news NASA review leaves projects on launch pad Washington Mission rules required that only one All US spacecraft missions scheduled for tracking station be guaranteed operational launch this year are undergoing a sweeping for launch. But the space agency decided it SPACE NEWS SPACE review following a spate of high-profile fail- wanted two as a precaution. Although there ures that culminated in the loss of two Mars had been no sign of trouble with the space- spacecraft last autumn. craft, it was returned to the east coast for test- Under the reviews, which have been ing, and the launch has slipped to May. ordered by Dan Goldin, administrator of the NASA has delayed other launches for rel- US space agency NASA, teams of NASA- atively minor reasons. IMAGE, which will appointed engineers are scrutinizing each study the Earth’s magnetosphere, is man- project. Two launches have already been aged by the Southwest Research Institute as postponed, and others may be delayed. the agency’s first Midsize Explorer mission. After investigations into the Mars acci- It was to have been launched on 15 February. dents had revealed a series of embarrassing But after review teams questioned certain mistakes and management lapses, Goldin technical aspects of the project, the launch directed the heads of his agency’s field cen- slipped to early March. tres last month to take extra measures to James Burch, the IMAGE principal inves- ensure that missions in the pipeline don’t tigator at Southwest, expects his spacecraft have similar problems. will ultimately be passed as fit. But he points The Jet Propulsion Laboratory in Califor- Delayed exposure: IMAGE is having to wait to out that NASA had long ago accepted the nia had already initiated a review of its Mars study Earth’s response to solar magnetic activity. inherent risk of fast, cheap missions. “If programme, while the Goddard Space Flight somebody’s going to say we don’t want to Center in Maryland responded by ordering spacecraft missions, which were a major fac- take the risk of not having significant redun- independent ‘Red Team’ reviews of each pro- tor in driving up costs. NASA reviews were to dancy in the system, then that puts all these ject under its purview. be kept to a minimum. The low-cost mis- spacecraft in the museum,” he says. At least a dozen Earth and space science sions were also understood to assume a cer- Although Burch, Harvey and other pro- missions scheduled for launch in 2000 will tain risk of failure by not taking the time and ject heads say they understand Goldin’s con- undergo the review. These include IMAGE, money to build in redundant systems. cern, they question how much review is Earth Observing-1, Cluster 2, the High Ener- Some scientists facing Red Team reviews enough, and whether the Red Team exercises gy Solar Spectroscopic Imager (HESSI), worry that NASA might change its rules in are productive. TIMED, the Microwave Anisotropy Probe mid-stream following the recent mission When a spacecraft loses its place in the and Aqua, the second satellite in the Earth failures. The Massachusetts Institute of queue, it can take months to get back to the Observing System. Technology’s $20 million HETE-2 satellite, launch pad. Burch estimates that keeping Mission scientists — many of whom are for example, was to have been launched in IMAGE on the ground past its scheduled at universities rather than NASA centres — late January from Kwajalein Atoll in the launch date costs around $60,000 a day. But, have mixed reactions to the NASA edict. Pacific Ocean. It had already been mated to he says, “if NASA is going to pay to slip things Most say the additional checks can in princi- its Pegasus rocket and was preparing to ship to make themselves satisfied that the risk is ple help root out problems. But many worry out from California when NASA called off low enough to go ahead, then that’s their pre- that adding a major review so close to launch the countdown (see Nature 403, 232; 2000). rogative”. Tony Reichhardt only disrupts projects with very tight sched- ules and cost margins. HESSI, for example, is due to launch in July to observe solar flares at high-energy wavelengths. Run by the University of Cali- Congress gets tough with gene therapy fornia at Berkeley, the $72 million Small Explorer mission is a shoestring operation by Washington legislation, authority for monitoring NASA standards, and has taken just two Legislation to tighten up the supervision of federally funded human clinical trials would years to build. federally funded human gene-therapy trials be transferred from the Office for Protection Peter Harvey, the HESSI project manager was introduced into the US House of from Research Risk, under the US at Berkeley, estimates that the project has Representatives last week. The move Department of Health and Human Services, already undergone 20 reviews. “To now have occurred on the day a Senate subcommittee to an independent agency. yet another review is killing us,” he says, not hearing examined the problems of Arthur Caplan, director of the University because of the one or two days taken up by monitoring such trials. of Pennsylvania’s Center for Bioethics, the Goddard team’s visit, but because of the The hearing was triggered by the case of argued that the rise in clinical-trial holds two previous weeks his staff will need to pre- Jesse Gelsinger, the Arizona man who died issued by the US Food and Drug pare for the review. four days after receiving experimental gene Administration (FDA) indicates a general Just when project engineers should be therapy at the University of Pennsylvania problem. The FDA issued few clinical holds focused on the launch, he says, they will be (see Nature 401, 517; 1999). But the in the eight years before 1999, but last year presenting graphs instead. “Our attention is subcommittee explored other issues stopped at least five trials not involving gene turned away from the spacecraft.” concerning clinical research in humans. therapy. A key assumption behind the ‘better, According to a spokeswoman, the At last week’s hearing, William Frist faster, cheaper’ approach adopted by NASA proposed legislation, introduced by Dennis (Republican, Tennessee) said that systems to is that it dispenses with much of the red tape Kucinich© 2000 (Democrat, Macmillan Ohio), Magazines had Ltdbeen protect human subjects enrolled in clinical and bureaucratic requirements of past drafted before Gelsinger’s death. Under the trials “are not working”, and he was not ▲ news

▲ certain that new regulatory bodies would solve the problem. The Gelsinger case revealed a failure Scientists reject blame for to report adverse events in gene-therapy trials. After his death, the National German genome shortfall Institutes of Health (NIH) asked researchers using adenoviral vectors — Munich the delivery vehicle used in Gelsinger’s German scientists have rejected claims that trial — to report all adverse events. lack of government funding for genome Eventually, 652 became public (see research is their own fault, for failing to con- Nature 403, 237; 2000), including several vince politicians of its importance. deaths not directly attributed to gene Although funding for the German therapy. Last week’s hearing revealed 40 Human Genome Project (DHGP) is expect- more adverse events, related to vectors ed to increase substantially next year, it will other than adenovirus. still fall well short of what many believe the Researchers are required to report country needs to compete internationally. “serious and unexpected” adverse events Walter Döllinger, a senior official in the only to the FDA, although they must research ministry, told a DHGP workshop disclose all adverse effects to the NIH’s last month that the scientific community and Recombinant DNA Advisory Committee industry must share the blame for waning (RAC). political support. Their lobbying activities Former RAC chair LeRoy Walters, have been ineffective, he said, and they have director of the Kennedy Institute of not put significant amounts of their own Ethics at Georgetown University, money into genomics research. rejects Döllinger’s claim that scientists have testified that NIH’s 1996 reduction of the Döllinger said the research ministry is try- failed to shift funds from old areas of RAC’s powers had sent a “mixed ing to maintain political momentum, which research. The Helmholtz Society has created message” to researchers, possibly has slowed as government priorities changed. a small strategy fund in genomics and intends indicating that they were no longer The ministry has drawn up a broad strategy to redistribute its own core funding in favour required to report to the RAC. paper for genome research that “covers the of genomics, he says. Its genome-related Walters also said that problems in whole chain of innovation, from basic re- research will be evaluated next month by an securing a patient’s informed consent search to development”. He expects it to be international committee. The Helmholtz revealed “a system-wide problem not approved during the 2001 budget talks in June. Society’s senate will use the results in its deci- unique to gene This extends an earlier paper, based on sion on genomics strategies in May. therapy”. Paul input from the scientific community, that “The research ministry is very well aware Gelsinger, the was to have been launched last year. To the of our activities,” says Ganten. “It should not patient’s father, dismay of researchers, the paper was shelved, make up excuses to justify its own inactivity. testified that apparently because research minister Edel- It is naive to say that shifting our money researchers had not gard Bulmahn felt that it lacked a sufficiently would be sufficient; we need a lot of extra told his son that strong political message to persuade the cabi- money.” two monkeys had net to provide the level of extra funding it The Helmholtz Society was a co-signatory died on the demanded (see Nature 402, 706; 1999). of a report to the ministry which argued for a Frist: safeguards experimental The present paper brings together all the tenfold increase in public funding. Other sig- “are not working”. treatment. ministry’s activities in genome research, natories included major research organiza- The researchers including its new DM100 million (US$50 tions, such as the DFG, and the Förderverein, had also incorrectly told Gelsinger that a million) BioChance programme for start-up a consortium of German companies that previous subject had benefited from the companies, along with the activities of support technology transfer from the DHGP. gene therapy. The two problems were research organizations such as the Deutsche DFG president Ernst-Ludwig Winnacker among 18 used by the FDA to to justify Forschungsgemeinschaft (DFG), Germany’s says he is “surprised” that Döllinger consid- shutting down five other gene-therapy main granting agency, and the Helmholtz ers scientists’ lobbying activities inadequate. trials at the University of Pennsylvania Society, which runs national research centres. He points out that the heads of all German (see Nature 403, 354; 2000). It proposes a “significant increase” — research organizations have written detailed More inspections may prevent future possibly more than 50 per cent, Döllinger reports and campaigning letters to the min- problems, said Michael Blaese, chief indicated — in project money for the DHGP, istry, and have launched an initiative to lobby scientific officer of Kimeragen, a currently around DM50 million a year. The parliamentarians. Pennsylvania-based biotechnology paper also proposes setting up a genomics “We have taken all opportunities to air the company. Blaese, previously a gene- programme for microorganisms and a fund debate in newspapers and the most impor- therapy researcher at the NIH, noted for ‘competence centres’ to reward inter- tant political circles,” says Winnacker. “Short that trials on the NIH campus were disciplinary programmes linking research of hiring a Zeppelin and flying it over Berlin, audited frequently. groups from different institutions. I’m not sure what more is expected of us.” Jay Siegel, director of the FDA’s Office The new package would be more politi- Werner Schiebler, director of technology of Therapeutics Research and Review, cally convincing than its predecessor, said licensing and alliances at Aventis, says: testified that the agency typically Döllinger. But researchers say that its scientif- “Industry recognizes its responsibility for conducts on-site investigations as a drug ic aspirations will not be met unless the supporting technology transfer and this is or treatment nears approval. He said that government supplies a lot more money. why we support the Förderverein by around the agency has begun to do spot checks at Detlev Ganten, director of the Max DM1.5 million a year.” But he adds that a “very limited” number of clinical sites. Delbrück© 2 000Centre Macmillan for Molecular Magazines Medicine Ltd in industry will only pay for basic research with “We would like to do more.” Paul Smaglik Berlin and head of the Helmholtz Society, clearly defined goals. Alison Abbott