The Prohibition of Diviner's Sage

by Thomas Munro

This essay was written in June 2002. It is now out of date, and some links are broken. A brief update (April 2006) can be found on pp. 63-66 of my PhD thesis.

INTRODUCTION

Ms G is a young Australian woman who has suffered depression since she was a teenager. Her doctor prescribed an antidepressant, but it was ineffective; she tried therapy, but that didn't work either. Recently, however, she finally found relief in a traditional Mexican herbal medicine, Diviner's Sage (Salvia divinorum). Tests by psychologist Dr Karl Hanes "confirmed remission of her symptoms of depression". She "maintained this improvement for the last 6 months, showing no signs of relapse and reporting only minimal side effects"[1]. There are others like her, and Dr Hanes is preparing another paper about them.

Sadly, it wasn't to last. On Saturday, June 1^st, this plant was prohibited. Hard as it may be to believe, an unelected committee has made possession of this herb a criminal offence. While it is freely available everywhere else in the world, in Australia it has been given the same legal status as heroin and crack cocaine.

Below I will reveal the basis for this bizarre decision. I will show that the text of the prohibition contains glaring and rudimentary scientific errors. And I will reveal the source of those errors - most of the text was not written by the committee at all. It was copied (without acknowledgement) from a bulletin board for criminals - a publication which is almost certainly illegal.

The committee did not consult with those affected. Their stated reasons are completely inadequate. Not only did they give no supporting evidence, they admit that none exists. Finally, and most importantly, the decision was made with no public consultation - the entire process was undemocratic. I call on our elected representatives to overturn this decision.

THE DECISION

The National Drugs and Poisons Schedule Committee (NDPSC) controls the legal status of chemicals in Australia by placing them in "schedules". The most restrictive of these is schedule nine, intended for "substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research…"[2] This schedule covers substances such as heroin and crack. The NDPSC has added two new entries to schedule nine:

"SALVIA DIVINORUM", and

"8-METHOXYCARBONYL-4A,8A-DIMETHYL-6-ACETOXY-
5-KETO-3,4,4B,7,9,10,10A-SEPTAHYDRO-3-(4-FURANYL)-
2,1-NAPHTHO[4,3-E]PYRONE *(SALVINORIN A)."[3]

Salvinorin A is a compound found in Salvia divinorum. The rest of the entry appears to be a systematic chemical name for salvinorin A. But it isn't.

THE ERRORS

Every single number in the name is incorrect. Essential details are missing; some of the details given are incorrect, while others are meaningless (for more detail, click here). Suffice it to say that Dr John Zdysiewicz, who edited the Australian Journal of Chemistry for 25 years, laughed out loud when I showed it to him.

These are not minor errors. They are both glaringly obvious and very serious - they render the name meaningless. My legal advice is that this would be a strong basis for challenging this law in court.

How is it that these errors went unnoticed by the committee's four "technical experts"? Were they not paying attention, or do they not understand chemical nomenclature? That is: was it negligence or incompetence?

If the technical experts didn't know what this compound was, the rest of the committee certainly didn't. How can you prohibit something if you don't know what it is?

It may simply appear that this committee made a mistake, and wrote a piece of bad law. But it's much more serious than that: they didn't write it at all. It was copied - without acknowledgement.

THE REAL AUTHOR

The name was actually written by William E. White, in his 1995 article "All about Salvia Divinorum":

"I tried to get a … name out of this; unfortunately, I gagged…The best I could do is

8-methoxycarbonyl-4a,8a-dimethyl-6-acetoxy-5-keto-
3,4,4b,7,9,10,10a-septahydro-3-(4-furanyl)-2,1-naphtho[4,3-e]pyrone.

(whew!) Sorry, I haven't done o-chem since the Reagan administration. If anyone wants to correct me, please feel free to do so."[4]

White, as he tells us himself, is no chemist. He's an American IT worker whose hobby is instructing people in recreational drug use. His most famous work is the "Dextromethorphan FAQ"[5], a guide to "getting high off cough syrup" (by drinking a bottle or more at a sitting). White openly acknowledges many serious risks - including addiction, mania, psychosis, permanent brain damage, cerebral haemorrhage and death. He goes on, however, to offer guidance on subjects like "What are Some Fun or Interesting Things to Do on DXM?" (such as swimming) and "How do I tell my friends I'm getting high off cough syrup?".

Manufacturers of cough syrup often add bitter or nauseating ingredients to deter excessive use. Enthusiasts therefore wonder "How Can I Get Rid of Other Drug Ingredients?". White provides step-by-step instructions using "materials and equipment that one could buy without any trouble at your nearest Woolworths".

He also covers "Injection and Other Routes" , considering the relative merits of intravenous, intramuscular and subcutaneous injection. And for the more adventurous there's "Mixing DXM and other drugs" (such as alcohol, barbiturates, amphetamines and PCP).

This man's word is now law throughout Australia.

THE SOURCE

White posted his article to the internet newsgroup "alt.drugs"[6]. This is an uncensored forum for users and manufacturers of illicit drugs - how to make them, use them, conceal them - in short, it's a place where criminals learn to commit crime.

Publications which "promote, incite or instruct in matters of crime"[7] are illegal in Australia. A Perth man was recently fined $25,000 for possession of books and downloaded documents describing illicit drug manufacture[8] - the kind of document which appears daily on alt.drugs.

The Therapeutic Goods Administration, the NDPSC's parent body, announced in a recent press release: "TGA SWEEPS INTERNET FOR FALSE CLAIMS"[9]. The question remains: where are they being swept?

And more importantly: how did glaring errors published in a squalid forum for criminals find their way into Australian law? Only the committee responsible can tell us that.

THE JUSTIFICATIONS

The initial justification given for this decision was that "there appeared to be a prima facie case for control of Salvia divinorum as an [sic] hallucinogen"[10].

Salvia divinorum is indeed hallucinogenic in high doses. But as we have just seen, this is true of cough syrup. It is also true of motion-sickness medications (such as Kwells) and ulcer treatments (like Atrobel). All of these products cause intense hallucinations in high doses, but none is prohibited. Indeed, they can all legally be sold without prescription.

Similarly, nutmeg is hallucinogenic (indeed, learned articles have been written on the subject of "nutmeg abuse")[11] . So too are many popular ornamental plants such as Datura species. Hallucinations can also be caused by numerous prescription medications, prolonged isolation, sleep deprivation, even extreme hunger and thirst [12].

We don't imprison people for being hungry and sleepy, or prosecute greengrocers for trafficking in nutmeg. Clearly, there is no prima facie case for prohibition simply because something is "an hallucinogen".

POTENTIAL FOR ABUSE - "MINIMAL"

At their next meeting, the NDPSC gave different reasons. This time they claimed the decision was made "on the basis of high potential for abuse and risk to public health and safety"[13].

No basis (either reasoning or evidence) was given for the claim that Salvia divinorum has a "high potential for abuse". Let's examine some evidence from the United States, where the use of this herb is far more prevalent than in Australia.

In a report to the U.S. Drug Enforcement Agency, Dr. Ethan Russo (Clinical Assistant Professor of Medicine at the University of Washington and Adjunct Associate Professor of Pharmacy at the University of Montana) wrote:

"No cases of dependency on S. divinorum or salvinorin A are reported in the literature … The plant and chemical have minimal abuse potential and no addictive potential."[14]

Dr. Alan Trachtenberg, a medical director in the federal ‘Center for Substance Abuse Treatment', the U.S. Department of Health and Human Services' peak body for addiction treatment, has said:

"We don't know much about treating it because we don't have people showing up with an addiction to it"[15]

Who told the NDPSC this plant has a "high potential for abuse"? William E. White?

RISK TO PUBLIC HEALTH AND SAFETY - "NO EVIDENCE"

The NDPSC similarly gives no evidence for the claimed "risk to public health and safety".

Dr. Russo's report to the DEA included a nationwide survey of hospital emergency room data which found no record of any hospitalisation, much less injury or death, resulting from the plant or compound.[14] By contrast, nutmeg has caused countless hospitalisations internationally, and several fatalities[11].

In mice, a concentrated extract of Salvia divinorum is approximately as toxic as vitamin B3[16],[17]. This is less than half as toxic as dextromethorphan, and ten times less toxic than atropine, both of which are available without prescription, as discussed above[18].

The same investigators found the toxicity of pure salvinorin A too low to measure: the largest dose they could administer, a quarter of a million times higher than an active human dose, caused no observable harm[19].

Dr. David Nichols, Professor of Medicinal Chemistry and Molecular Pharmacology at Purdue University, who has done detailed research into salvinorin A, has said:

"We haven't really heard of any adverse reactions."[20]

Even the NDPSC itself has admitted that there is "no evidence of a major public health hazard". Members representing all State and Territory Health Departments and various other interestsstated that "they had not been advised that this herb was causing public health problems"[21].

The NDPSC had no basis whatsoever for their claimed "risk to public health and safety". And they admit it.

WHO'S BEHIND THIS?

The scheduling process began when

"The Office of Complementary Medicines asked the NDPSC consider restricting access to Salvia divinorum on public health and safety grounds."[21]

This Office, also part of the Therapeutic Goods Administration, is very concerned with public health and safety. They have their own technical experts, and those experts have written a scientific report, dealing with another threat to public health and safety.

"TOXIC HONEY"

The "Honey Scientific Report" is "an evaluation of the safety of honey"[22]. It describes "three areas of potential safety risk associated with honey: toxic honey, allergy to honey, and infant botulism". It alerts us that "Deaths from toxic honey consumption have been recorded throughout history".

While the committee considered "prohibiting honey production in certain areas", it ultimately concluded that "Honey is a substance suitable for use" in therapeutic goods in Australia, although any of those goods intended for oral use "should be required to carry a warning that they are not suitable for use by infants without medical supervision" (No details are given of the warning label for non-oral use, which is probably a good thing).

We taxpayers can only thank the Office of Complementary Medicines for their vigilance. And ask: why is the NDPSC wasting its time on an obscure herb which has never caused a single hospitalisation, when a substance which has enslaved literally millions of Australians, and has killed even more people than nutmeg, can legally be sold to children - without warning labels!

BURDEN ON RESEARCH

Placing a substance in schedule nine does not prohibit scientific research into that substance outright. It is, however, the most restrictive category available, placing the heaviest possible financial and regulatory burden on research. Anyone wishing to do research in such an area must buy a permit (over $600 in Victoria), install a safe (if not present), and arrange a government inspection. All controlled materials must be signed in and out of the safe daily, with exact amounts accounted for in a written register, subject to unannounced audits. Any losses (spills, low-yielding reactions etc) which cannot be explained to the satisfaction of the relevant bureaucrat may result in loss of the permit at any time.

Australia is the only country in the world to place such burdens on researchers in this area. We have been placed at a unique competitive disadvantage, in a promising area which may lead to breakthroughs in disease treatment and the understanding of the human brain.

The world-leading research on Salvia divinorum's antidepressant effects cited above was Australian. Our Government should be supporting researchers in this area, not mummifying them in red tape and charging them a fee for the privilege.

PREVENTION OF THERAPEUTIC USE

The NDPSC has stated that "there was no evidence of traditional therapeutic use other than in shamanistic healing rituals"[21]. The distinction between "traditional therapeutic use" and "healing rituals" escapes me, but then I'm no technical expert.

Mazatec indians regarded this plant as a panacea, using it to treat illnesses including anemia, headache, rheumatism, diarrhoea and swelling of the stomach[23] While their ideas about these illnesses might now be considered mystical, preliminary scientific testing indicates there may be some basis to them. Extracts of the plant showed antibiotic effects against a range of bacteria, and slowed intestinal contractions[24]. These promising findings, and the antidepressant effects mentioned above, deserve further investigation.

If scientific testing reveals some therapeutic use for this plant or compound, their legal status will render medical use virtually impossible. Consider the failure of repeated attempts to institute heroin trials. If respected institutions with state government backing cannot even run controlled trials of schedule nine substances, what chance would a lone doctor have of gaining permission to actually prescribe one?

NO PARALLEL

Australia is the only country in the world to prohibit Salvia divinorum or salvinorin A. Not even the United States, the home of "zero tolerance", has moved to prohibit the plant or compound[25].

NO CONSULTATION

The NDPSC is required both by its own guidelines[26] and by the Therapeutic Goods Act[27] to "undertake public consultation on scheduling matters of public interest and/or significance."

The NDPSC's idea of consultation can be illustrated by visiting their website, on which they are required to give prior notice of proposed amendments[28]. As I write, six months after this decision was made, the site's search engine returns no reference either to "salvia" or "salvinorin"[29].

The information is there - if you know where to look. Ask a friend: "What's the legal status of Salvia divinorum?" Don't show them the links I've provided; don't tell them which committee is responsible. See for yourselves how accessible this information is. Join the consultation process!

http://www.tga.health.gov.au

No doubt your friend easily located the relevant documents, marked COMMERCIAL-IN-CONFIDENCE (presumably in order to "seek public comment"). Or perhaps your friend had already read about it in the popular Commonwealth Gazette.

Unsurprisingly, the NDPSC received "no response" from the public[30]. The consultation process was not entirely fruitless, however. They did receive a note of thanks from the Office of Complementary Medicines.

NO AVENUE FOR APPEAL

I emailed the NDPSC on the 3^rd of May, pointing out the errors in the proposed entry and asking for an opportunity to argue against this decision. I received no reply. I wrote again on the 17th, copying the Minister and Shadow Minister for Health. This time I got a reply. It stated that I had missed the deadline for public input by months. I confirmed by phone that the decision was final; the only available course of action is to request a rescheduling, which would take effect no sooner than May next year even if successful.

But what if someone had lodged a submission before the deadline, pointing out the committee's errors?

"If due process is not a basis for reconsideration (i.e. if the request relates only to technical or scientific matters) and if the Committee reaffirms its original decision (following reconsideration), the applicant or interested party may not appeal the Committee's reconsideration decision."[31]

In other words, if they make mistakes, you can ask them to reconsider; but if they don't, that's the end of it. There is no appeal.

What if the NDPSC didn't follow "due process"? What if, for instance, they didn't meet their evidently stringent requirements for public consultation? Then you could appeal to the Appeals Panel of the "Australian Health Ministers' Advisory Council (AHMAC)". And if you were lucky, they might:

"uphold the appeal and direct the NDPSC to rectify the error by reconsideration of the matter".[32]

So if you ask the NDPSC to reconsider, and they refuse, you may (in certain circumstances) appeal to AHMAC, who can tell them to reconsider. Not reverse the decision, just reconsider it.

NO DEMOCRATIC PROCESS

This decision took effect on June 1^st. Take Victoria for example: on that date Salvia divinorum and salvinorin A automatically entered schedule nine of the Victorian Poisons List[33], which made their possession illegal except for government-approved researchers with a permit.[34]

And the entire process, from conception to criminal law, took place without the involvement of a single elected official. The Australian people had no say, even indirectly.

The Concise Oxford Dictionary defines democracy as "government by the people". I don't know the word for government by unelected committee. Perhaps the NDPSC's technical experts can help.

SUMMARY

This ban was:

• proposed by people who think honey should carry a health warning,
• written by a man who instructs teenagers in "getting high off cough syrup",
• copied from a bulletin board for criminals by persons unknown,
• endorsed by "technical experts" who wouldn't know a chemical name from a cryptic crossword, and
• turned into law by an unelected committee who had no idea what they were banning, and gave justifications for which they admit there is no evidence.

It's tempting to ask: who's ringmaster of this circus? But that would trivialise a very serious situation: this ban will cripple world-leading Australian scientific research, and deprive people suffering from a terrible illness of a promising potential therapy. This decision may also result in the long-term imprisonment of otherwise law-abiding Australians. This decision is both unjustifiable and undemocratic.

CONCLUSION

If the NDPSC believe that restricting the availability of this plant will serve the public interest, they should choose a schedule which will not punish scientific researchers and the victims of disease. They should give sound supporting arguments, based on evidence from reputable sources, and the "public consultation" process should involve not just their fellow committees, but the actual public.

But if they wish to do so, they must disown this travesty and start the scheduling process again. This decision is irrevocably tainted, and must not stand.

WHAT SHOULD BE DONE

• I call on Stateand Territory Health Ministers to exempt Salvia divinorum and salvinorin A from Schedule 9.
• I call on Federal Parliament to reverse this decision by any means necessary, even if that requires amending the Therapeutic Goods Act.
• I call on the Senate to investigate how this decision was reached (and whether anything similar has occurred in the past), and take the necessary steps to prevent similar lapses in future.

Click here to learn what you can do

Click here to learn what you can do