SPAIN AUTHORIZES THE USE OF HEROIN FOR CLINICAL TREATMENT TRIALS

Catalonia And Andalusia May Initiate Experimental Treatments This
Fall

In less than 90 days, Andalusia, Catalonia and the other communities
that wish to will be able to conduct clinical studies that dispense
heroin as a treatment for addicts. The Heroin Committee, comprised
of the Ministry of Health, independent experts and representatives of
Spain's autonomous communities, yesterday gave the final research
authorization, which will be supervised by the Spanish Agency of
Medicine. Research subjects are limited to heroin addicts who have
failed in other attempts at rehabilitation.

The Committee's approval was the final requirement before the
government gave the green light to treatment research involving
heroin. Previously, the Ministry of Health had renewed the
authorization so that the medical use of the substance could be
evaluated. The government representative of the National Drug Plan
(Plan Nacional Sobre Drogas -- PNSD), Gonzalo Robles, announced the
Department of the Interior's approval of the research. Only two other
European countries, Switzerland and Holland, permit the controlled
distribution of heroin to addicts.

The text of the committee conclusions emphasized that there is still
"uncertainty regarding the effectiveness of heroin as a treatment for
opioid dependence," making it "reasonable" to authorize "clinical
trials in Spain to determine its efficacy." The drug will be
manufactured in authorized laboratories.

The "clinical trial" definition will determine the research protocol
of the autonomous projects. The dispensing of drugs as a therapeutic
measure will not be allowed (the drug is not considered a remedy for
any malady), nor will compassionate use qualify. To comply with the
law, the autonomous communities will have to follow the progress of
two test groups, one which will be given heroin, and the other an
alternative substance (typically methadone).

According to Royal Decree 561/1993, which regulates clinical research,
the authorities will have 90 days to approve a research plan, 60 to
complete the documentation, and another 30 to communicate the
authorization. Administrative silence will be interpreted as a negation.

Double-blind

Head of the Catalan program Joan Colom explained yesterday that the
research will use a double-blind design. Neither the medical
researcher who administers the substance nor the patient will know
which drug is being administered. The project, which was designed two
years ago, will involve 160 drug addicts and include a study on the
administration of morphine, something that has received "very little
study" according to Colom.

The research will allow for the comparison of reduction treatments
involving heroin, morphine and methadone, all taken orally. According
to Joan Colom, said project will take place over six months in the
Sant Pau Hospital, but only persons who have participated in methadone
detoxification projects and failed to detoxify despite repeat attempts
will qualify as research subjects, reports Miquel Noguer.

The Andalusian in charge of the fight against drugs, Andres Estrada,
was "very happy" with the authorization. "Logic and common sense have
won out" affirmed Estrada. Andalusia is the community that championed
heroin treatment trials and announced that their research plan will be
revealed shortly. It will last one year and involve 150 patients
divided into two groups who will be administered heroin or methadone.

The Commission has established that all those who agree to participate
in research studies will not be allowed to inject heroin outside the
control of program researchers. Additionally, it is indicated that it
is necessary to expand the treatments with opioid agonists (methadone
and derivatives), diversifying the treatment options and reinforcing
the rehabilitation process, as recommended by the World Health
Organization.

On the other hand, the Spanish Union of Addiction Associations and
Organizations (Union Espa=F1ola de Asociaciones y Entidades de
Atencion al Drogodependiente - UNAD) has approved of the governments'
decision, but has asked that the studies demonstrate that providing
the drug to addicts reduces harm and improves quality of life (a
parameter that all the research programs must study). UNAD is calling
for a modification of the law to allow for the medical use of heroin.

UNAD, which comprises 300 associations that attended to 35,000 addicts
last year, has asked that NGOs participate in the programs to include
social, work, family and psychological counseling and has insisted
that all the autonomous communities follow the lead of Andalusia and
Catalonia.

Cantabria, Galicia, Madrid and the Basque Country, all of which are
already involved in the Heroin Commission, could be next.

And when the studies end?

With the praise that accompanied the government authorization of
clinical heroin administration studies, there was only one contentious
point: What happens to those who have been receiving the drug free of
charge in a controlled environment once the research is concluded?

The document of the Heroin Commission only states that compassionate
use is not permitted; that is, distribution of the drug to persons
outside the study is not permitted. A spokesperson for the National
Plan on Drugs insisted yesterday that once the research plan was
completed, provision of the drug would cease. In fact, this
stipulation was leaked to the press before the Commission meeting was
over.

But the coordinator of the Andalusian program, Andres Estrada, did not
see it that way. According to the Andalusian representative, if the
program proves beneficial an alternative will be necessary such as the
authorization of individual use to addicts who have demonstrated that
the administration of heroin has helped them. The alternatives is to
"leave them to the streets again" according to Estrada.