Vioxx withdrawal fuels complaints against FDA

A US Food and Drug Administration (FDA) employee has charged that agency officials pressured him to water down a report on the lethal side effects of Merck's blockbuster arthritis drug, Vioxx.

On 30 September, Merck withdrew Vioxx from the market after a clinical trial conducted by the company showed the drug increases patients' risk of heart attack and stroke. At the time, the FDA was completing an unrelated review of the drug's safety based on the medical records of 1.4 million patients. Agency scientist David Graham, who led the review, reported at a conference in August that Vioxx triples the risk of heart attacks and warned against prescribing the drug at high doses.

In subsequent internal e-mails, FDA officials said that Graham's statement was too strong, particularly because the agency had not asked Merck to place a warning of cardiovascular side effects on the drug's label. One official also wrote that the agency should warn Merck of the results before they were made public. Graham ultimately—under duress, he says— revised the conclusions of the report's abstract. —AK

China's new Pasteur Institute to be Asia's largest

The Institut Pasteur of Shanghai, a collaborative effort of the Paris-based research institute and the Chinese Academy of Sciences, opened on 11 October to great fanfare and an appearance by French President Jacques Chirac.

The institute, set to be Asia's largest, will eventually house 25 research groups and 500 scientists and focus on infectious diseases, such as hepatitis C and HIV, that are taking a heavy toll in China. Institute director Vincent Deubel, a virologist and 26-year Pasteur veteran, will be the first foreigner to head a research laboratory in mainland China. Deubel says he is excited about the fast pace in Shanghai. “A lot of things are possible there,” he says.

Once a level-three biosafety laboratory is established at the institute, he says, he would like to add other common pathogens such as the hantavirus, with which he has much experience, to the institute's repertoire. Funding for the institute comes from the academy, the city of Shanghai and private companies in France and elsewhere. —DC

NIH set to ban outside consulting

The US National Institutes of Health (NIH) is set to adopt a year-long ban on paid consulting for drug companies by agency employees.

In June, a congressional panel charged that several researchers had failed to disclose illegal financial involvements with pharmaceutical companies (Nat. Med. 10, 765; 2004). Based on the internal investigation that followed, NIH officials concluded that a complete moratorium on outside consulting is necessary while the agency devises a stronger system of oversight and develops ethics training programs. NIH director Elias Zerhouni had previously argued against such extreme measures, but reversed his stance in September, noting that the agency's “vulnerabilities” need to be addressed.

The ban would apply to all 5,000 NIH scientists, many of whom have financial relationships with drug companies. Scientists have supported the need for stricter regulations to maintain the NIH's integrity. But some researchers caution that if the policy—which will take effect upon approval by the Office of Government Ethics—becomes permanent, it might drive top scientists to leave the agency for better-paid industry jobs. University officials have also voiced concern that the policy may affect academic researchers, many of whom receive NIH funding (Nature 431, 725; 2004). —AK

First baby born from ovarian transplant

A Belgian woman gave birth in September to the first baby born after an ovarian tissue transplant, boosting hopes for a breakthrough in infertility treatment.

Jacques Donnez and his team in Belgium harvested and froze five small strips of the woman's ovaries seven years ago, just before she underwent cancer treatment that left her infertile. When they grafted the tissue back into her body last year, she resumed ovulating and became pregnant.

Women diagnosed with cancer can have their eggs harvested and frozen before being treated, but the eggs often do not survive when thawed. Freezing embryos, though more reliable, is not possible for some patients, such as those too young to undergo the procedure or whose cancer is too aggressive to delay treatment. Fertility researchers say ovarian transplantation is a promising alternative.

In March 2004, scientists in New York transplanted ovarian tissue beneath the skin of a patient's abdomen. An egg produced in the graft was fertilized in vitro, but did not survive implantation (Nat. Med. 10, 764; 2004). Experts are optimistic after the birth of the healthy baby girl, Tamara, but some caution that the egg from which she developed may not have come from the transplant. Instead, they say, the egg could have survived in the woman's ovaries if they were not fully destroyed during cancer treatment. —AK

UN's largest anti-polio drive a success

Credit: WHO

The United Nations (UN) in October launched the largest ever polio immunization drive to vaccinate more than 80 million children in 23 African countries in 4 days. Health workers and volunteers traveled door to door in villages, carrying iceboxes with enough vaccine for all children under five years of age. The campaign reportedly reached 90% of target children and is set for another round in November.

According to the UN, all but two African countries—Nigeria and Niger—were free of the virus last year. But plans to eradicate polio by 2005 were stalled when officials in Kano, Nigeria, suspended immunizations in October 2003, charging that the vaccine was unsafe (Nat. Med. 10, 218; 2004). Although the region resumed the program in July 2004, 10 other African countries, including war-torn Sudan, became reinfected. The disease also remains endemic in India, Pakistan, Afghanistan and Egypt.

Nigeria remains the hotbed of the current epidemic, with 597 of the 786 polio cases worldwide this year. The country's president supported the vaccination effort by publicly administering the vaccine to children in Kano in a ceremony on 2 October. But safety fears resurfaced one week later in Benin, when some parents in that west African nation refused to vaccinate their children. —AK

Written by Alla Katsnelson and David Cyranoski