Tuesday, February 3, 2009
Studying the effect of drugs in humans
The clinical research group in human pharmacology and neurosciences of the pharmacology unit at IMIM-Hospital del Mar, directed by Magí Farré, has been studying both the physiologic and mental effects of drugs of abuse, such as ecstasy (MDMA) or cannabis, for more than 20 years.
They do cardiovascular and motor activity performance studies, as well as arterial pressure measurements and blood analyses to learn about the pharmacokinetics of drugs; how they are metabolized and distributed, etc. The mental effects are studied through questionnaires and behaviour studies, as well as by PET (positron emission tomography) and FMR (functional magnetic resonance) of the brain. These are done at the IAT, located also at the PRBB. The unit, which has 12 beds on their premises, also does phase I and II clinical trials to check the efficiency and tolerance of new drugs.
All the studies must follow a clinical assay protocol, which can take between 5 and 12 months to be accepted by the local Ethics Committee for Clinical Research and by the Spanish Drug Agency. The studies must also be double-blind: neither the patient nor the scientist knows whether the patient is taking a drug or a placebo. According to Farré, there are often surprises that exemplify the important role played by the mind. For example, in a study done years ago by Jordi Camí, founder of this laboratory and currently the director of the PRBB, it was demonstrated that the manipulation of the expectations – to think you are taking a drug when you are not, or the other way around – was as important than the real effect of the drug.
Some of the current studies of the laboratory, which can last from one single day to a whole year, are about the effects of recreational drugs in the inhibition of the metabolism of medications. Other studies are about how some genetic mutations can make the drugs affect us in different ways, or about the different effects of ecstasy in men and women. According to Farré, the most important contribution of the group has been in the ecstasy field, in which they have done things that had never been done before. Another characteristic of the group, nearly unique in the world, is that pretty much all the research process is done in humans; the substances are administered in humans and their effects, the drugs concentration and their metabolites in different biological fluids are measured.
The clinical assays laboratory, apart from their own studies, also offers services to third parties, including pharmaceutical companies such as GSK (GlaxoSmithKline). They also collaborate with the psychiatry and drug addiction service of the Hospital del Mar, and with Jaume Marrugat, director of the research program on inflammatory and cardiovascular processes. With him they do studies about nutrition, such as the effects of the antioxidants in olive oil or wine.