Tuesday, December 22, 2015

The UnSciences of Clinical Studies

The double blind placebo controlled clinical trial is often touted as the foundation of scientific medical studies. But the science of medicine is broken.

The double blind placebo controlled clinical trial is at the heart of the problem that has taken over the medial mentality, taken over medical science.

The problem? The double blind placebo controlled clinical trial cannot test cures. The problem is trivial, and also impossible. Cures are simply not defined for most diseases. Not only that, the list of incurable diseases is gradually being defined, due to the success of clinical studies.

There is a good reason 'cure' is the only path to sainthood.  Cures are miracles, not the results of medicine - the results of God, or occasionally the results of the servants of God, as evidence of their sainthood. Every cure is an anecdote. Every cure is a miracle.

The World Health Organization's (WHO) the Classification of Diseases, ICD-10 Version:2016: “International Statistical Classification of Diseases and Related Health Problems 10th Revision” identifies three general types of diseases:

 - communicable diseases : HIV, TB, etc.
 - non communicable diseases : hypertension, breast cancer, etc.
 - external causes of injuries : traffic accident, drowning.

In the WHO list of diseases, only communicable diseases can be cured. Non communicable diseases, like hypertension, heart disease, breast cancer, and arthritis cannot be cured. External diseases - broken arms and legs, gunshot wounds, and whacks on the side of the head cannot be cured. Diseases where we do not know the cause, like arthritis, depression and even obesity, cannot be cured. 

Cure is not defined by the WHO. Cure is not defined by medical science. Cure is defined, on a disease by disease basis, as killing the infection, and then testing to see if it is still present.  If you have an infection, and you take an antibiotic, and the infection disappears - you are cured. The medicine cured your disease. Antibiotics, anti fungal, antiviral medicines, and other medicines that kill parasites have the potential to cure. No other medicines can cure. There are no other cures recognized by the science of medicine, or the sciences of clinical studies. 

It is not possible to prove that an illness is incurable.  It is possible to prove an illness is curable, by curing it, but there is no way to prove an illness is incurable.

Why can't we cure every illness? Why can't clinical studies find cures for non communicable diseases? Because cure is not defined.  If you have hypertension, or if you are obese, or if you have heart disease - there is no scientific test to prove a cure.  There is no test that can be used in a clinical study, to prove a cure. If your disease is cured - the cure cannot be seen, cannot be measured, cannot be tested, by any clinical study. 

It has not always been that way. 

Clinical studies measure the number and severity of symptoms. Medicines are administered, and placebos to the control group, and the symptoms are measured again. If the patients with the medicines have fewer symptoms, the medicine wins and the study is published. If not, the placebo wins - and the study is not published. But when a 'cure' occurs, it is not noticed.  Most, perhaps all recent clinical studies don't test for cures. Diseases are 'incurable by omission'. Because cure is not defined, therefore cure is not tested. It cannot be tested. Because we can't test for cures, the disease is incurable. 

There's a perfect example to be found in a pair of clinical studies of Homeopathic Medicines to treat warts. Even though warts are in theory, caused by a virus - a communicable disease, and a cure is easy to see, medical scientists managed to measure symptoms (size of the wart) and ignore cure (absence of the wart), thus proving that a homeopathic medicine worked 'no better than a placebo'. 

In 1966 a clinical study "Homoeopathic versus placebo therapy of children with warts on the hands: a randomized, double-blind clinical trial." tested the application of a homeopathic medicine against a placebo, in the treatment of warts. It found that, in regards to symptoms - homeopathic medicines worked only slightly better than a placebo. Nine patients benefited from the homeopathic medicine, seven from the placebo. The study concluded: "There was no apparent difference between the effects of homoeopathic therapy and placebo in children with common warts under the conditions of this study." But the conclusion was marred a bit by the fact that the homeopathic treatment cured 20% of the patients warts.  The placebo cured 3.3 percent.

Thirty-two years later, in 1998, an almost identical study "A double-blind, controlled clinical trial of homeopathy and an analysis of lunar phases and postoperative outcome." was completed. You might wonder, as I do, about the objectivity of the scientists, who grouped it together with a study of the analysis of phases of the moon on postoperative outcomes. The wart portion repeated the first study almost exactly. There were the exact same number of participants and with regards as to symptoms - the exact same result.  Homeopathic medicines produced shrinkage in nine of the patients, and the placebo produced shrinkage in seven of the patients. The homeopathic medicine performed slightly better than the placebo - but no statistical difference. There was one difference between the studies. The second study did not measure, did not count 'cured'. The study parameters did not include testing for cures.

Because it didn't count 'cures', All ambiguity that had marred first study disappeared. Each and every cure became anecdotal evidence, which could safely be ignored.

What about obesity?  Surely it's possible to cure obesity?  Nope.  Your BMI is a scientific test for obesity, but when you check the 'medical diagnostic tests' for obesity, BMI is only a small part.  The rest? Not clearly defined. Not scientifically defined.  As a result, the 'cure' for obesity cannot be defined. You might bring your BMI down, but that doesn't prove 'the disease' is gone, does not prove a cure. You might, after all - eat a lot of food and the obesity will return, it was always there.  This logic is, frankly, ridiculous.  If anyone eats a lot of food - they will become obese. There is no scientific difference between the 'return of obesity' and an initial case of obesity. So there is no cure for obesity. 

Once you are diagnosed with obesity, you have the disease for life - even if you are no longer 'obese', because obesity is incurable, according to the current science of medicine. The National Obesity Foundation mission says "We believe that obesity is a disease ... that can and must be treated." But they don't use the word 'cure'. Cure, for obesity, is not defined. 

If we want to use clinical studies to search for cures - we need to define cure for every disease, every type of disease.  Until then, clinical studies cannot be used to search for cures. 

But, but, but... Aren't clinical studies already used to search for cures for cancer, for Alzheimer's, for hypertension, for heart disease?  No, they are not. You might have noticed the phrase '5 year cure' with regards to cancer.  Does this mean we can measure cancer cures, and that clinical studies can test for cancer cures? Nope. The five year cancer cure is not a medical test, not a scientific test, not a clinical test - it's a birthday test.  If you are diagnosed with cancer, and you are still alive five years after your diagnosis - you have been '5 year cured'. Some might argue that you need to be 'cancer free' 5 years later, but that's not technically true. You need only be 'not currently diagnosed with cancer'. Because of the long time span between the presence of cancer and the diagnosis, you may have many cancers and still be declared 'cancer free', declared '5 year cured'.  But if you were diagnosed 4 years and 9 months ago - you are still not '5 year cured'. duh.

When a cure occurs in a clinical study, it is generally ignored. Clinical studies are studies symptoms of disease, studies of patients with similar symptoms - where causes have not been identified. When cause is not identified, cure is not possible - except by accident, by 'anecdote'. If cure is accomplished, it is not noticed, not counted.  Cures are outside of the limited view of 'symptoms' measured by clinical studies. 

Cure is simply not defined for non communicable diseases, and have gradually come to be ignored by almost all clinical studies. Because cures are not defined, they are not recognized - except perhaps as anecdotes. Cures can only be noticed in specific, individual cases of an illness. Every cure is anecdotal evidence. 

Have you noticed.  Whenever anyone claims a cure, the cry is raised.  Is it just 'anecdotal evidence' or is it supported by 'double blind, placebo controlled clinical trials'.  No one notices that these double blind, placebo controlled, clinical trials - don't test cures, don't measure cures.  Cures are final. There are no more symptoms to measure. They are outside of the scope of most clinical trials. 

Clinical trials are broken.  They are breaking the science of medicine. Soon, in medicine, every disease will become incurable. In healthicine - every illness can be cured.

In healthicine, there are two kinds of cures, causal cures and healing cures.

A causal cure is a cure that successfully addresses the cause of the illness.  If you have a bacterial infection, and the infection is removed - you are cured.  Healing may be required for complete recovery.  If you have heart disease, due to an unhealthy diet, and the cause is successfully addressed - you are cured. Healing may be required for a complete recovery.

If you have a broken bone - the cause is gone. The only cure is to heal the damage. But if someone is 'breaking your arm' - you need to address the cause first.

To measure cures - we can measure the cause, and we can measure the healing.  Measuring symptoms does not lead to cures, it leads to 'slower diseases'.

But this test of cures brings an interesting observation.  The body heals.  Health heals.  Medicine does not 'heal'. Medicines cannot provide 'healing cures'. Removing the cause cures non communicable diseases - but adding a medicine cannot remove the cause.  Adding a medicine can only remove the cause of a communicable disease.

In most diseases - medicines cannot cure. Most clinical studies test medicines. Most clinical studies do not test cures.   The unsciences of clinical studies blocks the success of medicine.

to your health, tracy