Erika Check,WashingtonHow do you resurrect a therapy stalled by acrippling combination of regulatory,financial and scientific hurdles? At ameeting in Arlington, Virginia, last week,gene therapists spelled out the problems inunflinching detail, but concluded that genetherapy can be revived — if its practitionersare willing to make changes.

“This course of events has beenexperienced by other new therapeutics,” saidKatherine High, president of the AmericanSociety of Gene Therapy, which convened themeeting on 7–8 April. She cited the exampleof monoclonal antibodies, which wentthrough a cycle of hype, disappointment andeventual medical and commercial success.

Concerns about safety have made patients

reluctant to participate in clinical trials, andregulatory requirements have made trialsexpensive. The National Institutes of Health(NIH) does not have the resources to fundmany clinical trials, and big pharmaceuticalcompanies are not interested in diseases thatafflict relatively few patients.

So how can gene therapy continue?Suggestions from the meeting includedmodifying the molecules used to deliver thegenes, developing better animal models, andperforming more rigorous safety evaluationsbefore beginning trials in people.

But Daniel Salomon, a transplant surgeonat The Scripps Research Institute in La Jolla,California, who headed up the US Food andDrug Administration’s advisory panel ongene therapy until 2003, thinks the field

needs a more profound change of approach.He argues that trials ran into safety

problems because gene therapists did nottake the body’s immune response seriouslyenough.“Everything you do that damageshealthy tissue, you’re going to pay a price for.”

Others agree. “Some of us do molecularbiology because we don’t have to learnimmunology,” says Savio Woo, a genetherapist at the Mount Sinai School ofMedicine in New York.

Salomon is hopeful nevertheless. Genetherapists must understand and plan for theimmune system’s response to experimentaltreatments, he advises. This could entailusing immunosuppressive drugs. “Genetherapy is going to happen,” he says. “A doseof reality is all I’m talking about.” ■

David Cyranoski and Rachael Williams,TokyoEpidemiologists are meeting this week to dis-cuss whether they can pull off the biggesthealth survey ever attempted. The mammothproject would track the genes, lifestyles andhealth of more than a million people acrossAsia, giving researchers unprecedentedpower to pin down subtle causes of disease.

The aim is to understand how environ-mental factors such as diet, smoking andexercise affect disease development, and howthis risk varies with genetic make-up. TheAsian study,dreamed up by John Potter of theFred Hutchinson Cancer Research Center inSeattle, Washington, is intended to spanMalaysia, India, Korea, Japan, China, Taiwanand Singapore. It would dwarf most nationalefforts, which generally include fewer than

100,000 people.And it would be twice as large,and cover a much wider range of lifestyles,than the European Prospective Investigationinto Cancer and Nutrition (EPIC), the largeststudy of diet and health so far.

Potter plans to focus on people over 50and follow them for as long as possible. Aswell as asking questions about lifestyle, thestudy would collect regular blood samples to monitor how biological markers such asproteins and RNAs change in the early stagesof disease.

Some forty epidemiologists and otherresearchers from Asia and elsewhere aremeeting in Seattle this week to discuss theproject amid great enthusiasm. “A large sample with varied dietary habits offersmajor advantages,”says Nadia Slimani of the

International Agency for Research on Cancerin Lyon, France, a nutritionist who hasworked on EPIC. Single-country studies canmiss connections, she says. One wide-rang-ing European study found a clear linkbetween fibre intake and colon cancer,whereas a similar study based in the UnitedStates picked up nothing.

Such a large study would also have the statistical power to show up causes of rareand less-studied diseases such as brain orkidney cancer, says Shoichiro Tsugane of theNational Cancer Center in Tokyo, Japan. “Itwould be very powerful,”he says.

And it could turn up uniquely Asianinsights into disease.For example,known riskfactors for breast cancer, such as few childrenand obesity, do not hold for the oestrogenreceptor-negative class of breast tumours,which are particularly common in Asia. “Noone knows what causes these,”says Potter.

Pulling off such a huge collaborationwon’t be easy. Tricky issues include privacyand data distribution, as well as how to com-pare data from different regions. EPIC gotround that last problem by giving standardquestionnaires to a small proportion of eachstudy population to calibrate the results.

Working across such diverse cultures willpose special challenges. What foods shouldgo on the questionnaire is just one. Kee SingChia, a medical epidemiologist at theNational University of Singapore, spent fouryears working out nutrition tables for just200 dishes for a health survey of Singapore’sChinese population. Extending that to Sin-gapore’s Malay and Indian cuisines and thento others across the region will be a “horren-dous task”, he says. “Instead of being aresearcher, I could open a restaurant.” ■

news

812 NATURE | VOL 434 | 14 APRIL 2005 | www.nature.com/nature

Health study sets sights on a million people

Gene therapists urged to learn more immunology

Recruits wanted: the diet and health of a million people across Asia could go under the microscope.

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