RESEARCHERS running gene therapy and xenotransplantation trials in the US
will have to make the details of their work public, according to rules proposed
by the Food and Drug Administration.
Critics have been calling for tighter regulations, especially after
18-year-old Jesse Gelsinger died during a gene therapy trial in 1999. But some
companies say the rules will hamper research.
Researchers will have to reveal the genes and methods they are using, for
example, and the results of preclinical studies. They will also have to report
all deaths and adverse reactions, even if the treatment was not to blame. The
FDA already receives most of this information but keeps it secret.
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鈥淚 think it鈥檚 a very good idea. The more the public knows, the better off it
is,鈥� says Inder Verma, a gene therapy researcher at the University of California
at San Diego and the chairman of the American Society of Gene Therapy.
The FDA says that gene therapy and xenotransplantation 鈥減ose a remote, but
unique risk鈥� not only to people taking part in trials but also to the public.
For example, there are fears that xenotransplants might spread pig retroviruses
to people or that therapeutic genes might be passed on to the children of people
given gene therapy.
Researchers will have to submit a full version of trial information and also
one intended for the public, minus sensitive details such as the names of
volunteers. Companies will be allowed to delete information they consider to be
trade secrets. The rules will take effect later this year unless the FDA decides
to make changes based on public comments.
But the Biotechnology Industry Organization, a Washington-based trade group,
says gene therapy and xenotransplantation do not pose unique risks. It says the
new rules could violate patient confidentiality, force companies to give away
trade secrets, and might alarm the public unnecessarily. 鈥淲e think the FDA has
overstepped,鈥� says Michael Werner, a spokesman for BIO.
In another move, the FDA has also announced that genetically modified foods
will not need labels. It maintains that GM foods are not substantially different
from other foods. The move has angered activists who have been demanding
labelling.
鈥淚t鈥檚 clear the FDA has bent over backwards to placate the biotech industry,鈥�
says Joseph Mendelson of the Genetically Engineered Food Alert campaign, a
Washington DC-based campaign group. A recent Harris poll found 86 per cent of
Americans wanted mandatory labelling of GM foods. At least two bills have been
introduced in Congress that would override the FDA and require labelling, but it
is unclear whether they will ever become law.