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Br J Ophthalmol 2000;84:3 doi:10.1136/bjo.84.1.3
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Gene therapy in trouble?

Concerns have been raised (see editorial,Nature1999;402:107) about possible failure to disclose side effects related to gene therapy, which may include a number of fatalities, since the financing of gene therapy research has been progressively handed over to the commercial sector following its initial support from US government agencies such as the National Institutes of Health. At least six deaths have occurred recently in patients who were participating in trials of gene therapy for various conditions, including attempts to grow new cardiac vessels in heart attack patients. Not all of the deaths can be attributed directly to the gene therapy itself and the researchers involved justify their lack of disclosure of these events on this basis, indicating that the wrong message concerning the value of the therapy would get into the public domain. However, more ominously there appears to be a reluctance to involve the NIH's Recombinant DNA Advisory Committee (RAC), whose mandate is to debate the ethics of gene therapy in public, and who would finally offer opinion as to the true cause of the fatalities/side effects of gene therapy objectively. As the editorial states, “companies loathe disclosing anything that could harm share prices”. These must be the wrong reasons for lack of disclosure and will only harm the prospects for gene therapy in the long run.

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The writing, reading, and processing of scientific papers by authors, referees, and editors alike will take a very different form in the …

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