Hi Emaadama
W/ reference to placebos, many papers compare two vaccines or a vaccine vs the liquid the vaccine is suspended in. This is because the researchers wanted to assess the safety and efficacy of the vaccine itself when the other vaccine or carrier liquid has been well studied. Most of these papers do (and all of them should) refer to the previous data supporting the safety and efficacy of the controls tehy use if they are not saline.
The use of saline or sugar controls is used however, particularly when novel vaccines are introduced, such as
this study, or when vaccines are introduced into less studied groups as in
this study looking at children. Any of these experiments test both the efficacy and the safety of a vaccine by looking at different endpoints (the change in the number of people that get the flu and the other symptoms people have), and most studies build on data from many previous studies. This brings up the importance of looking at many of the studies before coming to a decision about a particular vaccine or procedure.
Assessing the long term effects of anything is a real problem in medicine (the studies above only follow individuals for a few weeks to months). The big question is how long should we withhold a potentially effective treatment to make sure there are no, or an acceptable amount of, side effects? In the US drugs are tested in stages, starting out with animal models, then small groups of people and finally 100-1000s of people in stage III trials (
Wikipedia has a good page describing this). Generally this process takes around 10 years and generally tracks the people in the studies over the whole time (note that papers are published at each stage so looking at a paper from a stage 1 clinical trial will likely only be a few weeks to months of observation.
This still doesn't account for potential problems in subsets of people, or drug interactions, post clinical observational studies are used. In the US and in the case of vaccines this is done by the CDC, which makes public the listing.
This brings us to aluminum. Ema adama, you are right, as far as I can tell, that the FDA approved its use without clinical trials. It’s used prior to the establishment of modern clinical trials allowed it to be grandfathered in, along with many other things like aspirin, morphine, and the homeopathic pharmacopoeia. You mention that there is no evidence that injecting aluminum is safe, however I would disagree. Here are many trials testing both the safety and efficacy of aluminum as an adjuvant here are the first few I pulled up with a simple Medline search:
S Westin, Reactions after triple vaccination in a child care clinic (with and without aluminum phosphate vehicle), Svensk Lakartidn 61 (1964), pp. 2438–2442.
WL Burland, WM Sutcliffe and MA Voyce et al., Reactions to combined diphtheria, tetanus and pertussis vaccine: a comparison between plain vaccine and vaccine adsorbed onto aluminium hydroxide, Med Offr 94 (1968), pp. 17–19.
Again, there is the problem of long term outcomes. Because aluminum has been used as an adjuvant for over 80 years, many epidemelogical studies have been done looking at groups of people who received the aluminum conaining vaccines vs those that did not
For instance:
I certainly do not mean to imply that there are not adverse reactions to aluminimum, as with
any medical treatment there are problems. The most common with aluminum seems to be increased irritation around the site of injection. Problems with aluminum given orally to people with renal problems has led to neurological problems, but only during long term use. As to the link with alzheimers, both
mainstream medicine and
avocacy groups ,who have studied the topic much more than myself, do not see a link.
To answer your question about my feeling on safety, I do, in general, support what is deemed safe in medicine. This however this is one of the hardest questions to assess. There is no treatment I know of that is without some risk, and no clinician that is infallible, so the decision to use or not use a medical intervention must be based on the benefits vs risks of the treatment.
Vaccines, especially those that have been used for years, have a lot of data from independent sources suggesting that the risk is low, and the comparative risk associated with contracting diseases such as mumps, measles etc. is higher. So I choose to vaccinate myself and my daughter.
In the case of vaccines the question has the additional complexity of disease transmission. Getting vaccinated helps to keep others from getting sick because if you can’t get the disease you can’t spread it to others, so even if your healthy enough that getting the flu is very unlikely to kill you, you are indirectly helping others. I worked in direct care of immumocompromised children, some of whom had too weak of an immune system to respond to vaccines and relied on the immunization of others to protect them, its those kids I think of when I get my flu shot.
. How that got past an ethics committee I just cannot think.
