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NATURE MEDICINE • VOLUME 5 • NUMBER 2 • FEBRUARY 1999 133

NEWS

Conscious of the rapid advances in cloningresearch and the need for worldwide leg-islation on human aspects of this tech-nique, in a new report, an advisory com-mittee to the Australian government hasbacked the international call for a ban oncloning to produce a human being. And inline with Europe (Nature Med., 5 6; 1999),the Australian Health Ethics Committee(AHEC) of the National Health and Med-ical Research Council (NHMRC) supportshuman DNA and cell cloning and embryoresearch within strict limits.

In a surprising twist, the report calls forthe establishment of a new, non-humanprimate center, which will apparently sub-stitute for human research and serve as ameans of boosting Australia’s capacity for‘therapeutic cloning’ research—the devel-opment of replacement organs and tissue.Some antipodean scientists are uncon-vinced of the value of such a facility andbelieve its inclusion in the report is theresult of action by the country’s powerfullobby of reproductive biology scientiststhat have traditionally favored primateresearch.

It is proposed that the primate center beused to test the feasibility of cloning tech-niques involving embryonic stem (ES) celland cell lineage research. The reportexpresses concern that existing primateresources in Australia are insufficient forsuch work and small by international com-parison. The new center may also be ofvalue, says the report, to associated disci-plines such as reproductive biology, gametebiology and endocrinology.

Director of Melbourne’s Murdoch Insti-tute, geneticist Bob Williamson, who wasconsulted by AHEC, argues that the pri-mate option is outdated. He believes thatAustralia should be spending money onethical ways of experimenting with ES cellsin culture. “My personal view is that thedays when primates should be sacrificedfor biomedical research are probably forthe most part over,” says Williamson.

Australian National University’s JohnHearn, former director of the Wisconsinprimate center, estimates that $AUS 5 mil-lion ($US 3 million) in capital and anannual maintenance budget of $AUS 3 mil-lion would be needed to improve on thehandful of breeding colonies of mar-mosets, macaques and baboons scatteredacross the country. But others are dividedon the desirability of such spending, andsay the cost of a new center has beenunderestimated. “Some scientists were

concerned it may deplete NHMRCresources, just as the Wills report has calledfor a doubling of the budget[Nature Med., 5, 9; 1999], andone of them called it `irre-sponsible’ to make such asuggestion,” conceded AHECchairman and lawyer DonChalmers. Even some of Aus-tralia’s most senior IVFresearchers—a group that hassupported primate researchfor many years—think it would be morecost-effective to fund grants to enable Aus-tralian scientists to travel to establishedcenters such as those in neighboring south-east Asia. This suggestion is included in thereport as an alternative strategy to enhanc-ing primate research.

Under its terms of reference, AHEC wasunable to make the primate center a formalrecommendation. “We didn’t feel it was ourrole to be recommending research infra-

structure like that, andthe proposal would haveto come forward as anapplication to theNHMRC research com-mittee,” explains Univer-sity of Queensland’s JohnMattick, who is on bothcommittees. “Further-more, a decision on its

merits should be based, not on the cloningdebate, but on whether or not it was a use-ful piece of infrastructure to have scientif-ically or medically,” he adds. A copy of thereport is available at http://www.health.gov.au/nhmrc/ ethics/clone.pdf

RADA ROUSE, BRISBANE

Australian report favors more monkey business

Destined for the lab.

Henney calls for more science at FDANewly appointed commissioner of the Food and Drug Administration(FDA), Jane Henney (Nature Med., 4, 262; 1998), has announced that“the discipline of science and a scientific approach must ground ourdecision-making,” and has called for a strengthening of the agency’sscience base. Quite how this will be achieved is not certain. The moveis likely in response to recent criticism suggesting that the agency hasa poor research base.

Lobbyists representing industry and patients have criticized the delayand expense of the drug approval process, whereas, consumer watchdog groups claimthat the FDA has allowed regulatory decisions to be driven by politics rather than pub-lic safety. Each year, the FDA is forced to retract its approval of some drugs and removethem from the market, or add warning labels to them.

Michael Friedman, Deputy Commissioner for Operations at the FDA, is naturally defen-sive: “[because] we never have all the information that we need to make a perfect deci-sion, the agency must make the very best use of the data as it exists at that moment.”Echoing Henney’s position, he adds, “having the best scientists engaged leads to mak-ing the best decisions.” Henney, the first woman to head the FDA and the first cancer spe-cialist, was previously the vice president of the University of New Mexico Health Sci-ence Center.

Until now, scientists have not been evenly distributed among the FDA divisions. TheBiologics division, for example, maintains a fully-fledged research facility on the campusof the National Institutes of Health, but no similar facility exists for the Drugs division.Henry Miller, a Fellow at Stanford University’s Hoover Institution and the former head of theFDA’s Biotechnology division, argues that Henney’s push for more science at the agencytherefore creates a dilemma: “If you think that research is an absolutely essential compo-nent of regulatory review and expertise, then it needs to be there for the people in Drugs.If it isn’t necessary, then Biologics is maintaining a hugely expensive research enterprise thatisn’t needed.”

Friedman concedes that the FDA, whose drug approval workload is increasing at a rateof 12 percent per year, has been unable to support as much science as it should. “FDA isthe spigot through which this vast amount of new research is being applied, and the agencyhas been under tremendous pressures to discharge all of its responsibilities within a fixedbudget ... one of the painful consequences has been insufficient investment in and atten-tion to the scientific base of the agency,” Friedman told Nature Medicine. A recent inter-nal review concluded that the agency, which has an FY99 budget of approximately $1.1billion, only completes 50–70 percent of its legally mandated duties on schedule, a fact thatFriedman says reflects the shortage of resources.

ALAN DOVE, NEW YORK

Jane Henney

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

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