Introduction

The earliest recorded indications of health risks associated with non-medical
use of GHB were in Sweden and in the United States during the early 1990s.
At that time in Sweden, the small number of GHB overdoses was associated
with bodybuilders. In the absence of systematic studies of non-medical use
of GHB, the epidemiological evidence regarding the public health risks of
GHB for this report is based on limited information collected from:

 the Reitox national focal points in the 15 EU Member States (1);
 Europol’s contribution to the risk assessment of GHB (2);
 EMEA’s contribution to the risk assessment of GHB (3);
 the Qualitative European Drugs Network (QED) (4);
 the literature (5);
 key European forensic scientists (6);
 key toxicologists in the United Kingdom (7);
 telephone interviews with international experts in the field of recreational
drugs (8);
 the Internet (English-language searches) (9); and
 youth and mass media (English-language searches) (10).

Table 6 presents the topics covered by this annex by briefly indicating the
extent and type of evidence that is available. The numbers in the list above
are used in the table to code the sources of information. Where information
is available, it is presented and examined in the text under the main category
headings. In general, there is insufficient information, or too much overlap,
to address each of the subheadings in the text.

Following the EMCDDA request to all 15 Reitox national focal points for
information about GHB, four responded stating that they were unable to

provide any formal evidence of GHB use in their countries (Austria, Greece,
Italy and Luxembourg). All except one of these had anecdotal reports of its use.
Laboratory analysis of samples of GHB, or its precursors, were reported by
all, except four, countries, either by focal points or by Europol. The information
provided is not always consistent in its detail and forensic analyses
of GHB samples has been, generally, very limited. The number of seizures
and quantities of GHB identified by laboratory analysis range from 3 800
grams in Finland to a single small sample of a GHB precursor identified by
the criminal police in Portugal in 2000.

There have been 11 reported deaths in which GHB was associated as cause
in the European Union between September 1995 and January 2000. The
majority of these were reported from the United Kingdom and Sweden and
most, but not all, also involved alcohol. Non-fatal hospital admissions associated
with GHB are difficult to assess in the absence of routine screening
for GHB by hospital toxicology laboratories but, as with deaths, the highest
number of reports also comes from the United Kingdom and Sweden.

Table 7 summarises key data on GHB including the indicators used.

Availability and quality of product on the market
GHB has marketing authority (10) in only three countries: in Italy for alcoholic
craving and in France and Germany as an anaesthetic (EMEA, 2000).
Growing concern about non-medical use of GHB in the United States,
Australia and Europe has prompted a number of countries to introduce new
and more stringent drug controls on GHB. Since 1998, six Member States
have put GHB under permanent control: Belgium (Decree 21.1.1998),
Denmark (Euphoriant Act, 16.12.1999), France (Decree 28.4.1999), Italy
(Decree 266, 11.11.1999), Ireland (Misuse of Drugs Act, May 1999) and
Sweden (Narcotics Act, 13.1.2000). In the United Kingdom, the
Netherlands, Austria and Finland GHB continues to be controlled by the
Medicine Act and monitoring is in progress. In the United Kingdom, the
Medicines Control Agency (MCA) has taken action against a number of unlicensed
operators.

The effect of these changes is evident in the withdrawal of open sales of
GHB from gyms, sex shops and smart shops and in the reduced level of
advertising and open supply on the Internet of GHB and kits for making GHB
at home. More discrete methods have been adopted by suppliers of GHB
alongside the appearance of substitutes for GHB in name or content. For
example, in August 2000, one bodybuilding site was marketing Furanone
Di-hydro as a product named ‘ReActive’, claiming that it was not GHB.
Smart drug and anti-ageing sites also market products with similar effects as
GHB under a range of different names. The disruption of overt supply has
lead to distribution patterns similar to illicit drug networks.

Availability at consumer level (extent/quantities)

In addition to GHB being made available via the Internet and other discrete
retail outlets, a home-made ‘kitchen-sink’ GHB industry has developed due
to the fact that it is easily manufactured (Elliott, 2000) and no special equipment
is required for this process.

Seizures

Austria, Greece, Italy and Luxembourg have reported that until now there
have been no seizures of GHB. In Belgium, there are regular seizures, particularly
during the summertime, when there is an increase in seizures of
small quantities of GHB in liquid form and capsules. GBL is more commonly
found than GHB and seizures usually occur near the Dutch border. In
1999, Spain reported 31 seizures in Zaragozza and three in Ibiza. In
Sweden, police seizures have found GHB in connection with other seizures
of narcotic drugs and anabolic steroids. In Denmark, since June 1999, there
have been five seizures of GHB providing six samples. In 1999, the Finnish
forensic laboratories analysed samples of GHB relating to total seizures of
over 3 800 grams. Germany reported 11 seizures of small insignificant quantities
of GHB. In 1999 in the Netherlands there were a number of small
seizures totalling 76 capsules of GHB. In the United Kingdom the forensic
science service handles less than 10 cases each year. In Ireland two seizures
were made, one of GHB in liquid form and one in powder. In France there
have been few seizures reported (Europol, 2000).

Dose and price

In recreational drug settings, GHB is most frequently sold in liquid form in
plastic opaque bottles or screw-cap doses and samples found to contain
GHB, which have been analysed by the DIMS project in the Netherlands are
commonly submitted already mixed with alcohol. Police sources in Europe
have made seizures in liquid, powder and capsule form.

Advised doses range from 250 to 500 mg for energy enhancement, 500 to
1 000 mg for euphoria/libido enhancing effects, and up to 3 grams for profound
relaxation and sleep. The United Kingdom focal point reports that
standard 30 ml bottles contain about 3 g of GHB but the amount of GHB
contained in the bottles consumed in recreational dance settings and elsewhere
across Europe is likely to vary considerably. There have been some
reports of burns to mouths due to high caustic soda content in home-made
varieties.

The liquid form is generally taken in capfuls by cautious users or ‘swigged’
from the bottle, less cautiously by others. In the United Kingdom, one of
these bottles is typically sold for approximately EUR 15. In Spain and
Sweden, prices of GHB reported by the focal points are considerably lower
but this is likely to be the result of different unit definitions and different
sources. For example, the number of doses in a 3 ml bottle varies and prices
for Internet or catalogue bulk order sales are lower than the 30 ml bottle
price at ‘street level’.

Knowledge, perceptions and availability of information

Knowledge and availability of information

The scientific knowledge about GHB is summarised in the review of pharmacotoxicological
data on GHB (Elliott, 2000).

The knowledge and perceptions of GHB among the general EU population
are not known, but are probably limited and subject to a low level of media
reporting. The most significant lack of information about GHB is with regard
to the variable strengths and quantities of GHB contained in ‘street sales’ and
the lack of predictable effects for individuals.

For the populations who use recreational drugs, smart drugs or bodybuilding
drugs information about GHB is mostly made available through the social
networks which serve those populations. A vast number of Internet sites and
newsgroups (4 300 in the English language identified from one search
engine) feed into these networks and promote the use of GHB for a wide
range of purposes including inducing sleep, mood enhancement, treatment
of drug and alcohol addiction, sexual enhancement, athletic performance
and combating ageing. One anti-ageing site reproduced a graph of a
Japanese clinical study that showed that a dose of 2.5 grams of GHB dramatically
increased growth hormone levels 16 times within 60 minutes.
Information about recipes, taste, effects and where to purchase supplies and
alternatives to GHB is available in many different languages and many offer
warnings with regard to doses and highlight the contraindications for use. In
February 2000, a web site dedicated to GHB was established (www.ghb.org)
and a book specifically about GHB has been published and distributed
through major bookstores in the United States and via the Internet (Ward,
2000).

Perceptions
There appears to be a lobby of GHB users and promoters, visible in Internet
discussion groups, which has recently put forward a conspiratorial view of
the American government and pharmaceutical industry’s strategies regarding
trials with GHB. Whilst government sanctions against the use of GHB are
increased, the GHB trials may result in FDA approval for GHB to be authorised
as a prescription drug for treating sleep disorders.

Within recreational drug settings, anecdotal reports suggest that the negative
effects of GHB with regard to associated nausea, unpredictable doses, subsequent
risks of losing physical control or consciousness and its generally
negative low-status image will restrict its popularity in widespread social settings.
Unlike MDMA, it appears to be considered an antisocial drug among
mainstream trend setters, music promoters, club owners and outreach workers.
For example, an outreach worker in Amsterdam described it as having:

a very negative effect on the atmosphere — we don’t like it

In the United Kingdom, club promoters and youth magazines are beginning
to speak out about the use of GHB. The April 2000 issue of Mixmag gave
four full pages to the coverage of information about GHB with the subheading:
‘Some call it the nastiest drug in Britain, others offer prayers at its alter.
What’s the truth about GHB? And what’s it doing to you’.

Prevalence and patterns of use

There are no data specifically on prevalence or on patterns of the use of
GHB and at present there is little evidence that GHB is used on a wide scale
in any EU Member State. However, there is evidence of its use predominantly
in the male homosexual social scene in the past and of it now making
inroads into heterosexual sub-populations for recreational purposes, into
the wider ecstasy market and into post-party settings (Newcombe, 1999).
According to the risk assessment conducted in the Netherlands, GHB is most
commonly found in Germany, the Netherlands and the United Kingdom
(CAM, 1999).

In the Netherlands, some use of GHB in party settings has been reported by
drug workers.

In parts of the United Kingdom, use of GHB is reported as having an affinity
with heavy alcohol users. However, a Liverpool study of 100 United
Kingdom clubbers over the Christmas period 1999–2000 found that nobody
had used GHB. A survey in France conducted in 1998 found that 3 % of regular
techno party goers said they had taken GHB but among a matched control
group consumption of GHB was non-existent, indicating that the use of
GHB is also not widespread in France (Médecins du Monde, 1999). The
French survey indicated that GHB was not only taken for the effects it
induced but that, in association with other substances, it enhanced the overall
effects or facilitated the ‘come down’ from taking stimulant drugs. The
Swedish report also indicates that GHB is not the drug of choice but used as
a complement to other drugs. A survey in Helsinki conducted in May 2000
suggested that the popularity of GHB had decreased since 1998 because of
supply restrictions and relatively short effects compared with MDMA
(www.qed.org).

Social research on illicit drug use is generally limited to recreational dance
or treatment settings, yet anecdotal and Internet evidence suggests that use
of GHB may not be confined to recreational party drug settings. Some specific
sub-populations appear to use GHB for specific effects — for example,
both gay and heterosexual men for its perceived muscle building and sexual
enhancement properties, stressed professionals to induce sleep, and middle-
aged populations for anti-ageing and sexual benefits. The Austrian focal
point reinforced this view with some anecdotal evidence of use among very
small closed groups outside the dance drug setting. Internet postings and
outreach workers suggest that GHB can also be used as a substitute for alcohol
or drugs to achieve inebriation whilst avoiding detection tests in treatment,
the workplace and for driving. Some police sources and media coverage
have expressed concern about the ease with which GHB may be used
to facilitate sexual assault. In this regard, Internet newsgroups discussions,
not infrequently, counter suggestions that GHB is tasteless by addressing the
issue of the bitter or unpleasant taste experienced by users.

It is clear that there is a considerable amount of information about GHB on
the Internet, in magazines, and media. However, the significance of this
information for the task of estimating the prevalence of its use is difficult to
interpret for a number of reasons. Also the role that media reports play in
reflecting or promoting harmful drug trends is not well understood.

Characteristics and behaviour of users

The limited information that is available about the characteristics and behaviour
of users has been reported above. However, it should be noted that the
comparatively low price of GHB provides a cheap alternative to alcohol and
when used for illicit purposes the effects of GHB are much closer to those
produced by alcohol, marijuana and diazepam than they are to MDMA and
other stimulant drugs. One drug worker in the United Kingdom observed
that the use of GHB was more prevalent among heavy alcohol users and
another in the Netherlands commented that he did not understand why
young people wanted to use GHB for going out. Compared with alcohol, the
physical incapacity and unconsciousness resulting from a relatively small
increase in GHB doses demonstrates that health risks in relation to road traffic
or operating machinery are particularly high.

Indicators of health consequences

Deaths

There have been 11 deaths in which GHB was implicated in the European
Union. In the United Kingdom between September 1995 and January 1999,
four deaths occurred in the United Kingdom associated with GHB in combination
with alcohol. In Sweden, the official number of fatal GHB intoxications
is four and in a fifth death GHB was identified but not considered to
be the cause of death. In Finland, two deaths have been reported and in
January 2000 one death was reported in Denmark (concentration of 34 mg
GHB/kg and alcohol blood content of 0.27). The majority of deaths also
involved alcohol.

Non-fatal hospital admissions

Non-fatal hospital admissions are difficult to assess in the absence of routine
screening for GHB by hospital toxicology laboratories (Hernandez M. et al.,
1998). From April 1996 to mid-1999, over 150 non-fatal intoxications were
reported in the United Kingdom. In 1997, following six hospital admissions
involving GHB in the Netherlands a study was conducted. The study
analysed blood and urine samples from 50 patients with suspected ecstasy
intoxication and consumption of GHB was confirmed in three patients out
of the 50.

More recently, since mid-1999, the United Kingdom reports that approximately
60 non-fatal intoxications involving GHB are treated in hospital each
year, whereas in the Netherlands none have been reported. In Denmark
there have been 12 reported non-fatal intoxications involving GHB since
mid-1999: in three of these cases the patients were unconscious on arrival
and in three cases GHB had been consumed in combination with alcohol.
In Sweden over 20 non-fatal hospital admissions were reported. The most
recent reports have come from Belgium where two non-fatal intoxications
were reported in July 2000. The French have not provided figures for GHB
intoxications or deaths associated with illicit use but the Pharmacovigilance
report submitted by the EMEA highlights the existence of overdose reports,
dependence and accidental poisoning of children (EMEA, 2000).

In 1998, the Advisory Council on the Misuse of Drugs considered whether
GHB should be controlled and concluded that it did not present a sufficient
social problem and in 1999 a risk assessment of GHB conducted in the
Netherlands also recommended continued monitoring (CAM, 1999).

Context of use

An important factor with regard to context of use is the lack of reliable indications
of dose accompanying sales of GHB at ‘street level’. However, the
steep dose response curve of GHB makes it risky for recreational use even
where dose is both accurately measured and known (Elliott, 2000). The combination
of GHB with other drugs, particularly alcohol and other sedative
drugs also increases substantially the risks related to taking GHB as does taking
GHB when suffering medical conditions such as epilepsy, hypertension
and diabetes. GHB taken at home for relaxation or sleep without combining
it with other drugs or alcohol reduces the risks of physical accidents and the
social/psychological harm associated with the drug. The continued and
heavy use of stimulant drugs which creates the need for the type of sedative
effects offered by GHB is likely to increase the demand for GHB. Also the
close affinity of GHB to alcohol, in terms of effect and mode of consumption,
could make diffusion to mainstream populations more probable, particularly
to those with low incomes and with drug or alcohol problems.

Implications for the non-using population

At present, the main implications for the non-using population appear to be
the increasingly negative atmosphere (vomiting, slurring, staggering and
unconsciousness) described in social recreational settings.

In the absence of traffic controls to prevent GHB users from driving there is
a risk for road users.

(10) Classification for the supply of medicinal products for human use is regulated by Directive
92/26/EEC of 31 March 1992 and that Article 12 of Directive 75/319/EEC of 20 May 1975
regulated through the Committee for Proprietary Medicinal Products (CPMP) the suspensions,
withdrawal or variations to the terms of the marketing authorisation, in particular to
take account of the information collected in accordance with Pharmacovigilance.