MAY 2007

MEPs divided over gene therapy rules

By Andrew Bounds in Strasbourg

Published: April 24 2007 18:24 | Last updated: April 25 2007 09:27

Lives – and millions of euros of corporate profits – were said to be hanging in the balance as European Union lawmakers prepared to vote on Wednesday on whether to allow a new generation of medicines based on controversial gene technologies.

MEPs, who are deeply split over the proposals, will vote on two options for European Union-wide regulation of so-called advanced therapies, one of which would ban those derived from stem cells.

Miroslav Mikolasik, the centre-right MEP who drafted the original report to parliament that called for the ban, has been challenged by opponents who say his ethical concerns are stifling innovation and are best left to national governments.

In a rare move, leftwing and centrist deputies have tabled counter-proposals. Mr Mikolasik’s own European people’s party is split, with its Christian Democrat component having reservations about the use of stem cells but others backing industry.

The debate echoes one last year, when parliament narrowly approved the use of EU funding for stem cell research but allowed member countries discretion over whether to allow it on their soil. Catholic states such as Poland have banned such research.

Biotechnology companies said the US’s competitive edge would grow if legislation were delayed. Others said the dispute threatened lives by holding up the introduction of new medicines.

“We urge MEPs not to delay the adoption of this regulation,” said the European Organisation for Rare Diseases, a patients’ lobbying group. It said sufferers of diseases such as Parkinson’s and muscular dystrophy were desperate for new remedies.

EuropaBio, which represents the biotechnology industry, called for the immediate adoption of the centre-left proposals.

“We have small companies across Europe spending millions on research into these new medicines. If you were an investor would you continue to fund it if there was no market opportunity? All eyes are on parliament today,” said Wills Hughes-Wilson of EuropaBio.

If Mr Mikolasik wins through he will have to begin fresh negotiations with the European commission, which backs the centre-left approach.

Copyright The Financial Times Limited 2007How does gene therapy work?
In most gene therapy studies, a "normal" gene is inserted into the genome to replace an "abnormal," disease-causing gene. A carrier molecule called a vector must be used to deliver the therapeutic gene to the patient's target cells. Currently, the most common vector is a virus that has been genetically altered to carry normal human DNA. Viruses have evolved a way of encapsulating and delivering their genes to human cells in a pathogenic manner. Scientists have tried to take advantage of this capability and manipulate the virus genome to remove disease-causing genes and insert therapeutic genes.

Target cells such as the patient's liver or lung cells are infected with the viral vector. The vector then unloads its genetic material containing the therapeutic human gene into the target cell. The generation of a functional protein product from the therapeutic gene restores the target cell to a normal state.


Looking for Something?
The mode of this experiment below is in itself a psychological signal of our times - Destroy everything in site until you find something you think you are looking for.. It has always mystified me that mankind formed an exclusive group around one consistent math development before creating the atomic bomb -and ignored the fact that an Indian scientist arrived, at the same time - with the same solution, derived in an entirely novel math development. The simple facts of nature show that there may be many paths to knowledge - but our age old "Way of Truth" was always related to temporal facts of elimination, warped strength or weakness, positive beyond the negative and has many times been proved a fraudulent path, related to power games of the race to win - a famous attraction. In relation to this experiment I ask myself : if those genes involved in cell division depend on circumstances - as everything does in nature - How can cell division occur when there is nothing to be gained by it, as everything that the cell plays a part in is now "silent", dead? The genes themselves in order to parallel the sweet difference between ourselves, dear reader, may prefer the music of orchestral genetic diffusion and need varieties of all the multitudes of different combinations, a chaotic or anarchic rule of one to trillions, to make just me or you.J.Braddell, editor.

A systematic search through human genes has begun at the European Molecular Biology Laboratory (EMBL) in Heidelberg, Germany. Working within the MitoCheck consortium that includes 10 other institutes throughout Europe, the EMBL scientists will silence all human genes, one-by-one, to find those involved in cell division (mitosis) and to answer fundamental questions of how cell division is regulated.

The scientists will use a method called 'RNA interference (RNAi)' where chemically synthesized RNA molecules are used to target and silence each human gene. About 22,000 genes will be suppressed and their impact on cell division monitored by live cell microscopy to understand each gene's role in cell division.

"To our knowledge, we are the first group to take on this systematic search through the genome in live cells. We will use the most potent RNAi reagent for this study, which is usually out of reach for academic labs because of the enormous cost and the ever-changing annotation of the human genome. But being part of the large EU project MitoCheck allowed us to work with one of the leading suppliers of siRNAs, Ambion Europe, Ltd., to produce a genome-wide library for this project," says Dr. Jan Ellenberg, EMBL Group Leader and co-initiator of the MitoCheck project.

Undertaking such a large project required tens of thousands of siRNA molecules, as two to three molecules are targeted specifically against each human gene. EMBL chose Ambion as a supplier of the siRNA library because its library could be tailored to the most up-to-date list of human target genes - a list provided by the Wellcome Trust Sanger Institute, the MitoCheck bioinformatics partner. Also, Ambion's siRNA libraries utilize a siRNA design algorithm developed by Cenix BioScience GmbH (an EMBL spin-off company), leading to high efficacy of the siRNAs.

"We are happy to work with Ambion and Cenix BioScience on this ambitious project. This represents the first use of a genome-wide library of chemically synthesized siRNAs in academic research and these partners have provided us with the tools to carry out this search," says Ellenberg. "Thousands of genes have been tested in the initial phase of the project and the results are very promising."

The systematic search and analysis of the screen is set to be completed by the end of 2005.

http://www.embl-heidelberg.de/