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Human Gene Therapy
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  1. Gene therapy
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  3. Gene therapy - Wikipedia
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All vectors carry their own advantages and disadvantages related to safety and toxicity, DNA carrying capacity, transfection efficiency, availability and costs. The difficulty lies in achieving a level of expression that leads to an amount of gene product in the body sufficient to abolish the dysfunction without causing significant adverse side effects. The considerable lack of knowledge about transport, transfection and expression of genes as well as issues related to their long-term functioning means that gene therapy today still carries major risks.

The issue of unknowable unknowns aside [3], even a comprehensive and reliable risk assessment remains difficult due to the incomplete understand- ing of the complexities of gene expression in vivo. In , a year-old student died during a gene therapy trial in the US due to multiple-organ collapse caused by an immune response against the adenoviral vector because of poorly conceived protocols and mal- practice Feinberg, this volume.

To much of the scientific community, they showed that gene therapy worked in principle, yet at the same time brought home the cur- rent lack of comprehensive knowledge. The resulting media coverage and public anxiety and mistrust led to a significant decrease in the enthusiasm related to the development of gene therapy. Promises of gene therapy have persisted and an increasing number of products has entered clinical trials.

Tannert not proven very successful in clinical trials.


  • Gene Therapy: The Potential Applicability of Gene Transfer Technology to the Human Germline;
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Little progress has been made since the first gene therapy clinical trial Many procedures have been developed to better understand the potential developments of a particular technology and assess its benefits and risks while taking into account public concern. Scenario workshops, Delphi stud- ies and other forms of participatory technology assessment have been described in detail elsewhere e. Therapy and drug development has so far invoked little public controversy as it has been seen as yielding high benefits while operating within a tightly controlled reg- ulatory regime.

Gene ther- apy, as a practice on the borderline between research and medical practice, presents a somewhat different and more complex case raising a host of eth- ical issues, from screening and informed consent to negative eugenics or even enhancement Ganguli and Feinberg, this volume as well as questions related to public perceptions of risk and trust in regulatory regimes Schmidt, this volume. Some would go further to include members of the public in technology assessment panels in an attempt to broaden the knowl- edge base with which developments are assessed [11,12].

While these approaches are perceived by most as useful, they implicitly perpetuate the view that scientific practice is able to control and evaluate itself while its outputs need to be debated in a broader context. A subtle critique of this per- ception of science as removed from and untainted by social practice argues for transparency of scientific process and an emancipation of different kinds of knowledges e. This volume is based on an interdisciplinary workshop, which tried to take this critique seriously. Rather than understanding science and med- icine as monolithic bodies of knowledge and practice, the workshop was based on an understanding of gene therapy as an epistemic culture [16], i.

Building Interdisciplinarity in Research on Gene Therapy xvii reflection of scientific output by experts external to the particular area of science under consideration, to a focus on scientific practice, which nec- essarily involves the practitioners themselves. The aim is a change in cul- ture, which introduces into scientific practice a process of reflection enabling the practitioners to appreciate the contingency of their own gaze.

It is important to note that science in this case does not only refer to the natural sciences and medicine but includes the social sciences and humanities. The process of understanding the contingency of the own gaze via learning to think differently applies to all those involved in highly specialised disciplines.

This concept in mind, the workshop brought together young post-docs from a wide range of different disciplines for a week explaining and debat- ing their own work as well as interviewing more established researchers in the field. Of course, this can only be a small step.

A transdisciplinary group process, that transfers knowledges from one discipline to another, begins to produce interdiscipli- nary individuals able to ask research questions located in between disci- plines. The book chapters are based on the initial contributions of all participants and reflect an intensive process of internal review and rewriting on the basis of the discussions. They are meant to present the outcome of an interdisciplinary experiment rather than reflecting the entire field of gene therapy. Many issues could not be dealt with.

Readers interested in compre- hensive reviews of gene therapy are pointed to recent articles [18,19] as well as specific journals in the field. We thank all participants for working extremely hard to put this volume together. Particular thanks goes to Ali ben Salem, whose hard work during and around the workshop has been absolutely essential for realizing this project.


  1. Measuring Gene Expression (THE BASICS (Garland Science)).
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  6. The statement on forthcoming challenges in research and policy was supported by all participants as a consensus paper. Four authors from the US and Pakistan were invited to broaden the European perspective of this book Mehmood et al. The workshop was funded by the German Ministry of Education and Research, grant no.

    Gene therapy

    Public funding is necessary to support the fundamentals of gene therapy. Gene therapy is now understood as an interdisciplinary research field. Tools have to be developed or adapted from other research areas with an interdisciplinary approach in order to render gene therapy research more efficient e.

    There is a gap between the availability of molecular diagnostics and that of molecular therapeutics for a variety of diseases.

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    Consideration should be given to setting limitations to restrict genetic intervention to therapeutic application. Communication needs to be established and facilitated not only between experts and public but also between the experts themselves, both within the same and between different fields.

    Communication of issues related to gene therapy has to respect a balance between transparency and privacy of information, clarity and consistency. One of the characteristics of gene therapy is that its clinical effects are not fully predictable. It contains various forms of uncertainty and these must be acknowledged and communicated. Terminology and vocabulary describing gene therapy must be carefully created and used. The concept behind the terminology is of primary impor- tance and should be considered when crossing cultural or national borders.

    Gene therapy - Wikipedia

    Information should not only include technical aspects about gene therapy but also all processes pertaining to its application e. Two-way communication is essential as well as constant appreciation of public awareness. The channels through which this bidirectional information is distributed have to be carefully created and constantly refined. Information should be put forward in an accessible manner, specific to the target audience.

    Taking these points into consideration may allow for a better grounding for a truly informed decision base. Taboos should be questioned in the public debate and legislation process. There is a need to set a flexible framework to regulate gene therapy in order to adapt to the rapidly changing scientific knowledge and social per- ception. It is possible to establish an independent regulatory body, which would be able to work on a case-by-case basis. It is very important that this body is not only made up of an expert panel but allows for public hearing and public participation.

    The legislative process for gene therapy can be made more flexible and expedient. For example, ensure that laws are revised at regular intervals. Building Interdisciplinarity in Research on Gene Therapy xix It is important to reach a consensus about terms as well as concepts at the European level while allowing for applications and enforcement to be regu- lated within the national context. Review the grounding behind legislation.

    Do our laws protect what we want them to? What is our concept of life, privacy, risk, appropriate use, individual freedom, and future generation choice? One of the key distinc- tions is that between therapy and enhancement. Public discussion should be encouraged in order to contribute to the definition of concepts e. Jablonka and M. Jaenisch and A. Bird, Epigenetic regulation of gene expression: How the genome integrates intrinsic and environmental signals, Nat.

    Stirling and S. Kasperson, O. Renn, P. Slovic, H. Brown, J. Emel, R. Goble, J. Kasperson and S. Ratick, The social amplification of risk — A conceptual framework of risk, Risk Anal. Renn, W.

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    Burns, J. Kasperson, R. Kasperson and P.

    Will Gene Therapy Cure Cancer?

    Slovic, The social ampli- fication of risk — Theoretical foundations and empirical applications, Risk Anal. Funtowicz and J. Ravetz Post-normal science: An insight now maturing, Futures, , 1, — Poortingaand N.


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    Pidgeon, Exploring the dimensionality of trust in risk regulation, Risk Anal. Joss and S. Bellucci eds. Joss, Danish consensus conferences as a model of participatory technology assess- ment: An impact study of consensus conferences on Danish Parliament and Danish pub- lic debate, Sci. Public Policy, , 25 1 , 2— Durant, Participatory technology assessment and the democratic model of the public understanding of science, Sci. Public Policy, , 26 5 , — Irwin and B. Wynne, Misunderstanding Science? Wynne, Misunderstood misunderstandings: Social identities and public uptake of sci- ence.

    Misunderstanding Science eds. Irwin, Science and citizenship, in Context and Channels eds. Scanlon, E. Whitelegg and S.