Under the microscope. a new report recommends the end of a decades-old panel that examines gene therapy trials, such as those using adenovirus ( above ) to provide new genes to cells, now that the field is mature.
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After 4 decades of vetting clinical trials of gene therapy for new risks, it is time to relax a bit, according to a report released today by a group of experts. But senior government officials welcomed the recommendation with caution.
Gene therapy has proved its worth and its leaders have managed the ethical issues, according to a panel convened by the Institute of Medicine (IOM) to the US National Academies. The long-term risks of gene therapy may not be clear yet, but the general risks seem no more than in other areas of experimental medicine, the report says, it is time to eliminate the American outfit created in 1974 which is dedicated to examining gene therapy, recombinant DNA Advisory Committee, or RAC.
"[M] no initial fears about gene transfer" -like concerns about the creation of new pathogens, modification of the human germ line, or hurt the company in other ways- "has not been confirmed," the panel concludes IOM. at the same time, he notes that "public perception has largely transition from negative to positive" thanks to the success of gene therapy in the treatment disorders such as hereditary blindness and hemophilia. The Committee urges the National Institutes of Health (NIH), home to the RAC and uses his advice, stop having RAC examining individual gene therapy protocols.
The report covers IOM This recommendation, however. While the former RAC should go out of business, the panel said, another RAC-like body should take his place, and with a broader mandate to consider all clinical research forms at risk than other organizations can not be able to adequately veterinarian. The IOM group also urges the government of the United States to maintain RAC will until a successor is created. During the transition, the IOM report said RAC examinations should be streamlined to make life easier for researchers and individual protocols should be considered only "in exceptional circumstances, for example where technology innovative gene therapy and treatment strategies to move forward in the field of clinical trials. "
gene therapists have long complained about the burden of RAC exams. Like other clinical researchers, they must get approval for the ethics of testing and biosecurity panels to their own institutions; they also have clear clinical trials in advance with the US Food and Drug Administration (FDA). But gene therapists have an additional duty to other researchers do not have: They must submit a detailed description of the proposed experiences with RAC. Unlike the FDA, RAC releases these proposals and may hold a public hearing before approving them a trial. Last year, the leading professional society of gene therapists issued a public call to end dual examination of the CARs. NIH asked IOM to address this issue, and today's report is the result of the application of the NIH.
The chair of the IOM panel, Lawrence Gostin, professor of public health and law at Georgetown University in Washington, DC, said he was well aware of the misfortune of gene therapists on multiple critical. Dismay "came loud and clear," during the public consultation sessions, Gostin said. The panel report IOM says that most gene therapy trials should now be reviewed by the FDA, it also recommends that the proposed gene therapy trials continue to be recorded in a record. But researchers should be required to file a single protocol, one prepared for review by the FDA. It seemed "prudent" to keep the tradition of free access to information in this area, said Gostin. RAC served an "extremely useful purpose," Gostin said, reassuring the public about the safety of this new field and once disturbing and aggregating the data each is precious, especially clinicians.
NIH Director Francis Collins, after being informed of the IOM report, issued a non-binding statement today to thank the panel for its work and said that NIH "will take a look closely the conclusions and recommendations and the study will determine the best way forward in light of our common interest to do what is best for patients and for the continued progress in the field. "American Society of Gene & Cell Therapy in a statement equally cautious, said today that he" welcomes "Collins" review and make decisions based on the results of the IOM. "
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