Time to re-examine our slavish devotion to the scientific method

Someone sent me a link to some research on Psoriasis and it got me thinking again about the way science and particularly drug research is conducted, and its limitations with respect to complex systems we do not understand, like the immune system.

The subject of the direction of research in the area of immunological diseases really bothers me. I think science, because of its history and prejudices, has gone in entirely the wrong direction, and that the scientific method is part of the problem.

The scientific method works very well for simple systems like the physics of semiconductors for instance, where all but one variable can be controlled for, where all variables have been identified and understood.

That just is not possible currently for the immune system, we do not even know all of its components, or even the behaviour of any one component in all circumstances. Never mind those circumstances we create with modern drugs.

Furthermore the timescale of research required to understand the long term effects of a drug are prohibitive, not possible. Bear that in mind when you read the known side effects for a drug introduced more recently than 30 or 50 years ago. That list may be incomplete.

Given the complexity of the immune system I am convinced that barring a breakthrough in research tools or methodology akin to the discovery and development of PCR technology and techniques, which has played out over the course of 25 years, current drug development methods are not going to produce anything effective and safe except by dumb luck.

Attempting to control disease by targeting specific components of the immune system with knockout drugs will never yield anything more effective or safe than the monoclonals that we have now. They are of course neither safe, nor effective.

Crudely knocking out a major component of the immune system using proteins or other molecules that themselves can become targets of the immune system, seems to me, guarantees bad side effects and a limited period of effectiveness.

So an approach like ours where you step back so that the resolution of what you are looking at and of your thinking is reduced, and the problem and challenge are simplified, presents a more promising approach.

Understanding that immunological diseases and those involving chronic inflammation arise out of damages to the environment defined by our bodies reduces the complexity of the problem and it’s possible solutions.

Another reason why the viewpoint of science and the regulators is skewed and inappropriate, helminthic therapy has been categorised as a drug based on the definition of drugs used by agencies like the FDA. But one has to realise that using their definition of a drug would mean sunlight and food, even a kiss, could be defined as drugs as well. Given how broad and therefore useless that definition is, its use in this case creates a damaging regulatory posture, as well as an attitude of fear and conservatism amongst the public and regulators, who do not understand all the issues. That limits the development and use of a therapeutic tool that is inherently safe, clearly effective, and were it not in a ghetto created by inappropriate regulation, very, very cheap: helminthic therapy.

Regulators, because of their inability or unwillingness, to appropriately categorise helminthic therapy, ensure that millions continue to unnecessarily get sick, remain sick, grow sicker, and suffer permanent damage, and death, while paying for approved drugs that kill.

Regulation was never intended to ensure that hundreds of millions of people entered and remained trapped in severe and progressive illness by reason of that regulation. All the while being provided, at the desperate patient’s insistence absent anything better, lethal and toxic molecules identified, tested and sold on the basis of perilously sparse and incomplete knowledge of their affect, or of the systems they are meant of change. Without testing sufficient, and invariably gamed, to understand potential side effects.

I think the reason drug and therapeutics development for complex diseases, like cancer, autoimmunity and chronic inflammation, has slowed to a crawl and become astronomically expensive, is because of this complexity. Self-imposed by the fetishisation of the scientific method, its status as a holy cow, perfect and unchanging, unchallengeable and immutable.

Our inability to spend the decades waiting to work out the consequences of a particular approach using current methods also means that drugs developed under the current system have not been appropriately tested given the potential risks.
Hence also the lack of movement on helminthic therapy because of categorisation it as a drug. That and the unwillingness of the drug industry to follow any potential route to a product that does not enjoy patent protection and the artificial monopoly that regulation creates. Something that is impossible commercially given the nature of our patent system and the motivation of drug companies by profit ahead of general welfare.

Without an almost complete understanding of the immune system and all its components, as well as a computer model of it that has predictive powers, it is impossible to develop safe effective drugs.

Helminthic therapy may be categorised as a drug by a regulatory system that has clearly not adapted to current knowledge and understanding, and is likely inhibited from doing so by it’s parasitic relationship with the collection of drug companies it purports to regulate.

But it is not a drug.

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I posted this on Facebook here if you are not aware of our Facebook page and a version to the Yahoo forum.

I post small snippets and shorter material to Facebook that does not show up here, and Twitter is linked to that as well, you can follow me @wormtherapy