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Sunday, June 10, 2012

Could two girls change the lives of Canadian junkies?

Well, Naomi and Salome aren't really girls; they are groundbreaking Canadian studies that can help change the world.  Of course, many studies may, rightfully or otherwise, claim that they are significant; NAOMI and SALOME, however,  are different in that they portray the harsh reality, one which politicians are unwilling to even acknowledge, in what must be the ugliest branch of medicine: addictions.  Traditional news media keep mentions of the studies under wraps, as the sensational 'articles' about the crimes of this community bring far too much resources for the cure to be revealed.  Even Big Pharma resists, as I'll reveal below, for the simple reason that (as a study staff member, whose name will remain anonymous, revealed) addiction medicine was not on their priorities.

The Conservatives, who are usually less wrong than the other parties in Canada, certainly make up for it this time.  In an ideal world, drugs, just like every other thing, would be traded on the free market like everything else; this was the case for nineteen centuries, in which chaos (contrary to common belief) did not rule the Earth. This isn't an ideal world, of course, so one has to live with such hare-brained ideas as Prohibition.

Prohibition, in fact, has three populations of people that it maims or kills.  The fulcrum is the addict himself, who risks amputation as a result of impure drug, loss of income when a company drug-tests (which, in Canada, are illicit unless solely for alcohol), and incarceration as a result of law enforcement activity.  The family 'only' suffers emotional complications, but these can be hell on wheels.  Those who choose to assume responsibility and either a) the satisfaction of a moderate amount supplied for free or at cost, or b) abstinence, are also in jeopardy of harm if neither the two usual treatments in Canada are effective.

The standard Canadian treatments for addiction are buprenorphine and l/r methadon (Metadol), although their use is far more common for pain (this is how I have had the opportunity to try both).  Methadon can be used in any dose; however, it is damaging to the nerves, causes tiredness and lethargy in some, and it is more difficult to cease use of.  Furthermore, because it is a mixture of two active drugs, to wit: a) l-methadon, an opiate, and b) r-methadon, a cough suppressant, taking methadon provides the effect of (for example) morphine and dextromethorphan (DM) simultaneously.  Although this is great in nerve pain, where r-methadon and its relatives work better than opiates, it is of no use in organic pain or in addiction.   Buprenorphine is harmless, but is a newer, less trusted drug, and only works up to 32 mg daily; above this, methadon becomes the sole option.

NOTE: For consistency, the drug diamorphine, also called diacetylmorphine, morphine acetate, and heroin, will be hereafter referred to as heroin.  The diluted form of this product sold as a drug of abuse will be referred to as crude heroin.

In other countries, such as Great Britain, all drugs can be, and are, prescribed for all conditions, although a licence is required to prescribe heroin, dipipanone (a drug available only in the UK), and cocaine for addiction treatment only.  Concurrent pain and addiction can be treated (in the bureaucratic sense) as simple pain.  There are a few opiates considered semi-standard for drug addiction treatment, however.   Morphine and heroin, in both oral and injectable form, continue to be used.  Dilaudid is also an option, as are methadon and buprenorphine.

Whew!  That was a damn long introduction.  Time for the story.  So, although the UK had originally floated the idea of quitting crude heroin by using pure heroin, this was also taken up by other countries: Switzerland, Denmark, Holland, and Germany all allow this treatment.  Canadians needed to also have this option; today, there are only two available treatments, neither of which is entirely the answer to the question.  Therefore, in 2005, a study known as NAOMI (the North American Opiate Medication Initiative) was launched in the cities of Vancouver, British Columbia, and Montréal, Québec.  Its goal was to independently test the efficacy of treatment with heroin.

The Vancouver arm of the study needs special mention.  It was held in the Downtown East Side, the poorest postcode in the country.  The problem with crude heroin in the DTES is so godawful that this area has the most heroin abusers per square mile in Canada.

This was a scientific trial; therefore, a control group was also established.  Study participants in the control group received methadon.  The rest of the participants received injections; one-fifth of these got dilaudid, while the rest got heroin. Neither the staff nor the participant knew which injection he was getting.  Each participant was in the study for a year; the trial ended entirely in 2008. Participants, who actually formed an advocacy group for themselves, were royally pissed off about the aftermath.  Some had successfully held down a job thanks to the heroin they received; then, even in its obvious success, the heroin was yanked from within their reach.  Nowhere else did this situation occur.  Either the study results were so good that the situation was made permanent, or the participants were given heroin on compassionate grounds.  In its infinite wisdom, Health Canada so magnanimously refused to do so.

The trial had one unexpected result.  The ten per cent. of people who unknowingly received dilaudid rated it as equal to heroin; there was no perceivable difference.  Although this was a breakthrough, it was nothing shocking.  In fact, a study in India, where buprenorphine is such a common hospital painkiller that it rivals or surpasses morphine in its usage, holds that drug addicts given it ranked buprenorphine (there known as Bupregesic or Morgesic) equal to morphine.

The results just had to be further tested, as if they weren't apparent already.  A new study was figured out, again with no exit plan, called SALOME (the Study to Assess Long-term Opiate Medication Effectiveness), to do so.  This experiment has only one location: Vancouver, again in the Downtown East Side.  The control group, this time, are receiving heroin by injection; the other half are receiving dilaudid.  After six months, half of each group will continue with injections, while the other half will receive oral treatment with the same drug.  The breakdown, then, is as follows: one-quarter of the subjects will be on heroin by injection; one-quarter, on heroin (morphine) by mouth; one-quarter, on dilaudid by injection; and one-quarter, on dilaudid by mouth.

The study started this year—2012.  Just as NAOMI was fraught with difficulties, so is SALOME; however, this time, the problems came from Big Pharma.

There is only one company in Canada which makes ampoules of the proper dosage for use in this setting: this company is Sandoz, the "generic products" (i.e., those that don't make any money) division of Swiss giant Novartis.  Sandoz is well aware that many of its products are habit-forming; it makes almost every known opiate in use around the world, with the exception of national specialties like dipipanone, piritramide, and dextromoramide.  It would stand to make a king's ransom on remedies for addictions, since those remedies are the products themselves.  Therefore, promoting these trials is in the best interest of Sandoz and Novartis.

Let it be said here that dilaudid is a naturally-derived product; it is essentially a chemically-transformed version of morphine, which is prohibitively expensive to manufacture synthetically.  The cheap and traditional way (five thousand years, in my opinion, constitutes tradition) to get morphine is from poppies that grow in the earth.  Therefore, it is possible to have a shortage in morphine, and thus a shortage in dilaudid.

In the true spirit of Murphy's Law, of course, this is what happened; Sandoz announced that there was a shortage of ampoules of the strength required for the SALOME project.  From March to June, SALOME had only enough hydromorphone for 12 or 13 patients (out of 25; the others were on heroin); the targeted number was 60 (out of 100).  It's understandable that there is a limited capacity for hydromorphone; the problem is that Sandoz obviously doesn't have its priorities straight.  Apparently, drug addictions patients are low on the list of priorities, because Sandoz doesn't get the idea of spend money now, make more money later.  Instead, it focuses on pharmacy and hospital distribution, because it makes more money at the present time.

What the people at Sandoz don't understand is that even though dilaudid is an off-patent drug (which means anyone can make and sell it), Sandoz effectively has a monopoly on its distribution within Canuckistan, which means they have zero competition and would receive all profits from the new patients prescribed it for their addictions.  Well, there is Knoll, the original inventors of dilaudid, and then there's Janssen Cilag, and Teva, and Sorres, and Pharmascience, and Purdue, but none of these make the injections.  Knoll makes quick release dilaudid pills; Purdue makes eight-hour delayed release pills; Janssen Cilag makes full-day extended release pills; and Pharmascience makes dilaudid cough syrup, but only Sandoz makes the injections.  Assuming that the situation would stay as it is, that the study would have a positive result, and that hard-core addicts would like the injections, Sandoz would stand to make a killing once doctors realise that the current programme of oral methadone and buprenorphine maintenance needs alternatives.

Thank God and the Flying Spaghetti Monster that the people at SALOME didn't fuck around.  The researchers were quick-minded enough to know that the manufacturing process for dilaudid is rather simple.  Somehow, they managed to obtain a manufacturing licence from Her Majesty's Government and are making the stuff onsite.

Seriously, this research is going to change the world, if politicians don't somehow find a way to bugger it up with moralistic, paternalistic, preachy laws.  Natural opiates like morphine and dilaudid are harmless enough; there is no organ they can harm.  Methadon, though, harms one's nerves and is harder to get off than either morphine or dilaudid.  It should be a valid choice for someone to prefer one of the natural opiates (even buprenorphine, though that isn't really an option at high doses) to the synthetic methadon, and I hope to God that the research which proves it so makes its way into current medical thinking and practice.  Morphine has been around for five thousand years.  Why the hell is it criminal to own it just now, for the last hundred years, when humanity got along just fine without this law before?  And if it must be criminal, give the people that become slaves to it a way out without making them slaves to something worse!