LONDONThe European Parliament decided last weekthat drugs authorized for use in childrenshould first be subjected to clinical trials inappropriate age groups.

Although researchers hope extra trialswill lead to a better understanding of howmedicines work in children, critics areconcerned that patent extensions intendedto sweeten the decision could delay theavailability of cheap drugs.

Many medications given to children inEurope are not licensed for the situations inwhich they are used. Doctors often take atrial-and-error approach, simply halvingthe adult dose, for example. But in somecases such drug use has caused side-effectsand even fatalities.

There are several reasons why drugcompanies are reluctant to test theirproducts in children. It is often necessary todevelop new equipment and techniques for

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Can we score the millennium goals?NEW YORKAs world leaders gather in New York this weekto discuss the future of the United Nations’Millennium Development Goals, critics arewarning that many of the targets cannot beevaluated scientifically. Unless the goals arepeer reviewed and amended to take account ofwhat can actually be measured, they say, theproject will fail.

Nearly 150 heads of state met in 2000 andpledged to fight problems ranging frompoverty to infectious disease in a historic doc-ument called the Millennium Declaration. Thiswas turned into a series of numerical targetswith a final deadline of 2015 that are known asthe Millennium Development Goals.

The ambitious and concrete-sounding aimscaptured imaginations and headlines world-wide, and have become symbolic of the globaldevelopment effort. They include halving thenumber of people that live on less than a dollara day and cutting deaths in children under fiveby two-thirds.

But analysts such as Amir Attaran of theUniversity of Ottowa, Canada, say that with-out drastic revision, the targets risk beingmeaningless. “We haven’t got the tools in placeto measure them,” he says.

The UN Statistics Division currently keepstabs on 48 ‘indicators’, which range fromschool enrolment numbers to malaria deathrates. These are provided by agencies such asthe World Health Organization (WHO) andthe World Bank, but Attaran argues that themethods used to gather data are scientificallyflawed. In the absence of birth and death reg-istries in most African countries, for example,many figures on death and illness are gatheredfrom household surveys. These often use con-flicting methods, and do not always acknowl-edge sources of error or apply statistical tests ofsignificance.

And although surveys may measure someindicators accurately — such as childhooddeaths, which parents will remember — othersare harder to estimate, such as cases of malariaor deaths in childbirth. For example, if awoman succumbs to fatal bleeding in hospitalafter giving birth at home, the link may not be recorded.

Attaran warns, in PLoS Medicine, that with-out accurate baseline figures and ongoing mea-surements it will be impossible to tell in 2015whether the millennium goals have achievedanything. He wants independent peer review-ers to assess individual targets and indicators to determine whether they can be measured

scientifically. If they cannot, he says, the goalsshould be amended or even abandoned.

Epidemiologists agree that the various indi-cators could be made more specific, and sayleaders should take the opportunity this weekto clarify them. “It needs to be talked aboutnow,” says Robert Kim-Farley of the Universityof California, Los Angeles, who used to gatherpublic-health data for the WHO.

“It is relevant to discuss whether we areinvesting enough in data-collection systems,”adds Stefano Bertozzi, director of health eco-nomics for the National Institute of PublicHealth in Cuernavaca, Mexico.

Some UN scientists have expressed con-cerns like Attaran’s. They tried to start a debatelast year about how to measure the goals moreaccurately. But the deputy secretary-general,

Louise Fréchette, deflected them in a messagesent to the expert committee in charge of goalstatistics. The New York summit “should notbe distracted by arguments over the measure-ment of the millennium development goals —or worse, over the different numbers beingused by different agencies for the same indica-tors”, she said.

John McArthur is deputy director of the UNMillennium Project — an independent bodybased in New York that advises the UnitedNations on the goals. He agrees that the prior-ity for this meeting is simply for nations toaffirm their support. He acknowledges thatsome of the targets are tough to track, butadds, “I don’t think that’s a reason not to makea concerted effort.” ■

Roxanne Khamsi

The United Nations has set targets for the relief of human suffering, but progress is hard to measure.

Europe backs trials on drugs for kids

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FIT BODY FOR FIT MINDAerobic exercise is the bestway to keep your memoryhealthy, says a review of ten years’ research.www.nature.com/news

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Scientists in Britain have been granted per-mission to perform controversial experimentsthat will create human embryos using geneticmaterial from three people. Teams carryingout similar research in the United States andChina have been forced to shut down theirexperiments, and say that they hope the UKdecision will help push the work forwardaround the world.

The UK Human Fertilisation and Embryol-ogy Authority (HFEA) said on 8 Septemberthat it will allow scientists at the University ofNewcastle upon Tyne to transfer the nucleus ofa fertilized egg into an egg donated by a secondwoman. The second egg’s own nucleus will beremoved before the transfer occurs, but it willstill contain genetic material in certain struc-tures outside the nucleus. These structures,called mitochondria, generate energy andcarry their own genes. So the Newcastle scien-tists will be creating embryos that containgenes from three people: the biologicalmother, the biological father and an unrelatedegg donor. That makes the experiments highlycontroversial.

The embryos that will be created in New-castle will not be transferred into women. Butadvocates of the technique say that if theexperiments work, they could eventually pre-vent mothers from passing on diseases causedby mitochondrial defects to their children.

Similar experiments were being done in theUnited States by James Grifo, a reproductiveendocrinologist at New York University Med-ical Center. But in the late 1990s the US Foodand Drug Administration (FDA) halted Grifo’sexperiments after he had created only a fewembryos, because it was worried that thehealth of the fetuses could not be guaranteed.Grifo’s postdoctoral fellow, John Zhang, con-

tinued the experiments in China, wherealtered embryos were transferred into twopatients before an international outcry shutthose experiments down too. Grifo, who hassince been pleading with the FDA to allow himto restart the experiments, told Nature that heis encouraged by the HFEA’s decision.

“I’m glad that at least one country in theworld is pioneering and smart enough to dothis, and hopefully it will help patients withmitochondrial diseases,” Grifo says.

He predicts that the British move willeventually spur action elsewhere, includingin the United States. “Once there’s some

semblance of success over there, they’ll say‘OK, now we can do it.’ Traditionally, that’show things go.”

More than 30 children have already beenborn thanks to a related technique that is usedto boost fertility. The method does not involvenuclear transfer — instead, scientists transfersome of the cytoplasm that surrounds a cell’snucleus from a donor egg to the fertilized egg.But that method has also been halted in theUnited States, leaving the Newcastleresearchers at the head of the field, for themoment at least. ■

Erika Check

UK embryo licence draws global attention

use on children. And there are sticky ethicalissues, such as deciding who gives informedconsent when parents are divorced, or whathappens when the parents say one thing andthe child another.

But the main obstacle, says SharonConroy, a paediatric pharmacologist at theUniversity of Nottingham,UK, is the timeand money it takes to do the extra tests.Especially as children are relatively healthy,so pharmaceutical companies do not standto gain much from investing in research ondrugs for them.

As an incentive to companies, the

European Parliament and the Council ofMinisters are supporting a six-monthextension on existing patents, similar tomeasures offered by the US Food and DrugAdministration since 1998.

The European Generic MedicinesAssociation supports the directive inprinciple, but says the extension may delaythe provision of affordable medications forthose in financial need.

Mark Schreiner, chairman of theCommittees for the Protection of HumanSubjects at the Children’s Hospital ofPhiladelphia, points out that the equivalent

regulation in the United States has been oftremendous benefit to research. “We’velearned how different children are fromadults,” he says. For example, Viagra is goodfor treating lung conditions in children. “We never would have discovered this ifdrug companies had not been required tocarry out rigorous tests with kids,” he says.

The parliament’s vote is a major steptowards enforcing the regulation legally.The proposal was first put forward lastSeptember and is expected to become lawwhen the parliament next meets, in 2006. ■

Jennifer Wild

Egged on:researchers inNewcastle willbe allowed tocreate anembryo thatcontains genesfrom threepeople.

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