[Ibogaine] FW: More from Alex

Nick Sandberg nick227 at tiscali.co.uk
Mon Feb 18 07:32:53 EST 2008


 

 

  _____  

From: Nick Sandberg [mailto:nick227 at tiscali.co.uk] 
Sent: 18 February 2008 12:20
To: 'Alex Wodak'
Cc: 'gerry.stimson at ihra.net'
Subject: RE: Ibogaine Talk

 

Hi Alex,

Thanks for your reply. Personally, I think you're copping out on the
humanitarian issues. I don't personally have a problem with accepting that,
thus far, there haven't been adequate clinical studies done for ibogaine to
bring it to the masses. I seems clear to me. However, rather simply accept
this as some inevitable ongoing reality I choose to also expand my vision
and look at the reasons as to why this should be so. I prefer colour to
monochrome.

It seems to me you are choosing to view the situation from purely a
scientific standpoint, rather than look at the wider humanitarian arena. Of
course anyone could sit in this tight academic box and make pronouncements
as to ibogaine being inadequately clinically proven. I could do it myself.
It's an exceptionally easy position to take, but when one has fully taken
it, I find that the other issues start to become of interest. To be honest,
I don't see that, in reality, there even is a real issue with the clinical
studies at the moment, because no one is financing studies so treatments
simply continue privately, as they have done for years. I would personally
love it if ibogaine, or one of the drugs being researched that have been
developed from ibogaine, could get out to the wider body of people who need
them

I don't believe the world is cruel. I rather like the world. I simply
believe that our existing for-profit healthcare model clearly grossly
underserves certain negatively-marginalised sectors of the community, namely
those dependent on illicit drugs. I am trying to promote change. That, in my
opinion, will not occur until adequate pressure can be brought onto
government and the Pharm business to do something positive here and invest
in development. Part of this process is to try and bring individuals like
yourself, if not actually on board, then not actually doing harm.

I got in contact with you because I was genuinely surprised that someone,
apparently from a caring viewpoint, could take such a tight stance on
ibogaine. For sure there has been inadequate testing, and for sure this
should be made clear, but you seem to me to almost relish in this somewhere.
I would invite you to look deeper at what is going on for you with this
drug. To me there is clearly something that you seem unaware of. 

Nick

 

  _____  

From: Alex Wodak [mailto:awodak at stvincents.com.au] 
Sent: 16 February 2008 12:10
To: Nick Sandberg
Cc: gerry.stimson at ihra.net
Subject: RE: Ibogaine Talk

 

Dear Nick,

 

We are starting to develop some common ground

 

We seems to agree that animal studies on their own cannot help to determine
the effectiveness and safety of treatments for humans

 

We agree that ibogaine hasn't been adequately tested

 

But now you want me to also agree with you that the world is very cruel and
unfair place because the studies that should have been done to prove the
effectiveness and safety of ibogaine haven't been done

 

And you want me to take account of 'the vast financial and humanitarian
issues'
when giving my talk

 

Sorry

 

Wrong guy

 

I see my job being like the guy who says that the plane that is about to fly
you half way across the world is safe to fly

 

Would you want that mechanic to say 'well the bloody company hasn't done the
right checks on its aircrafts and the mechanic's dog ate the plane's records
but considering how many people want to fly on this thing, it's probably
safe'?

 

I have no idea whether the people who advocate for ibogiane are doing this
for the best of motives, the worst of motives or a combination of the two

 

But I do know that when regulatory authorities cut corners on checking new
medical treatments, a lot of people got hurt

 

best wishes, 

 

Alex

 

 

 

Dr. Alex Wodak,
Director, Alcohol and Drug Service,
St. Vincent's Hospital, 
Darlinghurst, NSW, 2010,
AUSTRALIA

 

Telephone: (61+02) 9361 8012
If no prompt answer, try 9361 8014
Facsimile: (61+02) 8382 4738
awodak at stvincents.com.au

>>> "Nick Sandberg" <nick227 at tiscali.co.uk> 15/02/2008 9:26 pm >>>
Dear Alex,

Thanks for your reply and for details of your background. I do not for a
second dispute that appropriate animal and clinical trials are necessary
prior to a drug becoming available. The point I'm trying to make, in
discussing this matter with you, is that the existing financial climate that
prevails makes it exceptionally hard to get studies done without the backing
of the Pharmaceutical houses. 

Now if you want to take a "hardline" attitude and say "That's how it is, and
ibogaine hasn't been adequately tested" then I agree with what you are
saying but I also feel that it is good to simultaneously point out the
financial and political issues, just to give the listener a fair picture of
what is going on. From a man who clearly has invested a considerable amount
of his time in trying to make life better for drug-users, I would expect you
to be interested in this side of it.

The reality with ibogaine is that it has now become, as Frank Vocci,
Director of NIDA, stated, a "vast, uncontrolled experiment," with thousands
of addicts either self-treating, being treated by lay practitioners, or
being treated in one of many private clinics that have set themselves up
over the last decade. It's a complete chaos and at the heart of it is a
medication with specific benefits in treating addiction but which cannot get
legally where it's needed simply because of the dominance of the
"for-profit" healthcare model.

Pharm houses appear to have many grievances with ibogaine. Certainly the
following are among them...

* ibogaine is primarily a one-shot medication, thus reducing the potential
financial returns it could make against the considerable R&D outlay. Repeat
dosing can be undertaken, to help promote longer-term drug abstinence where
it's needed, but it's certainly not of the "take 3 times a day" model.
* ibogaine is naturally occurring and only use patents would be available.
* there's an industry prejudice against developing psychoactive medications.

The situation, by anyone's standards, is appalling. High profile scientists
like Deborah Mash and Stanley Glick have been working with ibogaine or
closely related drugs for years but simply cannot get Pharm house funding to
continue studies.

I do urge you to take account of the vast financial and humanitarian issues
when giving your talk. 

Regards

Nick Sandberg


________________________________________
From: Alex Wodak [mailto:awodak at stvincents.com.au]
<mailto:%5bmailto:awodak at stvincents.com.au%5d>  
Sent: 14 February 2008 00:53
To: Nick Sandberg
Cc: gerry.stimson at ihra.net 
Subject: RE: Ibogaine Talk

Dear Mr Sandberg,

People (like you) who want to give me a hard time because I am resolute
about the need for due scientific process for new drugs should know that I
am not someone who gives up easily

It is perfectly true that I associate iboguaine and thalidomide 

But it is also true that every drug that has been newly considered since
thalidomide has been influenced by the lessons so painfully learnt from the
sorry tale of thalidomide

And as iboguaine is being considered since thalidomide, it is going to have
to go through the same proper careful scientific process (that you obviously
know so little about) as every other drug since thalidomide has had to go
through

Now if you still want to call referring to this history as 'manipulation', I
suggest that you first learn about this process of scrutiny and then buy
yourself a dictionary and look up the word 'manipulation'

Dana Beal has already hectored me about ibogiane in New Orleans in December.


More to the point, he promised to send me published papers providing
evidence forthe efficacy and safety of iboguaine 

He has not done so - though I am not surprised by that

You have sent me just 2 (two) references to support your claims

The abstract of the first paper you have cited as evidence refers to 'the
purported efficacy' - note the word 'purported'. 

That means the authors think that the alleged efficacy is not yet supported
by enough evidence. 

The abstract then refers to 'preliminary efficacy for opiate detoxification'


These authors then report decreased cravings and decreased depression
scores. 

And that's it. 

I am sorry Mr Sandberg but that one paper is not 'evidence for efficacy and
safety'

The next paper is about 'the iboguaine subculture'

I will read that paper

But I don't expect a paper with that title to provide any more 'evidence for
efficacy and safety' than a paper on the methadone subculture would give me
'evidence for efficacy and safety' of methadone 

Your comments about animal studies indicate to me that, frankly, you are
quite out of your depth

Finding a drug that helps cockroaches to stop using heroin is interesting 

But it doesn't tell us whether that drug is going to be effective and safe
when used on your or my son in Bristol

I will leave to others the judgment about whether I am or am not
compassionate about injecting drug users 

But I started (with colleagues) as an act of civil disobedience the first
needle syringe programme in Australia in 1986 when this was in breach of the
Drugs Misuse and Trafficking Act (1985)

That led to the acceptance and implementation of needle syringe programmes
in Australia

I started (with colleagues) as an act of civil disobedience the first
medically supervised injecting centre in Australia in 1999 when this was in
breach of the law

That led to the acceptance and implementation of the first official
medically supervised injecting centre in Australia

I started (with a colleague) the first organisation of injecting drug users
in Australia (in 1989)

I have been the director of a major alcohol and drug treatment service for
more than 25 years

I have been responsible for getting drug users included on many official
Department of Health committees

Let's try and find where we can agree:

1 Do you agree that all new pharmaceutical drugs should be carefully
assessed before widespread implementation to make sure that they are safe?

2 Do you agree that all new pharmaceutical drugs should be carefully
assessed before widespread implementation to make sure that they are
effective?

3 Do you agree that ibogaine should be carefully assessed before widespread
implementation to make sure that it is safe? 

4 Do you agree that ibogaine should be carefully assessed before widespread
implementation to make sure that it is effective?

5 Do you believe that ibogaine has already been carefully assessed and shown
to be safe? 

6 If so, what is your evidence?

7 Do you believe that ibogaine has already been carefully assessed and shown
to be effective?

8 If so, what is your evidence?

9 Do you think that these above questions are fair and important?

10 If not, why not?

Although this has been a private correspondence, I will refer to your
answers - or lack of answers to these questions - in my talk in Barcelona

best wishes, 

Alex



Dr. Alex Wodak,
Director, Alcohol and Drug Service,
St. Vincent's Hospital, 
Darlinghurst, NSW, 2010,
AUSTRALIA

Telephone: (61+02) 9361 8012
If no prompt answer, try 9361 8014
Facsimile: (61+02) 8382 4738
awodak at stvincents.com.au 

>>> "Nick Sandberg" < nick227 at tiscali.co.uk > 14/02/2008 2:17 am >>>
Hi Alex,

Thanks for getting back to me. It is not my intention to mindlessly give you
a hard time. It is not nice to be on the receiving end, for sure, but I must
say that if you did associate ibogaine with thalidomide then it is perhaps
not surprising that it happens. If not then it is certainly unwarranted. The
2 papers I referred to in my letter to you are as follows:

- Ibogaine: Complex Pharmacokinetics, Concerns for Safety, and Preliminary
Efficacy Measures - Neurobiological Mechanisms of Drugs of Abuse, Volume 914
of the Annals of the New York Academy of Sciences, September 2000 - Ann N Y
Acad Sci 2000;914:394-401) DEBORAH C. MASH,a,b,h CRAIG A. KOVERA,o JOHN
PABLO,o RACHEL F. TYNDALE,c FRANK D. ERVIN,d IZBEN C. WILLIAMS,e EDWARD G.
SINGLETON,f AND MANNY MAYOR

- The Ibogaine Medical Subculture - Journal of Ethnopharmacology 115 (2008)
9-24 Kenneth R. Alper Howard S. Lotsof Charles D. Kaplan

I fully appreciate your concern as to the lack of good empiric data. It is
true that much more research needs to be done. I would however mention that
even a basic Medline search will reveal many hundreds of animal studies
involving ibogaine. By no means is it the primary intention of all of these
studies to demonstrate efficacy, but if you read at least some of them I
believe it will become clear that ibogaine's dependence-breaking
characteristics are increasingly well accepted by many scientists. Academics
give ibogaine to rats often to better understand the mechanistic pathways
involved in the neurobiology of addiction. 

As to the issue of manipulation. Firstly, I need to state that I am basing
my judgment on the abstract that was forwarded to me as being written by
yourself. If you did not write it then I unreservedly apologise. 

To be honest, I would accuse the writer of this piece of manipulation on two
counts. Firstly, referring to the drug Thalidomide in the manner that the
writer did clearly is likely to create a reasonable degree of association in
the mind of the reader with Ibogaine. I'm not a pharmacologist but my
understanding is that Thalidomide is not naturally-occurring and has not
been used by native peoples for at least some centuries. One might claim
that the word is simply being used to give some historical context as to the
need for extensive clinical trials and, whilst I would consider this fair, I
would still hold that the writer is creating an unwarranted association in
the mind of the reader. 

Secondarily, I find the picture of clinical trials that is presented by the
writer of this abstract utterly one-sided and, again, completely
manipulative. It is necessary to grasp that the business of bringing new
drugs to the market is almost wholly in the hands of "for profit" entities.
Ibogaine does not fit into the Pharm Corporation's idea of what a suitable
medication looks like and so they don't put money in to develop it. I can
give you more information here if you wish. Yet the writer of this abstract
fails to even mention this. If I were a casual reader I would be left with
the impression that ibogaine simply isn't good enough, that it's been tried
and found wanting. This is absolutely not the case as a decent study of the
background and history of the drug will clearly show.

You claim you are not biased against ibogaine. That is absolutely not my
impression from reading that piece. I consider it absolutely reprehensible
to portray in such a manner a medication that clearly has the potential to
transform the treatment of drug and alcohol dependency worldwide. I can
scarcely believe that the writer of it could give a damn about the plight of
those who suffer with this worldwide.

Nick Sandberg






________________________________________
From: Alex Wodak [mailto:awodak at stvincents.com.au]
<mailto:%5bmailto:awodak at stvincents.com.au%5d>  
Sent: 12 February 2008 23:53
To: Nick Sandberg
Cc: gerry.stimson at ihra.net 
Subject: Re: Ibogaine Talk

Dear Mr Sandberg,

It is very unusual for people to debate an abstract of a talk before the
paper has been presented

I was invited to do this talk and accepted the invitation

My reward for that acceptance has been to be subjected to tirades

My abstract states that 

'Published evidence for Ibogaine as a treatment for heroin dependence is
unimpressive'. 

Please provide me with a list of publications that provides strong empirical
evidence for iboguaine. 

I have defined in the abstract exactly the kinds of publications I need:

''Evidence' means several rigorous scientific trials published in reputable
peer-reviewed scientific journals demonstrating major benefits consistently
and in the absence of unacceptable side effects. Evidence of effectiveness
preferably (but not necessarily) requires randomised controlled trials where
this is possible. 'Evidence' is not a strong theoretical rationale'. 

I note that you have already had the opportunity to provide this information
for me in your e-mail and have not already done so. 

You refer instead to unnamed studies. 

Please provide more details: Author, title, journal, year, volume, pages. 

Please do so now. 

Please understand that neither of us has a monopoly on concern about the
plight of people you describe as 'addicts'

In my view it is not compassionate to advocate for a treatment unless we
know from evidence that the treatment is effective and safe (and
preferably also cost effective)

I am sure you know the saying 'The road to hell is paved with good
intentions....'

While you may regard the statment that 'Since the tragic experience of
thalidomide some decades ago, medicine has been based firmly on scientific
evidence' as manipluative, I note that you did not say it was wrong. 

Just as well. 

That statement is correct. 

How can it be manipulative. 

I have just used the very same sentence in an editorial for a medical
journal. 

Neither of my 3 distinguished co-authors, nor the editor nor the 2 reviewers
took exception to this comment. 

I don't have any position on iboguaine - I certainly want more and better
treatments for injecting drug users 

But I don't have any desire to see iboguaine come or go 

My position, as outlined in the abstract, is very simple. 

I assume that all interventions are ineffective, unsafe and cost-ineffective
until proven otherwise and that includes iboguaine. 

If you want me to be impressed by iboguaine, then show me the evidence. 

It's that simple 

I assume after reviewing your qualifications that you do not appear to have
had any training in empirical research relevant to evaluation of
pharmaceutical treatments. 

None of us can cover all the areas that this field encompasses. 

Perhaps your qualifications and expetrience put you at a disadvantage for
reviewing scientific literature on empirical research relevant to evaluation
of pharmaceutical treatments

best wishes, 

Alex

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