Spanish scientific research is not going through good times - especially if the substance being studied is an illegal drug.

A pioneer international study directed by a group from the Autónoma University of Madrid to study whether MDMA (an active form of Ecstasy) is effective and safe in the treatment of PTSD, suffered by many women who have experienced a sexual assault, has come to an end.

The reasons for halting this study, approved by La Paz Hospital Ethics Committee and the Spanish Medical Agency, are varied and can appear inscrutable to scientific and ethical motives.

In 1999, Jose Carlos Bouso, a licensed psychologist, initiated a protocol designed as a trial study looking for the dosage and therapeutic efficacy of MDMA in the treatment of PTSD as a consequence of sexual assault. Being a psychologist, he was not authorized to administer pharmaceuticals, but he was able to collaborate with the psychiatrist Pedro Sopelana as head investigator. The next step was to find a hospital. The one chosen was the psychiatric hospital where Sopelana worked. The then director Ramon Martin accepted, and granted space in the hospital for the clinical study to take place. In July 1999, La Paz Ethics committee evaluated the proposal made by Sopelana and Bouso, considered they met the requisites and that the risks to the patients were justified. In February of 2000, the Spanish Medical Agency gave the green light.

PTSD Between 60% and 70% of women who have suffered a sexual assault are affected by anxiety, anguish, fear and are unable to live a normal life. Ecstasy continues to be a demonized substance, even for scientific investigations. After two years a trial clinical study approved by the Spanish medical agency, intended to investigate safety and efficacy of MDMA in the treatment of Post Traumatic Stress - from which many rape victims suffer - has gone down the drain. Fear of using an illegal drug, limited political willingness, irregularities, bureaucratic problems...in the end the study is halted and the march goes backwards.

What was Sopelana's and Bouso's scientific objective? Between 60% and 70% of women who have been raped develop chronic posttraumatic stress. The symptoms: uncontrolled re-experiencing of the trauma, anxiety and fears associated with places and people that can remind them of the aggression. "There are only two ways to break this vicious cycle, with pharmaceuticals such as sertraline or paroxetine, that do not address the re-traumatization, or with psychotherapy bringing back the event but emphasizing internal control to the point where the memories do not cause anxiety" explained Jose Carlos Bouso. Why would ecstasy, a demonized drug due to the problems provoked by its abuse among youth, be effective? Bouso researched the experience of more than fifteen years, between 1970-85, when MDMA was placed on schedule 1 of prohibited substances.

"Until 1982, it was used in a therapeutic context. Until that date, more than 4,000 psychiatrists used it in almost 200,000 patients, most of them in the United States." According to the documentation analyzed by Bouso, MDMA caused minor conscious alterations in patients, without producing thought distortions; and it reduced and eliminated fears to express emotions.

"The idea," explains Bouso, "is to help the patient avoid escape from the event: they need to face the trauma. In the study, it was clear that only one dose was administered throughout the entire process and under safe conditions - inside a hospital, in a space conditioned so that the women would feel comfortable and safe."

Five groups of women were established. Each group would receive a different dosage, between 50 and 150 milligrams of MDMA, with one receiving a placebo. Until July of 2002, when the study was cautiously halted, six women had voluntarily participated in the study. In the first three sessions, "therapeutic alliances" were established and information about MDMA was given. During the fourth session, MDMA was administered and for six hours the women expressed their emotions, conscious of past and present. Bouso was expecting to prove efficacy and which dosage - between 100 and 125 milligrams - was safest, but it hasn't been obtained due to the halting of the study.

The odyssey for the investigative group began the day after the daily newspaper El Pais published the news of the trial beginning. On May 7th of 2002 inspectors from Public Health Pharmaceutical Board surprised the hospital and reviewed all the documentation. "By law, they had a month to submit a report about the trial's status, but that report was never done, nor was it ever communicated to anyone," says Bouso. In reality the only report given, accessed by this magazine, said they reproached the people responsible for the study for making study results public before due time and that the head investigator, Pedro Sopelana, had not been supervising the project for some time, and that documentation was not adequately kept in the hospital, but instead it was in the psychology department. These reports were never communicated to the investigators.

Javier Hernandez, pharmaceutical director, assured this magazine that "seeing it in the papers, we realized we didn't have any follow up information of the study. If it was in progress, it was because it had all the authorizations needed, but it is against regulations to publish results prematurely, since this can affect participation in the study. Before this happens, the scientific community should know the results. In addition, it wasn't clear to us where the trials were being done, since the head investigator was no longer part of the psychiatric hospital".

Interviu has verified Bouso's disclaimer to the newspaper who alluded to the supposed results. "We still don't have definitive data about the study - which is due to end in one year - but the results up to date, even though without statistical significance, are positive," is what the trial's promoter said.

On May 8th, a day after the inspection took place, the ethic's committee who had approved the study called Bouso and Sopelana - whom this magazine tried to locate without success - in relation to the information being spread. The next day Sopelana resigned as head investigator due to his transfer to a new center. On the 13th of May, Antonio Barba, who replaced Ramon Martin as the head manager at the hospital where the study was taking place, told Bouso that because Sopelana was no longer at the hospital he would dissociate himself from the project.

"I had a meeting with the hospital manager and asked him the reasons for not supporting the study. He told me specifically that he 'had received pressure from above' - in other words, from the Public Health Board - and that he would not yield the permissions to continue with the study," recalls Bouso. This explanation appears in the report that Bouso remitted to La Paz Ethics committee. Nevertheless, Antonio Barba, hospital manager, asserts that he doesn't remember very well what happened, that he was not being pressured and that he believes, "There was not much interest in the project."

The pharmaceutical director concurs: "I don't think there was any pressure given. Bouso is trying to hide the fact that during a year and a half the study went without the supervision of the head investigator - Pedro Sopelana. On the 17th of May, after giving explanations to the ethic's committee, Bouso himself requested the temporary interruption until a new head investigator was found. Twelve days later, a psychiatrist working in Vicente Corce hospital said he would act as head investigator, but it was already too late. In the month of July, the ethic's committee proposed the suspension of the study, and days later, the Spanish Medical Agency suspended the study. According to Bouso the project has never lacked a head investigator because both he and Sopelana carried this position together. "What it has lacked has been a head investigator who is part of a hospital, but this does not go against clinical trial norms. Furthermore, Sopelana resigned on May 9th of 2002, and until then, his scientific and collaborative assistance fit the protocol".

Other Trials, Other Uses The North American association MAPS, which conducts studies with psychedelic substances, financed this study with $57000. The responsible party Richard Doblin admits, "Investigations with MDMA are always controversial, but we understand that the war against drugs, with its heavy weight of exaggerated propaganda, cannot prevent the carrying out of studies dealing with the possible benefits of some substances." At the same time that the Spanish study was paralyzed, the FDA approved a psychotherapeutic study with MDMA, "that can begin in three months, as soon as the approval of the ethics committee and the DEA come through". Doblin maintains that MDMA risks have to do with higher levels of blood pressure and heart rate, which excludes patients with heart problems from trial participation. "This fact should not stop MDMA experiments in cases of anorexia, where it can help the patient to accept themselves; in couple's therapy where it facilitates communication and the ability to listen; even with schizophrenia."

Jose Manuel Torrecilla, Antidrug Agency director, admits that though the study had all the necessary government permits, there were irregularities. Torrecilla points out two other reasons: the women subjected to the study should not have been chosen at random, but instead referred from the Provincial Judicial District Courts where the violence was committed; and that the MDMA was not classified by the Medical Agency as a product of investigation since Bouso used MDMA confiscated by the police. The psychologist defends himself and says that the protocol specified that the women needed to have suffered a violation and failed in another form of therapy. "It didn't talk about other conditions. The women for the trial were chosen in partnership with agencies that work with rape victims in private clinics. About the confiscated material, we made an additional analysis and verified that the purity corresponded with the police analysis".

Bouso has given up all hope of resuming the study, "but what pains me more," he points out, "is that people with a chronic trauma are denied the possibility of finding relief for their suffering. And what worries me the most is that the powers that be are incapable of distinguishing between recreational consumption and the possible therapeutic use of substances like MDMA, cannabis, or ketamine. One last thing: The advances made by the Spanish scientific community in the area of psychology/psychiatry are -59* (*Note - this term could not be adequately translated). As Unamuno said, "Let them investigate."