Pubdate: Fri, 04 May 2001
Source: El Pais (Spain)
Contact: firstname.lastname@example.org (Spanish language LTEs only)
Author: Emilio de Benito
Translation by: Robert Sharpe http://www.drugpolicy.org
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.
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.