G8 nations endorse HIV vaccine initiative

HIV vaccine research has received a welcome boost as the Group of Eight (G8) industrialized nations endorsed a US proposal for a global vaccine enterprise at their summit meeting in Georgia.

Many new HIV vaccine candidates are being developed worldwide, but scientists have said that identifying and developing the most successful of these would be impossible without a common framework for conducting, evaluating and comparing clinical trials (Science 300, 2036–2039; 2003).

The initiative—a proposed collaborative effort between vaccine agencies and research groups around the world—aims to provide a unified strategic plan, together with the infrastructure to share data and identify and prioritize the most promising candidates. It was conceived by a panel of AIDS experts and by Richard Klausner of the Bill and Melinda Gates Foundation.

The G8 nations' endorsement is a kick-start to channeling global resources towards the initiative's goals. The US government has pledged $15 million toward the initiative for 2005, and some other countries are expected to follow suit.—CT

WHO endorses diet plan

After two years of debate, member states of the World Health Organization in May endorsed a Global Strategy on Diet, Physical Activity and Health. The document identifies sugar, salt and fats as major contributors to the obesity epidemic and outlines policy strategies to promote a healthier lifestyle. International agreement on the initiative had been stalled by the US government and by sugar manufacturers, who questioned its scientific basis. Experts have criticized the US for downplaying the industry's responsibility in achieving a healthy diet (Nature 428, 244; 2004)

Meanwhile, Rockefeller University scientists have embarked on a large-scale search for obesity-associated genes in an isolated population on the Micronesian island of Kosrae (Nat Med 10, 327; 2004). In collaboration with California-based Affymetrix, Inc., the researchers plan to analyze the genes of more than 3,200 adults in Kosrae, where diabetes and obesity are rampant.—AK

Comprehensive US clinical trial registry proposed

The American Medical Association is recommending that the US Department of Health and Human Services create a publicly accessible registry for all US clinical trials. Although registration in the database would not be legally required, industry compliance could be ensured if institutional review boards, which must approve human trials, require registration for approval, the organization suggests. The world's 12 top medical journals are also considering requiring registration as a prerequisite for publication.

Pharmaceutical companies report clinical trial results to the US Food and Drug Administration. But generally, only favorable results get published in journals, and the FDA does not disclose unpublished findings. Critics charge that selectively publishing positive results makes it difficult for physicians and researchers to judge safety and efficacy. The issue has now become a legal matter, with some governments contending that withholding negative information constitutes fraud (see News, page 655).

Several registries in the US—most notably www.clinicaltrials.gov—list clinical trials, but none are all-inclusive. In the European Union, the recently instituted clinical trials directive mandates the creation of a comprehensive clinical trials database (Nat. Med. 10, 555; 2004), but experts have criticized the decision to restrict access to regulatory authorities only.—AK

Europe set to tackle environmental health

The European Commission has placed research at the center of a six-year action plan to quell health problems related to environmental pollution.

Adopted on 9 June, the project will initially target the role of environmental factors in respiratory conditions, neurodevelopmental disorders, cancers and endocrine effects. The focus will later shift to evaluating policy decisions drawn from research. The plan also aims to develop a coordinated approach to monitoring environmental hazards and instituting appropriate policy responses such as consumer awareness programs and training for health workers.

The European Chemical Council has supported the plan as a good basis for tackling environmentally triggered health issues from a scientific standpoint. However, the European Parliament's Green Group has criticized the heavy research focus, saying it stalls necessary action.

The action plan constitutes the commission's chief contribution to the fourth ministerial conference on health and the environment, which this year will address issues in children's health. The World Health Organization, which sponsored the conference, estimates that one-sixth of the total burden of disease and death in children is due to environmental factors.—AK

Autism-vaccine link debunked—again

Credit: Alex Garcia/Chicago Tribune

In its eighth and final pronouncement, an expert committee of the Institute of Medicine has concluded that neither the mercury-based preservative thimerosal nor the combined measles, mumps, rubella (MMR) vaccine causes autism. The committee's findings settle the issue for most scientists, but some critics are calling for more research, saying the report is based on flawed data.

The panel of 13 experts was convened in 2001 in response to safety concerns from a study linking the onset of cognitive problems with MMR vaccination (Lancet 351, 637; 1998). After reviewing the published literature, the committee found no solid evidence of an MMR vaccine–autism link. But based on data available at that time, the panel concluded that thimerosal, routinely used in vaccines until 2000, could not be excluded as a cause.

The latest report, released on 18 May, examines subsequent epidemiological evidence and confirms that there is no causal relationship between thimerosal and autism. It recommends that future research efforts should focus on areas that “offer more promise for finding an answer.” Meanwhile, The Lancet has distanced itself from the 1998 study's findings after learning of the lead author's undeclared conflicts of interest (Nat. Med. 10, 321; 2004). Still, some researchers, members of the US Congress, and advocacy groups say the report is biased.—AK

Written by Alla Katsnelson and Clare Thomas