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What Is War On Drugs Nuanced Regulation?

Exactly what is war on drugs nuanced regulation? A question that has vexed me for some time.

Following on from my two previous articles about the “war on drugs,” here and here, this final part is a case study into what at least one expert means by regulation of illicit drugs, so they cease to be prohibited but subjected to regulations.

One has to assume that those regulations would be imposed by the government, in this case the UK government. I suppose that begs a philosophical argument along the lines of – isn’t that just another form of prohibition? In any event, I am with the folks who say the government has no right in interfering in and  regulating a market in drugs that produce a “high.” Yes, minors need protection but in the case of an adult then it is that individual’s prerogative to get high on some weed or drop an acid tab. People since time immemorial have partaken in such activities and no doubt always will. It’s human nature. Ultimately, I am against government interference. There is too much of it in many spheres of life.

Allow me to remind you about the LEAP UK mission statement:

We advocate reform and an evidence based policy with a public health focus including decriminalisation and nuanced regulatory models for all drugs.

I also remind you  of my irritation with the term “nuanced regulatory models.”  One such model is to be found in an excellent research paper produced by the Beckley Foundation.

The Foundation’s mission statement has this to say:

The Beckley Foundation is a UK-based think-tank and UN-accredited NGO founded and directed by Amanda Feilding. The Foundation’s dual purpose is the scientific investigation of consciousness and the creation of balanced drug policies. Our areas of focus include Science, Policy and Culture.

The paper is titled ROADMAPS TO REGULATION: NEW PSYCHOACTIVE SUBSTANCES (NPS) and I reproduce it in part below:

It demands that the manufacturers fully fund the assessment of the safety of the new psychoactive substances, to establish if they are low risk, before they can be offered to consumers as a licensed and regulated product. This is in contrast to the reactive prohibition regime, which assesses drugs once they are already in unregulated circulation. …

It would be safer for the consumer if he or she could satisfy his or her desire for a psychoactive substance with a compound which has been certified by a reputable body as being of acceptably low risk. …

The key features of the proposed regulation are:
a)
Precautionary prohibition of new psychoactive substances. A psychoactive substance that has not been approved by the Authority is prohibited, on a precautionary basis, until the Authority is satisfied that it poses no more than a low risk of harm to individual s who use it.
b)
Low risk products are approved .
A psychoactive product that poses no more than a low risk of harm to individuals who use the product must be approved. The Act places the responsibility on manufacturers to demonstrate that their products are low risk.
c)
Approval decisions are based on evidence.
Before a psychoactive product can be approved for use by individuals, the degree of harm posed by the product to individuals who use it should be assessed by the Authority on the basis of –
i.
the advice of an expert advisory committee; and
ii.
evidence, including the results of preclinical and clinical trials 

Traditionally, substances are deemed safe for human consumption if they pass a series of tests both clinical (in humans) and preclinical (before humans, i.e. in animals). Preclinical trials assess the pharmacological, toxicological, and behavioural profile of a drug, and allow for close examination of vital organs and tissues following exposure to the drug. Naturally, any substance shown to damage certain organs or systems in animal trials would not be allowed to progress to human trials. …

Once a drug is approved for human testing, it proceeds through multiple ‘phases’ of clinical trials, progressing from small ‘safety and feasibility’ studies in healthy subjects to large scale multi-site trials in patient populations. The resulting evidence gives a picture of the relative 38 risks and benefits of the drug, and if this ratio is favourable, the drug can move on to be marketed. …

 
Although this ‘development pipeline’ is standard for therapeutic drugs, it is not how any government currently approaches NPS or any other recreational drugs. There is, however, no reason why the same systematic and rigorous procedures could not be used to assess NPS. …

This procedure could be used in jurisdictions that disallow preclinical trials (e.g., New Zealand), since many of the measures gathered in animal studies can now be gathered in humans with the help of imaging, medical/neurological tools, and minimally-invasive blood and tissue tests. People are already self-administering NPS, providing ample opportunity to monitor these safety dimensions. …

The Act would impose a number of restrictions directly. These would include:

(m) Place-of-sale restrictions.
For example, approved products could not be sold in convenience stores, supermarkets, liquor stores, temporary stores, or petrol stations.
(n)
Advertising restrictions

Approved products could not be advertised on television, radio, the internet, or in a newspaper or periodical. Advertising of approved products would be confined to inside the premises of a retailer, and would be limited to objective information.
(o)
Purchase age
It would be an offence to supply products to any person under 18 years old.
(p)
Promotion restrictions

Approved products could not be offered for free, and could not be sold as part of a promotion.

The new regulatory landscape would allow chemical entrepreneurs to enter the market while being mindful of the potential adverse effects associated with each product. In terms of production, this translates into the creation of a formal system of assessment before commercialisation. Both this process, and the licensing of the product on the basis of standard criteria would significantly increase the reliability and safety of the NPS market. While the administrative and regulatory architecture to frame pre-production and production operations in this new market would lead to certain costs, these would be largely offset by law enforcement and public health savings, administrative and fiscal revenues, and an overall increase in the wellbeing of users. …

Tested and regulated NPS would , if such a regime were introduced, appear on the market much more slowly, as the process of testing is very expensive. In the scenario described above, vendors would test the safety of the products prior to bringing them to market. Since not all substances would pass the test successfully, the rate at which NPS appear on the regulated market would diminish. …

This is a noble effort at attempting to change long-held views on drug policy. Yet, I have to say that it is naive in the extreme.

Once more the likes of the Foundation and the Neil Woods’ of the world fall into the same bear pit. I am truly sorry to rain on their collective parades but it’s all impractical hogwash!

Let me explain by illustrating one or two parts of the report and underlining the naivety.

… demands that the manufacturers fully fund the assessment of the safety of the new psychoactive substances, to establish if they are low risk, before they can be offered to consumers as a licensed and regulated product. This is in contrast to the reactive prohibition regime, which assesses drugs once they are already in unregulated circulation. …

Have these people who draft such drivel any idea of the costs involved in trials? The costs would be way out of the reach of a small entrepreneur leaving the way clear for the Big Pharma-type to come in and take over. But would they? I suppose they might if there is a profit to be had.

Judging by the last paragraph that I reproduced the report’s authors do appear to have an appreciation of the costs involved in a testing regime:

Tested and regulated NPS would … appear on the market much more slowly, as the process of testing is very expensive. In the scenario described above, vendors would test the safety of the products prior to bringing them to market. Since not all substances would pass the test successfully, the rate at which NPS appear on the regulated market would diminish. …

All of this raises more questions than it answers. “Therapeutic” drugs are highly regulated on both sides of the Atlantic. Has that stopped scandals ripping through the heart of the pharmaceutical industry? Has it stopped corruption? Has it stopped greed and profiteering? Has it prevented life-threatening drugs deemed as safe being administered to patients? Has it aided a system of doctors being paid to prescribe certain drugs over another? Has it stopped a black market in prescription drugs?

The answers are No! No! And No! To each question¹.

Furthermore if such a system is to be adopted, surely the drug becomes more expensive than it is now? Many of these “high-inducing” drugs do not require the complex and vast GlaxoSmithKline-type laboratory. There is then a void in the market for a less expensive uncontrolled (unregulated) version of the drug.

Back to square one!

The “hippie” generation had a point, I suspect. With the benefit of hindsight I can now see that I was part of the world’s largest acid bust which served no useful purpose.

If only Richard Kemp’s acid was still around these days. Who knows, I may have even tried it to see what the fuss was all about.

One last thought, “nuanced” now has a new definition – flawed!


¹ See CNN report on Pfizer made to pay $1.2 billion in a criminal fine in connection with Bextra, the largest fine the federal government has ever collected [later exceeded by the fine imposed on GlaxoSmithKline].

 

 

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