The drugmaker, which sells the Iressa lung cancer treatment, donated between $7,500 and $190,000 to four members of a 10-person task force that developed new usage guidelines at the behest of the Ministry of Health, Labor and Welfare, The Mainichi Daily News reports.

The recipients are members of the Japan Lung Cancer Society, which has refused to disclose to the ministry the financial relationship between the doctors and the drugmaker. In response to the large number of deaths linked to Iressa, the ministry decided in December 2002 to hospitalize patients who had been administered the drug.

In January 2005, the ministry created a study team to reevaluate Iressa’s safety, and the team commissioned the Japan Lung Cancer Society to draw up new usage guidelines, according to the paper. Thestudy team later supported the validity of the new guidelines that were compiled in March 2005 and authorized the continued use of Iressa on condition that the guidelines were observed.

Three of the 10 doctors who were involved in making the guidelines admitted to receiving donations from AstraZeneca when they appeared in court as witnesses for the defense in a lawsuit in which the bereaved families of patients who died from the side effects of Iressa demanded the government and AstraZeneca pay compensation, the paper writes.

A former professor admitted in court to having received about $167,000 yen from AstraZeneca as a reward and a scholarship. By breakdown, he received approximately $34,000 as a personal reward; about $57,000 as a scholarship for research at a university course he was in charge of; and some $76,000 for funded research on Iressa at the university. The former professor told the court, “There was no personal inquiry from the academic society,” he told the court (see here).

The Japan Lung Cancer Society has ignored an open letter filed by an independent industry watchdog, Yakugai Ombudsperson Medwatcher Japan, which questioned the relationship of the doctors involved in the guideline making and the drugmaker.

During a session of the House of Representatives Budget Committee in February this year, Health Minister Yoichi Masuzoe pledged to investigate the situation and make public whatever was discovered.

However, the Japan Lung Cancer Society has not replied to a written inquiry filed by the ministry. The ministry’s Pharmaceutical and Food Safety Bureau said it will continue to ask the academic society to respond to the inquiry.

Former Tokyo Medical University professor Harubumi Kato, who serves as head of the Japan Lung Cancer Society and also worked on developing the guidelines says the society will not investigate the case. “We will make guidelines on funds provided by companies, but we will only disclose information on funds that are provided after the guidelines are implemented,” he tells the paper.

In the World Medical Association Declaration of Helsinki, it is stated that researchers need to declare whether they have conflicts of interests with certain companies when they announce their study results.

“The guidelines for the use of Iressa relate strongly to the general public, and the academic society has an obligation to sincerely answer the questions posed by outside parties,” Yasutsuna Sasaki of Saitama Medical University tells the paper.