30% of cancer drugs used in USA barred in Japan
The university's Translational Research Center (TRC) recently conducted a study of the anticancer drugs listed in the latest 2003 edition of 'Current Medical Diagnosis and Treatment,' a manual widely used by doctors in the United States.
According to the study, 31 of the 101 anticancer drugs used in the United States have yet to be approved by the Health, Labor and Welfare Ministry. Of the 68 drugs commonly used in the United States to alleviate cancer-related pain and mental distress, 27 have not been approved in Japan.
The latest findings are expected to prompt the government to make rapid improvements to the ministry's inefficient clinical testing and drug approval processes.
The anticancer drugs yet to be approved in Japan include new medicines, such as oxaliplatin, which is used to treat colon cancer; thalidomide, which treats multiple myeloma plasma cell cancer; and the medicine gemtuzumab, a common treatment for leukemia. These have all been approved by the U.S. government as standard anticancer drugs.
'World-class medical treatment is not available here due to inertia in the medical system, which causes delays in the drug approval process and places cancer patients at a serious disadvantage,' said Kyoto University Prof. Masanori Fukushima, a researcher at TRC.
Of the anticancer drugs the government has approved, about 80 are not covered by insurance if administered 'off-label' for cancers other than those for which they originally were approved.
On Tuesday, a ministry study panel held an inaugural meeting to approve anticancer drugs for wider use. The ministry plans to expand the use of about 10 to 15 drugs a year to treat other types of cancer.
Off-label problem
Many doctors specializing in cancer treatment who participated in Tuesday's meeting on expanding the use of anticancer drugs complained about the fact that the medical system does not insure the off-label use of some government-approved anticancer drugs.
'Even though it's a common anticancer therapy overseas, the government rejects my requests for remuneration for (off-label) medical treatment,' said a doctor who participated in the meeting, where off-label anticancer treatments were a major agenda item.
The government approves anticancer drugs used for different types of cancer--for example, stomach cancer and breast cancer.
If medical researchers abroad confirm the effectiveness of approved drugs for cancers other than those for which they originally were intended, the drugs in question must be reapproved for use treating other types of cancer.
To expand the use of drugs, the government must conduct clinical tests that cost time and money. Therefore, the government in 1999 allowed the use of anticancer drugs to be expanded without clinical testing if their effectiveness in treating other types of cancer was confirmed.
However, the government so far has only received applications to approve four anticancer drugs for wider use.
'For pharmaceutical companies, it (expanding drug use) is even more of a burden to carry out their own post-marketing research on side effects and the effectiveness of their drugs,' a doctor said.
30% de cancer de medicamente utilizate în SUA prescris în Japonia - 30% of cancer drugs used in USA barred in Japan - articole medicale engleza - startsanatate