Toxicologist Craig Harris of the University of Michigan, Ann Arbor, who has
studied thalidomide's effects on gene expression, says that the new data are consistent with some theories of the drug's action, however.
Not exact matches
Although
thalidomide has been the subject of hundreds of
studies, we still do not know exactly how it causes its effects.
When asked by Nature for relevant
studies, the plaintiffs» lawyers at Hagens Berman Sobol Shapiro in Seattle, Washington, pointed to work showing one - sided limb defects in chick embryos exposed to
thalidomide and
thalidomide analogues (C. Therapontos et al..
«There are no representative, controlled
studies documenting the true spectrum of
thalidomide injuries,» they write in the lawsuit.
The pharmacologist felt the animal
studies submitted were not a good indication of possible toxicity in humans, since animals absorb
thalidomide poorly.
At the FDA, Kelsey determined that
thalidomide studies were incomplete and did not support the maker's claims.
A new
study published in the March 12 issue of Science has identified one primary target of
thalidomide's teratogenicity (potential to cause fetal malformations)-- a protein called cereblon.
A pilot
study of
thalidomide, published in 2001, found the drug improved blood counts in some patients and enabled others to become transfusion - independent.
New treatment regimens using
thalidomide or lenalidomide are also being
studied.