© 1999 Nature America Inc. • http://medicine.nature.

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demonstrate that higher exposure levels

Indecision over human pesticide data can be tolerated. The subcommittee of
A scientific advisory subcommittee was required to begin re- bioethicists, toxicologists,
convened by the US Environmental certification of all pesti- and public health experts
Protection Agency (EPA), Washington cides in use in the US, was formed in 1998 to ad-
DC, to study the bioethics of testing pes- including a re-evaluation dress the ethics of testing
ticides on humans, has failed to reach a of human exposure lim- non-therapeutic chemi-

Courtesy of the USDA

consensus, delaying EPA rulings on the its, by August 3rd this cals on volunteers, and
issue. Even if the subcommittee eventu- year. When exposure lim- was expected to issue a
ally favors accepting data from human its are based on animal consensus report before
tests, it is likely to exclude industry- models, the agency re- Nurse sprays hospital bed the August deadline either
sponsored research projects like those quires an additional ten- with 5% kerosene favoring or opposing data
that have recently come under fire in fold margin of safety to from human testing.
the UK. allow for species differences. Pesticide Committee members contacted by
Under the Food Quality Protection manufacturers have lobbied the EPA to Nature Medicine revealed that the 14-
Act passed by Congress in 1996, the EPA accept data from human trials, which member group was split 10–4, with the
majority in favor of accepting human
test data. “I’ve been with the board 11
Advocates push for new NIH Office years. We’ve never had a group that
In keeping with the American penchant ease, multiple sclerosis, and type I diabetes could not come to some kind of a con-
© 1999 Nature America Inc. • http://medicine.nature.com

for public direction of the country’s bio- that affect an estimated 13.5 million sensus, or we had a majority and the re-
medical research strategy, Congressional Americans, 75 percent of which are port provided a statement of the
representatives Henry Waxman (D-CA) women. minority position as well,” says Sam
and Connie Morella (R-MD) have intro- The coordinating committee will spend Rondberg, the federal official responsi-
duced legislation requesting the creation $30 million in FY99 promoting basic and ble for overseeing the committee, but
of a permanent Office of Autoimmune clinical research that cuts across multiple the latter option was rejected by the sub-
Diseases within the Office of the Direc- autoimmune conditions. In addition, the committee.
tor (OD) at the National Institutes of collaborative network for clinical research Bernard Weiss, a professor of environ-
Health (NIH). on immune tolerance mental medicine at the University of
The bill, entitled (Nature Med. 5, 470; Rochester, downplays the disagreement:
“NIH Autoimmune Dis- 1999) will also provide “I don’t think it’s a really sharp division,
eases Act of 1999” was a staggering $120 mil- I think it’s more in the matter of tone.”
submitted on behalf of lion in funding to While the minority would refuse data
patient groups repre- support cooperative from any human pesticide testing, the
sented largely by the research studies on tol- majority would permit such tests only
American Autoimmune erance induction in when they would clearly advance scien-
Related Diseases Associ- autoimmune patients. tific knowledge. “Simply undertaking
ation (AAARDA). The But apparently this is human studies to revise or restore an
“ Stan Hochelmeister, of the grassroots
new Office would cost Medical Research Task Force, has suc- still not enough. older regulatory standard is not kosher,”
$950,000 to set up. cessfully lobbied Congress to allocate “Autoimmune dis- says Weiss.
There are currently 500 million dollars for research into a eases fall into all differ- Although the committee plans to
over 30 offices in the cure for Hochelmeister’s disease.” ent Institutes, and are meet again in late October to try to
OD, and the proposal not the single focuses reach an agreement, human tests may
appears to run contrary to the desires of of any one Institute,” complains AAAR- never form a basis for US pesticide regu-
NIH director Harold Varmus, who would DA’s executive director, Virginia Ladd. lations because of recent high-profile
rather consolidate the dozens of NIH insti- She says that the main goal of the new cases overseas. Some chemical compa-
tutes, offices and centers than add to office will be to promote the cooperation nies have drawn criticism for tests done
them. “There shouldn’t be any more inde- that is currently lacking between autoim- in Britain, where human testing of pesti-
pendent offices unless there’s a good rea- mune disease researchers from different cides is not illegal.
son,” says Varmus, “…consolidation is fields, and prevent replication of research In one case, Bayer AG hired Inveresk, a
more productive, and I am resistant to projects. company based in Edinburgh, UK, to
adding more administrative structures But the researchers in question are not carry out human exposure tests on azin-
than we already have.” convinced that the addition will have a phos methyl. Volunteers were offered
Last year, Congress urged the NIH to large impact on their work. Stephen £460 (US$770) and asked to swallow
convene a coordinating committee for Straus, chief of the National Institutes of small doses of the compound, an
autoimmune disease research “to syner- Allergy and Infectious Diseases laboratory organophosphate pesticide so toxic that
gize research efforts among the Institutes of Clinical Investigation, says “there are the EPA recently established strict limits
and facilitate advances in this area.” This advantages to having a somewhat more for its use on food crops. Bayer contends
new committee, which comprises one rep- focused way of addressing autoimmune that its trials were carried out in accor-
resentative from each NIH institute, diseases but I don’t feel that a separate dance with international ethical and
reviews NIH-funded research into autoim- NIH office would be needed to do so.” safety guidelines.
mune diseases such as lupus, Grave’s dis- KRISTINE NOVAK, NEW YORK ALAN DOVE, NEW YORK

972 NATURE MEDICINE • VOLUME 5 • NUMBER 9 • SEPTEMBER 1999