Is It Time to Change the Design of Clinical Trials?
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No one would argue the current design of clinical trials in the United States isn�t a big improvement over history, since early experiments in medicine involved unscientific and inefficient methods for assigning patients to treatments.
�Up until about 60 years ago�when the randomized trial came into existence�the standards in medical research were shoddy at best,� says Donald Berry, PhD, chairman of the department of biostatistics at M.D. Anderson Cancer Center in Houston. �Information was collected by anecdote and superstition more than science.�
I'd say Official Medicine must do better. It's far too difficult for the average patient to think clearly and rationally about his/her choices--even more difficult about alternative choices.
The way I see it, the problem is that a lot of emphasis is being placed on applied research without enough, or even neglecting or contradicting, basic research.
Basic research can be defined as research on finding out how or why things work. Applied research is research to solve a specific problem. Clinical trials fall in the realm of applied research.
However, results of clinical trials can only be as good or as bad as the basic research behind them. Unfortunately, in medicine, many applied research/clinical trials ignore or go against basic research info.
Cancer therapy emphasizes killing the cancer cell (applied research) without even considering already known data from basic research: the role of the immune system, nutrients like B-17, selenium, vitamin E, lycopene, fatty acids and others, as well as sunlight, sleep, exercise and more. If the therapy/research is built along these known basic research principles, we would not end up with all these poisons known as chemotherapy. (Basic research shows that such drugs are toxic to normal cells and wreck the immune system.)
Applied research has bombarded us with drugs to relieve pain and inflammation in spite of basic research showing that these are part of the healing process/immune response that should be aided instead of countered. It treats the symptom instead of the cause, even if basic research shows that if the cause is removed, the symptoms disappear.
Applied research gives us statins to lower blood cholesterol levels, in spite of basic research showing that blood cholesterol levels are from excess blood glucose and can thus be easily controlled by controlling blood glucose levels (diet and physical activity). More, basic research shows that the statins also block the enzyme that makes coenzyme Q10. Furthermore, basic research shows that blood cholesterol levels are not directly related to cardiovascular disease! nor is it related to dietary cholesterol.
I'm not saying that applied research is all wrong. Rather, applied research must be done based on data derived from basic research. Simply jumping into applied research without any foundation in basic research, or worse, in total neglect or contradiction of basic research info, results in what we already see today as wrong medicine.
In contrast, look at the other sciences. All that was done was to understand how things worked (basic research), and we went on ahead to apply the info without the necessity of a "clinical trial" equivalent. Thus we have electricity, orbiting satellites, wireless communication, transportation vehicles, computers, nuclear power, etc. Virtually no applied research was done on these. The inventors just went on ahead and applied the knowledge, knowing that as long as they work along the lines of such knowledge, their gadgets would work.
While our bodies can be considered a lot more complex than those gadgets, a LOT is already known about how it works -- biochemistry, physiology, immunology and pathology (to name a few). So why come up with "treatments" that go against how the body works?
This is why for me, a guage of any therapy is: does it work along the lines of how the body works?
If yes, well and good. If no, it's most likely to be wrong medicine even if it's backed by clinical trials.
In effect this is just a variation of the long known medical tenet: First, do no harm.
I'm not saying that applied research is all wrong. Rather, applied research must be done based on data derived from basic research. Simply jumping into applied research without any foundation in basic research, or worse, in total neglect or contradiction of basic research info, results in what we already see today as wrong medicine.
What would happen if it was ILLEGAL to do research--of any type--on any substance that is toxic? Well, without toxicity as an option, the collective consciousness of cancer research would direct their attention to non-toxic solutions.
We don't torture people with systemic poisons when they're not sick. Why is torturing people with systemic poisons when they are sick allowed? Such a proclivity is, well, sick.
Oncologists throw up their hands and say, "Chemo's all we've got for now." I say that as long as chemo is an option, toxic responses to cancer will be all we'll have for a very long time. Take this option completely off the table, and we may finally see some progress in the alleged "War on Cancer."
Pharmaceuticals are fine as a response to illness AS LONG AS they're non-toxic.
Pharmaceuticals are fine as a response to illness AS LONG AS they're non-toxic.
But how many are non-toxic?
Paracetamol destroys the liver and kills - one packet can do the trick. Paracetamol with Codeine can kill even quicker.
Two or three iron tablets can kill a toddler, hell, even fluoride toothpaste can kill a toddler!
Vioxx, Lipitor et al seem to need a few months before they start killing some people.
Vaccines are seen as a response to illness - get a few adult drug users with Hep B and they are trying to vaccinate EVERY newborn baby in the world! Yet one study of 55 fully vaccinated men found 2 men that managed to attain "carrier" status - isn't that the reason we are supposed to poison an entire generation? To prevent carrier status and the risks of liver cancer that go hand in hand with it?
What is the point of changing the design of clinical studies if they don't even do them? There has NEVER been ANY sort of clinical study on vaccinating newborns (or even infants) for ANYTHING let alone a disease of promiscuous or drug using adults - WTF? Even the vaccine manufacturers have admitted they have NEVER done a clinical trial of Hep B vaccine on any child younger than 5! And this trial did not have an unvaccinated control group to compare against.
NO vaccine clinical trial has ever been run against unvaccinated controls, just as NO chemo clinical trial has ever been run with completely untreated controls. Therefore these are not true clinical trials - so changing the design is irrelevant - first they need to run actual clinical trials!
The problem (to me) is that they're administered wrongly.
To elicit the "natural" or "proper" immune response, a vaccine against a certain disease must be administered by the route of the natural infection. Yet, almost all vaccines are injected, even if the natural route of almost all infections are by nose or by mouth (mucus membranes). The route of infection, as well as vaccination, determines whether the immune response is Th1 or Th2. We usually do not like the Th2 type of immune response, yet this is what we get when vaccines are administered by a route other than the natural mode of infection of the disease.
So for vaccines to elicit the proper immune response, most of them must be given by nose or mouth, not by injection into muscle or skin.
Of course, the other problem is that vaccines come with other non-vaccine substances like preservatives and antimicrobials.
Otherwise, the principle of vaccination is sound. (But that's a big "otherwise.")
What would happen if it was ILLEGAL to do research--of any type--on any substance that is toxic? Well, without toxicity as an option, the collective consciousness of cancer research would direct their attention to non-toxic solutions.
That's a nice thought.
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We don't torture people with systemic poisons when they're not sick. Why is torturing people with systemic poisons when they are sick allowed? Such a proclivity is, well, sick.
This, too.
Exactly what I mean by going against what we know of the body, going against what we know from basic research.
I think many clinical trials are endowed with multiple problems which confuse results. One of these problems is the lack of information on the �placebo�. Rarely is any information published as to what is actually in the placebo. If a study pharmaceutical is known to have, for example, the side effect of nausea, the pharmaceutical company, who also manufactures the placebo, could use an agent in the placebo which can cause nausea. This could mask the possible adverse effects of the pharmaceutical. On rare occasions, where the placebo is actually identified, there are recognized health effects from the placebo. Even sugar pills could have a physiological effect on some sensitive subjects. I would like to see the true ingredients of the placebo published. I would also like to see a third subject group added to trials which is a group who receives neither test pharmaceutical nor placebo.
Another problem I see is the emphasis on relative risk and the obscurance of absolute risk. As an example, a group of subjects taking a certain drug was shown to develop cancer at the rate of 0.68% while the placebo group developed cancer at the rate of 1.2%. The reduction in absolute risk is 0.52% (1.2% minus 0.68%). This seems like an insignificant reduction for very expensive therapy. However, the relative risk reduction of 43.33% (1.2% minus 0.68% divided by 1.2%) was the figure which was announced and publicized. This seems to be statistical manipulation for the benefit of the pharmaceutical company and not the patient.
This is only my theory, and it may remain so, since I have not yet acquired funding to do a large $tudy.
Hi All, Another problem I see is the emphasis on relative risk and the obscurance of absolute risk. As an example, a group of subjects taking a certain drug was shown to develop cancer at the rate of 0.68% while the placebo group developed cancer at the rate of 1.2%. The reduction in absolute risk is 0.52% (1.2% minus 0.68%). This seems like an insignificant reduction for very expensive therapy. However, the relative risk reduction of 43.33% (1.2% minus 0.68% divided by 1.2%) was the figure which was announced and publicized. This seems to be statistical manipulation for the benefit of the pharmaceutical company and not the patient.