Sunday, 19 July 2015

Skeptical About Drug Laws - Part 1

Phil Walsh at the Open Mic
On May 27th 2015 I decided to try my hand at giving a talk at Birmingham Skeptics in the Pub  (SitP) open mic night.  SitP have regular guest speakers who come to give presentations relating to an area of their expertise centred around dispelling misconceptions about a particular topic and focussing on good scientific enquiry.  Their open mic nights give us mere mortals a shot at presenting a topic of our choosing.

The presentation I gave was based on the current drug laws regarding certain compounds, and how these laws prevent vital medical research being carried out, and as such prevent treatments for some very serious medical conditions being available to those who need them the most.  I felt this was relevant to the spirit of SitP since skeptics by nature are very keen to dispel myths regarding bogus “miracle cures” and charlatans selling false hope, or worse, driving people to actually cause themselves harm.  My argument was that we don’t need to look far to find bad science regarding medicine – we have it right on our doorsteps governed by law right this moment, and that fact is worthy of equal scrutiny.

Typically we are asked to give a 15 minute talk, I think I was clocking in around 25 minutes before I threw myself off stage as it wasn’t fair to the other presenters that evening to hog all the stage time.  And I still had plenty of slides left.

With this in mind, I thought I would provide an overview of the topics covered in my presentation in blog form – this will allow me to go a little more in-depth on some parts, so that those that didn’t have a chance to attend the evening won’t miss out on what was presented, and those that were in attendance get a refresher with additional material.

To keep this interesting I will break the article into 3-4 parts, which should hopefully allow some time to reflect on the information being presented before the next part goes live. Without further ado, here is:

Skeptical about drug laws, Part 1:  The Current situation.

Currently in the UK, when British law states that a particular drug or compound is illegal, it is classified into both classes and schedules.  Classes you’ll likely be familiar with – these dictate the degree of punishment dealt if a person is found to be in possession of, producing, trafficking or distributing a particular drug.  Schedules however state the potential harm, and any medical utility of a given drug.

Schedule 1 drugs are described as such:
Drugs belonging to this schedule are thought to have no therapeutic value and therefore cannot be lawfully possessed or prescribed. These include LSD, MDMA (ecstasy) and cannabis. Schedule 1 drugs may be used for the purposes of research but a Home Office licence is required
Schedule 2 drugs are described as such:
Can be prescribed and therefore legally possessed and supplied by pharmacists and doctors. They can also be possessed lawfully by anyone who has a prescription. It is an offence contrary to the 1971 Act to possess any drug belonging to Schedule 2 or 3 without prescription or lawful authority. Examples of schedule 2 drugs are methadone and diamorphine (heroin). Schedule 3 drugs include subutex and most of the barbiturate family

Schedule 4 drugs are prescription only, and schedule 5 are over-the-counter medications and so require no prescription.

What we are concerned with is the statement for schedule 1 compounds Schedule 1 drugs may be used for the purposes of research but a Home Office licence is required.

What this means is that in practice, conducting medical research using schedule 1 compounds is virtually impossible, because obtaining a home office licence is a lengthy and arduous process.  And here’s why:

In order to obtain a home office licence, you must:
  • Apply for and pay for a home office licence this costs between £3000-5000 and lasts for 1 year. 
  • Adhere to the necessary storage and security requirements the compounds require storage in a designated secure location with careful management of who has access to them.
  • Carry out DBS checks for all personnel its not good for your application if your lead researcher happens to have a raging drug addiction after all!

So far, so good – these requirements aren’t unreasonable, and I don’t think anybody is suggesting that these compounds available on a free for all basis, but it should be noted that each of these adds to the administrative burden and cost of obtaining the licence and performing research.

The problems begin to arise when:

  • Additional costs come in the form of import licences – the majority of compounds will be sourced from overseas, simply due to availability.  This then requires an import/export licence to be obtained at the cost of the research group.
  • The compounds will likely also have to be manufactured to Good Manufacturing Practice (GMP) these are a set of guidelines that dictate a specific protocol for the manufacture of a particular compound in order to ensure quality and consistency.  This therefore means that the manufacturer must be approved to produce the compound to GMP specification.  Very few manufacturers, if any, will have this approval for the compounds in question this makes sense when you think about it: since no one is purchasing the drug (due to the difficulties being described here) then the manufacturer has no incentive to go to the expense and labour of obtaining GMP status for that drug, and as such are unable to offer the drug, so no one can buy the drug.and so it goes round and round in a circle.
  • Even if a suitable manufacturer is found, the price for a given product is usually astronomical – and example being  £10,000 for 1g of Psilocybin quoted by one manufacturer, which is quite remarkable when it is relatively simple to grow a mushroom containing this compound in its natural form at bigger quantities for 1/300th of the cost.
  • Once a compound is sourced and transported back to the UK, it will require tableting and dispensing from a schedule licenced site -  only 4 hospitals in the entire UK hold such a licence, therefore producing an array of logistical problems.
  • In addition, many documents have a time limit –as such, should a given task in the entire process take longer than expected or meet delays (and believe me, in R&D, there are no shortages in unexpected delays and circumstances) then it may be that the time limit for a given document expires, and thus the process has to be started from the beginning.
  • Funding is also an issue – government funding is little to none, and pharmaceutical companies have no incentive due to patents for these compounds being long expired, and therefore will not turnover a worthwhile profit for any investment.

In practice, obtaining a schedule 1 licence for the purpose of research takes several years at typically costs 10-fold above that for legal drugs (Nutt 2015). It should also be noted that the stigma attached to these drugs reduces enthusiasm for research groups to take them on, so the added red tape and administrative workload does nothing to encourage research groups from taking on a research project using these compounds.

So why are these compounds listed as schedule 1?

The rationale for placing any drug in a schedule 1 category is supposedly because these compounds have a high risk for harm and abuse, and therefore are restricted in this fashion in order to reduce their recreational use and abuse.

…….but how accurate is this?

Some may recall that Professor David Nutt was sacked from his position as chairman in the Advisory Council on the Misuse of Drugs (ACMD), triggered by his claims that ecstasy was statistically less harmful than horse riding based on a 2007 study on drug harm published in The Lancet (Nutt et al 2007), and ultimately because he argued that drug laws were not based on science but led by politics.  The findings of this study were in agreement with other studies across Europe which had reached similar conclusions (Van Amsterdam et al 2010).

I think it is important to note here that in response to his sacking, Dr Les King (advisor to the Department of Health and senior ACMD chemist), Marion Walker (Clinical Director of Berkshire Healthcare NHS foundation Trusts substance misuse service and Royal Pharmaceutical Society’s representative on the ACMD), Dr Simon Campbell (former president of the Royal Society of Chemistry and subsequent CBE and knighthood recipient for services to chemistry), Ian Ragan (scientific consultant) and psychologist Dr John Marsden all handed in their resignation form the ACMD in protest.  I mention this to highlight that Professor Nutt was not some lone maverick with leftfield ideas, but a respected scientist whose views and opinions were held in high regard by peers of equal esteem.

Following this dismissal, he set up the Independent Scientific Committee on Drugs (ISCD).  A 2010 study brought together a team of experts, who reviewed drug harms using a ranking system which based the harm potential of 20 drugs using a 16 category matrix, 9 of which related to drug harms towards the individual and 7 related to drug harm towards others (Nutt et al 2010). This then produced a rank of the most harmful drugs based on their cumulative scores out of a maximum of 100.

A pint of the Victoria Pubs finest Longhorn IPA to whoever can guess which drug came out ranking as the most harmful overall……

(image sourced from Nutt et al 2010).

That’s right friends, as the graph about demonstrates, alcohol is by far the leading contender for most harmful drug out of all those we see listed.  The following graph shows the same data with the categories under which each drug was scored.

(image sourced from Nutt et al 2010)

This perhaps isn’t so surprising – imagine if the papers tomorrow announced the rise in use of a new drug which caused lowered inhibitions, had high abuse and addictive potential, overdose could lead to organ failure, coma or even death, users were known to become violent and if driving under the influence posed serious danger to all around them, amongst a myriad of other consequences and lets not forget -in true tabloid fashion – THIS DRUG IS AVAILABLE IN YOUR CORNER SHOP AND TO YOUR KIDS NOW!  Well, we’d expect this drug to banned with immediate effect.  Yet all the above can be attributed to alcohol, and it has zero medicinal benefit.  This isn’t a bash at alcohol though – hundreds of thousands of people can and do enjoy a tipple without consequence every weekend up and down the country.  I simply use it to highlight that the laws which govern scientific research using certain compounds is not in line with the scientific evidence for potential harm and abuse.

The data presented isn’t perfect though – it only analyses the harm potential, and does not take into account any medical utility or benefit.  Were this to be factored in, we would expect substances like heroin, cocaine and cannabis to drop a few points (these do have legitimate medicinal uses) whereas compounds such as alcohol, tobacco and crack cocaine would remain where they are.  It also should be taken into consideration that for some points of harm to society, which factors in the cost of processing through the judicial system, prisons and customs.  This is not adjusted for the scale of use, so with cannabis as an example, the usage is far higher amongst the population than say GHB, and thus there will statistically be a far higher number of arrests and criminal charges brought up against cannabis related offences, which will subsequently skew the points ranking, making cannabis appear to be more harmful than compounds such as mephedrone, butane and benzodiazepines, which in realistic terms I do not believe to be the case, and I don’t think the evidence would agree with either.

Clearly, from what we have seen so far, the harm potential of a particular drug is not in line with the restrictions placed upon it.  It can be strongly argued that the holding back of medical research has caused far more harm than it has ever prevented.  As a result, research using certain drugs is made exceedingly difficult, and as such, potential therapies for a range of conditions go unexplored.

In part 2, I shall give an overview of some of the compounds in question which are currently subject to the restrictions discussed above detailing the evidence that shows they have the potential to become vital medicines for a range of very serious illnesses that affect thousands of people up and
down the country every day.

In the meantime, if you like the subject matter here, I encourage you to check out my previous blog post reviewing a previous talk given at SitP on the subject of lying by Dr Mike Drayton, and also to check out the SitP website to keep up to date on upcoming talks and articles of interest.

References used in this post:

NUTT D.J. (2015) Illegal drug laws: clearing a 50-year-old obstacle to research.  Public Library of Science Biology, Volume 13, Supp.1.
NUTT D.J., KING L.A., SAULSBURY W. and BLAKEMORE C. (2007) Development of a rational scale to assess the harm of drugs of potential misuse.  The Lancet, Volume 369, No.9566, pp1047-pp1053.
NUTT D.J, KING L.A. and PHILLIPS L.D. (2010) Drug harms in the UK: a multicriteria decision analysis.  The Lancet, Volume 376, No.9752,pp1558-1565.
VAN AMSTERDAM, J., OPPERHUIZEN A., KOETER M. and VAN DER BRINK W. (2010) Ranking the harm of alcohol, tobacco and illicit drugs for the individual and the population.  European Addiction Research, Volume 16, No.4, pp202-pp207.

This post was contributed by SitP regular Phil Walsh.

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