NIH to reveal financial stakes in trials

The US National Institutes of Health (NIH) implemented a policy to disclose researchers' financial stakes in clinical trials. Before it was enacted, many patients participated in such studies without knowing that the scientists involved had a financial interest.

Researchers who invent treatments or technologies while working at the NIH receive a percentage of the royalties they generate. The agency also receives a portion, which is reinvested into medical research.

Until now, the only way patients could find out about these monetary ties were from patent documents or disclosures in scientific journals. This practice drew criticism from consumer groups, who say that patients cannot make an informed decision about the risks of participation in a clinical trial without the information.

Under the new rule, scientists will have to report their financial interests on patient consent forms. The US Department of Health and Human Services pledged it would require such financial disclosure in 2000, but the new policy was not enacted until January 2005.

Developing nations create their own 'Nobels'

Scientists in developing countries have adopted their own version of the Nobel Prizes. The Academy of Sciences for the Developing World, in collaboration with an Italian coffee company, Illycafe, in December launched the $50,000 Trieste Science Prize.

The prize, named for the Italian city that has played a key role in promoting science and technology in the developing world, will be awarded in a different scientific field each year. The first two prizes, to be given in 2005, will focus on biology and physics. Subsequent prizes will be awarded in mathematics and medical sciences (2006), chemical and agricultural sciences (2007), and earth and engineering sciences (2008).

Organizers say the prize is designed to highlight the enormous contributions that developing-world scientists are making to international science. These researchers have been poorly represented in existing major scientific awards. Candidates must be nationals of developing countries and have conducted their research at institutions in developing countries. Rules and forms for nominations can be found on the academy website.

South Korea sets rules for stem cell research

South Korea in December announced new rules that would allow its scientists to clone human stem cells and develop treatments for 18 specific disorders, including diabetes and Alzheimer disease. The rules clarify a law passed in January 2004 that allows cloning for medical purposes only.

The new regulations permit fertility research, but ban commercial trade of eggs and sperm. Scientists can use leftover eggs from fertility clinics, after first obtaining consent from the donor couples. The rules also prohibit private companies from performing genetics tests on the general public. Several groups plan to file a petition against the new rules, saying the use of embryonic tissue for research purposes goes against the Constitution's respect for human life.

South Korea has emerged as a leader in stem cell research: in February 2004, Seoul National University researcher Woo Suk Hwang and his colleagues became the first in the world to clone a human embryo and harvest its stem cells (Science 303, 1669–1674; 2004).

In November 2004, Song Chang-hun of Chosun University announced that injecting stem cells from umbilical cord blood into the spinal cord of a paralyzed woman had restored her ability to walk. The results must be confirmed in other patients, but clinical trials of the technique are expected to begin soon.

Drug companies set to disclose trial results

The international pharmaceutical industry in January announced plans to make clinical trial results more publicly available. Under the voluntary agreement, set to begin on 1 July 2005, new trials must be registered within 21 days of their start.

Companies have one year after a drug is approved—or one year after trial completion for drugs already approved—to disclose clinical trial results. For reasons of confidentiality, the plan does not cover phase 1 clinical trials.

Pharmaceutical associations worldwide backed the plan, but some skeptics say the voluntary registry is a preemptive move to prevent stricter government regulations on results from failed or negative trials. Greater transparency may have brought adverse effects of some drugs, such as those associated with antidepressants and Cox-2 inhibitors, to light much sooner, the critics say. A group of leading medical journal editors said last year that they would only publish results of registered clinical trials.

The British Medical Journal reported in January that it had sent documents suggesting a link between the antidepressant Prozac and suicidal behavior to the US Food and Drug Administration for review. The documents had reportedly been lost during a 1994 lawsuit. Prozac manufacturer Eli Lilly said that the documents were already available. The company has announced plans to release its own clinical trial registry.

Tsunami disease threat averted

Credit: Reuters/Yves Herman

Despite fears that infectious disease outbreaks could double the death toll associated with the 26 December tsunami that ravaged parts of Asia and Africa, only sporadic cases have been reported. The news is a great relief to health officials, who worried that lack of basic needs such as fresh drinking water could spell serious disaster.

According to the World Health Organization (WHO), there has been a slight increase in the incidence of diarrhea, tetanus and respiratory infections, but nothing that suggests an impending epidemic. Officials attribute the relative lack of disease to speedy relief efforts and the destruction primarily of coasts, which left inland hospitals intact.

However, experts warn that it is too early to say that damaged regions are out of danger. One area of particular concern is the Aceh province on the Indonesian island of Sumatra, one of the areas hardest hit by the disaster. The tsunami's destruction reached further inland there than in other regions, hitting most of the area's hospitals and making it difficult to access some affected villages. The WHO says it is setting up a disease surveillance system in Aceh that would give early warning for disease outbreaks.

Two unconnected cases of measles were reported on Sumatra in early January. Representatives from UNICEF were already on the island to vaccinate children against the infectious disease, so they immediately immunized people living near the infected villages.

News briefs written by Emily Singer