WTO reaches pact on generic drug imports

Ending nearly two years of heated negotiations, the World Trade Organization in September agreed to permit poor countries facing health emergencies to bypass patent laws and import cheap generic drugs.

Under the new accord, countries can buy generic drugs from overseas manufacturers only if the countries prove they are unable to produce the drugs. To export generics to other countries, companies must acquire compulsory government licenses by making the generic brand look different from the patented drug, producing only the amount requested by an importing country, and publicly disclosing details of the deal.

The pact assures pharmaceutical companies that their patent rights will be protected, and adds to earlier stipulations that every member country—except the US—approved last December. It also calls for steps such as labeling drugs to ensure that sold medicines do not get smuggled back into rich countries.

The European Commission and the US commended the new pact. But health advocates, including Médecins Sans Frontières and Oxfam, denounced the agreement, saying it unfairly burdens developing countries with legal and bureaucratic paperwork, blocking swift access to drugs. PB

FBI expands charges against plague researcher

Experts are denouncing the federal prosecution of a leading plague researcher, saying the case could deter scientists from entering biodefense research.

The US Federal Bureau of Investigation (FBI) in January indicted Thomas Butler, chief of the infectious disease division at Texas Tech University, for illegally carrying plague bacteria from Tanzania to the US (Nat. Med. 9, 247; 2003). Prosecutors in September expanded the allegations to include charges of mail fraud, tax evasion and embezzlement.

Butler pleaded not guilty to the 69-count indictment. His trial is scheduled for November.

Prominent researchers have criticized the US Justice Department's aggressive stance toward both Butler and Steven Hatfill, whom US attorney general John Ashcroft called a “person of interest” in relation to the 2001 US anthrax mailings. PB

SARS returns to Singapore

In what could be the first case of severe acute respiratory syndrome (SARS) since the epidemic subsided in June, Singapore health authorities confirmed in September that a 27-year-old Singaporean researcher tested positive for the disease. At press time, the patient appeared to be recovering quickly, but Singapore's health ministry nonetheless quarantined 25 people. SARS killed over 800 people in 30 countries between November 2002 and May 2003.

The new case coincides with warnings by health experts that SARS is likely to resurface in coming months, when seasonal outbreaks of respiratory illnesses are common. The US National Intelligence Council released similar statements in a report that outlines three potential SARS-related scenarios: SARS could either afflict developing countries with weak public health systems, spread to major trade centers through international tourists or appear only sporadically without erupting into an epidemic.

Déjà vu: Patients wait to be screened for SARS at a hospital in Singapore. Credit: Reuters

Meanwhile, the global health community is still trying to answer questions about the SARS virus, including how best to detect it and where it stems from. Canadian laboratories recently clashed on the identity of a virus that in August killed eight residents of a nursing home. Initially identified as a mutated SARS coronavirus, the culprit was later shown to be a related virus from the same family. Chinese researchers also found a SARS-like virus in at least three animal species in a southern Chinese market. The findings prove that SARS jumped from animals to humans, but researchers remain unsure of the virus' true reservoir. PB

Ecstasy study retracted

Scientists at Johns Hopkins University have admitted that an error led to their finding last year that a single dose of 3,4-methylenedioxymethamphetamine (MDMA)—the recreational drug Ecstasy—can trigger the onset of Parkinson disease. The researchers in September published a retraction in Science (Science 301, 1479; 2003), where they had originally reported the work.

The researchers mistakenly injected monkeys and baboons with the more potent chemical methamphetamine—and not MDMA—because of a labeling mix-up. Two of the ten study primates died, and within six weeks, levels of the neurotransmitter dopamine fell by 65% in the remaining animals. Because Parkinson disease is associated with lower levels of dopamine, the Johns Hopkins team surmised that MDMA—by quelling dopamine levels—could cause the disorder.

Investigations are under way to detect the source of the labeling blunder. The results of the inquiry could have implications for all researchers who acquired MDMA from the same source as did the Johns Hopkins scientists.

The Science retraction comes in the midst of a five-year debate on whether MDMA causes long-term brain damage. PB

New stem cell lines created

Three research teams—based in the UK, the Czech Republic and China—each announced in August that it had created human embryonic stem cell lines. About a dozen human embryonic stem cell lines exist worldwide and a dozen more are in the making.

The UK and Czech cell lines are the first to emerge from either country; in both cases researchers generated the stem cells using embryos left over after in vitro fertilization treatments. The Czech researchers, who created three lines, are studying their cells' capacity to differentiate into neurons and other cells.

The UK researchers used embryos that may have had genetic flaws—a feature that may help understand disease pathways. The cells will be the first addition to Europe's UK-based stem cell bank, launched last year.

The Chinese work marks the first time researchers have derived embryonic stem cells from a cross-species hybrid embryo (Cell Res. 13, 251–263; 2003) Fusing human skin cells with rabbit eggs, the scientists grew more than 100 hybrids for several days before destroying them to procure stem cells. The cells did not, however, show evidence of growing indefinitely, so experts are unsure of their therapeutic value. Ethics groups are divided on the work. PB

News briefs written by Paroma Basu