ANDALUCIA TO PROVIDE PRESCRIPTION HEROIN TO LONG TERM ADDICTS

The Ministry Of Health Will Have To Authorize "Compassionate Use" Of
The Drug On A Case By Case Basis

Heroin as medicine. The Council of Andalucia is formally requesting
permission from the Ministry of Health to administer the drug to a
group of addicts in Granada as if it were an experimental medicine.
The Council's decision is based on the clinical research with heroin
it has undertaken, which shows that heroin maintenance improves health
twofold over methadone in long term addicts who have not been able to
give up the drug. The Health Ministry will have to authorize
compassionate use of the drug on a case by case basis, but the formal
request puts the Ministry in an awkward position. The department run
by Elena Salgado has until now opted to turn a blind eye to heroin
maintenance.

The Andalucian Council's Director of Drug Addiction, Andres Estrada,
explained to this newspaper yesterday: "We will request heroin
distribution to persons who need it on a case by case basis.
Medically supervised maintenance can be a way out for addicts." The
government's Council of Equality and Social welfare does not intend to
extend the clinical research the PP (Partido Popular) government
approved in 2003 after delaying it for years. Instead, heroin will be
considered "medicine in an experimental phase." "The results of the
clinical research have been positive and we will ask the Ministry for
compassionate use as we would with any medicine," Estrada added.

The Andalucian Executive will make use of the 1993 royal clinical
trial decree, which defines compassionate use of a medicine
administered to "select patients, following clinical research, of
products in the final phases of research."

The Andalucian researchers have already finished their research and
concluded that heroin maintenance improves physical health 2.5 times
as much as methadone and have published the results in the Journal of
Abuse Treatment. Additionally, patients treated with heroin break the
law less and have improved social situations. They have gone down
from injecting themselves in the streets from 25 times a month to
eight. Crimes have gone from 11 a month to one.

There have been similar studies in Holland, Switzerland and Germany,
all with similar results. The objective is not to cure addiction in
patients with poor health and years of use, but rather to improve
their state, bring them into the health system, reduce delinquency,
avoid infections and reduce the use of adulterated street drugs.

It Starts in Granada

The Council has developed a protocol which, beginning in February,
will make it possible to group long term addicts who have tried
getting off drugs with methadone and failed and have "infectious
diseases (like AIDS or hepatitis) and psychiatric problems," according
to Estrada. One by one, based on their clinical history and with
medical authorization, the Council will request authorization from the
Ministry of Health to use the drug as medicine. The Council will
begin with addicts in Granada, where they have the infrastructure in
place, and expect to enroll roughly 50 heroin addicts. "This is not
for a lot of people because heroin in Andalucia is very restricted and
in many cases this treatment comes too late for those who are already
dead," according to Estrada.

Two years ago the Council requested compassionate use for the 36
patients who participated in their clinical trials. The Spanish Agency
for Medicine, which falls under the Health Ministry, gave the patients
authorization to continue receiving the drug for life as the doctors
considered that heroin maintenance had been good for them. In
reality, any doctor in any part of Spain can request compassionate use
of heroin for a patient, based on the Andalucian research, but until
now none have requested it.

The Council's decision will force the Health Ministry to take a public
position on heroin maintenance. Since the pilot research was
completed in 2004, the Ministry has limited itself to stating they are
analyzing the research results and will evaluate them the first
trimester of the coming year. "It has to be done with caution,
because this is a very delicate subject," said the Ministry
spokesperson.

The extension of heroin maintenance treatment constitutes a rejection
of Carmen Moya, the government director of the National Drug Plan.
She has affirmed that, unless the research proves otherwise, current
policies (needle exchange and methadone), are enough to help addicts
get better.

Estrada assures that he has already informally communicated to the
Ministry of Health the intention of broadening the compassionate use
of heroin: "They told us to send them the cases and they will study
them." Health authorities will have trouble denying compassionate use
requests if the cases involve addicts similar to those who
participated in the clinical research. If they have already approved
compassionate use, how can they deny it now? Thus heroin, discovered
in 1883 and used widely since then, will be considered in Spain as an
experimental medicine.