar training and testing. Then I found Omega over in Westerly RI doing medical testing and started with them doing everything from flu vaccine delivery [ shot vs airgun vs a couple other things] to flu in combination with other vaccinations, some sort of topical goo for arthritis in the knees to MMR in combination with something else to the upcoming ebola. I do a couple studies a year, depending on how long they run - this is going to be another long one so I will probably only be able to pick up something in January now. It can range from $50 for basic flu shenanegans to the Ebola one - they had something a few years back that was a year long and a couple thousand but I didn’t qualify because I would have had to taper off a couple different meds and I am happy with what I am taking now and don’t want to screw with it.

Sometimes they can tel you, sometimes they don’t even know. I can guarantee that the guaifenesen one we did I got the damned stuff, it has a very distinctive taste [blech!]

They advertise. I saw adverts on the London Underground yesterday. Unfortunately I’m now 450 miles away.

There are situations where an individual has an extremely rare genetic defect leading to their inability to produce a specific enzyme. They are never diagnosed, because the enzyme is rarely needed. The one time it is necessary is to metabolize “X” or a breakdown product of “X”, a drug they are prescribed.

Thanks for the responses, aruvqan and Quartz.