Past Issues

Iressa (Gefitinib), an orally administered epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, was approved for marketing as a non-small cell lung cancer drug in July 2002 in Japan, for the first time in the world.

Prior to approval, AstraZeneca (AZ), the sales company of Iressa, advertised that the side effects of Iressa were less than other anticancer drugs.
But three months after the approval, the Ministry of Health and Labor (MHLW) of Japan announced an emergency warning report that 26 patients developed interstitial pneumonia, including 13 deaths.
The number of victims increased rapidly, 799 patients died by interstitial pneumonia as of Sep. 2009.
The special survey team reported that the frequency of interstitial pneumonia is 5.8% of those treated with Iressa, and the death rate was 2.5%.

Iressa was approved on the basis of an effect on a surrogate endpoint measured by tumor shrinkage, but it has failed to prove the overall survival benefit in as many as 4 superiority trials (INTACT-1 & -2, SWOG, ISEL), in addition to the non-inferiority trial (V15-32) that was required by the Japanese regulatory agency when marketing approval was given to the manufacturer.

Iressa raises serious concerns about the drug approval process and the way of advertisement developed under the guise of academic information.
And also, it poses a serious problem concerning the conflicts of interest. This is because a lot of members of The Japan Lung Cancer Society Guideline Committee on Gefitinib had a financial relationship with AstraZeneca (AZ).


Our activities are as follows:

2002-2003
Conducted a fact finding survey about patients who died after the use of Iressa

2002-12-24
Submission of an open question regarding application data to the MHLW and AZ

2003- 4- 4
Submission of a written request urging to withdraw Iressa to the MHLW and AZ

2003- 8- 1
Filed a lawsuit demanding disclosure of the information based on the FOIA

2003-11-23
Held a symposium entitled “What happened to the dream anti cancer drug Iressa”

2004-12-24
Issued an emergency statement urging withdrawal of Iressa, based on the failure of ISEL, a clinical trial of Iressa, to show an overall survival advantage.

2005- 2-22
Submission of a written request to MHLW board on Iressa

2005- 8- 9
Submission of an open question to Japan Lung Cancer Society to urge disclosure the conflict of interest of the members of Japan Lung Cancer Drug Society Guideline Committee on Gefitinib.

2006- 3-30
Submission of an open question again to Japan Lung Cancer Society urging disclosure of specifically the financial relationships between the members of The Japan Lung Cancer Drug Society Guideline Committee on Gefitinib and AZ.

2006- 3-31
Submission of a written request concerning the conflict of interest issue to MHLW, Science Council of Japan, The Japan Medical Association, and The Japanese Association of Medical Sciences

2006-11-28
Submission of a written request to the MHLW about the conflict of interest issue of the members of The Japan Lung Cancer Drug Society Guideline Committee on Gefitinib and AZ.

2007- 5-23
Submission of a written request urging withdrawal of Iressa, based on the failure of the non-inferiority trial (V15-32) that was required by the Japanese regulatory agency when marketing approval was given.

2008- 6- 8
Issued a joint statement urging to withdraw Iressa with humanitarian consideration given to patients who are currently under treatment with Iressa.

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